Concept-elicitation phase for the development of the pediatric patient-reported outcome version of the Common Terminology Criteria for Adverse Events

Cancer

Volumn 122, Issue 1, 2016, Pages 141-148

  Weaver, Meaghann S ^a,b   Reeve, Bryce B ^c,d   Baker, Justin N ^a   Martens, Christa E ^c   McFatrich, Molly ^c   Mowbray, Catriona ^b   Palma, Diana ^e   Sung, Lillian ^f   Tomlinson, Deborah ^f   Withycombe, Janice ^g,h   Hinds, Pamela ^b,i  

^a ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^b CHILDREN'S NATIONAL MEDICAL CENTER   (United States)

^c UNIVERSITY OF NORTH CAROLINA   (United States)

^d University of North Carolina at Chapel Hill   (United States)

^e CHILDREN S HOSPITAL LOS ANGELES   (United States)

^f HOSPITAL FOR SICK CHILDREN   (Canada)

^g Palmetto Richland Memorial Hospital   (United States)

^h EMORY UNIVERSITY   (United States)

ⁱ GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES   (United States)

Author keywords

adverse events; instrument development; patient communication; patient reported outcomes; pediatric oncology; qualitative research; symptoms

Indexed keywords

ADULT; ADVERSE OUTCOME; AGE DISTRIBUTION; ARTICLE; CHILD; CLINICAL FEATURE; CONCEIT ELICITATION PHASE; CONTROLLED STUDY; DISEASE ASSESSMENT; FATIGUE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; NAUSEA; OUTCOME ASSESSMENT; PAIN; PATIENT ASSESSMENT; PATIENT REPORTED OUTCOME; PHYSICAL PARAMETERS; PRIORITY JOURNAL; PROCESS DEVELOPMENT; SCHOOL CHILD; SYNDROME DELINEATION; VOMITING; WEAKNESS; YOUNG ADULT; ADOLESCENT; DRUG SURVEILLANCE PROGRAM; INTERPERSONAL COMMUNICATION; ORGANIZATION AND MANAGEMENT; PEDIATRICS; PROSPECTIVE STUDY; SELF REPORT;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; CHILD; COMMUNICATION; FEMALE; HUMANS; MALE; PATIENT OUTCOME ASSESSMENT; PEDIATRICS; PROSPECTIVE STUDIES; SELF REPORT; YOUNG ADULT;

EID: 84946059925     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.29702     Document Type: Article

References (29)

1. Basch E, Bennett AV,. Patient-reported outcomes in clinical trials of rare diseases. J Gen Intern Med. 2014; 29 (suppl 3): S801-S803.
2. Yeh CH, Wang CH, Chiang YC, Lin L, Chien LC,. Assessment of symptoms reported by 10- to 18-year-old cancer patients in Taiwan. J Pain Symptom Manage. 2009; 38: 738-746.
3. US Department of Health and Human Services FDA Center for Drug Evaluation and Research, US Department of Health and Human Services FDA Center for Biologics Evaluation and Research, US Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2009; 4: 79.
4. Dodd M, Janson S, Facione N, et al., Advancing the science of symptom management. J Adv Nurs. 2001; 33: 668-676.
5. Wolfe J, Orellana L, Ullrich C, et al., Symptoms and distress in children with advanced cancer: prospective patient-reported outcomes from the PediQUEST study. J Clin Oncol. 2015; 33: 1928-1935.
6. Riesch SK, Anderson LS, Angresano N, Canty-Mitchell J, Johnson DL, Krainuwat K,. Evaluating content validity and test-retest reliability of the children's health risk behavior scale. Public Health Nurs. 2006; 23: 366-372.
7. Stewart JL, Lynn MR, Mishel MH,. Evaluating content validity for children's self-report instruments using children as content experts. Nurs Res. 2005; 54: 414-418.
8. Schilling LS, Dixon JK, Knafl KA, Grey M, Ives B, Lynn MR,. Determining content validity of a self-report instrument for adolescents using a heterogeneous expert panel. Nurs Res. 2007; 56: 361-366.
9. Tomlinson D, Gibson F, Treister N, et al., Understandability, content validity, and overall acceptability of the Children's International Mucositis Evaluation Scale (ChIMES): child and parent reporting. J Pediatr Hematol Oncol. 2009; 31: 416-423.
10. Hedstrom M, Haglund K, Skolin I, von Essen L,. Distressing events for children and adolescents with cancer: child, parent, and nurse perceptions. J Pediatr Oncol Nurs. 2003; 20: 120-132.
11. Basch E, Jia X, Heller G, et al., Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes. J Natl Cancer Inst. 2009; 101: 1624-1632.
12. Basch E, Iasonos A, McDonough T, et al., Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol. 2006; 7: 903-909.
13. Laugsand EA, Sprangers MA, Bjordal K, Skorpen F, Kaasa S, Klepstad P,. Health care providers underestimate symptom intensities of cancer patients: a multicenter European study. Health Qual Life Outcomes. 2010; 8: 104.
14. Davis E, Nicolas C, Waters E, et al., Parent-proxy and child self-reported health-related quality of life: using qualitative methods to explain the discordance. Qual Life Res. 2007; 16: 863-871.
15. Cremeens J, Eiser C, Blades M,. Factors influencing agreement between child self-report and parent proxy-reports on the Pediatric Quality of Life Inventory 4.0 (PedsQL) generic core scales. Health Qual Life Outcomes. 2006; 4: 58.
16. Rajmil L, Lopez AR, Lopez-Aguila S, Alonso J,. Parent-child agreement on health-related quality of life (HRQOL): a longitudinal study. Health Qual Life Outcomes. 2013; 11: 101.
17. Upton P, Lawford J, Eiser C,. Parent-child agreement across child health-related quality of life instruments: a review of the literature. Qual Life Res. 2008; 17: 895-913.
18. Irwin DE, Gross HE, Stucky BD, et al., Development of six PROMIS pediatrics proxy-report item banks. Health Qual Life Outcomes. 2012; 10: 22.
19. National Quality Forum. Patient-reported outcomes in performance measurement. http://www.qualityforum.org/Publications/2012/12/Patient-Reported-Outcomes-in-Performance-Measurement.aspx. Accessed May 16, 2015.
20. Matza LS, Patrick DL, Riley AW, et al., Pediatric patient-reported outcome instruments for research to support medical product labeling: report of the ISPOR PRO good research practices for the assessment of children and adolescents task force. Value Health. 2013; 16: 461-479.
21. Tzelepis F, Rose SK, Sanson-Fisher RW, Clinton-McHarg T, Carey ML, Paul CL,. Are we missing the Institute of Medicine's mark? A systematic review of patient-reported outcome measures assessing quality of patient-centred cancer care. BMC Cancer. 2014; 14: 41.
22. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG,. Research Electronic Data Capture (REDCap)-a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009; 42: 377-381.
23. Miles MS, Holditch-Davis D,. Enhancing nursing research with children and families using a developmental science perspective. Annu Rev Nurs Res. 2003; 21: 1-20.
24. Lerner RM, Wertlieb D, Jacobs F,. Historical and theoretical bases of applied developmental science. In:, Lerner RM, Jacobs F, Wertlieb D, eds. Handbook of Applied Developmental Science. Thousand Oaks, CA: Sage Publications; 2003: 1-30.
25. 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. 2011; 14: 978-988.
26. Collins JJ, Byrnes ME, Dunkel IJ, et al., The measurement of symptoms in children with cancer. J Pain Symptom Manage. 2000; 19: 363-377.
27. Reeve BB, Withycombe JS, Baker JN, et al., 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; 60: 1231-1236.
28. Detmar SB, Aaronson NK, Wever LD, Muller M, Schornagel JH,. How are you feeling? Who wants to know? Patients' and oncologists' preferences for discussing health-related quality-of-life issues. J Clin Oncol. 2000; 18: 3295-3301.
29. Ward E, DeSantis C, Robbins A, Kohler B, Jemal A,. Childhood and adolescent cancer statistics, 2014. CA Cancer J Clin. 2014; 64: 83-103.