bluuebunny/crossref_metadata_2025_split huggingface dataset:
Adjunct role of potassium-rich vegetarian diet and a novel potassium food supplement to improve pain in chronic rheumatoid arthritis on supervised standard care: a randomised controlled study
Authors: Kianifard Toktam , Saluja Manjit , Sarmukaddam Sanjeev , Venugopalan Anuradha , Chopra Arvind 
Published: January 2024

IntroductionAn earlier food survey showed dietary potassium deficiency in rheumatoid arthritis (RA).ObjectiveTo evaluate an adjunct role of oral potassium to reduce joint pain in RA.Methods172 consenting eligible symptomatic patients (median duration 6.5 years) on standard care were randomised into an assessor blind, parallel efficacy, controlled, prospective, multiarm single-centre study (80% power, drug trial design) of 16 weeks duration—arm A (potassium-rich vegetarian diet), arm B (arm A plus novel potassium food supplement) and arm C (control, regular diet). Standard efficacy (American College of Rheumatology recommendation) and safety and diet intake (3-day recall) were assessed at monthly intervals (protocol). Standard soft-ware package (SPSS V.20) was used for statistical analysis; analysis of variance), Mann-Whitney statistic and χ2test.; significant p<0.05, two sided). Study arms were found matched at baseline. Background RA medication remained stable. Preset target for increased potassium intake (India standards) were mostly achieved and participants remained normokalemic.Results155 patients (90.1%) completed the study and several showed improvement (maximum improved measures in arm B). Potassium intervention was safe and well tolerated. Adverse events were mild; none caused patient withdrawal. On comparison, the mean change in pain visual analogue scale (−2.23, 95% CI −2.99 to −1.48) at week 16 (primary efficacy) from baseline was significantly superior in arm B (per protocol analysis). A high daily potassium intake (5–7.5 g, arm B) was significantly associated with low pain (study completion); OR 2.5 (univariate analysis), likelihood ratio 2.9 (logistic regression). Compliance (intervention), diet record and analysis, RA medication and absence of placebo were potential confounders.ConclusionHigh oral potassium intake, based on a suitable vegetarian diet and food supplement, reduced joint pain and improved RA. It was a safe adjunct to standard care, Further validation studies are required.Trial registrationCTRI/2022/03/040726; Clinical Trial Registry of India.
Prevalence and short-term change in symptoms of anxiety and depression following bariatric surgery: a prospective cohort study
Authors:   On behalf of The By-Band-Sleeve Collaborating Group
Published: January 2024

ObjectivesBariatric surgery is an effective treatment for severe obesity that leads to significant physical health improvements. Few studies have prospectively described the short-term impact of surgery on mental health using standardised case-finding measures for anxiety or depressive disorders. This study describes the prevalence and short-term course of these conditions following surgery.DesignProspective observational cohort study.Setting12 National Health Service centres in England.ParticipantsParticipants studied took part in the By-Band-Sleeve study, a multicentre randomised controlled trial evaluating the surgical management of severe obesity. We included participants who had undergone surgery (gastric bypass, gastric band or sleeve gastrectomy) within 6 months of randomisation.Primary and secondary outcome measuresAnxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline and 12 months post-randomisation. Sociodemographic variables collected at prerandomisation included body mass index, age, sex, ethnicity, marital status, tobacco use, employment status and income band.ResultsIn our sample of 758 participants, 94.5% (n 716) and 93.9% (n 712) had completed baseline anxiety (HADS-A) and depression (HADS-D) subscales. At pre-randomisation 46.1% (n 330/716, 95% CI 42.4% to 49.7%) met clinical case criteria for anxiety and 48.2% (n 343/712, 95% CI 44.5% to 51.8%) for depression. Among participants returning completed 12 months post-randomisation questionnaires (HADS-A n 503/716, HADS-D n 498/712), there was a significant reduction in the proportion of clinical cases with anxiety (−9.5%, 95% CI −14.3% to -4.8% p<0.001) and depression (−22.3%, 95% CI −27.0% to −17.6% p<0.001).ConclusionsAlmost half of people undergoing bariatric surgery had underlying anxiety or depressive symptoms. In the short term, these symptoms appear to substantially improve. Future work must identify whether these effects are sustained beyond the first post-randomisation year.Trial registration numberNCT02841527andISRCTN00786323.
Scope, range and effectiveness of interventions to address social norms to prevent and delay child marriage and empower adolescent girls: a systematic review
Authors: Greene Margaret E. , Edmeades Jeffrey , Siddiqi Manahil 
Published: January 2024

ObjectivesHarmful gender and social norms prescribe divergent opportunities for girls and boys and drive child marriage. This systematic review examines the scope, range and effectiveness of interventions to change social norms and delay child marriage.DesignWe systematically assess the contributions made by interventions that work to shift norms to prevent child marriage or to limit its harmful consequences. Our analysis classifies each study’s quality in evaluation and implementation design regarding shifting norms.Data sourcesWe conducted a search of electronic databases (PubMed, PsycINFO, Embase, CINAHL Plus, Popline, Web of Science and Cochrane Library) and grey literature (targeted hand-searches of 15 key organisations and Google Scholar).Eligibility criteriaIncluded interventions sought to change norms related to child marriage, were evaluated in experimental or quasi-experimental evaluations, collected data on age at marriage and norms/attitudes, and were published in English from January 2000 to September 2021.Data extraction and synthesisWe used a standardised form to extract data from all eligible studies, and double-screened to validate coding and reporting. We classified the studies by low, medium and high quality for evaluation and risk of bias, and separately by the extent to which they addressed social norms.ResultsOur assessment of the 12 eligible studies identified revealed little evidence of a systematic relationship between social norms related to marriage and changes in child marriage behaviours. We found stronger evidence of programme effect on child marriage outcomes than on social norms, though only a minority of studies found an effect for either. Studies that appeared effective in changing child marriage norms varied greatly in scale and extent of programming, and few attempted to identify the appropriate reference groups for measuring social norms.ConclusionThe studies evaluated by our review provide only weak evidence on the impact of interventions on norms, and on the link between shifts in norms and marriage behaviour.
Effect of extracorporeal shock wave combined with Kinesio taping on upper limb function during individuals with biceps brachii tendinopathy：protocol for a double-blind, randomised controlled trial
Authors: Liu Kun , Yin Lulu , Zhang Ye , Huang Lihua , Liu Gongliang , Zhu Ran , Fang Ping , Ma Yanhong , Ma Zheng 
Published: January 2024

IntroductionLong head of biceps brachii tendinopathy (LHBT) is characterised by persistent pain and disability of shoulder joint, impairing patients’ quality of life. Extracorporeal shock wave therapy (ESWT) is a non-invasive treatment, which promotes tissue regeneration and repair. However, ESWT has a side effect that often causes short-term pain and swelling in the treatment area. It is known that the effects of Kinesio taping (KT) on relieving swelling and pain. Due to insufficient clinical evidence from current limited studies, this randomised controlled study aims to explore the effects of ESWT combined with KT on upper limb function during individuals with LHBT.Methods and analysisA 2×2 factorial design, double-blind, randomised controlled trial will be conducted. A total of 144 participants will be randomly allocated into one of four groups (KT+ESWT, KT+sham ESWT, sham KT+ESWT or sham KT+sham ESWT) to participate in a 4-week treatment programme. Measurements will be taken at pretreatment (baseline), immediately after treatment and 6 weeks after treatment. The primary endpoint will be the Constant-Murley score (CMS), the secondary endpoints will include the pain Numerical Rating Scale, range of motion, pressure pain threshold and soft tissue hardness of biceps, speed test and global rating of change. Repeated measures analysis of variance will be used to compare differences among the effects of different interventions.Ethics and disseminationEthics approval was obtained from the Ethics Committee of the Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. In addition to international conference reports, findings will be disseminated through international publications in peer-reviewed journals.Trial registration numberChiCTR2100051324.
Distribution of intranasal naloxone to potential opioid overdose bystanders in Sweden: effects on overdose mortality in a full region-wide study
Authors: Håkansson Anders , Alanko Blomé Marianne , Isendahl Pernilla , Landgren Maria , Malmqvist Ulf , Troberg Katja 
Published: January 2024

ObjectivesDistribution of take-home naloxone is suggested to reduce opioid-related fatalities, but few studies have examined the effects on overdose deaths in the general population of an entire community. This study aimed to assess the effects on overdose deaths of a large-scale take-home naloxone programme starting in June 2018, using an observational design with a historic control period.DesignFrom the national causes of death register, deaths diagnosed as X42 or Y12 (International Classification of Diseases, 10th revision, ICD-10) were registered as overdoses. Numbers of overdoses were calculated per 100 000 inhabitants in the general population, and controlled for data including only individuals with a prior substance use disorder in national patient registers, to focus on effects within the primary target population of the programme. The full intervention period (2019–2021) was compared with a historic control period (2013–2017).SettingSkåne county, Sweden.ParticipantsGeneral population.InterventionsLarge-scale take-home naloxone distribution to individuals at risk of overdose.Primary and secondary outcome measuresDecrease in overdose deaths per 100 000 inhabitants, in total and within the population with substance use disorder diagnosis.ResultsAnnual average number of overdose deaths decreased significantly from 3.9 to 2.8 per 100 000 inhabitants from the control period to the intervention period (a significant decrease in men, from 6.7 to 4.3, but not in women, from 1.2 to 1.3). Significant changes remained when examining only prior substance use disorder patients, and decreases in overdose deaths could not be attributed to a change in treatment needs for opioid use disorders in healthcare and social services.ConclusionsThe present study, involving 3 years of take-home naloxone distribution, demonstrated a decreased overdose mortality in the population, however, only in men. The findings call for further implementation of naloxone programmes, and for further studies of potential effects and barriers in women.Trial registration numberNCT03570099.
What works, how and in which contexts when supporting parents to implement intensive speech and language therapy at home for children with speech sound disorder? A protocol for a realist review
Authors: Leafe Naomi , Pagnamenta Emma , Taggart Laurence , Donnelly Mark , Hassiotis Angela , Titterington Jill 
Published: January 2024

IntroductionSpeech and language therapists (SLTs) worldwide report challenges with providing recommended, evidence-based intervention intensity for children with speech sound disorder (SSD). Challenges such as service constraints and/or family contexts impact on access to optimal therapy intensity. Existing research indicates that empowering and training parents to deliver intervention at home, alongside SLT support, offers one possible solution to increasing the intensity of intervention children with SSD receive. Digital health could increase accessibility to intensive home practice and help sustain engagement with therapy activities. Further exploration is needed around what makes parent-implemented interventions for children with SSD effective, for who and in which situations. This paper outlines the protocol for a realist review which aims to explore the active ingredients and contextual factors of effective digital parent-led interventions.Methods and analysisA realist review will explore the research question, following six stages. The scope of the review will be determined, and initial programme theories will be developed about what works in digital parent-implemented interventions for SSD, for whom, how, why and in what circumstances. Relevant secondary data, identified through a formal search strategy, will be selected, appraised, analysed and synthesised using realist principles to test and further refine the initial programme theories. This process will develop refined underpinning explanatory theories which capture the interaction between contexts, mechanisms and outcomes of the intervention. An expert steering group will provide insight to inform explanatory theories, searches, and dissemination.Ethics and disseminationEthical approval is not required for this review. The refined programme theories from the review will inform the next stages of a wider study. A subsequent realist evaluation will test and further refine theories with key stakeholders. Following this, the underpinning programme theory will be used to coproduce a digital tool, to support parents to deliver home intervention alongside SLT support.
Burden of drug-resistant tuberculosis among contacts of index cases: a protocol for a systematic review
Authors: Akalu Temesgen Yihunie , Clements Archie C A , Gebreyohannes Eyob Alemayehu , Wolde Haileab Fekadu , Shiferaw Fasil Wagnaw , Alene Kefyalew Addis 
Published: January 2024

IntroductionPeople having close contact with drug-resistant tuberculosis (DR-TB) patients are at increased risk of contracting and developing the disease. However, no comprehensive review has been undertaken to estimate the burden of DR-TB among contacts of DR-TB patients. Therefore, the current systematic review will quantify the prevalence and incidence of DR-TB among contacts of DR-TB patients.Method and analysisSystematic searches will be conducted in Medline, Embase, Web of Science, Scopus, Cochrane Central Register of Controlled trials (CENTRAL) and Cumulative Index to Nursing and Allied Health Literature (CINHAL) databases. The search will be conducted without restrictions on time, language and geography. A random-effects meta-analysis will be conducted for effect estimates. The pooled prevalence and incidence of DR-TB will be compared between people with and without contact with DR-TB patients. The presence of heterogeneity between studies will be assessed by Higgins I2statistics. Subgroup analysis will be conducted to determine the source of heterogeneity. The risk of bias will be assessed using a visual inspection of the funnel plot and Egger’s regression test statistics. Trim and fill analysis will be done in the presence of publication bias. A sensitivity analysis will be conducted by trimming low-quality studies. The systematic review will be reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol guidelines.Ethics and disseminationEthical approval will not be required for this study as it will be a systematic review and meta-analysis based on previously published evidence. The findings of the systematic review will be presented at scientific conferences and published in scientific journals.Protocol registrationThe protocol is published in PROSPERO with registration number CRD42023390339.
Comparing the efficacy and safety of three surgical approaches for total hysterectomy (TSATH): protocol for a multicentre, single-blind, parallel-group, randomised controlled trial
Authors: Zhang Wenxi , Deng Li , Yang Fan , Liu Jianhong , Chen Sijing , You Xiaolin , Gou Jiani , Zi Dan , Li Yonghong , Qi Xiaoxue , Wang Yanzhou , Zheng Ying 
Published: January 2024

IntroductionHysterectomy is the most common surgical procedure in the field of gynaecology. The traditional multiport laparoscopy, transumbilical laparoendoscopic single-site surgery (TU-LESS) and transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy approaches have been implemented to varying degrees in clinical practice. At present, although their feasibility has been proven, there are no large randomised controlled studies on postoperative rehabilitation. This study aims to evaluate postoperative recovery and assess the safety and effectiveness of these three surgical approaches for total laparoscopic hysterectomy.Method and analysisThis is a multicentre, randomised, single-blind, three-arm, parallel-group, interventional clinical trial. Recruitment will be carried out in five tertiary hospitals in China. Patients diagnosed with benign uterine disease or precancerous lesions will be assigned to the vNOTES group, TU-LESS group and conventional laparoscopy group at a 1:1:1 ratio. The achievement rate of comprehensive indices of enhanced recovery after surgery (ERAS) within 24 hours postoperatively will be considered the primary outcome (the comprehensive indicators of ERAS include fluid intake, passing flatus, urination after catheter removal, ambulation and a Visual Analogue Scale score ≤3.) This study will use a non-inferiority test, with a power (1−ß) of 80% and a margin of −0.15, at a one-sided α of 0.0125. The sample size will be 480 patients (including an assumed 15% dropout rate), calculated according to the primary outcome.Ethics and disseminationThis study was approved on 25 April 2022 by the Medical Ethics Committee of West China Second University Hospital (2022(057)), Sichuan University, Chengdu, China. All participants will be required to provide informed consent before their participation in the study. The results of the trial will be submitted for publication in a peer-reviewed journal and presented at international conferences.Protocol versionV.3.0, 31 August 2023.Trial registration numberChiCTR2200057405.
Does use of GP and specialist services vary across areas and according to individual socioeconomic position? A multilevel analysis using linked data in Australia
Authors: Butler Danielle C , Larkins Sarah , Jorm Louisa , Korda Rosemary J 
Published: January 2024

ObjectiveTimely access to primary care and supporting specialist care relative to need is essential for health equity. However, use of services can vary according to an individual’s socioeconomic circumstances or where they live. This study aimed to quantify individual socioeconomic variation in general practitioner (GP) and specialist use in New South Wales (NSW), accounting for area-level variation in use.DesignOutcomes were GP use and quality-of-care and specialist use. Multilevel logistic regression was used to estimate: (1) median ORs (MORs) to quantify small area variation in outcomes, which gives the median increased risk of moving to an area of higher risk of an outcome, and (2) ORs to quantify associations between outcomes and individual education level, our main exposure variable. Analyses were adjusted for individual sociodemographic and health characteristics and performed separately by remoteness categories.SettingBaseline data (2006–2009) from the 45 and Up Study, NSW, Australia, linked to Medicare Benefits Schedule and death data (to December 2012).Participants267 153 adults aged 45 years and older.ResultsGP (MOR=1.32–1.35) and specialist use (1.16–1.18) varied between areas, accounting for individual characteristics. For a given level of need and accounting for area variation, low education-level individuals were more likely to be frequent users of GP services (no school certificate vs university, OR=1.63–1.91, depending on remoteness category) and have continuity of care (OR=1.14–1.24), but were less likely to see a specialist (OR=0.85–0.95).ConclusionGP and specialist use varied across small areas in NSW, independent of individual characteristics. Use of GP care was equitable, but specialist care was not. Failure to address inequitable specialist use may undermine equity gains within the primary care system. Policies should also focus on local variation.
Magnitude and associated factors of cutaneous leishmaniasis among patients visiting Nefas Mewcha primary hospital, Northern Ethiopia, 2022: An institution-based Cross-sectional study
Authors: Bantie Berihun , Kassaw Gebrie , Demelash Agmasie Tigabu , Abate Moges Wubneh , Nigat Adane Birhanu , Amare Abraham Tsedalu , Birlie Tekalign Amera , Tasew Sheganew Fetene , Zeleke Shegaw , Kassie Ayalew , Tantigegn Sharie , Ambaw Lidiya Anteneh , Muhamed Ahmed Nuru , Melese Biruk Demissie 
Published: January 2024

BackgroundCutaneous leishmaniasis (CL) is the most common neglected tropical disease, causing stigmatised skin lesions. It is an important public health concern, with 95% of cases occurring in low-income and middle-income countries. Despite its long-recognized endemicity and psychosocial impacts, it is largely overlooked.ObjectiveThe main aim of this study is to investigate the magnitude and associated factors of CL in north-central Ethiopia.DesignAn institution-based cross-sectional study was conducted.SettingThe study was conducted in Nefas Mewcha Primary Hospital (NMPH), north-central Ethiopia.ParticipantsThe study was conducted among 332 individuals visiting NMPH from June to July 2022.Primary and secondary outcomesThe primary outcome was to estimate the burden of CL among patients visiting NMPH, and the secondary outcome was to identify factors associated with the presence or absence of CL. The association between predictor variables and CL was assessed using a binary logistic regression model. Statistical significance was declared at a p _value of <0.05.ResultOut of the 332 study participants, 63 patients sought medical care with skin lesions, and 61 (18.37%, 95% CI: 14.5% to 22.9%) were patients with CL. Localized CL was the predominant type (86.9%). Male sex (adjusted OR (AOR): 4.51; 95% CI 1.94 to 10.45), older age (AOR 0.91, 95% CI: 0.87 to 0.94), secondary and tertiary educational status (AOR: 0.18, 95% CI: 0.05 to 0.6), poor knowledge of CL (AOR: 4.02, 95% CI: 1.81 to 9.76) and living with domestic animals (AOR: 5.29, 95% CI 3.24 to 7.5) were identified as predictors of CL.ConclusionIn the study area, the magnitude of CL was found to be high. Being male and young, having low educational status, having poor knowledge and living with domestic animals increase the risk of acquiring CL. As a result, increasing the knowledge of the community through scaling up of health education programmes and reducing activities that increase individuals’ exposure to sandflies should be prioritised.