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Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives

Por: Chatters · R. · Dimairo · M. · Cooper · C. · Ditta · S. · Woodward · J. · Biggs · K. · Ogunleye · D. · Thistlethwaite · F. · Yap · C. · Rothman · A.
Objectives

To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.

Design

Qualitative interviews analysed using thematic analysis.

Setting and participants

Five professionals (clinical researchers and methodologists) and three patient and public representatives (those with experience of early-phase clinical trials and/or those from ethnic minority backgrounds) were interviewed between June and August 2022. Participants were identified via their institutional web page, existing contacts or social media (eg, X, formerly known as Twitter).

Results

Professionals viewed that diversity is not currently considered in all early-phase clinical trials but felt that it should always be taken into account. Such trials are primarily undertaken at a small number of centres, thus limiting the populations they can access. Referrals from clinicians based in the community may increase diversity; however, those referred are often not from underserved groups. Referrals may be hindered by the extra resources required to approach and recruit underserved groups and participants often having to undertake ‘self-driven’ referrals. Patient and public representatives stated that diversity is important in research staff and that potential participants should be informed of the need for diversity. Those from underserved groups may require clarification regarding the potential harms of a treatment, even if these are unknown. Education may improve awareness and perception of early-phase clinical trials. We provide 14 recommendations to improve diversity in early-phase clinical trials.

Conclusions

Diversity should be considered in all early-phase trials. Consideration is required regarding the extent of diversity and how it is addressed. The increased resources needed to recruit those from underserved groups may warrant funders to increase the funds to support the recruitment of such participants. The potential harms and societal benefits of the research should be presented to potential participants in a balanced but accurate way to increase transparency.

REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia

Por: Ho · K. Y. · Gyanwali · B. · Dimayuga · C. · Eufemio · E. M. · Bernardo · E. · Raju · G. · Chong · K. W. · Waithayayothin · K. · Ona · L. · Castro · M. A. L. · Sawaddiruk · P. · Salvador · R. C. · Roohi · S. A. · Tangwiwat · S. · Wilairatana · V. · Oon · Z. H. · Gupta · A. · Nagrale · D.
Introduction

Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.

Methods and analysis

REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.

Ethics and dissemination

The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

Incidence of hospital‐acquired pressure injuries and predictors of severity in a paediatric hospital

Abstract

Background

Hospital-acquired pressure injuries (HAPIs) pose significant challenges in healthcare and cause increased patient suffering, longer hospital stays, and higher healthcare costs. Paediatric patients face unique risks, but evidence remains scarce. This study aimed to identify and describe HAPI admission incidence and severity predictors in a large Australian children's hospital.

Methods

This retrospective cohort study investigated all paediatric patients between January 2020 and December 2021 using a census approach. Demographic and clinical data including HAPI-related data were accessed from the incident monitoring and hospital administration databases. The incidence rate (per 1000 patient admissions) was calculated based on all admissions. Predictors of HAPI severity were identified using multivariable multinomial logistic regression. The study adhered to the STROBE guidelines for retrospective cohort studies.

Results

The HAPI incidence rate was 6.96 per 1000 patient admissions. Of the age groups, neonates had the highest HAPI incidence (15.5 per 1000 admissions). Critically ill children had the highest rate for admission location (12.8 per 1000 patient admissions). Most reported cases were stage I (64.2%). Age was associated with injury severity, with older paediatric patients more likely to develop higher-stage HAPIs. Additionally, Aboriginal and/or Torres Strait Islander patients had a higher HAPI severity risk.

Conclusion

HAPI injuries in paediatric patients are unacceptably high. Prevention should be prioritized, and the quality of care improved in Australia and beyond. Further research is needed to develop targeted prevention strategies for these vulnerable populations.

Implications for the Profession and Patient Care

This research emphasizes the need for standardized reporting, culturally sensitive care and tailored prevention strategies.

Impact

The research has the potential to influence healthcare policies and practices, ultimately enhancing the quality of patient care.

Reporting Method

STROBE guidelines.

No Patient or Public Contribution

There was no patient or public contribution to the conduct of this study.

Exploring dietary perception, beliefs and practices among pregnant adolescents, their husbands and healthcare providers in West Arsi, Central Ethiopia: a phenomenological study

Por: Tesfaye · A. · Wondimagegne · Y. A. · Tamiru · D. · Belachew · T.
Background

The two most physically active stages of life, pregnancy and adolescence, put the pregnant adolescent under a lot of stress. Adolescence is a crucial era in women’s nutrition that is frequently overlooked.

Objective

This study aimed to explore dietary perceptions, beliefs and practices among pregnant Adolescents in West Arsi, Central Ethiopia.

Design

A qualitative method, specifically, a phenomenological research design, was carried out from February to March 2023.

Settings

This study was conducted in the West Arsi zone, Oromia, Ethiopia, in four randomly selected districts.

Participants

Thirty participants, 12 pregnant adolescents, 8 husbands of pregnant adolescents and 10 healthcare providers were purposefully selected and participated.

Methods

In-depth and key informant interviews were conducted. To create relevant codes, subthemes and themes, ATLAS.ti V.7.1 software was used. An inductive qualitative data analysis approach was used. The results were presented using respondents’ clear verbatim and thematic analysis.

Results

The findings were organised into four major themes: (1) low nutritional awareness, (2) poor dietary practice, (3) barriers to good dietary practice and (4) facilitators for good dietary practice. A low perceived severity (one’s belief of the seriousness) of undernutrition and low perceived benefits (one’s belief of the benefits) of balanced nutrition have been reported. A monotonous diet (one type food usually cereal based), no change in dietary practices during pregnancy, and low intake of animal food sources (meat, egg and milk) were found under dietary practices. One of the most striking findings to emerge from this study is the Alliance for Development (AFD), the former Women Development Army, which can be a great facilitator of good dietary practice. Husbands’ involvement in nutrition education and specific nutrition training for healthcare providers are the other facilitators identified in this study. The lack of nutrition education, misconceptions and economic problems are barriers to dietary practices.

Conclusion

This study found a low nutritional awareness and poor dietary practices. Further experimental studies are recommended to assess whether AFD is capable of delivering effective nutrition interventions that improve dietary practice of pregnant.

Perceived barriers and facilitators to preventing hospital‐acquired pressure injury in paediatrics: A qualitative analysis

Abstract

Aim

This qualitative study aimed to identify nurses' and allied health professionals' perceptions and experiences of providing hospital-acquired pressure injury (HAPI) prevention in a paediatric tertiary hospital in Australia, as well as understand the perceived barriers and facilitators to preventing HAPI.

Design

A qualitative, exploratory study of hospital professionals was undertaken using semi-structured interviews between February 2022 and January 2023.

Methods

Two frameworks, the Capability, Opportunity and Motivation Model of Behaviour (COM-B) and the Theoretical Domains Framework (TDF), were used to give both theoretical and pragmatic guidance. Participants included 19 nursing and allied health professionals and data analysis was informed by the framework approach.

Results

Analysis revealed nine core themes regarding professionals' beliefs about the barriers and facilitators to HAPI prevention practices across seven TDF domains. Themes included HAPI prevention skills and education, family-centred care, automated feedback and prompts, allocation and access to equipment, everybody's responsibility, prioritizing patients and clinical demands, organizational expectations and support, integrating theory and reality in practice and emotional influence.

Conclusion

These findings provide valuable insights into the barriers and facilitators that impact paediatric HAPI prevention and can help identify and implement strategies to enhance evidence-based prevention care and prevent HAPI in paediatric settings.

Impact

Overcoming barriers through evidence-based interventions is essential to reduce HAPI cases, improve patient outcomes, and cut healthcare costs. The findings have practical implications, informing policy and practice for improved preventive measures, education, and staffing in paediatric care, ultimately benefiting patient well-being and reducing HAPIs.

Patient or Public Contribution

No patient or public contribution. The focus of the study is on healthcare professionals and their perspectives and experiences in preventing HAPIs in paediatric patients. Therefore, the involvement of patients or the public was not deemed necessary for achieving the specific research objectives.

Child eye health in Ethiopia: a mixed methods analysis of policy and commitment to action

Por: Sherief · S. T. · Tesfaye · S. · Eshetu · Z. · Ali · A. · Dimaras · H.
Background

Child eye health is a serious public health issue in Ethiopia, where children under the age of 15 account for over half of the population. Our aim was to review Ethiopian health policy and practice to reveal approaches and commitment to promotion and delivery of child eye health services.

Methods

We conducted a mixed-methods situational analysis employing documentary analysis and key informant interview methods. Government publications touching on any element of child eye health were included. Key informants were eligible if they were leaders, authorities, researchers or clinicians involved in child health. Data was combined and analysed by narrative synthesis, using an adaptation of the Eye Care Situation Analysis Tool as a framework.

Findings

Eleven documents developed by the Ministries of Health and Education were included and interviews with 14 key informants were conducted. A focus on child eye health was lacking in key health policy documents, demonstrated by limited allocation of funds, a shortage of human resources, and a subpar referral system across all levels of child eye care.

Conclusion

The study identified several gaps and limitations in child eye health in Ethiopia. There is a need for health policies that strengthen ownership, finance and partnerships for improved coordination, and collaboration with line ministries and other stakeholders to improve child eye health services in Ethiopia.

Arabic-speaking women's experiences of communication at antenatal care in Sweden using a tablet application – part of development and feasibility study

The purpose of this study was to explore Arabic-speaking women´s experiences of communication at antenatal care in Sweden when using a tablet application (app).
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