bluuebunny/crossref_metadata_2025_split huggingface dataset:
Societal and organisational influences on implementation of mental health peer support work in low-income and high-income settings: a qualitative focus group study
Authors: Ramesh Mary , Charles Ashleigh , Grayzman Alina , Hiltensperger Ramona , Kalha Jasmine , Kulkarni Arti , Mahlke Candelaria , Moran Galia S , Mpango Richard , Mueller-Stierlin Annabel S. , Nixdorf Rebecca , Ryan Grace Kathryn , Shamba Donat , Slade Mike 
Published: February 2024

ObjectivesDespite the established evidence base for mental health peer support work, widespread implementation remains a challenge. This study aimed to explore societal and organisational influences on the implementation of peer support work in low-income and high-income settings.DesignStudy sites conducted two focus groups in local languages at each site, using a topic guide based on a conceptual framework describing eight peer support worker (PSW) principles and five implementation issues. Transcripts were translated into English and an inductive thematic analysis was conducted to characterise implementation influences.SettingThe study took place in two tertiary and three secondary mental healthcare sites as part of the Using Peer Support in Developing Empowering Mental Health Services (UPSIDES) study, comprising three high-income sites (Hamburg and Ulm, Germany; Be’er Sheva, Israel) and two low-income sites (Dar es Salaam, Tanzania; Kampala, Uganda) chosen for diversity both in region and in experience of peer support work.Participants12 focus groups were conducted (including a total of 86 participants), across sites in Ulm (n=2), Hamburg (n=2), Dar es Salaam (n=2), Be’er Sheva (n=2) and Kampala (n=4). Three individual interviews were also done in Kampala. All participants met the inclusion criteria: aged over 18 years; actual or potential PSW or mental health clinician or hospital/community manager or regional/national policy-maker; and able to give informed consent.ResultsSix themes relating to implementation influences were identified: community and staff attitudes, resource availability, organisational culture, role definition, training and support and peer support network.ConclusionsThis is the first multicountry study to explore societal attitudes and organisational culture influences on the implementation of peer support. Addressing community-level discrimination and developing a recovery orientation in mental health systems can contribute to effective implementation of peer support work. The relationship between societal stigma about mental health and resource allocation decisions warrants future investigation.Trial registration numberISRCTN26008944.
Effectiveness and clinical application of multidisciplinary combined exercise and nutrition intervention for sarcopenic older adults with metabolic syndrome: study protocol for a multicentre randomised controlled trial
Authors: Lee Sang Yoon , Beom Jaewon , Choi Jun Hwan , Jang Hak Chul , Kim EunYoung , Kim Keewon , Kim Miji , Shim Ga Yang , Won Chang Won , Lim Jae-Young 
Published: February 2024

IntroductionAmong chronic diseases affecting older adults, metabolic syndrome (MetS) is known to be closely related to sarcopenia. Insulin resistance may play a key role in the increased frequency of sarcopenia associated with metabolic disorders. To date, an exercise–nutrition combined intervention has been the treatment of choice for sarcopenia. However, trials of combined interventions for individuals with sarcopenia and MetS are still lacking. This study aims to develop and conduct a standardised intervention, named the Multidisciplinary combined Exercise and Nutrition inTervention fOR Sarcopenia (MENTORS), for sarcopenic older patients with MetS.Methods and analysisThis multicentre, randomised controlled trial includes 168 community-dwelling older adults with sarcopenia and MetS. The 12-week MENTORS comprises an exercise intervention consisting of an introductory phase (3 weeks; twice-weekly visits), an expanded phase (3 weeks; twice-weekly visits) and a maintenance phase (6 weeks; once-weekly visits); and a nutrition intervention tailored to the nutritional status of individual subjects. Outcomes will be measured at 0-week, 12-week and 24-week postintervention. The data will be analysed using the intention-to-treat and per-protocol principle.Ethics and disseminationBefore screening, all participants will be provided with oral and written information. Ethical approval has already been obtained from all participating hospitals. The study results will be disseminated in peer-reviewed publications and conference presentations.Trial registration numberNCT04948736
Evaluating niraparib versus active symptom control in patients with previously treated mesothelioma (NERO): a study protocol for a multicentre, randomised, two-arm, open-label phase II trial in UK secondary care centres
Authors: Fennell Dean , Griffiths Daniel , Eminton Zina , Morgan-Fox Abigail , Hill Kayleigh , Ewings Sean , Stuart Charlotte , Johnson Lucy , Mallard Kim , Nye Mavis , Darlison Liz , Dulloo Sean , Cave Judith , Luo Jin-Li , Taylor Paul , Spicer Jake , Poile Charlotte , Bzura Aleksandra , Griffiths Gareth 
Published: February 2024

BackgroundMalignant mesothelioma is a rapidly lethal cancer that has been increasing at an epidemic rate over the last three decades. Targeted therapies for mesothelioma have been lacking. A previous study called MiST1 (NCT03654833), evaluated the efficacy of Poly (ADP-ribose) polymerase (PARP) inhibition in mesothelioma. This study met its primary endpoint with 15% of patients having durable responses exceeding 1 year. Therefore, there is a need to evaluate PARP inhibitors in relapsed mesothelioma patients, where options are limited. Niraparib is the PARP inhibitor used in NERO.MethodsNERO is a multicentre, two-arm, open-label UK randomised phase II trial designed to evaluate the efficacy of PARP inhibition in relapsed mesothelioma. 84 patients are being recruited. NERO is not restricted by line of therapy; however, eligible participants must have been treated with an approved platinum based systemic therapy. Participants will be randomised 2:1, stratified according to histology and response to prior platinum-based chemotherapy, to receive either active symptom control (ASC) and niraparib or ASC alone, for up to 24 weeks. Participants will be treated until disease progression, withdrawal, death or development of significant treatment limiting toxicity. Participants randomised to niraparib will receive 200 or 300 mg daily in a 3-weekly cycle. The primary endpoint is progression-free survival, where progression is determined by modified Response Evaluation Criteria in Solid Tumors (mRECIST) or RECIST 1.1; investigator reported progression; or death from any cause, whichever comes first. Secondary endpoints include overall survival, best overall response, 12-week and 24 week disease control, duration of response, treatment compliance and safety/tolerability. If NERO shows niraparib to be safe and biologically effective, it may lead to future late phase randomised controlled trials in relapsed mesothelioma.Ethics and disseminationThe study received ethical approval from London-Hampstead Research Ethics Committee on 06-May-2022 (22/LO/0281). Data from all centres will be analysed together and published as soon as possible.Trial registration numberISCRTN16171129;NCT05455424.
Protocol for a mixed-method study to assess chronic cough in patients with renal cell carcinoma: the prevalence, impact on quality of life, trigger and potential clinical application of chronic cough as an early screening tool in patients with kidney cancer
Authors: Smith Wendy , Loizidou Marilena , Mazzone Stuart , Mumtaz Faiz , Gurusamy Kurinchi , Ranieri Veronica , Tran Maxine GB 
Published: February 2024

IntroductionCough as a symptom of renal cell carcinoma (RCC) was first described by Creevy in 1935, and despite one (unpublished) study suggesting it may affect 31% of these patients, as well as cough being discussed in forums for patients with kidney cancer, few clinicians are aware of this association. The cough has been described as unusual in nature, resolving rapidly after treatment with nephrectomy/embolisation but returning if the tumour recurs.Methods and analysisA prospective study using a questionnaire will identify the prevalence of cough in patients with suspected or confirmed RCC attending the Specialist Centre for Kidney Cancer (London, UK). A longitudinal study in a representative sample of these patients, using EQ-5D-5L and Leicester Cough Questionnaires, together with the use of semi-structured interviews with patients, will identify the impact of cough in addition to having a diagnosis of suspected or confirmed RCC on quality of life. To investigate cough mechanisms, a pilot study using cough hypersensitivity testing will be performed on patients with RCC, with and without a cough. Clinical samples (urine, blood, phlegm and breath condensate) from patients with RCC, with and without a cough, will be collected and analysed for the presence of substances known to trigger or enhance cough and compared with the results obtained from healthy volunteers.Ethics and disseminationEthical approval has been granted (UK HR REC 22/PR/0791 dated 25/08/2022). Study outputs will be presented and published nationally and internationally at relevant conferences. This study will establish the prevalence of cough in patients with suspected or confirmed kidney cancer and support the education of clinicians to consider this diagnosis in patients with chronic cough (eg, recommending protocols to include both kidneys when investigating respiratory symptoms with chest CT scans). If substances known to trigger or enhance cough are identified and elevated in clinical samples, this research could offer potential targets for treatment for this distressing symptom.Trial registration numberNIHR CRN portfolio CPMS ID:53 372.
Multicentre pilot randomised control trial of a self-directed exergaming intervention for poststroke upper limb rehabilitation: research protocol
Authors: Broderick Michelle , Burridge Jane , Demain Sara , Johnson Louise , Brereton Joe , O'Shea Robert , Bentley Paul 
Published: February 2024

IntroductionTechnology-facilitated, self-directed upper limb (UL) rehabilitation, as an adjunct to conventional care, could enhance poststroke UL recovery compared with conventional care alone, without imposing additional resource burden. The proposed pilot randomised controlled trial (RCT) aims to assess whether stroke survivors will engage in self-directed UL training, explore factors associated with intervention adherence and evaluate the study design for an RCT testing the efficacy of a self-directed exer-gaming intervention for UL recovery after stroke.Methods and analysisThis is a multicentre, internal pilot RCT; parallel design, with nested qualitative methods. The sample will consist of stroke survivors with UL paresis, presenting within the previous 30 days. Participants randomised to the intervention group will be trained to use an exergaming device and will be supported to adopt this as part of their self-directed rehabilitation (ie, without formal support/supervision) for a 3-month period. The primary outcome will be the Fugl Meyer Upper Extremity Assessment (FM-UE) at 6 months poststroke. Secondary outcomes are the Action Research Arm Test (ARAT), the Barthel Index and the Modified Rankin Scale. Assessment time points will be prior to randomisation (0–1 month poststroke), 3 months and 6 months poststroke. A power calculation to inform sample size required for a definitive RCT will be conducted using FM-UE data from the sample across 0–6 months time points. Semistructured qualitative interviews will examine factors associated with intervention adoption. Reflexive thematic analysis will be used to code qualitative interview data and generate key themes associated with intervention adoption.Ethics and disseminationThe study protocol (V.1.9) was granted ethical approval by the Health Research Authority, Health and Care Research Wales, and the London- Harrow Research Ethics Committee (ref. 21/LO/0054) on 19 May 2021. Trial results will be submitted for publication in peer-reviewed journals, presented at national and international stroke meetings and conferences and disseminated among stakeholder communities.Trial registration numberNCT04475692
Effect of eye-tracking-based attention training for patients with poststroke cognitive impairment: a study protocol for a prospective, single-blinded, single-centre, randomised controlled trial in China
Authors: Wang Weijia , You Mingke , Ma Wanting , Yang Yonghong 
Published: February 2024

IntroductionPoststroke cognitive impairment (PSCI) is a common dysfunction that places a great burden on patients who had stroke and their families. Approximately 46%–92% of stroke survivors experience some degree of attention problems after a stroke. Improving attention is considered the core of successfully improving cognitive function and reintegrating patients into daily life. Eye tracking technology provides real-time feedback and accurate monitoring of cognitive processing, and using this technology to introduce attention training may improve patient treatment outcomes. The main purpose of this study was to investigate whether eye-tracking-based attention training has a positive effect on patients with PSCI.Methods and analysisThis study is a prospective randomised controlled trial. We will recruit 48 patients with PSCI referred to the Department of Rehabilitation Medicine at West China Hospital, Sichuan University, in Southwest China. The participants will be randomly distributed into two groups. Both groups will undergo conventional rehabilitation for 3 weeks, and the intervention group will receive 3 weeks of eye-tracking-based attention training (20–30 min/day). The primary outcome will be the patients’ cognitive function, measured by the Montreal Cognitive Assessment. The secondary outcomes will be the patients’ attention, independence of daily activities and event-related potential. These outcomes will be assessed at baseline, at the end of treatment (3 weeks) and at follow-up (1 month and 3 months after treatment). We will report the statistics and estimations using 95% CI.Ethics and disseminationThis trial received ethics approval from the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University (2023 review No. 258). The results from this study will be disseminated via academic publication.Trial registration numberChiCTR2300068727.
Comparison of two types of extension tubes for people with Parkinson’s disease in advanced treatment with levodopa–entacapone–carbidopa intestinal gel infusions: a prospective, crossover quality study
Authors: Thomsen Trine Hørmann , Olsen Louise , Javidi Mahsa , Karottki Nikolaj Folke La Cour , Biering-Sørensen Bo 
Published: February 2024

BackgroundWithin Parkinson’s disease (PD) management, a pivotal juncture often arises when individuals with PD (PwP) necessitate advanced therapies to stabilise symptom fluctuations and reduce off-periods, which are intrinsic to living with PD. One such intervention is the infusion of duodenal levodopa–entacapone–carbidopa intestinal gel (LECIG), which confers a more dependable levodopa plasma concentration compared with conventional oral therapy. It involves the insertion of a percutaneous endoscopic gastrojejunostomy (PEG-J) tube, facilitating direct access to the stomach and jejunum. Then, a slender tube extends into the small intestine, facilitating the continuous delivery of LECIG via a portable pump. The PEG-J incorporates an extension tube that permits patients with PD to connect the medication pump.ObjectiveThe objective of this study was to assess and compare two types of extension tubes a standard; a standard tube and the ENFit extension tube.MethodEmploying a prospective, crossover design at a single centre in Denmark. Each participant evaluated both extension tubes for 14 days. The primary outcome measure was patient-reported evaluation measures through a nine-item questionnaire using a 5-point Likert scale and 10th open-ended qualitative question.ResultsOf the 12 recruited PwP, 10 successfully completed both testing periods and submitted self-reported questionnaires. The participants, with an average age of 70.3 years, comprised three men and seven women. Among them, five had a spouse or cohabitant, while five lived independently (with one residing in a nursing home). The average duration of PD diagnosis was 16.4 years, with an average of 2.6 years since the implantation of the medication pump. The ENFit tube outperformed the standard tube across all nine evaluation criteria, particularly excelling in terms of usability (items 4–6), safety (item 2) and overall product preference (item 9).
Injuries and illnesses at the Munich 2022 European Championships: a prospective study of 5419 athletes from 52 countries involved in 9 sports
Authors: Edouard Pascal , Dandrieux Pierre-Eddy , Hollander Karsten , Zyskowski Michael 
Published: February 2024

ObjectiveTo describe the incidence and characteristics of the sports injuries and illnesses that occurred during the 2022 European Championships.MethodsWe conducted a prospective study on newly incurred injuries and illnesses collected by the national medical teams and the local organising committee physicians using a standardised online report form on a daily basis, in all athletes registered at the 2022 European Championships from 11 August 2022 to 21 August 2022 in Munich (Germany).ResultsIn total, 5419 athletes were registered at the 2022 European Championships in 9 sports. A total of 181 in-competition injuries were reported, representing an overall incidence of 33.4 injuries per 1000 registered athletes, with higher values in triathlon, cycling and athletics. More injuries located at the lower limb and involving the muscles and skin were reported in athletics, at the lower limb and involving the skin in triathlon, at the head and trunk and upper limb and involving head and skin in cycling. A total of 65 illnesses were reported, representing an overall incidence of 12.0 illnesses per 1000 registered athletes, with higher values in athletics and rowing. The most affected common system was the cardiovascular system (24.6%), followed by the gastrointestinal (18.5%) and upper respiratory tracts (16.9%). The most frequent causes were exercise (36.9%), infections (30.8%) and ‘others’ (10.8%).ConclusionThis was the first injury and illness surveillance during multisports European Championships providing relevant results to help anticipate medical services and athletes’ health protection, and highlighting the need for special attention for triathlon and cycling.
Injuries in the emerging sport of roundnet (Spikeball): a cross-sectional study of 166 players
Authors: Paul Ryan W , Gupta Richa , Muchintala Rahul , Boles Skyler , Bishop Meghan E , Freedman Kevin B 
Published: February 2024

ObjectivesTo describe injury frequency and characteristics in roundnet athletes and compare injury characteristics between elite and non-elite athletes.MethodsThis cross-sectional study was performed by convenience sampling recreational and competitive roundnet athletes via a REDCap survey distributed through social media platforms. The custom survey evaluated athlete demographics, past sport participation, training workload and roundnet-related injuries throughout their whole playing career. Injury characteristics were reported for the full study cohort and compared between elite and non-elite athletes.Results166 athletes participated in the study, with 33.7% playing at the elite level. 279 injuries were reported, with 86.1% (n=143) of athletes reporting at least one injury throughout their playing career. Injuries most frequently involved the shoulder (20%), ankle (18%), knee (14%) and elbow (14%). 47% of reported injuries occurred due to overuse, and 67% resulted in missed competition time averaging 2.0 months. There were 10 injuries (3.6%) that required surgery. No differences were found in regards to injury frequency (1.9±1.5 vs 1.6±1.1 injuries per athlete, p=0.159) or any injury characteristics between elite and non-elite athletes.ConclusionRoundnet athletes experienced a mean of 1.7±1.2 injuries while playing roundnet. Injuries most frequently involved the shoulder and ankle and often resulted in missed competition time. The level of competition does not significantly impact injury frequency or characteristics. Roundnet athletes may benefit from injury prevention programmes that include shoulder strengthening, maintaining shoulder range of motion and ankle stability.
Association of nociplastic and neuropathic pain components with the presence of residual symptoms in patients with axial spondyloarthritis receiving biological disease-modifying antirheumatic drugs
Authors: Al Mohamad Fares , Rios Rodriguez Valeria , Haibel Hildrun , Protopopov Mikhail , Rademacher Judith , Sieper Joachim , Torgutalp Murat , Käding Henriette , Proft Fabian , Poddubnyy Denis 
Published: February 2024

ObjectiveTo evaluate the association of nociplastic (NoP) and neuropathic pain (NP) components with residual symptoms in patients with radiographic axial spondyloarthritis (r-axSpA) receiving biological disease-modifying antirheumatic drugs (bDMARDs).Methods78 patients with r-axSpA from the GErman SPondyloarthritis Inception Cohort receiving a bDMARD for at least 3 months were included in this analysis. The Widespread Pain Index (WPI) and the PainDETECT (PD) questionnaire were used to quantify the NoP and the NP components, respectively. Axial Spondyloarthritis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) were used as measures of residual symptoms. C reactive protein (CRP) was used as a measure of systemic inflammatory activity. Univariable and multivariable regression analyses of disease activity were performed. The regions of the WPI score and items of the PD score were used for cluster analyses.ResultsLinear multivariable regression analysis showed that WPI and PD were independently associated with ASDAS (b=0.1, 95% CI 0.04 to 0.17, and b=0.05, 95% CI 0.02 to 0.08, respectively) and BASDAI (b=0.24, 95% CI 0.08 to 0.39, and b=0.17, 95% CI 0.1 to 0.25, respectively) in r-axSpA patients receiving stable treatment with bDMARDs. Furthermore, WPI and PD were found to be significantly associated with the presence of relevant residual symptoms as defined by BASDAI ≥4 (OR 1.93, 95% CI 1.09 to 4.15, and OR 1.32, 95% CI 1.04 to 1.85, respectively). The effects were present also in patients with normal level of CRP. Cluster analysis revealed three distinct pain distribution profiles and four specific sensory symptom constellations allowing differentiation of different pain subtypes.ConclusionBoth NoP and NP components seem to be associated with residual symptoms in patients with r-axSpA receiving treatment with bDMARDs.