bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluation of a codesigned group cognitive–behavioural therapy intervention for trans young people (TAG TEAM): protocol for a feasibility trial and a subsequent pilot RCT
Authors: Chinsen Alessandra , Cronin Tim J , Pace Carmen C , Tollit Michelle A , Pang Ken C 
Published: January 2024

IntroductionTrans young people are at a higher risk of mental health difficulties such as depression, anxiety and suicidality than their cisgender peers, due in part to their experiences of minority stress. This protocol describes a feasibility trial and subsequent pilot randomised controlled trial (RCT) of a codesigned group cognitive–behavioural therapy intervention for trans young people, named Trans Adolescent Group ThErapy for Alleviating Minority stress (TAG TEAM).Methods and analysisTo evaluate TAG TEAM, we will conduct a feasibility trial followed by a pilot RCT with trans young people aged 14–16 years who have been referred to the Royal Children’s Hospital Gender Service in Melbourne, Australia. In the feasibility trial, we aim to enrol 32 participants who will be randomised at a 1:1 ratio to either in-person or online intervention arms. Participants will be assessed at baseline and post-treatment, with a nested qualitative evaluation post-treatment. Primary outcomes are the feasibility and acceptability of the intervention and the study design and associated procedures, including comparison of the in-person and online delivery modes. In the subsequent pilot RCT, we aim to enrol 64 participants who will be randomised at a 1:1 ratio to an intervention or waitlist control arm, with delivery mode determined by the feasibility trial. Participants will complete assessments at baseline, post-treatment and 3-month follow-up. Primary outcomes are the feasibility and acceptability of the RCT study design. In both the feasibility trial and pilot RCT, participants will complete assessments related to mood, anxiety, suicidality, quality of life, minority stress, family support and social transition. Quantitative data will be analysed using descriptive statistics. Qualitative data will be analysed using thematic and interpretive analysis.Ethics and disseminationThe Royal Children’s Hospital Human Research Ethics Committee has approved this study (#91162). Informed consent will be obtained in writing from all participants and a legal guardian. Findings will inform the development of a full-scale RCT to evaluate the efficacy of TAG TEAM and will be disseminated through conferences and peer-reviewed journals.Trial registration numberACTRN12623000302651, ACTRN12623000318684.
Availability of evidence and comparative effectiveness for surgical versus drug interventions: an overview of systematic reviews and meta-analyses
Authors: Zavalis Emmanuel A , Rameau Anaïs , Saraswathula Anirudh , Vist Joachim , Schuit Ewoud , Ioannidis John P 
Published: January 2024

ObjectivesThis study aims to examine the prevalence of comparisons of surgery to drug regimens, the strength of evidence of such comparisons and whether surgery or the drug intervention was favoured.DesignSystematic review of systematic reviews (umbrella review).Data sourcesCochrane Database of Systematic Reviews.Eligibility criteriaSystematic reviews attempt to compare surgical to drug interventions.Data extractionWe extracted whether the review found any randomised controlled trials (RCTs) for eligible comparisons. Individual trial results were extracted directly from the systematic review.SynthesisThe outcomes of each meta-analysis were resynthesised into random-effects meta-analyses. Egger’s test and excess significance were assessed.ResultsOverall, 188 systematic reviews intended to compare surgery versus drugs. Only 41 included data from at least one RCT (total, 165 RCTs) and covered a total of 103 different outcomes of various comparisons of surgery versus drugs. A GRADE assessment was performed by the Cochrane reviewers for 87 (83%) outcomes in the reviews, indicating the strength of evidence was high in 4 outcomes (4%), moderate in 22 (21%), low in 27 (26%) and very low in 33 (32%). Based on 95% CIs, the surgical intervention was favoured in 38/103 (37%), and the drugs were favoured in 13/103 (13%) outcomes. Of the outcomes with high GRADE rating, only one showed conclusive superiority in our reanalysis (sphincterotomy was better than medical therapy for anal fissure). Of the 22 outcomes with moderate GRADE rating, 6 (27%) were inconclusive, 14 (64%) were in favour of surgery and 2 (9%) were in favour of drugs. There was no evidence of excess significance.ConclusionsThough the relative merits of surgical versus drug interventions are important to know for many diseases, high strength randomised evidence is rare. More randomised trials comparing surgery to drug interventions are needed.
Ultrasound-guided puncture drainage versus surgical incision drainage for deep neck space abscesses: a protocol for a systematic review with meta-analysis and trial sequential analysis
Authors: Nie Wei , Du Li , Chen Guo , Zheng Yongbo , Yang Xibiao , Li Bo , Zhang Weiyi , Zheng Jianqiao 
Published: January 2024

IntroductionDeep neck space abscesses (DNAs) are serious surgical emergencies, associated with life-threatening complications. Surgical incision and drainage combined with antibiotics is the main treatment for DNAs, but drawbacks still exist. Ultrasound-guided puncture drainage is an alternative treatment for some DNAs with limited clinical evidence. Hence, the optimal drainage technique for the treatment of DNAs remains unclear. Therefore, we will perform a protocol for a systematic review and meta-analysis to identify the efficacy of ultrasound-guided puncture drainage for DNAs.Methods and analysisPubMed, Ovid Medline, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure, Wanfang database, VIP database and trial registry databases will be searched from inception to September 2023 to identify randomised controlled trials of patients diagnosed with DNAs accepting ultrasound-guided puncture drainage. The primary outcome will be the length of hospital stay. The secondary outcomes will be the cure rate, incidence of retreatment, complications and overall cost to the healthcare system. Fixed-effects or random-effects model will be used according to the statistical heterogeneity. Mean differences or standardised mean differences with 95% CIs for continuous data and risk ratio (RR) with 95% CIs for dichotomous data. The Cochrane risk-of-bias tool 2, Grading of Recommendations Assessment, Development and Evaluation (GRADE) and trial sequential analysis will be conducted to evaluate the evidence quality and control the random errors. Funnel plots and Egger’s regression test will be performed to evaluate publication bias.Ethics and disseminationEthical approval was not required for this systematic review protocol. The results will be disseminated through peer-reviewed publications.PROSPERO registration numberCRD42023441031.
Wearables for early detection of atrial fibrillation and timely referral for Indigenous people ≥55 years: mixed-methods protocol
Authors: Henson Connie , Rambaldini Boe , Freedman Ben , Carlson Bronwyn , Parter Carmen , Christie Vita , Skinner John , Meharg David , Kirwan Morwenna , Ward Katrina , Speier Sophia Nala 'Ḵixsisa̱'las , Gwynne Kylie 
Published: January 2024

IntroductionDigital health technologies have the potential to provide cost-effective care to remote and underserved populations. To realise this potential, research must involve people not traditionally included. No research focuses on the acceptability and feasibility of older Indigenous people using wearables for early atrial fibrillation (AF) detection. This protocol compares digital augmentation against standard practice to detect AF, evaluate heart health self-efficacy and health literacy changes and identify barriers in collaboration with Aboriginal Community Controlled Health Organisations. It will establish a framework for implementing culturally safe and acceptable wearable programmes for detecting and managing AF in Indigenous adults ≥55 years and older.MethodsThis mixed-methods research will use the Rambaldini model of collective impact, a user-centred, co-design methodology and yarning circles, a recognised Indigenous research methodology to assess the cultural safety, acceptability, feasibility and efficacy of incorporating wearables into standard care for early AF detection.AnalysisQualitative data will be analysed to create composite descriptions of participants' experiences and perspectives related to comfort, cultural safety, convenience, confidence, family reactions and concerns. Quantitative device data will be extracted and analysed via Statistical Product and Service Solutions (SPSS).ConclusionPrioritising perspectives of older Indigenous adults on using wearables for detecting and monitoring cardiovascular disease will ensure that the findings are effective, relevant and acceptable to those impacted.Ethics and disseminationFindings will be published in open-source peer-reviewed journals, shared at professional conferences, described in lay terms and made available to the public. The AHMRC HREC Reference Number approved 1135/15.
Safety and efficacy of combined acupuncture (body and intradermal acupuncture) for dry eye disease: study protocol for a pilot, single-centre, assessor-blinded, randomised, artificial tear drop-controlled trial at Naju Dongshin University Korean Medicine Hospital
Authors: Song Ji-Hoon , Park Soo-Yeon 
Published: January 2024

IntroductionThe prevalence of dry eye disease (DED) has been consistently increasing yearly. However, the radical therapy has not yet been established. This study is to confirm the superiority of acupuncture over artificial tear drops (ATDs) in patients with DED.Methods and analysisThis study is a single-centre, investigator-initiated, assessor-blinded, parallel randomised controlled trial. 30 participants will be enrolled. Over a period of 4 weeks, the experimental group would receive two kinds of acupuncture three times a week. First, body acupuncture would be performed on bilateral BL2, GB14, TE23, EX-HN5 and ST1 for 15 min. Thereafter, intradermal acupuncture would be performed on the same acupoints for 4 hours. On the other hand, the control group would apply the provided ATD at least four times a day. As a rescue medication for severe DED symptoms, both groups can additionally apply ATD. The frequency of ATD use would be recorded during the trial. The primary outcomes are the Ocular Surface Disease Index and tear film break-up time. The secondary outcomes are subjective symptom Visual Analogue Scale, quality of life, Schirmer I test, tear lactoferrin level, treatment satisfaction and safety. The outcomes would be mostly assessed at visits 1, 13 and 14.Ethics and disseminationThis study was approved by the institutional review board of Naju Dongshin University Korean Medicine Hospital (Approval No. NJ-IRB-23-5). The obtained results will be disseminated through publication in a peer-reviewed journal.Trial registration numberKCT0008563.
Psychometric properties of the living with long term conditions scale in an English-speaking population living with long term conditions in the UK
Authors: Ambrosio Leire , Hislop-Lennie Kelly , Serrano-Fuentes Nestor , Driessens Corine , Portillo Mari Carmen 
Published: January 2024

ObjectiveTo present the psychometric properties of the living with long-term condition (LwLTCs) scale in an English-speaking population of people with different LTCs.DesignAn observational and cross-sectional study, with retest was conducted. Psychometric properties including feasibility, internal consistency, confirmatory factor analysis, reproducibility and content validity were tested.SettingThe study took place across the UK via primary care surgeries and voluntary organisations, between December 2021 and June 2022.ParticipantsThe study included 577 patients living with different LTCs, as chronic obstructive pulmonary disease, arthritis, chronic heart failure, Parkinson’s disease, chronic kidney disease and type 2 diabetes mellitus. Inclusion criteria included: (a) having been diagnosed with one or more of the conditions; (b) being able to read, understand and answer written questionnaires; (c) being fluent in English and (d) being able to provide written informed consent. Patients were involved in the design and pilot study of the scale.ResultsA total sample of 577 people with an age range of 37–97 years (98±9.65) were recruited. Internal consistency of the total 26-item LwLTCs scale score was excellent (ordinal alpha=0.90) but confirmatory factor analysis showed better fit indices (Normed Fit Index=0.96; standardised root mean square residual=0.051; Goodness of Fit Index=0.98) for a 20-item LwLTCs scale.ConclusionsA shorter version of the LwLTCs scale, with just 20 items and with excellent psychometric properties, is recommended. Having a short scale is key when considering the implementation of the scale in clinical practice to develop person-centred pathways and more comprehensive care plans.
Risk factors and glycaemic control in small-for-gestational-age infants born to mothers with gestational diabetes mellitus: a case–control study using propensity score matching based on a large population
Authors: Li Jianing , Pan Yuqing , Zheng Qingxiang , Chen Xiaoqian , Jiang Xiumin , Liu Rulin , Zhu Yu , Huang Ling 
Published: January 2024

BackgroundSmall for gestational age (SGA) poses a significant concern for newborns, being linked to neonatal complications and potential metabolic disorders in adulthood, especially when born to mothers with gestational diabetes mellitus (GDM), elevating their risk of complications and mortality. However, the pregnancy risk factors and glycaemic control associated with SGA infants born to mothers with GDM remain unclear.AimTo identify the pregnancy risk factors and glycaemic control associated with SGA infants born to mothers with GDM.MethodThis case–control study was conducted among 1910 women with GDM in China. Data were collected by the integrated electronic medical record system. Using 1:4 propensity score matching analysis, we adjusted for gestational age as confounder. Univariate and multivariate analyses were performed to identify risk factors.ResultsRisk factors for SGA born to mothers with GDM included a history of low birth weight, gestational hypertension, oligohydramnios, short maternal height, underweight pre-pregnancy body mass index and inadequate weight growth. While SGA was protected by weakly positive ketonuria levels in the first trimester, multiparous, anaemia and previous uterine scar were protective factors for SGA. Moreover, 2-hour postprandial glucose and haemoglobin A1c in the second trimester, as well as the 0-hour and 2-hour 75 g oral glucose tolerance test (OGTT) were linked to risk of SGA.ConclusionsSGA infants are the result of multifactorial interactions among GDM pregnant women. Notably, glycaemic control levels were associated with SGA. There is a need for enhanced perinatal monitoring and antenatal care to reduce SGA.
Incidence of community-acquired pneumonia among children under 5 years in Suzhou, China: a hospital-based cohort study
Authors: Qian Chen , Chen Qinghui , Lin Wanjing , Li Zhaojing , Zhu Jun , Zhang Jun , Luan Lin , Zheng Benfeng , Zhao Genming , Tian Jianmei , Zhang Tao 
Published: January 2024

ObjectivesTo depict the seasonality and age variations of community-acquired pneumonia (CAP) incidence in the context of the COVID-19 impact.DesignRetrospective cohort study.ParticipantsThe observational cohort study was conducted at Soochow University Affiliated Children’s Hospital from January 2017 to June 2021 and involved 132 797 children born in 2017 or 2018. They were followed and identified CAP episodes by screening on the Health Information Systems of outpatients and inpatients in the same hospital.OutcomeThe CAP episodes were defined when the diagnoses coded as J09–J18 or J20–J22. The incidence of CAP was estimated stratified by age, sex, birth year, health status group, season and month, and the rate ratio was calculated and adjusted by a quasi-Poisson regression model. Stratified analysis of incidence of CAP by birth month was conducted to understand the age and seasonal variation.ResultsThe overall incidence of CAP among children aged ≤5 years was 130.08 per 1000 person years. Children aged ≤24 months have a higher CAP incidence than those aged >24 months (176.84 vs 72.04 per 1000 person years, p<0.001). The CAP incidence increased from October, peaked at December and January and the highest CAP incidence was observed in winter (206.7 per 1000 person years, 95% CI 204.12 to 209.28). A substantial decline of CAP incidence was observed during the COVID-19 lockdown from February to August 2020, and began to rise again when the communities reopened.ConclusionsThe burden of CAP among children is considerable. The incidence of CAP among children ≤5 years varied by age and season and decreased during COVID-19 lockdown.
Effects of liposomal bupivacaine in preoperative fascia iliac block on postoperative pain and delirium in elderly patients undergoing hip fracture surgery: a study protocol for a randomised, parallel controlled prospective clinical study
Authors: Hao Yingxiang , Li Weiwen , Zheng Minjia , Li Xiang , Wu Xinwan , Yu Zhuang , Liu Shen , Li Jinbao , Xu Hongjiao 
Published: January 2024

IntroductionPostoperative delirium (POD) is the most common acute fluctuating mental state change after hip fractures in older adults. Postoperative pain is a Grade A risk factor for POD and is closely related to the prognosis of patients undergoing hip fracture surgery. The fascia iliac block has a definite analgesic effect and few side effects, and several studies have reported that it reduces the occurrence of POD in patients undergoing general anaesthesia for hip fracture surgery. Liposomal bupivacaine is a local anaesthetic with a long half-life that significantly reduces the use of opioids and is conducive to patient prognosis and recovery. However, whether regional nerve block analgesia can decrease the occurrence of POD in elderly patients undergoing hip fracture surgery has not been reported.Methods and analysisThis is a single-blinded, randomised, parallel-controlled prospective clinical study. Participants will be randomly assigned preoperatively to either the liposomal bupivacaine (ie, Exparel) or ropivacaine groups by block randomisation. Then, the occurrence of POD (primary outcome) and postoperative pain (secondary outcome) will be evaluated.Ethics and disseminationThis research protocol complies with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 guidelines and is approved by the Ethics Committee of Shanghai General Hospital (ID 2023–437). The original data are expected to be released in July 2029 on the ResMan original data-sharing platform (IPD-sharing platform) of the China Clinical Trial Registry, which can be viewed on the following website:http://www.medresman.org.cn.PROSPERO registration numberChiCTR2300074022.
Improving healthcare student experience of clinical placements
Authors: Rowland Esther , Trueman Hayley 
Published: January 2024

There is an expanding workforce gap in the NHS. Alongside national programmes to train, recruit and retain staff, efforts are needed on a local level. Clinical placements can make up to a third of healthcare student’s time while at university thus placement experience is an important factor to reducing attrition rates at universities and increase conversion rates from student to qualified professional. This quality improvement project aimed to increase reported rates of students’ satisfaction to 100% for each item of the student experience survey by March 2024 within Berkshire Healthcare National Health Service (NHS) Foundation Trust.To gain a deeper understanding of the experience and problems within healthcare student clinical placements interviews of students and staff were conducted alongside a literature review, which revealed six key themes around student placement experience: belonging and acceptance, familiarity and continuity, confidence and competence, preparation and preparedness, supervision and support, feeling overwhelmed/stress/impact on social and emotional health. These themes were translated into a student experience survey to achieve baseline and subsequent measurements.Changes were introduced to improve student satisfaction with clinical placements based on the baseline data of student satisfaction reported in the first student experience survey. Changes included introducing student inductions, better access to IT, student induction packs and newsletters. While the quantitative measurements of the items on the student experience survey remained positive, the nature of the qualitative feedback reflected the impact of the changes. Additionally, the improved communication and collaboration across teams because of the process highlighted the need for clear streamlined administrative processes. Regular review of student feedback has enabled timely feedback processes to placements and visible follow-up for students, highlighting the investment in them as the future workforce.
Unmet need for healthcare in the Russian Federation: subnational retrospective modelling analysis (2014–2018)
Authors: Nikoloski Zlatko , Somanathan Aparnaa , Shkolnikov Vladimir M , Sheiman Igor , Mossialos Elias 
Published: January 2024

IntroductionUnmet need for healthcare is a proxy indicator used to assess the performance of healthcare systems throughout the world. While the Russian Federation is committed to improving healthcare for its citizens, barriers to access remain.MethodsUsing data from a region-level survey, we document and analyse the extent of the unmet need for healthcare at both national and subnational levels in the Russian Federation for the years 2014–2018. We used a panel fixed effects modelling approach to examine the link between unmet need and its correlates at the subnational level. We also used data from various sources that addressed the reasons underlying unmet need to interpret the findings from the modelling analysis.ResultsApproximately one-third of the Russian population (34.7% in 2018) reported that healthcare was not received when it was needed with little change observed between 2014 and 2018. We observed significant variation across the various regions in Russia. The prevalence of unmet need was substantially higher in the regions of the Volga, Siberia and Far East Federal Districts. Our analysis revealed that the density of hospital beds and economic development across regions were correlated with the prevalence of unmet need. Dissatisfaction with healthcare services, perceived lack of effective treatments and financial constraints were the main reasons offered for forgoing healthcare when needed.ConclusionsAn unanticipated positive link between unmet need and hospital bed density might be attributed to the low accessibility and quality of primary healthcare. High demand and supply of inpatient care do not compensate for the structural imbalances of the current healthcare model. Strengthening and improving the quality of primary care might significantly reduce the prevalence of unmet need.