VOLUME
33
䡠
NUMBER
12
䡠
APRIL
20
2015
JOURNAL OF CLINICAL ONCOLOGY
User Beware: We Need More Science and Less Art When Measuring Financial Toxicity in Oncology TO THE EDITOR: An article by Khera1 recently appeared in the Art of Oncology section of Journal of Clinical Oncology. Although we acknowledge the author’s efforts in proposing a grading system for financial toxicity, one should embark on such a task on the basis of science, using well-defined and reproducible research methods performed with patients. In the social sciences, as described by Prawitz et al,2 there are several terms used to describe feelings about financial condition, including perceived economic wellbeing, personal financial wellness, financial satisfaction, perceived income adequacy, financial strain, financial stress, debt stress, economic strain, and economic distress. In the oncology literature, financial distress, financial burden, and financial toxicity have all been reported and used as synonyms. As a way to quantify the term, financial burden has also been defined and used in some studies as the ratio of health-related spending to household income.3 One of us introduced the term “financial toxicity” in 2009 to report the potential economic impact of modern oncology drugs.4 At that time, “grade 5 financial toxicity” was portrayed as a “suicide of cancer patient refused a lifeline.”5 Although not referenced by Khera,1 we would like to point out that there are instruments that have been described for use in measuring financial burden in cancer care. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire,6 a prominent health-related quality-of-life instrument developed in 1993, has long included one item that attempts to qualitatively assess the financial impact of disease on a patient’s quality of life (“Has your physical condition or medical treatment caused you financial difficulties?”). Similarly, the Financial WellBeing Scale, an 8-item instrument to evaluate the reaction of the general population to their financial situation, has also been used as a measure of financial burden in patients with cancer.2 More recently, by using standardized research processes and patient testing, along with various stages of refinement and planning for subsequent validation, our group developed the Comprehensive Score for Financial Toxicity Patient-Reported Outcome7 to quantitatively assess financial toxicity in patients with cancer. We fully agree with Khera that methods for measuring and grading financial burdens in cancer care from the patient’s perspective are needed. To this end, and consistent with our own process in developing the Comprehensive Score for Financial Toxicity Patient-Reported Outcome, as with the development of any metric for such a sensitive topic, it is imperative to be as transparent and scientific as possible regarding the methods. For example, establishing the theoretical model of perceived health or symptoms of interest is the first and most important step.8 Once that is done, the content should be validated through qualitative interviews. For 1414
© 2015 by American Society of Clinical Oncology
C O R R E S P O N D E N C E
example, although the proposed “consideration of suicide because of financial burden of care” may indeed be an important item, it is likely not in the same grade as “need to sell home to pay for medical bills.” Important distinctions such as these can likely be ascertained only through direct research with patients. Furthermore, as is the case for any standardized (and validated) measure, a series of statistical analyses should be performed to elicit the ranking as well as the internal consistency, nonredundancy, and validity of the instrument or grading system. For example, “current debts more than household income” as proposed by Khera may arguably happen before the “use of savings accounts, disability income, or retirement funds for medical expenditure.” Similarly, one could easily ask whether each numerical grade indicates a uniform interval increase in toxicity. Finally, an instrument is of minimal value if it cannot be correlated with objective and validated outcomes. Following Khera’s proposed grading, one would question whether there is any difference between “the need to stop treatment because of financial burden” and the “need to sell home to pay for medical bills” relative to patient outcomes. Therefore, an appropriate research hypothesis is also mandatory when developing and validating these instruments. As an example, one can hypothesize that increased financial toxicity correlates with worse health-related quality of life. Undoubtedly, when attempting to assess the impact of financial toxicities on care of patients with cancer, we are clearly dealing with a controversial issue because the costs of such care continue to rise. We agree with Khera that the best approach to tackling this issue is through an open discussion of the relevant issues with the patients. However, the bridge that will take us to this discussion mandates a powerful foundation: the voice of the patients through patient-reported outcomes and the required empirical research of the impact of this burden on clinically meaningful outcomes.
Jonas A. de Souza, Bonnie Yap, Mark J. Ratain, and Christopher Daugherty The University of Chicago, Chicago, IL
AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST
Disclosures provided by the authors are available with this article at www.jco.org. REFERENCES 1. Khera N: Reporting and grading financial toxicity. J Clin Oncol 32:3337-3338, 2014 2. Prawitz AD, Garman ET, Sorhaindo B, et al: InCharge Financial Distress/ Financial Well-Being Scale: Development, administration, and score interpretation. J Financl Couns Plann 17:34-50, 2006 3. Selden TM, Banthin JS: Health care expenditure burdens among elderly adults: 1987 and 1996. Med Care 41:III13-III23, 2003 4. Ratain MJ: Biomarkers and Clinical Care. Presented at the AAAS/FDLI Colloquium, Personalized Medicine in an Era of Health Care Reform, Washington, DC, October 27, 2009. http://shr01.aaas.org/projects/personalized_ med/colloquia/ppts/Ratain.pdf Journal of Clinical Oncology, Vol 33, No 12 (April 20), 2015: pp 1414-1415
Downloaded from jco.ascopubs.org on November 15, 2015. For personal use only. No other uses without permission. Copyright © 2015 American Society of Clinical Oncology. All rights reserved.
Correspondence
5. Camber R: Cancer patient kills himself day after he is told NHS Trust would not fund £25,000 drug. Daily Mail, June 25, 2008. http://www.dailymail.co.uk/news/article1029038/Cancer-patient-kills-day-told-NHS-Trust-fund-25-000-drug.html#ixzz3FT52E6MI 6. Aaronson NK, Ahmedzai S, Bergman B, et al: The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365-376, 1993 7. de Souza JA, Yap BJ, Hlubocky FJ, et al: The development of a financial toxicity patient-reported outcome in cancer: The COST measure. Cancer 120: 3245-3253, 2014
8. Patrick DL, Burke LB, Gwaltney CJ, 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 2. Assessing respondent understanding. Value Health 14:978-988, 2011
DOI: 10.1200/JCO.2014.59.4986; published online ahead of print at www.jco.org on March 2, 2015
■ ■ ■
www.jco.org
© 2015 by American Society of Clinical Oncology
Downloaded from jco.ascopubs.org on November 15, 2015. For personal use only. No other uses without permission. Copyright © 2015 American Society of Clinical Oncology. All rights reserved.
1415
Correspondence
AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST
User Beware: We Need More Science and Less Art When Measuring Financial Toxicity in Oncology The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships are self-held unless noted. I ⫽ Immediate Family Member, Inst ⫽ My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO’s conflict of interest policy, please refer to www.asco.org/rwc or jco.ascopubs.org/site/ifc. Jonas A. de Souza No relationship to disclose Bonnie Yap No relationship to disclose Mark J. Ratain Stock or Other Ownership: Biscayne Pharmaceuticals Consulting or Advisory Role: AbbVie, Biscayne Pharmaceuticals, Cantex Pharmaceuticals, Cyclacel Pharmaceuticals, Genentech, Fresenius
© 2015 by American Society of Clinical Oncology
Kabi, Teva Pharmaceuticals Industries, USV Limited, Kinex Pharmaceuticals, Onconova Therapeutics, Apotex, Shionogi, XSpray Research Funding: PharmaMar, Dicerna Pharmaceuticals, OncoTherapy Science, Bristol-Myers Squibb Patents, Royalties, Other Intellectual Property: System and methods for providing customized medical services, provisional patent application Christopher K. Daugherty No relationship to disclose
JOURNAL OF CLINICAL ONCOLOGY
Downloaded from jco.ascopubs.org on November 15, 2015. For personal use only. No other uses without permission. Copyright © 2015 American Society of Clinical Oncology. All rights reserved.
33
䡠
NUMBER
12
䡠
APRIL
20
2015
JOURNAL OF CLINICAL ONCOLOGY
User Beware: We Need More Science and Less Art When Measuring Financial Toxicity in Oncology TO THE EDITOR: An article by Khera1 recently appeared in the Art of Oncology section of Journal of Clinical Oncology. Although we acknowledge the author’s efforts in proposing a grading system for financial toxicity, one should embark on such a task on the basis of science, using well-defined and reproducible research methods performed with patients. In the social sciences, as described by Prawitz et al,2 there are several terms used to describe feelings about financial condition, including perceived economic wellbeing, personal financial wellness, financial satisfaction, perceived income adequacy, financial strain, financial stress, debt stress, economic strain, and economic distress. In the oncology literature, financial distress, financial burden, and financial toxicity have all been reported and used as synonyms. As a way to quantify the term, financial burden has also been defined and used in some studies as the ratio of health-related spending to household income.3 One of us introduced the term “financial toxicity” in 2009 to report the potential economic impact of modern oncology drugs.4 At that time, “grade 5 financial toxicity” was portrayed as a “suicide of cancer patient refused a lifeline.”5 Although not referenced by Khera,1 we would like to point out that there are instruments that have been described for use in measuring financial burden in cancer care. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire,6 a prominent health-related quality-of-life instrument developed in 1993, has long included one item that attempts to qualitatively assess the financial impact of disease on a patient’s quality of life (“Has your physical condition or medical treatment caused you financial difficulties?”). Similarly, the Financial WellBeing Scale, an 8-item instrument to evaluate the reaction of the general population to their financial situation, has also been used as a measure of financial burden in patients with cancer.2 More recently, by using standardized research processes and patient testing, along with various stages of refinement and planning for subsequent validation, our group developed the Comprehensive Score for Financial Toxicity Patient-Reported Outcome7 to quantitatively assess financial toxicity in patients with cancer. We fully agree with Khera that methods for measuring and grading financial burdens in cancer care from the patient’s perspective are needed. To this end, and consistent with our own process in developing the Comprehensive Score for Financial Toxicity Patient-Reported Outcome, as with the development of any metric for such a sensitive topic, it is imperative to be as transparent and scientific as possible regarding the methods. For example, establishing the theoretical model of perceived health or symptoms of interest is the first and most important step.8 Once that is done, the content should be validated through qualitative interviews. For 1414
© 2015 by American Society of Clinical Oncology
C O R R E S P O N D E N C E
example, although the proposed “consideration of suicide because of financial burden of care” may indeed be an important item, it is likely not in the same grade as “need to sell home to pay for medical bills.” Important distinctions such as these can likely be ascertained only through direct research with patients. Furthermore, as is the case for any standardized (and validated) measure, a series of statistical analyses should be performed to elicit the ranking as well as the internal consistency, nonredundancy, and validity of the instrument or grading system. For example, “current debts more than household income” as proposed by Khera may arguably happen before the “use of savings accounts, disability income, or retirement funds for medical expenditure.” Similarly, one could easily ask whether each numerical grade indicates a uniform interval increase in toxicity. Finally, an instrument is of minimal value if it cannot be correlated with objective and validated outcomes. Following Khera’s proposed grading, one would question whether there is any difference between “the need to stop treatment because of financial burden” and the “need to sell home to pay for medical bills” relative to patient outcomes. Therefore, an appropriate research hypothesis is also mandatory when developing and validating these instruments. As an example, one can hypothesize that increased financial toxicity correlates with worse health-related quality of life. Undoubtedly, when attempting to assess the impact of financial toxicities on care of patients with cancer, we are clearly dealing with a controversial issue because the costs of such care continue to rise. We agree with Khera that the best approach to tackling this issue is through an open discussion of the relevant issues with the patients. However, the bridge that will take us to this discussion mandates a powerful foundation: the voice of the patients through patient-reported outcomes and the required empirical research of the impact of this burden on clinically meaningful outcomes.
Jonas A. de Souza, Bonnie Yap, Mark J. Ratain, and Christopher Daugherty The University of Chicago, Chicago, IL
AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST
Disclosures provided by the authors are available with this article at www.jco.org. REFERENCES 1. Khera N: Reporting and grading financial toxicity. J Clin Oncol 32:3337-3338, 2014 2. Prawitz AD, Garman ET, Sorhaindo B, et al: InCharge Financial Distress/ Financial Well-Being Scale: Development, administration, and score interpretation. J Financl Couns Plann 17:34-50, 2006 3. Selden TM, Banthin JS: Health care expenditure burdens among elderly adults: 1987 and 1996. Med Care 41:III13-III23, 2003 4. Ratain MJ: Biomarkers and Clinical Care. Presented at the AAAS/FDLI Colloquium, Personalized Medicine in an Era of Health Care Reform, Washington, DC, October 27, 2009. http://shr01.aaas.org/projects/personalized_ med/colloquia/ppts/Ratain.pdf Journal of Clinical Oncology, Vol 33, No 12 (April 20), 2015: pp 1414-1415
Downloaded from jco.ascopubs.org on November 15, 2015. For personal use only. No other uses without permission. Copyright © 2015 American Society of Clinical Oncology. All rights reserved.
Correspondence
5. Camber R: Cancer patient kills himself day after he is told NHS Trust would not fund £25,000 drug. Daily Mail, June 25, 2008. http://www.dailymail.co.uk/news/article1029038/Cancer-patient-kills-day-told-NHS-Trust-fund-25-000-drug.html#ixzz3FT52E6MI 6. Aaronson NK, Ahmedzai S, Bergman B, et al: The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365-376, 1993 7. de Souza JA, Yap BJ, Hlubocky FJ, et al: The development of a financial toxicity patient-reported outcome in cancer: The COST measure. Cancer 120: 3245-3253, 2014
8. Patrick DL, Burke LB, Gwaltney CJ, 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 2. Assessing respondent understanding. Value Health 14:978-988, 2011
DOI: 10.1200/JCO.2014.59.4986; published online ahead of print at www.jco.org on March 2, 2015
■ ■ ■
www.jco.org
© 2015 by American Society of Clinical Oncology
Downloaded from jco.ascopubs.org on November 15, 2015. For personal use only. No other uses without permission. Copyright © 2015 American Society of Clinical Oncology. All rights reserved.
1415
Correspondence
AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST
User Beware: We Need More Science and Less Art When Measuring Financial Toxicity in Oncology The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships are self-held unless noted. I ⫽ Immediate Family Member, Inst ⫽ My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO’s conflict of interest policy, please refer to www.asco.org/rwc or jco.ascopubs.org/site/ifc. Jonas A. de Souza No relationship to disclose Bonnie Yap No relationship to disclose Mark J. Ratain Stock or Other Ownership: Biscayne Pharmaceuticals Consulting or Advisory Role: AbbVie, Biscayne Pharmaceuticals, Cantex Pharmaceuticals, Cyclacel Pharmaceuticals, Genentech, Fresenius
© 2015 by American Society of Clinical Oncology
Kabi, Teva Pharmaceuticals Industries, USV Limited, Kinex Pharmaceuticals, Onconova Therapeutics, Apotex, Shionogi, XSpray Research Funding: PharmaMar, Dicerna Pharmaceuticals, OncoTherapy Science, Bristol-Myers Squibb Patents, Royalties, Other Intellectual Property: System and methods for providing customized medical services, provisional patent application Christopher K. Daugherty No relationship to disclose
JOURNAL OF CLINICAL ONCOLOGY
Downloaded from jco.ascopubs.org on November 15, 2015. For personal use only. No other uses without permission. Copyright © 2015 American Society of Clinical Oncology. All rights reserved.
