bluuebunny/crossref_metadata_2025_split huggingface dataset:
Under-representation of older Indian persons with cancer in clinical trials
Authors: Noronha Vanita , Patil Vijay , Menon Nandini , Kolkur Manali , Peelay Zoya , Shah Minit , Mathrudev Vijayalakshmi , Shah Srushti , Nawale Kavita , Nair Nita S , Ramaswamy Anant , Ostwal Vikas , Ghosh-Laskar Sarbani , Agarwal Jai Prakash , Chaturvedi Pankaj , Chopra Supriya , Murthy Vedang , Myatra Sheila N , Divatia Jigeeshu , Gota Vikram , Gupta Sudeep , Chaudhari Vikram , Jiwnani Sabita , Shrikhande Shailesh V , Vaish Richa , Chaukar Devendra , Thiagarajan Shivakumar , Nair Sudhir , D'Cruz Anil , Oak Amey , Hawaladar Rohini , Roy Chowdhury Oindrila , Banavali Shripad , Badwe Rajendra , Prabhash Kumar 
Published: August 2024

ObjectiveOlder patients with cancer have traditionally been under-represented in global clinical trials. There are no data from India regarding this issue.Methods and analysisThis was a retrospective analysis done at our institute on interventional studies conducted between 2003 and 2023 in adult patients with malignancies. We excluded studies done exclusively in the paediatric population and observational studies.ResultsWe included 21 894 patients enrolled in 150 interventional trials from the departments of surgical, medical, and radiation oncology, anaesthesia, and clinical pharmacology; 110 (73.3%) were investigator initiated. There were 38 trials (25.3%) in breast cancer (6141 patients, 28%), and 33 (22%) in head and neck cancer (6975 patients, 31.9%). Studies were predominantly phase III (97 trials (64.7%)). Multicentric studies comprised approximately one-third (48, 32%). The median age of enrolled patients was 51 years (IQR 43–59). There were 5132 (23.4%) participants aged ≥60 years, 2678 (12.2%) ≥65 years and 1045 (4.8%) ≥70 years. Data from the hospital registry revealed that 30% of adult registrations were ≥60 years. There was a significant increase in the proportion of older patients enrolled in clinical trials from 2003 (8%) to 2019 (22%) compared with their proportion in the hospital registry (stable at 28%–29%); p<0.001.ConclusionThere is a gap between the proportion of older Indian adults with cancer in the hospital registry and those enrolled in interventional clinical trials, however, this gap has shrunk over time. Various factors that limit the recruitment of this vulnerable cohort like age-specific eligibility criteria are immediately actionable to make clinical trials more inclusive.
Elucidating the dynamics and impact of the gut microbiome on maternal nutritional status during pregnancy, effect on pregnancy outcomes and infant health in rural Pakistan: study protocol for a prospective, longitudinal observational study
Authors: Wasan Yaqub , Baxter Jo-Anna B , Spiegel-Feld Carolyn , Begum Kehkashan , Rizvi Arjumand , Iqbal Junaid , Hulst Jessie , Bandsma Robert , Suleman Shazeen , Soofi Sajid , Parkinson John , Bhutta Zulfiqar Ahmed 
Published: August 2024

IntroductionUndernutrition during pregnancy is linked to adverse pregnancy and birth outcomes and has downstream effects on the growth and development of children. The gut microbiome has a profound influence on the nutritional status of the host. This phenomenon is understudied in settings with a high prevalence of undernutrition, and further investigation is warranted to better understand such interactions.Methods and analysisThis is a prospective, longitudinal observational study to investigate the relationship between prokaryotic and eukaryotic microbes in the gut and their association with maternal body mass index (BMI), gestational weight gain, and birth and infant outcomes among young mothers (17–24 years) in Matiari District, Pakistan. We aim to enrol 400 pregnant women with low and normal BMIs at the time of recruitment (<16 weeks of gestation). To determine the weight gain during pregnancy, maternal weight is measured in the first and third trimesters. Gut microbiome dynamics (bacterial and eukaryotic) will be assessed using 16S and 18S rDNA surveys applied to the maternal stool samples. Birth outcomes include birth weight, small for gestational age, large for gestational age, preterm birth and mortality. Infant growth and nutritional parameters include WHO z-scores for weight, length and head circumference at birth through infancy. To determine the impact of the maternal microbiome, including exposure to pathogens and parasites on the development of the infant microbiome, we will analyse maternal and infant microbiome composition, micronutrients in serum using metallomics (eg, zinc, magnesium and selenium) and macronutrients in the stool. Metatranscriptomics metabolomics and markers of inflammation will be selectively deployed on stool samples to see the variations in dietary intake and maternal nutritional status. We will also use animal models to explore the bacterial and eukaryotic components of the microbiome.Ethics and disseminationThe study is approved by the National Bioethics Committee (NBC) in Pakistan, the Ethics Review Committee (ERC) at Aga Khan University and the Research Ethics Board (REB) at the Hospital for Sick Children, and findings will be published in peer-reviewed journals.Trial registration numberNCT05108675.
Patient experience in bariatric surgery: protocol of a French narrative inquiry and qualitative analysis
Authors: Vignot Marina , Jung Camille , Bathaei Sarah , Lazzati Andrea , Gateau Valérie , Angeli Frederica , Delorenzo Christian 
Published: August 2024

IntroductionThe quality of hospital care, especially surgery, is traditionally assessed using indicators derived from healthcare databases or safety indicators. Given the growing importance of placing the patient at the heart of care evaluation, the use of questionnaires such as the Patient-Reported Experience Measures and Patient-Reported Outcome Measures has become widespread in recent years. However, these tools—addressing factors such as satisfaction, pain management or wait times—only imperfectly reflect the patient’s experience, and all such attempts at patient-centred care quality assessment rely on questions or indicators defined in advance by healthcare providers and health authorities. A biopsychosocial model may allow to better understand the patient experience and to improve care pathways. This study seeks to construct a narrative of the bariatric surgical care journey with instruments from narrative inquiry, propose a metanarrative that can serve as a basis for more sophisticated and reliable patient-focused care quality models and define indicators linked to patients’ feelings and stories.Methods and analysisTo achieve these aims, 16 bariatric surgical patients at the hospital of Créteil, France (Centre Hospitalier Intercommunal de Créteil), will be included and interviewed once before and twice after surgery, at months 3 and 6. Narratives collected will be used to construct a metanarrative intended to encompass all possible narratives. This metanarrative may ultimately inform new patient care quality indicators, furthering care focused on patients and tailored to their needs and predispositions.Ethics and disseminationThe study is funded by the Group of Clinical Research and Innovation in Île-de-France and was approved by CPP SUD-EST VI Clermont-Ferrand (France) Research Ethics Committee. The results will be submitted for publication in peer-reviewed journals. The patient associations will be approached for the dissemination of the study results.Trial registration numberNCT05092659.
Identifying pain profiles in employees including work-related factors and pain perceptions: a cross-sectional study in Belgian companies
Authors: Keyaerts Stijn , Godderis Lode , Vanden Abeele Vero , Daenen Liesbeth 
Published: August 2024

ObjectivesStudies usually investigate a limited number or a predefined combinations of risk factors for sickness absence in employees with pain. We examined frequently occurring combinations across a wide range of work-related factors and pain perceptions.DesignCross-sectional study.SettingBelgian companies that are under supervision of IDEWE, an external service for prevention and protection at work.ParticipantsIn total, 249 employees experiencing pain for at least 6 weeks were included and filled out an online survey.OutcomesLatent profile analysis was used to differentiate profiles of work-related factors (physical demands, workload, social support and autonomy) and pain perceptions (catastrophising, fear-avoidance beliefs and pain acceptance). Subsequently, profiles were compared on sociodemographics (age, gender, level of education, work arrangement, duration of complaints, multisite pain and sickness absence in the previous year) and predictors of sickness absence (behavioural intention and perceived behavioural control).ResultsFour profiles were identified. Profile 1 (38.2%) had favourable scores and profile 4 (14.9%) unfavourable scores across all indicators. Profile 2 (33.3%) had relatively high physical demands, moderate autonomy levels and favourable scores on the other indicators. Profile 3 (13.7%) showed relatively low physical demands, moderate autonomy levels, but unfavourable scores on the other indicators. Predictors of profiles were age (OR 0.93 and 95% CI (0.89 to 0.98)), level of education (OR 0.28 and 95% CI (0.1 to 0.79)) and duration of sickness absence in the previous year (OR 2.29 and 95% CI (0.89 to 5.88)). Significant differences were observed in behavioural intention (χ2=8.92, p=0.030) and perceived behavioural control (χ2=12.37, p=0.006) across the four profiles.ConclusionThis study highlights the significance of considering the interplay between work-related factors and pain perceptions in employees. Unfavourable scores on a single work factor might not translate into maladaptive pain perceptions or subsequent sickness absence, if mitigating factors are in place. Special attention must be devoted to employees dealing with unfavourable working conditions along with maladaptive pain perceptions. In this context, social support emerges as an important factor influencing sickness absence.
Case management in primary healthcare for people with complex needs to improve integrated care: a large-scale implementation study protocol
Authors: Hudon Catherine , Chouinard Maud-Christine , Doucet Shelley , Piccinini-Vallis Helena , Fairman Kimberly , Sampalli Tara , Zed Joanna , Brodeur Magaly , Chênevert Denis , Dépelteau Andréa , Dupont Mariève , Karam Marlène , Légaré France , Luke Alison , Macdonald Marilyn , Morvannou Adele , Ramsden Vivian R , Rodriguez Del Barrio Lourdès , Wong Sabrina T , Lambert Mireille , Bisson Mathieu , Schwarz Charlotte , Benoit René , Poirier Marie-Dominique , Rock-Hervieux Audrey-Lise , Rubenstein Donna , Wilhelm Linda 
Published: August 2024

IntroductionCase management (CM) is among the most studied effective models of integrated care for people with complex needs. The goal of this study is to scale up and assess CM in primary healthcare for people with complex needs.Methods and analysisThe research questions are: (1) which mechanisms contribute to the successful scale-up of CM for people with complex needs in primary healthcare?; (2) how do contextual factors within primary healthcare organisations contribute to these mechanisms? and (3) what are the relationships between the actors, contextual factors, mechanisms and outcomes when scaling-up CM for people with complex needs in primary healthcare? We will conduct a mixed methods Canadian interprovincial project in Quebec, New-Brunswick and Nova Scotia. It will include a scale-up phase and an evaluation phase. At inception, a scale-up committee will be formed in each province to oversee the scale-up phase. We will assess scale-up using a realist evaluation guided by the RAMESES checklist to develop an initial programme theory on CM scale-up. Then we will test and refine the programme theory using a mixed-methods multiple case study with 10 cases, each case being the scalable unit of the intervention in a region. Each primary care clinic within the case will recruit 30 adult patients with complex needs who frequently use healthcare services. Qualitative data will be used to identify contexts, mechanisms and certain outcomes for developing context–mechanism–outcome configurations. Quantitative data will be used to describe patient characteristics and measure scale-up outcomes.Ethics and disseminationEthics approval was obtained. Engaging researchers, decision-makers, clinicians and patient partners on the study Steering Committee will foster knowledge mobilisation and impact. The dissemination plan will be developed with the Steering Committee with messages and dissemination methods targeted for each audience.
Barriers and facilitators to implementing psychosocial digital health interventions for older adults presenting to emergency departments: a scoping review protocol
Authors: Davison Neve , Waddell Alex , Chandrasekara Dharshani , Tran Thach , Hammarberg Karin , Kirkman Maggie , Nimesh Seema , Lowthian Judy A , Olivier Patrick , Romero Lorena , Fisher Jane , Dwyer Rosamond 
Published: August 2024

IntroductionOlder adults can face challenges when seeking care from emergency departments (EDs) due to presenting with multiple comorbidities and non-specific symptoms. Psychosocial care is a possible target to help improve ED care for this population. It is possible that digital health technologies can be implemented within emergency settings to improve the provision of psychosocial care. However, it is unclear what the barriers and facilitators are to implementing digital psychosocial interventions for older adults presenting to the ED. Therefore, the scoping review aims to determine what are these barriers and facilitators.Methods and analysisThe scoping review will be conducted in line with the Joanna Briggs Institute guidelines and will use the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. The databases Medline, Embase, PsycINFO and Scopus will be searched. The search strategy will be developed in consultation with a specialist research librarian and will cover three key concepts: EDs, digital health technologies and older adults. Additionally, the first 100 hits of a Google Scholar search will be screened for inclusion. We will include both qualitative and quantitative studies that investigate ED digital interventions for psychosocial care where the primary focus is the views, attitudes, experiences and perceptions of patients, families and staff. After extracting all data, analysis and synthesis will follow the ‘best-fit framework synthesis’ approach and the Theoretical Domains Framework will be used to identify barriers and facilitators.Ethics and disseminationEthics approval is not required for this scoping review since only publicly available data will be analysed and appraised. The findings of the scoping review will be disseminated through peer-reviewed publications and conference presentations.
Changing trend of cataract blindness and visual outcomes after cataract surgery in adults aged 50 years and older: findings from the national eye surveys in Malaysia
Authors: Salowi Mohamad Aziz , Naing Nyi Nyi , Mustafa Norasyikin , Wan Nawang Wan Radziah , Sharudin Siti Nurhuda , Ngah Nor Fariza 
Published: August 2024

Background/aimsPopulation surveys are required to measure the prevalence of cataract blindness in the community. We conducted simultaneous surveys in two regions in Malaysia in 2023 to estimate the prevalence of untreated cataract, measure the visual outcomes after cataract surgery and compare the results with the survey in 2014.MethodsThe surveys were done in Eastern and Sarawak administrative regions using the rapid assessment of avoidable blindness technique. It involved a multistage cluster sampling method, each cluster comprising 50 residents aged 50 years and older. The prevalence of cataract was determined through a visual acuity (VA) check and eye examination. The VA of those who had undergone cataract surgery was measured, and the findings were compared with the previous survey.ResultsA total of 9709 subjects, 50 years old and older, were examined (percentages of response were 94.5% and 96.2% for Eastern and Sarawak, respectively). Comparing the current to the previous survey in 2014, the prevalence of cataract at all levels of surgical thresholds (except unilateral VA <6/60 and <6/18 in the Eastern) was reduced. The percentages of cataract surgery visual outcomes with good VA (6/12) were improved, and those with poor VA (<6/60) were reduced in both regions.ConclusionThere was a reduction in cataract prevalence and improved visual outcomes in both regions. These favourable results could be attributed to the surgical performance monitoring initiatives and the community cataract programme implemented soon after the survey in 2014.
Clinical presentation, diagnosis and management of multisystem inflammatory syndrome in children (MIS-C): a systematic review
Authors: Abbas Qalab , Ali Haider , Amjad Fatima , Hussain Muhammad Zaid Hamid , Rahman Abdu R , Khan Maryam Hameed , Padhani Zahra A , Abbas Fatima , Imam Danyal , Alikhan Zuviya , Belgaumi Sameer M. , Mohsin Shazia , Sattar Faiza , Siddiqui Arsalan , Lassi Zohra S , Das Jai K 
Published: August 2024

Background
Knowledge about multisystem inflammatory syndrome in children (MIS-C) is evolving, and evidence-based standardised diagnostic and management protocols are lacking. Our review aims to summarise the clinical and diagnostic features, management strategies and outcomes of MIS-C and evaluate the variances in disease parameters and outcomes between high-income countries (HIC) and middle-income countries (MIC).

Methods
We searched four databases from December 2019 to March 2023. Observational studies with a sample size of 10 or more patients were included. Mean and prevalence ratios for various variables were pooled by random effects model using R. A mixed generalised linear model was employed to account for the heterogeneity, and publication bias was assessed via funnel and Doi plots. The primary outcome was pooled mean mortality among patients with MIS-C. Subgroup analysis was conducted based on the income status of the country of study.

Results
A total of 120 studies (20 881 cases) were included in the review. The most common clinical presentations were fever (99%; 95% CI 99.6% to 100%), gastrointestinal symptoms (76.7%; 95% CI 73.1% to 79.9%) and dermatological symptoms (63.3%; 95% CI 58.7% to 67.7%). Laboratory investigations suggested raised inflammatory, coagulation and cardiac markers. The most common management strategies were intravenous immunoglobulins (87.5%; 95% CI 82.9% to 91%) and steroids (74.7%; 95% CI 68.7% to 79.9%). Around 53.1% (95% CI 47.3% to 58.9%) required paediatric intensive care unit admissions, and overall mortality was 3.9% (95% CI 2.7% to 5.6%). Patients in MIC were younger, had a higher frequency of respiratory distress and evidence of cardiac dysfunction, with a longer hospital and intensive care unit stay and had a higher mortality rate than patients in HIC.

Conclusion
MIS-C is a severe multisystem disease with better mortality outcomes in HIC as compared with MIC. The findings emphasise the need for standardised protocols and further research to optimise patient care and address disparities between HIC and MIC.

PROSPERO registration number
CRD42020195823.
Epithelium/imcDC2 axis facilitates the resistance of neoadjuvant anti-PD-1 in human NSCLC
Authors: Chen Yongyuan , Shao Zheyu , Hao Zhixing , Xin Zhongwei , Chen Xiaoke , Huang Lijian , Chen Di , Lin Mingjie , Liu Qinyuan , Xu Xia , Li Jinfan , Wu Dang , Yan Jun , Chai Ying , Wu Pin 
Published: August 2024

BackgroundTherapeutic resistance is a main obstacle to achieve long-term benefits from immune checkpoint inhibitors. The underlying mechanism of neoadjuvant anti-PD-1 resistance remains unclear.MethodsMulti-omics analysis, including mass cytometry, single-cell RNA-seq, bulk RNA-seq, and polychromatic flow cytometry, was conducted using the resected tumor samples in a cohort of non-small cell lung cancer (NSCLC) patients received neoadjuvant anti-PD-1 therapy. Tumor and paired lung samples acquired from treatment-naïve patients were used as a control. In vitro experiments were conducted using primary cells isolated from fresh tissues and lung cancer cell lines. A Lewis-bearing mouse model was used in the in vivo experiment.ResultsThe quantity, differentiation status, and clonal expansion of tissue-resident memory CD8+ T cells (CD8+ TRMs) are positively correlated with therapeutic efficacy of neoadjuvant anti-PD-1 therapy in human NSCLC. In contrast, the quantity of immature CD1c+ classical type 2 dendritic cells (imcDC2) and galectin-9+ cancer cells is negatively correlated with therapeutic efficacy. An epithelium/imDC2 suppressive axis that restrains the antitumor response of CD8+ TRMs via galectin-9/TIM-3 was uncovered. The expression level of CD8+ TRMs and galectin-9+ cancer cell-related genes predict the clinical outcome of anti-PD-1 neoadjuvant therapy in human NSCLC patients. Finally, blockade of TIM-3 and PD-1 could improve the survival of tumor-bearing mouse by promoting the antigen presentation of imcDC2 and CD8+ TRMs-mediated tumor-killing.ConclusionGalectin-9 expressing tumor cells sustained the primary resistance of neoadjuvant anti-PD-1 therapy in NSCLC through galectin-9/TIM-3-mediated suppression of imcDC2 and CD8+ TRMs. Supplement of anti-TIM-3 could break the epithelium/imcDC2/CD8+ TRMs suppressive loop to overcome anti-PD-1 resistance.Trial registration numberNCT03732664.
Sexually transmitted infections and migration in Uganda: a population-based study
Authors: Moffa Michelle A , Feng Xinyi , Mpagazi Josephine , Kiboneka Stephen , Ssekubugu Robert , Kereba John Baptiste , Nakayijja Annet , Tukundane Julius , Jackson Jade , Kennedy Caitlin E , Kigozi Godfrey , Galiwango Ronald M , Manabe Yukari C , Gaydos Charlotte A , Chang Larry W , Kalibala Sarah , Reynolds Steven J , Tobian Aaron AR , Quinn Thomas , Grabowski M Kate , Kagayi Joseph 
Published: August 2024

ObjectivesMigration is associated with increased risk of HIV infection in Africa, but evidence about non-HIV sexually transmitted infection (STI) burden among African migrants is limited.MethodsWe used data from the Sexually Transmitted Infection Prevalence Study, a cross-sectional population-based study of chlamydia, gonorrhoea, trichomoniasis, syphilis and herpes simplex virus type 2 prevalence in southern Uganda, to compare STI prevalence between adults aged 18 and 49 years with and without a recent history of migration. Migration status was determined using household census data, with a recent migration history defined as having moved into one’s community of current residence within the last ~18 months. Unadjusted and adjusted modified Poisson regression models were used to compare individual STI prevalence risk by recent migration status with associations reported as adjusted prevalence risk ratios (adjPRRs) with 95% CIs. Adjusted models included participants’ sex, age, community type, education, occupation and marital status.ResultsAmong 1825 participants, 358 (19.6%) had a recent migration history. Overall, migrants exhibited a significantly higher combined prevalence of curable STIs (gonorrhoea, chlamydia, high-titre syphilis (rapid plasma regain ≥1:8) and trichomoniasis) as compared with long-term residents (34.4% vs 24.2%; adjPRR=1.23; 95% CI 1.03 to 1.47). Significant differences in curable STI prevalence by migration status were concentrated among persons living with HIV (49.4% prevalence in migrants vs 32.6% in long-term residents; adjPRR=1.42; 95% CI 1.10 to 1.85) and among women (38.8% in migrants vs 27.8% in long-term residents; adjPRR=1.26; 95% CI 1.01 to 1.58). High-titre syphilis prevalence was especially elevated among male migrants (11.2% in migrants vs 4.9% in long-term residents; adjPRR=1.82; 95% CI 1.06 to 3.13).ConclusionsThe prevalence of non-HIV STIs is higher among migrants. Tailored outreach and service delivery approaches that address the needs of mobile populations are crucial for integrated HIV and STI epidemic control in Uganda to optimise resources and reduce transmission risks.