Assessing Perspectivalism in Patient Participation: An Evaluation of FDA Patient and Consumer Representative Programs

Graham, S. Scott; Kessler, Molly M.; Kim, Sang-Yeon; Ahn, Seokhoon; Card, Daniel

doi:10.5744/rhm.2018.1006

Cited by 8 publications

(3 citation statements)

References 37 publications

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“…Measures such as shared decision-making, use of decision aids, consumer representatives, and application of electronic and Internet-based facilities have been proposed. [21][22][23][24] Successful PE, however, will depend on the approach taken and contextual factors, including barriers such as cost, organizational culture, and population-specific restrictions, as well as structural facilitators such as government support. 25 There is a need to help patients make the best choice of hospital beyond the geographical limits.…”

Section: Discussionmentioning

confidence: 99%

Qualitative Comparison of Perceptions Regarding Patient Engagement for Patient Safety by Physicians, Nurses, and Patients

Jang,

Ock,

Kim

2024

PPA

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Patient engagement in ensuring patient safety is widely acknowledged, there is still a need to explore how perceptions of patient engagement vary among different stakeholders within the healthcare system. We aimed to compare the perceptions regarding patient engagement for patient safety among physicians, nurses, and patients by exploring the perspectives. Patients and Methods: A qualitative study, comprising three focus group discussions (six to eight people each), was conducted in South Korea. Physicians and nurses who worked at the general hospital level or higher, and patients who had been hospitalized for more than 24 hours, were included. Researchers analyzed the transcripts, and a content analysis was performed to describe influencing elements of patient engagement for patient safety. A word cloud was created through keyword analysis of the transcripts. Results: Based on 479 coded data, three categories and eight sub-categories were derived. The first moment of patient engagement was viewed as the choice of medical institutions. Reputation occupied a large part in the hospital selection for all participants, but they did not know about or use the national hospital evaluation data. Participants said that continuous patient engagement, such as the patient's active questioning attitude, guardian's cooperation, sufficient medical personnel, and patient safety education was required during treatment. However, it was said that patient engagement was ignored after patient safety incidents occurred. They mentioned that they were emotional and busy arguing for their own positions, and that it was difficult to use a medical dispute resolution method in practice. In the word cloud by group, fall, explanation, hospital, and patient were common words. Conclusion: All three groups agreed on the importance of patient engagement for patient safety but differed in its influencing factors. Efforts should be made to reduce the difference between the three groups on how to involve patients for patient safety. Plain Language Summary:To what extent can patient engagement for patient safety be expanded?In this study, we confirmed the diverse perceptions of patients and medical personnel regarding patient engagement for patient safety. Physicians, nurses, and patients all answered that they did not generally know about the objective medical institutions evaluation data provided by the national, and said that when choosing a medical institution, patients depended on information from their reputation, social media, and web site search. During treatment, both patients and medical personnel expressed their hopes for active and independent engagement from patients, but also expressed the difficulty of requesting cooperation in engagement and difficulties in education. After the patient safety incident, both patients and medical personnel were emotional and occupied in asserting their respective positions, and they complained about difficulties in resolving medical disputes that are difficult to use in practice.

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Section: Discussionmentioning

confidence: 99%

Qualitative Comparison of Perceptions Regarding Patient Engagement for Patient Safety by Physicians, Nurses, and Patients

Jang,

Ock,

Kim

2024

PPA

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“…It is therefore foreseeable that if sponsors avail of an advisory committee under this new framework that the agency would, consistent with its current practices, use that as a public forum for hearing and trying to attend to patient interests. The new law's allowance for an advisory committee to be convened may, in other words, amount to a public hearing wherein the agency is likely to struggle to balance meaningful and inclusive participation from those impacted by its decision 91 with its core function of ensuring the safety and efficacy of drugs. 92 A more optimal way to proceed given the vexed nature of withdrawals would be to take the decision out of FDA's hands altogether.…”

Section: Withdrawal Challenges In the Face Of Sponsor And Patient Opp...mentioning

confidence: 99%

Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform

Herder

2023

J. Law. Med. Ethics

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The US Food and Drug Administration’s controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer’s disease, has motivated multiple policy reforms. Drawing a case series of other drugs granted accelerated approval and interviews of senior FDA officials, I argue that reform should be informed but not defined by aducanumab. Rather, structural reforms are needed to reshape FDA’s core priorities and restore the regulatory system’s commitment to scientific rigor.

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“…Their entry draws on their critiques of the writing and argument quality in these reports and suggestions for better documentation processes. In a related setting, Graham, Kessler, Kim, Ahn, and Card (2018) observed that efforts to expand patient participation in FDA expert advisory boards ironically often “further marginalize” their opinions (p. 59). These observations highlight the essential function of expert discourses.…”

Section: Connecting To Technical Communicationmentioning

confidence: 99%

Invention Questions for Intercultural Understanding: Situating Regulatory Medical Narratives as Narrative Forms

DeTora

Klein

2020

Journal of Technical Writing and Communication

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Patient safety narratives are a globally mandated format for representing individual patient experiences, and they include peer-reviewed case reports and narrative medicine. The authors show how the humanistic values described by Carolyn Miller in 1979 could enhance or contribute to international health and medical communication in relation to such narratives. They do so by expanding on twenty-first century work by Bowdon and Scott to provide a framework for considering how narrative competence and narrative humility may allow technical communicators to strengthen their practices within technical communication and the rhetorics of health and science by examining an individual problem within its broader, intercultural contexts.

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Assessing Perspectivalism in Patient Participation: An Evaluation of FDA Patient and Consumer Representative Programs

Cited by 8 publications

References 37 publications

Qualitative Comparison of Perceptions Regarding Patient Engagement for Patient Safety by Physicians, Nurses, and Patients

Qualitative Comparison of Perceptions Regarding Patient Engagement for Patient Safety by Physicians, Nurses, and Patients

Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform

Invention Questions for Intercultural Understanding: Situating Regulatory Medical Narratives as Narrative Forms

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