ISPOR Code of Ethics 2017 (4th Edition)

Santos, Jessica; Palumbo, Francis B.; Molsen-David, Elizabeth; Willke, Richard J.; Binder, Louise; Drummond, Michael; Ho, Anita; Marder, William D.; Parmenter, L.; Sandhu, Gurmit; Shafie, Asrul Akmal; Thompson, David

doi:10.1016/j.jval.2017.10.018

Cited by 17 publications

(13 citation statements)

References 22 publications

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“…In complement, engineers examined peer-reviewed literature of well-studied origins and agents of HD (per case study) as part of engineering ethics. Here, students were introduced to the research code of conduct [18] and its overlap with themes in social science [19], community health and public policy [20]. As per Table 1, the material highlighted how each HD agent related to STEM research and clinical trials [21–26], genetic screening [27–29], engineering technology [30,31], health care policy/access [32,33], quality of care [34–38] and historical societal factors [39–44].…”

Section: Resultsmentioning

confidence: 99%

Engaging Biomedical Engineering in Health Disparities Challenges

Vázquez

2018

J Community Med Health Educ

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Health Disparities (HD) are community-based, biomedical challenges in need of innovative contributions from Science, Technology, Engineering and Math (STEM) fields. Surprisingly, STEM professionals demonstrate a persistent lack of HD awareness and/or engagement in both research and educational activities. This project introduced Health Disparities (HD) as technical challenges to incoming undergraduates in order to elevate engineering awareness of HD. The objective was to advance STEM-based, HD literacy and outreach to young cohorts of engineers. Engineering students were introduced to HD challenges in technical and societal contexts as part of Engineering 101 courses. Findings demonstrate that student comprehension of HD challenges increased via joint study of rising health care costs, engineering ethics and growth of biomedical-related engineering areas.

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Section: Resultsmentioning

confidence: 99%

Engaging Biomedical Engineering in Health Disparities Challenges

Vázquez

2018

J Community Med Health Educ

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“…SML is typically used in market research, but with a rigorous approach using health economics and outcomes research (HEOR) methodologies to assess the value proposition for an intervention, it can also guide patientfocused drug development and patient-centered treatment strategies [14,15]. For example, an SML study of chronic obstructive pulmonary disease found that cough, mucus production, and shortness of breath were the symptoms of greatest concern for patients in terms of disease management [13].…”

Section: Discussionmentioning

confidence: 99%

“…As a retrospective analysis based on posts from publicly available social media sources, no approval from an Institutional Review Board was required or obtained. However, the study was conducted in accordance with International Society for Pharmacoeconomics and Outcomes Research guidelines for studies pertaining to health economics and outcomes research [15].…”

Section: Study Design and Data Sourcesmentioning

confidence: 99%

“…SML has been used to understand patient experiences in other therapeutic areas [12,13], and final 2020 guidelines from the FDA lists social media as an appropriate method for gathering patient input [14]. In addition, the International Society for Pharmacoeconomics and Outcomes Research notes that collecting data from social media sources can help bring attention to the issues that are most relevant to patients and their families [15]. Given the need for more patient-oriented research in TD, this study was conducted to analyze the emotional content of online posts from patients with presumed TD.…”

Section: Introductionmentioning

confidence: 99%

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Patient perspective of tardive dyskinesia: results from a social media listening study

2021

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Background Tardive dyskinesia (TD) is a persistent and potentially disabling movement disorder associated with prolonged exposure to dopamine receptor blocking agents such as antipsychotics. With the expanding use of antipsychotics, research is needed to better understand patient perspectives of TD, which clinical assessments may fail to capture. Social media listening (SML), which is recognized by the US FDA as a method that can advance ongoing efforts for more patient-focused drug development, has been used to understand patient experiences in other disease states. This is the first study to use SML analysis of unsolicited patient and caregiver insights to help clinicians understand how patients describe their symptoms, the emotional distress associated with TD, and the impact on caregivers. Methods In this pilot study, a comprehensive search was performed for publicly available, English-language, online content posted between March 2017 and November 2019 on social media platforms, blogs, and forums. An analytics platform (NetBase™) identified posts containing patient or caregiver experiences of assumed TD using predefined search terms. All posts were manually curated and reviewed to ensure quality and validity of the post and to further classify key symptoms, sentiments, and themes. Results A total of 261 posts from patients/caregivers (“patient insights”) were identified using predefined search terms; 107 posts were used for these analyses. Posts were primarily from forums (47%) and Twitter (33%). Analysis of the most common sentiment-related terms (e.g. “feel” [n = 31], “worse” [n = 17], “symptom” [n = 14], “better” [n = 12]) indicated that 64% were negative, 33% were neutral, and 3% were positive. Theme analysis revealed that patients often felt angry about having TD from a medication used to treat a different condition. In addition, patients felt insecure, including feeling unaccepted by society and fear of being judged by others. Conclusion Although this study was limited by inherent methodological constraints (e.g., small sample size, reliance on patient self-report), the perspectives generated from analyzing social media may help convey the unmet needs of patients with TD. This analysis indicated that movement-related symptoms are the most common patient concern, resulting in strong feelings of anger and insecurity.

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“…As part of ISPOR's Code of Ethics, 43 all members of the task force are asked to share conflict of interest information at the beginning and the end of the process. Additional aspects of the Code of Ethics require all ISPOR members to refrain from publishing or presenting material related to any ISPOR group at any stage without coauthor consultation.…”

Section: How Task Forces Work To Create the Reportmentioning

confidence: 99%

Criteria and Process for Initiating and Developing an ISPOR Good Practices Task Force Report

et al. 2020

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The International Society for Pharmacoeconomics and Outcomes Research (ISPOR)'s "Good Practices Task Force" reports are highly cited, multistakeholder perspective expert guidance reports that reflect international standards for health economics and outcomes research (HEOR) and their use in healthcare decision making. In this report, we discuss the criteria, development, and evaluation/consensus review and approval process for initiating a task force. The rationale for a task force must include a justification, including why this good practice guidance is important and its potential impact on the scientific community. The criteria include: (1) necessity (why is this task force required?); (2) a methodology-oriented focus (focus on research methods, approaches, analysis, interpretation, and dissemination); (3) relevance (to ISPOR's mission and its members); (4) durability over time; (5) broad applicability; and 6) an evidence-based approach. In addition, the proposal must be a priority specifically for ISPOR. These reports are valuable to researchers, academics, students, health technology assessors, medical technology developers and service providers, those working in other commercial entities, regulators, and payers. These stakeholder perspectives are represented in task force membership to ensure the report's overall usefulness and relevance to the global ISPOR membership. We hope that this discussion will bring transparency to the process of initiating, approving, and producing these task force reports and encourage participation from a diverse range of experts within and outside ISPOR.

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ISPOR Code of Ethics 2017 (4th Edition)

Cited by 17 publications

References 22 publications

Engaging Biomedical Engineering in Health Disparities Challenges

Engaging Biomedical Engineering in Health Disparities Challenges

Patient perspective of tardive dyskinesia: results from a social media listening study

Criteria and Process for Initiating and Developing an ISPOR Good Practices Task Force Report

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