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How can health economics be used in the design and analysis of adaptive clinical trials? A qualitative analysis
Introduction
Adaptive designs offer a flexible approach, allowing changes to a trial based on examinations of the data as it progresses. Adaptive clinical trials are becoming a popular choice, as the prudent use of finite research budgets and accurate decision-making are priorities for healthcare providers around the world. The methods of health economics, which aim to maximise the health gained for money spent, could be incorporated into the design and analysis of adaptive clinical trials to make them more efficient. We aimed to understand the perspectives of stakeholders in health technology assessments to inform recommendations for the use of health economics in adaptive clinical trials.
Methods
A qualitative study explored the attitudes of key stakeholders—including researchers, decision-makers and members of the public—towards the use of health economics in the design and analysis of adaptive clinical trials. Data were collected using interviews and focus groups (29 participants). A framework analysis was used to identify themes in the transcripts.
Results
It was considered that answering the clinical research question should be the priority in a clinical trial, notwithstanding the importance of cost-effectiveness for decision-making. Concerns raised by participants included handling the volatile nature of cost data at interim analyses; implementing this approach in global trials; resourcing adaptive trials which are designed and adapted based on health economic outcomes; and training stakeholders in these methods so that they can be implemented and appropriately interpreted.
Conclusion
The use of health economics in the design and analysis of adaptive clinical trials has the potential to increase the efficiency of health technology assessments worldwide. Recommendations are made concerning the development of methods allowing the use of health economics in adaptive clinical trials, and suggestions are given to facilitate their implementation in practice
Standardizing STI Screening in Child Sexual Abuse Cases at the CARES Institute
Children who are sexually abused have a higher risk of contracting STIs and/or becoming pregnant. CDC STI testing guidelines should be adhered to in order to provide the safest outcomes for patients. Physician compliance with testing guidelines plays a significant role in ensuring patient safety, which highlights the importance of ensuring high physician compliance. Identifying ways physicians can improve compliance can enhance patient care. In order to determine compliance rates of the CARES Institute physicians, data was extracted from 275 patient charts from 2017 and 100 patients charts from 2021, before and after a continuing medical education (CME) training was provided to CARES physicians. Statistical analyses were performed on these sets of data to determine compliance rates. A second CME training including conclusions from these analyses was provided to CARES physicians in 2023. Data collection and analysis from new 2023 patient statuses is currently in progress. Results from analysis of the 2017 and 2021 data showed an increase in compliance rates from 2017 to 2021. This highlights the potential benefit of physician education to increasing physician adherence to STI testing protocol. Further physician education is still necessary to reach higher rates of compliance. Future studies can focus on identifying commonly non-documented risk factors for STIs and determining ways to improve documentation
Creating Technology-enhanced Practice: A University-Home Care-Corporate Alliance
Insuring full benefit of consumer health informatics innovations requires integrating the technology into nursing practice, yet many valuable innovations are developed in research projects and never reach full integration. To avoid this outcome, a team of researchers partnered with a home care agency’s staff and patients and their corporate parent’s Information Systems and Research group to create a Technology-Enhanced Practice (TEP) designed to enhance care of home bound patients and their family care givers. The technology core of TEP, the HeartCare2 web site, was built in a collaborative process and deployed within the existing patient portal of the clinical partner. This paper describes the innovation and the experience of bringing it into full operation
Investigation of Emergency Department Visits and Hospitalization Rates of Child Physical Abuse at Cooper University Hospital Prior to and During the COVID-19 Pandemic
The COVID-19 pandemic has been detrimental for children. Many families have experienced stressors, including unemployment, financial hardship, and familial illness. These factors all pose increased risk for child physical abuse. Limitations in child welfare services affected investigations and provision of services to high-risk families. The extent to which the rates of physical abuse in NJ have been affected is unknown. We sought to answer the question of whether the COVID-19 pandemic affected the severity of physical abuse and the incidence of physical abuse presenting to Cooper University Hospital.
We hypothesized that there would be a higher proportion of severe child physical abuse cases presenting to the hospital during the COVID-19 pandemic as compared to prior to the pandemic
Providing support in a time of crisis: An investigation into how Educational Psychologists in the UK respond to a death by suicide within the school community
A key part of the Educational Psychologists role is to respond to school community critical incidents, including death by suicides. The number of suicides in young people under 25 years old is steadily increasing across the United Kingdom and many of those bereaved by a suicide will be in education. It is therefore an important issue to research to gain an understanding of EPs work in this area. The aim of this research was to investigate how EPs are responding to a school community death by suicide and their experience of this. The research used a mixed methods design combining a national survey, to gather an understanding of the scope of practice and experience of EPs, with semi-structured interviews to gather a more in-depth understanding of EPs experience in responding to this kind of incident. The survey received 76 responses from EPs and the researcher interviewed 5 of these. The survey data was analysed using descriptive statistics and the interview data was analysed using a Grounded Theory approach. The findings showed that the most common form of support EPs provide to schools is face to face consultations and support around the correct language to use when discussing suicide. The most common form of support EPs receive included co-working with a colleague and individual debriefs. The Grounded Theory analysis produced 15 axial codes leading to the overarching theory of ‘Containment Across and Within the System’. This study shows that there are multiple systems involved in responding to a death by suicide that the EPs provide containment to and receive containment from. Implications for practice and directions for future research are considered and discussed
Optimization of Simulated Electronic Medication Administration for Safe Management During Nursing Education
Background: Academic institutions have begun to implement electronic medication administration record (eMAR) technologies into simulated education for undergraduate nursing students. As these technologies are adopted, there is an increasing need to develop insights toward optimal medication administration practices, including the decision-making processes undertaken by nursing students.
Research Question: How do nursing students generate optimized medication administration processes using eMAR technology in simulated clinical practice?
Method: This study is underpinned by the theoretical lens of interdependent, cooperative Game Theory. Primary data collection was conducted using direct participant observation of nursing students administering medications using a simulated eMAR system and a semi-structured interview following the observation. The participants reacted to different scenarios that challenged the College of Nurses of Ontario’s medication administration heuristic of Clear, Complete, and Appropriate. Findings were individually and collectively summarized, including detailed descriptions of the participants’ actions and decision-making processes, visualized on Game Theory-informed payoff matrices.
Findings: A number of different findings were uncovered in this study. The repeated occurrence of a no relationship interaction between the student and eMAR; the inappropriate use of the Medication Rights heuristic during the administration process; and, the inherent trust in the eMAR system to be correct or assist in situations of uncertainty.
Conclusion: New insights into the complex relationships created between nursing students and an eMAR system have been explored. The dynamic relationship between eMAR administration best practice principles and process efficiency warrants further examination
Identifying Potential Target Beliefs for a Mass Media Campaign Aimed at Preventing Progression to Daily Tobacco Use: Final Findings and Recommendations for 18 – 25 Year Old Non-Daily Tobacco Users
Technology-Enhanced Practice for Patients with Chronic Cardiac Disease: Home Implementation and Evaluation
Objective: This 3-year field experiment engaged 60 nurses and 282 patients in the design and evaluation of an innovative home-care nursing model, referred to as technology-enhanced practice (TEP).
Methods: Nurses using TEP augmented the usual care with a web-based resource (HeartCareII) that provided patients with self-management information, self-monitoring tools, and messaging services.
Results: Patients exposed to TEP demonstrated better quality of life and self-management of chronic heart disease during the first 4 weeks, and were no more likely than patients in usual care to make unplanned visits to a clinician or hospital. Both groups demonstrated the same long-term symptom management and achievements in health status.
Conclusion: This project provides new evidence that the purposeful creation of patient-tailored web resources within a hospital portal is possible; that nurses have difficulty with modifying their practice routines, even with a highly-tailored web resource; and that the benefits of this intervention are more discernable in the early postdischarge stages of care
Identifying Potential Target Beliefs for a Mass Media Campaign Aimed at Encouraging Smoking Cessation: Final Findings and Recommendations for 18 – 25 Year Old Current Cigarette Smokers
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