A scoping review of nurse-led randomised controlled trials

Background: Nurses comprise the largest portion of the healthcare workforce worldwide. However, nurse representation in the leadership of clinical research and research funding is largely unknown. The Australasian Nursing and Midwifery Clinical Trials Network was established to provide a coordinated network, focussed on building research capacity in nursing and midwifery. To support this work, this scoping review of nurse-led randomised controlled trials was conducted to summarise research activity, as well as highlight future research directions, gaps and resources. Midwife-led trials will be reported elsewhere. Aim: To quantify number, type and quality of nurse-led randomised controlled trials registered between 2000–2021. Design: A scoping review of RCTs. Data Sources: Medline, Emcare and Scopus were searched from 2000 to August 2021. ANZCTR, NHMRC, MRFF and HRC (NZ) registries were searched from inception to July 2021. Review Methods: This review was informed by the JBI scoping review framework using the PRISMA-ScR. Results: Our search yielded 186 nurse-led publications and 279 registered randomised controlled trials. Multiple trials had the same nurse leaders. There were more registrations than publications. Publications were predominantly of high methodological quality; however, there was a reliance on active controls and blinding low. Trial registrations indicate that universities and hospital/healthcare organisations were the major sources of funding, while publications indicate that Governments and the National Health and Medical Research Council were the main funding bodies. Conclusion: A small number of high-quality, large-scale, nationally funded randomised controlled trials were identified, with a larger number of locally funded small trials. There was a disparity between the number of registered trials and those published. Additional infrastructure, funding and career frameworks are needed to enable nurses to design, conduct and publish clinical trials that inform the health system and improve health outcomes. Relevance to Clinical Practice: Research initiated and led by nurses has the potential to improve the health and well-being of individuals and communities, and current nurse-led research is of high methodological quality; however, there were very few nurse-led RCTs, conducted by a small pool of nurse researchers. This gap highlights the need for support in the design, conduct and publishing of nurse-led RCTs. Patient or Public Contribution: This is a scoping review; therefore, patient or public contribution is not applicable

Midwife led randomised controlled trials in Australia and New Zealand: A scoping review

Background: Midwives are the largest workforce involved in caring for pregnant women and their babies, and are well placed to translate research into practice and ensure midwifery priorities are appropriately targeted in researched. Currently, the number and focus of randomised controlled trials led by midwives in Australia and New Zealand is unknown. The Australasian Nursing and Midwifery Clinical Trials Network was established in 2020 to build nursing and midwifery research capacity. To aid this, scoping reviews of the quality and quantity of nurse and midwife led trials were undertaken. Aim: To identify midwife led trials conducted between 2000 and 2021 in Australia and New Zealand. Methods: This review was informed by the JBI scoping review framework. Medline, Emcare, and Scopus were searched from 2000-August 2021. ANZCTR, NHMRC, MRFF, and HRC (NZ) registries were searched from inception to July 2021. Findings: Of 26,467 randomised controlled trials registered on the Australian and New Zealand Clinical Trials Registry, 50 midwife led trials, and 35 peer-reviewed publications were identified. Publications were of moderate to high quality with scores limited due to an inability to blind participants or clinicians. Blinding of assessors was included in 19 published trials. Discussion: Additional support for midwives to design and conduct trials and publish findings is required. Further support is needed to translate registration of trial protocols into peer reviewed publications. Conclusion: These findings will inform the Australasian Nursing and Midwifery Clinical Trials Network plans to promote quality midwife led trials

Harnessing the nursing and midwifery workforce to boost Australia\u27s clinical research impact

For the Medical Research Future Fund (MRFF) to achieve its full impact, it is necessary for health practitioners to be trained and reliably funded to deliver research and translation alongside their clinical work. We offer insight into current systems, concerns and suggestions as this applies to clinical research in nursing and midwifery. Nurses and midwives globally have a long record of delivering high quality clinical research that improves care and outcomes. An analysis of four landmark nursing-led studies in the United States illustrates the value-adding potential of such research: for every grant dollar, the return on investment ranged from $202 to$1206. In Australia, investment in nursing- and midwifery-led research also pays dividends for health care costs and population and health system outcomes, as evidenced from the many research contributions of Australian nurses and midwives over the past decade (Box)

Understanding implementability in clinical trials : a pragmatic review and concept map

Background The translation of evidence from clinical trials into practice is complex. One approach to facilitating this translation is to consider the 'implementability' of trials as they are designed and conducted. Implementability of trials refers to characteristics of the design, execution and reporting of a late-phase clinical trial that can influence the capacity for the evidence generated by that trial to be implemented. On behalf of the Australian Clinical Trials Alliance (ACTA), the national peak body representing networks of clinician researchers conducting investigator-initiated clinical trials, we conducted a pragmatic literature review to develop a concept map of implementability. Methods Documents were included in the review if they related to the design, conduct and reporting of late-phase clinical trials; described factors that increased or decreased the capacity of trials to be implemented; and were published after 2009 in English. Eligible documents included systematic reviews, guidance documents, tools or primary studies (if other designs were not available). With an expert reference group, we developed a preliminary concept map and conducted a snowballing search based on known relevant papers and websites of key organisations in May 2019. Results Sixty-five resources were included. A final map of 38 concepts was developed covering the domains of validity, relevance and usability across the design, conduct and reporting of a trial. The concepts drew on literature relating to implementation science, consumer engagement, pragmatic trials, reporting, research waste and other fields. No single resource addressed more than ten of the 38 concepts in the map. Conclusions The concept map provides trialists with a tool to think through a range of areas in which practical action could enhance the implementability of their trials. Future work could validate the strength of the associations between the concepts identified and implementability of trials and investigate the effectiveness of steps to address each concept. ACTA will use this concept map to develop guidance for trialists in Australia

Keratinocyte cancers in South Australia: incidence, geographical variability and service trends

Abstract Objectives: To determine the incidence, multiplicity, geographical variability and service trends of keratinocyte cancers (KC) in South Australia (SA). Methods: Medicare Australia data with a unique identifier were used to assess the number of people treated over years 2010–2014. A maximum of one KC service claim per year was used to determine incidence. Age‐standardised rates were estimated as were KC service activity trends. Results: There were 497,581 services to 204,183 SA residents for KC, solar keratoses, locally aggressive skin tumours or suspicious skin lesions. Of these, n=159,137 services were for KC (77,502 people). The five‐year (2010–2014) age‐standardised rate of KC in SA was 1,466.6 (95%CI 1,458.3‐1,474.8) per 100,000. Forty per cent of people had more than one KC removed. Men accounted for more incident cases (59.2%). Age‐specific rates showed least variability over time in the youngest age group (15–44 years). For 26 geographical areas, higher age‐standardised ratios of KC were seen in coastal and agricultural areas. There was a 59% increase in services for KC from 2000 to 2015. Conclusions: Age‐standardised rates for KC are relatively stable in SA, but regional variations are evident. Services for KC continue to rise. Implications for public health: This is the first systematic report of KC in SA. We demonstrate the utility of using validated Medicare data for assessing KC incidence and trends

Barriers to Seeking Help for Skin Cancer Detection in Rural Australia

This study explores rural South Australians’ barriers to help-seeking for skin cancer detection. A total of 201 randomly selected rural adults (18–94 years, 66% female) were presented with a skin-cancer-related scenario via telephone and were asked the extent to which various barriers would impede their help-seeking, based on an amended version of the Barriers to Help-Seeking Scale. Older (≥63 years) and less educated participants endorsed barriers more strongly than their younger, more educated counterparts in the following domains; “Concrete barriers and distrust of caregivers”, “Emotional control”, “Minimising problem and Normalisation”, “Need for control and self-reliance” (every domain other than “Privacy”). Socioeconomic disadvantage, gender, and farmer status did not predict stronger overall barriers, but some gender and occupation-related differences were detected at the item level. Farmers were also more likely to endorse the “Minimising problem and normalization” domain than their non-farmer working rural counterparts. Widely endorsed barriers included the tendency to minimise the problem, a desire to remain in control/not be influenced by others, reluctance to show emotion or complain, and having concerns about privacy or waiting times

Establishing and Sustaining a Culture of Evidence-Based Practice: An Evaluation of Barriers and Facilitators to Implementing the Best Practice Spotlight Organization Program in the Australian Healthcare Context

Background: Nurses and midwives are central to the implementation and delivery of quality care through evidence-based practice (EBP). However, implementation of EBP in nursing and midwifery is under-researched with few examples of systematic and sustained change. The Registered Nurses Association of Ontario’s Best-Practice Spotlight Organization (BPSO) Program was adopted in South Australia as a framework to systematically implement EBP in two diverse and complex healthcare settings. Methods: The study was a post-implementation, mixed-method evaluation conducted at two healthcare settings in Adelaide, South Australia utilizing qualitative and quantitative data. Proctor’s implementation evaluation framework guided the evaluation design. Information sources included; interviews, focus groups, questionnaires, and document review. Results: Clinical and executive staff (n = 109 participants) from a broad range of stakeholder groups participated in the interviews, focus groups, and returned questionnaires. A number of facilitators directly affecting program implementation were identified; these pertained to embedding continuity into the program’s implementation and delivery, a robust governance structure, and executive sponsorship. Barriers to implementation were also identified. These barriers pertained to organizational or workforce challenges; staff turnover and movement (e.g., secondment), insufficient staff to allow people to attend training, and a lack of organizational commitment to the program, especially at an executive level. As a result of successful implementation, it was observed that over three years, the BPSO program positively influenced the uptake and implementation of EBP by clinicians and the organizations into which they were introduced. Conclusions: The BPSO model can be translocated to new healthcare systems and has the potential to act as a mechanism for establishing and sustaining EBP change. This study was the first to apply an implementation evaluation framework to the BPSO program, which allowed for structured analysis of facilitating or impeding factors that affected implementation success. The findings have important implications for other health systems looking to translocate the same or similar EBP programs, as well as contributing to the growing body of implementation evaluation literature

Gout prevalence and predictors of urate-lowering therapy use: results from a population-based study

Abstract Background Gout has an increasing global prevalence. Underutilization of urate-lowering therapy (ULT) is thought to be common, via both suboptimal dosing and poor medication adherence. The aims of this study were to determine the prevalence of self-reported gout and the key predictors of ULT use in those with gout in a representative population survey in South Australia. Methods Data were obtained from the Spring 2015 South Australian Health Omnibus Survey, a multilevel, systematic, survey in a representative population sample involving face-to-face interviews (n = 3005). This study analyzed responses from respondents aged ≥ 25 years (n = 2531) about self-reported gout, ULT use, sociodemographic factors, lifestyle factors, and comorbidities, using survey weighting. Univariate and subsequent adjusted logistic regression analyses on self-reported gout were performed. ULT use was divided into three categories (never use, prior use, and current use) and these data were analyzed using a multinomial logistic regression model. Results Self-reported gout prevalence was 6.8% (95% CI 5.8, 7.9). The mean age of respondents with gout was 64 years (standard deviation 16) and 82% were male. As expected, older age, male gender, lower socioeconomic status (SES), and higher body mass index (BMI) were associated with gout, as were high alcohol consumption, current smoking, other forms of arthritis, and hypertension or hypercholesterolemia medication, after adjustment for sociodemographic variables. Two thirds of respondents with gout reported ULT use (36% current; 29% previous) with only 55% continuing treatment. Predictors of ULT use included male gender, low SES, and concomitant cholesterol-lowering therapy. Respondents with gout with a higher BMI were more likely to remain on ULT. Conclusions Despite gout being a common, potentially disabling joint disease, only 55% of respondents with gout in this study adhered to ULT. Identification of key predictors of ULT use will provide guidance on prescribing strategy in clinical practice and on the quality of gout care in the community

Nurse- and midwife-led trials in Australia and New Zealand : Scoping review protocol

Background: Research led by nurses or midwives has the potential to successfully address current issues in clinical care. High-quality randomised controlled trials are needed to inform evidence-based practice; however, nursing and midwifery research has commonly been nonexperimental. Two connected scoping reviews of nurse- and midwife-led randomised controlled trials within Australia and New Zealand will be conducted to highlight potential research directions and identify resources for future research. Aim: The purpose of the two reviews is to map the number and types of randomised controlled trials led by nurses or midwives within Australia and New Zealand. Methods: The concept of interest is randomised controlled trials with a lead principal investigator holding nursing or midwifery credentials. The lead principal investigator must report an institutional affiliation in Australia or New Zealand, and the trial must recruit at a minimum of one site in Australia or New Zealand. Searches for academic literature will be conducted using Pubmed, Emcare, and Scopus. Sources for grey literature will include the Australian New Zealand Clinical Trials Registry, and grant outcomes published by the National Health and Medical Research Council, Medical Research Future Fund, and Health Research Council of New Zealand. Data analysis and presentation will be conducted separately for each review. Discussion: These reviews will comprehensively map the experimental research activity of nurses and midwives within Australia and New Zealand and highlight potential research directions. From this, strategies to facilitate high quality nurse- and midwife-led trials can be developed, which are vital for informing evidence-based practice.</p