Publications

Overview of PRO-CTCAE

  • Kluetz PG, Chingos DT, Basch EM, Mitchell SA. Patient-Reported Outcomes in Cancer Clinical Trials: Measuring Symptomatic Adverse Events With the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Am Soc Clin Oncol Educ Book. 2016;35:67-73. Review. [View Abstract]External Web Site Policy
  • Minasian LM, O'Mara A, Mitchell SA. Clinician and Patient Reporting of Symptomatic Adverse Events in Cancer Clinical Trials: Using CTCAE and PRO-CTCAE® to Provide Two Distinct and Complementary Perspectives Patient Relat Outcome Meas. 2022 Dec 8;13:249-258. doi:10.2147/PROM.S256567. [View Abstract]External Web Site Policy
  • Smith AW, Mitchell SA, K De Aguiar C, Moy C, Riley WT, Wagster MV, M Werner E. News from the NIH: Person-centered outcomes measurement: NIH-supported measurement systems to evaluate self-assessed health, functional performance, and symptomatic toxicity. Transl Behav Med. 2016 Sep;6(3):470-4. [Look up in PubMed]External Web Site Policy

PRO-CTCAE Item Development

  • Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 2014 Sep 29;106(9). pii: dju244. Print 2014 Sep. [View Abstract]External Web Site Policy

PRO-CTCAE Qualitative Content Validity

  • Arnold B, Mitchell SA, Lent L, Mendoza TR, Rogak LJ, Barragán NM, Willis G, Medina M, Lechner S, Penedo FJ, Harness JK, Basch EM; PRO-CTCAE Spanish Translation and Linguistic Validation Study Group. Linguistic validation of the Spanish version of the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Support Care Cancer. 2016 Jul;24(7):2843-51. [View Abstract]External Web Site Policy
  • Bæksted C, Nissen A, Pappot H, Bidstrup PE, Mitchell SA, Basch E, Dalton SO, Johansen C. Danish Translation and Linguistic Validation of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). J Pain Symptom Manage. 2016 Aug;52(2):292-7. [View Abstract]External Web Site Policy
  • Caminiti C, Bryce J, Riva S, Ng D, Diodati F, Iezzi E, Sparavigna L, Novello S, Porta C, Del Mastro L, Procopio G, Cinieri S, Falzetta A, Calabrò F, Lorusso V, Cogoni AA, Tortora G, Maruzzo M, Passalacqua R, Cognetti F, Adamo V, Capelletto E, Ferrari A, Bagnalasta M, Bassi M, Nicelli A, De Persis D, D'Acunti A, Iannelli Patient E, Perrone F, Mitchell SA. Cultural adaptation of the Italian version of the Patient-Reported Outcomes Common Terminology Criteria for Adverse Event (PRO-CTCAE®). Tumori. 2022 Jun 8:3008916221099558. doi: 10.1177/03008916221099558. [Epub ahead of print] [View Abstract]External Web Site Policy
  • Cheng Kkf, Mitchell SA, Chan N, Ang E, Tam W, Kanesvaran R. Linguistic validation of the simplified Chinese version of the U.S. National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™). BMC Cancer. 2020 Nov 26;20(1):1153. [View Abstract]External Web Site Policy
  • Cho J, Yoon J, Kim Y, Oh D, Kim SJ, Ahn J, Suh GY, Nam SJ, Mitchell SA. Linguistic Validation of the U.S. National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Korean. J Glob Oncol. 2019 Mar;5:1-10. doi: 10.1200/JGO.18.00193. [View Abstract]External Web Site Policy
  • Hay JL, Atkinson TM, Reeve BB, Mitchell SA, Mendoza TR, Willis G, Minasian LM, Clauser SB, Denicoff A, O'Mara A, Chen A, Bennett AV, Paul DB, Gagne J, Rogak L, Sit L, Viswanath V, Schrag D, Basch E; NCI PRO-CTCAE Study Group. Cognitive interviewing of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Qual Life Res. 2014 Feb;23(1):257-69. [View Abstract]External Web Site Policy
  • Kirsch M, Mitchell SA, Dobbels F, Stussi G, Basch E, Halter JP, De Geest S. Linguistic and content validation of a German-language PRO-CTCAE-based patient-reported outcomes instrument to evaluate the late effect symptom experience after allogeneic hematopoietic stem cell transplantation. Eur J Oncol Nurs. 2015 Feb;19(1):66-74. [View Abstract]External Web Site Policy
  • Miyaji T, Iioka Y, Kuroda Y, Yamamoto D, Iwase S, Goto Y, Tsuboi M, Odagiri H, Tsubota Y, Kawaguchi T, Sakata N, Basch E, Yamaguchi T. Japanese translation and linguistic validation of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). J Patient Rep Outcomes. 2017;1(1):8. [View Abstract]External Web Site Policy
  • Sandler KA, Mitchell SA, Basch E, Raldow AC, Steinberg ML, Sharif J, Cook RR, Kupelian PA, McCloskey SA. Content Validity of Anatomic Site-Specific Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Sets for Assessment of Acute Symptomatic Toxicities in Radiation Oncology. Int J Radiat Oncol Biol Phys. 2018 Sep 1;102(1):44-52. [View Abstract]External Web Site Policy
  • Veldhuijzen E, Walraven I, Mitchell SA, Moore EY, McKown SM, Lauritzen M, Kim KJ, Belderbos JSA, Aaronson NK. Dutch translation and linguistic validation of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™). J Patient Rep Outcomes. 2020 Oct 6;4(1):81. [View Abstract]External Web Site Policy

PRO-CTCAE Reliability, Validity, Recall Period, & Cross-Mode Equivalence

  • Atkinson TM, Hay JL, Dueck AC, Mitchell SA, Mendoza TR, Rogak LJ, Minasian LM, Basch E. What Do "None," "Mild," "Moderate," "Severe," and "Very Severe" Mean to Patients With Cancer? Content Validity of PRO-CTCAE™ Response Scales. J Pain Symptom Manage. 2018 Mar;55(3):e3-e6. [Look up in PubMed]External Web Site Policy
  • Bennett AV, Dueck AC, Mitchell SA, Mendoza TR, Reeve BB, Atkinson TM, Castro KM, Denicoff A, Rogak LJ, Harness JK, Bearden JD, Bryant D, Siegel RD, Schrag D, Basch E; National Cancer Institute PRO-CTCAE Study Group. Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Health Qual Life Outcomes. 2016 Feb 19;14:24. doi: 10.1186/s12955-016-0426-6. [View Abstract]External Web Site Policy
  • Dueck AC, Mendoza TR, Mitchell SA, Reeve BB, Castro KM, Rogak LJ, Atkinson TM, Bennett AV, Denicoff AM, O'Mara AM, Li Y, Clauser SB, Bryant DM, Bearden JD 3rd, Gillis TA, Harness JK, Siegel RD, Paul DB, Cleeland CS, Schrag D, Sloan JA, Abernethy AP, Bruner DW, Minasian LM, Basch E; National Cancer Institute PRO-CTCAE Study Group. Validity and Reliability of the U.S. National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol. 2015 Nov;1(8):1051-9. Erratum in: JAMA Oncol. 2016 Jan;2(1):146. [View Abstract]External Web Site Policy
  • Hagelstein V, Ortland I, Wilmer A, Mitchell SA, Jaehde U. Validation of the German patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™). Ann Oncol. 2016 Dec;27(12):2294-2299. [View Abstract]External Web Site Policy
  • Knoerl R, Gray E, Stricker C, Mitchell SA, Kippe K, Smith G, Dudley WN, Lavoie Smith EM. Electronic versus paper-pencil methods for assessing chemotherapy-induced peripheral neuropathy. Support Care Cancer. 2017 Nov;25(11):3437-3446. [View Abstract]External Web Site Policy
  • Lee MK, Basch E, Mitchell SA, Minasian LM, Langlais BT, Thanarajasingam G, Ginos BF, Rogak LJ, Mendoza TR, Bennett AV, Schrag D, Mazza GL, Dueck AC. Reliability and validity of PRO-CTCAE® daily reporting with a 24-hour recall period. Qual Life Res. 2023 Jul;32(7):2047-2058. doi: 10.1007/s11136-023-03374-5. Epub 2023 Mar 10. [Look up in PubMed]External Web Site Policy
  • Mendoza TR, Dueck AC, Bennett AV, Mitchell SA, Reeve BB, Atkinson TM, Li Y, Castro KM, Denicoff A, Rogak LJ, Piekarz RL, Cleeland CS, Sloan JA, Schrag D, Basch E. Evaluation of different recall periods for the U.S. National Cancer Institute's PRO-CTCAE. Clin Trials. 2017 Jun;14(3):255-263. [View Abstract]External Web Site Policy
  • Paudel R, Enzinger AC, Uno H, Cronin C, Wong SL, Dizon DS, Hazard Jenkins H, Bian J, Osarogiagbon RU, Jensen RE, Mitchell SA, Schrag D, Hassett MJ. Effects of a change in recall period on reporting severe symptoms: an analysis of a pragmatic multisite trial. J Natl Cancer Inst. 2024 Mar 5:djae049. doi: 10.1093/jnci/djae049. [Epub ahead of print.] [View Abstract]External Web Site Policy
  • Yoon J, Sim SH, Kang D, Han G, Kim Y, Ahn J, Oh D, Lee ES, Kong SY, Cho J, Mitchell SA. Reliability and Validity of the Korean Language Version of the U.S. National Cancer Institute's Patient-Reported Outcomes Common Terminology Criteria for Adverse Events. J Pain Symptom Manage. 2020 Feb 8. pii: S0885-3924(20)30067-1. [Epub ahead of print] [View Abstract]External Web Site Policy

Ped-PRO-CTCAE Module Reliability and Validity

  • McFatrich M, Brondon J, Lucas NR, Hinds PS, Maurer SH, Mack JW, Freyer DR, Jacobs SS, Baker JN, Mowbray C, Wang M, Castellino SM, Barz Leahy A, Reeve BB. Mapping child and adolescent self-reported symptom data to clinician-reported adverse event grading to improve pediatric oncology care and research. Cancer. 2020 Jan 1;126(1):140-147. [View Abstract]External Web Site Policy
  • Reeve BB, McFatrich M, Lin L, Lucas NR, Mack JW, Jacobs SS, Withycombe JS, Baker JN, Freyer DR, Hinds PS. Validation of the caregiver Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events measure. Cancer. 2020 Dec 17. [View Abstract]External Web Site Policy.
  • Reeve BB, McFatrich M, Mack JW, Maurer SH, Jacobs SS, Freyer DR, Withycombe JS, Baker JN, Castellino SM, Lin L, Lucas NR, Hinds PS. Validity and Reliability of the Pediatric Patient-Reported Outcomes - Common Terminology Criteria for Adverse Events. J Natl Cancer Inst. 2020 Jan 30. pii: djaa016. [Epub ahead of print] [View Abstract]External Web Site Policy
  • Reeve BB, McFatrich M, Pinheiro LC, Freyer DR, Basch EM, Baker JN, Withycombe JS, Sung L, Mack JW, Waldron MK, Mowbray C, Palma D, Hinds PS. Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer. J Pain Symptom Manage. 2017 Apr;53(4):759-766. [View Abstract]External Web Site Policy
  • Reeve BB, McFatrich M, Pinheiro LC, Weaver MS, Sung L, Withycombe JS, Baker JN, Mack JW, Waldron MK, Gibson D, Tomlinson D, Freyer DR, Mowbray C, Jacobs S, Palma D, Martens CE, Gold SH, Jackson KD, Hinds PS. Eliciting the child's voice in adverse event reporting in oncology trials: Cognitive interview findings from the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events initiative. Pediatr Blood Cancer. 2017 Mar;64(3). [View Abstract]External Web Site Policy
  • Reeve BB, Withycombe JS, Baker JN, Hooke MC, Lyons JC, Mowbray C, Wang J, Freyer DR, Joffe S, Sung L, Tomlinson D, Gold SH, Hinds PS. The first step to integrating the child's voice in adverse event reporting in oncology trials: a content validation study among pediatric oncology clinicians. Pediatr Blood Cancer. 2013 Jul;60(7):1231-6. [View Abstract]External Web Site Policy
  • Shen N, Ruan H, Sun J, Li Y, He M, Yuan C, Chang L. Translation Into Simplified Chinese and Cultural Validation of the Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Using Cognitive Interviewing. Cancer Nurs. 2023 Jan-Feb 01;46(1):E31-E40. [View Abstract]External Web Site Policy
  • Weaver MS, Reeve BB, Baker JN, Martens CE, McFatrich M, Mowbray C, Palma D, Sung L, Tomlinson D, Withycombe J, Hinds P. Concept-elicitation phase for the development of the pediatric patient-reported outcome version of the Common Terminology Criteria for Adverse Events. Cancer 2016 Jan 1;122(1):141-8. [View Abstract]External Web Site Policy
  • Zucchetti G, Tirtei E, Bertorello N, De Luna E, Vallero S, Fagioli F. Translation and cultural adaptation of the U.S. National Cancer Institute's patient-reported outcome (PRO) version of the CTCAE for Italian pediatric oncology populations. Eur J Oncol Nurs. 2018 Aug;35:67-72. [View Abstract]External Web Site Policy

Regulatory Science

  • George GC, Barata PC, Campbell A, Chen A, Cortes JE, Hyman DM, Jones L, Karagiannis T, Klaar S, Le-Rademacher JG, LoRusso P, Mandrekar SJ, Merino DM, Minasian LM, Mitchell SA, Montez S, O'Connor DJ, Pettit S, Silk E, Sloan JA, Stewart M, Takimoto CH, Wong GY, Yap TA, Cleeland CS, Hong DS. Improving attribution of adverse events in oncology clinical trials. Cancer Treat Rev. 2019 Jun;76:33-40. Review. [View Abstract]External Web Site Policy
  • Kim J, Singh H, Ayalew K, Borror K, Campbell M, Johnson LL, Karesh A, Khin NA, Less JR, Menikoff J, Minasian L, Mitchell SA, Papadopoulos EJ, Piekarz RL, Prohaska KA, Thompson S, Sridhara R, Pazdur R, Kluetz PG. Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections. Clin Cancer Res. 2018 Apr 15;24(8):1780-1784. Review. [View Abstract]External Web Site Policy
  • Kluetz PG, Kanapuru B, Lemery S, Johnson LL, Fiero MH, Arscott K, Barbachano Y, Basch E, Campbell M, Cappelleri JC, Cella D, Cleeland C, Coens C, Daniels S, Denlinger CS, Fairclough DL, Hillard JR, Minasian L, Mitchell SA, O'Connor D, Patel S, Rubin EH, Ryden A, Soltys K, Sridhara R, Thanarajasingam G, Velikova G, Coons SJ. Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop. Value Health. 2018 Jun;21(6):742-747. [View Abstract]External Web Site Policy

Other Selected Publications

  • Chung AE, Shoenbill K, Mitchell SA, Dueck AC, Schrag D, Bruner DW, Minasian LM, St Germain D, O'Mara AM, Baumgartner P, Rogak LJ, Abernethy AP, Griffin AC, Basch EM. Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). J Am Med Inform Assoc. 2019 Apr 1;26(4):276-285. doi: 10.1093/jamia/ocy169. [View Abstract]External Web Site Policy
Last Updated: 20 Jun, 2024