HRB open research最新文献

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: 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  Secondary use of health data provides opportunities to drive improvements in healthcare provision, personalised medicine, comparative effectiveness research, health services innovation, and policy and practice. However, secondary data use requires compliance with relevant legislation, implementation of technical safeguards, ethical data management, and respect for data sharers. Existing evidence suggests widespread support for secondary use of health data among the public, which co-exists with concerns about privacy, confidentiality and misuse of data. Balancing the protection of individuals' rights against the use of their health data for societal benefits is of vital importance, and trust underpins this process. The study protocol explores how to build public trust and confidence in the secondary use of health data through all key stakeholder groups in Ireland, towards developing a culture that promotes a safe and trustworthy use of data. Methods  This study will adopt a qualitative cross-sectional approach conducted in accordance with the Consolidated Criteria for Reporting Qualitative Research COREQ guidelines. Participants in the study will include academics and researchers; healthcare professionals, data protection, ethics and privacy experts and data controllers; pharmaceutical industry and patients and public. Purposive and convenience sampling techniques will be utilised to recruit the participants, and data will be collected utilizing focus groups that may be supplemented with semi-structured interviews. Data will be coded by themes using reflexive thematic analysis (TA) and collective intelligence (CI) will be convened post-analysis to explore the preliminary findings with the participants. Ethics and Dissemination  Ethical approval was obtained from the Royal College of Surgeons in Ireland Research Ethics Committee (REC202208013). Final data analysis and dissemination is expected by Q1 2024. Findings will be disseminated through peer-reviewed journal publications, presentations at relevant conferences, and other academic, public and policy channels. Lay summaries will be designed for Public and Patient Involvement (PPI) contributors and general public.

Background: Patient centred healthcare is the corner stone to many healthcare strategies. Patient specific health needs should be at the fore of healthcare improvements and quality measurements. Patient reported outcome measures (PROM) that support real world clinical effectiveness assessments are increasingly being used to highlight domains where there is the greatest scope for change.

Objectives: This systematic review aims to identify and evaluate existing patient reported assessment measures/tool(s) that can be used in developing a PROM for postpartum women. We will assess and evaluate their measurement properties in a transparent and structured way in accordance with the COSMIN guidelines.

Methods: Methodological guidelines for systematic reviews of PROMs have been developed by the COSMIN initiative and will be followed for this systematic review. A systematic literature review will be performed using PubMed, CINAHL and EMBASE from inception to the present day. Two reviewers independently will judge eligibility, conduct data extraction and assess the methodological quality of each study as per COSMIN guidelines. Inclusion criteria: studies should concern PROM with an aim to evaluate measurement properties in the development or the evaluation of a PROM of interest. Included PROM will focus upon postpartum women assessing morbidity and quality of care. All peer reviewed studies with an assessment tool designed for patient completion will be considered. Exclusion criteria; abstract, letters and non-peer reviewed publications. Studies will be graded on measurement properties and quality of evidence as laid out by COSMIN. All studies and characteristics eligible for inclusion will be summarised and a recommendation to the most suitable measurement tool(s) will be given.

Discussion: We will provide a comprehensive description of all available patient reported assessment tools available for childbirth and postpartum quality of life and recommend based on COSMIN guidelines the most suitable instrument(s) available for use.

Background: Despite its importance, recruiting a sufficient sample size for randomised controlled trials (RCTs) can pose a significant challenge, which has real-world impact on reliability of evidence, trial completion and ultimately, patient care. Technology has potential to enhance the recruitment process, but there is a lack of evidence regarding its current use and effectiveness. Consistent with findings from the PRioRiTy I study, the current research aims to explore the advantages and disadvantages to using technology during the recruitment process for RCTs.

Methods: Semi-structured interviews (n=7) were conducted with researchers involved in RCT recruitment in Ireland. Subsequently, a Public & Patient Involvement (PPI) panel focus group (n=3) was conducted to add further depth to these findings. The data were qualitatively analysed through 'Reflexive Thematic Analysis' to extract prominent themes.

Results: A superordinate theme arose: 'Tech is just a medium so that you can reach more people', along with two themes, which were corroborated by the PPI focus group: 'Technology is used if and when the benefits outweigh the costs' and 'Success of recruitment through technology depends on the nature of the study.'

Conclusions: This study provided a deeper understanding of the factors which influence researchers to employ technology in recruitment for RCTs. Implications suggest that future researchers should aim to adapt their recruitment approaches to meet digital tool preferences of their target cohort; and engage with patient groups in the community to allow networking opportunities for future studies. This research may contribute towards maximising efficiency in RCT recruitment.