bluuebunny/crossref_metadata_2025_split huggingface dataset:
Randomised controlled trial of the clinical and cost-effectiveness of a peer-delivered self-management intervention to prevent relapse in crisis resolution team users: study protocol
Authors: Johnson Sonia , Mason Oliver , Osborn David , Milton Alyssa , Henderson Claire , Marston Louise , Ambler Gareth , Hunter Rachael , Pilling Stephen , Morant Nicola , Gray Richard , Weaver Tim , Nolan Fiona , Lloyd-Evans Brynmor 
Published: May 2024

IntroductionCrisis resolution teams (CRTs) provide assessment and intensive home treatment in a crisis, aiming to offer an alternative for people who would otherwise require a psychiatric inpatient admission. They are available in most areas in England. Despite some evidence for their clinical and cost-effectiveness, recurrent concerns are expressed regarding discontinuity with other services and lack of focus on preventing future relapse and readmission to acute care. Currently evidence on how to prevent readmissions to acute care is limited. Self-management interventions, involving supporting service users in recognising and managing signs of their own illness and in actively planning their recovery, have some supporting evidence, but have not been tested as a means of preventing readmission to acute care in people leaving community crisis care. We thus proposed the current study to test the effectiveness of such an intervention. We selected peer support workers as the preferred staff to deliver such an intervention, as they are well-placed to model and encourage active and autonomous recovery from mental health problems.Methods and analysisThe CORE (CRT Optimisation and Relapse Prevention) self-management trial compares the effectiveness of a peer-provided self-management intervention for people leaving CRT care, with treatment as usual supplemented by a booklet on self-management. The planned sample is 440 participants, including 40 participants in an internal pilot. The primary outcome measure is whether participants are readmitted to acute care over 1 year of follow-up following entry to the trial. Secondary outcomes include self-rated recovery at 4 and at 18 months following trial entry, measured using the Questionnaire on the Process of Recovery. Analysis will follow an intention to treatment principle. Random effects logistic regression modelling with adjustment for clustering by peer support worker will be used to test the primary hypothesis.Ethics and disseminationThe CORE self-management trial was approved by the London Camden and Islington Research Ethics Committee (REC ref: 12/LO/0988). A Trial Steering Committee and Data Monitoring Committee oversee the progress of the study. We will report on the results of the clinical trial, as well as on the characteristics of the participants and their associations with relapse.Trial registration numberISRCTN01027104; pre-results stage.
Return-to-work intervention versus usual care for sick-listed employees: health-economic investment appraisal alongside a cluster randomised trial
Authors: Lokman Suzanne , Volker Danielle , Zijlstra-Vlasveld Moniek C , Brouwers Evelien PM , Boon Brigitte , Beekman Aartjan TF , Smit Filip , Van der Feltz-Cornelis Christina M 
Published: May 2024

ObjectiveTo evaluate the health-economic costs and benefits of a guided eHealth intervention (E-health module embedded in Collaborative Occupational healthcare (ECO)) encouraging sick-listed employees to a faster return to work.DesignA two-armed cluster randomised trial with occupational physicians (OPs) (n=62), clustered and randomised by region into an experimental and a control group, to conduct a health-economic investment appraisal. Online self-reported data were collected from employees at baseline, after 3, 6, 9 and 12 months.SettingOccupational health care in the Netherlands.ParticipantsEmployees from small-sized and medium-sized companies (≥18 years), sick-listed between 4 and 26 weeks with (symptoms of) common mental disorders visiting their OP.InterventionsIn the intervention group, employees (N=131) received an eHealth module aimed at changing cognitions regarding return to work, while OPs were supported by a decision aid for treatment and referral options. Employees in the control condition (N=89) received usual sickness guidance.Outcomes MeasuresNet benefits and return on investment based on absenteeism, presenteeism, health care use and quality-adjusted life years (QALYs) gained.ResultsFrom the employer’s perspective, the incremental net benefits were €3187 per employee over a single year, representing a return of investment of €11 per invested Euro, with a break-even point at 6 months. The economic case was also favourable from the employee’s perspective, partly because of QALY health gains. The intervention was costing €234 per employee from a health service financier’s perspective. The incremental net benefits from a social perspective were €4210. This amount dropped to €3559 in the sensitivity analysis trimming the 5% highest costs.ConclusionsThe data suggest that the ECO intervention offers good value for money for virtually all stakeholders involved, because initial investments were more than recouped within a single year. The sometimes wide 95% CIs suggest that the costs and benefits are not always very precise estimates and real benefits could vary considerably.Trial RegistrationNTR2108; Results.
Qualitative interview study of antibiotics and self-management strategies for respiratory infections in primary care
Authors: McDermott Lisa , Leydon Geraldine M , Halls Amy , Kelly Jo , Nagle Amanda , White Jennifer , Little Paul 
Published: May 2024

ObjectiveTo explore perceptions of illness, the decisions to consult and the acceptability of delayed antibiotic prescriptions and self-help treatments for respiratory tract infections (RTIs).DesignQualitative semistructured interview study.SettingUK primary care.Participants20 adult patients who had been participating in the ‘PIPS’ (Pragmatic Ibuprofen Paracetamol and Steam) trial in the South of England.MethodSemistructured telephone interviews were conducted with participants to explore their experiences and views on various treatments for RTI.ResultsParticipants had concerns about symptoms that were not clinically serious and were mostly unaware of the natural history of RTIs, but were aware of the limitations of antibiotics and did not expect them with every consultation. Most viewed delayed prescriptions positively and had no strong preference over which technique is used to deliver the delayed antibiotic, but some patients received mixed messages, such as being told their infection was viral then being given an antibiotic, or were sceptical about the rationale. Participants disliked self-help treatments that involved taking medication and were particularly concerned about painkillers in combination. Steam inhalation was viewed as only moderately helpful for mild symptoms.ConclusionDelayed prescribing is acceptable no matter how the delay is operationalised, but explanation of the rationale is needed and care taken to minimise mixed messages about the severity of illnesses and causation by viruses or bacteria. Better access is needed to good natural history information, and the signs and symptoms requiring or not requiring general practitioner advice. Significant concerns about paracetamol, ibuprofen and steam inhalation are likely to need careful exploration in the consultation.
Pharmacy Diabetes Screening Trial: protocol for a pragmatic cluster-randomised controlled trial to compare three screening methods for undiagnosed type 2 diabetes in Australian community pharmacy
Authors: Krass Ines , Carter Rob , Mitchell Bernadette , Mohebbi Mohammadreza , Shih Sophy T F , Trinder Peta , Versace Vincent L , Wilson Frances , Namara Kevin Mc 
Published: May 2024

IntroductionWith the rising prevalence of type 2 diabetes in Australia, screening and earlier diagnosis is needed to provide opportunities to intervene with evidence-based lifestyle and treatment options to reduce the individual, social and economic impact of the disease. The objectives of the Pharmacy Diabetes Screening Trial are to compare the clinical effectiveness and cost-effectiveness of three screening models for type 2 diabetes in a previously undiagnosed population.Methods and analysisThe Pharmacy Diabetes Screening Trial is a pragmatic cluster randomised controlled trial to be conducted in 363 community pharmacies across metropolitan, regional and remote areas of Australia, randomly allocated by geographical clusters to one of three groups, each with 121 pharmacies and 10 304 screening participants. The three groups are: group A: risk assessment using a validated tool (AUSDRISK); group B: AUSDRISK assessment followed by point-of-care glycated haemoglobin testing; and group C: AUSDRISK assessment followed by point-of-care blood glucose testing. The primary clinical outcome measure is the proportion of newly diagnosed cases of type 2 diabetes. Primary outcome comparisons will be conducted using the Cochran-Mantel-Haenszel test to account for clustering. The secondary clinical outcomes measures are the proportion of those who (1) are referred to the general practitioner (GP), (2) take up referral to the GP, (3) are diagnosed with pre-diabetes, that is, impaired glucose tolerance or impaired fasting glucose and (4) are newly diagnosed with either diabetes or pre-diabetes. The economic outcome measure is the average cost (direct and indirect) per confirmed new case of diagnosed type 2 diabetes based on the incremental net trial-based costs of service delivery and the associated incremental longer term health benefits from a health funder perspective.Ethics and disseminationThe protocol has been approved by the Human Research Ethics Committees at University of Sydney and Deakin University. Results will be available on the Sixth Community Pharmacy Agreement website and will be published in peer reviewed journals.Trial registration numberACTRN12616001240437; Pre-results.
Factors influencing smartwatch use and comfort with health data sharing: a sequential mixed-method study protocol
Authors: Goodings Anthony James , Fadahunsi Kayode Philip , Tarn Derjung Mimi , Henn Patrick , Shiely Frances , O'Donoghue John 
Published: May 2024

IntroductionSmartwatches have become ubiquitous for tracking health metrics. These data sets hold substantial potential for enhancing healthcare and public health initiatives; it may be used to track chronic health conditions, detect previously undiagnosed health conditions and better understand public health trends. By first understanding the factors influencing one’s continuous use of the device, it will be advantageous to assess factors that may influence a person’s willingness to share their individual data sets. This study seeks to comprehensively understand the factors influencing the continued use of these devices and people’s willingness to share the health data they generate.Methods and analysisA two-section online survey of smartwatch users over the age of 18 will be conducted (n ≥200). The first section, based on the expectation-confirmation model, will assess factors influencing continued use of smartwatches while the second section will assess willingness to share the health data generated from these devices. Survey data will be analysed descriptively and based on structural equation modelling.Subsequently, six focus groups will be conducted to further understand the issues raised in the survey. Each focus group (n=6) will consist of three smartwatch users: a general practitioner, a public health specialist and an IT specialist. Young smartwatch users (aged 18–44) will be included in three of the focus groups and middle-aged smartwatch users (aged 45–64) will be included in the other three groups. This is to enhance comparison of opinions based on age groups. Data from the focus groups will be analysed using the microinterlocutor approach and an executive summary.After the focus group, participants will complete a brief survey to indicate any changes in their opinions resulting from the discussion.Ethics and disseminationThe results of this study will be disseminated through publication in a peer-reviewed journal, and all associated data will be deposited in a relevant, publicly accessible data repository to ensure transparency and facilitate future research endeavours.This study was approved by the Social Research Ethic Committee (SREC), University College Cork—SREC/SOM/21062023/2.
Personalised functional imaging-guided multitarget continuous theta burst stimulation for post-stroke aphasia: study protocol for a randomised controlled trial
Authors: Huang Jianting , Ren Jianxun , Xie Wuxiang , Pan Ruiqi , Xu Na , Liu Hesheng 
Published: May 2024

IntroductionContinuous theta burst stimulation (cTBS), a form of repetitive transcranial magnetic stimulation (rTMS), targeting the language network in the right hemisphere of post-stroke aphasia (PSA) patients shows promising results in clinical trials. However, existing PSA studies have focused on single-target rTMS, leaving unexplored the potential benefits of multitarget brain stimulation. Consequently, there is a need for a randomised clinical trial aimed to evaluate the efficacy and safety of cTBS targeting on multiple critical nodes in the language network for PSA.Methods and analysisThis is a prospective, multicentre, double-blind, two-arm parallel-group, sham-controlled randomised trial. The study will include a total of 60 participants who will be randomly assigned in a 1:1 ratio to either the active cTBS group or the sham cTBS group. Using precision resting-state functional MRI for each participant, we will map personalised language networks and design personalised targets in the inferior frontal gyrus, superior temporal gyrus and superior frontal gyrus. Participants will undergo a 3-week cTBS intervention targeting the three personalised targets, coupled with speech and language therapy. The primary outcome is the change in the Western Aphasia Battery-Revised aphasia quotient score among participants after a 3-week treatment. Secondary outcomes include Boston Diagnostic Aphasia Examination severity ratings, Token Test and the Chinese-version of the Stroke and Aphasia Quality of Life Scale 39-generic version.Ethics and disseminationThe study has been approved by the ethics committees of Affiliated Hospital of Hebei University, Hebei General Hospital and Affiliated Hospital of Chengde Medical University. The findings of this study will be reported in peer-reviewed scientific journals.Trial registration numberThe study has been registered on ClinicalTrials.gov (NCT05957445).
11 Caring for patients in a faith based setting: demonstrating a model for ‘hard to reach’ communities and achieving preferred place of death
Authors: Craig Rachel , Tookman Adrian , Gishen Faye 
Published: May 2024

IntroductionA Marie Curie review1highlighted that the Jewish population, alongside Black and Minority Ethnic (BME) groups, are under-represented in utilising palliative care.2Explanations may include concerns around gaining trust and being culturally understood. Preferred Place of Death (PPoD) has been used as a key performance indicator (KPI) for measuring effective palliative care.AimTo establish a palliative care outreach clinic in a faith-based setting and subsequently evaluate patient experience and measure the KPI of PPoD.MethodsIn 2011 a cancer charity supporting the Jewish community, in collaboration with Marie Curie and The Royal Free London NHS Foundation Trust, developed a palliative care clinic, serving an area with a large Jewish population. The clinic runs weekly. A palliative care consultant sees and discusses all patients at the Marie Curie multidisciplinary team meeting. Data was collected via anonymous semi-structured patient experience survey in 2013 and 2016 and all patients are offered Advance Care Planning, including PPoD. Actual place of death has been recorded for all deceased patients.Results39 patients completed the survey. 100% rated the service ‘excellent’ or ‘good’In 2016, 17 patients in the service died. 13 achieved their PPoD (76%).ConclusionAchieving a 76% PPoD contrasts with the London average of 38.1% deaths in usual place of residence.3This demonstrates the success of a faith based service catering for a traditionally ‘hard to reach’ population and represents a unique model within the United Kingdom. This model could be extended to other faith based communities to broaden access to palliative care.References1. https://www.mariecurie.org.uk/globalassets/media/documents/policy/policy-publications/june-2013/palliative-and-end-of-life-care-for-black-asian-and-minority-ethnic-groups-in-the-uk.pdf2. Dorff E. End of Life; Jewish Perspectives.The Lancet2005;366:862–53. https://www.endoflifecare.org.uk/data_sources/place_of_death
24 The nordoff robbins music therapy service at marie curie hospice
Authors: Jezard Joseph 
Published: May 2024

IntroductionThe music therapy provision at Marie Curie Hospice Hampstead was established in September 2016. The service is provided by Nordoff-Robbins, the largest independent music therapy charity in the UK. The therapeutic approach is based on Nordoff-Robbins music therapy theory,1Community Music Therapy theory2and Resource Orientated music therapy theory.3The findings presented here are taken from a service evaluation report undertaken in March 2017.Aim(s)To inform music therapists and other health care professionals how a successful music therapy provision can be implemented and of the perceived impact a music therapy service can have within a hospice or similar setting.based on findings from a service evaluation report.Marie Curie aims to ‘help people and their families with terminal illness make the most of the time they have together by delivering expert care, emotional support, research and guidance.‘ (1) This study will present if Nordoff Robbins music therapy fulfils the aim.Method(s)Questionnaires were distributed to service-users, family members, carers, friends, staff and the music therapist. Where appropriate participants were also asked to leave comments.ResultsThe findings show that music therapy was seen to have a positive impact in four key themes: 100% of the respondents reported that music therapy had a positive impact on the skills and working environment within the Marie Curie Hospice, 96% of respondents reported that music therapy enabled people to engage in music, 93% of respondents reported a positive impact on interaction, communication and relationships and 90% of respondents reporting a positive impact of quality of life and well being.Conclusion(s)Marie Curie aims to ‘help people and their families with terminal illness make the most of the time they have together by delivering expert care, emotional support, research and guidance.4The results from the service evaluation indicate that the music therapy provision successfully contributes to the attainment of these aims and is a valued intervention.References. Nordoff P, Robbins C. Creative Music Therapy: A Guide to Fostering Clinical Musicianship (2nd Edition) 2007. Gilsum, NH: Barcelona Publishers.. Pavlicevic M, Ansdell G, (Eds). Community Music Therapy 2004. London: Jessica Kingsley. Rolvsjord R. Resource-Oriented Music Therapy in Mental Health Care 2010. Gilsum, NH: Barcelona Publishers.. Marie Curie2017. Vision and Strategic Plan, UK, viewed 13 June 2017 https://www.mariecurie.org.uk/who/plans-reports-policies/vision-strategic-plan.
31 ’I’m fine’: exploring patient and carer assertions of status in advanced COPD and clinical implications
Authors: Moore Caroline , Gardener Anita Carole , Farquhar Morag , Ewing Gail , Duschinsky Robbie 
Published: May 2024

IntroductionPatients can be reluctant to say that they need help and support, telling clinicians they are ‘’fine’’ despite having unmet needs. Research with patients in mental health settings suggests that when patients do this they are less likely to follow their treatment plans, and that their informal carers may be at a risk of depression. To date these findings have not been explored in patients with advancing physical health conditions or their carers.AimTo explore the presence and role of “I’m Fine” or equivalent assertions for patients with advanced COPD and their carers; and to examine the impact denials of support needs may have on their health and service-use.MethodsCriteria based on Attachment Theory was used to identify ‘I’m Fine’ cases from the Living with Breathlessness Study (LWB) dataset of 235 patient and 115 carer qualitative interview transcripts. Data will be further analysed to explore discourses within cases using a Framework approach.ResultsPatients and carers who asserted they were ‘fine’ and not in need of further clinical support despite unmet needs had a distinct profile. Patients’ self-management attitudes and beliefs included minimising the effects and symptoms towards COPD, avoidance of thinking about the future and using stoical language in an attempt to downplay experiences. Carers focused on the needs of the patient whilst downplaying their own problems or distress.ConclusionBetter understanding of the processes and implications of assertions of status will support future work on interventions to support patients and carers.
Safety and biological outcomes following a phase 1 trial of GD2-specific CAR-T cells in patients with GD2-positive metastatic melanoma and other solid cancers
Authors: Gargett Tessa , Truong Nga T H , Gardam Bryan , Yu Wenbo , Ebert Lisa M , Johnson Amy , Yeo Erica C F , Wittwer Nicole L , Tapia Rico Gonzalo , Logan Jesikah , Sivaloganathan Purany , Collis Maria , Ruszkiewicz Andrew , Brown Michael P 
Published: May 2024

BackgroundChimeric antigen receptor (CAR) T cell therapies specific for the CD19 and B-cell maturation antigen have become an approved standard of care worldwide for relapsed and refractory B-cell malignancies. If CAR-T cell therapy for non-hematological malignancies is to achieve the same stage of clinical development, then iterative early-phase clinical testing can add value to the clinical development process for evaluating CAR-T cell products containing different CAR designs and manufactured under differing conditions.MethodsWe conducted a phase 1 trial of third-generation GD2-specific CAR-T cell therapy, which has previously been tested in neuroblastoma patients. In this study, the GD2-CAR-T therapy was evaluated for the first time in metastatic melanoma patients in combination with BRAF/MEK inhibitor therapy, and as a monotherapy in patients with colorectal cancer and a patient with fibromyxoid sarcoma. Feasibility and safety were determined and persistence studies, multiplex cytokine arrays on sera and detailed immune phenotyping of the original CAR-T products, the circulating CAR-T cells, and, in select patients, the tumor-infiltrating CAR-T cells were performed.ResultsWe demonstrate the feasibility of manufacturing CAR-T products at point of care for patients with solid cancer and show that a single intravenous infusion was well tolerated with no dose-limiting toxicities or severe adverse events. In addition, we note significant improvements in CAR-T cell immune phenotype, and expansion when a modified manufacturing procedure was adopted for the latter 6 patients recruited to this 12-patient trial. We also show evidence of CAR-T cell-mediated immune activity and in some patients expanded subsets of circulating myeloid cells after CAR-T cell therapy.ConclusionsThis is the first report of third-generation GD2-targeting CAR-T cells in patients with metastatic melanoma and other solid cancers such as colorectal cancer, showing feasibility, safety and immune activity, but limited clinical effect.Trial registration numberACTRN12613000198729.