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Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) trial: a protocol for a pragmatic randomised study of diverticulitis treatment in the USA

Por: Hantouli · M. N. · Schmicker · R. H. · Tufte · J. E. · Ali · F. G. · Bennett · R. D. · Cohan · J. N. · Comstock · B. A. · Curran · T. · Davidson · G. H. · Eisenstein · S. · Fischkoff · K. N. · Fleming · F. J. · Gribovskaja-Rupp · I. · Jafari · M. D. · Kessler · L. G. · Krane · M. K.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT04095663.

Sleep improvement strategies for people with vision impairment: a scoping review

Por: Leonard-Hawkhead · B. · Piyasena · M. P. · Peto · T. · Virgili · G. · van Nispen · R. M. A. · Curran · K.
Objectives

To explore existing strategies for managing sleep disorders in individuals with vision impairment (VI), identifying interventions, geographical trends and research gaps.

Design

Scoping review.

Data sources

Medline ALL (Ovid), Embase and Web of Science Core Collection, with supplementary searches in Google Scholar. The final search was completed on 28 November 2025.

Eligibility criteria for selecting studies

Original research studies examining strategies to manage sleep disorders in adults (≥18 years) with VI, published in English. Studies focusing on animal models or unrelated to sleep management were excluded.

Data extraction and synthesis

Two reviewers independently screened titles, abstracts and full texts using Covidence, extracted data using a predefined form and resolved discrepancies by consensus. A narrative synthesis approach was used to summarise findings by intervention type, study design and outcomes.

Results

Of 4368 records screened, 16 studies met inclusion criteria. Participants ranged from 18 years to 85 years (median 40.5). Most studies included individuals with no light perception, though VI definitions were often inconsistent. Pharmacological interventions dominated (13/16, 81.3%), mainly melatonin or melatonin receptor agonists, with some use of zopiclone, low-dose benzodiazepines and tricyclic antidepressants. Non-pharmacological approaches were under-represented, including bright light exposure (n=1), virtual Hatha yoga (n=1) and caffeine modulation (n=1). Substantial variation existed in sleep assessment methods.

Conclusions

This scoping review highlights the predominant focus on pharmacological treatments, especially melatonin, while non-pharmacological strategies remain underexplored. Future research should explore accessible, non-pharmacological interventions and address sleep health inequities faced by individuals with VI.

Registration

10.17605/OSF.IO/7E83R.

Testing oral nicotine pouches versus nicotine replacement therapy for cigarette harm reduction in Appalachia: The ARISE study protocol

by Amy Wermert, Theodore M. Brasky, Alison M. Newton, Alice Hinton, Hayley Curran, Amy K. Ferketich, Matthew J. Carpenter, Peter G. Shields, Patrick Tomko, Theodore L. Wagener, Brittney Keller-Hamilton

Background

With the highest cancer incidence and mortality rates in the country, rural Appalachia has experienced a decades-long health decline, due in part to high smoking rates. Cigarette smoking prevalence exceeds 30% in much of the region. Oral nicotine pouches (ONPs), which contain nicotine but no tobacco, present an unexplored opportunity to reduce cigarette smoking and cancer incidence.

Objectives

We outline the protocol for the Appalachian Research to Impact Smoking’s Effects (ARISE) study, a randomized controlled trial to determine whether ONPs affect cigarette smoking patterns short- and long-term, and to evaluate their abuse liability versus nicotine replacement therapy (NRT) in a large sample of Appalachian smokers (clinicaltrials.gov: NCT06763536).

Methods

Between 2025 and 2029, we will recruit 1,000 adult smokers living in rural Appalachian counties across 11 states. Participants will be identified via media outreach, mobile cancer screening, community events, and respondent-driven sampling, then randomized to ONP or NRT and complete four study phases: Baseline, Sampling, Switch, and Observation. In the Sampling phase, participants will receive varied flavors and nicotine strengths of their assigned product and select preferred options for use. During the Switch Phase, they will attempt to quit smoking and switch completely to their assigned product. The Observation phase will monitor tobacco use after discontinuation of study products. Study procedures will be conducted online and by mail, including surveys, expired carbon monoxide verification, and product delivery. The primary outcome is 7-day biochemically verified cigarette abstinence at the end of the Switch Phase. Secondary outcomes include switching rates, product appeal, craving, withdrawal, dependence, and purchases during the Observation phase. An intention-to-treat log-binomial regression model will estimate the effect of intervention assignment on cigarette abstinence.

Conclusions

Results will inform whether and how ONPs should be regulated, approached clinically, and used in public health interventions to reduce the burdens of cigarette smoking in Appalachia.

Using 'research cafes as a proof-of-concept model for engaging minoritised communities in UK health research: a mixed-methods feasibility study in South West London

Por: Kurade · S. S. N. · Heffernan · C. · Curran · N. · Lelliott · Z. · Milocco · S. · Ocloo · J.
Objective

This proof-of-concept study explored the feasibility and acceptability of research cafés as a community-based model to engage racially minoritised communities in health research, with a focus on mental health.

Design

Adopting a community peer research approach, a research team led by researchers from racially minoritised backgrounds, partnered with four voluntary organisations to conduct four research cafés. A mixed-methods feasibility design combined descriptive quantitative questionnaire data with thematic analysis of discussion notes to evaluate the impact of these cafés in South West London.

Setting

The study took place in Wandsworth, Kingston, Croydon and Sutton, in community venues provided by the voluntary organisations.

Participants

A total of 75 participants from racially minoritised backgrounds attended the sessions. Participants were intentionally selected based on age, ethnicity, location, mental well-being experiences and willingness to engage in mental health research.

Main outcome measures

Quantitative data were collected on participant attendance, demographics and feedback. Qualitative data captured participant perceptions and experiences related to healthcare and research.

Results

The study took place between October 2023 and March 2024. Out of the 112 individuals who registered, 75 people attended with 74 contributing to the analysis (excluding one on the day sign-up). Participants were predominantly Asian/Asian British (62%) and Black/Black British (31%). All participants reported feeling comfortable and respected. Understanding of research improved for 96% and 95% expressed interest in further research involvement, most commonly the idea of joining a peer research network (64%). Participants also highlighted a need for training in research methods and communication skills for ongoing involvement. Five main themes emerged from the café discussions: (1) systemic barriers to accessing safe healthcare and mistrust of UK healthcare systems; (2) the need for cultural competence and sensitivity in healthcare and research; (3) research as a positive step for change; (4) barriers to research participation and (5) the importance of incentives and feedback for research participation.

Conclusions

Preliminary findings suggest that diverse and inclusive community-based partnerships are the basis for developing research cafés as a feasible and acceptable model for engaging racially minoritised communities in health research. They complement existing participatory approaches by creating inclusive, peer-facilitated spaces that build trust, improve awareness and generate high intention for future involvement and participation. Future studies are needed to test the model’s scalability across different geographic and demographic contexts and evaluate its long-term impact on research literacy, participation and equity.

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