bluuebunny/crossref_metadata_2025_split huggingface dataset:
Measuring the duration of kangaroo mother care for neonates: a scoping review
Authors: Tumukunde Victor Spector , Loucaides Eva , Medvedev Melissa M , Nyirenda Moffat , Lawn Joy , Tann Cally J 
Published: January 2025

ObjectivesKangaroo mother care (KMC) is high impact for survival of low birth weight neonates, but there are few rigorous evaluations of duration required for impact. We conducted a scoping review of KMC duration measurement methods and assessed their validation.DesignScoping review in accordance with Joanna Briggs Institute guidance for conducting scoping review.Data sourcesMEDLINE, Embase, Cochrane Library, PsycINFO, African Index Medicus, Latin American and Caribbean Health Sciences Literature, ClinicalTrials.gov, International Clinical Trials Registry Platform, International Standard Randomised Controlled Trial Number Registry, Medrxiv and OpenGrey were searched through November 2022.Eligibility criteria for selecting studiesPublications with primary data on KMC duration were included. We excluded short procedural skin-to-skin care studies.Data extraction and synthesisSelection and data abstraction were conducted by two independent reviewers. A data charting form based on the variables of interest was used to abstract data.ResultsA total of 213 publications were included, of which 54 (25%) documented a method of measuring KMC duration. Only 20 publications (9%) provided a detailed description of the duration measurement method, and none reported validity. Most studies used caregiver reports (29, 54%) or healthcare worker observations (17, 31%). Other methods included independent observers and electronic monitoring devices.ConclusionOnly 9% of KMC studies reporting duration documented the measurement method applied, and no studies were found with documented validation of duration measurement methods. Accurate and comparable data on the dose response of KMC will require duration measurement methods to be validated against a gold standard such as an independent observer.
Blinding assessment in randomised sham-controlled trials of acupuncture:protocol for a systematic survey
Authors: Yang Jiahui , Liu Jiali , Luo Xiaochao , Yao Minghong , Fu Yong , Li Ling , Sun Xin 
Published: January 2025

IntroductionAlthough various sham acupuncture techniques have been employed to ensure blinding in randomised controlled trials (RCTs) of acupuncture, the effectiveness of blinding in these trials and its influence on trial effect size estimates remain unclear. The objectives of this study are the following: (1) to investigate the proportion and study characteristics of sham-controlled trials reporting on blinding assessment, (2) to assess the blinding effectiveness of different types of sham acupuncture, (3) to investigate the relationship between blinding effectiveness and effect sizes in acupuncture RCTs.Methods and analysisWe will search PubMed and EMBASE from inception to 1 January 2025 to identify RCTs that compared acupuncture with sham acupuncture in humans with any disease or symptom, with no restrictions on language. Paired investigators will independently determine eligibility and use pilot-tested standardised forms for data extraction. We will calculate the proportion of sham-controlled trials that assessed and reported blinding success and conduct descriptive analyses of general study characteristics, acupuncture treatment details, sham acupuncture details and blinding assessments for included trials. We will assess the effectiveness of blinding success using the James blinding index (BI) and Bang BI, and pool data from included trials using random-effects models. We will use Hedges’ g, a standardised mean difference, with its 95% CI, to calculate treatment effects. We will use Pearson’s r correlation coefficient to assess the relationship between blinding effectiveness and trial effect sizes when variable distributions meet the assumptions of normality and linearity; otherwise, we will consider employing non-parametric tests. When sufficient data are available, we will also use random-effects meta-regression to explore the relationship.Ethics and disseminationEthical approval is not required. The findings of this study will be disseminated through peer-reviewed publications, conference presentations and condensed summaries for clinicians, health policymakers and guideline developers regarding the design, conduct, analysis and interpretation of blinded assessment of sham acupuncture RCTs.Study registrationOpen Science Framework (https://doi.org/10.17605/OSF.IO/B3U7K).
Emotion regulation-based internet-delivered cognitive behavioural therapy for premenstrual dysphoric disorder: study protocol for a randomised controlled trial in Sweden
Authors: Hoppe Johanna M. , Weise Cornelia , Kleinstaeuber Maria , Skalkidou Alkistis , Vegelius Johan , Comasco Erika , Gröndal Maria , Kaltsouni Elisavet , Sundström Felicia , Sampaio Filipa , Andersson Gerhard , Buhrman Monica 
Published: January 2025

IntroductionPremenstrual dysphoric disorder (PMDD) is a cyclic mood disorder affecting around 2%–5% of women of reproductive age. Pharmacological interventions exist, but many patients with PMDD experience residual symptoms, discontinue medications or refrain from them due to side effects. Thus, non-pharmacological treatments are needed as an alternative or additive treatment strategy. Evidence indicates that cognitive behavioural therapy (CBT) is a promising candidate. However, further research is required to establish its efficacy and identify ways to improve the treatment. Specifically, incorporating components targeting emotional and interpersonal dysregulation could theoretically enhance its effects. Furthermore, increasing the generally low accessibility of CBT for PMDD necessitates scalable and cost-effective ways to deliver treatment. The current study aims to evaluate the effects and cost-effectiveness of an internet-delivered CBT (ICBT) intervention for PMDD incorporating skills training in emotion regulation and interpersonal effectiveness.Methods and analysisThe study is a parallel two-group randomised controlled trial with 1:1 allocation to 8 weeks of therapist-guided ICBT or a waitlist control condition. Following recruitment and inclusion, 164 individuals aged 18–45 years who fulfil the Diagnostic Manual of Mental Disorders-5 criteria for PMDD will be randomly assigned to the two groups. Primary outcomes are pretreatment to post-treatment group differences in premenstrual symptoms and their impact on everyday life, as well as psychological and functional impairment during the premenstrual phase. Secondary outcomes include treatment effects on quality of life and difficulties in emotion regulation. Long-term treatment effects will be assessed 6 and 12 months postintervention. Data will be analysed using latent Gaussian process modelling and linear mixed models. The economic evaluation will analyse individual-level societal costs and outcomes between trial arms. Recruitment is expected to begin in February 2025, with study completion anticipated by February 2028.Ethics and disseminationThe study has been approved by the Swedish Ethical Review Authority (2023-00655-01). Results will be disseminated via presentations and publications in international journals and national outlets for clinicians and patients with PMDD.Protocol versionPS2024_v1.Trial registration numberNCT06496139.
Effect of photobiomodulation as preventive treatment of diabetic foot ulcer: randomised, controlled, double-blind, clinical trial protocol
Authors: Lourenço Roselene , Perez Silvana Torres , Motta Lara Jansiski , Duran Cinthya Cosme Gutierrez , Padilha Alexandre Rocha Santos , Bussadori Sandra Kalil , Malavazzi Tainá Caroline dos Santos , Horliana Anna Carolina Ratto Tempestini , Mesquita-Ferrari Raquel Agnelli , Fernandes Kristianne Porta Santos 
Published: January 2025

IntroductionThe prevention of diabetic foot ulcer (DFU) involves the classification of risk, systemic care, regular examinations, foot care, therapeutic education and adjunct treatments. Photobiomodulation (PBM) has been successfully administered for the healing of DFU and its preventive effects have drawn the interest of researchers.Methods and analysisThe purpose of the study is to assess the effect of PBM for the prevention of DFU through a randomised, controlled, double-blind, clinical trial. Individuals from 18 to 75 years of age of both sexes with type 2 diabetes mellitus (DM) at moderate to high risk of developing DFU will be randomly allocated to two groups of 32 participants each. The PBM group will wear a boot with 1344 light-emitting diodes (LEDs)—504 with a wavelength of 660 nm located on the sides of the boot (28.5 mW, 10 J per LED), 504 with a wavelength of 850 nm also on the sides of the boot (23 mW, 8 J per LED), 168 with a wavelength of 660 nm on the base of the boot (28.5 mW, 10 J per LED) and 168 with a wavelength of 850 nm also on the base of the boot (23 mW, 8 J per LED). The boot will be worn once a day for 6 min over 60 days and the participants will also receive therapeutic education. The control group will wear a non-therapeutic LED boot (sham) under the same conditions and will also receive therapeutic education. Assessments will be performed at the beginning of the study, after 30 days (clinical examination) and after 60 days (clinical examination, assessment of peripheral neuropathy (PN) and peripheral artery disease (PAD), blood and urine examinations and quality of life).Ethics and disseminationThis protocol received approval from the Human Research Ethics Committee of Nove de Julho University and the Mandaqui Hospital Complex (certificate number: 66098522.0.3001.5511; final approval date: 22 June 2023). The findings will be published in a peer-reviewed journal.Trial registration numberNCT06353568, ClinicalTrials.gov.
Effect of ethnicity and other sociodemographic factors on attendance at ophthalmology appointments following referral from a Diabetic Eye Screening Programme: a retrospective cohort study
Authors: Banks James , Olvera-Barrios Abraham , Pitt Matilda , Williams Daisy , Seltene Michael , Rutowska Celestine , Khatun Mumina , Huemer Josef , Khan Yasir , Ockrim Zoe , Heng Ling Zhi , Rudnicka Alicja R , Tufail Adnan , A Egan Catherine , Owen Christopher G 
Published: January 2025

Background/aimsTo examine the association between sociodemographic characteristics and attendance at Hospital Eye Service (HES) referrals from the Diabetic Eye Screening Programme (DESP), in a large, ethnically diverse urban population.MethodsRetrospective cohort study (4 January 2016–12 August 2019) of people with diabetic retinopathy (DR) referred from an English DESP to a tertiary referral eye hospital. We conducted a multivariable logistic regression with attendance as the primary outcome, controlling for age, sex, ethnicity, Index of Multiple Deprivation, best eye visual acuity and baseline DR grade.ResultsOf 7793 people referred (mean age 64 years, 62.6% male, 13.9% white, 12.5% black, 25.3% South Asian, 6.5% any other Asian background, 19.3% no recorded ethnicity and 20.9% of ‘Other’ ethnic origin), 69% attended. Compared with white individuals, people of black ethnic origin were similarly likely to attend. South Asians and those of other Asian backgrounds were more likely, and people with ‘Other’ or missing ethnicity were less likely to attend. Those with higher levels of deprivation, younger (aged 18–45 years) and older (76–90 years) age groups and worse visual acuity were less likely to attend, whereas people identified as having proliferative DR in both eyes were more likely to attend.ConclusionSociodemographic patterns in attendance after referral from the DESP to the HES exist, and these do not appear to explain ethnic differences in more severe sight-threatening DR, suggesting other explanations. More work is needed to understand and reduce inequalities in HES attendance.
Factors influencing therapeutic efficacy of denosumab against osteoporosis in systemic lupus erythematosus
Authors: Yang Jiwon , Park Youngjae , Lee Jennifer Jooha , Kwok Seung-Ki , Ju Ji Hyeon , Kim Wan-Uk , Park Sung-Hwan 
Published: January 2025

ObjectiveOsteoporosis is a common comorbidity in patients with SLE, and bone loss in patients with SLE has a multifactorial aetiology. This study aimed to evaluate the therapeutic efficacy of denosumab in patients with SLE with osteoporosis and to analyse the factors influencing therapeutic efficacy.MethodsA total of 166 patients with SLE with osteoporosis who initiated denosumab between January 2016 and December 2023 were included. Changes in the T-score and areal bone mineral density (BMD) at the lumbar spine, total hip and femur neck from denosumab initiation to 12 months were measured. Correlation analysis was performed between the degree of BMD improvement and covariates including SLE-specific factors such as SLE duration, SLE Disease Activity Index 2000 (SLEDAI-2K) score, glucocorticoid dose and hydroxychloroquine use. Multiple linear regression analysis was conducted to identify predictors of the therapeutic efficacy of denosumab.ResultsDenosumab significantly increased BMD and decreased bone turnover markers at 12 months compared with baseline. The degree of BMD improvement revealed a significant negative correlation with SLEDAI-2K score, hydroxychloroquine use, prior osteoporosis treatment and baseline BMD values. In contrast, body mass index and c-telopeptide of collagen type 1 levels were positively correlated with the degree of BMD improvement. Higher baseline BMD values, SLEDAI-2K scores and hydroxychloroquine use were significant predictors of attenuated BMD improvement.ConclusionsOur study suggests that denosumab is an effective treatment option for osteoporosis in patients with SLE. The therapeutic efficacy of denosumab can be predicted by baseline BMD values, SLEDAI-2K scores and hydroxychloroquine use.
Systemic disease activity measured with ESSDAI varies largely over 5 years in a prospective, longitudinal cohort of patients with Sjögren’s disease
Authors: de Wolff Liseth , Verstappen Gwenny , Stel Alja , van Zuiden Greetje , van Nimwegen Jolien , Vissink Arjan , Kroese Frans , Arends Suzanne , Bootsma Hendrika 
Published: January 2025

ObjectivesThe objectives are to evaluate variation in systemic disease activity (European Alliance of Associations For Rheumatology (EULAR) Sjögren’s Syndrome Disease Activity Index (ESSDAI)) over time at group and individual patient level and to assess associations of ESSDAI low disease activity (LDA) with other outcome measures in a standard-of-care cohort of patients with Sjögren’s disease (SjD).MethodsPatients with SjD participating in a prospective longitudinal study (REgistry of Sjögren Syndrome LongiTudinal cohort) fulfilling the 2016 American College of Rheumatology/EULAR classification criteria with ≥2 years of follow-up were included. ESSDAI was assessed at least yearly, up to 5 years. Patient-reported, objective glandular and laboratory outcomes were compared between patients with ESSDAI LDA (score<5) for <75% vs ≥75% of time.ResultsOf 265 included patients with SjD, 236 (89%) were women, median disease duration was 6 years (IQR 2–10) and 114 (43%) received immunosuppressive treatment at some point during follow-up. At group level, median ESSDAI decreased slightly, from 4 (IQR 2–7) at baseline to 3 (IQR 2–5) at year 5, with a concomitant decrease in variation, indicating regression to the mean. At the individual patient level, ESSDAI varied in the majority of patients: 50/102 (49%) untreated patients with ESSDAI<5 at baseline changed to ESSDAI≥5 at least once during follow-up. Of the untreated patients with ESSDAI≥5 at baseline, 41/45 (91%) changed to ESSDAI<5. Patients with ESSDAI LDA for ≥75% of time showed better outcomes on saliva production.ConclusionsIn this cohort of patients with SjD, overall ESSDAI slightly decreased during 5 years of follow-up, whereas at individual patient level, large variation was seen over time for the majority of patients. Longer time in ESSDAI LDA was associated with better salivary gland outcomes.
Diagnostic performance ofTreponema pallidumparticle agglutination tests against electrochemiluminescence immunoassays for the detection of anti-TP antibodies: Evaluation study
Authors: Lejisa Tadesse , Bikila Demiraw , Bashea Chala , Tolcha Yosef , Meles Mehari , Getahun Tigist , Ashebir Genet , Habtu Wossene , Challa Feyissa , Desalegn Daniel Melese , Anbessa Adisu Kebede , Ayana Gonfa , Tola Habteyes Hailu 
Published: January 2025

ObjectivesAlthough the burden of syphilis is slightly increasing worldwide, there are a limited number of rapid, simple-to-use, accurate and cost-effective diagnostic tools available. Thus, we aimed to determine the diagnostic performance of theTreponema pallidumparticle agglutination (TPPA) test (hereafter called index test) against an electrochemiluminescence immunoassay (ECLIA) (hereafter called reference test). We selected the available treponemal reference test (ECLIA) to evaluate the index test (TPPA) which is not currently in use in Ethiopia.MethodsWe conducted a multicentre cross-sectional study to evaluate the diagnostic performance of the index test against the reference test. We enrolled 581 syphilis-suspected cases from the five selected health facilities in Addis Ababa in this study. We collected data on sociodemographic and clinical characteristics and whole blood from each participant. We estimated the sensitivity, specificity and positive and negative predictive values of the index test.ResultsOf the 581 participants, 380 (65.4%) were female. The mean age of the participants was 39.7 years (±SD 16.6), with an age range of 18–94 years. The sensitivity of the index test was 99.4% (95% CI 96.4% to 100%), while the specificity was 100%. The positive predictive value of the index test was 100%, and the negative predictive value was 99.8% (95% CI 98.4% to 100%). There was no invalid test result.ConclusionsThe diagnostic performance of TPPA for syphilis was equivalent to that of ECLIA. Thus, TPPA can be used for the diagnosis of syphilis at the health facility level equivalent to a reference test.
Hamilton–Jacobi method in non-minimal coupling inflation: metric vs. Palatini
Authors: Zhang Feng-Yi , Lin Wenbin 
Published: January 2025

Abstract
The Hamilton–Jacobi approach offers a natural framework for analyzing inflationary dynamics, relying on the specified Hubble parameter rather than the potential, particularly in extended gravity theories. In this study, we apply this method to investigate inflation with non-minimal coupling, comparing the metric and Palatini formulations. Using a power-law Hubble parameter in the Jordan frame, we find that both formalisms satisfy the attractor condition, with a slight suppression in the Palatini case. Our results align closely with the latest observational data, demonstrating the Palatini formalism’s heightened sensitivity to coupling constants and model parameters. Furthermore, we show that within the model’s viable parameter space, the reheating process can achieve sufficiently high temperatures to support successful leptogenesis.
Random Survival Forest Machine Learning for the Prediction of Cardiovascular Events Among Patients With a Measured Lipoprotein(a) Level: A Model Development Study
Authors: Lusk Jay B. , O’Brien Emily C. , Hammill Bradley G. , Li Fan , Mac Grory Brian , Patel Manesh R. , Pagidipati Neha J. , Shah Nishant P. 
Published: January 2025

BACKGROUND:
Established risk models may not be applicable to patients at higher cardiovascular risk with a measured Lp(a) (lipoprotein[a]) level, a causal risk factor for atherosclerotic cardiovascular disease.

METHODS:
This was a model development study. The data source was the Nashville Biosciences Lp(a) data set, which includes clinical data from the Vanderbilt University Health System. We included patients with an Lp(a) measured between 1989 and 2022 and who had at least 1 year of electronic health record data before measurement of an Lp(a) level. The end point of interest was time to first myocardial infarction, stroke/TIA, or coronary revascularization. A random survival forest model was derived and compared with a Cox proportional hazards model derived from traditional cardiovascular risk factors (ie, the variables used to estimate the Pooled Cohort Equations for the primary prevention population and the variables used to estimate the Second Manifestations of Arterial Disease and Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention scores for the secondary prevention population). Model discrimination was evaluated using Harrell’s C-index.

RESULTS:
A total of 4369 patients were included in the study (49.5% were female, mean age was 51 [SD 18] years, and mean Lp(a) level was 33.6 [38.6] mg/dL, of whom 23.7% had a prior cardiovascular event). The random survival forest model outperformed the traditional risk factor models in the test set (c-index, 0.82 [random forest model] versus 0.69 [primary prevention model] versus 0.80 [secondary prevention model]). These results were similar when restricted to a primary prevention population and under various strategies to handle competing risk. A Cox proportional hazard model based on the top 25 variables from the random forest model had a c-index of 0.80.

CONCLUSIONS:
A random survival forest model outperformed a model using traditional risk factors for predicting cardiovascular events in patients with a measured Lp(a) level.
Evaluation of a Machine Learning-Guided Strategy for Elevated Lipoprotein(a) Screening in Health Systems
Authors: Aminorroaya Arya , Dhingra Lovedeep S. , Oikonomou Evangelos K. , Khera Rohan 
Published: January 2025

BACKGROUND:
While universal screening for Lipoprotein(a) [Lp(a)] is increasingly recommended, <0.5% of patients undergo Lp(a) testing. Here, we assessed the feasibility of deploying Algorithmic Risk Inspection for Screening Elevated Lp(a) (ARISE), a validated machine learning tool, to health system electronic health records to increase the yield of Lp(a) testing.

METHODS:
We randomly sampled 100 000 patients from the Yale-New Haven Health System to evaluate the feasibility of ARISE deployment. We also evaluated Lp(a)-tested populations in the Yale-New Haven Health System (n=7981) and the Vanderbilt University Medical Center (n=10 635) to assess the association of ARISE score with elevated Lp(a). To compare the representativeness of the Lp(a)-tested population, we included 456 815 participants from the UK Biobank and 23 280 from 3 US-based cohorts of Atherosclerosis Risk in Communities, Coronary Artery Risk Development in Young Adults, and Multi-Ethnic Study of Atherosclerosis.

RESULTS:
Among 100 000 randomly selected Yale-New Haven Health System patients, 413 (0.4%) had undergone Lp(a) measurement. ARISE score could be computed for 31 586 patients based on existing data, identifying 2376 (7.5%) patients with a high probability of elevated Lp(a). A positive ARISE score was associated with significantly higher odds of elevated Lp(a) in the Yale-New Haven Health System (odds ratio, 1.87 [95% CI, 1.65–2.12]) and the Vanderbilt University Medical Center (odds ratio, 1.41 [95% CI, 1.24–1.60]). The Lp(a)-tested population significantly differed from other study cohorts in terms of ARISE features.

CONCLUSIONS:
We demonstrate the feasibility of deployment of ARISE in US health systems to define the risk of elevated Lp(a), enabling a high-yield testing strategy. We also confirm the markedly low adoption of Lp(a) testing, which is also being restricted to a highly selected population.