Each year, millions of people experience recurrent diverticulitis episodes. Elective sigmoid colon resection reduces the risk of recurrence, but The American Society of Colon and Rectal Surgeons recommends individualising surgical decisions based on the impact of the condition on a patient’s quality of life (QoL). However, no threshold for QoL impairment has been established to guide decision-making, and evidence comparing elective colectomy with medical management in terms of QoL limitation is limited. To address these gaps and to guide treatment decision-making, we designed the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) trial.
The COSMID trial is a large, pragmatic randomised trial including patients with QoL-limiting diverticulitis that aims to determine if partial colectomy is superior to medical management and explore subgroups that are more likely to respond to each treatment.
COSMID will recruit 250 English-speaking and Spanish-speaking adults with imaging-confirmed and QoL-limiting diverticulitis (defined using a modified diverticulitis-related QoL survey). Participants are randomly assigned to undergo elective partial colectomy or receive comprehensive medical management (eg, selected from options including fibre, probiotics, mesalamine and rifaximin). A total of 100 patients who decline randomisation but consent to follow-up will be included in a parallel observational cohort. The primary outcome is the time-averaged score of the Gastrointestinal Quality of Life Index at 6, 9 and 12 months after randomisation. Secondary outcomes include clinical adverse events, healthcare utilisation, recurrent episodes of diverticulitis and additional patient-reported outcomes like the Diverticulitis Quality of Life instrument, decisional regret and work productivity. Exploratory analyses aim to identify differential treatment effects based on patients’ characteristics.
This trial was approved by the Vanderbilt Institutional Review Board (IRB) on 26 August 2019 (IRB #191217). Vanderbilt serves as the institutional review board of record for the following study sites: Albany Medical College, Allegheny Health, Atrium Health Carolinas Medical Center, Virginia Mason Medical Center, Boston University Medical Center, Cedars-Sinai Medical Center, UT Health Lyndon B. Johnson Hospital, Medical University of South Carolina, New York-Presbyterian Queens, Stanford University, University of Pennsylvania, University of California San Diego, University of California San Francisco, University of Colorado Denver, University of Florida, University of Iowa, University of Utah, University of Washington Medical Center, University of South Florida, University of Rochester Medical Center, University of Texas Southwestern Medical Center, Virginia Commonwealth University, Lahey Hospital & Medical Center, Weill Cornell Medical Center and Northwell Health. Rush University Medical Center (approved 8 January 2020), Columbia University Medical Center (approved 28 January 2020), Northwestern University (approved 19 March 2020), Mount Carmel Health System (approved 5 May 2020) and Memorial Health University Medical Center (approved 4 April 2022) are regulated and were approved by their respective IRBs. Results from this trial will be presented at international conferences and published in peer-reviewed journals.
To estimate the prevalence of sleep problems among children aged 2–5 years residing in South India, assess its association with screen time and identify a predictive screen time threshold.
Population-based cross-sectional study.
Field practice areas in rural and urban centres of a medical college in South India.
In total, 523 children aged 2–5 years were selected by simple random sampling.
Sleep problems were assessed using the validated bedtime problems, excessive daytime sleepiness, awakenings during the night, regularity of sleep and snoring sleep screening tool. Sociodemographic and behavioural factors, including screen time, were also examined. The optimal predictive screen time cut-off was identified using receiver operating characteristic (ROC) analysis.
Sleep disturbances were reported in 39.6% of children (95% CI 35.5% to 43.8%). The most common sleep problems were irregular sleep (22.2%), bedtime resistance (20.8%) and night awakening (19.9%). Multivariate logistic regression showed strong associations between sleep problems and screen use in bed (adjusted OR (AOR) = 3.8; 95% CI 2.4 to 6.1), excess screen time (AOR=3.3; 95% CI 1.8 to 6), smaller family size (AOR=3.1; 95% CI 1.5 to 6.1), reduced physical activity (AOR=2.6; 95% CI 1.6 to 4.2), shorter birth spacing (AOR=1.8; 95% CI 1.1 to 2.8), lower socioeconomic status (AOR=1.8; 95% CI 1.2 to 2.8) and maternal screen time>2 hours/day (AOR=1.6; 95% CI 1.04 to 2.6). ROC analysis identified ≥2.4 hours per day of screen time as the optimal threshold for predicting sleep problems (area under the curve=0.800; sensitivity, 73.9% and specificity, 77.2%).
In this large population-based study, two of the five preschool children experienced sleep problems, with excess screen time, particularly screen use in bed, being the key contributing factor. This is one of the few Indian studies to establish an ROC-derived screen time threshold for identifying sleep problems. These findings can guide targeted parental advice and early preventive strategies to promote healthy sleep in preschool children.
Adolescents and young adults (AYAs) represent a significant proportion of the global population, yet they face persistent barriers to accessing HIV services. In Sub-Saharan Africa, nearly 90% of AYA HIV cases occur within the region, with young women disproportionately affected. In Chad, while the overall HIV prevalence has declined, the risk remains high among AYA, accounting for 26.3% of all new infections. Stigma, lack of confidentiality, negative provider attitudes and structural barriers continue to hinder service utilisation, underscoring the urgent need for evidence-based, AYA-centred interventions. However, little is known about which attributes of HIV services AYA prioritise when accessing HIV care. This study applies a discrete choice experiment in Chad to systematically quantify AYA preferences for HIV services to inform the design of youth-responsive interventions.
The study employs a D-efficient fractional factorial design, developed through extensive qualitative research and pilot testing. The final design comprises 80 choice scenarios, divided into 10 blocks to reduce participant burden. The study will recruit 1000 AYA living with HIV aged 15–24 years across eight provinces, ensuring geographical and epidemiological representativeness. Participants will be randomly assigned to one of the blocks and complete eight choice tasks. Choice data will be analysed using conditional logit, mixed logit and latent class models to estimate trade-offs and preference heterogeneity.
Ethical approval was obtained from the National Committee on Bioethics of Chad (#010/MESRS/SE/SG/2024). In addition to disseminating findings through scientific publications, policy briefs and stakeholder engagements, the study will incorporate a codesign process with AYA, healthcare providers and policymakers to translate research findings into actionable interventions that align with AYA preferences and improve HIV service delivery.
Indigenous Mayan-Yucatecan communities in Mexico have a high prevalence of chronic non-communicable diseases (NCDs) such as diabetes, hypertension, obesity and rheumatic diseases (RMDs). According to the syndemic theory, these diseases combined with social, economic and cultural factors affect the quality of life. The aim of this protocol is to describe the methodological process to create, implement and evaluate a Syndemic-Based Care Model (SCM), using a Community Based-Participatory Research (CBPR) strategy in three Mayan-Yucatecan communities.
This is a convergent mixed-methods protocol. The quantitative component is a before-after study, and the qualitative component is an ethnographic study. The intervention will be a SCM co-constructed with Mayan communities based on their particular needs and aiming for reduction of the negative impact of NCD/RMD through a multidisciplinary approach. We will follow four phases of the CBPR: (1) situational analysis, through community censuses and semistructured interviews to understand the prevalence of NCDs and the syndemics in these communities; (2) co-construction of the elements of a SCM based on the health priorities identified by researchers, community members and healthcare workers; (3) implementation of this SCM and (4) evaluation of the SCM through (1) statistical analyses involving the construction of a syndemic index through stepwise logistic regression of the normalised and standardised key clinical, social and economic variables; interval and ratio variables will be normalised by their z-score and categorical variables will be one-hot encoded; similarity and social networks analysis with clustering to identify syndemic subpopulations; and cost-effectiveness and cost-utility analyses using Markov modelling and (2) narrative and thematic qualitative analysis of the SCM’s implementation and impact on community members’ health, function and quality of life.
Research ethics boards of participant institutions approved this research protocol. This project will be presented to municipal authorities, community meetings and community leaders for observation and acceptance. For people who wish to participate, informed consent will be provided written and verbally in Spanish or Mayan-Yucatecan according to the participant preferences, and it can be signed by either autograph or fingerprint. The results of this research will be disseminated to various groups: (a) local and regional authorities of the Mexican health system and municipal authorities; (b) the participating communities will be informed in an assembly of the results and (c) academic dissemination will be done through publications in public science journals and institutional press releases and will also be presented at national and international congresses or symposia.
Black adults are generally exposed to more stressors over the life course and, due to the intersections of racism and economic and social resources, they tend to have more limited resources to cope with social stressors than white adults. This mismatch between stress exposures and resources may lead to dysregulated responses or reactivity to stressors and contribute to persistent racial disparities seen in adverse pregnancy outcomes (APOs). Prior studies examining stress exposures have been hampered by the challenge of capturing stress exposures comprehensively, given they are manifold, dynamic and accumulate over time. The Stress Reactivity and Maternal Health Study seeks to overcome this limitation by examining the impact of physiological and psychological stress reactivity to everyday stressors on APOs.
We are recruiting 700 nulliparous self-identified non-Hispanic black and white pregnant individuals from academic medical centres in the USA. We use ecological momentary assessments administered via smartphones to collect repeated measurements of exposure to everyday stressors throughout the day over the course of seven consecutive days at two different time points mid-pregnancy (14–22 weeks and 22–28 weeks). At the same time, we collect intensive measurements of heart rate variability, blood pressure, salivary cortisol and positive and negative affect. We will use mixed-effects models to estimate personalised indicators of cardiovascular, neuroendocrine and affective reactivity to everyday stressors. We will then use linear and logistic regression modelling to examine associations of these personalised indicators of stress reactivity with placental histological lesions and the occurrence of APOs. Finally, we will use the gap-closing estimand method to quantify the extent to which racial disparities in adverse placental and pregnancy outcomes are explained by differences in prenatal stress exposure and prenatal stress reactivity.
The Northwestern University institutional review board (IRB) approved this study and serves as the single IRB of record (STU00218683). All participants will sign an informed consent document prior to participation, and data will be treated confidentially. Findings will be disseminated in peer-reviewed scientific journals, briefs, infographics and presentations.
The objective of this review is to examine the current available evidence regarding the assessment of speech sound disorders (SSD) in multilingual preschoolers. This review will be conducted through the lens of the International Classification of Functioning and Disability—Child and Youth (ICF) framework, WHO. The ICF has been adopted by speech–language associations globally, offering an appropriate structure to inform this review. Most children across the world speak more than one language daily. However, measures designed to assess SSDs primarily focus on monolingual populations, placing multilingual children at risk for the misdiagnosis of SSD. A deeper understanding of available assessment measures, as well as what aspects of the ICF they address, will support clinicians in assessing SSD in multilingual children and aid researchers in identifying areas for future research. This review will explore studies that involve multilingual preschoolers (up to age 5 years 11 months) with SSD. It will examine measures used to evaluate the current status and/or progress over time in multilingual children with and without SSDs.
This scoping review protocol implements the updated Joanna Briggs Institute (JBI) Scoping Review Methodology. The search will be conducted using Ovid MEDLINE, CINAHL Plus, EMBASE and Web of Science. Grey literature will also be searched using Google Scholar and ProQuest Dissertations and Theses Global. Search, screening, data extraction and data analysis will be conducted by a team of three reviewers. Data will be analysed and mapped through the ICF framework.
Ethical approval is not required for this scoping review. Available evidence will be mapped according to the language pairings and the ICF. This review aims to support clinical and research speech–language pathologists in identifying current evidence and gaps in the knowledge base. Planned dissemination activities include a peer-reviewed publication and conference presentations.