Skip to main content
Top
Gepubliceerd in: Quality of Life Research 1/2014

01-02-2014

Cognitive interviewing of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Auteurs: Jennifer L. Hay, Thomas M. Atkinson, Bryce B. Reeve, Sandra A. Mitchell, Tito R. Mendoza, Gordon Willis, Lori M. Minasian, Steven B. Clauser, Andrea Denicoff, Ann O’Mara, Alice Chen, Antonia V. Bennett, Diane B. Paul, Joshua Gagne, Lauren Rogak, Laura Sit, Vish Viswanath, Deborah Schrag, Ethan Basch, the NCI PRO-CTCAE Study Group

Gepubliceerd in: Quality of Life Research | Uitgave 1/2014

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail

Abstract

Purpose

The National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a library of question items that enables patient reporting of adverse events (AEs) in clinical trials. This study contributes content validity evidence of the PRO-CTCAE by incorporating cancer patient input of the relevance and comprehensiveness of the item library.

Methods

Cognitive interviews were conducted among patients undergoing chemotherapy or radiation therapy at multiple sites to evaluate comprehension, memory retrieval, judgment, and response mapping related to AE terms (e.g., nausea), attribute terms (regarding frequency, severity, or interference), response options, and recall period. Three interview rounds were conducted with ≥20 patients completing each item per round. Items were modified and retested if ≥3 patients exhibited cognitive difficulties or if experienced by ≤25 % patients.

Results

One hundred and twenty-seven patients participated (35 % ≤high school, 28 % non-white, and 59 % female). Most AE terms (63/80) generated no cognitive difficulties. The remaining 17 were modified without further difficulties by Round 3. Terms were comprehended regardless of education level. Attribute terms and response options required no modifications. Patient adherence to recall period (7 days) was improved when the reference period was incorporated.

Conclusions

This study provides evidence confirming comprehension of the US English language versions of items in the PRO-CTCAE library for measuring symptomatic AEs from the patient perspective within the context of cancer treatment. Several minor changes were made to the items to improve item clarity, comprehension, and ease of response judgment. This study helps to establish the content validity of PRO-CTCAE items for patient reporting of AEs during cancer treatment.
Bijlagen
Alleen toegankelijk voor geautoriseerde gebruikers
Literatuur
1.
go back to reference Trotti, A., Colevas, A. D., Setser, A., Rusch, V., Jaques, D., Budach, V., et al. (2003). CTCAE v3.0: Development of a comprehensive grading system for the adverse events of cancer treatment. Seminars in Radiation Oncology, 13, 176–181.PubMedCrossRef Trotti, A., Colevas, A. D., Setser, A., Rusch, V., Jaques, D., Budach, V., et al. (2003). CTCAE v3.0: Development of a comprehensive grading system for the adverse events of cancer treatment. Seminars in Radiation Oncology, 13, 176–181.PubMedCrossRef
4.
go back to reference Basch, E., Iasonos, A., McDonough, T., Barz, A., Culkin, A., Kris, M. G., et al. (2006). Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: Results of a questionnaire-based study. Lancet Oncology, 7, 903–909. doi:10.1016/S1470-2045(06)70910-X.PubMedCrossRef Basch, E., Iasonos, A., McDonough, T., Barz, A., Culkin, A., Kris, M. G., et al. (2006). Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: Results of a questionnaire-based study. Lancet Oncology, 7, 903–909. doi:10.​1016/​S1470-2045(06)70910-X.PubMedCrossRef
5.
go back to reference Basch, E., Jia, X., Heller, G., Barz, A., Sit, L., Fruscione, M., et al. (2009). Adverse symptom event reporting by patients versus clinicians: Relationships with clinical outcomes. Journal of the National Cancer Institute, 101(23), 1624–1632. doi:10.1093/jnci/djp386.PubMedCrossRef Basch, E., Jia, X., Heller, G., Barz, A., Sit, L., Fruscione, M., et al. (2009). Adverse symptom event reporting by patients versus clinicians: Relationships with clinical outcomes. Journal of the National Cancer Institute, 101(23), 1624–1632. doi:10.​1093/​jnci/​djp386.PubMedCrossRef
8.
go back to reference Greimel, E. R., Bjelic-Radisic, V., Pfisterer, J., Hilpert, F., Daghofer, F., Pujade-Lauraine, E., et al. (2011). Toxicity and quality of life outcomes in ovarian cancer patients participating in randomized controlled trials. Supportive Care in Cancer, 19(9), 1421–1427. doi:10.1007/s00520-010-0969-8.PubMedCrossRef Greimel, E. R., Bjelic-Radisic, V., Pfisterer, J., Hilpert, F., Daghofer, F., Pujade-Lauraine, E., et al. (2011). Toxicity and quality of life outcomes in ovarian cancer patients participating in randomized controlled trials. Supportive Care in Cancer, 19(9), 1421–1427. doi:10.​1007/​s00520-010-0969-8.PubMedCrossRef
9.
go back to reference Flores, L. T., Bennett, A. V., Law, E. B., Hajj, C., Griffith, M. P., & Goodman, K. A. (2012). Patient-reported outcomes versus clinician symptom reporting during chemoradiation for rectal cancer. Gastrointestinal Cancer Research, 5(4), 119–124.PubMed Flores, L. T., Bennett, A. V., Law, E. B., Hajj, C., Griffith, M. P., & Goodman, K. A. (2012). Patient-reported outcomes versus clinician symptom reporting during chemoradiation for rectal cancer. Gastrointestinal Cancer Research, 5(4), 119–124.PubMed
10.
go back to reference Basch, E., Iasonos, A., Barz, A., Culkin, A., Kris, M. G., Artz, D., et al. (2007). Long-term toxicity monitoring via electronic patient-reported outcomes in patients receiving chemotherapy. Journal of Clinical Oncology, 25(34), 5374–5380. doi:10.1200/JCO.2007.11.2243.PubMedCrossRef Basch, E., Iasonos, A., Barz, A., Culkin, A., Kris, M. G., Artz, D., et al. (2007). Long-term toxicity monitoring via electronic patient-reported outcomes in patients receiving chemotherapy. Journal of Clinical Oncology, 25(34), 5374–5380. doi:10.​1200/​JCO.​2007.​11.​2243.PubMedCrossRef
11.
13.
go back to reference European Medicines Agency. Committee for medicinal products for human use (CHMP). Pre-authorisation evaluation of medicines for human use: Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products (January 2006, Available from: http://www.ispor.org/workpaper/emea-hrql-guidance.pdf. Accessed 20 May 2013). European Medicines Agency. Committee for medicinal products for human use (CHMP). Pre-authorisation evaluation of medicines for human use: Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products (January 2006, Available from: http://​www.​ispor.​org/​workpaper/​emea-hrql-guidance.​pdf. Accessed 20 May 2013).
14.
go back to reference Ashley, L., Jones, H., Thomas, J., Forman, D., Newsham, A., Morris, E., et al. (2011). Integrating cancer survivors’ experiences into UK cancer registries: Design and development of the ePOCS system (electronic Patient-reported Outcomes from Cancer Survivors). British Journal of Cancer, 105, S74–S81. doi:10.1038/Bjc.2011.424.PubMedCentralPubMedCrossRef Ashley, L., Jones, H., Thomas, J., Forman, D., Newsham, A., Morris, E., et al. (2011). Integrating cancer survivors’ experiences into UK cancer registries: Design and development of the ePOCS system (electronic Patient-reported Outcomes from Cancer Survivors). British Journal of Cancer, 105, S74–S81. doi:10.​1038/​Bjc.​2011.​424.PubMedCentralPubMedCrossRef
16.
go back to reference Boers-Doets, C. B., Gelderblom, H., Lacouture, M. E., Epstein, J. B., Nortier, J. W., & Kaptein, A. A. (2013). Experiences with the FACT-EGFRI-18 instrument in EGFRI-associated mucocutaneous adverse events. Supportive Care in Cancer,. doi:10.1007/s00520-013-1752-4. Boers-Doets, C. B., Gelderblom, H., Lacouture, M. E., Epstein, J. B., Nortier, J. W., & Kaptein, A. A. (2013). Experiences with the FACT-EGFRI-18 instrument in EGFRI-associated mucocutaneous adverse events. Supportive Care in Cancer,. doi:10.​1007/​s00520-013-1752-4.
17.
go back to reference Chan, A., & Tan, E. H. (2011). How well does the MESTT correlate with CTCAE scale for the grading of dermatological toxicities associated with oral tyrosine kinase inhibitors? Supportive Care in Cancer, 19(10), 1667–1674. doi:10.1007/s00520-010-0999-2.PubMedCrossRef Chan, A., & Tan, E. H. (2011). How well does the MESTT correlate with CTCAE scale for the grading of dermatological toxicities associated with oral tyrosine kinase inhibitors? Supportive Care in Cancer, 19(10), 1667–1674. doi:10.​1007/​s00520-010-0999-2.PubMedCrossRef
18.
go back to reference Farnell, D. J., Mandall, P., Anandadas, C., Routledge, J., Burns, M. P., Logue, J. P., et al. (2010). Development of a patient-reported questionnaire for collecting toxicity data following prostate brachytherapy. Radiotherapy and Oncology, 97(1), 136–142. doi:10.1016/j.radonc.2010.05.011.PubMedCrossRef Farnell, D. J., Mandall, P., Anandadas, C., Routledge, J., Burns, M. P., Logue, J. P., et al. (2010). Development of a patient-reported questionnaire for collecting toxicity data following prostate brachytherapy. Radiotherapy and Oncology, 97(1), 136–142. doi:10.​1016/​j.​radonc.​2010.​05.​011.PubMedCrossRef
19.
go back to reference Quinten, C., Maringwa, J., Gotay, C. C., Martinelli, F., Coens, C., Reeve, B. B., et al. (2011). Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. Journal of the National Cancer Institute, 103(24), 1851–1858. doi:10.1093/Jnci/Djr485.PubMedCrossRef Quinten, C., Maringwa, J., Gotay, C. C., Martinelli, F., Coens, C., Reeve, B. B., et al. (2011). Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. Journal of the National Cancer Institute, 103(24), 1851–1858. doi:10.​1093/​Jnci/​Djr485.PubMedCrossRef
20.
go back to reference Stacey, D., Bakker, D., Ballantyne, B., Chapman, K., Cumminger, J., Green, E., et al. (2012). Managing symptoms during cancer treatments: evaluating the implementation of evidence-informed remote support protocols. Implementation Science, 7, 110. doi:10.1186/1748-5908-7-110.PubMedCrossRef Stacey, D., Bakker, D., Ballantyne, B., Chapman, K., Cumminger, J., Green, E., et al. (2012). Managing symptoms during cancer treatments: evaluating the implementation of evidence-informed remote support protocols. Implementation Science, 7, 110. doi:10.​1186/​1748-5908-7-110.PubMedCrossRef
21.
go back to reference Johansen, M. A., Henriksen, E., Horsch, A., Schuster, T., & Berntsen, G. K. R. (2012). Electronic symptom reporting between patient and provider for improved health care service quality: A systematic review of randomized controlled trials. Part 1: State of the Art. Journal of Medical Internet Research, 14(5). doi:10.2196/jmir.2214. Johansen, M. A., Henriksen, E., Horsch, A., Schuster, T., & Berntsen, G. K. R. (2012). Electronic symptom reporting between patient and provider for improved health care service quality: A systematic review of randomized controlled trials. Part 1: State of the Art. Journal of Medical Internet Research, 14(5). doi:10.​2196/​jmir.​2214.
22.
go back to reference Johansen, M. A., Henriksen, E., Berntsen, G., & Horsch, A. (2011). Electronic symptom reporting by patients: A literature review. Studies in Health Technology and Informatics, 169, 13–17.PubMed Johansen, M. A., Henriksen, E., Berntsen, G., & Horsch, A. (2011). Electronic symptom reporting by patients: A literature review. Studies in Health Technology and Informatics, 169, 13–17.PubMed
23.
24.
go back to reference King, A., Daniels, J., Lim, J., Cochrane, D. D., Taylor, A., & Ansermino, J. M. (2010). Time to listen: A review of methods to solicit patient reports of adverse events. Quality and Safety in Health Care, 19(2), 148–157. doi:10.1136/qshc.2008.030114.PubMedCrossRef King, A., Daniels, J., Lim, J., Cochrane, D. D., Taylor, A., & Ansermino, J. M. (2010). Time to listen: A review of methods to solicit patient reports of adverse events. Quality and Safety in Health Care, 19(2), 148–157. doi:10.​1136/​qshc.​2008.​030114.PubMedCrossRef
26.
go back to reference Detmar, S. B., Muller, M. J., Schornagel, J. H., Wever, L. D., & Aaronson, N. K. (2002). Health-related quality-of-life assessments and patient-physician communication: A randomized controlled trial. JAMA, 288(23), 3027–3034.PubMedCrossRef Detmar, S. B., Muller, M. J., Schornagel, J. H., Wever, L. D., & Aaronson, N. K. (2002). Health-related quality-of-life assessments and patient-physician communication: A randomized controlled trial. JAMA, 288(23), 3027–3034.PubMedCrossRef
27.
28.
go back to reference Stull, D. E., Leidy, N. K., Parasuraman, B., & Chassany, O. (2009). Optimal recall periods for patient-reported outcomes: Challenges and potential solutions. Current Medical Research and Opinion, 25(4), 929–942. doi:10.1185/03007990902774765.PubMedCrossRef Stull, D. E., Leidy, N. K., Parasuraman, B., & Chassany, O. (2009). Optimal recall periods for patient-reported outcomes: Challenges and potential solutions. Current Medical Research and Opinion, 25(4), 929–942. doi:10.​1185/​0300799090277476​5.PubMedCrossRef
30.
go back to reference Wild, D., Eremenco, S., Mear, I., Martin, M., Houchin, C., Gawlicki, M., et al. (2009). Multinational trials-recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: The ISPOR patient-reported outcomes translation and linguistic validation good research practices task force report. Value in Health, 12(4), 430–440. doi:10.1111/j.1524-4733.2008.00471.x.PubMedCrossRef Wild, D., Eremenco, S., Mear, I., Martin, M., Houchin, C., Gawlicki, M., et al. (2009). Multinational trials-recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: The ISPOR patient-reported outcomes translation and linguistic validation good research practices task force report. Value in Health, 12(4), 430–440. doi:10.​1111/​j.​1524-4733.​2008.​00471.​x.PubMedCrossRef
31.
go back to reference Basch, E., Reeve, B. B., Mitchell, S. A., Clauser, S. B., Minasian, L. M., Atkinson, T. M., et al. (Under Review). Development of the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Journal of National Cancer Institute. Basch, E., Reeve, B. B., Mitchell, S. A., Clauser, S. B., Minasian, L. M., Atkinson, T. M., et al. (Under Review). Development of the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Journal of National Cancer Institute.
32.
go back to reference Willis, G. B. (2005). Cognitive interviewing: A tool for improving questionnaire design. Thousand Oaks, CA: SAGE Publications, Inc. Willis, G. B. (2005). Cognitive interviewing: A tool for improving questionnaire design. Thousand Oaks, CA: SAGE Publications, Inc.
33.
go back to reference Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., et al. (2011). 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 in Health, 14(8), 978–988. doi:10.1016/j.jval.2011.06.013.PubMedCrossRef Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., et al. (2011). 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 in Health, 14(8), 978–988. doi:10.​1016/​j.​jval.​2011.​06.​013.PubMedCrossRef
36.
go back to reference Jobe, J. B., & Mingay, D. J. (1989). Cognitive research improves questionnaires. American Journal of Public Health, 79(8), 1053–1055.PubMedCrossRef Jobe, J. B., & Mingay, D. J. (1989). Cognitive research improves questionnaires. American Journal of Public Health, 79(8), 1053–1055.PubMedCrossRef
37.
go back to reference Jobe, J. B. (2003). Cognitive psychology and self-reports: Models and methods. Quality of Life Research, 12(3), 219–227.PubMedCrossRef Jobe, J. B. (2003). Cognitive psychology and self-reports: Models and methods. Quality of Life Research, 12(3), 219–227.PubMedCrossRef
38.
go back to reference Miller, K. (2003). Conducting cognitive interviews to understand question-response limitations. American Journal of Health Behavior, 27(Suppl 3), S264–S272.PubMedCrossRef Miller, K. (2003). Conducting cognitive interviews to understand question-response limitations. American Journal of Health Behavior, 27(Suppl 3), S264–S272.PubMedCrossRef
39.
go back to reference Schwarz, N., Oyserman, D., & Petycheva, E. (2010). Cognition, communication, and culture: Implications for the survey response process. In J. A. Harkness, M. Braun, B. Edwards, T. P. Johnson, L. E. Lyberg, P. P. Mohler, et al. (Eds.), Survey methods in multinational, multicultural, and multiregional contexts (pp. 177–190). Hoboken, NJ: John Wiley & Sons. Schwarz, N., Oyserman, D., & Petycheva, E. (2010). Cognition, communication, and culture: Implications for the survey response process. In J. A. Harkness, M. Braun, B. Edwards, T. P. Johnson, L. E. Lyberg, P. P. Mohler, et al. (Eds.), Survey methods in multinational, multicultural, and multiregional contexts (pp. 177–190). Hoboken, NJ: John Wiley & Sons.
40.
go back to reference Tourangeau, R. (1984). Cognitive science and survey methods. In T. Jabine, M. Straf, J. Tanur, & R. Tourangeau (Eds.), Cognitive aspects of survey design: Building a bridge between disciplines (pp. 73–100). Washington, DC: National Academy Press. Tourangeau, R. (1984). Cognitive science and survey methods. In T. Jabine, M. Straf, J. Tanur, & R. Tourangeau (Eds.), Cognitive aspects of survey design: Building a bridge between disciplines (pp. 73–100). Washington, DC: National Academy Press.
41.
go back to reference Namey, E., Guest, G., Thairy, L., & Johnson, L. (2008). Data reduction techniques for large qualitative data sets. In G. Guest & K. M. MacQueen (Eds.), Handbook for team-based qualitative research (pp. 137–161). Lanham, MD: AltaMira Press. Namey, E., Guest, G., Thairy, L., & Johnson, L. (2008). Data reduction techniques for large qualitative data sets. In G. Guest & K. M. MacQueen (Eds.), Handbook for team-based qualitative research (pp. 137–161). Lanham, MD: AltaMira Press.
42.
go back to reference Saldana, J. (2009). The coding manual for qualitative researchers. Los Angeles, CA: Sage Publications. Saldana, J. (2009). The coding manual for qualitative researchers. Los Angeles, CA: Sage Publications.
45.
go back to reference Mitchell, S. A., Lang, K., Nichols, C., Clauser, S. B., Federico, V., Lalla, D., et al. (2012). Validation of the NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in women receiving treatment for metastatic breast cancer. Chicago, IL: Annual Meeting of the American Society of Clinical Oncology. Mitchell, S. A., Lang, K., Nichols, C., Clauser, S. B., Federico, V., Lalla, D., et al. (2012). Validation of the NCI Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in women receiving treatment for metastatic breast cancer. Chicago, IL: Annual Meeting of the American Society of Clinical Oncology.
46.
go back to reference Dueck, A. C., Mendoza, T., Mitchell, S. A., Reeve, B. B., Castro, K., Denicoff, A., et al. (2012). Validity and reliability of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Chicago, IL: Annual Meeting of the American Society of Clinical Oncology. Dueck, A. C., Mendoza, T., Mitchell, S. A., Reeve, B. B., Castro, K., Denicoff, A., et al. (2012). Validity and reliability of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Chicago, IL: Annual Meeting of the American Society of Clinical Oncology.
47.
go back to reference Coons, S. J., Gwaltney, C. J., Hays, R. D., Lundy, J. J., Sloan, J. A., Revicki, D. A., et al. (2009). Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO good research practices task force report. Value in Health, 12(4), 419–429. doi:10.1111/j.1524-4733.2008.00470.x.PubMedCrossRef Coons, S. J., Gwaltney, C. J., Hays, R. D., Lundy, J. J., Sloan, J. A., Revicki, D. A., et al. (2009). Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO good research practices task force report. Value in Health, 12(4), 419–429. doi:10.​1111/​j.​1524-4733.​2008.​00470.​x.PubMedCrossRef
48.
go back to reference (2012) Methodological standards and patient-centeredness in comparative effectiveness research—The PCORI perspective. JAMA, 307(15), 1636–1640. doi:10.1001/jama.2012.466. (2012) Methodological standards and patient-centeredness in comparative effectiveness research—The PCORI perspective. JAMA, 307(15), 1636–1640. doi:10.​1001/​jama.​2012.​466.
Metagegevens
Titel
Cognitive interviewing of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Auteurs
Jennifer L. Hay
Thomas M. Atkinson
Bryce B. Reeve
Sandra A. Mitchell
Tito R. Mendoza
Gordon Willis
Lori M. Minasian
Steven B. Clauser
Andrea Denicoff
Ann O’Mara
Alice Chen
Antonia V. Bennett
Diane B. Paul
Joshua Gagne
Lauren Rogak
Laura Sit
Vish Viswanath
Deborah Schrag
Ethan Basch
the NCI PRO-CTCAE Study Group
Publicatiedatum
01-02-2014
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 1/2014
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-013-0470-1

Andere artikelen Uitgave 1/2014

Quality of Life Research 1/2014 Naar de uitgave