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Understanding the language barriers to translating informed consent documents for maternal health trials in Zambia: a qualitative study

Por: Beardmore-Gray · A. · Simwinga · M. · Vwalika · B. · Chinkoyo · S. · Chappell · L. · Sandall · J. · Shennan · A.
Objective

Providing comprehensible information is essential to the process of valid informed consent. Recruitment materials designed by sponsoring institutions in English-speaking, high-income countries are commonly translated for use in global health studies in other countries; however, key concepts are often missed, misunderstood or ‘lost in translation’. The aim of this study was to explore the language barriers to informed consent, focusing on the challenges of translating recruitment materials for maternal health studies into Zambian languages.

Design

We used a qualitative approach, which incorporated a multistakeholder workshop (11 participants), in-depth interviews with researchers and translators (8 participants) and two community-based focus groups with volunteers from community advisory boards (20 participants). Content analysis was used to identify terms commonly occurring in recruitment materials prior to the workshop. The framework analysis approach was used to analyse interview data, and a simple inductive thematic analysis approach was used to analyse focus group data.

Setting

The study was based in Lusaka, Zambia.

Results

The workshop highlighted difficulties in translating research terms and pregnancy-specific terms, as well as widespread concern that current templates are too long, use overly formal language and are designed with little input from local teams. Framework analysis of in-depth interviews identified barriers to participant understanding relating to design and development of recruitment materials, language, local context and communication styles. Focus group participants confirmed these findings and suggested potential solutions to ensure the language and content of recruitment materials can be better understood.

Conclusion

Our findings demonstrate that the way in which recruitment materials are currently designed, translated and disseminated may not enable potential trial participants to fully understand the information provided. Instead of using overly complex institutional templates, recruitment materials should be created through an iterative and interactive process that provides truly comprehensible information in a format appropriate for its intended participants.

ATME--Needs, requirements and cross-sectoral patient journeys of patients with out-of-hospital mechanical ventilation and intensive care in outpatient settings: study protocol for an observational study

Por: Knizia · N.-A. · Hirschler · J. · Stegbauer · C. · Schwinger · A. · Büscher · A. · Englert · N. · Peters · L. · Bayarassou · H. A. · Mallmann · L. · Willms · G.
Introduction

An increasing number of tracheotomised and/or ventilated patients with high-cost out-of-hospital intensive care needs and, at the same time, a decreasing number of healthcare professionals inevitably lead to challenges in the care of this patient population. In addition, little is known about this population, their health restrictions, needs, patient journeys, care structures and processes. The project ‘Needs, requirements and cross-sectoral care pathways of out-of-hospital ventilated intensive care patients’ (ATME) aims to analyse these aspects and explore current care structures to inform further development of care in line with patients’ needs and requirements.

Methods and analysis

Qualitative and quantitative methods will be used. In preparation of a semistandardised survey, exploratory interviews will be conducted with tracheotomised and/or ventilated patients with out-of-hospital intensive care needs (TVPOI) (n=15), nursing care providers (n=30), outpatient medical centres, as well as outpatient medical, medical technology and therapeutic care providers (n=35). Three semistandardised survey questionnaires for TVPOI (n=2,000) will be developed and conducted with nursing care facilities (n=250) and outpatient medical centres for mechanical ventilation (n=25). Content analyses will be conducted for qualitative data; survey data will be analysed descriptively. In addition, healthcare claims data will be analysed descriptively to provide information on patient journeys. Three result workshops and one consensus conference will be carried out with representatives of the relevant target groups to analyse the suitability of care structures and to develop recommendations for action to improve TVPOI.

Ethics and dissemination

The ATME study received a positive vote from the Ethics Committee of the Osnabrück University of Applied Sciences and is registered in ‘Deutsches Register Klinischer Studien (DRKS)’ (registration number: DRKS00030891). The study results will be presented at national conferences and in relevant peer-reviewed journals. Additionally, study results will be published by the funding institution (the Innovation Committee of the Federal Joint Committee) on their website.

Evaluation of the implementation of advanced practice nursing roles in France: A multiple case study

Abstract

Aims

The aims of the study were to describe the processes used to introduce advanced practice nursing roles and factors that facilitated or hindered role implementation, examine the time advanced practice nurses (APNs) spend in role activities and how these activities relate to domains of advanced practice nursing and examine how implementation processes influenced APN integration within healthcare teams.

Design

A multiple case study was conducted.

Methods

Five cases were included, representing the four population areas approved for advanced practice nursing in France. Data were collected from January to March 2021 using observation, interview and document analysis methods. Data were examined using thematic analysis.

Results

Participants included APNs (n = 5), nurses/allied health providers (n = 5), physicians (n = 5), managers (n = 4) and decision-makers (n = 4). Stakeholder engagement and leadership provided by decision-makers, managers, physicians and APNs facilitated role implementation. Poor stakeholder role understanding, uncertain role funding, and the COVID-19 pandemic hindered role implementation. APNs spent the most time in clinical activities. Participants perceived the integration of APNs within the healthcare team and their impact on patient care to be positive.

Conclusion

Stakeholder engagement and organizational and APN leadership facilitated the implementation of the roles, especially related to team-based patient care. Further efforts are needed to strengthen APN involvement in non-clinical activities and address role barriers.

Implications for nursing and patient care

Systematic and system-wide approaches are needed to improve role clarity, role autonomy and health systems integration of APNs. Research should examine patient perspectives about APNs in France.

Impact

The results highlight how policies can create favourable conditions for advanced practice nursing role implementation in France. Internationally, this study serves as a reminder to APNs and nurse leaders about the strategies for and importance of implementation evaluation to support the optimal development of advanced practice nursing roles.

Reporting Method

The study reporting followed the Consolidated Criteria for Reporting Qualitative Research.

Patient or Public Contribution

No Patient or Public Contribution.

INdigenous Systems and Policies Improved and Reimagined for Ear and hearing care (INSPIRE): a multi-method study protocol

Por: Nash · K. · Gwynne · K. · Dimitropoulos · Y. · Fitzpatrick · M. · Gunasekera · H. · Halvorsen · L. · Kong · K. · Lumby · N. · Macniven · R. · Parter · C. · Wingett · A. · McMahon · C.
Introduction

Otitis media (middle ear disease) severity and chronicity among Aboriginal and Torres Strait Islander people, as well as gaps in socioeconomic outcomes related to hearing loss, indicates a breakdown in the current ear and hearing care system. The ear and hearing care system spans multiple sectors due to long-term impacts of otitis media and hearing loss in health, education and employment, necessitating a multi-disciplinary cross-sectorial approach to ear and hearing care. Public policies shape the current ear and hearing care system and here it is argued that a critical public policy analysis across different sectors is needed, with strong Aboriginal and Torres Strait Islander leadership and guidance. The current study aims to establish consensus-based ear and hearing care policy solutions for Aboriginal and Torres Strait Islander people in Australia.

Methods and analysis

This multi-method study will be guided by a Brains Trust with strong Aboriginal and Torres Strait Islander leadership. Public policies in hearing health, social services, and education will be scoped to identify policy gaps, using the World Health Organization framework. Qualitative data will be collected through a culturally specific process of yarning circles to identify policy challenges and/or limitations in enabling accessible ear and hearing care programs/services for Aboriginal and Torres Strait Islander people, using dimensions of Morestin’s public policy appraisal tool as an interview guide for stakeholders. Themes from the yarning circles will be used to inform an expert Delphi process to establish consensus-based policy solutions for optimising the ear and hearing care system for Aboriginal and Torres Strait Islander people.

Ethics and dissemination

This study has approval from the Australian Institute of Aboriginal and Torres Strait Islander Studies Ethics Committee. Study findings will be disseminated to community through Brains Trust members and study participants, as well as through publications in peer-reviewed journals and research forum presentations.

Work‐related stress, stress reactions and coping strategies in ambulance nurses: A qualitative interview study

Abstract

Aim

To describe experiences of work-related stress, stress reactions and coping strategies among registered nurses (RNs) in the ambulance service (AS).

Design

A descriptive and qualitative design.

Methods

Participants were recruited from eight different ambulance stations from different geographical locations in central Sweden. Data were collected from 14 RNs during the period from January 2022 to May 2022 using a semi-structured interview guide. Qualitative content analysis was used to analyse data using an abductive approach.

Results

Three categories describe the RNs' experiences; (1) Situations that cause work-related stress, (2) Reactions and feelings that occur and (3) Management of work-related stress. These three main categories included a total of 12 subcategories. Work-related stress was experienced when participants were a part of traumatic events or experienced insufficient cooperation or a disturbing event in the work environment. The different causes lead to different kinds of reactions with feelings of frustration, fear and loneliness being prominent. To manage the work-related stress, RNs used different kinds of strategies and support from colleagues or lack thereof seemed to have a major impact.

Conclusions

Findings revealed the importance of having competent colleagues in the AS. Working with a competent colleague can reduce experiences of stress and prevent feelings of loneliness. It is important for the AS to provide stress-reduction support, to promote cooperation and to maintain and develop RNs' professional competence to ensure quality care and patient safety in the AS.

Diversity and characterization of culturable fungi associated with the marine sea cucumber <i>Holothuria scabra</i>

by Lakkhana Kanhayuwa Wingfield, Jirawalan Atcharawiriyakul, Ninadia Jitprasitporn

Fungi associated with the marine echinoderm, Holothuria scabra, produces extracellular enzymes and bioactive metabolites, and mycoviruses that could be used for biotechnological and pharmaceutical applications. The species identification based on molecular and morphological characteristics classified the culturable fungi into twenty-three genera belonging to eight orders, Chaetothyriales, Eurotiales, Hypocreales, Mucorales, Mycosphaerellales, Onygenales, Pleosporales and Venturiales, from four classes, Eurotiomycetes, Dothideomycetes, Mucoromycetes and Sordariomycetes of the two phyla Ascomycota and Mucoromycota. The most frequent genera were Aspergillus (relative frequency, 45.30%) and Penicillium (relative frequency, 22.68%). The Menhinick species richness and Shannon species diversity indices were 1.64 and 2.36, respectively, indicating a high diversity of fungi. An enzymatic production test revealed that sixteen isolates could produce proteases and amylases at different levels. The presence of mycoviruses was detected in eight isolates with different genomic profiles. Thirty-two of the 55 isolates produced antimicrobial metabolites which had an inhibitory effect on various microbial pathogens. Most of these active isolates were identified as Aspergillus, Penicillium and Trichoderma. Notably, Aspergillus terreus F10M7, Trichoderma harzianum F31M4 and T. harzianum F31M5 showed the most potent activity against both Gram-positive and Gram-negative bacteria and human pathogenic fungi. Our study represents the first report of the mycobiota associated with the marine echinoderm Holothuria scabra.

Evaluating niraparib versus active symptom control in patients with previously treated mesothelioma (NERO): a study protocol for a multicentre, randomised, two-arm, open-label phase II trial in UK secondary care centres

Por: Fennell · D. · Griffiths · D. · Eminton · Z. · Morgan-Fox · A. · Hill · K. · Ewings · S. · Stuart · C. · Johnson · L. · Mallard · K. · Nye · M. · Darlison · L. · Dulloo · S. · Cave · J. · Luo · J.-L. · Taylor · P. · Spicer · J. · Poile · C. · Bzura · A. · Griffiths · G.
Background

Malignant mesothelioma is a rapidly lethal cancer that has been increasing at an epidemic rate over the last three decades. Targeted therapies for mesothelioma have been lacking. A previous study called MiST1 (NCT03654833), evaluated the efficacy of Poly (ADP-ribose) polymerase (PARP) inhibition in mesothelioma. This study met its primary endpoint with 15% of patients having durable responses exceeding 1 year. Therefore, there is a need to evaluate PARP inhibitors in relapsed mesothelioma patients, where options are limited. Niraparib is the PARP inhibitor used in NERO.

Methods

NERO is a multicentre, two-arm, open-label UK randomised phase II trial designed to evaluate the efficacy of PARP inhibition in relapsed mesothelioma. 84 patients are being recruited. NERO is not restricted by line of therapy; however, eligible participants must have been treated with an approved platinum based systemic therapy. Participants will be randomised 2:1, stratified according to histology and response to prior platinum-based chemotherapy, to receive either active symptom control (ASC) and niraparib or ASC alone, for up to 24 weeks. Participants will be treated until disease progression, withdrawal, death or development of significant treatment limiting toxicity. Participants randomised to niraparib will receive 200 or 300 mg daily in a 3-weekly cycle. The primary endpoint is progression-free survival, where progression is determined by modified Response Evaluation Criteria in Solid Tumors (mRECIST) or RECIST 1.1; investigator reported progression; or death from any cause, whichever comes first. Secondary endpoints include overall survival, best overall response, 12-week and 24 week disease control, duration of response, treatment compliance and safety/tolerability. If NERO shows niraparib to be safe and biologically effective, it may lead to future late phase randomised controlled trials in relapsed mesothelioma.

Ethics and dissemination

The study received ethical approval from London-Hampstead Research Ethics Committee on 06-May-2022 (22/LO/0281). Data from all centres will be analysed together and published as soon as possible.

Trial registration number

ISCRTN16171129; NCT05455424.

Barriers to cardiac rehabilitation and patient perceptions on the usage of technologies in cardiac rehabilitation: A cross‐sectional study

Abstract

Aims and Objectives

The study aimed to identify factors associated with participation in Phase II cardiac rehabilitation and to assess patient perceptions towards the usage of technologies in cardiac rehabilitation.

Background

Despite efforts to promote utilisation of cardiac rehabilitation (CR), participation among patients remains unsatisfactory. Little is known of patient decision to participate Phase II CR in a multi-ethnic country.

Design

A cross-sectional study design.

Methods

A consecutive sampling of 240 patients with coronary heart disease completed Coronary Artery Disease Education Questionnaire (CADE-Q) II, Hospital Anxiety and Depression Scale (HADS), Multidimensional Scale of Perceived Social Support (MSPSS) and Cardiac Rehabilitation Barriers Scale (CRBS).

Results

Seventy per cent of patients (mean age 60.5 [SD = 10.6] years, 80.8% male) participated in phase II cardiac rehabilitation. Self-driving to cardiac rehabilitation centres, higher barriers in perceived need/health care and logistical factors were significantly associated with decreased odds of participation. Patients with more barriers from comorbidities/functional status, higher perceived social support from friends, and anxiety were more likely to participate. Chinese and Indians were less likely to participate when compared with Malays. More than 80% of patients used both home and mobile broadband internet, and 72.9% of them would accept the usage of technologies, especially educational videos, instant messenger, and video calls to partially replace the face-to-face, centre-based cardiac rehabilitation approach.

Conclusion

Several barriers were associated with non-participation in phase II cardiac rehabilitation. With the high perceived acceptance of technology usage in cardiac rehabilitation, home-based and hybrid cardiac rehabilitation may represent potential solutions to improve participation.

Relevance to clinical practice

By addressing the barriers to cardiac rehabilitation, patients are more likely to be ready to adopt health behaviour changes and adhere to the cardiac rehabilitation programme. The high perceived acceptance of using technologies in cardiac rehabilitation may provide insights into new delivery models that can improve and overcome barriers to participation.

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