Development and alpha-testing of a patient decision aid for patients with chronic myeloid leukemia regarding dose reduction.

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  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101088682 Publication Model: Electronic Cited Medium: Internet ISSN: 1472-6947 (Electronic) Linking ISSN: 14726947 NLM ISO Abbreviation: BMC Med Inform Decis Mak Subsets: MEDLINE
    • Publication Information:
      Original Publication: London : BioMed Central, [2001-
    • Subject Terms:
      Leukemia, Myelogenous, Chronic, BCR-ABL Positive*/drug therapy ; Decision Support Techniques*; Humans ; Middle Aged ; Male ; Adult ; Female ; Protein Kinase Inhibitors/administration & dosage ; Protein Kinase Inhibitors/therapeutic use ; Aged ; Patient Participation ; Decision Making, Shared
    • Abstract:
      Background: Dose reduction of tyrosine kinase inhibitors (TKIs) is an option for some chronic myeloid leukemia (CML) patients to minimize side effects while maintaining efficacy. Shared decision-making (SDM) and patient decision aids (PDAs) are advocated to make informed choices such as reducing the dose of TKIs. This paper describes the development and alpha-testing of a PDA for patients with CML receiving TKI dose reduction.
      Methods: The PDA was iteratively developed following IPDAS guidelines. First, a needs assessment with semi-structured interviews was conducted to understand the needs and preferences of patients and healthcare providers. Second, through feedback cycles with the project team and steering group the scope, content, and format were defined. Third, three rounds of alpha-testing were performed via individual "think aloud" sessions with patients (round 1) and healthcare providers (round 2) to qualitatively assess the comprehensibility, acceptability, and desirability of the PDA. Round 3 included quantitative evaluation via an acceptability and usability questionnaire. Qualitative data were categorized, and quantitative data were descriptively analyzed.
      Results: The majority valued the development of the PDA during the needs assessment (n = 30). The PDA included disease and treatment information, information about dose reduction, knowledge questions, and a value clarification section. During alpha-testing, the PDA was considered clear, balanced, and helpful for decision-making. A total of 76% of the patients (n = 17) and 100% of the healthcare providers (n = 9) recommended it with overall mean scores of 7.4 and 7.8, respectively. The above average usability score was 68.1.
      Conclusion: A well-accepted online PDA for chronic phase CML patients to consider TKI dose reduction was developed.
      Competing Interests: Declarations. Ethics approval and consent to participate: Ethical review was waived by the Medical Ethical Review Committee of the Radboud university medical center (protocol No.2021–7342). Written informed consent was obtained from participants. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.
      (© 2024. The Author(s).)
    • References:
      Bower H, Björkholm M, Dickman PW, Höglund M, Lambert PC, Andersson TM-L. Life expectancy of patients with chronic myeloid leukemia approaches the life expectancy of the General Population. J Clin Oncol. 2016;34(24):2851–7. (PMID: 10.1200/JCO.2015.66.286627325849)
      Senapati J, Sasaki K, Issa GC, Lipton JH, Radich JP, Jabbour E, Kantarjian HM. Management of chronic myeloid leukemia in 2023 – common ground and common sense. Blood Cancer J. 2023;13(1):58. (PMID: 10.1038/s41408-023-00823-93708879310123066)
      El-Jawahri A, Nelson-Lowe M, VanDusen H, Traeger L, Abel GA, Greer JA, Fathi A, Steensma DP, LeBlanc TW, Li Z, et al. Patient-clinician discordance in perceptions of treatment risks and benefits in older patients with Acute myeloid leukemia. Oncologist. 2019;24(2):247–54. (PMID: 10.1634/theoncologist.2018-031730139841)
      Clark RE, Polydoros F, Apperley JF, Milojkovic D, Pocock C, Smith G, Byrne JL, de Lavallade H, O’Brien SG, Coffey T, et al. De-escalation of tyrosine kinase inhibitor dose in patients with chronic myeloid leukaemia with stable major molecular response (DESTINY): an interim analysis of a non-randomised, phase 2 trial. Lancet Haematol. 2017;4(7):e310–6. (PMID: 10.1016/S2352-3026(17)30066-228566209)
      Claudiani S, Apperley JF, Szydlo R, Khan A, Nesr G, Hayden C, Dominy AJI, Foskett K, Foroni P. TKI dose reduction can effectively maintain major molecular remission in patients with chronic myeloid leukaemia. Br J Haematol. 2021;193(2):346–55. (PMID: 10.1111/bjh.1728633368155)
      Martín Roldán A, Sánchez Suárez MDM, Alarcón-Payer C, Jiménez Morales A, Puerta Puerta JM. A real-world evidence-based study of long-term tyrosine kinase inhibitors dose reduction or discontinuation in patients with chronic myeloid leukaemia. Pharmaceutics. 2023;15(5):1363. (PMID: 10.3390/pharmaceutics150513633724260510222180)
      Cheng F, Li Q, Cui Z, Hong M, Li W, Zhang Y. Dose optimization strategy of the tyrosine kinase inhibitors imatinib, dasatinib, and nilotinib for chronic myeloid leukemia: from clinical trials to real-life settings. Front Oncol. 2023;13:1146108. (PMID: 10.3389/fonc.2023.11461083709118810113500)
      Castagnetti F, Bocchia M, Abruzzese E, Capodanno I, Bonifacio M, Rege Cambrin G, Crugnola M, Binotto G, Elena C, Lucchesi A, et al. P698: Bosutinib dose optimization in the second-line treatment of elderly cml patients: extended 3-year follow-up and final results of the best study. HemaSphere. 2022;6:593–4. (PMID: 10.1097/01.HS9.0000845676.81208.c2)
      Latagliata R, Attolico I, Trawinska MM, Capodanno I, Annunziata M, Elena C, Luciano L, Crugnola M, Bergamaschi M, Bonifacio M, et al. Bosutinib in the real-life treatment of chronic myeloid leukemia patients aged > 65 years resistant/intolerant to previous tyrosine-kinase inhibitors. Hematol Oncol. 2021;39(3):401–8. (PMID: 10.1002/hon.285133617659)
      Jabbour E, Apperley J, Cortes J, Rea D, Deininger M, Abruzzese E, Chuah C, DeAngelo DJ, Hochhaus A, Lipton JH, et al. Dose modification dynamics of ponatinib in patients with chronic-phase chronic myeloid leukemia (CP-CML) from the PACE and OPTIC trials. Leukemia. 2024;38(3):475–81. (PMID: 10.1038/s41375-024-02159-03828713210912029)
      Clements J, Fleischman A, Lerner V, Ruiz C. The importance of developing open communication and a professional, long-term relationship between patients with chronic myeloid leukemia and their oncologist. Future Oncol. 2023;19(17):1197–208. (PMID: 10.2217/fon-2022-126737218534)
      Stiggelbout AM, Pieterse AH, De Haes JC. Shared decision making: concepts, evidence, and practice. Patient Educ Couns. 2015;98(10):1172–9. (PMID: 10.1016/j.pec.2015.06.02226215573)
      Geerts PAF, van der Weijden T, Moser A, Bos GMJ. The Perception of Shared decision-making in Hematology by patients and Physicians seems satisfactory, but important steps are still ahead of us. Hemasphere. 2020;4(4):417. (PMID: 10.1097/HS9.0000000000000417)
      Stacey D, Légaré F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017;4(4):Cd001431. (PMID: 28402085)
      O’Connor AM, Légaré F, Stacey D. Risk communication in practice: the contribution of decision aids. BMJ. 2003;327(7417):736. (PMID: 10.1136/bmj.327.7417.73614512487200814)
      Djodikromo MF, Hermens RP, Bemt B, Smit Y, Govers TM, Bekker CL, Blijlevens NM. Patient-guided dose reduction of tyrosine kinase inhibitors in chronic myeloid leukaemia (RODEO study): study protocol for a prospective, multicentre, single-arm trial. BMC Cancer. 2023;23(1):231. (PMID: 10.1186/s12885-023-10697-63689929510007754)
      Resources. [ http://ipdas.ohri.ca/resources.html ].
      Coulter A, Stilwell D, Kryworuchko J, Mullen PD, Ng CJ, van der Weijden T. A systematic development process for patient decision aids. BMC Med Inf Decis Mak. 2013;13:S2. (PMID: 10.1186/1472-6947-13-S2-S2)
      Hoe maak ik een. keuzehulp bij een richtlijn? [ https://www.patientenfederatie.nl/downloads/brochures/493-hoe-maak-ik-een-keuzehulp-bij-een-richtlijn/file ].
      Vaisson G, Provencher T, Dugas M, Trottier M-È, Chipenda Dansokho S, Colquhoun H, Fagerlin A, Giguere AMC, Hakim H, Haslett L, et al. User involvement in the design and development of patient decision aids and other Personal Health tools: a systematic review. Med Decis Making. 2021;41(3):261–74. (PMID: 10.1177/0272989X2098413433655791)
      O’Connor AMC. A.: User Manual - Acceptability [document on the Internet]. In. Ottawa: Ottawa Hospital Research Institute 1996 [modified 2002].
      Brooke J. SUS: A quick and dirty usability scale. In: Usability evaluation in industry. Edited by Patrick W. Jordan BT, Ian Lyall McClelland, Bernard Weerdmeester. London; 1996: 189–194.
      Lewis JR. The System Usability Scale: past, Present, and Future. Int J Hum Comput Interact. 2018;34:577–90. (PMID: 10.1080/10447318.2018.1455307)
      Jeff Sauro JRL. Quantifying the User Experience Practical Statistics for User Research (2nd ed.). In.: Morgan Kaufmann; 2016: 198–209.
      Shaffer VA, Brodney S, Gavaruzzi T, Zisman-Ilani Y, Munro S, Smith SK, Thomas E, Valentine KD, Bekker HL. Do personal stories make patient decision Aids more effective? An update from the International patient decision Aids standards. Med Decis Making. 2021;41(7):897–906. (PMID: 10.1177/0272989X21101110034027739)
      Hillen MA, Koning CC, Wilmink JW, Klinkenbijl JH, Eddes EH, Kallimanis-King BL, de Haes JC, Smets EM. Assessing cancer patients’ trust in their oncologist: development and validation of the Trust in Oncologist Scale (TiOS). Support Care Cancer. 2012;20(8):1787–95. (PMID: 10.1007/s00520-011-1276-821947560)
      Muscat DM, Smith J, Mac O, Cadet T, Giguere A, Housten AJ, Langford AT, Smith SK, Durand M-A, McCaffery K. Addressing health literacy in patient decision aids: an update from the International patient decision Aid standards. Med Decis Making. 2021;41(7):848–69. (PMID: 10.1177/0272989X211011101340533618815094)
    • Grant Information:
      10140021910501 Netherlands ZONMW_ ZonMw; 10140021910501 Netherlands ZONMW_ ZonMw; 10140021910501 Netherlands ZONMW_ ZonMw; 10140021910501 Netherlands ZONMW_ ZonMw; 10140021910501 Netherlands ZONMW_ ZonMw
    • Contributed Indexing:
      Keywords: Chronic myeloid leukemia; Clinical decision support; Dose reduction; Shared decision making; Tyrosine kinase inhibitors
    • Accession Number:
      0 (Protein Kinase Inhibitors)
    • Publication Date:
      Date Created: 20241220 Date Completed: 20241221 Latest Revision: 20241220
    • Publication Date:
      20241222
    • Accession Number:
      10.1186/s12911-024-02806-7
    • Accession Number:
      39707396