Nursing Research Research Articles

A roadmap for social determinants of health and biological nursing research in the National Institute of Nursing Research 2022–2026 Strategic Plan: Optimizing health and advancing health equity using antiracist framing

BackgroundHealth equity is essential for improving the well-being of all individuals and groups, and research remains a critical element for understanding barriers to health equity. While considering how to best support research that acknowledges current health challenges, it is crucial to understand the role of social justice frameworks within health equity research and the contributions of minoritized researchers. Additionally, there should be an increased understanding of the influence of social determinants of health on biological mechanisms. PurposeBiological health equity research seeks to understand and address health disparities among historically excluded populations. DiscussionWhile there are examples of studies in this area led by minoritized researchers, some individuals and groups remain understudied due to underfunding. Research within minoritized populations must be prioritized to authentically achieve health equity. Furthermore, there should be increased funding from National Institutes of Health to support minoritized researchers working in this area.

Interaction Model of Client Health Behavior for Informal Caregivers: A Theoretical Analysis.

Background: Reliance on informal caregivers is expected to increase, yet there are not many studies examining their characteristics and behaviors. Purpose: The aim of this review is to relate the interaction model of client health behavior (IMCHB) to informal caregiver outcomes. Methods: The literature associated with the IMCHB was examined for current usage to determine use in guiding theories related to informal caregiver outcomes. Cumulative Index to Nursing and Allied Health Literature, Cochrane, EBSCO, Google Scholar, Journals@Ovid, Medical Literature Analysis and Retrieval System Online, and ScienceDirect databases were searched for peer-reviewed literature. Walker and Avant's method guided this theoretical analysis. Results: Seven articles were retained for discussion in this theoretical analysis. Implications: The IMCHB has been used in past health promotion research and can guide future nursing research that supports interventions for informal caregivers. The model's inclusion of the client-professional interaction component allows for further caregiver behavioral associations and relationships that influence optimal outcomes.

Decision-making in nursing research and practice-Application of the Cognitive Continuum Theory: A meta-aggregative systematic review.

To explore how the Cognitive Continuum Theory has been used in qualitative nursing research and to what extent it has been integrated in the research process using the Qualitative Network for Theory Use and Methodology (QUANTUM). Theory, research and nursing are intrinsically linked, as are decision-making and nursing practice. With increasing pressure on nurses to improve patient outcomes, systematic knowledge regarding decision-making is critical and urgent. A meta-aggregative systematic review. DATABASES: CINAHL, Medline, PsycINFO, Embase and PubMed were searched from inception until May 2022 for peer-reviewed research published in English. Seven studies were included and assessed for methodological quality using the Joanna Briggs Institute checklist for qualitative research. A meta-aggregative synthesis was conducted using Joanna Briggs methodology. The QUANTUM typology was used to evaluate the visibility of the Cognitive Continuum Theory in the research process. The review identified five synthesised findings, namely: 1. the decision-making capacity of the individual nurse, 2. nurses' level of experience, 3. availability of decision support tools, 4. the availability of resources and 5. access to senior staff and peers. Only two of seven studies rigorously applied the theory. The included studies were mainly descriptive-exploratory in nature. The transferability of the Cognitive Continuum Theory was demonstrated; however, evolution or critique was absent. A gap in the provision of a patient-centric approach to decision-making was identified. Education, support and research is needed to assist decision-making. A new Person-Centred Nursing Model of the Cognitive Continuum Theory has been proposed to guide future research in clinical decision-making. Nurses make numerous decisions every day that directly impact patient care, therefore development and testing of new theories, modification and revision of older theories to reflect advances in knowledge and technology in contemporary health care are essential.

Nursing and midwifery research priorities for Kenya: Results from a national Delphi survey.

The International Council of Nurses and the World Health Organization have prioritized evidence-based nursing and midwifery practice derived from nurse-led research. However, in a low-resource country like Kenya, there is a need to identify research priorities to optimize utilization of limited existing research infrastructure and funding. Kenya lacks a nursing and midwifery research strategy to guide research prioritization. The goal of this study was to identify and describe nursing and midwifery research priorities for Kenya. A cross-sectional Delphi survey using two iterative rounds of electronic data collection was used to reach a consensus about priorities for nursing and midwifery research in Kenya. NVivo-12 was used to analyze the qualitative data to identify categories, sub-themes, and themes; descriptive statistics were used to analyze quantitative data. Participants included 159 nurse managers, administrators, and educators representing regional, county, and national referral, private, and faith-based hospitals, nurse training schools, research institutions, and nursing organizations in Kenya. Staffing challenges, motivation, remuneration, and funding for higher education were ranked as the top critically important issues using a cutoff point of≥70% agreement. There is a need for the development of a National Framework for Nursing and Midwifery Research Priorities in Kenya to guide research that builds excellence in meeting nursing and midwifery human resource concerns and ultimately improves patient care practices and outcomes. The objective of Kenya's health goals delineated within three key national health documents cannot be attained without adequate numbers of nursing and midwifery professionals and policies that address nursing and midwifery staffing challenges, remuneration for employment, and improved funding for higher education.

"What Do We Know about Hope in Nursing Care?": A Synthesis of Concept Analysis Studies.

Hope is a central concept within the nursing literature, which is crucial towards the development of nursing knowledge. Nursing teams play a crucial role in exploring the meaning of hope and promoting hope among patients and their families. This study aims to synthesize concept analysis studies of hope in the context of nursing care and to propose an evidence-based update of the definition of hope in the International Classification for Nursing Practice (ICNP®). Method: This is a literature review, involving the synthesis of studies concerning the concept analysis of hope in nursing practice. Peer-reviewed articles with fully accessible Portuguese or English text were considered. As we aimed to include a historical perspective of the concept, no restriction upon the time of publication was set. Articles were selected in March 2022 and updated in July 2023 using the Medline, CINAHL, and Scopus databases. The search terms used were "hope" AND "concept" AND "analysis" AND "nurs*". Only articles written in English or Portuguese were included. Two reviewers conducted the research synthesis and report independently to minimize the risk of bias in the included studies. This paper adheres to the PRISMA checklist. To clarify the concept of hope as perceived by patients and develop hope as an evidence-based nursing concept, 13 studies were reviewed. The concept of hope, its attributes, antecedents, and consequences, as well as similar concepts, were studied by nurses and synthesized into a definition. The identified antecedents include pivotal life events, stressful stimuli, and experiencing satisfaction with life. The analysis of its attributes, antecedents, and consequences has contributed to understanding its relevance in nursing care and provided a proposed update of hope in the ICNP®. This review provides conceptual clarity on how hope is defined and used in nursing practice and the potential factors that may impact the promotion of hope to provide opportunities for future nursing research.

Research Self-Efficacy and Research-Related Behavior Among Nurses in Qatar: A Cross-Sectional Study.

Research self-efficacy helps predict the individual interest and confidence in conducting research. The study was conducted to identify the research self-efficacy among nurses working in a group of tertiary hospitals and their research-related behavior. The study design was descriptive cross-sectional and conducted among nurses at Hamad Medical Corporation, Qatar Convenient sampling was done and 500 is the sample size. Data were collected through an online survey during 2 months in 2019 by using a validated "Nursing Research Self-Efficacy Scale" questionnaire. The scale includes 38 items under five domains, and the response was collected on a Likert scale from 1 to 5. The authors of the scale suggested excellent reliability score for the subscales, ranging from .94 to .97 and the existence of subscales was supported by exploratory and confirmatory factor analysis. A completed survey was collected from 780 nurses. The mean self-efficacy score was 2.92 ± 0.97. The mean score for the subscale of obtaining science-based knowledge resources was the highest (3.24 ± 1.03) and the lowest for critically read and evaluate qualitative research literature (2.63 ± 1.12). Nurses with higher educational qualifications and those who enrolled in any educational program further to their nursing education have statistically significantly high research self-efficacy. The overall research self-efficacy of working nurses is moderate. However, nurses' confidence in the ability to perform critiquing research and understand the concept and methodology in research is minimal. Introduction of nurse-tailored research training, which covers fundamental aspects of research to an advanced level, will help make them more confident in research.

Breaking ground: nursing-led approach to alleviating constipation in Parkinson’s disease

BackgroundConstipation is one of the most common non-motor symptoms in PD patients, and the constipation, can appear before motor symptoms. Incorrect treatment of constipation in PD patients can result in colonic volvulus and pseudo intestinal obstruction, as well as a reduction in the therapeutic effect of anti-PD drugs due to absorption issues. There is, however, no comprehensive and scientific nursing intervention plan for PD patients’ constipation who are constipated.MethodsA multi-disciplinary nursing research group of five people was established to construct the first draft of intervention plan through literature review. We chose 15 experts from 7 universities and tertiary hospitals spread over 5 provinces (cities), including 4 neurologists, 9 clinical nursing specialists in neurology, 1 dietician, and 1 rehabilitator. Two rounds of consultations were held from April to July 2022 with 15 experts to screen and revise the indicators at each level, confirming their importance and feasibility at each level.ResultsThere were three primary indicators (pre-intentional stage, intentional stage, and action stage) in the two rounds of expert correspondence, nine secondary indicators (disease risk perception, adverse consequence expectation, self-efficacy and intention of action; action plan, coping plan and coping self-efficacy; produce healthy behaviors, maintain healthy behaviors, recover behaviors and recover self-efficacy), and 22 tertiary indicators.ConclusionsAfter the implementation of two rounds of Delphi method, the final formed constipation intervention program for PD patients provides the basis for clinical nursing practice, which has the characteristics of convenience, comprehensiveness, dependence, scientific and feasibility. Therefore, it has application and promotion value.

Awareness of Medical Professionals Regarding Research Ethics in a Tertiary Care Hospital in Riyadh, Saudi Arabia: A Survey to Assess Training Needs.

Ethics is an essential component of human research, and knowledge and awareness of ethical guidelines are required to conduct research involving human subjects and ensure the participants' safety. To investigate medical professionals' and researchers' knowledge of national and international research ethics guidelines, key principles in human research projects, ethical issues in different types of research, the importance of informed consent, and institutional review boards. A cross-sectional study with 251 participants, including physicians, nurses, and researchers from three different research centers and hospitals in Riyadh city, was carried out using an electronic self-structured questionnaire. The sample size was estimated using OpenEpi, Version 3. The questionnaire contained six different sets of questions to analyze knowledge about research ethics and guidelines. The results were analyzed using SAS version 9.4 (SAS Institute Inc., Cary, NC, USA). About 53.78% of the participants had received research ethics education, out of which 78.51% of the participants expressed the need for more training in research ethics education. The Belmont Report showed a high level of unawareness among nurses (88.3%), physicians (73.8%), and researchers (55.32%). Nurses had a high level of positive attitude about all the key principles of human research. The highest level of awareness of ethical issues in clinical trials and interventional studies was found among researchers (54%), and the lowest level of awareness was exhibited by nurses (19.32%). Nurses (74.34%) and physicians (62.79%) had the lowest positive attitudes about obtaining children's assent in pediatric research. Physicians and researchers had a higher awareness of the IRB than nurses. Researchers were well-versed in research ethics, regulatory guidelines, and ethical issues in various types of research, whereas nurses were enthusiastic about key principles in human research and the importance of informed consent. This study shows that a very low percentage of nurses have received research ethics education and emphasizes the critical importance of including research ethics education in nursing curricula, as the involvement of nurses in research is inevitable. This study also shows the lack of knowledge among nurses, researchers, and doctors about various international guidelines. It emphasizes the importance of adding regulatory guidelines to the curriculum and teaching them effectively to students. Also, periodic workshops should be conducted to enhance the practical knowledge of the professionals regarding the guidelines and guide them in overcoming the practical difficulties they encounter during their practice.

Insights into the barriers and enablers faced by nurse/midwife clinician researchers in Australia

BackgroundClinician researchers are described as health professionals who conduct research and provide clinical care. Whilst this dual expertise is common in medicine and increasingly in allied health disciplines, fewer nurses and midwives are engaged in clinician researcher roles. AimThis study aimed to understand the barriers and enablers experienced by clinician researchers in nursing and midwifery in the Australian health systems. MethodsSemi-structured interviews were conducted with current nurse or midwife clinician researchers in Australia. Participants were classified as clinician researchers if they were registered nurses or midwives currently practising clinically whilst concurrently engaged in research. Interview data were analysed using iterative thematic analysis. In total, 15 interviews were conducted. FindingsKey themes identified included (i) perceived value; (ii) structural factors; and (iii) personal factors. Nurse and midwife clinician researchers reported feeling challenged by the absence of a clear career trajectory, and the constant undervaluing of nurse and midwife clinician researchers by health service leaders and peers. DiscussionBarriers included insufficient funding, motivation, mentorship, and leadership support. Enablers included protected research time, leadership support, and capacity-building. Participants also proposed changes to support clinician researcher career progression. These suggestions were used to put forward evidence-based recommendations for such a pathway. ConclusionThis study highlighted the need for a clearly articulated workforce model to support sustainable clinician researcher careers for nurses and midwives to overcome these barriers.

The intensive care unit diary as a valuable care tool: A qualitative study of patients’ experiences

ObjectivesThe aim is to learn about patients' experience of reading the diary, assess attributed meaning and explore patients’ experience and memories during their stay in the intensive care unit. SettingEleven patients who received the diary after a stay in a nine-bed cardiac intensive care unit in Southern Switzerland, from November 2019 to October 2021. Main Outcome MeasuresDescriptive qualitative research was performed using semi-structured interviews, followed by thematic analysis. Three research nurses conducted individual telephone or face-to-face interviews. FindingsFifteen sub-themes emerged from the data interviews and were grouped into five main categories: a) the experience in the intensive care unit; b) Post Intensive Care Syndrome symptoms; c) the patient diary; d) new meaning of life; and e) sharing. Patients showed difficulties in remembering and understanding what happened during the hospitalization period. Reading the diary enabled them to understand the impact that the illness had on their daily experience. For some of them, reading the diary was helpful in reacting positively during moments of discouragement. ConclusionQualitative approach allowed us to assess how patients perceive the diary in the intensive care unit in a cultural context of Central and Southern Europe, which is still poorly investigated. The diary responded to the person's need to know what happened during a period that they had no memory of. Its use demonstrated important benefits, allowing people to understand the impact that the illness had on everyday life. It allowed them to relate to the difficulties encountered during the healing process. Thus, the diary played an important role during the healing process. Implications for clinical practiceThe diary was appreciated by patients during all stages of recovery from severe and acute illness. Gaps within the narration were avoided, in order to provide patients with a better timeline of the events occurred during the time they were unconscious.

Development and usability testing of an electronic patient-reported outcome (ePRO) solution for patients with inflammatory diseases in an Advanced Therapy Medicinal Product (ATMP) basket trial

BackgroundElectronic patient-reported outcome (ePRO) systems are increasingly used in clinical trials to provide evidence of efficacy and tolerability of treatment from the patient perspective. The aim of this study is twofold: (1) to describe how we developed an electronic platform for patients to report their symptoms, and (2) to develop and undertake usability testing of an ePRO solution for use in a study of cell therapy seeking to provide early evidence of efficacy and tolerability of treatment and test the feasibility of the system for use in later phase studies.MethodsAn ePRO system was designed to be used in a single arm, multi-centre, phase II basket trial investigating the safety and activity of the use of ORBCEL-C™ in the treatment of patients with inflammatory conditions. ORBCEL-C™ is an enriched Mesenchymal Stromal Cells product isolated from human umbilical cord tissue using CD362+ cell selection. Usability testing sessions were conducted using cognitive interviews and the ‘Think Aloud’ method with patient advisory group members and Research Nurses to assess the usability of the system.ResultsNine patient partners and seven research nurses took part in one usability testing session. Measures of fatigue and health-related quality of life, the PRO-CTCAE™ and FACT-GP5 global tolerability question were included in the ePRO system. Alert notifications to the clinical team were triggered by PRO-CTCAE™ and FACT-GP5 scores. Patient participants liked the simplicity and responsiveness of the patient-facing app. Two patients were unable to complete the testing session, due to technical issues. Research Nurses suggested minor modifications to improve functionality and the layout of the clinician dashboard and the training materials.ConclusionBy testing the effectiveness, efficiency, and satisfaction of our novel ePRO system (PROmicsR), we learnt that most people with an inflammatory condition found it easy to report their symptoms using an app on their own device. Their experiences using the PROmicsR ePRO system within a trial environment will be further explored in our upcoming feasibility testing. Research nurses were also positive and found the clinical dashboard easy-to-use. Using ePROs in early phase trials is important in order to provide evidence of therapeutic responses and tolerability, increase the evidence based, and inform methodology development.Trial registration: ISRCTN, ISRCTN80103507. Registered 01 April 2022, https://www.isrctn.com/ISRCTN80103507

Using the making Visible the ImpaCT Of Research (VICTOR) questionnaire to evaluate the benefits of a fellowship programme for nurses, midwives and allied health professionals.

There is increasing emphasis in the UK on developing a nurse, midwife and allied health professional (NMAHP) workforce that conducts research. Training for clinical academic careers is provided by the National Institute for Health and Care Research (NIHR). However, the low number of successful applicants suggested there were barriers to achieving this. The Centre for Nursing and Midwifery Led Research (CNMR) launched a fellowship programme in 2016 to backfill two days a week of NMAHPs' time for up to a year, to give them time to make competitive applications to the NIHR. To report a study evaluating the CNMR fellowship programme. The making Visible the ImpaCT Of Research (VICTOR) tool ( Cooke et al 2019 ) was developed to describe the organisational impact of research. The 2016-17 CNMR fellows completed VICTOR and their responses were analysed using a framework approach. The analysis found the main benefits of participating in the programme were protected time for research, opportunities to develop collaborations, increasing intra- and inter-professional awareness of NMAHPs' research, peer-reviewed publications, and conference presentations. Challenges included a lack of support from line managers, limited value placed on NMAHPs' research and failure to backfill posts. There were some challenges with the fellowship programme, but all recipients found it to be a positive experience and undertook significant scholarly activity. A contractual agreement must be established to foster committed partnerships between higher education institutions (HEIs) and the NHS. HEIs and the NHS should conduct frank discussions of the challenges encountered in fellowship programmes. Positive initiatives and outcomes in tertiary education and clinical settings should be shared to improve fellows' experiences and enhance partnerships between HEIs and the NHS. Job descriptions should include time allocation to review fellowship candidates' applications regardless of outcome. The showcasing of research successes and the benefits of NMAHP research must evolve to secure organisational 'buy in', which is the precursor to widening access to clinical academic pathways.

Hotspots and Global Trends of Nursing Research on Telehealth From 2012 to 2021: A Bibliometric Analysis by CiteSpace.

Telehealth is commonly used in nursing in recent years; however, there is a lack of information on hotspots and global trends over time. This study aimed to analyze the bibliometric patterns of telehealth research in nursing. This is a descriptive bibliometric study. Data were obtained from Web of Science Core Collection. CiteSpace version 6.1.R6 was used to perform analysis. The co-occurrence and co-citation analyses were conducted. A total of 1365 articles were analyzed. A total of 354 authors and 352 institutions from 68 countries have contributed telehealth research in nursing. The most productive author was Kathryn H. Bowles with six articles. The United States with 688 articles and University of Pennsylvania with 22 articles were the most productive country and institution, respectively. The top 10 keywords on this research area were care, intervention, management, health, technology, quality of life, outcome, mobile application, telemedicine, and experience. In addition, the common themes on keywords were nurse practitioner student perception, hemodialysis patients, and heart failure. The study will help to finding potential collaborators, countries, and institutions for future researchers. In addition, it will guide researchers, practitioners, and scholars in further studies, health policy development, and evidence-based practice on telehealth in nursing.

Factors Influencing the Implementation of Interprofessional Collaborative Practice in Teaching Hospital Setting: A Mixed-Method Study.

Health service in the current global era requires health workers to provide qualified service, this also applies to teaching hospitals. Collaboration between several professions involved (doctors, nurses, and pharmacists) in an interprofessional collaboration system is needed in providing such service. Factors influencing interprofessional collaboration is unique to each health care center. The purpose of this study was to determine the factors that influence the implementation of interprofessional collaborative practice among health workers in Dr. Wahidin Sudirohusodo General Hospital. This is a mixed-method explanatory sequential design study, utilizing quantitative and qualitative data. Quantitative data were obtained from the Indonesian-validated Collaborative Practice Assessment Tool (CPAT) questionnaire. CPAT in Indonesian language has been validated in previous research by Findyartini, et al. in 2019 in Indonesian population. The questionnaire was internally validated with the study population with Cronbach alpha of 0.812. All health care professionals meeting the selection criteria were enrolled for the quantitative study. The questionnaire was given to 152 health professionals enrolled as research subjects, including nutritionists, nurses, doctors, pharmacists, and medical rehabilitation specialists serving in Dr. Wahidin Sudirohusodo Hospital for >3 years. Five participants with highest and lowest CPAT score from each profession were invited for FGD entitled "Exploring factors involved in interprofessional collaboration in Wahidin Sudirohusodo General Hospital" and divided into 2 groups according to the CPAT score. The score from each subscale in the questionnaire is obtained for each research subjects and the median is compared among each profession group using Kruskall-Wallis test significant to a p value of <0.05. Qualitative data as recording transcript is acquired from FGD; the transcript was then coded into several general themes by 2 of the authors and was discussed using thematic analysis using MaxQDA. Research subjects were predominantly women (121 respondents (79.6%)), 32.9% were nurses, and most of the healthcare professional (81 subjects (55.1%)) have been working for >10 years. Among profession groups (Doctors, Pharmacists, Medical Rehabilitation Specialists, Nutritionists, and Nurses), difference in score distribution (p<0.05) was found in relationships among team members (40 vs 39 vs 39.5 vs 36 vs 42, p<0.001), barriers to team collaboration (10 vs 18.5 vs 14 vs 18 vs 10, p<0.001), and leadership (20 vs 20 vs 23 vs 20 vs 20, p 0.045). From the FGD, factors influencing interpersonal collaborative practice are leadership factors, system/rule factors, and personal factors. This research showed that personal, system/organizational and leadership factors influence the implementation of interprofessional collaboration. In this study, there is a different perception regarding relationships among team members, barriers to team collaboration, and leadership among profession group.

In what ways are HR analytics and artificial intelligence transforming the healthcare sector?

Our Special Issue is focused on the healthcare sector relevant to the Asia Pacific region, including hospitals, aged care facilities, allied health, doctors, nurses, management and administration staff and all services associated with the healthcare industry. There are a range of issues that impact on healthcare including the growing use of health services during the pandemic, emergency situations, complex forms of technology, worker expectations, work intensification, and government reporting requirements. More research needs to be carried out in these issues as well as social policy, the delivery and quality of patient care, gender in the workplace, disability, and management innovation (Cooke and Bartram, 2015; Human Resource Management, 2015, 54, 711). There are high levels of stress due to staff being overworked and experiencing a lack of coping skills (Pariona‐Cabrera et al., 2023; Health Care Management Review, 2023, 48, 42), burnout manifestations through emotional exhaustion (Maslach, 2017; Consulting Psychology Journal: Practice and Research, 2017, 69, 143) which often result in intention to leave (Holland et al., 2019; Applied Nursing Research, 2019, 49, 70; Pariona‐Cabrera, Cavanagh and Bartram, 2020; Journal of Advanced Nursing, 2020, 76, 1581; Shao et al., 2023; Human Resource Management Journal, 2023, 33,187). In Australia, more than 70% of 366,000 nurses working in aged care facilities have reported at least one experience of workplace violence during the previous 12 months including physical and verbal violence from residents, relatives, and visitors (Schablon et al., 2018; International Journal of Environmental Research and Public Health, 2018, 15, 1274). There are too many managers who rely on underdeveloped HR processes and outdated management perceptions to make decisions about the well‐being of healthcare staff. Countries in the Asia‐Pacific region are actively seeking partnership projects and new ways to enhance the performance of healthcare staff and their organisations. We have touched on broad issues here and argue it is possible some of the answers can be found in the use of HR analytics and artificial intelligence (AI).

Assessing Evidence-Based Practice Knowledge: An Innovative Approach by a Nursing Research Council.

Assessing Evidence-Based Practice Knowledge: An Innovative Approach by a Nursing Research Council.

The complexities of human procedural nursing research ethical approval processes in Indonesia

Introduction: Research requires high quality ethical practices. However, research approvals vary between developed and developing countries resulting in additional challenges for researchers wishing to participate in collaborative research projects. The aim of this paper is to describe and discuss three nursing research ethics application processes in different locations in Indonesia that had an Australian university overseeing them. Methods: Three nurse researchers provide a reflective account of the ethics application processes of their qualitative research projects conducted between 2014 and 2021. A collective case-study methodology using descriptive analysis was applied where the information was collated and compared for similarities, differences and challenges. Results: Ethics and site approvals varied at each Indonesian site. The ethical and approval application processes were time-consuming at all levels. which delayed the start of all the projects, which varied from between one to six months. As a result, all three projects experienced delayed completion. Conclusions: Ethical approval is required for medical research prior to any data collection. Approval processes need to be consistent so that delays in the application processes are avoided. Any delays in approval to conduct research has implications for research projects. It is essential that timeframe factors need to be considered when applying for grant funding, gatekeepers are identified early, and payments are identified and planned for. It is recommended that, to improve consistency with ethical application processes, streamlining of applications and approvals in Indonesia needs to be reviewed, particularly since the introduction of the WHO March 2022 Standard Operating Procedures.

Clinical research stakeholders’ experiences of clinical research during COVID-19: a qualitative study

BackgroundThe COVID-19 pandemic created a complex high-risk clinical research environment with clinical research activities significantly impacted. Clinical research stakeholders adapted rapidly to new clinical practices; PPE, infection control policies, all while engaging with a more unwell patient demographic. The aim of this study is to explore the experiences of conducting clinical research during COVID-19 with clinical research stakeholders.MethodsThis qualitative study of semi-structured interviews conducted with clinical research stakeholders in an acute Hospital setting across a variety of disciplines; Consultant Geriatrician, Clinical Research Nurse, Occupational Therapy, Physiotherapy. Interviews were fully transcribed prior to reflexive thematic analysis. NVivo software was used to support data management and analysis.ResultsThree main themes were produced; (1) The challenging COVID-19 clinical research landscape, (2) COVID-19 clinical research communication barriers, and (3) Adaptations and learnings from clinical research during COVID-19.ConclusionsThis study explored the experiences of conducting clinical research during COVID-19 with clinical research stakeholders examining challenges faced and adaptations required. The findings inform, equip and support clinical research stakeholders in the event of future adverse public health events.

Interview: Maggie Shepherd

Maggie Shepherd | Associate Director for Nursing Research; Consultant Nurse, Royal Devon University Healthcare NHS Foundation Trust; and Honorary Clinical Professor of Monogenic Diabetes, University of Exeter, UK

Treating acute exacerbations of COPD with Chinese herbal medicine to aid antibiotic use reduction (Excalibur): a randomised double-blind, placebo-controlled feasibility trial.

Background: Although many acute exacerbations of COPD (AECOPD) are triggered by non-bacterial causes, they are often treated with antibiotics. Preliminary research suggests that the Chinese herbal medicine "Shufeng Jiedu" (SFJD), may improve recovery and therefore reduce antibiotic use in patients with AECOPD. Aims: To assess the feasibility of conducting a randomised placebo-controlled clinical trial of SFJD for AECOPD in UK primary care. Methods: GPs opportunistically recruited patients experiencing an AECOPD. Participants were randomised 1:1 to usual care plus SFJD or placebo for 14 days. Participants, GPs and research nurses were blinded to treatment allocation. GPs could prescribe immediate, delayed or no antibiotics, with delayed prescribing encouraged where appropriate. Participants were asked to complete a participant diary, including EXACT-PRO and CAT™ questionnaires for up to 4 weeks. Outcomes included recruitment rate and other measures of study feasibility described using only descriptive statistics and with no formal comparisons between groups. We also conducted qualitative interviews with recruited and non-recruited COPD patients and clinicians, analysed using framework analysis. Results: Over 6 months, 19 participants (6 SFJD, 13 placebo) were recruited. Sixteen (84%) participants returned diaries or provided a diary by recall. Overall, 1.3 participants were recruited per 1,000 patients on the COPD register per month open. Median duration of treatment was 9.8 days in the intervention group vs 13.3 days in the placebo group. The main reason for discontinuation in both groups was perceived side-effects. in both groups. Point estimates for both the EXACT-PRO and CAT™ outcomes suggested possible small benefits of SFJD. Most patients and clinicians were happy to try SFJD as an alternative to antibiotics for AECOPD. Recruitment was lower than expected because of the short recruitment period, the lower incidence of AECOPD during the COVID-19 pandemic, patients starting antibiotics from "rescue packs" before seeing their GP, and workforce challenges in primary care. Conclusion: Recruitment was impaired by the COVID-19 pandemic. Nevertheless, we were able to demonstrate the feasibility of recruiting and randomising participants and identified approaches to address recruitment challenges such as including the trial medication in COPD patients' "rescue packs" and delegating recruitment to a central trials team. Clinical Trial Registration: Identifier, ISRCTN26614726.