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An increasing number of new pharmaceuticals have used questionnaires to capture [[Patient-reported outcome]] (PROs) of health care as a metric to complement their clinical effectiveness.<ref>Kingsley C, Patel S. Patient-reported outcome measures and patient-reported experience measures. British Journal of Anaesthesia. 2016;17(4):137-144. doi: 10.1093/bjaed/mkw060</ref> These PROs require stringent [[reliability testing]] and [[validation]], necessitating standardization for their development and use.<ref>Bannigan K, Watson R. Reliability and validity in a nutshell. J Clin Nurs. 2009 Dec;18(23):3237-43. doi: 10.1111/j.1365-2702.2009.02939.x.</ref> The [[International Society for Quality of Life Research]] (ISOQOL) developed a minimum set of measurement standards to properly use PRO instruments.<ref>Reeve BB, et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res. 2013 Oct;22(8):1889-905. doi: 10.1007/s11136-012-0344-y.</ref> Moreover, ISPOR developed a set of standards to properly test these PRO instruments for reliability and validity, which has been adopted by the [[Food and Drug Administration]] (FDA).<ref>Patrick DL, et al. Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument. Value Health. 2011 Dec;14(8):967-77. doi: 10.1016/j.jval.2011.06.014.</ref> Currently, the FDA refers to the ISPOR Task Force's publications on [[content validity]] for the development of new clinical outcome assessment instruments or tools.<ref>U.S. Food & Drug Administration Clinical Outcome Assessment (COA): Frequently Asked Questions URL: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm370261.htm [Accessed August 3, 2018]</ref>
An increasing number of new pharmaceuticals have used questionnaires to capture [[Patient-reported outcome]] (PROs) of health care as a metric to complement their clinical effectiveness.<ref>Kingsley C, Patel S. Patient-reported outcome measures and patient-reported experience measures. British Journal of Anaesthesia. 2016;17(4):137-144. doi: 10.1093/bjaed/mkw060</ref> These PROs require stringent [[reliability testing]] and [[validation]], necessitating standardization for their development and use.<ref>Bannigan K, Watson R. Reliability and validity in a nutshell. J Clin Nurs. 2009 Dec;18(23):3237-43. doi: 10.1111/j.1365-2702.2009.02939.x.</ref> The [[International Society for Quality of Life Research]] (ISOQOL) developed a minimum set of measurement standards to properly use PRO instruments.<ref>Reeve BB, et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res. 2013 Oct;22(8):1889-905. doi: 10.1007/s11136-012-0344-y.</ref> Moreover, ISPOR developed a set of standards to properly test these PRO instruments for reliability and validity, which has been adopted by the [[Food and Drug Administration]] (FDA).<ref>Patrick DL, et al. Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument. Value Health. 2011 Dec;14(8):967-77. doi: 10.1016/j.jval.2011.06.014.</ref> Currently, the FDA refers to the ISPOR Task Force's publications on [[content validity]] for the development of new clinical outcome assessment instruments or tools.<ref>U.S. Food & Drug Administration Clinical Outcome Assessment (COA): Frequently Asked Questions URL: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm370261.htm [Accessed August 3, 2018]</ref>


In 2019, ISPOR announced the release of a series of papers that document how decision makers assess healthcare value at their annual summit meeting.<ref>Newswise.com. Healthcare Experts Debate New Methods of Assessing the Value of Prescription Drugs, Medical Devices, and Procedures. June 18, 2019. URL: https://www.newswise.com/articles/healthcare-experts-debate-new-methods-of-assessing-the-value-of-prescription-drugs-medical-devices-and-procedures [Accessed July 12, 2019]</ref> The rising cost of healthcare has raised concerns about its value, especially for pharmaceuticals. However, measuring value in healthcare is a challenging endeavor prompting several organizations to develop value-based frameworks.<ref>Dubois RW, Westrich K. Value Assessment Frameworks: How Can They Meet The Challenge? Health Affairs Blog. URL: https://www.healthaffairs.org/do/10.1377/hblog20170302.058979/full/ [Accessed July 12, 2019]</ref> The [[National Pharmaceutical Council]], [[Institute for Clinical and Economic Review]], and the [[National Health Council]] have developed value-assessment frameworks to help guide decision makers and stakeholders to value healthcare.<ref>Institute for Clinical and Economic Review - Value Assessment Framework. URL: https://icer-review.org/methodology/icers-methods/icer-value-assessment-framework-2/ [Accessed September 7, 2019]<ref><ref>National Health Council - Value Frameworks and Assessment. URL: http://www.nationalhealthcouncil.org/public-policy/value-frameworks [Accessed September 7, 2019]</ref> ISPOR's value-assessment framework focuses on patient centricity and the use of [[cost-effectiveness analysis]] where the costs of the intervention are compared to standard of care in terms of costs and [[quality-adjusted life years]] (QALYs). However criticisms of the use of a QALY-centric approach due to the limitations associated with these metrics have been voiced.<ref>Perfetto EM. ISPOR's initiative on US value assessment frameworks: A missed opportunity for ISPOR and patients. Value in Health. 2018;21(2): 169-170. https://doi.org/10.1016/j.jval.2017.12.002</ref> Most recently, ISPOR commented on the [[American Society of Clinical Oncology]] value framework for new oncology treatment because it did not embrace the use of QALYs.<ref>Malone DC, Berg NS, Claxton K, Garrison LP Jr, IJzerman M, Marsh K, Neumann PJ, Sculpher M, Towse A, Uyl-de Groot C, Weinstein MC. International Society for Pharmacoeconomics and Outcomes Research Comments on the American Society of Clinical Oncology Value Framework. J Clin Oncol. 2016 Aug 20;34(24):2936-7. doi: 10.1200/JCO.2015.64.4328.</ref><ref>Messori A. New Expensive Anticancer Agents: Which Role Is Played by Quality-Adjusted Life-Years in the Selection of a Specific Treatment? J Glob Oncol. 2016 Aug 10;3(1):82-83. doi: 10.1200/JGO.2016.006361.</ref>
In 2019, ISPOR announced the release of a series of papers that document how decision makers assess healthcare value at their annual summit meeting.<ref>Newswise.com. Healthcare Experts Debate New Methods of Assessing the Value of Prescription Drugs, Medical Devices, and Procedures. June 18, 2019. URL: https://www.newswise.com/articles/healthcare-experts-debate-new-methods-of-assessing-the-value-of-prescription-drugs-medical-devices-and-procedures [Accessed July 12, 2019]</ref> The rising cost of healthcare has raised concerns about its value, especially for pharmaceuticals. However, measuring value in healthcare is a challenging endeavor prompting several organizations to develop value-based frameworks.<ref>Dubois RW, Westrich K. Value Assessment Frameworks: How Can They Meet The Challenge? Health Affairs Blog. URL: https://www.healthaffairs.org/do/10.1377/hblog20170302.058979/full/ [Accessed July 12, 2019]</ref> The [[National Pharmaceutical Council]], [[Institute for Clinical and Economic Review]], and the [[National Health Council]] have developed value-assessment frameworks to help guide decision makers and stakeholders to value healthcare.<ref>Institute for Clinical and Economic Review - Value Assessment Framework. URL: https://icer-review.org/methodology/icers-methods/icer-value-assessment-framework-2/ [Accessed September 7, 2019]</ref><ref>National Health Council - Value Frameworks and Assessment. URL: http://www.nationalhealthcouncil.org/public-policy/value-frameworks [Accessed September 7, 2019]</ref> ISPOR's value-assessment framework focuses on patient centricity and the use of [[cost-effectiveness analysis]] where the costs of the intervention are compared to standard of care in terms of costs and [[quality-adjusted life years]] (QALYs). However criticisms of the use of a QALY-centric approach due to the limitations associated with these metrics have been voiced.<ref>Perfetto EM. ISPOR's initiative on US value assessment frameworks: A missed opportunity for ISPOR and patients. Value in Health. 2018;21(2): 169-170. https://doi.org/10.1016/j.jval.2017.12.002</ref> Most recently, ISPOR commented on the [[American Society of Clinical Oncology]] value framework for new oncology treatment because it did not embrace the use of QALYs.<ref>Malone DC, Berg NS, Claxton K, Garrison LP Jr, IJzerman M, Marsh K, Neumann PJ, Sculpher M, Towse A, Uyl-de Groot C, Weinstein MC. International Society for Pharmacoeconomics and Outcomes Research Comments on the American Society of Clinical Oncology Value Framework. J Clin Oncol. 2016 Aug 20;34(24):2936-7. doi: 10.1200/JCO.2015.64.4328.</ref><ref>Messori A. New Expensive Anticancer Agents: Which Role Is Played by Quality-Adjusted Life-Years in the Selection of a Specific Treatment? J Glob Oncol. 2016 Aug 10;3(1):82-83. doi: 10.1200/JGO.2016.006361.</ref>


Since the passage of the [[21st Century Cures Act]] in 2016, the FDA has established the [[Real World Evidence]] program to help facilitate the approval process for drugs already approved under 505(c) of the [[Federal Food, Drug, and Cosmetic Act]]. The FDA will use recommendations from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the [[International Society for Pharmacoepidemiology]] (ISPE) to develop a set of standards that would use good procedural practices for treatment effectiveness studies, including transparency and reproducibility.<ref>Food and Drug Administration. Framework for FDA's Real World Evidence Program. December 2018. URL: https://www.fda.gov/media/120060/download [Accessed on July 12, 2019]</ref>
Since the passage of the [[21st Century Cures Act]] in 2016, the FDA has established the [[Real World Evidence]] program to help facilitate the approval process for drugs already approved under 505(c) of the [[Federal Food, Drug, and Cosmetic Act]]. The FDA will use recommendations from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the [[International Society for Pharmacoepidemiology]] (ISPE) to develop a set of standards that would use good procedural practices for treatment effectiveness studies, including transparency and reproducibility.<ref>Food and Drug Administration. Framework for FDA's Real World Evidence Program. December 2018. URL: https://www.fda.gov/media/120060/download [Accessed on July 12, 2019]</ref>

Revision as of 02:51, 8 September 2019

  • Comment: As publisher of a clearly notable journal, and as a source of internationally used evaluation data, it's notable, tho this has to be shown. If there are problems finding reference, it can be rewritten as an article on the journal. DGG ( talk ) 00:08, 20 August 2019 (UTC)
  • Comment: The refs are nearly all from the org and its publications Legacypac (talk) 04:55, 23 October 2018 (UTC)
International Society for Pharmacoeconomics and Outcomes Research
AbbreviationISPOR
TypeProfessional Association
HeadquartersLawrenceville, NJ
FieldsPharmacoeconomics, Health economics, Outcomes research
Membership>10,000 individual members
CEO & Executive Director
Nancy S. Berg
Websiteispor.org

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a non-profit global professional organization in pharmacoeconomics and outcomes research.[1] It was founded in 1995 as an international multidisciplinary professional organization that advances the policy, science, and practice of pharmacoeconomics (health economics) and outcomes research (the scientific discipline that evaluates the effect of health care interventions on patient well-being including clinical, economic, and patient-centered outcomes). ISPOR's mission is to promote health economics and outcomes research to improve decision making for health globally.

As of August 2018, ISPOR has over 10,000 international members from 120 countries with a majority in North America (41%) followed by Europe (37%), Asia Pacific (11%), Latin America (5%), Africa & Oceania (4%), and Middle East (2%).[2]

Contributions

ISPOR has contributed to the health economics and outcomes research literature by developing good practices for outcomes research.[3] The documents encompass a wide-array of outcomes research including comparative effectiveness research methods, economic evaluation methods, modelling methods, observational study methods-database methods, observational study methods-medication adherence methods, clinical outcomes assessment methods, preference-based methods, risk benefits methods, and use of outcomes research in health care decisions. ISPOR collaborated with the Society for Medical Decision Making to develop a comprehensive list of papers that outline the ideal practice for develop decision analytic models for pharmacoeconomic analysis.[4][5][6][7][8][9][10]

ISPOR has also collaborated with the Academy of Managed Care Pharmacy to develop guidelines for training programs and fellowships for future professionals in pharmacoeconomics and outcomes research.[11]

An increasing number of new pharmaceuticals have used questionnaires to capture Patient-reported outcome (PROs) of health care as a metric to complement their clinical effectiveness.[12] These PROs require stringent reliability testing and validation, necessitating standardization for their development and use.[13] The International Society for Quality of Life Research (ISOQOL) developed a minimum set of measurement standards to properly use PRO instruments.[14] Moreover, ISPOR developed a set of standards to properly test these PRO instruments for reliability and validity, which has been adopted by the Food and Drug Administration (FDA).[15] Currently, the FDA refers to the ISPOR Task Force's publications on content validity for the development of new clinical outcome assessment instruments or tools.[16]

In 2019, ISPOR announced the release of a series of papers that document how decision makers assess healthcare value at their annual summit meeting.[17] The rising cost of healthcare has raised concerns about its value, especially for pharmaceuticals. However, measuring value in healthcare is a challenging endeavor prompting several organizations to develop value-based frameworks.[18] The National Pharmaceutical Council, Institute for Clinical and Economic Review, and the National Health Council have developed value-assessment frameworks to help guide decision makers and stakeholders to value healthcare.[19][20] ISPOR's value-assessment framework focuses on patient centricity and the use of cost-effectiveness analysis where the costs of the intervention are compared to standard of care in terms of costs and quality-adjusted life years (QALYs). However criticisms of the use of a QALY-centric approach due to the limitations associated with these metrics have been voiced.[21] Most recently, ISPOR commented on the American Society of Clinical Oncology value framework for new oncology treatment because it did not embrace the use of QALYs.[22][23]

Since the passage of the 21st Century Cures Act in 2016, the FDA has established the Real World Evidence program to help facilitate the approval process for drugs already approved under 505(c) of the Federal Food, Drug, and Cosmetic Act. The FDA will use recommendations from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) to develop a set of standards that would use good procedural practices for treatment effectiveness studies, including transparency and reproducibility.[24]

Publications

ISPOR is the publisher of the international, peer-reviewed journal Value in Health, which publishes "articles for pharmacoeconomics, health economics, and outcomes research (clinical, economic, and patient-reported outcomes/preference-based research), as well as conceptual and health policy articles that provide valuable information for health care decision-makers, as well as the research community. As the official journal of ISPOR, Value in Health provides a forum for researchers, as well as health care decision-makers, to translate outcomes research into health care decisions."[25] ISPOR also publishes Value In Health Regional Issues, which focuses on encouraging and enhancing "the science of pharmacoeconomic/health economic and health outcomes research and its use in health care decisions in Asia, Latin America, Central & Eastern Europe, Western Asia, and Africa."[26] Value in Health has an current impact factor of 5.494 and is 3rd among 94 journals in Health Care Sciences and Services, 3rd among 79 journals in Health Policy and Services, and 6th among 353 journals in Economics.[27]

ISPOR also published the pharmacoeconomics and outcomes research text Health Care Cost, Quality, and Outcomes: ISPOR Book of Terms, which contains a comprehensive list of terms associated with health economics and outcomes research.[28]

Awards and Accolades

In 2016, Nancy Berg, ISPOR's current CEO, was selected to be part of the 2016 PharmVOICE 100, which recognizes those "inspirational individuals recognized for their positive contributions to the life sciences industry".[29]

ISPOR received the “Power of A” Silver Award for its Good Practices for Outcomes Research Reports in 2018.[30] The "Power of A" Award recognizes an organization that "showcase how associations leverage their unique resources to solve problems, advance industry/professional performance, kickstart innovation and improve world conditions. Associations are involved in activities every day that make a substantial, positive impact on our lives."[31]

ISPOR is a member of the National Health Council, a nonprofit association of health organizations that represents the patient voice.[32]

References

  1. ^ ISPOR Official Website. URL: https://www.ispor.org/
  2. ^ ISPOR Membership profile. URL: https://www.ispor.org/about/our-members [Accessed August 9, 2018]
  3. ^ ISPOR Good Practices for Outcomes Research. URL: https://www.ispor.org/workpaper/practices_index.asp [Accessed: July 24, 2018]
  4. ^ Caro JJ, Briggs AH, Siebert U, Kuntz KM; ISPOR-SMDM Modeling Good Research Practices Task Force. Modeling good research practices--overview: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-1. Med Decis Making. 2012 Sep-Oct;32(5):667-77.
  5. ^ Roberts M, Russell LB, Paltiel AD, Chambers M, McEwan P, Krahn M; ISPOR-SMDM Modeling Good Research Practices Task Force. Conceptualizing a model: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-2. Med Decis Making. 2012 Sep-Oct;32(5):678-89.
  6. ^ Siebert U, Alagoz O, Bayoumi AM, Jahn B, Owens DK, Cohen DJ, Kuntz KM. State-transition modeling: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-3. Med Decis Making. 2012 Sep-Oct;32(5):690-700.
  7. ^ Karnon J, Stahl J, Brennan A, Caro JJ, Mar J, Möller J. Modeling using discrete event simulation: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-4. Med Decis Making. 2012 Sep-Oct;32(5):701-11.
  8. ^ Pitman R, Fisman D, Zaric GS, Postma M, Kretzschmar M, Edmunds J, Brisson M; ISPOR-SMDM Modeling Good Research Practices Task Force. Dynamic transmission modeling: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force Working Group-5. Med Decis Making. 2012 Sep-Oct;32(5):712-21.
  9. ^ Briggs AH, Weinstein MC, Fenwick EA, Karnon J, Sculpher MJ, Paltiel AD; ISPOR-SMDM Modeling Good Research Practices Task Force. Model parameter estimation and uncertainty analysis: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force Working Group-6. Med Decis Making. 2012 Sep-Oct;32(5):722-32.
  10. ^ Eddy DM, Hollingworth W, Caro JJ, Tsevat J, McDonald KM, Wong JB; ISPOR-SMDM Modeling Good Research Practices Task Force. Model transparency and validation: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-7. Med Decis Making. 2012 Sep-Oct;32(5):733-43.
  11. ^ Kane-Gill S, Reddy P, Gupta SR, Bakst AW. Guidelines for pharmacoeconomic and outcomes research fellowship training programs: joint guidelines from the American College of Clinical Pharmacy and the International Society of Pharmacoeconomics and Outcomes Research. Pharmacotherapy. 2008 Dec;28(12):1552. doi: 10.1592/phco.28.12.1552.
  12. ^ Kingsley C, Patel S. Patient-reported outcome measures and patient-reported experience measures. British Journal of Anaesthesia. 2016;17(4):137-144. doi: 10.1093/bjaed/mkw060
  13. ^ Bannigan K, Watson R. Reliability and validity in a nutshell. J Clin Nurs. 2009 Dec;18(23):3237-43. doi: 10.1111/j.1365-2702.2009.02939.x.
  14. ^ Reeve BB, et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res. 2013 Oct;22(8):1889-905. doi: 10.1007/s11136-012-0344-y.
  15. ^ Patrick DL, et al. Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument. Value Health. 2011 Dec;14(8):967-77. doi: 10.1016/j.jval.2011.06.014.
  16. ^ U.S. Food & Drug Administration Clinical Outcome Assessment (COA): Frequently Asked Questions URL: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm370261.htm [Accessed August 3, 2018]
  17. ^ Newswise.com. Healthcare Experts Debate New Methods of Assessing the Value of Prescription Drugs, Medical Devices, and Procedures. June 18, 2019. URL: https://www.newswise.com/articles/healthcare-experts-debate-new-methods-of-assessing-the-value-of-prescription-drugs-medical-devices-and-procedures [Accessed July 12, 2019]
  18. ^ Dubois RW, Westrich K. Value Assessment Frameworks: How Can They Meet The Challenge? Health Affairs Blog. URL: https://www.healthaffairs.org/do/10.1377/hblog20170302.058979/full/ [Accessed July 12, 2019]
  19. ^ Institute for Clinical and Economic Review - Value Assessment Framework. URL: https://icer-review.org/methodology/icers-methods/icer-value-assessment-framework-2/ [Accessed September 7, 2019]
  20. ^ National Health Council - Value Frameworks and Assessment. URL: http://www.nationalhealthcouncil.org/public-policy/value-frameworks [Accessed September 7, 2019]
  21. ^ Perfetto EM. ISPOR's initiative on US value assessment frameworks: A missed opportunity for ISPOR and patients. Value in Health. 2018;21(2): 169-170. https://doi.org/10.1016/j.jval.2017.12.002
  22. ^ Malone DC, Berg NS, Claxton K, Garrison LP Jr, IJzerman M, Marsh K, Neumann PJ, Sculpher M, Towse A, Uyl-de Groot C, Weinstein MC. International Society for Pharmacoeconomics and Outcomes Research Comments on the American Society of Clinical Oncology Value Framework. J Clin Oncol. 2016 Aug 20;34(24):2936-7. doi: 10.1200/JCO.2015.64.4328.
  23. ^ Messori A. New Expensive Anticancer Agents: Which Role Is Played by Quality-Adjusted Life-Years in the Selection of a Specific Treatment? J Glob Oncol. 2016 Aug 10;3(1):82-83. doi: 10.1200/JGO.2016.006361.
  24. ^ Food and Drug Administration. Framework for FDA's Real World Evidence Program. December 2018. URL: https://www.fda.gov/media/120060/download [Accessed on July 12, 2019]
  25. ^ Value in Health. URL: https://www.valueinhealthjournal.com/
  26. ^ Value in Health Regional Issues. URL: https://www.ispor.org/publications/VIHRI/index.asp
  27. ^ Impact Factor for Value in Health. 2018. URL: https://www.healtheconomics.com/industry-news/ispor-value-in-health-impact-factor-hits-5-494 [Accessed om July 12, 2019
  28. ^ Health Care Cost, Quality, and Outcomes: ISPOR Book of Terms. URL: https://www.ispor.org/publications/books/healthcare-cost-quality-and-outcomes-ispor-book-of-terms
  29. ^ ISPOR CEO Nancy Berg Named a PharmaVOICE 100 URL: https://www.newswise.com/articles/ispor-ceo-nancy-berg-named-a-pharmavoice-100
  30. ^ ISPOR Wins 2018 “Power of A” Award for Its Good Practices for Outcomes Research Reports, July 9, 2018 URL: https://www.newswise.com/articles/ispor-wins-2018-%E2%80%9Cpower-of-a%E2%80%9D-award-for-its-good-practices-for-outcomes-research-reports- [Accessed: July 24, 2018]
  31. ^ ISPOR Membership profile. URL: https://www.thepowerofa.org/awards/ [Accessed: July 24,2018]
  32. ^ National Health Council. URL: http://www.nationalhealthcouncil.org/about-nhc/members/international-society-pharmacoeconomics-and-outcomes-research-coalition-ispor [Accessed: June 11, 2019]
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