bluuebunny/crossref_metadata_2025_split huggingface dataset:
tREatment of trIaNgular FibrOcaRtilage ComplEx Ruptures (REINFORCER): protocol for randomised, controlled, blinded, efficacy trial of triangular fibrocartilage complex tears
Authors: Kaivorinne Antti , Räisänen Mikko Petteri , Karjalainen Teemu , Jokihaara Jarkko , Gvozdenovic Robert , Wilcke Maria , Reito Aleksi , Anttila Turkka , Pönkkö Annele , Lauridsen Carsten , Tanskanen Tuukka , Mattila Ville M 
Published: December 2024

IntroductionTriangular fibrocartilage complex (TFCC) tear is often considered to be the cause of ulnar wrist pain. The primary treatment typically involves non-operative methods; however, in cases of persistent symptoms, operative intervention has been proposed as a viable option. Depending on the tear’s morphology, treatment may involve debridement (central or radial tear) or repair (peripheral tear). Efficacy of operative treatment has not been studied in a randomised controlled trial.Methods and analysisThis is a prospective, randomised, controlled, blinded multicentre trial, with two randomisation stratums. The first stratum includes central or radial TFCC tears, while the second stratum comprises peripheral TFCC tears. Each stratum consists of two parallel 1:1 arms, comparing the efficacy of (1) debridement of central or radial tear with placebo surgery and (2) repair of peripheral tear with physiotherapy. Participants are recruited from secondary and tertiary referral hospitals in Denmark, Finland and Sweden.Primary outcome is the Patient-Rated Wrist Evaluation (PRWE) at 1 year. Secondary outcomes include subjective and objective outcome measures at 6 months, 1, 2, 5 and 10 years follow-ups.Ethics and disseminationThe trial was approved by the Pirkanmaa Hospital District Institutional Review Board in March 2020. All participants will be asked to give a written informed consent. The results of the trial will be disseminated as published articles in peer-reviewed journals.Trial registration numberNCT04576169.
Knee osteotomy combined with meniscal allograft transplantation versus knee osteotomy alone in patients with unicompartmental knee osteoarthritis: a prospective double-blind randomised controlled trial protocol
Authors: Zanasi Lorenzo , Boffa Angelo , De Marziani Luca , Lisignoli Gina , Belvedere Claudio , Miceli Marco , Zaffagnini Stefano , Filardo Giuseppe , Di Martino Alessandro 
Published: December 2024

IntroductionKnee osteotomy combined with meniscal allograft transplantation (MAT) showed promising results to treat unicompartmental knee osteoarthritis (OA) secondary to meniscal deficiency and knee malalignment. However, there is still no high-level evidence to demonstrate whether the combination of these two treatments is superior to osteotomy alone.Methods and analysis52 patients with unicompartmental knee OA Kellgren-Lawrence grade ≤3 secondary to meniscal deficiency and knee malalignment (aged 20–60 years) are randomised to undergo knee osteotomy associated with MAT or knee osteotomy alone in a 1:1 ratio. The primary outcome is the International Knee Documentation Committee (IKDC) subjective score at 12 months. The secondary outcomes are the IKDC subjective score at 1, 3 and 6 months, the Western Ontario and McMaster Universities Osteoarthritis Index score, the Knee Injury and Osteoarthritis Outcome Score, the Visual Analogue Scale, the EuroQol Visual Analogue Scale, the Tegner Activity Level Scale, objective parameters (transpatellar circumference, suprapatellar circumference and range of motion), patient expectation on treatment efficacy and patient satisfaction at 1, 3, 6 and 12 months. Radiographs are performed at baseline and at 1-, 6- and 12-month follow-ups and magnetic resonance evaluations at baseline and at 12 months. Biomechanical assessment is performed through gait analysis before surgery and at 12 months, investigating motion data, biomechanical parameters and muscle activation through electromyography. In addition, to detect early joint environment changes and potential MAT effects in protecting the articular surface providing a better knee homeostasis, biological markers of cartilage turnover and inflammation obtained from synovial fluid, serum and urine are evaluated at baseline and at 24 hours, 1-, 3-, 6- and 12-month follow-ups.Ethics and disseminationThe study protocol has been approved by Emilia Romagna’s Ethics Committee (CE-AVEC), Bologna, Italy. Written informed consent is obtained from all participants. Findings of this study will be disseminated through peer-reviewed publications and conference presentations.Protocol versionMarch 2023.Trial registration numberNCT05840887.
Cost-effectiveness of percutaneous mitral repair for patients with severe secondary mitral regurgitation: an updated evaluation using a modelling approach based on COAPT final data after 5-year follow-up
Authors: Connock Martin , Auguste Peter , Obadia Jean-François , Armoiry Xavier 
Published: December 2024

ObjectivesTo evaluate the cost-effectiveness of percutaneous repair (PR) for secondary mitral regurgitation.DesignAn economic evaluation using a time-varying Markov model comprising three states to assess the cost and effectiveness of PR added to guideline-directed medical treatment (GDMT) compared with GDMT alone. Clinical outcomes considered within the model were overall survival and heart failure (HF) hospitalisations (HFH), and the incremental cost-effectiveness ratio (ICER) was calculated. Cost data were derived from a literature search. Sensitivity analyses were undertaken.SettingThe French healthcare system perspective assuming a lifetime horizon.ParticipantsPublished data at 5 years obtained from patients enrolled in the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation study.ResultsIn our base case, we chose cubic spline models to extrapolate overall survival, and we used log-logistic models to estimate cumulative HFH. After discounting, the model generated life-years of 3.843 years and 3.055 years for PR+GDMT and GDMT, respectively. Discounted total quality-adjusted life-year (QALY) values were 2.572 and 1.945 for PR+GDMT and GDMT, respectively (incremental 0.627 QALY). Discounted total costs were €42 709 and €20 732 for the intervention and the control groups, respectively (incremental €21,977), resulting in an ICER of €35,068/QALY. At a threshold of €50 000 per QALY, PR had a 0.85 probability of being cost-effective.ConclusionUpdated trial data have enabled investigators to provide a more reliable estimation of the ICER, which suggests that PR has good value for money compared with GDMT alone.
Exploring the landscape of Canadian midwifery research: strengths, gaps and priorities – results of a scoping review
Authors: Ruby Emma , Brunton Ginny , Rack Joanne , Al Balkhi Sofia , Banfield Laura , Grenier Lindsay N , Ghandi Shikha , Ahmed Maisha , Hutton Eileen Katherine , Darling Elizabeth Kathleen , Mattison Christina , Kaufman Karyn , Murray-Davis Beth 
Published: December 2024

ObjectivesThe 2014 Lancet Series on Midwifery developed the Quality of Maternal and Newborn Care (QMNC) framework outlining care needed for all childbearing people and newborns. Furthermore, this was a global call to action to invest in research capacity building. While evidence-informed care is a cornerstone of midwifery practice, there has been limited exploration of how Canadian midwifery research priorities within the Canadian context align with the global framework. In response to the call from the Lancet series, this scoping review aimed to investigate the current strengths and gaps of midwifery research in Canada. Secondarily, our goal was to map existing Canadian evidence to the QMNC framework to guide future priority setting and build research capacity.DesignA scoping review.Data sourcesWe searched nine electronic databases for articles up to 2022, inclusive: AMED (Allied and Complementary Medicine), CINAHL, EconLit, EMBASE, HealthSTAR, MEDLINE, PsycINFO, EmCare and Web of Science.Eligibility criteria for selecting studiesWe included research conducted by (a) Canadian midwives on Canadian and non-Canadian populations, (b) international midwives on Canadian midwifery populations or (c) non-midwife researchers on Canadian midwifery populations.Data extraction and synthesisWe analysed data using categories from the Lancet Series’ QMNC framework. At least two independent reviewers conducted screening and data extraction.ResultsWe identified 590 articles for inclusion. Most Canadian midwifery research is related to organisation of care and care providers, clinical practice categories including promoting normal physiological processes during pregnancy, research pertaining to prenatal and intrapartum periods, and policy. Research gaps included neonatal and postpartum outcomes, midwifery education, and midwifery values and philosophy. Lastly, there were gaps in the number of randomised trials and systematic reviews, which may impact guidance of clinical decision-making.ConclusionsThere has been an exponential increase in midwifery-led research in Canada. Assessment against the QMNC framework has highlighted gaps related to research conduct, clinical and non-clinical research focuses. Identifying midwifery research priorities is an important next step of consolidating Canadian research evidence. Future directions may include collaboration with midwifery stakeholders to prioritise research topics related to improving care for clients, strengthening the profession and building research capacity.
Alienation and/or anomie in pharmacists: a protocol for a narrative systematic review
Authors: Forsyth Paul , Maguire Barry , O'Brien Robert , Carey James , Rushworth Gordon F , Cunningham Scott , Radley Andrew 
Published: December 2024

IntroductionEpisodes of alienation and/or anomie in pharmacists have been reported in historical accounts since the 19th century. Alienation and anomie are distinct types of psychological or social ills where people are problematically separated from, or their skills and values are misaligned with, others and their environment. Alienation and/or anomie can be important precursors of many negative work experiences, including job dissatisfaction, burnout and/or intention to leave.Methods and analysisWe aim to study alienation and/or anomie in pharmacists from across the globe, reviewing all types of methodological designs, published in peer-reviewed journals, including all primary qualitative, quantitative and/or mixed-method research studies. We will narratively describe any focuses, causes, associated factors and/or consequences of alienation and/or anomie. We will identify all published peer-reviewed research by searching seven electronic databases (MEDLINE, Embase, APA PsychINFO, CINAHL Plus, Cochrane Library, Web of Science Core Collection and Scopus) and Google Scholar in May 2024. Extensive hand and citation-searching will also take place. Two independent reviewers will identify eligible studies, conduct a critical appraisal of the study conduct, extract data and synthesise reported findings by narratively exploring relationships within and between studies. The synthesis will follow a hybrid thematic analysis. Initially, we will deductively structure the findings according to six themes from underpinning alienation and anomie theory: Care, Values, Meaning, Recognition, Autonomy and Shared Responsibility. This structure may thereafter be inductively adapted, by creating new additional themes, if required from the data. A GRADE Confidence in the Evidence from Reviews of the Qualitative research approach will be used to determine a confidence profile of each theme. A thematic map showing the links between themes will also be produced.Ethics and disseminationEthical permission is not required, as this study uses data from published research. Dissemination will be through publication in peer-reviewed journals and conference presentations.PROSPERO registration numberCRD42024536336.
Multimodal prehabilitation combined with perioperative enhanced recovery after surgery care for older patients undergoing spinal fusion surgery in China: protocol for a multicentre randomised controlled trial (PRACTICE trial)
Authors: Wang Shuai-Kang , Wang Peng , Wang Wei , Lu Shibao 
Published: December 2024

IntroductionBesides the comorbid risk factors shared by older and younger patients, older individuals may also experience malnutrition, as well as cognitive or functional impairments. The accumulation of frailty and various geriatric syndromes in older individuals results in decreased physiological reserves, which makes the recovery process after spine surgery particularly challenging. Theoretically, combining the presurgery optimisation provided by a multimodal prehabilitation programme with the reduction of surgical stress provided by an enhanced recovery after surgery (ERAS) programme could improve postoperative recovery of older patients.Methods and analysisThis is a prospective, multicentre, assessor-blinded, randomised controlled study. Patients who are 75 years of age or older and are scheduled for spinal fusion surgery will be enrolled on three academic medical centres. Regular preadmission education and perioperative ERAS care will be given to participants who were randomised to the control group. Participants randomised to the intervention group will receive multimodal prehabilitation combined with ERAS (PREERAS) management. We will include 164 patients with spinal fusion in three hospitals in China. All included patients will be followed for 90 days after surgery or until death. The primary outcome is the Comprehensive Complication Index (CCI), which ranges from 0 to 100, where a score of 100 indicates death due to complications. Secondary outcomes include length of stay and non-home discharge, rates of postoperative complications and unplanned readmission, North American Spine Society satisfaction, and Oswestry Disability Index/Neck disability index. Ninety-day CCI will be compared between groups using linear regression. Other continuous or categorical outcomes will be compared using linear or logistic regression.Ethics and disseminationThis study has received ethical approval from the Xuanwu Hospital of Capital Medical University Ethics Committees (2024-088-001). The findings will be submitted to a peer-reviewed journal for publication.Trial registration numberNCT06140797.
Effectiveness and cost-effectiveness of a structured integrated post-pulmonary embolism follow-up care model (Attend-PE): a rationale and protocol for a multicentre clinical pre-post study
Authors: Rolving Nanna , Lindegaard Stine Foged , Johnsen Søren Paaske , Grove Erik Lerkevang , Kümler Thomas , Valentin Jan Brink , Risør Bettina Wulff , Klok Frederikus A , Konstantinides Stavros , Højen Anette Arbjerg 
Published: December 2024

IntroductionPatients with pulmonary embolism (PE) experience impaired functional ability and reduced quality of life long after discharge from the hospital. However, there are no structured follow-up programmes in Denmark for these patients, and there is considerable variation in practice patterns of post-PE management. No studies have investigated the effectiveness of structured follow-up care models in patients with PE. This study aims to investigate the effect and cost-effectiveness of a structured integrated post-pulmonary embolism follow-up care model (Attend-PE) compared with usual care. The Attend-PE model outlines a structured approach for in-hospital follow-up, involving group-based patient education, individual consultations and systematic use of patient-reported outcome measures to assess the patient’s physical and psychological well-being.Methods and analysisThe study is conducted in Denmark, where the healthcare system is tax-funded and services are freely available for all citizens, with an expected inclusion of 2000 patients in total. A pre-post-intervention study design is used to compare outcomes in the post-implementation cohort with the pre-implementation cohort. The co-primary outcomes are (1) health-related quality of life (patient-reported outcome, PRO) and (2) adherence to medical treatment (register-based data). Secondary outcomes include PROs on disability, treatment satisfaction, self-management, anxiety, depression and work productivity, and register-based outcomes, including recurrent PE, bleeding, mortality and healthcare use. Register-based data will be assessed at baseline (date of PE event), 6 and 12 months, while PRO-data will be assessed at 6 and 12 months after the PE event. The health economic evaluation of the Attend-PE model will include a cost-effectiveness analysis and a cost-utility analysis.Ethics and disseminationThe project will be conducted by the Declaration of Helsinki. In accordance with the Danish Act on Health Research Ethics §14, the study is exempt from approval. The use of survey responses in research (in anonymous form) is, however, contingent on participants’ consent, and the invitation letter therefore included information about the purpose of the study and participants’ rights to withdraw consent at any time, and that completion of the questionnaire is considered as consent to their survey data to be included in research.Study findings will be disseminated in scientific peer-reviewed journals, at national and international conferences, and for staff and decision-makers at participating hospitals and patients and relatives via the Danish Heart Association.Trial registration numberClinicaltrials.govNCT06037096.
Typologies of activity-related behaviours during adolescence and their transitions: a longitudinal analysis of the ELSPAC cohort
Authors: Janda David , Gába Aleš , Contardo Ayala Ana María , Timperio Anna , Andrýsková Lenka , Piler Pavel , Arundell Lauren 
Published: December 2024

ObjectivesThe objective of this study was to identify typologies of activity-related behaviours during adolescence and to explore transitions between the identified typologies. Additionally, we aimed to identify demographic indicators associated with the transitions and typology membership.DesignProspective cohort study.SettingCzech Republic.ParticipantsIndividuals involved in the Czech part of the European Longitudinal Study of Pregnancy and Childhood study, aged 11 to 18 years. The study involved over 563 individuals, of whom 380 provided complete data for the analysis.Primary outcome measuresTime spent outdoors, participation in organised physical activity (PA) and sport activities, time spent watching television and using a personal computer, and total sleep duration at ages 11, 15 and 18 years. Typologies were identified using Latent Transition Analysis.ResultsFour typologies of activity-related behaviours were identified and labelled to reflect their behavioural profiles: (1)Actives(high outdoor time and organised PA and sport participation, low screen time and optimal sleep duration); (2)Active screeners(median outdoor time, high organised PA and sport participation, high screen time, and optimal sleep duration); (3)Poor sleepers(average outdoor time and organised PA and sport participation, low screen time and not meeting sleep guidelines) and (4)Averages(average duration of all behaviours and optimal sleep duration). A major shift in typology membership from 11 to 18 years was observed, with a decreasing proportion of individuals in typologies characterised by a high proportion of outdoor time and participation in organised PA and sport activities (ie,Actives;Active screeners). A high proportion of individuals also transitioned to the typology with poor sleeping habits (ie,Poor sleepers). Sex and maternal education were associated with the typology membership and transition probabilities (p<0.05).ConclusionsTargeting lifestyle interventions to those with specific lifestyle patterns in early adolescence may be beneficial for reducing the risk of poor sleep and promoting healthy lifestyle patterns later in life.
Customised 96-ocular TaqMan (iCAM) microarray PCR card for rapid diagnosis of microbial keratitis
Authors: Yang Yunfei , Roble Ahmed , Deshmukh Rashmi , Myerscough James , Curran Martin D , Rajan Madhavan S 
Published: December 2024

AimTo validate the diagnostic performance of a custom 96-micro-organism TaqMan PCR card (iCAM) for microbial keratitis (MK) from a single corneal epithelial sample.MethodsPatients over the age of 18 referred to Cambridge University Hospital with MK were recruited in this single-site prospective cohort study between September 2021 and January 2023. An ocular-specific, customised microarray card (iCAM) was constructed according to primer and probe nucleotide sequences developed in our department to detect bacteria, viruses,Acanthamoebaand fungi commonly implicated in MK using a single corneal epithelial sample. Part of the corneal epithelial sample was taken for conventional cultures per local protocol, followed by iCAM array. Microbial detection rate and positive predictive value (PPV) were evaluated.Results38 corneal epithelial samples from 32 patients with MK and 4 control samples from healthy participants were obtained from 36 consecutive patients. A causative microbe was isolated in 15/34 samples (44%) using the iCAM test, compared with 15 by conventional methods (44%). iCAM test processing time varied between 6 and 24 hours compared with up to 7 days for conventional tests. Combined, the microbial detection rate was 65%, with the correlation between methods at 62%. The iCAM test could detect all major micro-organism groups with 56% sensitivity and 60% PPV.ConclusionsThe iCAM test can detect bacterial, fungal, viral and protozoan organisms using one corneal epithelial sample. The limitations include small patient cohort size and reduced volume of available corneal epithelial sample when shared between the iCAM PCR test and conventional culture methods utilised in the study. A multicentre trial is being planned to validate the clinical impact of using iCAM test on accuracy of diagnosis, early institution of appropriate antimicrobials and clinical outcomes.Trial registration numberISRCTN17422545.
Acceptability of artificial intelligence in breast screening: focus groups with the screening-eligible population in England
Authors: Gatting Lauren , Ahmed Syeda , Meccheri Priscilla , Newlands Rumana , Kehagia Angie A , Waller Jo 
Published: December 2024

IntroductionPreliminary studies of artificial intelligence (AI) tools developed to support breast screening demonstrate the potential to reduce radiologist burden and improve cancer detection which could lead to improved breast cancer outcomes. This study explores the public acceptability of the use of AI in breast screening from the perspective of screening-eligible women in England.Methods64 women in England, aged 50–70 years (eligible for breast screening) and 45–49 years (approaching eligibility), participated in 12 focus groups—8 online and 4 in person. Specific scenarios in which AI may be used in the mammogram reading process were presented. Data were analysed using a reflexive thematic analysis.ResultsFour themes described public perceptions of AI in breast screening found in this study: (1)Things going wrong and being missedsummarises a predominant and pervasive concern about an AI tool being used in breast screening; (2)Speed of change and loss of controlcaptures a positive association of AI with technological advances held by the women but also feelings of things being out of their control, and that they were being left behind and in the dark; (3)The importance of humansreports concern around the possibility that AI excludes humans and renders them redundant and (4)Desire for thorough research, staggered implementation and double-checkingof scans included insistence that any AI be thoroughly trialled, tested and not solely relied on when initially implemented.ConclusionsIt will be essential that future decision-making and communication about AI implementation in breast screening (and, likely, in healthcare more widely) address concerns surrounding (1) the fallibility of AI, (2) lack of inclusion, control and transparency in relation to healthcare and technology decisions and (3) humans being left redundant and unneeded, while building on women’s hopes for the technology.