Exploring the perspectives of selectors and collecters of trial outcome data: an international qualitative study.

INTRODUCTION: Selecting and collecting data to support appropriate primary and secondary outcomes is a critical step in designing trials that can change clinical practice. In this study, we aimed to investigate who contributes to the process of selecting and collecting trial outcomes, and how these people are involved. This work serves two main purposes: (1) it provides the trials community with evidence to demonstrate how outcomes are currently selected and collected, and (2) it allows people involved in trial design and conduct to pick apart these processes to consider how efficiencies and improvements can be made. METHODS: One-with-one semi-structured interviews, supported by a topic guide to ensure coverage of key content. The Framework approach was used for thematic analysis of data, and themes were linked through constant comparison of data both within and across participant groups. Interviews took place between July 2020 and January 2021. Participants were twenty-nine international trialists from various contributor groups, working primarily on designing and/or delivering phase III pragmatic effectiveness trials. Their experience spanned various funders, trial settings, clinical specialties, intervention types, and participant populations. RESULTS: We identified three descriptive themes encompassing the process of primary and secondary outcome selection, collection, and the publication of outcome data. Within these themes, participants raised issues around the following: 1) Outcome selection: clarity of the research question; confidence in selecting trial outcomes and how confidence decreases with increased experience; interplay between different interested parties; how patients and the public are involved in outcome selection; perceived impact of poor outcome selection including poor recruitment and/or retention; and use of core outcome sets. 2) Outcome collection: disconnect between decisions made by outcome selectors and the practical work done by outcome collectors; potential impact of outcome measures on trial participants; potential impact on trial staff workload; and use of routinely collected data. 3) Publication of outcome data: difficulties in finding time to write and revise manuscripts for publication due to time and funding constraints. Participants overwhelmingly focused on the process of outcome selection, a topic they talked about unprompted. When prompted, participants do discuss outcome collection, but poor communication between selectors and collectors at the trial design stage means that outcome selection is rarely linked with the data collection workload it generates. DISCUSSION: People involved in the design and conduct of trials fail to connect decisions around outcome selection with data collection workload. Publication of outcome data and effective dissemination of trial results are hindered due to the project-based culture of some academic clinical trial research.

Understanding Unmet Care Needs of Rural Older Adults with Chronic Health Conditions: A Qualitative Study.

BACKGROUND: Rural populations experience poorer access to the necessary health services for chronic health conditions. Although studies of rural healthcare access continue to expand, most are based on quantitative data, yet normative views and lived experiences of rural adults might offer a better understanding of healthcare access and their specific unmet needs. This qualitative study sought the views of both rural-centric older people and healthcare professionals to understand health needs, barriers, and enablers of accessing health services, with a focus on chronic health condition(s). METHODS: Between April and July 2022, separate in-depth interviews were conducted with 20 older people (≥60 years) in a rural South Australian community. Additionally, focus group interviews were conducted with 15 healthcare professionals involved in providing health services to older adults. Transcripts were coded using the NVivo software and data were thematically analysed. RESULTS: Participants described a range of unmet care needs including chronic disease management, specialist care, psychological distress, and the need for formal care services. Four barriers to meeting care needs were identified: Workforce shortages, a lack of continuity of care, self-transportation, and long waiting times for appointments. Self-efficacy, social support, and positive provider attitudes emerged as crucial enabling factors of service use among rural ageing populations. DISCUSSION: Older adults confront four broad ranges of unmet needs: Chronic disease management care, specialist care, psychological care, and formal care. There are potential facilitators, such as self-efficacy, provider positive attitudes, and social support, that could be leveraged to improve healthcare services access for older adults.

A good use of time? Providing evidence for how effort is invested in primary and secondary outcome data collection in trials.

BACKGROUND: Data collection is a substantial part of trial workload for participants and staff alike. How these hours of work are spent is important because stakeholders are more interested in some outcomes than others. The ORINOCO study compared the time spent collecting primary outcome data to the time spent collecting secondary outcome data in a cohort of trials. METHODS: We searched PubMed for phase III trials indexed between 2015 and 2019. From these, we randomly selected 120 trials evaluating a therapeutic intervention plus an additional random selection of 20 trials evaluating a public health intervention. We also added eligible trials from a cohort of 189 trials in rheumatology that had used the same core outcome set. We then obtained the time taken to collect primary and secondary outcomes in each trial. We used a hierarchy of methods that included data in trial reports, contacting the trial team and approaching individuals with experience of using the identified outcome measures. We calculated the primary to secondary data collection time ratio and notional data collection cost for each included trial. RESULTS: We included 161 trials (120 phase III; 21 core outcome set; 20 public health), which together collected 230 primary and 688 secondary outcomes. Full primary and secondary timing data were obtained for 134 trials (100 phase III; 17 core outcome set; 17 public health). The median time spent on primaries was 56.1 h (range: 0.0-10,746.7, IQR: 226.89) and the median time spent on secondaries was 190.7 hours (range: 0.0-1,356,832.9, IQR: 617.6). The median primary to secondary data collection time ratio was 1.0:3.0 (i.e. for every minute spent on primary outcomes, 3.0 were spent on secondaries). The ratio varied by trial type: phase III trials were 1.0:3.1, core outcome set 1.0:3.4 and public health trials 1.0:2.2. The median notional overall data collection cost was £8015.73 (range: £52.90-£31,899,140.70, IQR: £20,096.64). CONCLUSIONS: Depending on trial type, between two and three times as much time is spent collecting secondary outcome data than collecting primary outcome data. Trial teams should explicitly consider how long it will take to collect the data for an outcome and decide whether that time is worth it given importance of the outcome to the trial.

Rural disability workforce perspective on effective inter-disciplinary training-A qualitative pilot study.

OBJECTIVE: Inter-professional education is a growing area of importance that enables training of health care professionals and students to develop skills in collaborative clinical practice, a critical aspect of disability care. However, research is limited on appropriate on-site inter-professional training for the rural and remote disability workforce. This paper aims to explore the features of an effective inter-professional training approach for rural disability workforce. SETTING: Riverland, South Australia. PARTICIPANTS: Clinical educators, allied health professionals, health and service providers and students. DESIGN: A qualitative-explorative research design, involving focus group discussion and a thematic analysis method were employed in this study. Participants of the focus group discussion completed a capacity building training program centred on inter-professional education, cultural-safety and the National Disability Insurance Scheme. National Disability Services Social Impact Measurement Tool was used to evaluate and explore the features of effective inter-professional training program for existing and emerging disability workforce in rural regions. RESULTS: Four themes emerged from data analysis: inter-professional education focus; structured inter-professional training; building collaborative learning environment; and culturally appropriate care practice. Inter-professional supervision was identified as a key enabler for capacity building in an area with limited health workforce. Inter-agency collaboration and professional network were identified as important elements to support disability health workforce retention and the transition from novice to practitioner. Prior knowledge about the needs of persons with disability and empathetic relationships influenced the quality of practice. CONCLUSION: In situ training programs, which provide real-life rural practice context and harness inter-agency collaboration, improve effectiveness of rural disability workforce readiness for practice.

BSR Spondyloarthritis Course, 27 February 2020. Spondyloarthritis: pathogenesis, diagnosis and management.

High-quality continuous medical education is essential to maintain excellence in health-care delivery, upskilling professionals and improving patient outcomes. This is particularly relevant when addressing rare disease groups, such as the spondyloarthritides, a group of heterogeneous inflammatory conditions that affect joints and other organs, such as the skin, bowel and eye. Professional bodies, such as the British Society for Rheumatology (BSR), are well placed to deliver this type of education. In 2020, the BSR ran a dedicated SpA course aimed at rheumatology health-care professionals wishing to update their basic knowledge of SpA with a review of the latest advances in the field. Here, we summarize the proceedings of the meeting and discuss the value of such an initiative.

Conflict between nursing student's personal beliefs and professional nursing values.

BACKGROUND: Studies have established that negative perceptions of people living with HIV/AIDS exist among nursing students throughout the world, perceptions which can be detrimental to the delivery of high-quality nursing care. OBJECTIVES: The purpose of this research was to explore socio-cultural influences on the perceptions of nursing students towards caring for people living with HIV/AIDS. RESEARCH DESIGN: The study was guided by stigma theory, a qualitative descriptive research approach was adopted. Data collected via semi-structured interviews were thematically analysed. PARTICIPANTS AND RESEARCH CONTEXT: Participants were 21 international and Australian undergraduate nursing students enrolled in a Bachelor of Nursing programme at an Australian university. ETHICAL CONSIDERATIONS: Ethical approval was granted by the Social and Behavioural Research Ethics Committee at the study university. Participation was entirely voluntary; informed consent was obtained before the study commenced; confidentiality and anonymity were assured. FINDINGS: Three major themes were found: blame, othering and values. Complex and interrelated factors constructed participant perceptions of people living with HIV/AIDS, perceptions underscored by the prevailing culturally construed blame and othering associated with HIV/AIDS. The study found discordance between the negative personal beliefs and perceptions some nursing students have towards people living with HIV/AIDS, and the professional values expected of them as Registered Nurses. DISCUSSION: There was considerable commonality between this and previous studies on how homosexuality and illicit drug use were perceived and stigmatised, correlating with the blame directed towards people living with HIV/AIDS. These perceptions indicated some nursing students potentially risked not fulfilling the ethical and professional obligations the Registered Nurse. CONCLUSION: Nursing curriculum should be strengthened in relation to comprehending the meaning of being stigmatised by society. Educational institutions need to work towards enhancing strategies that assist nursing students to reconcile any incongruity between their personal beliefs and requisite professional nursing values.

Culturally construed beliefs and perceptions of nursing students and the stigma impacting on people living with AIDS: A qualitative study.

BACKGROUND: Since HIV and AIDS were discovered, studies have demonstrated that negative perceptions and reluctance to provide care to affected people persist among nursing students throughout the world. This leads to poor quality care. OBJECTIVES: To report on a study that explored socio-cultural influences on the perceptions of international nursing students toward caring for people living with HIV/AIDS. METHODS: A qualitative descriptive research design, guided by stigma theory, was utilised. Participants were 21 international and Australian undergraduate nursing students enrolled in a Bachelor of Nursing program at an Australian university. Data were collected via semi-structured interviews in 2009 and 2011; manual thematic analysis was performed on interview data. FINDINGS: Three major themes emerged: blame; othering; values. Perceptions were influenced by complex, interrelated factors and underscored by culturally construed blame and othering. People living with HIV/AIDS were perceived as alien and assumed as homosexuals, drug users, or promiscuous. They were labelled 'bad people'. Many participants were compassionate but others struggled with differences between their personal values and professional values expected of a Registered Nurse. There was considerable variation in the degree to which participants were willing to embrace different perspectives and values. CONCLUSION: Nursing curricula is vital to patient health and wellbeing and requires increased focus on the impact of HIV/AIDS. It is important for educators to recognise that simply providing information to students does not necessarily change their existing stigmatising perceptions. By addressing the effect of being stigmatised and marginalised by society nursing care to all patients will be enhanced. Students must also reflect on their perceptions and values so as to embrace diversity.

Diurnal variation of gait in patients with rheumatoid arthritis: The DIVIGN study.

BACKGROUND: Circadian variation of joint stiffness (morning stiffness) and its impact on functional ability are widely recognised in rheumatoid arthritis. Subsequent within-day variation of walking ability is important due to the increased availability of instrumented gait analysis. This study aimed to quantify diurnal variation of gait in patients with rheumatoid arthritis, and explore associations with disease characteristics. METHODS: Thirty one inpatients with rheumatoid arthritis walked at a self-selected speed along a GAITRite instrumented walkway 5 times during a single day. FINDINGS: Participants showed marked diurnal variation in gait, leading to a systematic variation throughout the day (F=19.56, P=<0.001). Gait velocity and stride length both increased, whereas the proportion of each gait cycle spent in stance phase or double support decreased, consistent with improving function throughout the day. Although absolute gait velocity correlated with disease characteristics, the magnitude of diurnal variation appeared to be independent of disease activity (rho=0.26, P=0.15), disease duration (rho=-0.19, P=0.324), and underlying functional ability (rho=0.09, P=0.65). INTERPRETATION: Although morning stiffness is well recognised in rheumatoid arthritis, this is the first time that its effect on gait has been quantified. Patients with rheumatoid arthritis exhibited a systematic change in walking ability throughout the day, which was independent of disease characteristics. These findings have important implications for the interpretation of existing data and the design of future studies. Repeat measures should be conducted at the same time of day to exclude the effects of diurnal variation.

The nurse's role in addressing unmet treatment and management needs of patients with rheumatoid arthritis: Delphi-based recommendations.

PURPOSE: Evaluate nurse's role in management of patients with rheumatoid arthritis (RA). METHODS: Modified Delphi with two rounds of questionnaires, followed by in-person meeting. International group of 12 nurses experienced with RA patients receiving biologic therapy. FINDINGS: Nurses often spend more time with patients than doctors do. Nurse is in unique position to explore patient needs; educate about treatment, administration, product storage, and self-injection technique; determine readiness for and understanding of treatment; monitor safety and progress; and coordinate care within multidisciplinary setting. CONCLUSIONS: Nurse's role is complex and vitally important to optimal RA patient care. Additional nurse involvement may address unmet needs. IMPLICATIONS FOR NURSING PRACTICE: Rheumatology nurses can address unmet patient needs by expanding current roles and by adopting additional functions.

The Nurse's Role in Addressing Unmet Treatment and Management Needs of Patients With Rheumatoid Arthritis: Delphi-Based Recommendations.

PURPOSE: Evaluate nurse's role in management of patients with rheumatoid arthritis (RA). METHODS: Modified Delphi with two rounds of questionnaires, followed by in-person meeting. International group of 12 nurses experienced with RA patients receiving biologic therapy. FINDINGS: Nurses often spend more time with patients than doctors do. Nurse is in unique position to explore patient needs; educate about treatment, administration, product storage, and self-injection technique; determine readiness for and understanding of treatment; monitor safety and progress; and coordinate care within multidisciplinary setting. CONCLUSIONS: Nurse's role is complex and vitally important to optimal RA patient care. Additional nurse involvement may address unmet needs. IMPLICATIONS FOR NURSING PRACTICE: Rheumatology nurses can address unmet patient needs by expanding current roles and by adopting additional functions.

MRI identifies plantar plate pathology in the forefoot of patients with rheumatoid arthritis.

Previous cadaveric studies have suggested that forefoot deformities at the metatarsophalangeal (MTP) joints in patients with rheumatoid arthritis (RA) might result from the failure of the ligamentous system and displacement of the plantar plates. This study aimed to examine the relationship between plantar plate pathology and the rheumatoid arthritis magnetic resonance imaging score (RAMRIS) of the lesser (second to fifth) MTP joints in patients with RA using high-resolution 3 T magnetic resonance imaging (MRI). In 24 patients with RA, the forefoot was imaged using 3 T MRI. Proton density fat-suppressed, T2-weighted fat-suppressed and T1-weighted post gadolinium sequences were acquired through 96 lesser MTP joints. Images were scored for synovitis, bone marrow oedema and bone erosion using the RAMRIS system and the plantar plates were assessed for pathology. Seventeen females and 7 males with a mean age of 55.5 years (range 37-71) and disease duration of 10.6 years (range 0.6-36) took part in the study. Plantar plate pathology was most frequently demonstrated on MRI at the fifth MTP joint. An association was demonstrated between plantar plate pathology and RAMRIS-reported synovitis, bone marrow oedema and bone erosion at the fourth and fifth MTP joints. In patients with RA, 3 T MRI demonstrates that plantar plate pathology at the lesser MTP joints is associated with features of disease severity. Plantar plate pathology is more common at the fourth and fifth MTP joints in subjects with RA in contrast to the predilection for the second MTP reported previously in subjects without RA.

Undergraduate nursing student's attitudes towards caring for people with HIV/AIDS.

The aim of this quantitative study was to determine the attitudes of Australian nursing students towards caring for people with HIV/AIDS. This research study was conducted among second year undergraduate nursing students at a university in South Australia, during August 2007. The survey tool consisted of six demographic questions and the AIDS Attitude Scale. This questionnaire was completed by 396 students, giving a response rate of 94.7%. The vast majority (95.7%) of students participating in this study demonstrated very positive attitudes towards caring for people with HIV/AIDS and only 4.3% demonstrated negative attitudes. No statistically significant differences were found in attitude score based on participants' age, gender, previous HIV/AIDS education, previous nursing experience or previous experience of caring for someone with HIV/AIDS. A statistically significant difference in AIDS attitude score was found in relation to participants' country/region of citizenship, with nursing students from China, East Asia, South East Asia, and Central Asia and Middle East having more negative attitudes than students from other countries/regions. As an increasing number of nursing students have been recruited to Australia from these countries/regions, nurse educators need to be aware of such differences when planning and delivering HIV/AIDS educational programs in tertiary institutions.

Attitudes of nursing students towards caring for people with HIV/AIDS: thematic literature review.

TITLE: Attitudes of nursing students towards caring for people with HIV/AIDS: thematic literature review. AIM: This paper is a report of a literature review conducted to examine current research studies into attitudes of nursing students towards caring for people with HIV/AIDS and to identify factors that influenced those attitudes to inform current nursing practice and to develop nursing education regarding care provided to people with HIV/AIDS. BACKGROUND: Attitudes of nurses towards people living with HIV/AIDS have long been scrutinized. Studies show that some nurses have negative attitudes and are reluctant to provide care to people with HIV/AIDS, resulting in poorer quality nursing support being provided. Attitudes of nursing students towards caring for people with HIV/AIDS is thus of vital importance since they become the future practising nurses. DATA SOURCES: Eight electronic data bases were searched from 1996-2008. REVIEW METHODS: Criteria used for study selection were: attitudes of nursing students towards caring for people with HIV/AIDS, primary research studies, published in English language in peer reviewed journals from 1996 to June 2008. Sixteen studies were identified for inclusion in this thematic review. RESULTS: The following themes were identified: education and knowledge of HIV/AIDS; fear of contracting HIV/AIDS; reluctance to care for people with HIV/AIDS; homophobia; and stigma associated with HIV/AIDS. CONCLUSION: There is reluctance on the part of some nursing students in specific regions of the world to provide care for people with HIV/AIDS. Educational programmes based on research evidence must play a leading role in developing strategies to help nursing students understand and overcome such attitudes.