How to Make an Impact on Healthcare Decision Making? Develop an ISPOR Good Practices Task Force Proposal
Marc L. Berger, MD, ISPOR Special Advisor for Real World Evidence
Editor's Note: As Value & Outcomes Spotlight evolves into a more digitally focused magazine, we will be introducing complementary online content, and we begin that transformation with a video interview that is a companion piece to this article. In the video interview, Editor-in-Chief Zeba Khan spoke to Dr Berger about his work on ISPOR task forces, his long illustrious career, and even offered some advice for new professionals. That conversation is featured in the accompanying video, which you can access here.
The Value and Importance of ISPOR Good Practices Task Force Reports
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. From 2003 through 2019, ISPOR has published more than 60 Good Practices Task Force Reports covering a variety of methods, including patient preference measurement, indirect treatment comparisons and network meta-analyses, prospective and retrospective observational studies, decision analytic modeling, economic evaluation, and clinical outcomes assessment.
These reports have been cited by regulatory and health technology assessment agencies in the United States, Canada, Germany, France, The Netherlands, Brazil, and others. Other organizations, such as the Academy of Managed Care Pharmacy, European Network for Health Technology Assessment, the US Food and Drug Administration (FDA), and the Equator Network cite multiple ISPOR Good Practices Task Force Reports. Furthermore, the Journal of the American Medical Association (JAMA) and the International Committee of Medical Journal Editors recommend the Equator Network guidelines that include Consolidated Health Economic Evaluation Reporting Standards (CHEERS) Statement and 3 other ISPOR Good Practices Task Force Reports, in their instructions to authors.
"ISPOR has published more than 60 Good Practices Task Force Reports covering a variety of methods."
The ISPOR Good Practices for Real-World Data Studies of Treatment and/or Comparative Effectiveness Report1 was cited in Framework for FDA’s Real-World Evidence Program.2 This particular report has been part of a bigger ISPOR effort to address a recurring topic in ISPOR’s Top 10 Healthcare Trends Report: real-world evidence (RWE) in healthcare decision making. Thus, these efforts have been a cornerstone in support of ISPOR’s mission: “To promote health economics and outcomes research excellence to improve decision making for health globally.”
ISPOR has also been involved in translating regulatory guidance into practical recommendations for trial sponsors and other stakeholders. ISPOR has published 11 ISPOR Patient-Reported Outcomes/Clinician Outcomes Assessment Good Practices Task Force Reports that provide recommendations based on the FDA’s PRO Guidance for Industry.3 Two more related task forces are currently underway: the Performance Outcome Assessments and Measurement Comparability of Patient-Reported Outcomes Measures.
What Issues Do ISPOR Good Practices Reports Address?
ISPOR Good Practices Task Forces serve several purposes. They can represent consensus guidance on the appropriate methods, analysis, and reporting standards to conduct research to inform healthcare decisions and improve health. They can provide specific recommendations on the design and approach for conducting research, how analyses should be performed, and how the results from HEOR should be interpreted and disseminated. At their very simplest, these task force reports can provide a roadmap for the reader to follow on how to accomplish the desired result.
The reports address areas of agreement, as well as issues where there are gaps or controversies that have not been resolved or integrated in the HEOR literature. The reports can address topics for which there is little or no published guidance (eg, patient-reported outcome and observer-reported outcome assessment in rare disease clinical trials and clinician-reported outcomes) or methods from other fields now applied to healthcare (eg, dynamic simulation-modeling methods in healthcare delivery research and health preference methods research). In this case, the reports are designated as ISPOR Emerging Good Practices Task Force Reports. This specific type of reports describes “the developing state of the art,” identifies issues that require additional research and development, as well as makes some provisional recommendations.
"Mid-career members are encouraged to consider developing task force proposals on new areas of research where good practices are lacking or areas where the science has advanced..."
Why and How to Get Involved
Any ISPOR member can develop a task force proposal.i Indeed, most task force proposals have been initiated by one or more ISPOR members based on their own judgment of the need for expert guidance on a given topic. For example, several Value in Health reviewers initiated proposals after repeatedly seeing incorrect analyses on discrete choice experiments and mapping health-state utilities from nonpreference-based outcomes measures.
Personally, I have initiated 3 task forces and actively participated in 6 altogether; they have been among the most satisfying experiences of my career. Most recently, I instigated an effort to formally propose the registration of real-world data studies of treatment and/or comparative effectiveness. This quickly evolved into a collaborative effort with the International Society of Pharmacoepidemiology (ISPE), the Joint ISPE/ISPOR Special Task Forceii resulting in joint publication of 2 reports in Value in Health and Pharmacoepidemiology and Drug Safety.
Mid-career members are encouraged to consider developing task force proposals on new areas of research where good practices are lacking or areas where the science has advanced to a point where a report might provide a timely update on evolving standards or provide a framework for understanding and assessing important new approaches that are being applied to HEOR. The Machine Learning in HEOR Task Force is an example of the latter, and the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) II Task Force is an example of the former.
In some cases, members are informed by the topics that ISPOR—via its councils, conferences, or publications—has indicated are of high importance and timeliness. For example, the Health Science Policy Council Task Force Review Committee looks forward to seeing member-initiated proposals on topics from ISPOR’s Top 10 HEOR Trends and from the upcoming ISPOR Scientific Strategy, to be released in January 2021. Topics are encouraged to address issues that are or will be of enduring interest to multiple stakeholders in the healthcare ecosystem.
The Task Force Review Committee has established criteria for task force proposals and a proposal format for initiators. The criteria and process for approving new task forces are straightforward. The rationale for the proposal must include a justification including why this good practice guidance is important and its potential impact on the scientific community. The rationale should include the following criteria:
• Necessity: Why is this task force required? What are the controversies, issues, or concerns the task force will address?
• Methodology oriented: Inherent in ISPOR Good Practices Task Force reports is a focus on methods and approaches to conducting research to inform healthcare decisions and improve health.
• Relevance to ISPOR’s mission and its members: The task force must be relevant to ISPOR’s mission. The report should be of broad interest to ISPOR members and applicable in more than one geographic area.
• Durability: The topic of interest should not be a passing trend. It should stand the test of time.
• Broader applicability: The task force should not focus on a particular product, technology or program, but rather be applicable to a wide array of technologies, situations, and geographic areas. ISPOR is a global organization.
• Evidence-based: The rationale should be supported by empirical studies that resolve or identify underlying uncertainty about research methods. The rationale should also discuss the implications of using different approaches to study the phenomena, and the expected outcomes from the task force in terms of obtaining consensus or providing recommendations.
If insufficient studies are available to resolve uncertainty for most issues facing the task force, then the emerging task force designation is appropriate.
Proposals should address why a task force is needed, what specific issues it intends to address in the design, conduct, or reporting of outcomes research and/or health economic analyses, and how the task force will support ISPOR’s mission.
For more details, see the recently published article, Criteria and Process for Initiating and Developing an ISPOR Good Practices Task Force Report in the April issue of Value in Health.4
What’s Next?
The practical influence of ISPOR task force reports cannot be understated. ISPOR Good Practices Task Force Reports are among the most highly cited articles in Value in Health and have raised the profile of ISPOR as a premier professional organization in the fields of outcomes research and health economics.
ISPOR staff are available to discuss with any member ideas and proposals for new good practices task forces. They are happy to brainstorm with you and help shepherd you through the process. Send an email to taskforce@ispor.org for more information. •
References
1. Berger ML, Sox H, Willke RJ, et al. Good Practices for Real-World Data Studies of Treatment and/or Comparative Effectiveness: Recommendations from the Joint ISPOR-ISPE Special Task Force on Real-World Evidence in Health Care Decision Making. Value Health. 2017;20(8):1003-1008.
2. US Food & Drug Administration. Framework for FDA’s real-world evidence program. Published December 2018. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence. Accessed Jan 29, 2020.
3. US Food & Drug Administration. Patient-reported outcome measures: use in medical product development to support labeling claims—guidance for industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims. Published December 2009. Accessed Jan 29, 2020.
4. Malone DC, Ramsey SD, Patrick DL, et al. Criteria and Process for Initiating and Developing an ISPOR Good Practices Task Force Report. Value Health. 2020;23(4):409-415.
i In addition, any interested ISPOR member can volunteer as a task force report reviewer. Please visit the task force homepage at https://www.ispor.org/member-groups/task-forces to sign up.
ii The real-world evidence collaborative was actually a Special Task Force. Special Task Forces are formed to address time-sensitive, policy-related issues. They are subject to different criteria and a different Health Science Policy Council review process.
