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Stereotactic ablative radiotherapy versus video-assisted lobectomy for operable stage I non-small-cell lung cancer: study protocol for an emulated target trial

Por: Bedir · A. · Hassan · L. · Wittenberg · I. · Müller · J. A. · Oesterling · F. · Walles · T. · Stang · A. · Vordermark · D. · Medenwald · D.
Introduction

Video-assisted thoracoscopic surgery (VATS) lobectomy is a commonly employed surgical technique for the management of operable early stage non-small cell lung cancer (NSCLC). This procedure, however, is dependent on the patient’s ability to tolerate surgery. In light of this, stereotactic ablative radiotherapy (SABR) has emerged as a viable alternative treatment strategy for patients who are inoperable or who refuse surgery. Considering the lack of randomised controlled trials and the increased risk of bias in observational cohort studies, this study protocol proposes an emulated target trial design to investigate the causal effect of SABR, in comparison to VATS, on overall survival in operable early stage NSCLC patients.

Methods and analysis

Data on NSCLC patients will be collected from routinely collected university hospital records linked with German cancer registry data. This study protocol was developed using the target trial methodology outlined by Hernan et al. The protocol establishes specific parameters for key trial components in order to mitigate bias in the analysis of observational data and to facilitate the calculation of causal estimands. The target trial design that would be emulated is a multicentre open-label two-parallel arm superiority randomised trial. Mediators and confounding variables were determined through the use of a directed acyclic graph. The statistical analysis aims to measure the per-protocol and intention to treat effect of SABR versus VATS within 3 months of diagnosis, on survival, through the difference in restricted mean survival times, using weighted non-parametric Kaplan-Meier curves.

Ethics and dissemination

The Ethics Committee of the Medical Faculty of Martin Luther University Halle-Wittenberg with an approved addendum with Dnr 2023–112 has approved this study. The study uses anonymised routinely collected hospital and cancer registry data in accordance with applicable data protection regulations. Results will be disseminated through peer-reviewed publications and presentations at scientific conferences.

HIV diagnostic implementation in the Dominican Republic: an in-depth qualitative context analysis for health technology developers

Por: Lee · K. · Arango · D. · Morel · S. · Sterling · K. · Agenor · M. · Tripathi · A. · Rodriguez · C. · Rosen · R. · Sanchez · M.
Objectives

To understand the political, economic, social and technological facilitators and barriers in obtaining an HIV diagnosis to inform implementation strategies for HIV diagnostics in the Dominican Republic (DR).

Design

In-depth, semi-structured qualitative interviews.

Setting

A high complexity public hospital in Santiago de los Caballeros, DR.

Participants

A convenience and purposive sample of 36 internal medicine physicians and laboratory personnel involved in sample collection, sample analysis or oversight of biological sample analysis.

Results

Using the Social Ecological Model, our results highlighted several interrelated barriers and facilitators to sample analysis at the individual (patient), interpersonal (interactions between laboratory personnel, physicians and patients), organisational (the hospital), community (Santiago de Los Caballeros) and societal (the DR) levels. Some key findings include the importance of psychological support in receiving an HIV diagnosis, how spoken language can be a barrier to care, how inconsistent access to laboratory supplies is a barrier for patients, laboratory personnel and clinicians, and the importance of government public health investment.

Conclusions

Employing qualitative methods to investigate a bioengineering challenge yielded rich data on the sociotechnical implementation context of HIV diagnostics in the DR. Several context-relevant suggestions were developed for HIV diagnostic developers which include incorporating psychological support into the diagnosis workflow, delivering information in multiple languages (ie, Haitian Creole and Spanish) and with non-stigmatising phrasing, working with the public sector to develop and implement technologies, and reducing the supply chain reliance on high-income countries to lessen delays in care. These findings can apply to other types of health technologies and settings and demonstrate the importance of utilizing human-centered design to understand implementation context and promote global health equity in health technology development and adoption.

Measuring and monitoring safety of older adults living in retirement homes: a scoping review protocol

Por: Backman · C. · Engel · F. D. · Tonjock Kolle · A. · Papp · R. · Lam · A. · Freeman · L. · Li · W. · Sterling · E. · Fung · S. G. · Sinha · S. K. · Manis · D. R. · Wang · T.-F. · Kehoe MacLeod · K. · Hecimovich · C. · Webber · C. · Maskerine · C. · Syrowatka · A. · Fancott · C. · Kobewka · D
Background

The global population of older adults has grown at an unprecedented rate, and projections indicate that the number of older adults will continue to increase considerably in the coming decades. The clinical complexity of older adults living in retirement homes, also known as assisted living settings, is also increasing, and the regulations to ensure quality and safety standards in retirement homes are highly variable. The purpose of this scoping review is to map and summarise the methods used to monitor and measure the safety of older adults living in retirement homes, providing an overview of existing approaches and areas requiring further investigation.

Methods

This scoping review will follow the five stages of the Arksey and O’Malley scoping review process. We will report this review using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. A comprehensive search of four electronic databases (MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCO) and Web of Science Core Collection) will be performed, and reference lists of included articles will be searched. We will conduct a two-step screening process, data extraction and analysis of the included studies. We will include all primary study designs that report on safety measurement and monitoring of any type of harms. Relevant grey literature will also be identified. We will exclude studies that only report results from facilities providing 24-hour skilled nursing care or specialised care services, and those not published in English or French. This protocol is registered on the Open Science Framework (osf.io/8rheq).

Ethics and dissemination

No ethical approval is needed for the review, and we plan to present the results at research conferences and in a peer-reviewed article. Our findings may inform future research studies that seek to support and improve safety practices in retirement homes.

Reducing decisional conflict in COVID-19 vaccination in ethnocultural communities through sensemaking: a participatory action mixed-methods study

Objective

To examine how cultural health brokers, as trusted intermediaries between formal systems and diverse ethnocultural communities, help navigate decisional conflict and misinformation regarding COVID-19 vaccination and to identify how their work contributes to system resilience in crisis contexts.

Design

A community-based participatory action sensemaking research project to capture the real-time work of cultural health brokers in helping people navigate decisional conflict for vaccination.

Setting, participants

Multicultural Health Broker Cooperative in Edmonton, Alberta where brokers speak 54 languages and serve more than 10 000 people from diverse ethnolinguistic communities. 28 cultural health brokers (9 male; experience 4–25 years) contributed to data collection and analysis between 16 September 2021 and 16 December 2021.

Data collection and analysis

The brokers captured real-time reflections and self-interpretations in the SenseMaker platform through a theoretically informed, codesigned, mixed-method data collection tool. The team engaged in 13 weekly, 90 minute, audio-recorded and transcribed sessions: seven focused on understanding and action planning and five reflecting on the SenseMaker data, the focus of the thematic analysis. Data were managed in NVivo (QSR International, Version 12, 2018).

Results

Brokers collected 277 narratives and conducted 13 sensemaking sessions. Understanding and purpose were identified in 68% of narratives as key to achieving coherence; 81% of narratives highlighted trust as crucial to what was needed for action; 62% of narratives reflected on a potential risk, with loss of trust a concern in 70% of them. A rich understanding of the sources of decisional conflict and misinformation was achieved and managed through outreach. There were four entwined components to navigation of the evolving complexity of COVID-19 vaccination: (1) building and sustaining trust; (2) strengthening relationships; (3) creating safe spaces for collective sensemaking and solution finding; and (4) leveraging cultural and social capital to address barriers. Through these mechanisms, brokers reduced decisional conflict and misinformation, supporting informed, values-congruent decisions.

Conclusions

Cultural health brokers, embedded within communities and linked to formal systems, play a critical role in crisis response by fostering trust, mobilising resources and enabling collective sensemaking. This study demonstrates how these intermediaries’ contextually and culturally attuned work provides a model for building system resilience for future crisis response.

Long-term recovery from post-traumatic neck pain: protocol for a prospective cohort study in the emergency department

Por: Lynaes · C. · Ravn · S. L. · Skou · S. T. · Mogensen · C. B. · Arvig · M. D. · Christensen · S. W. M. · Sterling · M. · Andersen · T. E.
Introduction

Post-traumatic neck pain is common, representing a substantial human and societal burden. About 15%–25% of individuals involved in an accident causing whiplash continue to experience moderate-to-severe symptoms and functional impairment 1 year post-trauma. Factors such as age, high pain intensity, hypersensitivity to pain and early post-traumatic hyperarousal are associated with persistent neck pain. However, multiple questions remain unanswered regarding how best to improve early care. As such, research on recovery patterns (including indicators for health economic burden) and their predictors is still needed, including biomarkers for pre-traumatic and peri-traumatic stress, and the value of early prediction tools.

Methods and analysis

This prospective cohort study will include 100 participants (18 years) suffering from post-traumatic neck pain sustained within 72 hours of an accident. At baseline (a combination of inclusion and 1 week assessment), eligible participants will undergo a thorough evaluation, including assessment of descriptive characteristics, self-reported variables (eg, pain, disability, sleep quality and post-traumatic stress), biomarkers (eg, heart rate variability (HRV) and hair cortisol) and clinical tests (eg, cervical range of motion). Follow-up will be conducted at 3, 6 and 12 months post-trauma. Further, register data (eg, data on labour market attachment) will be added for the period. Among other methods, a receiver operating characteristic (ROC) curve and multivariable regression analyses will be used to evaluate performance and associations of the prediction tools and their associations with measures of HRV.

The sample size calculation is based on previous studies, estimating that 15% of participants will develop moderate-to-severe ongoing symptoms. Using a conservative estimate, 64 participants are needed to achieve a statistical power of 90% with an expected area under the curve of 0.80. Accounting for a 25% loss to follow-up, 80 participants are required. For regression analysis, 100 participants will be included. The prediction tool will be validated using ROC analysis, sensitivity and specificity. Logistic regression models will be performed with and without biomarkers and pain sensitivity. Health economic costs will be compared across groups. Multivariable regression will examine the link between HRV and post-traumatic stress disorder, adjusting for confounders and a moderation analysis will assess hair cortisol as a potential moderator.

Ethics and dissemination

The study is approved by the Regional Committee on Health Research Ethics of Southern Denmark (S-20230037). Due to the acute nature of recruitment, the study design does not allow for a 24-hour reflection period; however, this approach has been approved by the Committee.

Study results will be published in peer-reviewed journals and disseminated through non-scientific outlets, including patient and professional publications, press releases and social media. If effective, workshops for clinicians will be organised. Results will be published regardless of outcome, with coauthorships following ICMJE guidelines.

Trial registration number

NCT06176209.

Best Practices in Supporting Inpatient Communication With Technology During Visitor Restrictions: An Integrative Review

imageBackground Since the onset of the COVID-19 pandemic, healthcare workers around the world have experimented with technologies to facilitate communication and care for patients and their care partners. Methods Our team reviewed the literature to examine best practices in utilizing technology to support communication between nurses, patients, and care partners while visitation is limited. We searched four major databases for recent articles on this topic, conducted a systematic screening and review of 1902 articles, and used the Johns Hopkins Nursing Evidence-Based Practice for Nurses and Healthcare Professionals Model & Guidelines to appraise and translate the results of 23 relevant articles. Results Our evaluation yielded three main findings from the current literature: (1) Virtual contact by any technological means, especially video visitation, improves satisfaction, reduces anxiety, and is well-received by the target populations. (2) Structured video rounding provides effective communication among healthcare workers, patients, and offsite care partners. (3) Institutional preparation, such as a standardized checklist and dedicating staff to roles focused on facilitating communication, can help healthcare workers create environments conducive to therapeutic virtual communication. Discussion In situations that require healthcare facilities to limit visitation between patients and their care partners, the benefits of virtual visitation are evident. There is variance in the types of technologies used to facilitate virtual visits, but across all of them, there are consistent themes demonstrating the benefits of virtual visits and virtual rounding. Healthcare institutions can prepare for future limited-visitation scenarios by reviewing the current evidence and integrating virtual visitation into modern healthcare delivery.
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