Abstract
Purpose
We aimed to rate the importance of outcomes from a systematic review about biosimilars in oncology from patients’ perspective.
Methods
This is a qualitative research with nominal group technique. Patients with cancer were selected by convenience sampling and invited for two mediated virtual meetings in 2022. Twelve outcomes from a systematic review on biosimilars for oncology developed following a protocol were explained in plain language to participants who classified them as critical, important, or not important according to the Grading of Recommendations Assessment, Development and Evaluation approach. We employed Iramuteq software for lexical categorization of the meeting transcripts, and content analysis for interpretation.
Results
Five women participated (three had metastatic cancer, one non-metastatic, one recurrent). Six outcomes were classified as critical: duration of response, progression-free survival, pathological complete response, overall survival, severe adverse events, and quality of life; three as important: mortality, event-free survival, and objective response; and three as non-important: neutralizing anti-drug antibody, any adverse event, and non-neutralizing anti-drug antibody. Duration of response, pathological complete response, severe adverse events, and quality of life were considered secondary in the review protocol, but critical by the patients. The main themes influencing the importance classification were related to the disease (progression and control) and treatment (recognition and healthcare setting).
Conclusion
Patients rated most outcomes as critical or important, some of them previously regarded as secondary by the researchers, which reinforces the need to include stakeholders’ perspectives in oncology research. Aspects of the disease progression and treatment effects influenced participants’ judgment on outcomes’ relevance.
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Data Availability
Data is available upon request to the corresponding author, respecting the ethical restrictions.
References
Kim H, Goodall S, Liew D (2019) Health technology assessment challenges in oncology: 20 years of value in health. Value in Health 22:593–600. https://doi.org/10.1016/j.jval.2019.01.001
Andersen MR, Urban N (1999) Involvement in decision-making and breast cancer survivor quality of life1,2. Ann Behav Med 21:201–209. https://doi.org/10.1007/bf02884834
Panje CM, Glatzer M, Sirén C et al (2018) Treatment options in oncology. JCO Clin Cancer Inf 1–10. https://doi.org/10.1200/CCI.18.00017
Thorne S, Oliffe JL, Stajduhar KI (2013) Communicating shared decision-making: cancer patient perspectives. Patient Educ Couns 90:291–296. https://doi.org/10.1016/j.pec.2012.02.018
Løwe MM, Osther PJS, Ammentorp J et al (2021) The balance of patient involvement: patients’ and health professionals’ perspectives on decision-making in the treatment of advanced prostate cancer. Qual Health Res 31:29–40. https://doi.org/10.1177/1049732320962759
Pollock A, Campbell P, Struthers C et al (2018) Stakeholder involvement in systematic reviews: a scoping review. Syst Rev 710.1186/s13643–018–0852–0
Pollock A, Campbell P, Struthers C et al (2017) Stakeholder involvement in systematic reviews: a protocol for a systematic review of methods, outcomes and effects. Res Involv Engagem 3:9. https://doi.org/10.1186/s40900-017-0060-4
Pollock A, Campbell P, Struthers C et al (2018) Stakeholder involvement in systematic reviews: a scoping review. Syst Rev 7:208. https://doi.org/10.1186/s13643-018-0852-0
Staley K, Barron D (2019) Learning as an outcome of involvement in research: what are the implications for practice, reporting and evaluation? Res Involvement Engagement 5:14. https://doi.org/10.1186/s40900-019-0147-1
Osei-Frimpong K, Wilson A, Lemke F (2018) Patient co-creation activities in healthcare service delivery at the micro level: the influence of online access to healthcare information. Technol Forecast Soc Chang 126:14–27. https://doi.org/10.1016/j.techfore.2016.04.009
Hoffmann TC, Montori VM, Del Mar C (2014) The connection between evidence-based medicine and shared decision making. JAMA 312:1295–1296. https://doi.org/10.1001/jama.2014.10186
Montori VM, Brito JP, Murad MH (2013) The optimal practice of evidence-based medicine: incorporating patient preferences in practice guidelines. JAMA 310:2503–2504. https://doi.org/10.1001/jama.2013.281422
Schünemann Hj HJ, Vist Ge, Glasziou P, Akl Ea, Skoetz N, Guyatt Gh (2021) Chapter 14: completing ‘summary of findings’ tables and grading the certainty of the evidence. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). In: Cochrane (ed) Cochrane Handbook for Systematic Reviews of Interventions version 6.2 (updated February 2021).
Munthe-Kaas H, Nøkleby H, Lewin S et al (2020) The TRANSFER approach for assessing the transferability of systematic review findings. BMC Med Res Methodol 20:11. https://doi.org/10.1186/s12874-019-0834-5
Wiering B, De Boer D, Delnoij D (2017) Patient involvement in the development of patient-reported outcome measures: a scoping review. Health Expect 20:11–23. https://doi.org/10.1111/hex.12442
Boundouki G, Wilson R, Duxbury P et al (2021) Patient and public priorities for breast cancer research: a qualitative study in the UK. BMJ Open 11:e036072. https://doi.org/10.1136/bmjopen-2019-036072
Galvão TF, Livinalli A, Lopes LC et al (2020) Biosimilar monoclonal antibodies for cancer treatment. Cochrane Database Syst Rev. https://doi.org/10.1002/14651858.CD013539
Rak Tkaczuk KH, Jacobs IA (2014) Biosimilars in oncology: from development to clinical practice. Semin Oncol 41:S3–S12. https://doi.org/10.1053/j.seminoncol.2014.03.008
Leonard E, Wascovich M, Oskouei S et al (2019) Factors affecting health care provider knowledge and acceptance of biosimilar medicines: a systematic review. J Manag Care Spec Pharm 25:102–112. https://doi.org/10.18553/jmcp.2019.25.1.102
European Medicines Agency EC (2019) Biosimilars in the EU: information guide for healthcare professionals. In:
Markus R, Liu J, Ramchandani M et al (2017) Developing the totality of evidence for biosimilars: regulatory considerations and building confidence for the healthcare community. BioDrugs 31:175–187. https://doi.org/10.1007/s40259-017-0218-5
Delbecq AL, Van De Ven AH, Gustafson DH (1975) Group techniques for program planning: a guide to nominal group and Delphi processes. Scott, Foresman
Mcmillan SS, King M, Tully MP (2016) How to use the nominal group and Delphi techniques. Int J Clin Pharm 38:655–662. https://doi.org/10.1007/s11096-016-0257-x
Tong A, Sainsbury P, Craig J (2007) Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care 19:349–357. https://doi.org/10.1093/intqhc/mzm042
IRaMuTeQ. Un tutoriel en portugais réalisé par Brigido Vizeu Camargo et Ana Maria Justo (Universidade Federal de Santa Catarina, Brésil) - Nouvelle version du 22/11/2021. In:
Noordzij M, Tripepi G, Dekker FW et al (2010) Sample size calculations: basic principles and common pitfalls. Nephrol Dial Transplant 25:1388–1393. https://doi.org/10.1093/ndt/gfp732
Mckenzie Je BS, Ryan Re, Thomson Hj, Johnston Rv, Thomas J (2022) Chapter 3: defining the criteria for including studies and how they will be grouped for the synthesis. In: Higgins JPT TJ, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (ed) Cochrane Handbook for Systematic Reviews of Interventions version 6.3 (updated February 2022). Cochrane
Lee Mortensen G, Madsen IB, Krogsgaard R et al (2018) Quality of life and care needs in women with estrogen positive metastatic breast cancer: a qualitative study. Acta Oncol 57:146–151. https://doi.org/10.1080/0284186X.2017.1406141
Mertz S, Benjamin C, Girvalaki C et al (2022) Progression-free survival and quality of life in metastatic breast cancer: the patient perspective. Breast 65:84–90. https://doi.org/10.1016/j.breast.2022.07.006
Räsänen P, Roine E, Sintonen H et al (2006) Use of quality-adjusted life years for the estimation of effectiveness of health care: a systematic literature review. Int J Technol Assess Health Care 22:235–241. https://doi.org/10.1017/S0266462306051051
Brett J, Staniszewska S, Mockford C et al (2014) Mapping the impact of patient and public involvement on health and social care research: a systematic review. Health Expect 17:637–650. https://doi.org/10.1111/j.1369-7625.2012.00795.x
Becker R (2022) Gender and survey participation: an event history analysis of the gender effects of survey participation in a probability-based multi-wave panel study with a sequential mixed-mode design. 2022 1610.12758/mda.2021.08
Downe-Wamboldt B (1992) Content analysis: method, applications, and issues. Health Care Women Int 13:313–321
Bengtsson M (2016) How to plan and perform a qualitative study using content analysis. NursingPlus Open 2:8–14. https://doi.org/10.1016/j.npls.2016.01.001
Paim J, Travassos C, Almeida C et al (2011) The Brazilian health system: history, advances, and challenges. Lancet 377:1778–1797. https://doi.org/10.1016/s0140-6736(11)60054-8
Strasser-Weippl K, Chavarri-Guerra Y, Villarreal-Garza C et al (2015) Progress and remaining challenges for cancer control in Latin America and the Caribbean. Lancet Oncol 16:1405–1438. https://doi.org/10.1016/S1470-2045(15)00218-1
Da Silva MJS, O’dwyer G, Osorio-De-Castro CGS (2019) Cancer care in Brazil: structure and geographical distribution. BMC Cancer 19:987. https://doi.org/10.1186/s12885-019-6190-3
Fonseca BDP, Albuquerque PC, Saldanha RDF et al (2022) Geographic accessibility to cancer treatment in Brazil: a network analysis. The Lancet Regional Health – Americas 710.1016/j.lana.2021.100153
Ambroggi M, Biasini C, Del Giovane C et al (2015) Distance as a barrier to cancer diagnosis and treatment: review of the literature. Oncologist 20:1378–1385. https://doi.org/10.1634/theoncologist.2015-0110
European Medicines Agency. Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. In, https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-immunogenicity-assessment-monoclonal-antibodies-intended-vivo-clinical-use_en.pdf. Accessed 19 October 2023
Food and Drug Administration. Immunogenicity testing of therapeutic protein products-developing and validating assays for anti-drug antibody detection — guidance for industry. In, https://www.federalregister.gov/documents/2019/02/01/2019-00666/immunogenicity-testing-of-therapeutic-protein-products-developing-and-validating-assays-for. Accessed 19 October 2023
Domecq JP, Prutsky G, Elraiyah T et al (2014) Patient engagement in research: a systematic review. BMC Health Serv Res 14:89. https://doi.org/10.1186/1472-6963-14-89
Acknowledgements
The authors thank Espaço da Escrita–Pró-Reitoria de Pesquisa — UNICAMP — for the language services provided.
We thank professor Luciane Cruz Lopes, from the Universidade de Sorocaba, Brazil, for her contributions in the two sessions of the meetings with patients.
Funding
The authors declare that no funds, grants, or other support were received during the preparation of this manuscript. GTF receives productivity scholarship from the National Council for Scientific and Technological Development (CNPq, grant 310238/2020–0).
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All authors contributed to the study conception and design. Material preparation was performed by VLZ, GTF, and LA; data collection was performed by VLZ, GTF, LA, and BJOM; data analysis was performed by VLZ, GTF, and SMT; figures translation was performed by VLZ. The first draft of the manuscript was written by VLZ, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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The study was performed in accordance with the Resolution Number 466, of December 12, 2012, from the Brazilian National Health Council of the Ministry of Health of Brazil. Ethical approval was given by the Research Ethics Committee of Universidade Estadual de Campinas, opinion number 5.109.137/2021 on November 17, 2021, Certificate of Presentation for Ethical Appreciation number 52377021.2.0000.5404.
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Vecoso, L.v.Z., Silva, M.T., Livinalli, A. et al. Patients’ perspectives on the relevance of biosimilars’ outcomes in oncology: qualitative study with nominal group technique. Support Care Cancer 31, 722 (2023). https://doi.org/10.1007/s00520-023-08184-6
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DOI: https://doi.org/10.1007/s00520-023-08184-6