Validation of a treatment satisfaction questionnaire in non-hodgkin lymphoma: Assessing the change from intravenous to subcutaneous administration of rituximab

Patient Preference and Adherence

Volumn 10, Issue , 2016, Pages 1767-1776

  Theodore Oklota, Christina ^a   Humphrey, Louise ^b   Wiesner, Christof ^a   Schnetzler, Gabriel ^c   Hudgens, Stacie ^d   Campbell, Alicyn ^a  

^a GENENTECH INC   (United States)

^b ADELPHI REAL WORLD   (United Kingdom)

^c F HOFFMANN LA ROCHE LTD   (Switzerland)

^d Clinical Outcomes Solutions   (United States)

Author keywords

Cognitive interview; MabCute; Non Hodgkin lymphoma; Patient reported outcome measure; PrefMab; Questionnaire; RASQ

Indexed keywords

RITUXIMAB;

ADULT; AGED; ARTICLE; ATTITUDE ASSESSMENT; CONCURRENT VALIDITY; CONTENT VALIDITY; CONTROLLED STUDY; CORRELATIONAL STUDY; DRUG DOSAGE FORM COMPARISON; FACE VALIDITY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY (TOPIC); NONHODGKIN LYMPHOMA; PATIENT SATISFACTION; PERCEPTION; PERFORMANCE MEASUREMENT SYSTEM; PHASE 3 CLINICAL TRIAL (TOPIC); PSYCHOMETRY; QUALITATIVE RESEARCH; RANDOMIZED CONTROLLED TRIAL (TOPIC); RELIABILITY; RITUXIMAB ADMINISTRATION SATISFACTION QUESTIONNAIRE; VALIDATION STUDY;

EID: 84987923233     PISSN: None     EISSN: 1177889X     Source Type: Journal    
DOI: 10.2147/PPA.S108489     Document Type: Article

References (35)

1. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012;62(1):10-29.
2. Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014;32(27):3059-3068.
3. Seiler TM, Hiddemann W. Advances in the management of follicular lymphoma. Curr Opin Oncol. 2012;24(6):742-747.
4. Cultrera JL, Dalia SM. Diffuse large B-cell lymphoma: current strategies and future directions. Cancer Control. 2012;19(3):204-213.
5. Colwell HH, Mathias SD, Ngo NH, Gitlin M, Lu ZJ, Knoop T. The impact of infusion reactions on oncology patients and clinicians in the inpatient and outpatient practice settings: oncology nurses’ perspectives. J Infus Nurs. 2007;30(3):153-160.
6. Schwartzberg LS, Stepanski EJ, Walker MS, athias S, Houts AC, Fortner BV. Implications of IV monoclonal antibody infusion reaction for the patient, caregiver, and practice: results of a multicenter study. Support Care Cancer. 2009;17(1):91-98.
7. Chadda S, Larkin M, Jones C, et al. The impact of infusion reactions associated with monoclonal antibodies in metastatic colorectal cancer: a European perspective. J Oncol Pharm Pract. 2013;19(1):38-47.
8. Salar A, Avivi I, Bittner B, et al. Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study. J Clin Oncol. 2014;32(17):1782-1791.
9. Davies A, Merli F, Mihaljevic B, MacDonald D. Pharmacokinetics (PK), safety and overall response rate (ORR) achieved with subcutaneous (SC) administration of rituximab in combination with chemotherapy were comparable to those achieved with intravenous (IV) administration in patients (pts) with follicular lymphoma (FL) in the first-line setting: stage 1 results of the phase III SABRINA study (BO22334). Presented at: 54th ASH Annual Meeting and Exposition; December 8-11; 2012; Atlanta, USA.
10. Shpilberg O, Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer. 2013;109(6):1556-1561.
11. Stilgenbauer S, Zenz T, Winkler D, et al. Subcutaneous alemtuzumab in fludarabine-refractory chronic lymphocytic leukemia: clinical results and prognostic marker analyses from the CLL2H study of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2009;27(24):3994-4001.
12. Bookbinder LH, Hofer A, Haller MF, et al. A recombinant human enzyme for enhanced interstitial transport of therapeutics. J Control Release. 2006;114(2):230-241.
13. Frost GI. Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Exp Opin Drug Deliv. 2007;4(4):427-440.
14. Thomas JR, Wallace MS, Yocum RC, Vaughn DE, Haller MF, Flament J. The INFUSE-Morphine IIB study: use of recombinant human hyaluronidase (rHuPH20) to enhance the absorption of subcutaneously administered morphine in patients with advanced illness. J Pain Symptom Manage. 2009;38(5):663-672.
15. Harb G, Lebel F, Battikha J, Thackara JW. Safety and pharmacokinetics of subcutaneous ceftriaxone administered with or without recombinant human hyaluronidase (rHuPH20) versus intravenous ceftriaxone administration in adult volunteers. Curr Med Res Opin. 2010;26(2):279-288.
16. Pivot X, Gligorov J, Müller V, et al. Patient preference for subcutaneous versus intravenous adjuvant trastuzumab: results of the PrefHer study. Presented at: the 13th St Gallen International Breast Cancer Conference; March 13-16; 2013; St Gallen, Switzerland.
17. Moreau P, Pylypenko H, Grosicki S, et al. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. Lancet Oncol. 2011;12(5):431-440.
18. Yost KJ, Thompson CA, Eton DT, et al. The functional assessment of cancer therapy-general (FACT-G) is valid for monitoring quality of life in non-Hodgkin lymphoma patients. Leuk Lymphoma. 2013;54(2):290-297.
19. Abetz L, Coombs JH, Keninger DL, et al. Development of the cancer therapy satisfaction questionnaire: item generation and content validity testing. Value Health. 2005;8(S1):S41-S53.
20. Trask PC, Tellefsen C, Espindle D, Getter C, Hsu MA. Psychometric validation of the cancer therapy satisfaction questionnaire. Value Health. 2008;11(4):669-679.
21. Hay JL, Atkinson TM, Reeve BB, et al. 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;23(1):257-269.
22. US Department of Health and Human Services. FDA Center for Drug Evaluation and Research. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Available from: http://ispor.org/workpaper/FDA%20PRO%20Guidance.pdf. Accessed May 1, 2014.
23. Leidy NK, Vernon M. Perspectives on patient-reported outcomes: content validity and qualitative research in a changing clinical trial environment. Pharmacoeconomics. 2008;26(5):363-370.
24. Lasch KE, Marquis P, Vigneux M, et al. PRO development: rigorous qualitative research as the crucial foundation. Qual Life Res. 2010;19(8):1087-1096.
25. European Medicines Agency. Reflection Paper on the Regulatory Guidance for the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products. Available from: http://ispor.org/workpaper/EMEA-HRQL-Guidance.pdf. Accessed November 21, 2013.
26. 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 1-eliciting concepts for a new PRO instrument. Value Health. 2011;14(8):967-977.
27. 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(8):978-988.
28. Ericsson K, Simon H. Verbal reports as data. Psychol Rev. 1980;87(3):215-251.
29. Streiner DL. Being inconsistent about consistency: when coefficient alpha does and doesn’t matter. J Pers Assess. 2003;80(3):217-222.
30. Rummel M, Kim TM, Plenteda C, et al. Prefmab: final analysis of patient preference for subcutaneous versus intravenous rituximab in previously untreated CD20+ diffuse large B-cell lymphoma and follicular lymphoma. Blood. 2015;126:3972.
31. Knutsen AP, Siegal J. Understanding subcutaneous immunoglobulin therapies for primary immunodeficiency diseases. Pharmacy Practice News: Special Report. New York: McMahon Publishing, 2010.
32. Cappellini MD, Bejaoui M, Agaoglu L, et al. Prospective evaluation of patient-reported outcomes during treatment with deferasirox or deferoxamine for iron overload in patients with beta-thalassemia. Clin Ther. 2007;29(5):909-917.
33. Fallowfield L, Atkins L, Catt S, et al. Patients’ preference for administration of endocrine treatments by injection or tablets: results from a study of women with breast cancer. Ann Oncol. 2006;17(2):205-210.
34. Scarpato S, Antivalle M, Favalli EG, et al. Patient preferences in the choice of anti-TNF therapies in rheumatoid arthritis. Results from a questionnaire survey (RIVIERA study). Rheumatology (Oxford). 2010;49(2):289-294.
35. Allen PB, Lindsay H, Tham TC. How do patients with inflammatory bowel disease want their biological therapy administered? BMC Gastroenterol. 2010;10(1):1.