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Background The involvement of husbands and male partners in childbirth no longer ceases at conception and pregnancy, rather fathers wish to be more involved in supporting their partners during childbirth. This aligns with the World Health Organization's (WHO) call for promoting male participation in childbirth, emphasising the benefits of support and the positive impact attending childbirth has for husbands/partners, and their maternal partner. This knowledge has led to global initiatives promoting "humanised" birth and a family-approach. To gain in-depth insight and understanding of childbirth attendance from the perspectives of fathers, a qualitative evidence synthesis is proposed. Methods To explore fathers' experiences, views, and perspectives of childbirth attendance. All studies that used qualitative methodologies to explore the phenomenon of interest will be included. MEDLINE, CINAHL, PsycINFO, MIDIRS, Web of Science, and Google Scholar will be systematically searched from their dates of inception to present, supplemented by a search for grey literature and a search of the reference list of included studies. Peer Review of Electronic Search Strategies (PRESS) will be used to ensure the comprehensiveness of the search strategy. Methodological quality assessment of included studies, using The Critical Appraisal Skills Programme assessment tool, and will be extracted from the included studies by two reviewers independently using a standard data extraction form. Thomas and Harden’s three-stage approach will be used to thematically synthesise the data: coding of data, developing descriptive themes, and generation of analytical themes. The Grading of Recommendations Assessment, Development, and Evaluation-Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual confidence in the synthesised findings Comprehensive insight and understanding of fathers’ perspectives of childbirth attendance will be ascertained PROSPERO Registration No CRD42023470902

Objective Despite widespread use of azathioprine (AZA) during pregnancy, no studies evaluated the impact of pregnancy on AZA metabolites 6-thioguanine nucleotide (6-TGN) and 6-methylmercaptopurine nucleotide (6-MMPN) disposition in rheumatic diseases. This study characterises changes in AZA metabolite concentrations throughout pregnancy in women with rheumatic disease and explores relationships between metabolite concentrations, maternal disease activity, and neonatal outcomes.Methods Patients with rheumatic disease from a single centre prescribed AZA prior to pregnancy and ≥1 blood sample during pregnancy (5/2016 to 4/2022) were included. Commercial laboratories quantified AZA metabolite concentrations. The upper safety limit for 6-MMPN was >5700 pmol/8×108 RBC. The therapeutic target for 6-TGN was ≥159 pmol/8×108 RBC. Repeated correlation measures were used to evaluate the relationship between metabolite concentrations and pregnancy duration, and the relationship between 6-TGN concentration and SLE Physician Global Assessment (PGA). The relationship between pregnancy average 6-TGN and neonatal gestational age at birth was analysed using linear regression.Results Thirty-seven pregnancies in 35 women with 108 serum samples were included. There was no significant difference in dose-adjusted 6-TGN concentrations across pregnancy and peripartum, whereas 6-MMPN concentrations appeared higher during pregnancy. No elevated transaminases or cholestasis were observed concurrently with 6-MMPN above 5700 pmol/8×108 RBC. Metabolite concentrations were related to total AZA dosage, weight-based dosage and TPMT phenotype. In pregnant women with SLE achieving average 6-TGN in the therapeutic range, we observed a non-significant reduction in PGA and increase in neonatal gestational age at birth.Conclusions In this exploratory study, we did not observe systematic changes in 6-TGN concentrations throughout pregnancy and peripartum, whereas 6-MMPN concentrations were higher during pregnancy. Monitoring AZA metabolite concentrations in pregnancy is a potential tool to identify medication non-adherence as well as patients with high 6-MMPN in whom dosage adjustment or close laboratory monitoring may optimise safety.

Background People with intellectual disabilities have poorer health and die earlier than their peers without identified disabilities. This difference represents a significant inequality. Until recently, it was considered that cancer was less common in this population, mainly because they did not live long enough to develop age-related cancers. However, recent evidence has identified that people with intellectual disabilities may be at an increased risk of developing cancer but more likely to present for medical treatment at a later stage when cancer has spread. Nonetheless, the evidence is lacking and there is a need to understand the prevalence and incidence of cancer and subtypes of cancer in adults with intellectual disabilities. Methods A systematic review and meta-analysis will be undertaken to investigate the prevalence and incidence of cancer and subtypes of cancer in adults with an intellectual disability. The JBI Systematic reviews of prevalence and incidence and the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed to develop this protocol. Electronic databases will be searched using predefined search terms to identify relevant studies using the Condition Context Population (CoCoPop) framework. Eligible studies should be observational and have published baseline data that have estimated or presented data on the prevalence or incidence of cancer in adults with intellectual disabilities. To assess the methodological quality of studies included in this review a modified version of the JBI Critical Appraisal Checklist for Studies Reporting Prevalence Data will be used. Prevalence and incidence proportions will be analysed separately with individual study data being pooled using the DerSimonian-Laird proportion method and a random effects meta-analysis will be undertaken. Discussion This review will advance the epidemiological evidence to identify where targeted cancer care interventions are needed to help reduce the inequalities that this population experiences. Systematic review registration PROSPERO registration number: CRD42023423584

Background: Veterans living with HIV have up to twice the risk of atherosclerotic cardiovascular disease (ASCVD) compared to those without HIV. Objective: Our study seeks to test a non-physician led virtual self-management implementation strategy to reduce ASCVD risk among people living with HIV (PWH). We aim to conduct a randomized control trial among PWH (n = 300) with a diagnosis of hypertension (HTN) who are enrolled in Veterans Health Administration (VHA) clinics, on suppressive antiretroviral therapy (ART), randomized 1:1 to intervention vs. education control for a 12-month duration. Methods: Using human centered design approach, we have adapted a previous 5-component telehealth focused, non-physician led intervention to a Veteran population. The education control arm receives enhanced education in addition to usual care. The primary outcome is 6 mmHg reduction in systolic BP over 12-month in the intervention arm compared to the control arm. The secondary outcome is a 12-month difference in non-HDL cholesterol. While each component of our intervention has an evidence base, they have not been tested together in an HIV context. Conclusion: The proposed multicomponent intervention has the potential to improve cardiovascular outcomes in PWH using novel virtual care methods in a patient centered care approach.

Background Core outcome sets (COS) represent agreed-upon sets of outcomes, which are the minimum that should be measured and reported in all trials in specific health areas. Use of COS can reduce outcome heterogeneity, selective outcome reporting, and research waste, and can facilitate evidence syntheses. Despite benefits of using COS, current use of COS in trials is low. COS use can be understood as a behaviour, in that it is something trialists do, or not do, adequately. The aim of this study is to identify strategies, informed by behaviour change theory, to increase COS use in trials. Methods The project will be conducted in two stages, informed by the behaviour change wheel (BCW). The BCW is a theoretically based framework that can be used to classify, identify, and develop behaviour change strategies. In Stage 1, barriers and enablers to COS use will be extracted from published studies that examined trialist’s use of COS. Barriers and facilitators will be mapped to the components of COM-B model (capability, opportunity, and motivation), which forms part of the BCW framework. Stage 2 will build on Stage 1 findings to identify and select intervention functions and behaviour change techniques to enhance COS use in trials. Discussion The findings of this study will provide an understanding of the behavioural factors that influence COS use in trials and what strategies might be used to target these factors to increase COS use in trials.

Background: Dementia with Lewy bodies (DLB) is an important cause of dementia with a range of clinical manifestations, including motor, neuropsychiatric, and autonomic symptoms. Compared with more common forms of dementia such as Alzheimer’s disease, DLB has been the focus of significantly fewer treatment studies, often with diverse outcome measures, making comparison and clinical implementation difficult. A core outcome set (COS) can address this by ensuring that data are comparable, relevant, useful, and usable for making the best healthcare decisions. Methods: Using a multi-stage approach, development of the DLB-COS will include the following stages: (1) A systematic review, following PRISMA guidelines to create an initial long list of outcomes; (2) A two-round online Delphi including clinicians, scientists, policymakers, and individuals with lived experience of DLB and their representatives; (3) An online consensus meeting to agree on the final core list of outcomes (the final DLB-COS) for use in research and clinical practice; (4) A literature search to identify appropriate measurement instruments for the DLB-COS outcomes; (5) A final consensus meeting of the professional stakeholders who attended the online consensus meeting to agree on the instruments that should be used to measure the outcomes in the DLB-COS; and (6) Global dissemination. Discussion: This is a multi-stage project to develop a COS to be used in treatment trials for DLB. A DLB-COS will ensure the selection of relevant outcomes and will identify the instruments to be used to measure DLB globally.

Background: Patient and public involvement (PPI) has the potential to improve the relevance of trial outcomes and improve participant recruitment within clinical trials. However, the literature on PPI approaches, outcomes, and attitudes towards PPI in specific clinical research areas is limited. We are interested to know the current approaches to and views of PPI within maternal and neonatal clinical trials, from the perspective and experience of involved stakeholders. Methods: A qualitative evidence synthesis (QES) of stakeholders’ perspectives and experiences of PPI will be conducted. Stakeholders will include any individual involved in maternal or neonatal clinical trials with experience of PPI in the area or who expresses their views on PPI. The electronic bibliographic databases CINAHL, MEDLINE, PsycINFO, EMBASE, Web of Science and the Maternity and Infant Care (OVID) will be searched from inception. Qualitative studies, mixed-methods studies where the qualitative data can be extracted independently, and surveys with open-ended qualitative questions, will be included. Aims: The QES seeks to explore stakeholders’, including PPI contributors, trial participants and guardians, and trial researchers, perspectives and experiences of PPI in maternal and neonatal clinical trials. Discussion: THE QES will provide an understanding of how PPI is understood, operationalised and experienced by stakeholders in maternal and neonatal clinical trials, with the aim of identifying good practice and areas for improvement. PROSPERO registration: CRD42023383878 (2nd March 2023)

Background Vitamin D promotes bone and muscle growth in non-athletes, suggesting supplementation may be ergogenic in athletes. Our primary aim was to determine if modest Vitamin D supplementation augments favorable body composition changes (increased bone and lean mass and decreased fat mass) and performance in collegiate basketball players following 12 weeks of standardized training. Methods Members of a men’s and women’s NCAA D1 Basketball team were recruited. Volunteers were randomized to receive either a weekly 4000 IU Vitamin D3 supplement (D3) or placebo (P) over 12 weeks of standardized pre-season strength training. Pre- and post-measurements included 1) serum 25-hydroxy vitamin D (25(OH)D); 2) body composition variables (total body lean, fat, and bone mass) using dual-energy X-ray absorptiometry (DXA) scans and 3) vertical jump test to assess peak power output. Dietary intake was assessed using Food Frequency questionnaires. Main outcome measures included changes (∆: post-intervention minus pre-intervention) in 25(OH)D, body composition, and performance. Results Eighteen of the 23 players completed the trial (8 females/10 males). Eight received the placebo (20 ± 1 years; 3 females) while ten received Vitamin D3 (20 ± 2 years; 5 females). Weekly Vitamin D3 supplementation induced non-significant increases (∆) in 25(OH)D (2.6 ± 7.2 vs. −3.5 ± 5.3 ng/mL; p = 0.06), total body bone mineral content (BMC) (73.1 ± 62.5 vs. 84.1 ± 46.5 g; p = 0.68), and total body lean mass (2803.9 ± 1655.4 vs. 4474.5 ± 11,389.8 g; p = 0.03), plus a non-significant change in body fat (−0.5 ± 0.8 vs. −1.1 ± 1.2%; p = 0.19) (Vitamin D3 vs. placebo supplementation groups, respectively). Pre 25(OH)D correlated with both Δ total fat mass (g) (r = 0.65; p = 0.003) and Δ total body fat% (r = 0.56; p = 0.02). No differences were noted in peak power output ∆ between the D3 vs. P group (−127.4 ± 335.4 vs. 50.9 ± 9 W; NS). Participants in the D3 group ingested significantly fewer total calories (−526.2 ± 583.9 vs. −10.0 ± 400 kcals; p = 0.02) than participants in the P group. Conclusions Modest (~517 IU/day) Vitamin D3 supplementation did not enhance favorable changes in total body composition or performance, over 3 months of training, in collegiate basketball players. Weight training provides a robust training stimulus for bone and lean mass accrual, which likely predominates over isolated supplement use with adequate caloric intakes.

Abstract Background As COVID-19 continued to impact society and health, maternity care, as with many other healthcare sectors across the globe, experienced tumultuous changes. These changes have the potential to considerably impact on the experience of maternity care. To gain insight and understanding of the experience of maternity care during COVID-19, from the perspectives of women and maternity care providers, we undertook a qualitative evidence synthesis (QES). Methods The population of interest for the QES were pregnant and postpartum women, and maternity care providers, who provided qualitative data on their experiences of maternity care during COVID-19. The electronic databases of MEDLINE, CINAHL, EMBASE, PsycINFO and the Cochrane COVID study register were systematically searched from 01 Jan 2020 to 13 June 2021. The methodological quality of the included studies was appraised using a modified version of the quality assessment tool, based on 12-criteria, designed by the Evidence for Policy and Practice Information coordinating Centre (EPPI-Centre). Data were extracted by two reviewers independently and synthesised using the Thomas and Harden framework. Confidence in the findings was assessed using the Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual). Results Fifty records relating to 48 studies, involving 9,348 women and 2,538 maternity care providers, were included in the QES. The methodological quality of the studies varied from four studies meeting all 12 quality criteria to two studies meeting one quality criterion only. The synthesis revealed eight prominent themes. Five of these reflected women’s experiences: 1) Altered maternity care (women), 2) COVID-related restrictions, 3) Infection prevention and risk, 4) ‘the lived reality’ – navigating support systems, and 5) Interactions with maternity services. Three themes reflected maternity care providers’ experiences: 6) Altered maternity care (providers), 7) Professional and personal impact, and 8) Broader structural impact. Confidence in the findings was high or moderate. Conclusion Although some positive experiences were identified, overall, this QES reveals that maternity care during COVID-19 was negatively experienced by both women and maternity care providers. The pandemic and associated changes evoked an array of emotive states for both populations, many of which have the potential to impact on future health and wellbeing. Resource and care planning to mitigate medium- and longer-term adverse sequelae are required. PROSPERO registration CRD42021232684.

Abstract Background Concerns regarding reduced fetal movements (RFM) are reported in 5–15% of pregnancies, and RFM are associated with adverse pregnancy outcomes including fetal growth restriction and stillbirth. Studies have aimed to improve pregnancy outcomes by evaluating interventions to raise awareness of RFM in pregnancy, such as kick counting, evaluating interventions for the clinical management of RFM, or both. However, there is not currently a core outcome set (COS) for studies of RFM. This study aims to create a COS for use in research studies that aim to raise awareness of RFM and/or evaluate interventions for the clinical management of RFM. Methods A systematic review will be conducted, to identify outcomes used in randomised and non-randomised studies with control groups that aimed to raise awareness of RFM (for example by using mindfulness techniques, fetal movement counting, or other tools such as leaflets or mobile phone applications) and/or that evaluated the clinical management of RFM. An international Delphi consensus will then be used whereby stakeholders will rate the importance of the outcomes identified in the systematic review in (i) awareness and (ii) clinical management studies. The preliminary lists of outcomes will be discussed at a consensus meeting where one final COS for awareness and management, or two discrete COS (one for awareness and one for management), will be agreed upon. Discussion A well-developed COS will provide researchers with the minimum set of outcomes that should be measured and reported in studies that aim to quantify the effects of interventions.

Objective To investigate neonatal outcomes within 28 days in the subsequent birth in women who gave birth to their first baby by caesarean section (CS).Design and setting National retrospective population-based register study. A cohort of 94 451 neonates who were born in Sweden between 1999 and 2015 as a second child to a mother who had her first birth by emergency or planned caesarean.Methods Data were retrieved from the national registers held by Statistics Sweden and the National Board of Health and Welfare. Logistic regression was used to calculate unadjusted and adjusted ORs (aOR) with 95% CIs for each outcome.Main outcome measures Neonatal infection, neonatal asphyxia/respiratory distress, neonatal hospital care and neonatal death within 28 days.Results Emergency CS and instrumental vaginal birth were associated with a doubled risk of neonatal infection (aOR 2.0) and planned CS with a decreased risk (aOR 0.7) compared with spontaneous vaginal birth. Compared with spontaneous vaginal birth, an increased risk of birth asphyxia and/or respiratory distress was identified with all other modes of birth (aOR 2.2–3.2). Emergency CS and instrumental vaginal birth, but not planned CS, were associated with neonatal hospital care (aOR 1.8 and 1.7) and an increased mortality rate during the neonatal period (aOR 2.9 and 3.2), compared with spontaneous vaginal birth.Conclusions In childbirth following a previous birth by CS, spontaneous vaginal birth appears to confer better neonatal outcomes within 28 days after birth overall than other modes of birth.

Adequate serum vitamin D and iron levels are thought to influence physical training adaptations and mood positively. The primary purpose of this prospective, observational study was to investigate relationships between serum 25-OH vitamin D/25(OH)D and serum ferritin levels with body composition and athlete burnout symptoms. Seventy-three collegiate athletes (female: n = 49; male: n = 24) from indoor (swimming, basketball) and outdoor (soccer, cross-country) sports were tested pre-season and post-season for serum 25(OH)D and serum ferritin (nutrient biomarkers) via venipuncture; body composition (total lean mass, bone mineral density/BMD, and % body fat) via dual energy X-ray absorptiometry (DXA) scans; and athlete burnout symptoms (post-season) via the athlete burnout questionnaire (ABQ). When male and female cohorts were combined, significant correlations (Pearson’s r) were noted between pre-season serum 25(OH)D versus the change (∆: post-season minus pre-season) in both BMD (r = −0.34; p = 0.0003) and % body fat (r = −0.28; p = 0.015). Serum ferritin ∆ was significantly associated with lean mass ∆ (r = −0.34; p = 0.003). For burnout symptoms, serum 25(OH)D ∆ significantly explained 20.6% of the variance for devaluation of the sport in the male cohort only. Across time, serum 25(OH)D levels decreased while serum ferritin levels increased, non-significantly, in both males and females. Relationships between nutrient biomarkers and body composition were opposite of physiological expectations.

Background: Dementia with Lewy bodies (DLB) is an important cause of dementia with a range of clinical manifestations, including motor, neuropsychiatric, and autonomic symptoms. Compared with more common forms of dementia such as Alzheimer’s disease, DLB has been the focus of significantly fewer treatment studies, often with diverse outcome measures, making comparison and clinical implementation difficult. A core outcome set (COS) can address this by ensuring that data are comparable, relevant, useful, and usable for making the best healthcare decisions. Methods: Using a multi-stage approach, development of the DLB-COS will include the following stages: (1) A systematic review, following PRISMA guidelines to create an initial long list of outcomes; (2) A two-round online Delphi including clinicians, scientists, policymakers, and individuals with lived experience of DLB and their representatives; (3) An online consensus meeting to agree on the final core list of outcomes (the final DLB-COS) for use in research and clinical practice; (4) A literature search to identify appropriate measurement instruments for the DLB-COS outcomes; (5) A final consensus meeting of the professional stakeholders who attended the online consensus meeting to agree on the instruments that should be used to measure the outcomes in the DLB-COS; and (6) Global dissemination. Discussion: This is a multi-stage project to develop a COS to be used in treatment trials for DLB. A DLB-COS will ensure the selection of relevant outcomes and will identify the instruments to be used to measure DLB globally.

Abstract Background Research investigating exercise interventions in oesophagogastric cancer survivors is sparse, and the outcomes are varied. The aim of this systematic review is to identify the domains and outcomes reported in exercise interventions in oesophagogastric cancer survivors to be included in a Delphi study, with a view to informing the development of a core outcome set (COS). Methods EMBASE, PubMed, CINHAL, Cochrane Library, SCOPUS, and PEDro were searched up to March 2020 using a predefined search strategy. The outcomes identified during data extraction were categorised using the core areas outlined in the OMERACT Filter 2.0. Results Fourteen domains and 63 outcomes were identified. The most frequently reported outcomes were in the domains of quality of life using the EORTC-QLQ-C30 questionnaire and the relevant disease-specific modules (100%), exercise capacity/fitness/physical function (100%), anthropometrics (83.33%), physical activity (66.67%), and biomarker analysis (50%). Conclusion This systematic review quantifies and describes the domains and outcomes examined in exercise interventions in oesophagogastric cancer survivors. Some inconsistency exists within the domains and outcomes used, and little attention was given to nutritional or economic endpoints. In order to develop a COS, a Delphi consensus process with key stakeholders is needed to identify the relevant domains and outcomes for inclusion.

Background: The International Committee of Medical Journal Editors (ICMJE) requires trials submitted for publication to be registered before recruitment of the first participant; however, there is ambiguity around the definition of recruitment and in anchoring the trial start date, end date, and recruitment, or as often interchangeably referred to, enrolment, temporally to trial processes. There is potential for variation in how recruitment is reported and understood in trial protocols and trial reports. We report on a concept analysis of ‘trial recruitment’ and develop an operational definition of ‘trial recruitment’. Methods: A concept analysis using the hybrid model. In Phase 1 we examined randomised and non-randomised trial reports (n=150) published between January 2018 and June 2019 to conceptually explore how recruitment was temporally aligned to the four time-points of screening/eligibility, consent, randomisation and allocation. A preliminary operational definition of ‘trial recruitment’ was determined. This definition was further explored, refined and finalised in Phase 2 (field work), through an interactive, discussion-focused workshop with trial recruiters and trial participants. Results: Of the 150 trial reports analysed, over half did not identify a clear time point of when recruitment took place and varying terminology is used when reporting on trial recruitment. In Phase 2, the workshop attendees agreed that the proposed definition of ‘trial recruitment’ offers an acceptable definition that provides a standardised approach of how trial recruitment may be temporally understood as part of overall trial processes. Conclusion: There is ambiguity around temporal descriptions of ‘trial recruitment’ in health care journals. Informed by the findings of this concept analysis we propose a temporal operational definition of trial recruitment based on i) trial recruitment of an individual or cluster and ii) the trial recruitment period.

Abstract Background Raising awareness of the importance of fetal movements (FMs) and advising women on the appropriate action to take if they experience reduced FMs, is important for minimising or avoiding adverse perinatal outcomes. To gain insight and understanding of women’s perspectives of assessing FMs in pregnancy, we conducted a qualitative evidence synthesis. Methods A qualitative evidence synthesis using thematic synthesis was conducted. Studies were eligible if they included pregnant women who were at least 20 weeks gestation and reported qualitative data from women on assessing FMs in pregnancy. MEDLINE, CINAHL, EMBASE, PsycINFO and Social Science Citation Index, from inception to July 2020, were searched. The methodological quality of included studies was assessed by at least two reviewers using an Evidence for Policy and Practice Information (EPPI)-Centre quality assessment tool. Data synthesis, using the Thomas and Harden framework, involved line by line coding of extracted data, establishing descriptive themes, and determining analytical themes. Confidence in the findings was assessed using GRADE CER-Qual. Results Nine studies, involving 2193 women, were included in the review. The methodological quality of the studies was overall generally high. The synthesis revealed three dominant themes, and seven sub-themes that reflected women’s perspectives of assessing FMs in pregnancy. These were; 1) How women engage with FMs, with subthemes of informal engagement, formal engagement, and strategies to stimulate FMs; 2) ‘ … like a feather inside my belly’ - articulating and describing FMs, with sub-themes of sensations associated with FMs and timing and frequency of FMs; and 3) FMs and help/health seeking, with sub-themes of information sources and interacting with healthcare professionals. Confidence in the findings was either high or moderate, although two findings were rated low confidence and one very low. Conclusion This qualitative evidence synthesis reveals that women informally engage with FMs during pregnancy. Women commonly adopt strategies to stimulate FMs when concerned. The use of the internet was a common source of obtaining information regarding FMs. Women require better support when contacting healthcare professionals about FMs. As only three of the nine included studies were exclusively qualitative in design, further qualitative studies exploring women’s perspective of assessing FMs in pregnancy are required.

Abstract Background As the development of core outcome sets (COS) increases, guidance for developing and reporting high-quality COS continues to evolve; however, a number of methodological uncertainties still remain. The objectives of this study were: (1) to explore the impact of including patient interviews in developing a COS, (2) to examine the impact of using a 5-point versus a 9-point rating scale during Delphi consensus methods on outcome selection and (3) to inform and contribute to COS development methodology by advancing the evidence base on COS development techniques. Methods Semi-structured patient interviews and a nested randomised controlled parallel group trial as part of the Pelvic Girdle Pain Core Outcome Set project (PGP-COS). Patient interviews, as an adjunct to a systematic review of outcomes reported in previous studies, were undertaken to identify preliminary outcomes for including in a Delphi consensus survey. In the Delphi survey, participants were randomised (1:1) to a 5-point or 9-point rating scale for rating the importance of the list of preliminary outcomes. Results Four of the eight patient interview derived outcomes were included in the preliminary COS, however, none of these outcomes were included in the final PGP-COS. The 5-point rating scale resulted in twice as many outcomes reaching consensus after the 3-round Delphi survey compared to the 9-point scale. Consensus on all five outcomes included in the final PGP-COS was achieved by participants allocated the 5-point rating scale, whereas consensus on four of these was achieved by those using the 9-point scale. Conclusions Using patient interviews to identify preliminary outcomes as an adjunct to conducting a systematic review of outcomes measured in the literature did not appear to influence outcome selection in developing the COS in this study. The use of different rating scales in a Delphi survey, however, did appear to impact on outcome selection. The 5-point scale demonstrated greater congruency than the 9-point scale with the outcomes included in the final PGP-COS. Future research to substantiate our findings and to explore the impact of other rating scales on outcome selection during COS development, however, is warranted.

BackgroundCaesarean section rates continue to rise in most parts of the world. While CS is a lifesaving procedure there is evidence that, beyond a certain threshold, CS rates may contribute to increased maternal and perinatal morbidity. This study aimed to elicit the views of pregnant women's and clinicians' on how CS rates might be reduced.MethodsPregnant women and their partners, and clinicians working with pregnant women in a maternity hospital in the Republic of Ireland of Ireland, were invited to participate in focus groups. Eligibility criteria included all women attending antenatal classes and clinicians working with pregnant women. A convenience sample was used and interviews were audio recorded, transcribed, and analysed using thematic analysis.ResultsFour focus group interviews were conducted with 30 clinicians and 15 pregnant women and two partners participated in three focus groups. A further two women were interviewed individually. Participants expressed a view that rising CS rates were impacted by a societal perception that CS had become a 'normal mode of birth'. Suggestions for reducing CS rates were offered by clinicians and pregnant women and their partners.ConclusionsClinicians and pregnant women consider that CS rates can be reduced if a shared philosophy supporting normal birth is prioritised alongside adequate resourcing. Women and their partners also believe that enhanced communication with clinicians is central to reducing CS rates.

Abstract Background Population prevalence estimates by the World Health Organisation suggest that 1 in 160 children worldwide has an Autism Spectrum Disorder (ASD). Accessing respite care services for children with an ASD can often be a daunting and exhaustive process, with parents sometimes forced to access acute hospital services as an initial point of contact for respite care or in a crisis situation. To gain an in-depth understanding of accessing respite care for children with an ASD, from the perspectives of parents, a systematic review of the evidence on parent’s experiences and views of respite care for children with an ASD at the acute and primary interface was undertaken. Methods Pubmed, Embase, CINAHL and PsycINFO were systematically searched. Studies identified as relevant based on predetermined eligibility criteria were selected for inclusion. The search strategy also targeted unpublished studies and grey literature. Qualitative data and qualitative components of mixed method studies that represented the experiences of parents accessing respite care for children with an ASD were eligible for inclusion. A meta-aggregative approach was used during data synthesis. Results Database searching elicited 430 records of which 291 studies remained after removal of duplicates. These 291 studies were screened for title and abstract by two reviewers resulting in 31 studies to be screened at full text and assessed for eligibility. Six studies met the inclusion criteria and a further additional study also met the inclusion criteria during a manual search. As a result, 7 studies were selected for the review as set out in Fig. 1. Conclusion In the absence of appropriate services and defined pathways to support services such as respite care, overwhelmed parents and community providers of mental health resources may not be in a position to meet the specific needs of children with an ASD and their families which may be contributing to a direct increase in hospitalizations. This systematic review identified a number of barriers to respite care, of which the findings can be used to inform future service development and further research. Knowledge of parental experiences in caring for a child with an ASD is vital in addressing the need and type of respite care required for children with an ASD. Systematic review registration PROSPERO CRD42018106629.

Abstract Background Despite evidence supporting the safety of vaginal birth after caesarean section (VBAC), rates are low in many countries. Methods OptiBIRTH investigated the effects of a woman-centred intervention designed to increase VBAC rates through an unblinded cluster randomised trial in 15 maternity units with VBAC rates 24 weeks gestation occurred in the intervention group (0.34%) and 4/782 in the control group (0.51%), and two uterine ruptures (one per group), a rate of 1:1000. Conclusions Changing clinical practice takes time. As elective repeat CS is the most common reason for CS in multiparous women, interventions that are feasible and safe and that have been shown to lead to decreasing repeat CS, should be promoted. Continued research to refine the best way of promoting VBAC is essential. This may best be done using an implementation science approach that can modify evidence-based interventions in response to changing clinical circumstances. Trial registration The OptiBIRTH trial was registered on 3/4/2013. Trial registration number ISRCTN10612254 .

Background: Family members, or others, often assume the role of informal (unpaid) carers of people with chronic illnesses. Care-giving, however, can impact profoundly on the quality of life of carers and can cause carer worry, stress and guilt. Implementing interventions that positively affect the lives of carers is important; however, carers as a group are often difficult to reach. We embedded a study within a pilot-feasibility trial of a mindfulness based intervention to determine and prioritise the key motivators and challenges influencing informal carers’ decisions for participating in a trial. Methods: We used a multi-method approach involving interviews with participants from a ‘host trial’ and data from systematic reviews to develop a survey that was distributed to informal carers in Ireland. The survey consisted of 28 motivator and 17 challenge statements. Participants rated how important they thought each statement was when deciding to take part in a trial on a 5-point Likert Scale. Mean scores and standard deviations were calculated for each statement and arranged in descending order to provide the priority lists. Results: Thirty-six carers responded to the survey. Helping to create awareness about carers was the top ranked motivator, followed by four study design statements related to the time at which the study occurs, the study location, format of delivery and venue. The least important motivator related to how carers were invited to take part in a study. Difficulties in planning due to the caring role emerged as the most important challenge, followed by being unable to leave the care recipient on his/her own. Conclusions: Insight into decision-making for research participation will assist trial developers tailor trial processes for informal carer populations. We recommend that trialists should consider these motivators and challenges when designing future trials involving informal carers so as to enhance trial feasibility and success.

Background: Early warning systems (EWS) have been widely adopted for use in maternity settings internationally. The idea in using these systems is early recognition of potential or actual clinical deterioration in pregnant or postpartum women, and escalation of care. Barriers to successful implementation and use of EWS, however, have been identified. If EWS are to be applied consistently, a greater understanding of the views and experiences of EWS from the perspectives of those using and applying EWS in maternity practice is needed. This protocol describes a qualitative evidence synthesis of maternity care providers’ (midwives, obstetricians, and allied maternity care professionals) views and experiences of EWS use and application in practice. Methods: Studies will be included in the review if they report on maternity care providers use and application of EWS in any birth setting. Qualitative studies and studies of mixed methods design, where qualitative data can be extracted separately, will be included. To source relevant literature the electronic databases of MEDLINE, CINHAL, Web of Science Core Collection (incorporating Social Science Citation Index) and Maternity and Infant Care (MIDIRS), from date of inception, will be searched. The methodological quality of the included studies will be appraised using the 12-criteria of the assessment tool developed by the Evidence for Policy and Practice Information and Co-ordinating Centre. Thematic synthesis will be used for synthesising the qualitative data from included studies. The confidence in the findings will be assessed using the Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research. Conclusions: The findings of this qualitative evidence synthesis may provide valuable information on the barriers, challenges, and facilitators for EWS use based on the experiences of those directly involved in EWS application in maternity care provision. PROSPERO registration: CRD42021235137 (08/04/2021)

Abstract 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.

Abstract Background Pelvic Girdle Pain (PGP) is an important cause of disability and economic cost worldwide. There is a need for effective preventative and management strategies. Emerging studies measure a variety of outcomes rendering synthesis and translation to clinical practice difficult. A Core Outcome Set (COS) can address this problem by ensuring that data are relevant, useful and usable for making well-informed healthcare choices. The aim of this study is to develop a consensus-based PGP-COS, including agreement on methods (e.g. instruments) for measuring the construct outcomes in the COS for use in research and clinical practice. Furthermore, as there is uncertainty as to whether incorporating stakeholder interviews in addition to conducting a systematic review to determine an initial list of outcomes for the Delphi survey, or, whether using different rating scales in a Delphi survey impacts on the final COS, we propose to embed two methodological studies within the PGP-COS development process to address these questions. Methods The PGP-COS study will include five phases: (1) A systematic review of the literature and semi-structured interviews with 15 patients (three countries) to form the initial list of outcomes for the Delphi survey; (2) A 3-round Delphi including patients, clinicians, researchers and service providers; (3) A systematic review of methods for measuring the outcomes in the preliminary PGP-COS identified in the Delphi survey; (4) A face-to-face consensus meeting to agree on the final PGP-COS and methods for measuring the COS; (5) Global dissemination. To address the methodological questions, we will assess the number and type of outcomes, in the final PGP-COS, that were exclusively derived from the interviews. Secondly, we will randomise Delphi survey participants to either a 5-point or 9-point importance rating scale, and examine potential differences in ‘important’ ratings between the groups. Discussion There is currently no COS for measuring/monitoring PGP in trials and clinical practice. A PGP-COS will ensure that relevant outcomes are measured using appropriate measurement instruments for patients with PGP globally. Core outcome set registration This PGP-COS was registered with COMET (Core Outcome Measures for Effectiveness Trials) in January 2017 (http://www.comet-initiative.org/studies/details/958).

Abstract Background Plasmodium ovale spp. and P. malariae cause illness in endemic regions and returning travellers. Far less is known about these species than P. falciparum and P. vivax. Methods The UK national surveillance data, collected 1987 to 2015, were collated with the International Passenger Survey and climatic data to determine geographical, temporal and seasonal trends of imported P. ovale spp. and P. malariae infection. Results Of 52,242 notified cases of malaria, 6.04% (3157) were caused by P. ovale spp. and 1.61% (841) by P. malariae; mortality was 0.03% (1) and 0.12% (1), respectively. Almost all travellers acquired infection in West or East Africa. Infection rate per travel episode fell fivefold during the study period. The median latency of P. malariae and P. ovale spp. was 18 and 76 days, respectively; delayed presentation occurred with both species. The latency of P. ovale spp. infection imported from West Africa was significantly shorter in those arriving in the UK during the West African peak malarial season compared to those arriving outside it (44 days vs 94 days, p

Background: Considerable changes in maternity care provision internationally were implemented in response to COVID-19. Such changes, often occurring suddenly with little advance warning, have had the potential to affect women’s and maternity care providers experience of maternity care, both positively and negatively. For this reason, to gain insight and understanding of personal and professional experiences, we will perform a synthesis of the available qualitative evidence on women and maternity care providers’ views and experiences of maternity care during COVID-19. Methods and analysis: A qualitative evidence synthesis will be conducted. Studies will be eligible if they include pregnant or postpartum women (up to six months) and maternity care providers who received or provided care during COVID-19. To retrieve relevant literature the electronic databases of CINAHL, EMBASE, MEDLINE, PsycINFO, and the Cochrane COVID study register (https://covid-19.cochrane.org/) will be searched from 01-Jan-2020 to date of search. A combination of search terms based on COVID-19, pregnancy, childbirth and maternity care, and study design, will be used to guide the search. The methodological quality of the included studies will be assessed by at least two reviewers using the Evidence for Policy and Practice Information (EPPI)-Centre 12-criteria quality assessment tool. The Thomas and Harden approach to thematic synthesis will be used for data synthesis. This will involve line by line coding of extracted data, establishing descriptive themes, and determining analytical themes. Confidence in the findings of the review will be assessed by two reviewers independently using Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual). Conclusion: The proposed synthesis of evidence will help identify maternity care needs during a global pandemic from the perspectives of those receiving and providing care. The evidence will inform and help enhance care provision into the future.

Background: Outcome heterogeneity, selective reporting, and choosing outcomes that do not reflect needs and priorities of stakeholders, limit the examination of health intervention effects, particularly in late phase trials. Core outcome sets (COS) are a proposed solution to these issues. A COS is an agreed-upon, standardised set of outcomes that should be measured and reported as a minimum in all trials in a specific area of health or healthcare. COS are intended to increase standardisation of outcome measurement and reporting to better enable comparisons between, and synthesis of findings of trials in a particular health area. Methods: This study will examine late phase trials, published between October 2019 and March 2020 (inclusive), in the following five medical journals: New England Journal of Medicine, Journal of the American Medical Association, Lancet, BMJ, and Annals of Internal Medicine. Trials will be examined to determine if they refer to a COS, and whether they use a COS. Trialists for each identified trial will subsequently be contacted to complete an online survey examining trialists’ awareness of, and decisions to search for and use a COS. Discussion: This study will provide important information on uptake of COS by later phase trialists in major medical journals, and the views of these trialists on COS use in trials. These findings will inform approaches to increasing awareness and uptake of COS in future health trials.

BackgroundInconsistent reporting of outcomes in clinical trials of women with Pelvic Girdle Pain (PGP) hinders comparison of findings and the reliability of evidence synthesis. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials on the condition. The aim of this study was to develop a consensus-based COS for evaluating the effectiveness of interventions in PGP during pregnancy and postpartum for use in research and clinical practice.MethodsA systematic review of previous studies on PGP and semi-structured interviews with women were undertaken to identify all outcomes that were reported in prior studies and that are relevant to those experiencing the condition. Key stakeholders (clinicians, researchers, service providers/policy makers and individuals with PGP) then rated the importance of these outcomes for including in a preliminary PGP-COS using a 3-round Delphi study. The final COS was agreed at a face-to-face consensus meeting.ResultsConsensus was achieved on five outcomes for inclusion in the final PGP-COS. All outcomes are grouped under the "life impact" domain and include: pain frequency, pain intensity/severity, function/disability/activity limitation, health-related quality of life and fear avoidance.ConclusionThis study identified a COS for evaluating the effectiveness of interventions in pregnancy-related and postpartum-related PGP in research and clinical settings. It is advocated that all trials, other non-randomised studies and clinicians in this area use this COS by reporting these outcomes as a minimum. This will ensure the reporting of meaningful outcomes and will enable the findings of future studies to be compared and combined. Future work will determine how to measure the outcomes of the PGP-COS.Core outcome set registrationThis PGP-COS was registered with COMET (Core Outcome Measures for Effectiveness Trials) in January 2017 (http://www.comet-initiative.org/studies/details/958).

Background: Studies within trials (SWATs) present an opportunity to examine design factors that may impact on the successful delivery of trials. One area in need of research is trial recruitment. Recruiting patients to trials is a major challenge facing trialists. Failure to meet recruitment targets can result in delays and underpowered studies. This SWAT evaluates the effectiveness of hand-held digital multimedia presentation of trial information and standard written patient information to potential participants on recruitment and retention to a host trial. Methods: This is the protocol for SWAT 15, a two-group, embedded parallel randomised controlled trial (RCT) (ISRCTN12838042) designed within a host trial - the SATIN trial (ISRCTN88111427), a RCT designed for implementation in the Irish primary care setting. The SWAT eligibility criteria was determined by the host trial. General practices who agree to participate in the host trial will provide women (participants) who are willing to consider participating in the host trial with either a multimedia digital information resource facilitated through a handheld tablet device, plus a written participant information leaflet (Intervention) or a written participant information leaflet (comparator). Outcomes are recruitment and retention to the host SATIN trial and participant’s quality of decision-making. Discussion: Although designed to be implemented in a host trial, the host trial, was suspended and therefore this SWAT was not implemented. The protocol and the lessons learnt whilst developing it offer guidance to researchers who wish to answer similar research questions in the future in a similar context or setting. Trial registration: ISRCTN Registry ISRCTN12838042 (11/10/2017)

Context:The US Congress in 2010 established the Program of Comprehensive Assistance for Family Caregivers (PCAFC) in the Department of Veterans Affairs’ (VA) healthcare system, expanding services for family caregivers of eligible veterans with injuries sustained or aggravated in the line of duty on or after 11 September 2001. The program includes a Caregiver Support Coordinator, stipends for caregivers, education/training, and additional services.Objective: The primary goal of this study was to examine the types of services that family caregivers of veterans use and value, how services are used and any limitations family caregivers’ experienced. Given that few interventions assess caregiver satisfaction with services, there is a gap in the existing literature addressing these outcomes.Methods: We assessed how caregivers use and value services with a national, web-based survey (N=1,407 caregivers) and semi-structured phone interviews (N=50 caregivers).Findings: Caregivers rated all services as helpful and especially valued financial support to be with the veteran, training in skills for symptom management, and assistance with navigating the healthcare system. A majority reported more confidence in caregiving, knowing about resources for caregiving and feeling better prepared to support the veteran’s progress and healthcare engagement. However, only a minority reported awareness of the full range of PCAFC services.Limitations: There was a low response rate to the survey, which may have implications for generalisability to the whole population of caregivers accessing PCAFC. Additionally, we rely on self-report rather than objective measures of service use and outcomes.Implications: This is the first in-depth examination of experiences of caregivers of using the innovative PCAFC model of support. It acknowledges the important role of caregivers in health and long-term (social) care delivery and can be used to inform development of strategies outside the VA healthcare system to recognise caregivers. Findings suggest that a system-wide program to effectively include caregivers as part of the care team should include mechanisms to help connect caregivers with an array of resources, options from which to find those which best fit their personal needs and preferences.

Abstract Background Many women are not prepared for changes to their sexual health after childbirth. The aim of this paper is to report on the prevalence of and the potential risk factors (pre-pregnancy dyspareunia, mode of birth, perineal trauma and breastfeeding) for sexual health issues (dyspareunia, lack of vaginal lubrication and a loss of interest in sexual activity) at 6 and 12 months postpartum. Methods A longitudinal cohort study of 832 first-time mothers who were recruited in early pregnancy and returned postnatal surveys at 3, 6, 9 and 12 months postpartum were assessed for sexual health issues and associated risk factors. Results Nearly half of the women (46.3%) reported a lack of interest in sexual activity, 43% experienced a lack of vaginal lubrication and 37.5% of included women had dyspareunia 6 months after birth. On univariate analysis, vacuum-assisted birth, 2nd degree perineal tears, 3rd degree perineal tears and episiotomy were all associated with dyspareunia 6 months postpartum, but, of these only 3rd degree tears, in association with breastfeeding and pre-existing dyspareunia, remained significant on multivariable analysis. Breastfeeding, in combination, with other significant factors, was associated with dyspareunia, a lack of vaginal lubrication and a loss of interest in sexual activity 6 months postpartum, and, dissatisfaction with body image emerged as a significant factor associated with lack of interest in sexual activity at 12 months postpartum. Pre-pregnancy dyspareunia and breastfeeding emerged as common factors associated with all three outcomes of dyspareunia, a lack of vaginal lubrication and a loss of interest in sexual activity at 6 months postpartum. Conclusion Breastfeeding and pre-existing dyspareunia are associated with sexual health issues at 6 months postpartum. Pre-existing dyspareunia is associated with a lack of vaginal lubrication at 12 months postpartum and breastfeeding is associated with dissatisfaction with body image. Preparing women and their partners during the antenatal period and advising on simple measures, such as use of lubrication to avoid or minimise sexual health issues, could potentially remove stress, anxiety and fears regarding intimacy after birth. Introducing the topic of pre-existing sexual health issues antenatally may facilitate appropriate support, treatment or counselling for women.

Abstract Background We examined the mental health status and severity of psychological distress symptoms among young adults residing in Kabul, Afghanistan and determined how such outcomes might be influenced by an array of risk and protective factors. Methods A cross-sectional study design was adopted using convenience, snowball, and street-intercept recruitment techniques. Surveys were completed by 232 young adults between 18 and 35 years of age in September 2015. We used both etic (mental health component of the SF-8) and emic (Afghan Symptom Checklist) measures of mental health and psychological distress, respectively, and regressed these outcome measures against socio-demographic, physical health, and psychological variables (resilience, hope-optimism) using ordinary least squares (OLS) regression methods. Results We found that poor mental health is common in this sample, affecting 75% of participants; and, that distress symptoms (depressive, anxiety, and somatoform symptoms) occur often. Regression models were consistent in showing higher education as a risk-factor for both outcomes, whereas, age, ethnicity, and income significantly contributed only to the ASCL model as risk-factors. However, both outcomes were strongly influenced by protective factors such as good physical health status and higher perceived hope-optimism. Conclusions Our study provides further evidence of how current economic conditions in Kabul contribute to poor mental health and symptom severity, but also show how positive physical health and perceived hope-optimism can be protective. This study provides support for developing culturally-competent policies and interventions that build on protective factors.

Abstract Background Despite the problem of inadequate recruitment to randomised trials, there is little evidence to guide researchers on decisions about how people are effectively recruited to take part in trials. The PRioRiTy study aimed to identify and prioritise important unanswered trial recruitment questions for research. The PRioRiTy study - Priority Setting Partnership (PSP) included members of the public approached to take part in a randomised trial or who have represented participants on randomised trial steering committees, health professionals and research staff with experience of recruiting to randomised trials, people who have designed, conducted, analysed or reported on randomised trials and people with experience of randomised trials methodology. Methods This partnership was aided by the James Lind Alliance and involved eight stages: (i) identifying a unique, relevant prioritisation area within trial methodology; (ii) establishing a steering group (iii) identifying and engaging with partners and stakeholders; (iv) formulating an initial list of uncertainties; (v) collating the uncertainties into research questions; (vi) confirming that the questions for research are a current recruitment challenge; (vii) shortlisting questions and (viii) final prioritisation through a face-to-face workshop. Results A total of 790 survey respondents yielded 1693 open-text answers to 6 questions, from which 1880 potential questions for research were identified. After merging duplicates, the number of questions was reduced to 496. Questions were combined further, and those that were submitted by fewer than 15 people and/or fewer than 6 of the 7 stakeholder groups were excluded from the next round of prioritisation resulting in 31 unique questions for research. All 31 questions were confirmed as being unanswered after checking relevant, up-to-date research evidence. The 10 highest priority questions were ranked at a face-to-face workshop. The number 1 ranked question was “How can randomised trials become part of routine care and best utilise current clinical care pathways?” The top 10 research questions can be viewed at www.priorityresearch.ie. Conclusion The prioritised questions call for a collective focus on normalising trials as part of clinical care, enhancing communication, addressing barriers, enablers and motivators around participation and exploring greater public involvement in the research process.

Abstract Background Complex interventions encompassing several interconnecting and interacting components can be challenging to evaluate. Examining the underlying trial processes while an intervention is being tested can assist in explaining why an intervention was effective (or not). This paper describes a process evaluation of a pan-European cluster randomised controlled trial, OptiBIRTH (undertaken in Ireland, Italy and Germany), that successfully used both quantitative and qualitative methods to enhance understanding of the underlying trial mechanisms and their effect on the trial outcome. Methods We carried out a mixed methods process evaluation. Quantitative and qualitative data were collected from observation of the implementation of the intervention in practice to determine whether it was delivered according to the original protocol. Data were examined to assess the delivery of the various components of the intervention and the receipt of the intervention by key stakeholders (pregnant women, midwives, obstetricians). Using ethnography, an exploration of perceived experiences from a range of recipients was conducted to understand the perspective of both those delivering and those receiving the intervention. Results Engagement by stakeholders with the different components of the intervention varied from minimal intensity of women’s engagement with antenatal classes, to moderate intensity of engagement with online resources, to high intensity of clinicians’ exposure to the education sessions provided. The ethnography determined that, although the overall culture in the intervention site did not change, smaller, more individual cultural changes were observed. The fidelity of the delivery of the intervention scored average quality marks of 80% and above on repeat assessments. Conclusion Nesting a process evaluation within the trial enabled the observation of the mode of action of the intervention in its practice context and ensured that the intervention was delivered with a good level of consistency. Implementation problems were identified as they arose and were addressed accordingly. When dealing with a complex intervention, collecting and analysing both quantitative and qualitative data, as we did, can greatly enhance the process evaluation. Trial registration Current Controlled Trials Register, ISRCTN10612254 . Registered on 3 April 2013.

Little is known about who and what Afghans turn to cope with mental distress precipitated by ongoing socio-political and economic problems. In a cross-sectional survey, the authors examined help-seeking behaviour for mental distress in 306 Afghans residing in Kabul, Afghanistan, and how their choice of what to access for help is influenced by various social and mental health-related factors. Factors predicting the use of six distinct resources for support were examined, including biomedical and behavioural health and community-based resources. Results indicated that Afghans mostly draw on their faith, followed by social support, to cope with mental distress. Higher distress symptoms had a moderate, but statistically significant influence, on seeking help across all resources, whereas demographic factors only predicted encounters with primary care physicians. Female gender predicted social support seeking, and income increased the likelihood of encounters with herbalists. Meeting the psychosocial needs of Afghans through promoting a more integrated mental healthcare system is discussed. Key implications for practiceHelp-seeking for mental distress among Afghans in Kabul is highly pluralistic Although religious activities were the most widely used coping resource, those seeking care outside, from biomedical practitioners and traditional healers were, on average, more distressed. An integrated mental health system that embraces both modern and traditional healing practices may be more efficacious than medicalised mental health systems in meeting the unmet psychosocial needs of Afghans.

Abstract Background Changes to physiological parameters precede deterioration of ill patients. Early warning and track and trigger systems (TTS) use routine physiological measurements with pre-specified thresholds to identify deteriorating patients and trigger appropriate and timely escalation of care. Patients presenting to the emergency department (ED) are undiagnosed, undifferentiated and of varying acuity, yet the effectiveness and cost-effectiveness of using early warning systems and TTS in this setting is unclear. We aimed to systematically review the evidence on the use, development/validation, clinical effectiveness and cost-effectiveness of physiologically based early warning systems and TTS for the detection of deterioration in adult patients presenting to EDs. Methods We searched for any study design in scientific databases and grey literature resources up to March 2016. Two reviewers independently screened results and conducted quality assessment. One reviewer extracted data with independent verification of 50% by a second reviewer. Only information available in English was included. Due to the heterogeneity of reporting across studies, results were synthesised narratively and in evidence tables. Results We identified 6397 citations of which 47 studies and 1 clinical trial registration were included. Although early warning systems are increasingly used in EDs, compliance varies. One non-randomised controlled trial found that using an early warning system in the ED may lead to a change in patient management but may not reduce adverse events; however, this is uncertain, considering the very low quality of evidence. Twenty-eight different early warning systems were developed/validated in 36 studies. There is relatively good evidence on the predictive ability of certain early warning systems on mortality and ICU/hospital admission. No health economic data were identified. Conclusions Early warning systems seem to predict adverse outcomes in adult patients of varying acuity presenting to the ED but there is a lack of high quality comparative studies to examine the effect of using early warning systems on patient outcomes. Such studies should include health economics assessments.

Abstract Background Controversy exists regarding ankyloglossia (tongue-tie) and its clinical impact on breastfeeding, including the benefits, or otherwise, of tongue-tie release (frenotomy). As exclusive breastfeeding rates in Ireland are already considerably low (46% on discharge home from the maternity unit following birth in 2014), it is imperative to protect and support breastfeeding, including identifying the associated effects that frenotomy might have on breastfeeding variables. Objective To determine the associated effects of frenotomy on breastfeeding variables in infants with ankyloglossia. Methods A prospective before and after cohort study was conducted. Following ethical approval, two self-reported questionnaires were administered to women whose infants were undergoing frenotomy at seven healthcare clinics in the Republic of Ireland. Data on breastfeeding variables prior to the frenotomy procedure and at 1-month post-frenotomy were collected and compared. Descriptive statistics (frequencies and proportions) were used to analyse, separately, the pre- and post-frenotomy data. Inferential statistics (z-test scores for differences between proportions (alpha

Abstract Background Recent policy and service provision recommends a woman-centred approach to maternity care. Midwife-led models of care are seen as one important strategy for enhancing women’s choice; a core element of woman-centred care. In the Republic of Ireland, an obstetric consultant-led, midwife-managed service model currently predominates and there is limited exploration of the concept of women centred care from the perspectives of those directly involved; that is, women, midwives, general practitioners and obstetricians. This study considers women’s and clinicians’ views, experiences and perspectives of woman-centred maternity care in Ireland. Methods A descriptive qualitative design. Participants (n = 31) were purposively sampled from two geographically distinct maternity units. Interviews were face-to-face or over the telephone, one-to-one or focus groups. A thematic analysis of the interview data was performed. Results Five major themes representing women’s and clinicians’ views, experiences and perspectives of women-centred care emerged from the data. These were Protecting Normality, Education and Decision Making, Continuity, Empowerment for Women-Centred Care and Building Capacity for Women-Centred Care. Within these major themes, sub-themes emerged that reflect key elements of women-centred care. These were respect, partnership in decision making, information sharing, educational impact, continuity of service, staff continuity and availability, genuine choice, promoting women’s autonomy, individualized care, staff competency and practice organization. Conclusion Women centred-care, as perceived by participants in this study, is not routinely provided in Ireland and women subscribe to the dominant culture that views safety as paramount. Women-centred care can best be facilitated through continuity of carer and in particular through midwife led models of care; however, there is potential to provide women-centred care within existing labour wards in terms of consistency of care, education of women, common approaches to care across professions and women’s choice. To achieve this, however, future research is required to better understand the role of midwife-led care within existing labour ward settings. While a positive view of women-centred care was found; there is still a difference in approach and imbalance of power between the professions. More research is required to consider how these differences impact care provision and how they might be overcome.

Abstract Background Maternity intrapartum care research and clinical care more often focus on outcomes that minimise or prevent adverse health rather than on what constitutes positive health and wellbeing (salutogenesis). This was highlighted recently in a systematic review of reviews of intrapartum reported outcomes where only 8% of 1648 individual outcomes, from 102 systematic reviews, were agreed as being salutogenically-focused. Added to this is variation in the outcomes measured in individual studies rendering it very difficult for researchers to synthesise, fully, the evidence from studies on a particular topic. One of the suggested ways to address this is to develop and apply an agreed standardised set of outcomes, known as a ‘core outcome set’ (COS). In this paper we present a protocol for the development of a salutogenic intrapartum COS (SIPCOS) for use in maternity care research and a SIPCOS for measuring in daily intrapartum clinical care. Methods The study proposes three phases in developing the final SIPCOSs. Phase one, which is complete, involved the conduct of a systematic review of reviews to identify a preliminary list of salutogenically-focused outcomes that had previously been reported in systematic reviews of intrapartum interventions. Sixteen unique salutogenically-focused outcome categories were identified. Phase two will involve prioritising these outcomes, from the perspective of key stakeholders (users of maternity services, clinicians and researchers) by asking them to rate the importance of each outcome for inclusion in the SIPCOSs. A final consensus meeting (phase three) will be held, bringing international stakeholders together to review the preliminary SIPCOSs resulting from the survey and to agree and finalise the final SIPCOSs for use in future maternity care research and daily clinical care. Discussion The expectation in developing the SIPCOSs is that they will be collected and reported in all future studies evaluating intrapartum interventions and measured/recorded in future intrapartum clinical care, as routine, alongside other outcomes also deemed important in the context of the study or clinical scenario. Using the SIPCOSs in this way, will promote and encourage standardised measurements of positive health outcomes in maternity care, into the future.

Abstract Background Midwife-led maternity care is shown to be safe for women with low-risk during pregnancy. In Ireland, two midwife-led units (MLUs) were introduced in 2004 when a randomised controlled trial (the MidU study) was performed to compare MLU care with consultant-led care (CLU). Following study completion the two MLUs have remained as a maternity care option in Ireland. The aim of this study was to evaluate maternal and neonatal outcomes and transfer rates during six years in the larger of the MLU sites. Methods MLU data for the six years 2008–2013 were retrospectively analysed, following ethical approval. Rates of transfer, reasons for transfer, mode of birth, and maternal and fetal outcomes were assessed. Linear-by-Linear Association trend analysis was used for categorical data to evaluate trends over the years and one-way ANOVA was used when comparing continuous variables. Results During the study period, 3,884 women were registered at the MLU. The antenatal transfer rate was 37.4% and 2,410 women came to labour in the MLU. Throughout labour and birth, 567 women (14.6%) transferred to the CLU, of which 23 were transferred after birth due to need for suturing or postpartum hemorrhage. The most common reasons for intrapartum transfer were meconium stained liquor/abnormal fetal heart rate (30.3%), delayed labour progress in first or second stage (24.9%) and woman’s wish for epidural analgesia (15.1%). Of the 1,903 babies born in the MLU, 1,878 (98.7%) were spontaneous vaginal births and 25 (1.3%) were instrumental (ventouse/forceps). Only 25 babies (1.3%) were admitted to neonatal intensive care unit. All spontaneous vaginal births from the MLU registered population, occurring in the study period in both the MLU and CLU settings (n = 2,785), were compared. In the MLU more often 1–2 midwives (90.9% vs 69.7%) cared for the women during birth, more women had three vaginal examinations or fewer (93.6% vs 79.9%) and gave birth in an upright position (standing, squatting or kneeling) (52.0% vs 9.4%), fewer women had an amniotomy (5.9% vs 25.9%) or episiotomy (3.4% vs 9.7%) and more women had a physiological management of third stage of labour (50.9% vs 4.6%). Conclusions Midwife-led care is a safe option that could be offered to a large proportion of healthy pregnant women. With strict transfer criteria there are very few complications during labour and birth. Maternity units without the option of MLU care should consider its introduction.

Abstract Objective: To use grounded theory and participatory research methodology to explain how Aboriginal people learn to understand and manage type 2 diabetes. Methods: Aboriginal people with diabetes were invited to participate in one of five focus groups (n=25, male=12, female=13). Focus groups and education sessions were conducted by Aboriginal members of the research team. Focus groups were audio recorded and transcribed, with coding and first level analysis undertaken by all members of the research team. Results: Participants described colonisation and dislocation from Country and family members’ experiences with diabetes as significant historical influences which, in conjunction with the model of care experienced and the type of interaction with health services, shaped how they came to understand and manage their diabetes. Conclusions: Patient experience of a model of care alone is not what influences understanding and management of diabetes in Aboriginal people. Implications for Public Health: Health service improvements should focus on understanding past experiences of Aboriginal patients, improving interactions with health services and supporting holistic family centred models of care. Focusing on just the model of care in absence of other improvements is unlikely to deliver health benefits to Aboriginal people.

Concern has been expressed globally over rising caesarean birth rates. Recently, the International Federation of Gynaecology and Obstetrics (FIGO) called for help from governmental bodies, professional organisations, women's groups, and other stakeholders to reduce unnecessary caesareans. As part of a wider research initiative, we conducted an overview of systematic reviews of antenatal and intrapartum interventions, and reports of evidence based recommendations, to identify and highlight those that have been shown to be effective for reducing caesarean birth, promoting vaginal birth and reducing fear of childbirth. Following registration of the review protocol, (PROSPERO 2018 CRD42018090681), we searched The Cochrane Database of Systematic Reviews, PubMed, CINAHL and EMBASE (Jan 2000-Jan 2018) and searched for grey literature in PROSPERO, and on websites of health professional and other relevant bodies. Screening and selection of reviews, quality appraisal using AMSTAR-2, and data extraction were performed independently by pairs of at least two reviewers. Excluding reviews assessed as 'critically low' on AMSTAR-2 (n = 54), 101 systematic reviews, and 10 reports of evidence based recommendations were included in the overview. Narrative synthesis was performed, due to heterogeneity of review methodology and topics. The results highlight twenty-five interventions, across 17 reviews, that reduced the risk of caesarean, nine interventions across eight reviews that increased the risk of caesarean, eight interventions that reduced instrumental vaginal birth, four interventions that increased spontaneous vaginal birth, and two interventions that reduced fear of childbirth. This overview of reviews identifies and highlights interventions that have been shown to be effective for reducing caesarean birth, promoting vaginal births and reducing fear of childbirth. In recognising that clinical practices change over time, this overview includes reviews published from 2000 onwards only, thus providing contemporary evidence, and a valuable resource for clinicians when making decisions on practices that should be implemented for reducing unnecessary caesarean births safely. Protocol Registration: PROSPERO 2018 CRD42018090681. Available from: http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42018090681.

Background: Hepatitis C virus (HCV) infection is an important cause of liver disease worldwide. Identification of risk factors can guide screening and prevention. Sexual transmission in monogamous heterosexual relationships is rare but it is uncertain which sexual behaviours are linked to HCV transmission. This review aimed to determine risk factors for sexual HCV transmission in heterosexuals in low HCV prevalence countries (PROSPERO registration CRD42016051099). Methods: We searched Medline, Embase, Science Citation Index-Expanded, Social Sciences Citation index, Conference proceedings (Web of Science), CINAHL, Scopus, LILACS, PubMed, and grey literature (04/11/2016). We included studies published in/after the year 2000 that examined sexual risk factors for HCV infection, other than interspousal transmission, in heterosexual adults (≥18 years). We excluded prisoners, people who inject drugs (PWIDs), people co-infected with HIV or from high prevalence countries. Two reviewers completed study selection, data extraction, risk of bias and quality of evidence assessment (GRADE) independently. Meta-analysis could not be conducted. Results: Eight studies were included, examining seven factors (multiple sex partners, receiving/providing sex commercially, PWID partner, and unprotected vaginal, oral, anal sex). None were significant, except the evidence for the factor having a PWID partner was conflicting. Conclusions: We are uncertain about the results due to the very low quality of evidence (GRADE). A more liberal approach to review inclusion criteria might be useful in further identifying factors associated with an increased risk of sexual transmission of HCV infection in a heterosexual population. However, caution should be applied to avoid the impact of confounders on the findings.

BackgroundThe Core Outcome Measures in Effectiveness Trials (COMET) database is a publically available, searchable repository of published and ongoing core outcome set (COS) studies. An annual systematic review update is carried out to maintain the currency of database content.MethodsThe methods used in the fourth update of the systematic review followed the same approach used in the original review and previous updates. Studies were eligible for inclusion if they reported the development of a COS, regardless of any restrictions by age, health condition or setting. Searches were carried out in March 2018 to identify studies that had been published or indexed between January 2017 and the end of December 2017.ResultsForty-eight new studies, describing the development of 56 COS, were included. There has been an increase in the number of studies clearly specifying the scope of the COS in terms of the population (n = 43, 90%) and intervention (n = 48, 100%) characteristics. Public participation has continued to rise with over half (n = 27, 56%) of studies in the current review including input from members of the public. The rate of inclusion of all stakeholder groups has increased, in particular participation from non-clinical research experts has risen from 32% (mean average in previous reviews) to 62% (n = 29). Input from participants located in Australasia (n = 17; 41%), Asia (n = 18; 44%), South America (n = 13; 32%) and Africa (n = 7; 17%) have all increased since the previous reviews.ConclusionThis update included a pronounced increase in the number of new COS identified compared to the previous three updates. There was an improvement in the reporting of the scope, stakeholder participants and methods used. Furthermore, there has been an increase in participation from Australasia, Asia, South America and Africa. These advancements are reflective of the efforts made in recent years to raise awareness about the need for COS development and uptake, as well as developments in COS methodology.

BackgroundCore outcome sets (COS) comprise a minimum set of outcomes that should be measured and reported in all trials for a specific health condition. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative maintains an up to date, publicly accessible online database of published and ongoing COS. An annual systematic review update is an important part of this process.MethodsThis review employed the same, multifaceted approach that was used in the original review and the previous two updates. This approach has identified studies that sought to determine which outcomes/domains to measure in clinical trials of a specific condition. This update includes an analysis of the inclusion of participants from low and middle income countries (LMICs) as identified by the OECD, in these COS.ResultsEighteen publications, relating to 15 new studies describing the development of 15 COS, were eligible for inclusion in the review. Results show an increase in the use of mixed methods, including Delphi surveys. Clinical experts remain the most common stakeholder group involved. Overall, only 16% of the 259 COS studies published up to the end of 2016 have included participants from LMICs.ConclusionThis review highlights opportunities for greater public participation in COS development and the involvement of stakeholders from a wider range of geographical settings, in particular LMICs.

The detrimental effects of dehydration, to both mental and physical health, are well-described. The potential adverse consequences of overhydration, however, are less understood. The difficulty for most humans to routinely ingest ≥2 liters (L)—or “eight glasses”—of water per day highlights the likely presence of an inhibitory neural circuit which limits the deleterious consequences of overdrinking in mammals but can be consciously overridden in humans. This review summarizes the existing data obtained from both animal (mostly rodent) and human studies regarding the physiology, psychology, and pathology of overhydration. The physiology section will highlight the molecular strength and significance of aquaporin-2 (AQP2) water channel downregulation, in response to chronic anti-diuretic hormone suppression. Absence of the anti-diuretic hormone, arginine vasopressin (AVP), facilitates copious free water urinary excretion (polyuria) in equal volumes to polydipsia to maintain plasma tonicity within normal physiological limits. The psychology section will highlight reasons why humans and rodents may volitionally overdrink, likely in response to anxiety or social isolation whereas polydipsia triggers mesolimbic reward pathways. Lastly, the potential acute (water intoxication) and chronic (urinary bladder distension, ureter dilation and hydronephrosis) pathologies associated with overhydration will be examined largely from the perspective of human case reports and early animal trials.

The COMET (Core Outcome Measures in Effectiveness Trials) Initiative promotes the development and application of core outcome sets (COS), including relevant studies in an online database. In order to keep the database current, an annual search of the literature is undertaken. This study aimed to update a previous systematic review, in order to identify any further studies where a COS has been developed. Furthermore, no prioritization for COS development has previously been undertaken, therefore this study also aimed to identify COS relevant to the world's most prevalent health conditions.The methods used in this updated review followed the same approach used in the original review and the previous update. A survey was also sent to the corresponding authors of COS identified for inclusion in this review, to ascertain what lessons they had learnt from developing their COS. Additionally, the COMET database was searched to identify COS that might be relevant to the conditions with the highest global prevalence.Twenty-five reports relating to 22 new studies were eligible for inclusion in the review. Further improvements were identified in relation to the description of the scope of the COS, use of the Delphi technique, and the inclusion of patient participants within the development process. Additionally, 33 published and ongoing COS were identified for 13 of the world's most prevalent conditions.The development of a reporting guideline and minimum standards should contribute towards future improvements in development and reporting of COS. This study has also described a first approach to identifying gaps in existing COS, and to priority setting in this area. Important gaps have been identified, on the basis of global burden of disease, and the development and application of COS in these areas should be considered a priority.

Plasmodium malariae is widely distributed across the tropics, causing symptomatic malaria in humans with a 72-hour fever periodicity, and may present after latency periods lasting up to many decades. Delayed occurrence of symptoms is observed in humans using chemoprophylaxis, or patients having received therapies targeting P. falciparum intraerythrocytic asexual stages, but few investigators have addressed the biological basis of the ability of P. malariae to persist in the human host. To investigate these interesting features of P. malariae epidemiology, we assembled, here, an extensive case series of P. malariae malaria patients presenting in non-endemic China, Sweden, and the UK who returned from travel in endemic countries, mainly in Africa. Out of 378 evaluable P. malariae cases, 100 (26.2%) reported using at least partial chemoprophylaxis, resembling the pattern seen with the relapsing parasites P. ovale spp. and P. vivax. In contrast, for only 7.5% of imported UK cases of non-relapsing P. falciparum was any chemoprophylaxis use reported. Genotyping of parasites from six patients reporting use of atovaquone-proguanil chemoprophylaxis did not reveal mutations at codon 268 of the cytb locus of the P. malariae mitochondrial genome. While travellers with P. malariae malaria are significantly more likely to report prophylaxis use during endemic country travel than are those with P. falciparum infections, atovaquone-proguanil prophylaxis breakthrough was not associated with pmcytb mutations. These preliminary studies, together with consistent observations of the remarkable longevity of P. malariae, lead us to propose re-examination of the dogma that this species is not a relapsing parasite. Further studies are needed to investigate our favoured hypothesis, namely that P. malariae can initiate a latent hypnozoite developmental programme in the human hepatocyte: if validated this will explain the consistent observations of remarkable longevity of parasitism, even in the presence of antimalarial prophylaxis or treatment.

The present study had two main objectives. The first objective was to compare the sleep architecture of young and older adults, with an emphasis on sleep spindle density and REM density. The second objective was to examine two aspects of age differences that have not been considered in previous studies: age differences in the variability of sleep measures as well as the magnitude of age differences in phasic events across the distribution of values (i.e., at each decile rather than a single measure of location such as the mean or median. A total of 24 young (mean age=20.75 ± 1.78 years) and 24 older (mean age=71.17 ± 6.15 years) adults underwent in-home polysomnography. Whole-night spindle density was significantly higher in young adults than older adults. The two age groups did not differ significantly in whole-night REM density, although significant increases in REM density across the night were observed in both age groups. These results suggest that spindle density is more affected by age than REM density. Although age differences were observed in the degree of absolute variability (older adults had significantly larger variances than young adults for sleep efficiency and time spent awake after sleep onset), a similar pattern was also observed within the two age groups: the four sleep measures with the lowest degrees of relative variability were the same and included time spent in REM and Stage 2 sleep, total sleep time, and sleep efficiency. The distributional analysis of age differences in sleep spindle density revealed that the largest age differences were initially observed in the middle of the distributions, but as the night progressed, they were seen at the upper end of the distributions. The results reported here have potential implications for the causes and functional implications of age-related changes in sleep architecture.