Examining the notion of informed consent and lessons learned for increasing inclusion among marginalised research groups

2013 ◽  
pp. 231-241
2021 ◽  
Author(s):  
Shengjie Dong ◽  
Chenshu Shi ◽  
Zhiying Jia ◽  
Minye Dong ◽  
Yuyin Xiao ◽  
...  

BACKGROUND Studies have shown that hospitals or physicians with multiple malpractice claims are more likely to be involved in new claims; this finding indicates that medical malpractice may be clustered by institutions. OBJECTIVE We aimed to identify common factors that contribute to developing interventions to reduce future claims and patient harm. METHODS This study implemented a null hypothesis whereby malpractice claims are random events—attributable to bad luck with random frequency. As medical malpractice is a complex issue, thus, this study applied the complex network theory, which provided the methodological support for understanding interactive behavior in medical malpractice. Specifically, this study extracted the semantic network in 6610 medical litigation records (unstructured data) obtained from a public judicial database in China; they represented the most serious cases of malpractice in the country. The medical malpractice network of China (MMNC) was presented as a knowledge graph; it employs the International Classification of Patient Safety from the World Health Organization as a reference. RESULTS We found that the MMNC was a scale-free network: the occurrence of medical malpractice in litigation cases was not random, but traceable. The results of the hub nodes revealed that orthopedics, obstetrics and gynecology, and emergency department were the three most frequent specialties that incurred malpractice; inadequate informed consent work constituted the most errors. Non-technical errors (e.g. inadequate informed consent) showed a higher centrality than technical errors. CONCLUSIONS Hospitals and medical boards could apply our approach to detect hub nodes that are likely to benefit from interventions; doing so could effectively control medical risks. CLINICALTRIAL Not applicable


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Laura Jadwin-Cakmak ◽  
Sari L. Reisner ◽  
Jaclyn M. W. Hughto ◽  
Liz Salomon ◽  
Miguel Martinez ◽  
...  

Abstract Background In the U.S., transgender and gender diverse (TGD) populations face structural, interpersonal, and individual barriers to healthcare. Less is known, however, about the HIV prevention and treatment experiences of TGD youth in the U.S. The current study was developed to fill this research gap. Methods This article describes the research protocol for a multi-site, U.S.-based mixed-methods study that sought to identify the multi-level facilitators and barriers that influence participation of TGD youth in various stages of the HIV prevention (e.g., pre-exposure prophylaxis uptake) and care continua. A sample of diverse TGD youth ages 16–24 was recruited from 14 U.S. sites. TGD youth participants completed a one-time, in-person visit that included an informed consent process, computer-based quantitative survey, and in-depth qualitative interview assessing experiences accessing HIV prevention and/or care services. Providers serving TGD youth were recruited from the same 14 sites and completed a one-time visit via phone that included informed consent, demographic questionnaire, and in-depth qualitative interview assessing their experiences providing HIV prevention or treatment services to TGD youth. Results Overall, 186 TGD youth ages 16–24 and 59 providers serving TGD youth were recruited and enrolled from across the 14 U.S. sites. TGD youth participants had a mean age of 20.69; 77.3% youth of color; 59.7% trans-feminine; 15.5% trans-masculine; 24.9% non-binary; 53.6% family income under poverty level. Providers included medical and mental health providers as well as case manager/care coordinators, HIV test counselors, and health educators/outreach workers. Providers were 81.3% cisgender and 30.5% people of color. Successes with community-engagement strategies and gender-affirming research methods are reported. Conclusions This study addresses critical gaps in current knowledge about the HIV prevention and care experiences of TGD youth. Findings have implications for the development of HIV interventions across levels to support the health and well-being of TGD youth. Future research is warranted to replicate and expand on lessons learned regarding recruitment and engagement of communities of TGD youth, including longitudinal designs to assess engagement across their developmental stages. Lessons learned working with TGD youth through developing and implementing the study protocol are shared. Trial registration Registered on ClinicalTrials.gov on 05/20/2015 (NCT02449629).


2012 ◽  
Vol 5 (1) ◽  
pp. 624 ◽  
Author(s):  
Heather E Riden ◽  
Kya N Grooms ◽  
Cheryl R Clark ◽  
Laura R Cohen ◽  
Josh Gagne ◽  
...  

Author(s):  
Jamie I. Forrest ◽  
Angeli Rawat ◽  
Felipe Duailibe ◽  
Christina M. Guo ◽  
Sheila Sprague ◽  
...  

In response to the COVID-19 pandemic, clinical research groups across the world developed trial protocols to evaluate the safety and efficacy of treatments for COVID-19. Despite this initial enthusiasm, only a small portion of these protocols were implemented. Of those implemented, a fraction successfully recruited their target sample size to analyze and disseminate findings. More than a year and a half into the COVID-19 pandemic, only a few clinical trials evaluating treatments for COVID-19 have generated new evidence. Productive randomized platform clinical trials evaluating COVID-19 treatments may attribute their success to intentional investments in developing resilient clinical trial infrastructures. Health system resiliency discourse provides a conceptual framework for characterizing attributes for withstanding shocks. This framework may also be useful for contextualizing the attributes of productive clinical trials evaluating COVID-19 therapies. We characterize the successful attributes and lessons learned in developing the TOGETHER Trial infrastructure using a health system resiliency framework. This framework may be considered by clinical trialists aiming to build resilient trial infrastructures capable of responding rapidly and efficiently to global health threats.


2009 ◽  
Vol 19 (10) ◽  
pp. 754-756 ◽  
Author(s):  
Christian J. Apfelbacher ◽  
Adrian Loerbroks ◽  
Uwe Matterne ◽  
Tamara Strassner ◽  
Marion Büttner ◽  
...  

2017 ◽  
Vol 45 (1) ◽  
pp. 51-59 ◽  
Author(s):  
Arthur R. Derse

The Wisconsin Supreme Court, after adopting the doctrine of the objective (reasonable) patient standard, expanded it in bold and innovative ways over nearly four decades, until the Wisconsin legislative and executive branches drastically reversed this course. The saga has implications for other jurisdictions considering adoption or expansion of the objective patient standard doctrine


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Guillaume Marquis-Gravel ◽  
Holly Robertson ◽  
W. Schuyler Jones ◽  
Danielle Riley ◽  
Daniel E. Ford ◽  
...  

Abstract Background New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic “Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)” randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed. Main text ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease. The electronic informed consent form is completed online by the participants at the time of enrollment, and endpoint ascertainment is conducted through queries of electronic health records. IRB challenges encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination in ADAPTABLE are described in this manuscript. The experience of ADAPTABLE encapsulates how pragmatic protocol components intended to facilitate the study conduct have been tempered by unexpected, yet justified concerns raised by local IRBs. How the lessons learned can be applied to future similar pragmatic trials is delineated. Conclusion Development of engaging communication channels between IRB and study personnel in pragmatic randomized trials as early as at the time of protocol design allows to reduce issues with IRB approval. Integrations of the lessons learned in ADAPTABLE regarding the IRB process for centralized IRBs, informed consent, patient engagement, and risk determination can be emulated and will be instrumental in future pragmatic studies.


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