bluuebunny/crossref_metadata_2025 huggingface dataset:
GLR36T807I Mutation of Casuarina equisetifoli Is Associated With a Decreased JA Response to Insect Feeding by Lymantria xylina
Authors: Chang Huan , Li Chengli , Zhu Tengfei , Cai Shouping , Chen Jie , Zhan Fangfang , Zeng Liqiong , Fang Yu , Ye Gongfu , Li Jian , Su Jun
Published: December 2024

Lymantria xylina is the most important defoliator, damaging the effective coastal windbreak tree species Casuarina equisetifolia. However, the underlying genetic mechanisms through which C. equisetifolia responds to L. xylina attacks remain unknown. Here, we compared the transcriptional, phytohormone and metabolic differences between susceptible (S) and resistant (R) C. equisetifolia cultivars in response to L. xylina feeding. The main L. xylina‐induced resistance in C. equisetifolia was a jasmonate (JA) response and JA synthesis was highly induced by L. xylina feeding at both the transcriptional and metabolic levels, thus promoting flavonoid accumulation. The JA response was highly activated by L. xylina feeding on the R but not in the S cultivar, although the JA signalling pathway was intact in both cultivars. We found a single amino acid mutation in the homologues of glutamate receptor‐like protein 3.6 (CeGLR3.6T807I) in the S cultivar. Compared with the GLR3.6 homologues in the R cultivar, phosphorylation of CeGLR3.6T807I was not induced by insect feeding, leading to a decreased JA response in the S cultivar. Collectively, this study provides new insights into the function of CeGLR3.6 in regulating the JA response of C. equisetifolia to L. xylina feeding.
Cooperación sur-sur con perspectiva cultural: interdependencia, dialogo y coexistencia
Authors: Wabgou Maguemati
Published: December 2024

El texto analiza diversas posibilidades de realización y consolidación de iniciativas que faciliten y potencien dinámicas de cooperación sur-sur entre África, Asia, América Latina y el Caribe, desde una perspectiva cultural. También afianza la interdependencia, el diálogo y la coexistencia como elementos dinamizadores de los acercamientos entre pueblos, Estados e instituciones de estas regiones, y busca abordar el asunto de la cooperación sur-sur con recursos teóricos específicos y con referencias a la colaboración intelectual y cultural. Además, recurre a epistemologías alternativas, descolonizadoras y críticas para elucidar la historia de la alteridad africana, que se posiciona como un puente entre la asiática, la latinoamericana y caribeña. Esto permite alimentar reflexiones cargadas de improntas culturales, académicas e históricas que buscan intensificar dicha cooperación, y pone énfasis en el protagonismo de la comunidad de investigadores/as en estas iniciativas de colaboración académica. Igualmente, pretende establecer condiciones favorables para un mejor acercamiento de los pueblos, los Estados y las instituciones de este sur global. En definitiva, apuesta por la creación de alianzas fructíferas e indispensables para un diálogo sostenido, una coexistencia enriquecedora y una interdependencia constructiva que obren a favor del fortalecimiento de los intercambios culturales, políticos y económicos en este escenario internacional.
Hybrid Quantum Neural Network and Shapely Additive Explanations in Railway Track Geometry Modeling
Authors: Alabintei Dengimowei D. , Attoh-Okine Nii
Published: December 2024

This research investigates the application of explainable quantum machine learning (QML) for predictive maintenance in the railroad industry. By utilizing ground-penetrating radar (GPR) data to characterize subsurface track conditions (ballast fouling index, ballast thickness index, layer roughness index, and moisture likelihood index), a quantum neural network (QNN) model was developed to predict track geometry (profile and alignment) defects in a Class 3 railroad track. Shapley additive explanations (SHAP) were employed to analyze the feature importance and the model’s decision-making processes to ensure model interpretability. The QNN model correctly predicted 42 out of 55 test data points. SHAP analysis identified the ballast fouling index and layer roughness index as the most important parameters, aligning with engineering expectations.
Individual differences in the distributional learning and overnight consolidation of the Mandarin level-falling tone contrast
Authors: Chui Yin-To , Qin Quentin Zhen
Published: December 2024

In perceptual studies, musicality and pitch aptitude have been implicated in tone learning, while vocabulary size has been implicated in distributional (segment) learning. Moreover, working memory plays a role in the overnight consolidation of explicit-declarative L2 learning. This study examines how these factors uniquely account for individual differences in the distributional learning and consolidation of an L2 tone contrast, where learners are tonal language speakers, and the training is implicit. Following a previous study investigating distributional tone learning, 66 L1-Cantonese participants who learned and consolidated a Mandarin level-falling tone contrast through distributional exposure were measured in a pitch threshold task, Montreal Battery of Evaluation of Amusia, Mandarin Peabody Picture Vocabulary Test, and an Operation Span task. Pitch threshold predicted immediate learning improvement while working memory predicted overnight consolidation by a bimodal group (not a unimodal group). The findings imply that pitch aptitude may be important in encoding stepwise tonal tokens, and the predictive power of working memory in overnight consolidation extends to implicit tone learning. Meanwhile, musical aptitude may not confer an additional advantage for speakers with native-tone experiences, and learners with a larger L2 vocabulary size might have resisted adaptation to distributional exposure because of robust L2 tonal representations.
Relationship between pharmacotherapy for major depressive disorder and healthcare utilisation in British Columbia, Canada: a retrospective population-based cohort
Authors: Vijh Rohit , Waheed Zeina , Peterson Sandra , Bunka Mary , Pang Nick , Edwards Louisa , Ghanbarian Shahzad , Wong Gavin , Cressman Sonya , Riches Linda , Austin Jehannine , Bryan Stirling , Hoens Alison , McGrail Kimberlyn
Published: December 2024

Objectives

To describe the population that meets the criteria for major depressive disorder (MDD) in British Columbia (BC), compare patterns of healthcare utilisation between those with MDD who are and are not prescribed pharmacotherapy, and assess these relationships in models that control for potential confounding variables.

Design

We used a population cross-sectional study design among a cohort of individuals living with MDD and examined the relationship between pharmacotherapy and healthcare utilisation between 2019 and 2020 using linked billing and administrative data.

Setting

This study identified individuals with MDD using a validated case definition of International Classification of Diseases (ICD) codes in BC, Canada.

Participants

The final study cohort included 549 029 adult participants who met the MDD case definition.

Explanatory variable

Explanatory variable was the use of prescription antidepressant medication during the study period, based on BC PharmaNet data.

Covariates

Covariates include sociodemographic characteristics (age, sex, urban/rural residence, neighbourhood income quintile and comorbidities).

Primary outcome measure

Primary outcome measure was healthcare utilisation (outpatient physician visits, emergency department (ED) visits and hospitalisations).

Results

We stratified our analysis based on whether study participants were classified as ‘recently incident’ or ‘actively prevalent’. The odds ratio (OR) for health service utilisation between the pharmacotherapy group and the non-pharmacotherapy group for individuals who were recently incident was 8.14 (95% CI 7.40, 8.95) for outpatient physician visits, 1.04 (95% CI 1.02, 1.07) for ED visits and 1.05 (95% CI 1.00, 1.10) for hospitalisations, after adjusting for comorbidities and other sociodemographic variables in our regression analyses, whereas for the actively prevalent group the ORs were 7.57 (7.27, 8.49), 0.91 (0.89, 0.92) and 1.00 (0.98, 1.02), respectively.

Conclusion

This study examined the association of pharmacotherapy on healthcare utilisation for adults with MDD in BC. The study revealed higher outpatient physician visits for the pharmacotherapy group and no major association for inpatient visits. For ED visits, recently incident individuals on pharmacotherapy had slightly higher odds of having an ED visit, whereas individuals who were actively prevalent and on pharmacotherapy had a slight decrease in odds. This may suggest a protective effect of pharmacotherapy against a utilisation of resource-intensive healthcare services.
Readability of online and offline written health information: a protocol of a systematic review of systematic reviews
Authors: Okuhara Tsuyoshi , Furukawa Emi , Okada Hiroko , Kiuchi Takahiro
Published: December 2024

Introduction

Healthcare organisations should create and disseminate readable information to citizens and patients to reduce the level of health literacy required for individuals. Several systematic reviews have reported overviews of the readability of written health information for each subject area. This systematic review of systematic reviews will synthesise evidence from existing systematic reviews to provide an overview of studies that assessed readability in diverse areas and identify gaps to be filled in future research and practice to improve the readability of health information.

Methods and analysis

The following databases will be searched: PubMed, MEDLINE, CINAHL, PsycINFO, Web of Science Core Collection, Scopus, Cochrane Database of Systematic Reviews, and Google Scholar. The reference lists of the eligible studies will be searched to identify additional studies. The eligible literature will be systematic reviews of published empirical studies that quantitatively assessed the readability of health information for patients and/or citizens. Two independent reviewers will screen the titles, abstracts and full texts of all identified literature. A lead researcher will extract the data, and a second reviewer will check the results. Discrepancies will be resolved through discussion, and a third reviewer will be involved if necessary. Data, such as the characteristics of the systematic review, characteristics of the reviewed literature in the systematic review, subject area, material characteristics, definition(s) of readability, readability assessment methods, main results and quality assessment, will be extracted. The findings will be synthesised in a numerical summary and a descriptive and narrative review.

Ethics and dissemination

This review does not involve any ethical concerns. The results and implications of this systematic review will be disseminated at conferences and in peer-reviewed journals.
Duration, course and caregiver burden of croup in children: two observational cohorts
Authors: Bjornson Candice Leigh , Nettel-Aguirre Alberto , Williamson Janielee , Johnson David W
Published: December 2024

Objectives

Although croup is a common respiratory illness, there is little published regarding symptom course. We aimed to assess symptom progression and caregiver burden, and whether age, sex or season and initial severity of disease are associated with symptom duration.

Design, setting and participants

We conducted a secondary analysis of two Canadian prospective cohorts of children 0–16 years old diagnosed with croup; one recruited from a paediatric emergency department (ED) (307 children) between November 1999 and March 2000, and the other from 26 general EDs (1214 children) between September 2002 and April 2006. Baseline data included age, sex, season, corticosteroid treatment and clinical severity score based on the presence or absence of a barky cough, stridor at rest or with agitation and chest wall indrawing (mild, moderate or severe). For both cohorts, the child’s primary caregiver was telephoned daily to collect symptom progression and psychosocial data (caregiver stress, lost sleep and work) until the child was symptom-free for over 24 hours.

Results

The paediatric and general ED cohorts are reported separately; croup symptoms peaked at initial ED presentation for 96% and 77%, respectively. The longest-lived symptom was a barky cough, resolving by 34 and 47 hours for 50%, and 78 and 119 hours for 90% of children, respectively. Neither sex nor severity at presentation were significantly associated with symptom duration in either cohort. Season of illness was associated in both; age was associated in the general but not the paediatric ED cohort. The primary caregiver lost a mean (SD) of 4.1 (4.9) and 2.8 (4.7) hours of sleep during the illness.

Conclusions

Most children with croup presented for care at the peak of symptom severity. Symptoms resolved for half of the children in 1.5–2 days and for 90% in 3–5 days after presentation. Caregivers experienced a significant loss of sleep.
Effectiveness and compliance of telemedicine on blood pressure management in poststroke patients: a systematic review and meta-analysis of randomised controlled trials
Authors: Yang Yulin , Xu Hongli , Chang Wanpeng , Li Chenying , Cao Pengyu
Published: December 2024

Objective

To examine the effectiveness of telemedicine on blood pressure control and compliance.

Design

Systematic review and meta-analysis.

Data sources

A search of PubMed, Web of Science, Embase and Cochrane Library for studies of randomised controlled trials (RCTs) of telemedicine on blood pressure control in poststroke survivors from the time of their construction until November 2023. Inclusion criteria were as follows: (1) studies that were RCTs; (2) enrolment of patients who were stroke survivors; (3) studies that compared subjects who received telemedicine with usual care treatment. Exclusion criteria were as follows: (1) studies in which telemedicine was used for other diseases; (2) study protocols with no data; (3) non-English language articles and (4) case reports, conference papers, letters or articles with incomplete data. Quality assessment of included studies was performed using the Cochrane Risk of Bias Tool.

Primary outcome measures

The primary outcomes was the systolic blood pressure (SBP) (mm Hg), diastolic blood pressure (DBP) (mm Hg), patient compliance and the proportion of patients achieving target blood pressure.

Results

A total of 11 studies with 2903 patients were included in this paper. There were 1453 cases in the telemedicine group and 1450 cases in the usual care group. Meta-analysis showed a statistically significant decrease in SBP (mm Hg) in the telemedicine group compared with the usual care group at weeks 3, 6 and 12 of follow-up (week 3: mean difference (MD), −8.8; 95% CI, −12.05 to −5.56; p<0.00001; week 6: MD, −5.13; 95% CI, −8.07 to −2.18; p=0.0007; week 12: MD, −2.78; 95% CI, −4.68 to −0.89; p=0.004). At week 12 of follow-up, there was a statistically significant decrease in DBP (mm Hg) in the telemedicine group compared with the usual care group (MD, −1.57; 95% CI, −2.59 to −0.55; p=0.003). In addition, patient compliance was better in the telemedicine group than in the usual care group (OR, 1.61; 95% CI, 1.29 to 2.01; p<0.0001), and the proportion of patients achieving target blood pressure was higher than in the usual care group (OR, 3.49; 95% CI, 2.64 to 4.63; p<0.00001).

Conclusions

Compared with usual care, telemedicine interventions can better improve blood pressure control in poststroke survivors and increase patient compliance.

Trial registration number

CRD42022382001.
In-hospital mortality among neonates with necrotising enterocolitis in Ethiopia: a systematic review and meta-analysis
Authors: Bimerew Melaku , Getie Addisu , Gebreegziabher Araya Freweyni , Dessalegn Nigatu , Wondmieneh Adam , Ayalneh Manay
Published: December 2024

Objective

To assess the pooled in-hospital mortality among neonates with necrotising enterocolitis (NEC) in Ethiopia.

Design

This was a systematic review and meta-analysis reported based on the Preferred Reporting Items for Systematic Review and Meta-analysis guideline.

Data sources

African Journals Online, PubMed/Medline, Google Scholar, Cochrane Library and repositories of Ethiopian Universities.

Eligibility criteria

Published and unpublished articles that had reported the in-hospital mortality among neonates with NEC in Ethiopia were included, whereas, articles with no abstracts and/or inaccessible full texts, citations, reviews, commentaries editorials, conference abstracts, anonymous reports and articles reported in non-English language were excluded.

Data extraction and synthesis

Articles that passed the eligibility criteria were assessed for their quality using the quality appraisal criteria for prevalence studies. Data extraction and cleaning were done by using the Microsoft Excel work sheet, and data were analysed by STATA V.11.0 using the random effects model at 95% CI. Test of heterogeneity, publication bias, sensitivity analysis, subgroup analysis and meta-regression were performed.

Results

A total of 12 articles involving 588 neonates were included. The pooled in-hospital mortality among neonates with NEC in Ethiopia was found to be 70.0% (95% CI=60.0% to 80.0%; I2=87.5%). There was significant difference in mortality by study population as the in-hospital mortality among neonates with NEC was 83.0% (95% CI=76.0% to 89.0%; I2=42.8%; five studies) in preterm neonates and 73.0% (95% CI=60.0% to 86.0%; I2=66.3%; four studies) in low birthweight neonates (p<0.001).

Conclusion

The in-hospital mortality of neonates with NEC in Ethiopia was found to be high in which 7 out of 10 neonates diagnosed with NEC ends with death. Therefore, the currently available NEC prevention strategies should be evaluated for individual units and introduced where possible.
Efficacy of opioid combination versus single opioid for adult cancer pain: a protocol for systematic review and meta-analysis
Authors: Maeng Chi Hoon , Hui David , Kang Ji-Yeon , Kim Soo Young , Kwon Jung Hye
Published: December 2024

Introduction

Chronic pain is one of the most common and serious symptoms of cancer. Despite the limitations of dose titration using only one type of opioid, the effects of opioid combinations are poorly understood.

Methods and analysis

This study will be conducted in accordance with the Cochrane Handbook of Systematic Reviews of Interventions 6.3. We will search the Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Web of Science databases from their inception to June 2023. This review will consider all clinical trials involving patients aged ≥18 years who received opioids for chronic cancer pain. Two reviewers will independently screen and select relevant studies. The intervention will be a combination of opioids, including both strong and weak, to control cancer pain. The comparator will be set as a single opioid, with or without a placebo. For randomised controlled trials, version 2 of the Cochrane tool will be used to assess the risk of bias. For non-randomised studies, the risk of bias will be assessed using a tool for assessing the Risk of Bias In Non-randomised Studies of Interventions (ROBINS-I). The primary outcome will be pain response; if a quantitative synthesis is not appropriate, a synthesis without a meta-analysis will be undertaken. The quality of evidence for each primary outcome will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation guidelines.

Ethics and dissemination

Ethical approval was not required for this systematic review and meta-analysis. The findings will be disseminated through peer-reviewed (open-access) journal publications and conference presentations. Given the widespread use of opioid-based cancer pain management in clinical practice, this study is expected to generate significant interest among physicians, many of whom are likely to review and consider the findings in the context of their clinical decision-making.

PROSPERO registration number

PROSPERO CRD42023427299.
Basic ENT training for enhanced healthcare worker knowledge, attitudes and practices in a resource-limited setting: a pre-post and post-post cross-sectional study
Authors: Lukama Lufunda , Aldous Colleen , Mbewe Sinoya , Michelo Charles , Kalinda Chester
Published: December 2024

Introduction

Diagnostic errors in ear, nose and throat (ENT) diseases are prevalent among healthcare workers (HCWs) in resource-limited settings, yet comprehensive data that describe HCW knowledge, attitudes and practices (KAP) regarding ENT disease management remains scarce. Further, the impact of basic ENT training on HCW KAP in such settings is largely undetermined.

Objective

We assessed HCW KAP before and after basic training in ENT disease management.

Methods

This questionnaire-based pre-post-test cross-sectional survey employed HCW training in public hospitals in a resource-limited setting. We conducted a 2-day training, preceded by a pretraining survey, followed by immediate and 5-month post-training assessments using a prevalidated questionnaire. 416 HCWs participated and were selected through probability-proportionate-to-size random sampling. Wilcoxon matched-pairs signed-rank and Kruskal-Wallis tests were used to assess pre-post training KAP variations.

Results

At baseline, the median (IQR) percentage knowledge scores for HCWs in general ENT, ear, sinonasal and head and neck disease management were 60 (40), 55 (18), 58.3 (25) and 56 (22.6), respectively. Only 33.8% (133/394) of HCWs had access to an otoscope, 25.5% (101/396) to a headlight and 12.1% (48/397) to a nasal speculum. While 99.2% (390/393) of HCWs considered ENT important, 57.8% (226/391) of them lacked the confidence to correctly diagnose and manage most ENT conditions. At the immediate post-training assessment, HCWs’ median knowledge scores increased by 20%, 18%, 25% and 33% for general ENT, ear, sinonasal and head and neck disease management, respectively (p<0.001). Further, the proportions of HCWs consistently performing otoscopy and using ENT guidelines increased from 15.1% (43/284) and 13.8% (48/282) to 35.5 (44/124) and 23.9% (27/113) 5 months post-training.

Conclusions

This study underscores the critical need for continuous medical education (CME) to address knowledge gaps and improve HCW attitudes and practices. The findings provide valuable insights for policymakers aiming to enhance ENT healthcare delivery in resource-limited settings.
The MyLungHealth study protocol: a pragmatic patient-randomised controlled trial to evaluate a patient-centred, electronic health record-integrated intervention to enhance lung cancer screening in primary care
Authors: Kukhareva Polina , Balbin Christian , Stevens Elizabeth , Mann Devin , Tiase Victoria , Butler Jorie , Del Fiol Guilherme , Caverly Tanner , Kaphingst Kim , Schlechter Chelsey R , Fagerlin Angela , Li Haojia , Zhang Yue , Hess Rachel , Flynn Michael , Reddy Chakravarthy , Warner Phillip , Choi Joshua , Martin Douglas , Nanjo Claude , Metzger Quyen , Kawamoto Kensaku
Published: December 2024

Introduction

Early lung cancer screening (LCS) through low-dose CT (LDCT) is crucial but underused due to various barriers, including incomplete or inaccurate patient smoking data in the electronic health record and limited time for shared decision-making. The objective of this trial is to investigate a patient-centred intervention, MyLungHealth, delivered through the patient portal. The intervention is designed to improve LCS rates through increased identification of eligible patients and informed decision-making.

Methods and analysis

MyLungHealth is a multisite pragmatic trial, involving University of Utah Health and New York University Langone Health primary care clinics. The MyLungHealth intervention was developed using a user-centred design process, informed by patient and provider focus groups and interviews. The intervention’s effectiveness will be evaluated through a patient-randomised trial, comparing the combined use of MyLungHealth and DecisionPrecision+ (a provider-focused shared decision-making intervention) against DecisionPrecision+ alone. The first study hypothesis is that among patients aged 50–79 with uncertain LCS eligibility (eg, 10–19 pack-years or unknown pack-years or unknown quit date for individuals who used to smoke), MyLungHealth eligibility questionnaires will result in increased identification of LCS-eligible patients (n~26 729 patients). The second study hypothesis is that among patients aged 50–79 with documented LCS eligibility (20+ pack-years, quit within the last 15 years if individuals who used to smoke, and no recent screening or screening discussion), MyLungHealth education will result in increased LDCT ordering (n~4574 patients). Primary outcomes will be identification of LCS-eligible patients among individuals with uncertain LCS eligibility and LDCT ordering rates among individuals with documented LCS eligibility.

Ethics and dissemination

The protocol was approved by the University of Utah Institutional Review Board (# 00153806). The patient data collected for this study will not be shared publicly due to the sensitive nature of the patient health information and the fact that we will not be obtaining written informed consent to allow public sharing of their data. Results will be disseminated through peer-reviewed publications.

Trial registration number

Clinicaltrials.gov,NCT06338592.
Workplace and social support, treatment satisfaction, and their impact on quality of life in Swedish women with multiple sclerosis: a cross-sectional survey study
Authors: Machado Alejandra , Wredendal Elin , Fink Katharina , Friberg Emilie
Published: December 2024

Objective

To evaluate health-related quality of life (HRQoL), in relation to support from work, social, as well as treatment satisfaction, in women with multiple sclerosis (MS). Further, to predict the satisfaction on these support dimensions based on sociodemographic and clinical variables.

Design

Cross-sectional survey: a web-based questionnaire conducted in 2021 of people with MS (PwMS) linked to Nationwide Swedish registers.

Setting

Sweden.

Participants

Working women with MS, living in Sweden, aged 20–50 responding to the survey during the spring of 2021 (n=2967).

Outcome measures

Health-related quality of life was measured using the EuroQol Visual Analogue Scale (EQ-VAS). Linear regression models were applied to estimate the association between demographic and clinical factors, as well as reported survey answers with HRQoL. Odds of perceived satisfactory support in one, two or all three support dimensions (work, social or treatment) were performed with multinomial logistic regressions.

Results

Lower MS severity and fatigue, higher cognitive processing speed, living in cities and higher educational attainment were individually associated with higher levels of HRQoL (p<0.001). Contrary, lower HRQoL was associated with progressive type of MS, self-reported visible or invisible symptoms, and no or unsatisfactory support from work, social and treatment (p<0.001). When explored altogether, higher levels in HRQoL were predominantly explained by lower MS severity (t=−9.318, p<0.001), less fatigue (t=−22.190, p<0.001) and more support from work (t=4.824, p<0.001) and to some extent, social support (t=−2.448, p=0.014). Further, compared with women who reported no support, those experiencing lower fatigue and receiving ongoing treatment were more likely to receive support in one or more of all three dimensions (work, social and satisfaction with their treatment). In contrast, higher HRQoL (OR=1.033; CI=1.015 to 1.052) was only significant when receiving simultaneous support from all three support dimensions.

Conclusion

Clinical factors and support from work and social support are the strongest contributors to HRQoL in working women with MS. Further, support across several life dimensions is essential when assessing HRQoL. Particularly, satisfaction with the perceived support from work, which plays a crucial role in the HRQoL of women with MS. This underscores the importance of prioritising clinical management and strong support systems to significantly improve HRQoL outcomes in patients with MS.
Development of ICF-based patient-reported outcome and experience measures to study social participation among people with chronic diseases: a mixed-methods protocol
Authors: Van den broecke Maxim , de Jong Sarah , Kiasuwa Mbengi Régine , Vanroelen Christophe
Published: December 2024

Introduction

Living with a chronic disease impacts many aspects of life, including the ability to participate in activities that enable interactions with others in society, that is, social participation (SP). Despite efforts to monitor the quality of care and life of chronically ill people in Belgium, no disease-specific patient-reported measures (PRMs) have been used. These tools are essential to understand SP and to develop evidence-based recommendations to support its improvement. This protocol presents the phases for the disease-specific development of patient-reported outcome and experience measures to assess SP and its potential determinants among people living in Belgium with cancer, cystic fibrosis, diabetes, HIV or a neuromuscular disease.

Methods and analysis

This protocol applies the PROMIS Instrument Development and Validation Scientific Standards and COnsensus-based Standards for the selection of health Measurement INstruments to develop PRMs in a disease-specific manner to quantify the components of the International Classification of Functioning, Disability and Health (ICF). A mixed-method approach is used to create broad initial item pools based on patient (focus groups) and literature perspectives which are compared within ICF-standardised language by applying the refined ICF linking rules. An item set is first created based on this cross-matching exercise and then validated by multidisciplinary expert panels. Cognitive assessment and pilot testing are followed by the dissemination of the survey to a representative sample in Belgium. Advanced psychometric testing (classical test theory and item response theory) is applied to inform an item reduction strategy for the final measures and to develop scales for the ICF components.

Ethics and dissemination

Ethical approval was granted by the Ethics Committee of the Ghent University Hospital on 20 February 2023 to organise the patient focus groups (ONZ-2022-0470). Ethical approval for dissemination of the PRMs and psychometric testing will be sought at the Ghent University Hospital Ethics Committee at the start of Phase 6. Results will be disseminated through peer-reviewed journals and professional conferences.
Managing the work of living with heart failure: a qualitative study using the cumulative complexity model from Southeastern Minnesota
Authors: Smith Jamie , Shippee Nathan , Finnie Dawn , Killian Jill M , Montori Victor M , Redfield Margaret M , Dunlay Shannon
Published: December 2024

Objective

Patients with heart failure (HF) perform a variety of self-care activities to control symptoms and minimise the risk of HF decompensations. The objective of this study was to understand how patients build capacity and manage the work of living with HF.

Design

A qualitative study using semi-structured telephone interviews. The interview guide was informed by the Cumulative Complexity Model, a conceptual framework that focuses on a patient’s workload and their capacity to manage that work. Interview transcripts were analysed using a mixed inductive and deductive coding approach with organisation into larger thematic categories.

Setting

Southeastern Minnesota USA (11 counties) with capture of data from local community healthcare providers under the auspices of the Rochester Epidemiology Project.

Participants

Intentional sampling of local patients with HF (n=24, median age 69.5 years, 54% women, 63% rural, 54% preserved ejection fraction) who reported high treatment burden and/ or poor health status on a questionnaire.

Results

Three major themes emerged: using capacity to manage workload, disruptions resulting in workload exceeding capacity and regaining workload-capacity balance. Participants described routinising the daily tasks associated with living with HF to minimise the associated burden and identified disruptions to their routines, including hospitalisations, emergency room visits, worsening health status and changes in healthcare access. To accommodate disruptions and regain workload-capacity balance, participants decreased workload and/or transferred tasks to others to maximise capacity.

Conclusions

Participants with HF described managing patient workload in times of stable health, but they sometimes struggled to accommodate disruptions and worsening health status. These findings can inform the design of interventions to minimise workload, maximise capacity and improve quality of life for patients with HF.
Randomised, multicentre, placebo-controlled trial of fenofibrate for treatment of diabetic macular oedema with economic evaluation (FORTE study): study protocol for a randomised control trial
Authors: Nguyen Helen , Kha Richard , Gopinath Bamini , Mitchell Paul , Liew Gerald
Published: December 2024

Introduction

Diabetic macular oedema (DMO), a serious ocular complication of diabetic retinopathy (DR), is a leading cause of vision impairment worldwide. If left untreated or inadequately treated, DMO can lead to irreversible vision loss and blindness. Intravitreal injections using antivascular endothelial growth factor (anti-VEGF) and laser are the current standard of treatment for DMO. These treatments are costly and invasive and must be repeated over several years with a high service load. Fenofibrate has been shown to reduce the progression of DR. However, there is a lack of high-quality data on the effects of fenofibrate on established DMO. This study aims to evaluate the effectiveness of oral fenofibrate for the treatment of DMO.

Methods and analysis

This randomised double-blind, placebo-controlled trial recruited 204 patients with DMO across three different clinics in Sydney. Participants will be randomly allocated in a 1:1 ratio to intervention and control groups. The intervention group will receive oral fenofibrate (145 mg) taken once daily for 24 months, while the control group will receive placebo tablets taken once daily for 24 months. Standard care with anti-VEGF injections, focal lasers or observation will also be provided to all participants regardless of their group allocation. The primary outcome is the reduction in DMO measured using central macular subfield thickness (CSMT) on optical coherence tomography imaging at 24 months. Secondary outcomes at 24 months include the proportion of eyes with CSMT <250 µm, number of anti-VEGF injections, number of laser sessions needed, best-corrected visual acuity letter score gains, rates of adverse events, progression in DR lesions and changes in quality of life measures. Comparison between groups will be evaluated using analysis of variance. Multiple regression analyses adjusting for age, glycated haemoglobin, number of injections and other covariates will also be performed.

Ethics and dissemination

Ethics approval has been granted by the University of Sydney Human Ethics Committee (HREC-2019/892), and the trial has been registered with the Australia New Zealand Clinical Trials Registry (ACTRN12618000592246). The study adheres to the principles of the Helsinki Declaration and the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research. Trial results will be disseminated to the public in de-identified form through publications in peer-reviewed journals.

Trial registry name

Australian New Zealand Clinical Trials Registry.

Trial registration number

ACTRN12618000592246.
Impact of dexmedetomidine-ropivacaine versus sufentanil-ropivacaine combination for epidural labour analgesia on neonatal outcomes: a pilot randomised clinical trial
Authors: Jin Ke-Xin , Deng Chun-Mei , Ding Ting , Qu Yuan , Wang Dong-Xin
Published: December 2024

Objective

To investigate the impact of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine combination for epidural labour analgesia on neonatal and maternal outcomes and test the feasibility of a future large, randomised trial.

Design

A randomised, double-blind, pilot clinical trial from 16 March 2023 to 15 June 2023.

Setting

A tertiary-care hospital in Beijing, China.

Participants

200 women aged≥18 years who had full-term single pregnancy and were scheduled for vaginal delivery with epidural analgesia.

Interventions

Eligible participants were randomly assigned in a 1:1 ratio to receive self-controlled epidural labour analgesia using ropivacaine supplemented with either dexmedetomidine (0.45 µg/mL for induction and 0.36 µg/mL for maintenance) or sufentanil (0.45 µg/mL for induction and 0.36 µg/mL for maintenance).

Main outcomes and measures

The primary endpoint was a composite of neonatal morbidity, including 1- or 5 min Apgar score<7, umbilical artery PH<7.1, requirement for immediate assisted ventilation and admission to neonatal ward or intensive care unit within 24 hours. Secondary and other endpoints included effect of analgesia and occurrence of adverse events. The feasibility of implementing the protocol was evaluated.

Results

All 200 women were included in the intention-to-treat analysis. Composite neonatal morbidity occurred in 14.0% (14/100) of women with dexmedetomidine versus 17.0% (17/100) of women with sufentanil: relative risk 0.82, 95% CI 0.43 to 1.58. Women in the dexmedetomidine group had a comparable area under curve of pain intensity (median difference −2.0 point⋅h, 95% CI −9.9 to 5.9, p=0.638), required more self-controlled boluses (median difference two boluses, 95% CI 0 to 3, p=0.040) and epidural analgesics (median difference 17 mL, 95% CI 4 to 29, p=0.007), and experienced less pruritus (0.0% (0/100) vs 30.0% (30/100), p<0.001) but more lower limb weakness (13.0% (13/100) vs 1.0% (1/100), p<0.001). Recruitment rate was satisfactory (87.7%); the protocol was well accepted by anaesthesiologists and nurses.

Conclusions

Compared with sufentanil-ropivacaine combination, use of dexmedetomidine-ropivacaine combination for epidural labour analgesia was associated with a 18% decrease in composite neonatal endpoint and deserve further investigation. The dexmedetomidine-ropivacaine combination provided comparable analgesia but increased mild motor block. The conduct of a large, randomised trial using same protocol requires careful re-evaluation.

Trial registration number

NCT05698407.
Acupuncture for angina post percutaneous coronary intervention: a protocol for systematic review and meta-analysis
Authors: Zhou Xin , Li Yanwei , Yin Yongjun , Wang Yilan , Xie Wen , Ren Yulan
Published: December 2024

Introduction

Ischaemic heart disease (IHD) is a pathological process characterised by a blockage or non-obstructive accumulation of atherosclerotic plaques in the epicardial arteries. Percutaneous coronary intervention (PCI) is widely used in clinical practice to treat IHD. However, angina post PCI (APPCI) impairs quality of life and portends a worse prognosis. Hence, an effective and safe treatment option remains an urgent need for patients with APPCI. In recent years, there has been an increasing body of clinical trials regarding the use of acupuncture for the prevention and treatment of APPCI, and the results have indicated it might be a promising therapeutic intervention. However, to our knowledge, the potential benefits of acupuncture for the prevention and treatment of APPCI to justify either their recommendation or their clinical role have not been evaluated.

Methods and analysis

PubMed, Embase, Cochrane Library, Web of Science Core Collection, Chinese Biomedical Database, Chinese National Knowledge Infrastructure, Wanfang Database and VIP Database will be searched from inception to 8 June 2024 without language restrictions. Two investigators will independently screen studies, extract data, assess the risk of bias from randomised controlled trials (RCTs) and assess the risk of bias. The third reviewer will arbitrate any disagreements. Data synthesis and analysis will be conducted using the RevMan V.5.4 software. Subgroup analyses, sensitivity analysis, meta-regression and bias reporting assessments will be performed if necessary and appropriate. Finally, the quality of evidence from RCTs will be assessed using the Grading of Recommendations Assessment, Development, and Evaluation System tool.

Ethics and dissemination

Ethical approval is unnecessary since no private or confidential patient data will be included. The systematic review will be published in peer-reviewed journals.

PROSPERO registration number

CRD42024562116.
Development and validation of a pragmatic measure of cocreation in research engagement: a study protocol
Authors: Perez Jolles Monica , Willging Cathleen , Tufte Janice , Ostendorf Danielle , Kwan Bethany M , Sevick Carter , Dorsey Holliman Brooke , Weiner Bryan J
Published: December 2024

Introduction

Cocreation, a collaborative process of key interested partners working alongside researchers, is fundamental to community-engaged research. However, the field of community-engaged research is currently grappling with a significant gap: the lack of a pragmatic and validated measure to assess the quality of this process. This protocol addresses this significant gap by developing and testing a pragmatic cocreation measure with diverse community and research partners involved in participatory health-related research. A valid measure for evaluating the quality of the cocreation process can significantly promote inclusive research practices and outcomes.

Methods and analysis

The measure consists of two components: (1) an iterative group assessment to prioritise cocreation principles and identify specific activities for achieving those principles and (2) a survey assessing individual partner experience. An expert panel of 16–20 patients, community, healthcare providers and research partners, will participate in a modified Delphi process to assist in construct delineation and assess content validity using group discussions and rating exercises. We will compute survey items using an Item-Level Content Validity Index and a modified kappa statistic to adjust for chance agreement with panel members’ ratings. We will then conduct cognitive interviews with a new group of 40 participants to assess survey item comprehension and interpretation, applying an iterative coding process to analyse the data. Finally, we will assess the measure’s psychometric and pragmatic characteristics with a convenience sample of 300 participants and use the Psychometric and Pragmatic Evidence Rating Scale. Construct validity will be assessed by examining survey data using confirmatory and exploratory factor analysis.

Ethics and dissemination

This funded study (years 2024–2025) has been approved by the Institutional Review Board at the University of Colorado, Denver. The team will share the study findings online, with key partners, and by publishing results in a peer-reviewed journal.
IntestinalMicrobiota Transplant Prior toAllogeneicStem CellTransplant (MAST) trial: study protocol for a multicentre, double-blinded, placebo-controlled, phase IIa trial
Authors: Mullish Benjamin H , Innes Andrew J , Roberts Lauren A , Anim-Burton Shian , Webber Lee , Johnson Nicholas A , Ghani Rohma , Farshi Pakhshan , Khan Anjum B , Kinsella Francesca , Kottaridis Panagiotis , Krishnamurthy Pramila , Nicholson Emma , Palanicawandar Renuka , Wheeler Graham , Davies Frances , Marchesi Julian R , Pavlů Jiří
Published: December 2024

Introduction

Lower diversity of the gut microbiome prior to allogeneic haematopoietic cell transplantation (HCT) correlates with reduced survival after the intervention. Most patients undergoing HCT for a haematological malignancy have previously received intensive chemotherapy, resulting in prolonged neutropenic episodes requiring broad-spectrum antibiotics; use of these has been linked to reduced microbiome diversity. Intestinal microbiota transplant (IMT) is a novel treatment approach that restores this diversity. We hypothesised that IMT performed prior to initiation of HCT conditioning restores microbiome diversity during the early stages of HCT, leading to decreased frequency of complications and improved outcomes of HCT.

Methods and analysis

50 adult patients receiving allogeneic HCT will be recruited into this phase IIa trial and randomised 1:1 to receive capsulised IMT or matched placebo shortly prior to initiation of HCT conditioning and followed for up to 12 months. The primary outcome will be to assess the increase in alpha diversity between pre-IMT and that measured at ~42 days after IMT administration (day +28 of HCT), comparing the difference between patients receiving IMT compared with placebo. Secondary outcomes will include tolerability, the dynamics of gut microbiome diversity metrics and taxonomy over all time points assessed, as well as clinical outcomes (including burden of invasive infections, days of fever, admission to intensive care, development of graft-vs-host disease and mortality).

Ethics and dissemination

This study was approved by a UK Research Ethics Committee (REC reference: 23/NE/0105). Dissemination of results will be in concert with patient and public involvement group input and is expected to be primarily via abstract presentation at conferences and manuscripts in peer-reviewed journals.

Trial registration numbers

NCT6355583; EudraCT: 2022-003617-10.
Physical activity for children and adolescents with attention deficit hyperactivity disorder: a protocol of a systematic review and meta-analysis
Authors: Jensen Marie-Louise , Storebø Ole Jakob , Bjerrum Merete Bender , Vamosi Marianne
Published: December 2024

Introduction

Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder among children and adolescents. The disorder negatively influences their academic performance and social relations, and their quality of life (QoL) is lower than that of peers without ADHD. The majority of children and adolescents with ADHD are treated with medication that potentially has an insufficient effect or frequently occurring adverse events. Physical activity is thought to alter the physiology of ADHD by affecting the same catecholaminergic system in the brain which is targeted by medication.

Methods and analysis

This protocol is written in accordance with the ‘Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols’ guideline. Randomised clinical trials with participating children and adolescents between the ages of 3 and 18 years with a primary diagnosis of ADHD or hyperkinetic disorder will be included in the systematic review. The main objective of the review is to examine the effect of physical activity on QoL, executive functions, symptoms and functional impairment in this population. Previous systematic reviews on the effect of physical activity in children and adolescents with ADHD have several methodological and conceptual limitations. These reviews, for example, included both randomised and non-randomised clinical trials or had restrictions regarding the frequency and intensity of the physical activity interventions they included. The present review will include the newest studies in the field and follow the main principles outlined in the ‘Cochrane Handbook for Systematic Reviews of Interventions’. Furthermore, it will be the first review in the field to include QoL as an outcome and to apply trial sequential analysis as part of the meta-analysis.

Ethics and dissemination

As the systematic review is a secondary analysis of data from primary trials, approval from an ethics committee is not required. The results of the review will be published in a peer-reviewed scientific journal and presented at relevant conferences.

Trial registration number

This protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 16 August 2024 (CRD42024576670).