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. doi: 10.14694/EDBK_159514. [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 [Read Article]External Web Site Policy

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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. doi: 10.1093/jnci/dju244. [View Abstract]External Web Site Policy

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PRO-CTCAE Qualitative Content Validity

  • 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. International Journal of Radiation Oncology, Biology and Physics 2018. doi: 10.1016/j.ijrobp.2018.04.048. [EPub ahead of print] [View Abstract]External Web Site Policy
  • Miyaji T, Iioka Y, 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 US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). J Patient Rep Outcomes 2017;1:8. doi: 10.1186/s41687-017-0012-7. [Read Article]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. doi: 10.1016/j.jpainsymman.2016.02.008. [View Abstract]External Web Site Policy
  • 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. doi: 10.1007/s00520-015-3062-5. [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. doi: 10.1016/j.ejon.2014.07.007. [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 US 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. doi: 10.1007/s11136-013-0470-1. [View Abstract]External Web Site Policy

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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 2017 Nov 9. pii: S0885-3924(17)30628-0. [Epub ahead of print] [Look up in PubMed]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
  • 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 US National Cancer Institute's PRO-CTCAE. Clin Trials 2017 Jun;14(3):255-263. [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. doi: 10.1093/annonc/mdw422. [View Abstract]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 US 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

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PRO-CTCAE for Children & Adolescents

  • 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). doi: 10.1002/pbc.26261. [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. doi: 10.1002/pbc.24463. [View Abstract]External Web Site Policy

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Feasibility & Acceptability of PRO-CTCAE Implementation in Cancer Research

  • Schoen MW, Basch E, Hudson LL, Chung AE, Mendoza TR, Mitchell SA, St. Germain D, Baumgartner P, Sit L, Rogak LJ, Shouery M, Shalley E, Reeve BB, Fawzy MR, Bhavsar NA, Cleeland C, Schrag D, Dueck AC, Abernethy AP. Software for Administering the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study. JMIR Hum Factors 2018;5(3):e10070. doi: 10.2196/10070. [Read Article]External Web Site Policy
  • Baeksted C, Pappot H, Nissen A, Hjollund NH, Mitchell SA, Basch E, Bidstrup PE, Dalton SO, Johansen C. Feasibility and acceptability of electronic symptom surveillance with clinician feedback using the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Danish prostate cancer patients. J Patient Rep Outcomes 2017;1:1. doi: 10.1186/s41687-017-0005-6. [Read Article]External Web Site Policy
  • Basch E, Dueck AC, Rogak LJ, Minasian LM, Kelly WK, O'Mara AM, Denicoff AM, Seisler D, Atherton PJ, Paskett E, Carey L, Dickler M, Heist RS, Himelstein A, Rugo HS, Sikov WM, Socinski MA, Venook AP, Weckstein DJ, Lake DE, Biggs DD, Freedman RA, Kuzma C, Kirshner JJ, Schrag D. Feasibility Assessment of Patient Reporting of Symptomatic Adverse Events in Multicenter Cancer Clinical Trials. JAMA Oncol 2017 Aug 1;3(8):1043-1050. doi: 10.1001/jamaoncol.2016.6749. [View Abstract]External Web Site Policy
  • Bruner DW, Hanisch LJ, Reeve BB, Trotti AM, Schrag D, Sit L, Mendoza TR, Minasian L, O'Mara A, Denicoff AM, Rowland JH, Montello M, Geoghegan C, Abernethy AP, Clauser SB, Castro K, Mitchell SA, Burke L, Trentacosti AM, Basch EM. Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Transl Behav Med 2011 Mar;1(1):110-22. doi: 10.1007/s13142-011-0025-3. [View Abstract]External Web Site Policy

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Regulatory Science

  • 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 2017 Dec 13. pii: clincanres.2555.2017. [Epub ahead of print] [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 (PRO) measures: Summary of an FDA and Critical Path Institute Workshop. Value in Health 2017. [View Publication]External Web Site Policy

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Other Publications

  • Chera BS, Eisbruch A, Murphy BA, Ridge JA, Gavin P, Reeve BB, Bruner DW, Movsas B. Recommended patient-reported core set of symptoms to measure in head and neck cancer treatment trials. J Natl Cancer Inst 2014 Jul 8;106(7). pii: dju127. Print 2014 Jul. Review. [View Abstract]External Web Site Policy
  • Chen RC, Chang P, Vetter RJ, Lukka H, Stokes WA, Sanda MG, Watkins-Bruner D, Reeve BB, Sandler HM. Recommended patient-reported core set of symptoms to measure in prostate cancer treatment trials. J Natl Cancer Inst 2014 Jul 8;106(7). pii: dju132. Print 2014 Jul. Review. [View Abstract]External Web Site Policy
  • Donovan KA, Donovan HS, Cella D, Gaines ME, Penson RT, Plaxe SC, von Gruenigen VE, Bruner DW, Reeve BB, Wenzel L. Recommended patient-reported core set of symptoms and quality-of-life domains to measure in ovarian cancer treatment trials. J Natl Cancer Inst 2014 Jul 8;106(7). pii: dju128. Print 2014 Jul. Review. [View Abstract]External Web Site Policy
  • Reeve BB, Mitchell SA, Dueck AC, Basch E, Cella D, Reilly CM, Minasian LM, Denicoff AM, O'Mara AM, Fisch MJ, Chauhan C, Aaronson NK, Coens C, Bruner DW. Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. J Natl Cancer Inst 2014 Jul 8;106(7). pii: dju129. Print 2014 Jul. Review. [View Abstract]External Web Site Policy

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