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Items: 1 to 20 of 148

1.

Patient-reported outcomes and the evolution of adverse event reporting in oncology.

Trotti A, Colevas AD, Setser A, Basch E.

J Clin Oncol. 2007 Nov 10;25(32):5121-7. Review.

PMID:
17991931
3.

Supporting quality and patient safety in cancer clinical trials.

Badalucco S, Reed KK.

Clin J Oncol Nurs. 2011 Jun;15(3):263-5. doi: 10.1188/11.CJON.263-265. Review.

PMID:
21624861
4.

Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).

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.

J Natl Cancer Inst. 2014 Sep 29;106(9). pii: dju244. doi: 10.1093/jnci/dju244. Print 2014 Sep.

5.

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.

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.

Pediatr Blood Cancer. 2017 Mar;64(3). doi: 10.1002/pbc.26261. Epub 2016 Sep 21.

6.

The first step to integrating the child's voice in adverse event reporting in oncology trials: a content validation study among pediatric oncology clinicians.

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.

Pediatr Blood Cancer. 2013 Jul;60(7):1231-6. doi: 10.1002/pbc.24463. Epub 2013 Jan 17.

PMID:
23335328
7.

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance.

Banerjee AK, Okun S, Edwards IR, Wicks P, Smith MY, Mayall SJ, Flamion B, Cleeland C, Basch E; Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium.

Drug Saf. 2013 Dec;36(12):1129-49. doi: 10.1007/s40264-013-0113-z.

8.

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

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.

Qual Life Res. 2014 Feb;23(1):257-69. doi: 10.1007/s11136-013-0470-1. Epub 2013 Jul 20.

9.

Is there room for improvement in adverse event reporting in the era of targeted therapies?

Edgerly M, Fojo T.

J Natl Cancer Inst. 2008 Feb 20;100(4):240-2. doi: 10.1093/jnci/djm324. Epub 2008 Feb 12.

PMID:
18270340
10.

Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

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.

JAMA Oncol. 2015 Nov;1(8):1051-9. doi: 10.1001/jamaoncol.2015.2639. Erratum in: JAMA Oncol. 2016 Jan;2(1):146.

11.

Methods for Implementing and Reporting Patient-reported Outcome (PRO) Measures of Symptomatic Adverse Events in Cancer Clinical Trials.

Basch E, Rogak LJ, Dueck AC.

Clin Ther. 2016 Apr;38(4):821-30. doi: 10.1016/j.clinthera.2016.03.011. Epub 2016 Apr 2.

12.

Integrating patient-reported outcomes into cancer symptom management clinical trials supported by the National Cancer Institute-sponsored clinical trials networks.

Sloan JA, Berk L, Roscoe J, Fisch MJ, Shaw EG, Wyatt G, Morrow GR, Dueck AC; National Cancer Institute.

J Clin Oncol. 2007 Nov 10;25(32):5070-7. Review.

PMID:
17991923
13.

Adverse event reporting in publications compared with sponsor database for cancer clinical trials.

Scharf O, Colevas AD.

J Clin Oncol. 2006 Aug 20;24(24):3933-8.

PMID:
16921045
14.

A Drug Safety Rating System Based on Postmarketing Costs Associated with Adverse Events and Patient Outcomes.

Hoffman KB, Dimbil M, Kyle RF, Tatonetti NP, Erdman CB, Demakas A, Chen D, Overstreet BM.

J Manag Care Spec Pharm. 2015 Dec;21(12):1134-43.

15.

Current status of patient-reported outcomes in industry-sponsored oncology clinical trials and product labels.

Gondek K, Sagnier PP, Gilchrist K, Woolley JM.

J Clin Oncol. 2007 Nov 10;25(32):5087-93. Review.

PMID:
17991926
16.

The Imperative for a New Approach to Toxicity Analysis in Oncology Clinical Trials.

Thanarajasingam G, Hubbard JM, Sloan JA, Grothey A.

J Natl Cancer Inst. 2015 Aug 1;107(10). pii: djv216. doi: 10.1093/jnci/djv216. Print 2015 Oct.

PMID:
26232762
17.

Issues and challenges with integrating patient-reported outcomes in clinical trials supported by the National Cancer Institute-sponsored clinical trials networks.

Bruner DW, Bryan CJ, Aaronson N, Blackmore CC, Brundage M, Cella D, Ganz PA, Gotay C, Hinds PS, Kornblith AB, Movsas B, Sloan J, Wenzel L, Whalen G; National Cancer Institute.

J Clin Oncol. 2007 Nov 10;25(32):5051-7. Review.

18.

Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

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.

Transl Behav Med. 2011 Mar;1(1):110-22. doi: 10.1007/s13142-011-0025-3.

19.

Adherence to CONSORT adverse event reporting guidelines in randomized clinical trials evaluating systemic cancer therapy: a systematic review.

PĂ©ron J, Maillet D, Gan HK, Chen EX, You B.

J Clin Oncol. 2013 Nov 1;31(31):3957-63. doi: 10.1200/JCO.2013.49.3981. Epub 2013 Sep 23. Review.

PMID:
24062406
20.

Feasibility Assessment of Patient Reporting of Symptomatic Adverse Events in Multicenter Cancer Clinical Trials.

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.

JAMA Oncol. 2017 Aug 1;3(8):1043-1050. doi: 10.1001/jamaoncol.2016.6749.

PMID:
28208174

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