Background: Gluteal tendinopathy (GT) is a degenerative tendon condition characterised by pain over the greater trochanter of the hip. A randomised controlled trial (RCT) in Australia found that 14 sessions of EDucation on load management plus eXercise (EDX) delivered over 8 weeks resulted in greater improvements in global rating of change and pain outcomes at 8 and 52 weeks, compared with corticosteroid injection or 'wait and see'. Typically, 5-6 physiotherapy sessions are provided in public and private physiotherapy settings in Ireland, therefore, the aim of this study is to examine the feasibility of conducting a future definitive RCT to investigate effectiveness of 6 sessions of the EDX programme compared to usual care.
Methods: We will randomly allocate 64 participants with GT to physiotherapist-administered EDX or usual care. The EDX intervention (EDX-Ireland) will be delivered in 6 sessions over 8 weeks.To determine feasibility of an RCT, we will assess recruitment and retention and outcome measure completion. The health status outcomes to be assessed at baseline, 8 weeks and 3 months include: Global Rating of Change, pain severity, the Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G), the Patient-Specific Functional Scale, the Pain Catastrophizing Scale, Patient Health Questionnaire (PHQ), Pain Self-Efficacy Questionnaire, the EQ-5D-5L, the Central Sensitisation Inventory and hip abductor muscle strength. We will explore acceptability of the EDX-Ireland intervention from the perspective of patients and treatment providers, and the perspective of referrers to the trial. A Study Within A Trial will be also applied to compare recording of exercise adherence using app-based technology to paper diaries.
Discussion: There is a need to establish effective treatments for GT that potentially can be implemented into existing health systems. The findings of this feasibility trial will inform development of a future definitive RCT.
Registration: The trial is registered prospectively on ClinicalTrials.gov ( NCT05516563, 27/10/2022).
Background: Perimenopause precedes menopause and can cause a myriad of symptoms for women. General practitioners (GPs) are frequently the first contact for perimenopausal women with symptoms. However, women express feeling dissatisfied with the consultations they have with their GPs for perimenopausal symptoms. Moreover, diagnostic difficulties can make these consultations challenging for GPs. Despite these challenges, research to date has focused on menopause, not the transition to menopause. To date, no evidence synthesis has examined how women experience perimenopause consultations, nor how GPs experience providing care to these women.
Objective: To systematically search, collate, and appraise the qualitative literature to understand general practitioners' and women's experiences of perimenopause consultations and examine how treatment decisions are made during consultations.
Methods: A meta-ethnography will be conducted following Sattar et al. (2021) guidelines for conducting a meta-ethnography as developed by Noblit and Hare (1988). Seven databases will be systematically searched. To be included, studies must report on the experiences of either general practitioners and/or perimenopausal women and published since 2014 to capture the most up-to-date evidence. Quality assessment will be conducted using CASP (Critical Appraisal Skills Programme) tools. A GRADE-CERqual (Confidence in the Evidence from Reviews of Qualitative research) will be conducted to assess the confidence of the findings. PROSPERO registration number CRD42024520537.
Discussion: Findings will provide new and useful insight into how GPs and women experience consultations for perimenopause and how decisions are made during these consultations.
Background: Improved Pregnancy Outcomes via Early Detection (IMPROvED) is a multi-centre, European phase IIa clinical study. The primary aim of IMPROvED is to enable the assessment and refinement of innovative prototype preeclampsia risk assessment tests based on emerging biomarker technologies. Here we describe IMPROvED's profile and invite researchers to collaborate.
Methods: A total of 4,038 low-risk nulliparous singleton pregnancies were recruited from maternity units in Ireland (N=1,501), United Kingdom (N=1,108), The Netherlands (N=810), and Sweden (N=619) between November 2013 to August 2017. Participants were interviewed by a research midwife at ~11 weeks (optional visit), ~15 weeks, ~20 weeks, ~34 weeks' gestation (optional visit), and postpartum (within 72-hours following delivery).
Findings to date: Clinical data included information on maternal sociodemographic, medical history, and lifestyle factors collected at ~15 weeks' gestation, and maternal measurements, collected at each study visit. Biobank samples included blood, urine, and hair collected at each study visit throughout pregnancy in all units plus umbilical cord/blood samples collected at birth in Ireland and Sweden. A total of 74.0% (N=2,922) had an uncomplicated pregnancy, 3.1% (N=122) developed preeclampsia, 3.6% (N=143) had a spontaneous preterm birth, and 10.5% (N=416) had a small for gestational age baby. We evaluated a panel of metabolite biomarkers and a panel of protein biomarkers at 15 weeks and 20 weeks' gestation for preeclampsia risk assessment. Their translation into tests with clinical application, as conducted by commercial entities, was hampered by technical issues and changes in test requirements. Work on the panel of proteins was abandoned, while work on the use of metabolite biomarkers for preeclampsia risk assessment is ongoing.
Future plans: In accordance with the original goals of the IMPROvED study, the data and biobank are now available for international collaboration to conduct high quality research into the cause and prevention of adverse pregnancy outcomes.
Background: Care bundles, introduced in 2001, are described as a set of at least three evidence-based healthcare interventions delivered together in a clinical care episode by all healthcare providers. Although widely implemented in some healthcare areas, care bundle use in maternity care appears relatively recent. To identify the types of care bundles that have been developed, evaluated, or implemented for women during the perinatal period, we undertook a scoping review.
Methods: Joanna Briggs Institute methodological guidance for scoping reviews was used. MEDLINE, CINAHL, Embase, Maternity and Infant Care, and Epistemonikos were searched from January 2000 to October 2023. Records that reported on women during pregnancy and up to six-weeks postpartum as the intended or actual recipients of a care bundle, were included. The concept of interest was development, evaluation, or implementation of a care bundle. The context was maternity care provision, in any setting or geographical location.
Results: The search yielded 147 eligible records of which 69 originated in the USA. Most records were concerned with care bundle evaluation (n=74), and most were published in the last five-years (n=95). Eleven categories of clinical conditions were identified. These were surgical site infection, obstetric haemorrhage, perineal trauma, sepsis, stillbirth, hypertension, safe reduction of caesarean section, enhanced recovery after caesarean, placenta accrete, perinatal anxiety/depression, and 'other' which contained 21 records reporting on care bundles for one clinical condition. Few clinical conditions had good overlap of care bundle elements. Systematic reviews based on data from non-randomised studies may be feasible for some clinical conditions.
Conclusions: This scoping review provides comprehensive insight on care bundles in maternity care. Few studies were found that evaluated the effectiveness of these bundles, and many bundles for similar clinical conditions contained diverse elements. A more global approach to care bundle development, evaluation, and implementation in maternity care is recommended.
Background: Constipation is a common problem in childhood that can have psychological, emotional, social, and health-related quality-of-life (HRQOL) consequences on children and their families. Primary or functional constipation (FC) has no known underlying pathology but is associated with lifestyle, psychological, and behavioural factors. Misdiagnosis and inadequate management of constipation can result in chronicity that can continue to adulthood, reducing quality of life for the child and their parents/family. It also causes emotional, psychological and emotional distress and concern for children and their families. This scoping review aims to answer the research question, "What has been reported about the psychosocial implication of childhood constipation among children and their families?"
Methods: The methodology for this scoping review will draw on the six stages of Arksey and O'Malley Framework and the updated and refined version by Peters et al. (2022). The process and reporting will follow the PRISMA-ScR guidelines. The Population, Concept and Context (PCC) framework will guide the development of inclusion criteria and the search strategy for this scoping review. Systematic literature searches of PUBMED, CINAHL, ASSIA, PsycInfo and Cochrane Library will be conducted from inception to present. The critical appraisal will be performed on selected articles to promote trustworthiness and methodological rigour. Plans for consultation exercise and dissemination of findings will also be presented.
Conclusion: This scoping review aims to present a comprehensive synthesis of the characteristics and extent of available literature to develop an understanding of and identify gaps in current knowledge regarding the psychosocial implication of childhood constipation on children and their families.

