scholarly journals Bringing New Meaning to the Term “Adaptive Trial”: Challenges of Conducting Clinical Research During the Coronavirus Disease 2019 Pandemic and Implications for Implementation Science

2020 ◽  
Vol 7 (11) ◽  
Author(s):  
Westyn Branch-Elliman ◽  
A Rani Elwy ◽  
Paul Monach

Abstract Although implementation of evidence-based practices takes an average of 17 years, in the context of the global pandemic, coronavirus disease 2019 (COVID-19) interventions were adopted in a greatly compressed time frame. This rapid uptake creates major challenges for conducting COVID-19 clinical research studies, because quickly evolving standards make it difficult to adapt in real time. The rapid dissemination and implementation of COVID-19 interventions is the realization of goals long pursued by the implementation science community. However, the downside of the rapid implementation is that low-quality evidence with little to no scientific vetting may be quickly integrated into clinical care, resulting in lost opportunities to advance our scientific understanding about how to manage infected patients. In the future, novel adaptive designs embedded into electronic health records (Embedded Quantified, Integrated-into-Practice Trial [EQuIPT] designs) that allow for easier and better access to clinical trials may simultaneously improve care and advance healthcare innovations.

2018 ◽  
Author(s):  
April Idalski Carcone ◽  
Karin Coyle ◽  
Sitaji Gurung ◽  
Demetria Cain ◽  
Rafael E Dilones ◽  
...  

BACKGROUND The Exploration, Preparation, Implementation, and Sustainment (EPIS) model is an implementation framework for studying the integration of evidence-based practices (EBPs) into real-world settings. The EPIS model conceptualizes implementation as a process starting with the earliest stages of problem recognition (Exploration) through the continued use of an EBP in a given clinical context (Sustainment). This is the first implementation science (IS) study of the integration of EBPs into adolescent HIV prevention and care settings. OBJECTIVE This protocol (ATN 153 EPIS) is part of the Scale It Up program, a research program administered by the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN), described in this issue by Naar et al. The EPIS study is a descriptive study of the uptake of 4 EBPs within the Scale It Up program. The goal of EPIS is to understand the barriers and facilitators associated with the Preparation, Implementation, and Sustainment of EBPs into HIV prevention and clinical care settings. METHODS The EPIS study is a convergent parallel mixed-methods IS study. Key implementation stakeholders, that is, clinical care providers and leaders, located within 13 ATN sites across the United States will complete a qualitative interview conducted by telephone and Web-based surveys at 3 key implementation stages. The Preparation assessment occurs before EBP implementation, Implementation occurs immediately after sites finish implementation activities and prepare for sustainment, and Sustainment occurs 1 year postimplementation. Assessments will examine stakeholders’ perceptions of the barriers and facilitators to EBP implementation within their clinical site as outlined by the EPIS framework. RESULTS The EPIS baseline period began in June 2017 and concluded in May 2018; analysis of the baseline data is underway. To date, 153 stakeholders have completed qualitative interviews, and 91.5% (140/153) completed the quantitative survey. CONCLUSIONS The knowledge gained from the EPIS study will strengthen the implementation and sustainment of EBPs in adolescent prevention and clinical care contexts by offering insights into the barriers and facilitators of successful EBP implementation and sustainment in real-world clinical contexts. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/11202


Author(s):  
Hilary E. Kratz ◽  
Mary L. Phan ◽  
Jacqueline E. Buck ◽  
Kelsey Sanner ◽  
Alexandra R. Tabachnick ◽  
...  

Although a number of trauma treatments for youth have demonstrated efficacy in research settings, the promise of these treatments has not yet been realized via widespread implementation in usual care settings. Implementation science, the scientific study of methods to increase the adoption, uptake, and sustainment of evidence-based practices (EBPs), can help to inform this research-to-practice gap. This chapter applies principles from implementation science to review what has been learned so far about the dissemination and implementation of EBPs for youth impacted by trauma in the United States and the next steps for this field. First, the chapter describes the large-scale efforts that have been made in the United States to disseminate and implement these EBPs. Second, it applies an implementation science framework, the exploration, preparation, implementation, and sustainment framework, to organize what has been learned from these efforts about barriers and facilitators to implementation and sustainability. Third, a case study is presented illustrating how this knowledge was applied to develop a trauma-informed system of care in Philadelphia. Finally, the chapter offers research and practical recommendations to improve the dissemination and implementation of EBPs for trauma-affected youth.


Author(s):  
Ross C. Brownson ◽  
Graham A. Colditz ◽  
Enola K. Proctor

This chapter highlights just a sample of the many rich areas for dissemination and implementation research that will assist us in shortening the gap between discovery and practice, thus beginning to realize the benefits of research for patients, families, and communities. Greater emphasis on implementation in challenging settings, including lower and middle-income countries and underresourced communities in higher income countries will add to the lessons we must learn to fully reap the benefit of our advances in dissemination and implementation research methods. Moreover, collaboration and multidisciplinary approaches to dissemination and implementation research will help to make efforts more consistent and more effective moving forward. Thus, we will be better able to identify knowledge gaps that need to be addressed in future dissemination and implementation research, ultimately informing the practice and policies of clinical care and public health services.


Author(s):  
Ana A. Baumann ◽  
Leopoldo J. Cabassa ◽  
Shannon Wiltsey Stirman

This chapter focuses on adaptations in the context of dissemination and implementation research and practice. Consistent with the existing literature, the authors recommend that adaptations be proactively and iteratively determined, strongly informed by a variety of stakeholders, and that efforts be made to carefully describe and document the nature of the adaptations and evaluate their impact on desired service, health, and implementation outcomes. While this chapter focuses on adaptations to interventions and the context of practice, the authors also note that adaptations may need to be made to implementation strategies. Following the call by Proctor and colleagues for further precision in defining and operationalizing implementation strategies, and based on evidence that scholars are not necessarily reporting what and how they are adapting the interventions, scholars are urged to define and evaluate the adaptations they are making not only to the interventions and context of practice but also to the implementation strategies.


Author(s):  
Gregory A. Aarons ◽  
Joanna C. Moullin ◽  
Mark G. Ehrhart

Both organizational characteristics and specific organizational strategies are important for the effective dissemination and implementation of evidence-based practices (EBPs) in health and allied health care settings, as well as mental health, alcohol/drug treatment, and social service settings. One of the primary goals of this chapter is to support implementers and leaders within organizations in attending to and shaping the context in which implementation takes place in order to increase the likelihood of implementation success and long-term sustainment. The chapter summarizes some of the most critical organizational factors and strategies likely to impact successful evidence-based practice implementation. There are myriad approaches to supporting organizational development and change—this chapter focuses on issues supported by relevant scientific literatures, particularly those germane to EBP implementation in health care and related settings.


2019 ◽  
Vol 8 (4) ◽  
pp. 555 ◽  
Author(s):  
Cátia Caneiras ◽  
Cristina Jácome ◽  
Sagrario Mayoralas-Alises ◽  
José Ramon Calvo ◽  
João Almeida Fonseca ◽  
...  

The increasing number of patients receiving home respiratory therapy (HRT) is imposing a major impact on routine clinical care and healthcare system sustainability. The current challenge is to continue to guarantee access to HRT while maintaining the quality of care. The patient experience is a cornerstone of high-quality healthcare and an emergent area of clinical research. This review approaches the assessment of the patient experience in the context of HRT while highlighting the European contribution to this body of knowledge. This review demonstrates that research in this area is still limited, with no example of a prescription model that incorporates the patient experience as an outcome and no specific patient-reported experience measures (PREMs) available. This work also shows that Europe is leading the research on HRT provision. The development of a specific PREM and the integration of PREMs into the assessment of prescription models should be clinical research priorities in the next several years.


Author(s):  
Jeremy Smelt ◽  
Gowthanan Santhirakumaran ◽  
Paul Vaughan ◽  
Ian Hunt ◽  
Carol Tan

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a novel coronavirus primarily affecting the respiratory system, was initially diagnosed in Wuhan, China, in late 2019. Identified as coronavirus disease 2019 (COVID-19) by the World Health Organization, the virus rapidly became a global pandemic. The effects on health care worldwide were unprecedented as countries adapted services to treat masses of critically ill patients.The aim of this study is to analyze the effect that the COVID-19 pandemic had on thoracic surgery at a major trauma center during peak prevalence. Methods Prospective unit data were collected for all patients who underwent thoracic surgery during March 2020 until May 2020 inclusive. Retrospective data were collected from an earlier comparable time period as a comparison. Results In the aforementioned time frame, 117 thoracic surgical operations were performed under the care of four thoracic surgeons. Six operations were performed on three patients who were being treated for SARS-CoV-2. One operation was performed on a patient who had recovered from SARS-CoV-2. There were no deaths due to SARS-CoV-2 in any patient undergoing thoracic surgery. Conclusion This study demonstrates that during the first surge of SARS-CoV-2, it was possible to adapt a thoracic oncology and trauma service without increase in mortality due to COVID-19. This was only possible due to a significant reduction in trauma referrals, cessation of benign and elective work, and the more stringent reprioritization of cancer surgery. This information is vital to learn from our experience and prepare for the predicted second surge and any similar future pandemics we might face.


2021 ◽  
Author(s):  
Aristides Moustakas

Abstract Disease spread is a complex phenomenon requiring an interdisciplinary approach. Covid-19 exhibited a global spatial spread in a very short time frame resulting in a global pandemic. Data of new Covid-19 cases per million were analysed worldwide at the spatial scale of a country and time replicated from the end of December 2019 to late May 2020. Data driven analysis of epidemiological, economic, public health, and governmental intervention variables was performed in order to select the optimal variables in explaining new Covid-19 cases across all countries in time. Sequentially, hierarchical variance partitioning of the optimal variables was performed in order to quantify the independent contribution of each variable in the total variance of new Covid-19 cases per million. Results indicated that from the variables available new tests per thousand explained the vast majority of the total variance in new cases (51.6%) followed by the governmental stringency index (15.2%). Availability of hospital beds per 100k inhabitants explained 9% extreme poverty explained 8.8%, hand washing facilities 5.3%, the fraction of the population aged 65 or older explained 3.9%, and other disease prevalence (cardiovascular diseases plus diabetes) explained 2.9%. The percentage of smokers within the population explained 2.6% of the total variance, while population density explained 0.6%.


Author(s):  
Morinne Osborne, B.S. ◽  
Emily Boniface, M.P.H. ◽  
Marcella Messerle Forbes, N.P. ◽  
Jeffrey Jensen

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