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RETurn to work After stroKE (RETAKE) Trial: protocol for a mixed-methods process evaluation using normalisation process theory

Por: Radford · K. A. · McKevitt · C. · Clarke · S. · Powers · K. · Phillips · J. · Craven · K. · Watkins · C. · Farrin · A. · Holmes · J. · Cripps · R. · McLellan · V. · Sach · T. · Brindle · R. · Holloway · I. · Hartley · S. · Bowen · A. · O'Connor · R. J. · Stevens · J. · Walker · M. · Murray
Objectives

This mixed-method process evaluation underpinned by normalisation process theory aims to measure fidelity to the intervention, understand the social and structural context in which the intervention is delivered and identify barriers and facilitators to intervention implementation.

Setting

RETurn to work After stroKE (RETAKE) is a multicentre individual patient randomised controlled trial to determine whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care is a clinically and cost-effective therapy to facilitate return to work after stroke, compared with usual care alone. This protocol paper describes the embedded process evaluation.

Participants and outcome measures

Intervention training for therapists will be observed and use of remote mentor support reviewed through documentary analysis. Fidelity will be assessed through participant questionnaires and analysis of therapy records, examining frequency, duration and content of ESSVR sessions. To understand the influence of social and structural contexts, the process evaluation will explore therapists’ attitudes towards evidence-based practice, competency to deliver the intervention and evaluate potential sources of contamination. Longitudinal case studies incorporating non-participant observations will be conducted with a proportion of intervention and usual care participants. Semistructured interviews with stroke survivors, carers, occupational therapists, mentors, service managers and employers will explore their experiences as RETAKE participants. Analysis of qualitative data will draw on thematic and framework approaches. Quantitative data analysis will include regression models and descriptive statistics. Qualitative and quantitative data will be independently analysed by process evaluation and Clinical Trials Research Unit teams, respectively. Linked data, for example, fidelity and describing usual care will be synthesised by comparing and integrating quantitative descriptive data with the qualitative findings.

Ethics and dissemination

Approval obtained through the East Midlands—Nottingham 2 Research Ethics Committee (Ref: 18/EM/0019) and the National Health ServiceResearch Authority. Dissemination via journal publications, stroke conferences, social media and meetings with national Stroke clinical leads.

Trial registration number

ISRCTN12464275.

Family support person role during resuscitation: A qualitative exploration

Abstract

Aims and objectives

To provide guidance to nurses by examining how critical care nurses perceive and perform the family support person role during resuscitation.

Background

Nurses can serve as family support person when families witness a loved one's resuscitation. However, few studies have examined the role of family support person to provide nurses with sufficient knowledge to enact the role.

Design

An exploratory-descriptive qualitative design with individual, semi-structured interviews.

Methods

Sixteen critical care nurses who had served as family support person completed interviews. The data were analysed by thematic analysis. COREQ guidelines were followed.

Results

Six themes were identified: Hard but Rewarding Role, Be With, Assess, First Moments, Explain and Support. Findings explicated nurses’ perceptions of the role and key role activities.

Conclusions

Nurses perceived the role as hard but rewarding. Role challenges included the need for quick, accurate assessments and interventions to keep family members safe, informed and supported, while allowing them to witness resuscitation. Key role activities included: being fully present and compassionately attentive to family, continuously assessing family members, coordinating the first moments when family presence during resuscitation commences, explaining in simple, tailored terms the resuscitation activities, and supporting the family emotionally and psychologically through a variety of strategies. Nurses noted the high variability in how families respond and the complexity of simultaneously performing the multi-faceted role activities.

Relevance to clinical practice

To effectively support the growing global trend of family presence during resuscitation, nurses need the knowledge this study provides about how to fulfil the family support person role. Identifying the role activities may facilitate development of clinical guidelines and educational preparation for the role. Nurses can refine the many skills this role requires, building their competence and confidence, to increase opportunities for family members to experience family presence during resuscitation in a safe, and high-quality manner.

Defining CD4 T helper and T regulatory cell endotypes of progressive and remitting pulmonary sarcoidosis (BRITE): protocol for a US-based, multicentre, longitudinal observational bronchoscopy study

Por: Koth · L. L. · Harmacek · L. D. · White · E. K. · Arger · N. K. · Powers · L. · Werner · B. R. · Magallon · R. E. · Grewal · P. · Barkes · B. Q. · Li · L. · Gillespie · M. · Collins · S. E. · Cardenas · J. · Chen · E. S. · Maier · L. A. · Leach · S. M. · OConnor · B. P. · Hamzeh · N. Y.
Introduction

Sarcoidosis is a multiorgan granulomatous disorder thought to be triggered and influenced by gene–environment interactions. Sarcoidosis affects 45–300/100 000 individuals in the USA and has an increasing mortality rate. The greatest gap in knowledge about sarcoidosis pathobiology is a lack of understanding about the underlying immunological mechanisms driving progressive pulmonary disease. The objective of this study is to define the lung-specific and blood-specific longitudinal changes in the adaptive immune response and their relationship to progressive and non-progressive pulmonary outcomes in patients with recently diagnosed sarcoidosis.

Methods and analysis

The BRonchoscopy at Initial sarcoidosis diagnosis Targeting longitudinal Endpoints study is a US-based, NIH-sponsored longitudinal blood and bronchoscopy study. Enrolment will occur over four centres with a target sample size of 80 eligible participants within 18 months of tissue diagnosis. Participants will undergo six study visits over 18 months. In addition to serial measurement of lung function, symptom surveys and chest X-rays, participants will undergo collection of blood and two bronchoscopies with bronchoalveolar lavage separated by 6 months. Freshly processed samples will be stained and flow-sorted for isolation of CD4 +T helper (Th1, Th17.0 and Th17.1) and T regulatory cell immune populations, followed by next-generation RNA sequencing. We will construct bioinformatic tools using this gene expression to define sarcoidosis endotypes that associate with progressive and non-progressive pulmonary disease outcomes and validate the tools using an independent cohort.

Ethics and dissemination

The study protocol has been approved by the Institutional Review Boards at National Jewish Hospital (IRB# HS-3118), University of Iowa (IRB# 201801750), Johns Hopkins University (IRB# 00149513) and University of California, San Francisco (IRB# 17-23432). All participants will be required to provide written informed consent. Findings will be disseminated via journal publications, scientific conferences, patient advocacy group online content and social media platforms.

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