bluuebunny/crossref_metadata_2025_split huggingface dataset:
A Self-led Self-management Intervention Supporting Teens with IBD (ASSIST-IBD): protocol for a feasibility study of a novel digital treatment adherence intervention
Authors: Screti Cassandra , Atkinson Lou , Shaw Rachel , Muhammed Rafeeq , Heath Gemma 
Published: October 2024

IntroductionTreatment non-adherence is common in young people with inflammatory bowel disease (IBD), yet support is lacking. A self-led self-management intervention supporting teens with IBD (ASSIST-IBD) is a new theory-based digital treatment adherence intervention, co-developed by young people living with IBD. ASSIST-IBD includes 10 short modules supporting adolescents to feel confident to follow their treatment plan, develop skills to overcome adherence obstacles, feel confident when talking to others about IBD and feel positive about the future. This research aims to determine the feasibility of implementing and measuring the effectiveness of ASSIST-IBD, using a single-arm mixed-methods feasibility trial.Methods and analysis24 young people (aged 13–17) with IBD identified as being ≤80% adherent, and their parents, will use ASSIST-IBD for 6–12 weeks. For the primary endpoint of progression to randomised controlled trial, qualitative and quantitative data will be collected on; number of eligible members of the target population; number of recruited participants; reasons for non-participation and ineligibility; retention and follow-up rates; reasons for early withdrawal; completeness and utility of outcome measures; as well as further data on intervention acceptability, user experiences and user engagement. Secondary outcomes of preliminary effectiveness will include pre-intervention and post-intervention measures of treatment adherence (MARS-5), quality-of-life (IMPACT-III) and well-being (WEMWBS), and self-reported behaviour change success. Quantitative data will be analysed using descriptive statistics; qualitative data will be analysed thematically. An active patient and public involvement and engagement group will advise on the research throughout, including the development of the protocol.Ethics and disseminationThe study has been granted ethical approval by Aston University’s Health and Life Sciences Research Ethics Committee (ref:#HLS2112) and NHS Research Ethics Committee, Nottingham 1 Board (IRAS:#344918). Findings will be disseminated via peer-reviewed publications and lay summaries.Registration detailsThis protocol is registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/KC649).
How professional development can be supported for health and care research methodologists: results of the PROfesSionnal develoPmEnt for Research methodologists (PROSPER) e-Delphi and consensus study
Authors: Iflaifel Mais , Williamson Paula R , Mitchell Eleanor J 
Published: October 2024

ObjectiveResearch methodologists play a pivotal role in health and care research, yet they face many challenges relating to their professional development. The PROfesSional develoPmEnt for Research methodologists study was designed to understand and prioritise the professional development and capacity-building needs of research methodologists in the UK.Design, setting and participantsThree-round electronic Delphi (e-Delphi) survey, with input from stakeholders in the development of the candidate list of professional development aspects followed by a national consensus meeting of health and care research methodologists in the UK.Main outcome measuresRated importance of each professional development aspects on a 9-point scale.Results207 participants gave their consent to participate in the e-Delphi survey. 189 (91%) completed round 1 and 76% completed all three rounds. In round 1, 35 professional development aspects were rated by priority, with 21 additional aspects suggested by participants and included in subsequent rounds. Rounds 2 and 3 involved rating 56 aspects: 22 achieved ‘consensus in’, 20 were ‘consensus out’ and 14 had ‘no consensus’. The top ‘consensus in’ aspects were supportive line managers, clear career pathways and promotion criteria and time for training. A consensus meeting with 18 participants rerated the 14 ‘no consensus’ aspects, adding three more to the final list. The final list includes 25 priority areas for research methodologists’ professional development.ConclusionsThis study has established the priorities from a professional development perspective for research methodologists. These priorities particularly focus on the importance of support from others, training and development, the value and recognition of the role, employer/contractual agreements and methodological research funding. The list of priorities could help individuals, managers, employers and research funders to improve professional development opportunities and could form the start of the development of a ‘methodologists’ charter’.
Protocol for a scoping review of older informal carers and digital health service use
Authors: Sala Emanuela , Cretazzo Federica 
Published: October 2024

IntroductionThe ageing population and increasing demands for healthcare pose challenges for national health services, which are increasingly looking to digital health services (DHS) as a potential solution. However, older informal carers, who provide unpaid care, often lack the digital skills necessary to access and use DHS, placing them at risk of social exclusion. This scoping review aims to systematically map and explore the existing literature on this topic, with the goal of identifying and addressing gaps in the research.Methods and analysisThis scoping review follows Arksey and O'Malley’s methodological framework. A systematic search will be conducted across seven databases: AgeLine, PubMed, ScienceDirect, Scopus, Social Sciences Abstracts, SocINDEX and Web of Science, focusing on studies published in English from 2010 onwards. The research team will collectively work on all stages of the review, ensuring consistency and collaboration throughout. Data extraction will capture key information on study topics, participant demographics, types of DHS and study design. The findings will be analysed using descriptive statistics.Ethics and disseminationEthical approval is not required for this scoping review as it will rely solely on previously published data. The findings will be disseminated through peer-reviewed publications, conference presentations and engagements with non-academic stakeholders through seminars and workshops to maximise societal impact.
Rating of perceived exertion as a tool for managing exercise intensity during pregnancy: a scoping review
Authors: Gjestvang Christina , Olsen Malin Landro , Dalhaug Emilie Mass , Haakstad Lene A H 
Published: October 2024

ObjectiveDuring pregnancy, international guidelines recommend ≥150 min of moderate-intensity aerobic physical activity per week, with an intensity perceived as fairly light to somewhat hard on the Borg Rating of Perceived Exertion (RPE) scale (ranging from 6 ‘no exertion’ to 20 ‘maximal exertion’, corresponding to 60% to 80% of maximum heart rate). However, the determination and monitoring of exercise intensity seem to be a particular source of confusion, and the most effective method to monitor exercise intensity remains uncertain. This study aimed to examine existing research on the correlation between the Borg RPE scale and maternal heart rate (MHR) for monitoring exercise intensity during pregnancy.DesignScoping review using the mixed methods appraisal tool (MMAT) and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach.Data sourcesPubMed, Web of Science and SPORTDiscus were searched from 16–17 April 2023, with a subsequent search on 1 November 2023.Eligibility criteriaWe included studies investigating the correlation between perceived intensity on the Borg RPE scale (6–20) and MHR during exercise in pregnant individuals and written in English/Scandinavian language. There were no restrictions on publication year or study design.Data extraction and synthesisTwo independent reviewers screened the articles based on title and abstract. Selected articles were read in full text and reference lists of screened articles were also checked. Out of 120 studies screened, six articles met the inclusion criteria after removing one duplicate. The results were qualitatively summarised to provide an overview of common themes and variations between studies. MMAT and GRADE assessed the risk of bias and the certainty of the evidence.ResultsThe six studies involved a total of 260 healthy pregnant individuals (gestational week: from 16 to 38), with various exercise protocols (cycling, walking, running and resistance exercise) and intensities (from light to moderate). Three studies supported the Borg RPE scale to estimate exercise intensity during pregnancy, while three found no correlation between this scale and MHR. The certainty of the evidence was graded as low to moderate, with a potential risk of bias due to small sample sizes, incomplete outcome data and inconsistencies across studies.ConclusionThe mixed results highlight the complexity of monitoring exercise intensity during pregnancy. Using both the Borg RPE scale and MHR might be better than using them separately for monitoring exercise intensity during pregnancy. Due to limited and inconsistent research, more extensive studies are needed.
What is the carbon footprint of academic clinical trials? A study of hotspots in 10 trials
Authors: Griffiths Jessica , Adshead Fiona , Al-Shahi Salman Rustam , Anderson Craig , Bedson Emma , Bliss Judith , Boshoff Ana , Chen Xiaoying , Cranley Denise , Doran Peter , Dunne Fidelma , Gamble Carrol , Gillies Katie , Hood Kerenza , Kavanagh Columb , Malone Julia , McGregor Naomi , McNamara Carolyn , Midha Elis , Moore Keith , Murphy Lucy , Newman Christine , O'Reilly Seamus , Perkins Alexis M , Pett Sarah , Sydes Matthew Robert , Whitty Laura , You Frank , Fox Lisa , Williamson Paula R 
Published: October 2024

BackgroundClinical trials are fundamental to healthcare, however, they also contribute to anthropogenic climate change. Following previous work to develop and test a method and guidance to calculate the carbon footprint of clinical trials, we have now applied the guidance to 10 further UK and international, academically sponsored clinical trials to continue the identification of hotspots and opportunities for lower carbon trial design.Methods10 collaborating clinical trial units (CTUs) self-identified and a trial was selected from their portfolio to represent a variety of designs, health areas and interventions. Trial activity data was collated by trial teams across 10 modules spanning trial setup through to closure, then multiplied by emission factors provided in the guidance to calculate the carbon footprint. Feedback was collected from trial teams on the process, experience and ease of use of the guidance.ResultsWe footprinted 10 trials: 6 investigational medicinal product trials, 1 nutritional, 1 surgical, 1 health surveillance and one complex intervention trial. Six of these were completed and four ongoing (two in follow-up and two recruiting). The carbon footprint of the 10 trials ranged from 16 to 765 tonnes CO2e. Common hotspots were identified as CTU emissions, trial-specific patient assessments and trial team meetings and travel. Hotspots for specific trial designs were also identified. The time taken to collate activity data and complete carbon calculations ranged from 5 to 60 hours. The draft guidance was updated to include new activities identified from the 10 trials and in response to user feedback.DiscussionThere are opportunities to reduce the impact of trials across all modules, particularly trial-specific meetings and travel, patient assessments and laboratory practice. A trial’s carbon footprint should be considered at the design stage, but work is required to make this common place.
High-load strength training compared with standard care treatment in young adults with joint hypermobility and knee pain: study protocol for a randomised controlled trial (the HIPEr-Knee study)
Authors: Liaghat Behnam , Bojsen-Møller Jens , Juul-Kristensen Birgit , Henriksen Peter , Mohammadnejad Afsaneh , Heiberg Bibi Dige , Thorlund Jonas Bloch 
Published: October 2024

IntroductionPatients with generalised joint hypermobility, including knee hypermobility (GJHk), often experience knee pain and are typically managed with low-intensity strength training and/or proprioceptive training as part of standard care. However, not all patients experience satisfactory outcomes. High-load strength training may offer additional benefits, such as increased muscle cross-sectional area, neural drive and tendon stiffness, which may reduce pain and improve active knee joint stability during movement tasks and daily activities. So far, no randomised controlled trials (RCTs) have compared high-load strength training with traditional treatment strategies (standard care) for this patient group.Methods and analysisIn this RCT, we aim to recruit patients with GJHk and knee pain from primary care physiotherapy clinics in the Region of Southern Denmark and via social media. Patients with competing injuries or experience with high-load strength training will be excluded. Patients will be randomised (1:1 ratio) to either 2 weekly sessions of high-load strength training or standard care for 12 weeks. The primary outcome is self-reported knee pain during an activity nominated by the patient as the most aggravating for their present knee pain measured using the Visual Analogue Scale for Nominated Activity (VASNA, 0–100; 0=no pain and 100=worst imaginable pain). This will be collected at baseline, 6 weeks, 12 weeks and 12 months. Secondary outcomes include self-reported knee function and adverse events (collected at baseline, 12 weeks and 12 months), objective measurements including a 5-repetition maximum single-leg press, proprioception and single-leg-hop for distance (collected at baseline and 12 weeks), and a range of other outcome measures such as fear of movement, tendon stiffness and global perceived effect. We aim to recruit 90 patients in total to detect a 10 mm group difference in the primary outcome with 80% power.Ethics and disseminationThis study was funded by Independent Research Fund Denmark (grant number 2034-00088B) on 14 June 2022; the Regional Committees on Health Research Ethics for Southern Denmark approved it (S-20230050) on 30 August 2023. The first recruitment site opened on 15 February 2024, and the final results will be submitted to a peer-reviewed journal to inform rehabilitation strategies for symptomatic GJHk.Protocol version 1, dated 4 July 2024.Trial registration numberNCT06277401.
Cross-disciplinary working between gynaecologists and mental healthcare professionals: a mixed-methods systematic review protocol
Authors: Hartnett Yvonne , Conlan-Trant Rebecca , Duffy Richard , Doherty Anne M 
Published: October 2024

IntroductionReproductive hormone transitions (menstrual cycle, post partum and menopause) can trigger mental disorders in a subset of women. Gynaecological diseases, such as endometriosis and polycystic ovary syndrome, can also elevate the risk of mental illness. The link between psychiatrists and obstetricians is already well established in the peripartum period; however, the link between gynaecology and psychiatry is less so. This mixed-methods systematic review aims to synthesise the existing evidence for integrated mental healthcare for gynaecological illnesses or reproductive hormone transitions outside the perinatal period.Methods and analysisA systematic search of the MEDLINE, Embase, Scopus, PsycInfo, CINAHL and Web of Science databases will be conducted. All study types will be considered, both quantitative and qualitative. Opinion and expert consensus statements, as well as government and professional body documents, will also be included, but separately analysed and reported. Studies examining the unmet clinical needs and experiences of women experiencing mental disorders related to reproductive hormone transitions (menarche, menstrual, menopause, but not pregnancy or breast feeding) or gynaecological illness will be included. Studies related to the experience or training of professionals caring for them will be included, specifically on the concept of integrated or interdisciplinary work with colleagues outside their specialty. Abstracts of the identified papers will be screened independently by two reviewers. Full texts will be assessed by two reviewers, and data will be extracted using predetermined data extraction tools. Quantitative studies will be synthesised in narrative format. A thematic synthesis of qualitative studies will be conducted and an integrated narrative synthesis will be described.Ethics and disseminationEthical approval is not required for this systematic review, as no primary data will be collected. The results will be disseminated via a peer-reviewed publication in a relevant scientific journal.PROSPERO registration numberCRD42024523590.
Patient preferences for ocular hypertension monitoring: a discrete choice experiment
Authors: Wu Hangjian , Hernández Rodolfo , Crabb David P , Gazzard Gus , Harper Robert A , King Anthony , Morgan James E , Takwoingi Yemisi , Azuara-Blanco Augusto , Watson Verity 
Published: October 2024

Background/aimsTo elicit the preferences and calculate the willingness to pay (WTP) of patients with ocular hypertension (OHT) for eye monitoring services in the UK.MethodsPatients with OHT aged at least 18 years recruited from four NHS ophthalmology departments were included in the study. Patients’ preferences and WTP for an OHT monitoring service in the National Health Service were elicited using a discrete choice experiment (DCE) within a postal survey based on six attributes: (1) how OHT monitoring is organised, (2) monitoring frequency, (3) travel time from home, (4) use of a risk calculator for conversion to glaucoma, (5) risk of developing glaucoma in the next 10 years and (6) cost of monitoring. We used a sequential mixed-methods approach to design the survey.Results360 patients diagnosed with OHT were recruited with a mean age of 69 years. In the DCE, reducing the risk of conversion to glaucoma was the most important factor influencing respondents’ choice of monitoring service. Respondents preferred hospital-based monitoring services to community optometrist monitoring, and annual monitoring compared with more frequent (every 6 months) and less frequent (every 18 or 24 months) monitoring. These results can be monetised using WTP. Results of heterogeneity analysis suggest that patients with prior experience in community optometrist monitoring preferred this to hospital-based monitoring.ConclusionsAlthough hospital-based monitoring is generally preferred, patients with prior experience in community services have a different opinion, suggesting that patients who are unfamiliar with community optometry services may need additional support to accept monitoring in this setting.
Evaluating the effects, implementation experience and political economy of primary healthcare facility autonomy reforms within counties in Kenya: a mixed methods study protocol
Authors: Musiega Anita , Amboko Beatrice , Maritim Beryl , Nzinga Jacinta , Tsofa Benjamin , Mugo Peter Mwangi , Wong Ethan , Mazzilli Caitlin , Ng'ang'a Wangari , Hagedorn Brittany L , Turner Gillian , Musuva Anne , Murira Felix , Ravishankar Nirmala , Barasa Edwine 
Published: October 2024

IntroductionThere is a growing emphasis on improving primary healthcare (PHC) services and granting frontline service providers more decision-making autonomy. In October 2023, Kenya enacted legislation mandating nationwide facility autonomy. There is limited understanding of the effects of health facility autonomy on PHC facilities performance. It is recognised that stakeholder interests influence reforms, and gender plays a critical role in access to health and its outcomes. This protocol outlines the methods for a study that plans to evaluate the effects, implementation experience, political economy and gendered effects of health facility autonomy reforms in Kenya.Methods and analysisThe research will use a before-and-after quasi-experimental study design to measure the effects of the reform on service readiness and service utilisation and a cross-sectional qualitative study to explore the implementation experience, political economy and gendered effects of these reforms. Data to measure the effects of autonomy will be collected from a sample of 80 health facilities and 1600 clients per study arm. Qualitative interviews will involve approximately 83 facility managers and policymakers at the county level, distributed across intervening (36) and planning to intervene (36) counties. Additionally, 11 interviews will be conducted at the national level with representatives from the Ministry of Health, the National Treasury, the Controller of Budget, the Council of Governors, the Auditor General and development partners. Given the uncertainty surrounding the implementation of the reforms, this study proposes two secondary designs in the event our primary design is not feasible—a cross-sectional study and a quasi-experimental interrupted time series design. The study will use a difference-in-difference analysis for the quantitative component to evaluate the effects of the reforms, while using thematic analysis for the qualitative component to evaluate the political economy and the implementation experience of the reforms.Ethics and disseminationThis study was approved by the Kenya Medical Research Institute Scientific and Ethics Review Unit (KEMRI/SERU/CGMR-C/294/4708) and the National Commission for Science, Technology and Innovation (NACOSTI/P/23/28111). We plan to disseminate the findings through publications, policy briefs and dissemination workshops.
Prospective randomized evaluation of the sustained impact of assistive artificial intelligence on anesthetists’ ultrasound scanning for regional anesthesia
Authors: Kowa Chao-Ying , Morecroft Megan , Macfarlane Alan J R , Burckett-St Laurent David , Pawa Amit , West Simeon , Margetts Steve , Haslam Nat , Ashken Toby , Sebastian Maria Paz , Thottungal Athmaja , Womack Jono , Noble Julia Alison , Higham Helen , Bowness James S 
Published: October 2024

ObjectivesUltrasound-guided regional anesthesia (UGRA) relies on acquiring and interpreting an appropriate view of sonoanatomy. Artificial intelligence (AI) has the potential to aid this by applying a color overlay to key sonoanatomical structures.The primary aim was to determine whether an AI-generated color overlay was associated with a difference in participants’ ability to identify an appropriate block view over a 2-month period after a standardized teaching session (as judged by a blinded assessor). Secondary outcomes included the ability to identify an appropriate block view (unblinded assessor), global rating score and participant confidence scores.DesignRandomized, partially blinded, prospective cross-over study.SettingSimulation scans on healthy volunteers. Initial assessments on 29 November 2022 and 30 November 2022, with follow-up on 25 January 2023 – 27 January 2023.Participants57 junior anesthetists undertook initial assessments and 51 (89.47%) returned at 2 months.InterventionParticipants performed ultrasound scans for six peripheral nerve blocks, with AI assistance randomized to half of the blocks. Cross-over assignment was employed for 2 months.Main outcome measuresBlinded experts assessed whether the block view acquired was acceptable (yes/no). Unblinded experts also assessed this parameter and provided a global performance rating (0–100). Participants reported scan confidence (0–100).ResultsAI assistance was associated with a higher rate of appropriate block view acquisition in both blinded and unblinded assessments (p=0.02 and <0.01, respectively). Participant confidence and expert rating scores were superior throughout (all p<0.01).ConclusionsAssistive AI was associated with superior ultrasound scanning performance 2 months after formal teaching. It may aid application of sonoanatomical knowledge and skills gained in teaching, to support delivery of UGRA beyond the immediate post-teaching period.Trial registration numberNCT05583032.