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Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study: protocol for a national randomised pragmatic trial

Por: Sage · L. · Hart · E. · Meyer · N. · Hnilicka · O. · Penkin · A. · Poteat · T. C. · Aguayo-Romero · R. · Comstock · B. A. · STRIVE Publications Committee · Dy · G. W. · Blasdel · Corman · Deutsch · Gallo · Gore · Marsiglio · Sevelius · Solo
Introduction

Transgender and gender-diverse individuals often face significant barriers to accessing gender-affirming care, such as hormones and/or surgery, leading to poorer mental health, lower quality of life, and higher rates of substance use and suicidal ideation. Vaginoplasty, the most commonly sought genital gender-affirming surgery (GGAS), is desired by over half of all trans women but has been performed in only a minority. This is due largely to limited surgeon availability and long wait times. Peer support has been shown to improve health outcomes and reduce stigma in marginalised populations, including trans communities, but has never been studied for efficacy during the perioperative period of GGAS. Building on priorities identified by multi-stakeholder engagement from the Transgender & Non-Binary Surgery Allied Research Collective, the Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study aims to evaluate the efficacy of a centralised peer support and education intervention for patients seeking vaginoplasty, addressing a critical gap in perioperative care.

Methods and analysis

The STRIVE Study is a pragmatic, multi-site randomised controlled trial enrolling trans adults seeking full depth vaginoplasty. Participants are randomised to one of two arms; enhanced usual care, or a facilitated group intervention. The primary outcome is coping self-efficacy at 6 months, with a secondary outcome of surgical readiness. Primary analysis uses an intention-to-treat approach with linear mixed effects modelling, adjusting for selected baseline values and site. The feasibility evaluation data collected via qualitative interviews will be analysed thematically.

Ethics and dissemination

Approvals were granted by the primary site’s Institutional Review Board on 10 May 2024 (STUDY00026957). The trial was registered on 24 May 2024. Results will be published in open access journals and made available to community members in plain language formats.

Trial registration number

NCT06436560.

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.

Economic evaluation of a hospital-initiated tobacco dependence treatment service

Por: Robins · J. · Alltimes · G. · Patel · I. · McNeill · A. · Moxham · J. · Duckworth Porras · S. · Stock · A. · Woodhouse · A. · Robson · D.
Objectives

The treatment of tobacco dependence in patients admitted to hospital is a priority for the National Health Service in England. We aimed to conduct an economic analysis of a pilot ‘opt-out’ tobacco dependence treatment intervention adapted from the Ottawa Model of Smoking Cessation.

Design

Observational cost analysis of an inpatient tobacco dependence treatment intervention, and matched cohort study comparing readmission costs between patients who received the intervention and benchmarked equivalents who did not.

Setting

11 acute inpatient wards in a major teaching hospital in London, England.

Participants

673 patients who smoked, admitted between 1 July 2020 and 30 June 2021.

Interventions

The intervention consisted of the systematic identification of smoking status, automatic referral to tobacco dependence advisors, provision of pharmacotherapy and behavioural support throughout the hospital stay and telephone support for 6 months after discharge.

Primary and secondary outcome measures

The primary outcomes were cost-per-patient, cost-per-quit and incremental cost effectiveness ratio among patients who received the intervention. The secondary outcomes were patient-level readmission costs and bed-days from 6 months after discharge, compared between the intervention group and a group of matched benchmark patients who smoked but did not receive the intervention.

Results

The total cost of the intervention was £178 105. On the basis of 104 patients who reported not smoking at 6 months, the cost-per-quit was £1712.55, equating to an estimated age-adjusted incremental cost per life year gained of £3325. Among 611 patients who were successfully matched to a benchmark cohort, readmissions for patients in the intervention group cost £492 k less than their benchmark equivalents over 21 months from 1 January 2021 to 30 September 2022 (£266 k vs £758 k), incurred 414 fewer bed days (303 vs 717) and readmitted at a lower rate (5% vs 11%). There were reduced readmission rates and costs among all patients who received the intervention compared with their benchmarked equivalents, regardless of smoking status at 6 months, except among those who opted out.

Conclusions

A pilot ‘opt-out’ tobacco dependence treatment intervention implemented in an acute hospital setting in London demonstrated value for money through reduced readmission rates and costs among all patients who received it.

Trimodal age distribution of frequent attendance at the emergency department: a descriptive analysis of national, English, secondary care data using a retrospective cohort

Por: Marshall · C. · Kumar · A. · Saraiva · S. · West · R. M. · Mason · S. M. · Burton · C. D. · van der Feltz-Cornelis · C. M. · Lee · W. · Bojke · C. · Mattock · R. · de la Haye · S. · Relton · S. D. · Guthrie · E.
Objectives

Frequent use of emergency departments (EDs) places a considerable burden on healthcare systems. Although frequent attenders are known to have complex physical, mental health and social needs, national-level evidence on their characteristics and patterns of attendance remains limited. This study aimed to provide a comprehensive, population-level description of frequent ED attendance in England, with a focus on age-based subgroups.

Design

Retrospective cohort study.

Setting

EDs in England via the Hospital Episode Statistics and the Emergency Care Dataset data linked with primary care prescribing and mortality data, between March 2016 and March 2021.

Participants

The dataset received from National Health Service Digital contained approximately 150 million ED attendances by 30 million adult (>18 years) patients over the time period April 2016 to March 2021. A random sample of 5 million people was used for this analysis.

Outcome measures

The primary outcome was the number of attendances in each financial year by frequent attenders compared with the remaining patients, split by age bands. Patients were classified as frequent attenders if they had ≥5 or ≥10 ED attendances within a rolling 12-month period. Secondary outcomes included demographic, diagnostic and prescribing characteristics, as well as the number of different ED sites visited.

Results

A Gaussian mixture model was used to identify age-based subgroups. Descriptive statistics were used to summarise key features; 95% CIs were reported where applicable. Among 3.91 million unique adult ED attenders, there were 8.7 million attendances. Of these, 222 160 individuals (5.7%) had ≥5 attendances in a year, accounting for 12.6% of total attendances. A trimodal age distribution was identified, with three distinct peaks corresponding to ages 18–34, 35–64 and 65+. Frequent attenders were more likely to live in deprived areas and have a history of psychotropic or analgesic prescribing. Mental health diagnoses and polypharmacy were particularly common in the younger and middle-aged groups. Multisite attendance was uncommon, with over 80% of frequent attenders using only one ED site annually.

Conclusions

This national analysis reveals a trimodal age pattern among frequent ED attenders, with differing clinical and socio-demographic profiles across age groups. These findings highlight the need for age-tailored approaches to managing high-intensity ED use and inform targeted service development.

Supporting parents and families of children with life-limiting conditions: the impact of advance care planning

Por: Moody · A. · Stocks · K. L. · Tatterton · M. J.

Commentary on: Lyon, M. E., Fraser, J. L., Thompkins, J. D., et al (2024). Advance Care Planning for Children With Rare Diseases: A Pilot RCT. Pediatrics, 153(6), e2023064557. https://doi.org/10.1542/peds.2023-064557.

Implications for research and practice

  • Having access to advance care planning, despite social and financial constraints is imperative. It is evident that in the population included in this study, advance care planning was invaluable for those below the 2021 financial poverty line.

  • Further research is required to determine if the current medical model in the USA is meeting the requirements of caregivers and children with rare diseases.

  • Context

    Rare diseases in babies, children and young people (children) are often life-shortening, and children can require constant caregiving. Bösch et al1 report that 82% of children in tertiary hospitals in the USA have a rare disease. This study was designed to establish...

    Contemporary, postpandemic description of UK occupational therapy and physiotherapy practice to rehabilitate the upper limb after stroke: the SUPPLES 2 online survey

    Por: Jarvis · K. A. · Connell · L. · Peel · R. · Stockley · R. C.
    Objectives

    To provide a contemporary, postpandemic description of UK occupational therapy and physiotherapy practice to rehabilitate the upper limb after stroke.

    Setting

    A national online survey, first undertaken in 2018 (prepandemic), was readministered to describe postpandemic practice.

    Participants

    The survey was distributed to UK-based occupational therapists and physiotherapists working with people after stroke, via professional and social networks.

    Primary measures

    Shaped by the Template for Intervention Description and Replication Checklist, the survey collected and subsequently analysed the content, frequency and duration of upper limb rehabilitation after stroke.

    Results

    A total of 122 occupational therapists (n=42) and physiotherapists (n=80) currently working clinically, across in-patient, out-patient and community settings, in the UK completed the survey. Respondents reported treating the upper limb a median of three times a week (IQR 2–4; range 0–6) for a median of 25 min (IQR: 20–35; range 3–60; n=119). Repetitive, functionally-based activities were the most commonly reported interventions for mild (n=93; 81%) and moderate (n=72; 64%) impairment. Stretching (n=73; 66%) and positioning (n=49; 45%) were most frequently reported for severe impairment. In each of the three impairment categories, a larger number of interventions were reported than in the 2018 survey.

    Conclusions

    While the pandemic promoted the use of virtual interventions, most therapists had returned to face-to-face interventions. The findings highlight that the current reported provision of upper limb therapy continues to be markedly less than the dose shown to be effective. The study provides important data which can be used to judge the success of attempts to align practice with new guidelines and inform ‘usual therapy’ for the upper limb after stroke in comparative studies.

    Scoping review of interventions aimed at promoting healthy screen use among adolescents

    Por: Tock · W. L. · Gauvin · L. · Hudon · F. · Tremblay · F. · Belanger · R. E. · Turcotte-Tremblay · A.-M.
    Objectives

    The objective of this scoping review is to map and synthesise existing literature on interventions aimed at promoting healthy screen use among adolescents. This review identifies the types, functions and settings of interventions, explores the diversity of targeted outcomes and highlights equity considerations and research gaps.

    Design

    We conducted a scoping review in accordance with the Arksey and O’Malley framework and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines.

    Data sources

    We systematically searched Medline, PsycINFO and ERIC from January 2013 to June 2024. Reference lists of included studies were also manually screened.

    Eligibility criteria

    We included peer-reviewed experimental, quasi-experimental, observational and qualitative studies reporting on interventions designed to promote healthy screen use among adolescents aged 10–19 years.

    Data extraction and synthesis

    One author extracted data using a structured charting form, and a second author verified all entries. Results were synthesised descriptively across key themes including target populations, theoretical frameworks, intervention components and reported outcomes.

    Results

    From 6433 records, we identified 93 articles on 81 interventions, mainly conducted in high school settings in the USA and Australia. Most examined short-term interventions targeting recreational screen time. Outcomes included media literacy, cyberbullying, internet and gaming addiction, safe internet use, social media use and mental and sexual health. Seventy-eight per cent of interventions attempted to educate adolescents, while 34% offered training activities (eg, educational sessions to elevate risk awareness and skill-based training to enhance digital literacy and self-regulation). Interventions targeting external influences were used less frequently. About 20% of studies showed no statistically significant findings, highlighting the need to promote evidence-based interventions.

    Conclusion

    This review identifies a need for broader, multilevel strategies that account for contextual factors and social determinants in influencing screen use and its related health issues. Future research should explore long-term effectiveness while examining the potential moderating and mediating effects of social determinants. Equity considerations were not a primary focus of most interventions, underscoring an important gap in this literature. Future interventions could incorporate equity-focused design and evaluation to ensure they respond to the needs of diverse adolescent populations.

    VR READY: a protocol for a non-randomised, single-arm, mixed methods, feasibility trial of a coproduced ViRtual REality intervention to AiD recoverY in people recently admitted to intensive care

    Por: Drew · C. J. G. · Smallman · K. · Gill · S. · Greenstock · C. · Cullen · K. · Irving · A. · Twose · P. · Battle · C. · White · D. · Smalley · M. · Lynch · C.
    Introduction

    Post-intensive care syndrome (PICS) describes a cluster of ongoing symptoms experienced by a large proportion of patients previously admitted to critical care. Despite a large rise in survival following critical care, interventions to support recovery and combat PICS are lacking. It has been suggested that the use of digital tools such as virtual reality (VR) may play a useful role in the development of recovery-supporting interventions. We engaged with people with lived experience of critical care admission to coproduce a VR intervention (ViRtual REality to AiD recoverY post ICU (VR READY)). Here, we present a protocol for the initial feasibility and acceptability testing of this intervention.

    Methods and analysis

    This is a single-arm, single-site, non-randomised feasibility trial of VR READY. Up to 25 participants recently admitted to critical care will be recruited to use the VR READY intervention for at least 5 min per day for a period of 14 days. Participants must have capacity to consent and be free from ongoing delirium in order to participate. Outcomes relating to sleep and well-being will be measured at baseline and at day 14 after intervention delivery. The primary outcome is feasibility, which will be assessed according to prespecified criteria. Participants will complete a qualitative interview to assess acceptability of the intervention, trial design and outcomes approximately 1 month after completing the intervention period. No formal statistical analysis of outcomes will be conducted, but these will be summarised descriptively. Interviews will be subjected to reflexive thematic analysis.

    Ethics and dissemination

    This study received a favourable ethical opinion by North-East York Research Ethics Committee (Ref 23/NE/0113) in June 2024. Study results will be disseminated through the peer review literature, ISRCTN registry and directly to participants, which will be facilitated by the study public and patient involvement steering group.

    Trial registration number

    ISRCTN88854487.

    Trends in diabetes monitoring and control among Aboriginal and Torres Strait Islander Peoples attending general practice in urban and rural locations in Australia: a repeated cross-sectional study using data from a national general practice database (Medi

    Por: Liddell · A. · Pink · N. · Baldim Jardim Nobre · F. · Bernardo · C. · Williams · S. · Stocks · N. · Gonzalez-Chica · D.
    Objective

    To determine the proportion of Aboriginal and/or Torres Strait Islander Peoples with diabetes who were monitored according to recommended national guidelines and had their clinical parameters within recommended targets. We also examined trends over time (2013–2022) and compared urban and rural areas.

    Design

    A repeated cross-sectional study using data from a national general practice database (MedicineInsight, 2013–2022).

    Setting

    De-identified electronic health records (EHR) of people attending 427 mainstream general practices across Australia.

    Participants

    This study included all Aboriginal and/or Torres Strait Islander adults (18+ years) diagnosed with diabetes mellitus who were regular patients (attended at least once a year in three consecutive years) within the MedicineInsight database.

    Outcome measures

    Outcomes measured were (i) monitoring of blood glucose, lipids, blood pressure (BP), renal function and Body Mass Index (BMI)/waist circumference (WC) and (ii) achieving recommended targets: glycosylated haemoglobin (HbA1c) ≤7.0%, fasting glucose 4–7 mmol/L, random glucose 5–10 mmol/L, total cholesterol ≤4.0 mmol/L, low-density lipoprotein 60 mL/min/1.73 m2, urine albumin-creatinine ratio (uACR) 2, WC

    Results

    Between 70% and 90% of individuals were monitored for the clinical parameters above, except for BMI/WC (55%–75%). Trends in monitoring over time were similar across remoteness areas, increasing slightly in 2013–2014 and declining from 2019. Among those monitored, 53%–86% achieved targets for blood glucose, lipids and renal function; 32%–42% for BP; and

    Conclusion

    The risk of diabetes complications among Aboriginal and/or Torres Strait Islander Peoples could be reduced by improving management of blood pressure and overweight/obesity in all areas, and blood glucose and lipids in rural areas.

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