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Establishing comparability between measured outcomes in clinical trials poses a significant obstacle for systematic reviewers. Core outcome sets (COSs) were developed to address this issue. The macular degeneration (MD) COS is designed to standardise outcome measurement across clinical trials for MD. This study investigates the uptake of the MD COS in standardising outcome measurement across clinical trials.
Cross-sectional analysis
We conducted a search on ClinicalTrials.gov to locate MD clinical trials that were registered 5 years prior to COS publication through the search date of 26 June 2023 and obtained a pool of 2152 registered studies. After applying various inclusion and exclusion criteria, we analysed 159 trials. We then analysed the COS uptake using an interrupted time series analysis (ITSA) and performed performed analyses of variance (ANOVAs) and Pearson correlations to evaluate associations between trial characteristics and outcome measurement.
ITSA showed no significant change in uptake following the MD COS (2016): mean percentage of completion of the COS increased by 0.24% per month before publication (p=0.27) and by 0.07% per month after publication (p=0.62), indicating no meaningful post-publication slope change in COS use. For context, visual acuity was most commonly measured, while several patient-reported and disutility domains were infrequently captured.
No discernible patterns in COS usage for MD trials were observed. We recommend further collaboration between regulators and COS developers to help with COS uptake. Additionally, we suggest that further studies analyse adherence to COSs in respect to regulatory recommendations.
To identify the proportion of Advanced Practice Nurses' workload that takes place virtually in the delivery of direct patient care.
An observational study was conducted for this research.
An overt non-participatory time and motion study was undertaken using a predefined data collection tool to identify the activities of the study participants, and the mode used for delivery of the activities identified.
Fourteen Advanced Practice Nurses were observed. A total of 5190 min of observation time was conducted. The time participants were observed delivering direct patient care virtually (care delivered without in-person contact) was recorded in minutes and calculated as a percentage of their overall observation time. The proportion of time recorded in the delivery of virtual direct patient care was calculated as 22% of participants' work time. The primary modes of telecommunication technologies used in this research were landline telephones and desktop computers. The most frequently performed direct patient care activity was gathering and interpreting assessment data to formulate a plan of care.
This is the first research to calculate the proportion of Advanced Practice Nurses' time that is spent delivering direct patient care virtually. The findings indicate that a substantial proportion of Advanced Practice Nurse time is spent delivering virtual care.
No patient or public contribution in this research.
Implications for the profession and/or patient care.
What problem did the study address? There is an increase in the digitalisation of healthcare delivery, resulting in virtual care provided by nurses. It is therefore important to explore what and how much virtual care is delivered by Advanced Practice Nurses in Ireland. The study calculated the proportion of Advanced Practice Nurses' time spent in the delivery of virtual direct patient care. What were the main findings? A significant volume of work is conducted virtually. It should be conducted in a secure environment using secure devices. The nurses conducting virtual direct patient care ought to be adequately resourced with appropriate technology supported by electronic recording of care delivered to ensure accurate communication between healthcare professionals. Education for nurses conducting virtual work should be provided from the outset. Where and on whom will the research have an impact? The research will impact nurse leaders by providing them evidence of the delivery of virtual direct patient care by nurses. This leads to an opportunity to explore funding models where direct patient care is delivered yet unseen. There is a requirement to provide nurses with the necessary equipment to support the delivery of virtual patient care. Further research is recommended on the virtual role of nurses in healthcare delivery.
The STROBE cross-sectional guidelines were followed to report the research.
This article on realist reviews is the second in a four-part series on realist research.
Realist reviews (or realist evidence syntheses) are a theory-building, interpretative approach to evidence synthesis. Realist reviews aim to go beyond seeking whether interventions work (ie, are effective), to generating explanations as to...
This article is the first in a series exploring realist research, a methodological approach well suited to the complexity of nursing practice. Unlike traditional approaches such as randomised controlled trials (RCTs) and systematic reviews, which focus on whether interventions work, realist research examines how and why interventions work when implemented in specific groups; reflecting the individualised care nurses provide. By introducing the key concepts of realist research, this article highlights its relevance to nursing and lays the groundwork for using realist research to drive meaningful improvements in healthcare.
Realist research offers a unique lens to examine the complexity of healthcare delivery. While traditional research methods often seek to determine if interventions work or not in controlled environments, realist research seeks to explain how, why, for whom and under what circumstances interventions succeed—or fail—in real-world settings.
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