20
Views
0
CrossRef citations to date
0
Altmetric
PERSPECTIVES

Patient Involvement in the Design of an Innovative Clinical Study to Compare the Palatability of Anti-Hyperkalemia Medications

Pages 1059-1064 | Received 25 Oct 2023, Accepted 08 May 2024, Published online: 30 May 2024

References

  • Yeoman G, Furlong P, Seres M, et al. Defining patient centricity with patients for patients and caregivers: a collaborative endeavour. BMJ Innov. 2017;3(2):76–83. doi:10.1136/bmjinnov-2016-000157
  • Kaba R, Sooriakumaran P. The evolution of the doctor-patient relationship. Int J Surg. 2007;5(1):57–65. doi:10.1016/j.ijsu.2006.01.005
  • Kilbride MK, Joffe S. The New Age of Patient Autonomy: Implications for the Patient-Physician Relationship. JAMA. 2018;320(19):1973–1974. doi:10.1001/jama.2018.14382
  • Taylor K. Paternalism, participation and partnership - The evolution of patient centeredness in the consultation. Patient Educ Couns. 2009;74(2):150–155. doi:10.1016/j.pec.2008.08.017
  • Edwards D, Best S. The Textbook of Health and Social Care. 1st ed. Sage Publications; 2020.
  • Brett J, Staniszewska S, Mockford C, et al. Mapping the impact of patient and public involvement on health and social care research: a systematic review. Health Expect. 2014;17(5):637–650. doi:10.1111/j.1369-7625.2012.00795.x
  • The Patient-Centred Outcomes Research Institute (PCORI). The Value of Engagement in Research. Available from: https://www.pcori.org/engagement/value-engagement. Accessed May 21, 2024.
  • Burke MD, Keeney M, Kleinberg R, Burlage R. Challenges and Opportunities for Patient Centric Drug Product Design: Industry Perspectives. Pharm Res. 2019;36(6):85. doi:10.1007/s11095-019-2616-5
  • Stergiopoulos S, Michaels DL, Kunz BL, Getz KA. Measuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and Development. Ther Innov Regul Sci. 2020;54(1):103–116. doi:10.1007/s43441-019-00034-0
  • du Plessis D, Sake J-K, Halling K, Morgan J, Georgieva A, Bertelsen N. Patient Centricity and Pharmaceutical Companies: Is It Feasible? Ther Innov Regul Sci. 2017;51(4):460–467. doi:10.1177/2168479017696268
  • Dockendorf MF, Hansen BJ, Bateman KP, Moyer M, Shah JK, Shipley LA. Digitally Enabled, Patient-Centric Clinical Trials: Shifting the Drug Development Paradigm. Clin Transl Sci. 2021;14(2):445–459. doi:10.1111/cts.12910
  • Geißler J, Isham E, Hickey G, Ballard C, Corbett A, Lubbert C. Patient involvement in clinical trials. Communicat Med (Lond). 2022;2(1):94. doi:10.1038/s43856-022-00156-x
  • Hoos A, Anderson J, Boutin M, et al. Partnering With Patients in the Development and Lifecycle of Medicines: A Call for Action. Ther Innov Regul Sci. 2015;49(6):929–939. doi:10.1177/2168479015580384
  • Smith J, Damm K, Hover G, Chien J. Lessons from an Experiential Approach to Patient Community Engagement in Rare Disease. Clin Ther. 2021;43(2):421–429. doi:10.1016/j.clinthera.2020.12.002
  • Leiter A, Sablinski T, Diefenbach M, et al. Use of crowdsourcing for cancer clinical trial development. J Natl Cancer Inst. 2014;106(10):dju258. doi:10.1093/jnci/dju258
  • Levitan B, Getz K, Eisenstein EL, et al. Assessing the Financial Value of Patient Engagement:A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project. Ther Innov Regul Sci. 2018;52(2):220–229. doi:10.1177/2168479017716715
  • Edwards V, Wyatt K, Logan S, Britten N. Consulting parents about the design of a randomized controlled trial of osteopathy for children with cerebral palsy. Health Expect. 2011;14(4):429–438.
  • Davies-Teye BB, Medeiros M, Chauhan C, Baquet CR, Mullins CD. Pragmatic patient engagement in designing pragmatic oncology clinical trials. Future Oncol. 2021;17(28):3691–3704. doi:10.2217/fon-2021-0556
  • The Economist Intelligence Unit. The Innovation Imperative: The Future of Drug Development Part I: Research Methods and Findings. Available from: https://druginnovation.eiu.com/wp-content/uploads/2019/05/Parexel-innovations-in-drug-development-part-1_V14.pdf. Accessed August 18, 2023.
  • Menditto E, Orlando V, De Rosa G, et al. Patient Centric Pharmaceutical Drug Product Design—The Impact on Medication Adherence. Pharmaceutics. 2020;12(1):44. doi:10.3390/pharmaceutics12010044
  • Brixner D, Rubin DT, Mease P, et al. Patient Support Program Increased Medication Adherence with Lower Total Health Care Costs Despite Increased Drug Spending. J Manag Care Spec Pharm. 2019;25(7):770–779. doi:10.18553/jmcp.2019.18443
  • European Medicines Agency. Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man: The use of patient-reported outcome (PRO) measures in oncology studies. Available from: https://www.ema.europa.eu/en/documents/other/appendix-2-guideline-evaluation-anticancer-medicinal-products-man_en.pdf. Accessed August 18, 2023.
  • U.S. Food and Drug Administration. Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation - Final Guidance: March 1, 2022. Available from: https://www.fda.gov/media/156929/download. Accessed August 18, 2023.
  • PharmaPhorum. Patient Engagement is no longer optional. Available from: https://pharmaphorum.com/views-and-analysis/patient-engagement-is-no-longer-optional/. Accessed August 18, 2023.
  • Brogan AP, DeMuro C, Barrett AM, D’Alessio D, Bal V, Hogue SL. Payer Perspectives on Patient-Reported Outcomes in Health Care Decision Making: Oncology Examples. J Manag Care Spec Pharm. 2017;23(2):125–134. doi:10.18553/jmcp.2017.23.2.125
  • Lubkeman M, Lee M, Barrios G. What Do Patients Want, and Is Pharma Delivering? Available from: https://www.bcg.com/publications/2020/what-patients-want-is-pharma-delivering. Accessed August 18, 2023.
  • Palmer BF. Potassium Binders for Hyperkalemia in Chronic Kidney Disease—Diet, Renin-Angiotensin-Aldosterone System Inhibitor Therapy, and Hemodialysis. Mayo Clin Proc. 2020;95(2):339–354. doi:10.1016/j.mayocp.2019.05.019
  • Morales E, Cravedi P, Manrique J. Management of Chronic Hyperkalemia in Patients With Chronic Kidney Disease: An Old Problem With News Options. Front Med (Lausanne). 2021;8:653634. doi:10.3389/fmed.2021.653634
  • Weir MR, Rolfe M. Potassium Homeostasis and Renin-Angiotensin-Aldosterone System Inhibitors. Clin J Am Soc Nephrol. 2010;5(3):531–548. doi:10.2215/CJN.07821109
  • Yu M-Y, Yeo JH, Park J-S, Lee CH, Kim G-H. Long-term efficacy of oral calcium polystyrene sulfonate for hyperkalemia in CKD patients. PLoS One. 2017;12(3):e0173542. doi:10.1371/journal.pone.0173542
  • Zann V, McDermott J, Jacobs JW, et al. Palatability and physical properties of potassium-binding resin RDX7675: comparison with sodium polystyrene sulfonate. Drug Des Devel Ther. 2017;11:2663–2673. doi:10.2147/DDDT.S143461
  • Laureati P, Xu Y, Trevisan M, et al. Initiation of sodium polystyrene sulphonate and the risk of gastrointestinal adverse events in advanced chronic kidney disease: a nationwide study. Nephrol Dial Transplant. 2020;35(9):1518–1526. doi:10.1093/ndt/gfz150
  • Noel JA, Bota SE, Petrcich W, et al. Risk of Hospitalization for Serious Adverse Gastrointestinal Events Associated With Sodium Polystyrene Sulfonate Use in Patients of Advanced Age. JAMA Intern Med. 2019;179(8):1025–1033. doi:10.1001/jamainternmed.2019.0631
  • Hsu KL, Fink JC, Ginsberg JS, et al. Self-reported Medication Adherence and Adverse Patient Safety Events in CKD. Am J Kidney Dis. 2015;66(4):621–629. doi:10.1053/j.ajkd.2015.03.026