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Perspectives

Preference Testing in Medical Devices: Current Framework and Regulatory Gaps

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Pages 199-213 | Published online: 06 Jul 2022

References

  • E2943-15, A. Standard guide for two-sample acceptance and preference testing with consumers; 2021; Available from: https://www.astm.org/e2943-15r21.html. Accessed June 16, 2022.
  • Hein K, Jaeger SR, Tom Carr B, et al. Comparison of five common acceptance and preference methods. Food Qual Prefer. 2008;19(7):651–661. doi:10.1016/j.foodqual.2008.06.001
  • FDA, Virtual ISPOR-FDA Summit 2020. Using patient preference information in medical device regulatory decisions: benefit-risk and beyond; 2020.
  • Ellis BH. Acceptance and consumer preference testing. J Dairy Sci. 1969;52(6):823–831. doi:10.3168/jds.S0022-0302(69)86658-0
  • Zbrozek A, Hebert J, Gogates G, et al. validation of electronic systems to collect patient-reported outcome (PRO) data—recommendations for clinical trial teams: report of the ISPOR ePRO systems validation good research practices task force. Value Health. 2013;16(4):480–489. doi:10.1016/j.jval.2013.04.002
  • Syam A, Ulfasari I, Ishak A, Akhmar AM. Preference test of biscuit products from pumpkin seeds (Cucurbita sp.). Enferm Clin. 2020;30(Suppl 4):375–378. doi:10.1016/j.enfcli.2019.10.115
  • Sasaki K, Ooi M, Nagura N, et al. Classification and characterization of Japanese consumers’ beef preferences by external preference mapping. J Sci Food Agric. 2017;97(10):3453–3462. doi:10.1002/jsfa.8204
  • Lawlor J, Sheehan EM, Delahunty CM, et al. Sensory characteristics and consumer preference for cooked chicken breasts from organic, corn-fed, free-range and conventionally reared animals. Int J Poult Sci. 2003;2(6):409–416. doi:10.3923/ijps.2003.409.416
  • Watts BM, Ylimaki GL, Jeffery LE, Elias LG. Basic Sensory Methods for Food Evaluation. Ottawa, ON, CA: IDRC; 1989.
  • FDA. Patient preference information - voluntary submission, review in premarket approval applications, humanitarian device exemption applications, and de novo requests, and inclusion in decision summaries and device labeling; 2016. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-preference-information-voluntary-submission-review-premarket-approval-applications. Accessed June 16, 2022.
  • FDA, Patient-engagement in the design and conduct of medical device clinical investigations; 2019.
  • FDA, Patient Preference Information (PPI) in Medical Device Decision-Making; 2020.
  • Russell AL. The 21st Century Cures: Requirement on Patient Experience Data and Related Information. National Health Council; 2019.
  • de Bekker-Grob EW, Berlin C, Levitan B, et al. Giving Patients’ Preferences a Voice in Medical Treatment Life Cycle: The PREFER Public–Private Project. Springer; 2017.
  • Whichello C, Bywall KS, Mauer J, et al. An overview of critical decision-points in the medical product lifecycle: where to include patient preference information in the decision-making process? Health Policy. 2020;124(12):1325–1332. doi:10.1016/j.healthpol.2020.07.007
  • PREFER. Including the patient perspective; 2021. Available from: https://www.imi-prefer.eu/about/. Accessed June 16, 2022.
  • PREFER. CHMP & EUnetHTA parallel scientific advice: qualification of a framework and “points to consider” for method selection along with five methods for performing patient preference studies to inform regulatory and HTA body medical product decision-making; 2021.
  • PREFER, Missed the PREFER framework webinar? Recording now available; 2021.
  • Consortium, M.D.I., A framework for incorporating information on patient preferences regarding benefit and risk into regulatory assessments of new medical technology; 2015.
  • Ho M, Saha A, McCleary KK, et al. A framework for incorporating patient preferences regarding benefits and risks into regulatory assessment of medical technologies. Value Health. 2016;19(6):746–750. doi:10.1016/j.jval.2016.02.019
  • Memon M Preference tests: when should you conduct one and how? Preference Tests: when Should You Conduct One and How?; 2021. Available from: https://maze.co/blog/preference-testing/. Accessed June 16, 2022.
  • Pietzsch JB, Shluzas LA, Paté-Cornell ME, et al. Stage-gate process for the development of medical devices. J Med Device. 2009;3(2). doi:10.1115/1.3148836
  • Commission. IE, Medical devices – part 1: application of usability engineering to medical devices (IEC 62366); 2016.
  • Harrison M, Milbers K, Hudson M, et al. Do patients and health care providers have discordant preferences about which aspects of treatments matter most? Evidence from a systematic review of discrete choice experiments. BMJ Open. 2017;7(5):e014719. doi:10.1136/bmjopen-2016-014719
  • Cook N, Geier A, Schmid A, et al. Assessing physician preferences on future therapeutic options and diagnostic practices in non-alcoholic steatohepatitis. JHEP Rep. 2020;2(2):100081. doi:10.1016/j.jhepr.2020.100081
  • Burns LR, Housman M, Booth R, et al. Physician preference items: what factors matter to surgeons? Does the vendor matter? Medical Devices. 2018;11:39–49. doi:10.2147/MDER.S151647
  • Bouvy JC, Cowie L, Lovett R, et al. Use of patient preference studies in HTA decision making: a NICE perspective. Patient. 2020;13(2):145–149. doi:10.1007/s40271-019-00408-4
  • World Health Organization. The World Health Organization Quality of Life (WHOQOL); 2012. Available from: https://www.who.int/publications/i/item/WHO-HIS-HSI-Rev.2012.03. Accessed June 16, 2022.
  • van Dongen VC, Vanelderen PJL, Koopmans‐Klein G, et al. Patient preference with respect to QoL and reduction in opioid-induced constipation (OIC) after treatment with prolonged-release (PR) oxycodone/naloxone compared with previous analgesic therapy [PREFER study]. Int J Clin Pract. 2014;68(11):1364–1375. doi:10.1111/ijcp.12468
  • Lee Mortensen G, Rasmussen PV. The impact of quality of life on treatment preferences in multiple sclerosis patients. Patient Prefer Adherence. 2017;11:1789–1796. doi:10.2147/PPA.S142373
  • Williams CP, Miller‐Sonet E, Nipp RD, et al. Importance of quality‐of‐life priorities and preferences surrounding treatment decision making in patients with cancer and oncology clinicians. Cancer. 2020;126(15):3534–3541. doi:10.1002/cncr.32961
  • Rawlins MD, Culyer AJ. National institute for clinical excellence and its value judgments. BMJ. 2004;329(7459):224–227. doi:10.1136/bmj.329.7459.224
  • Raymakers AJN, Regier DA, Peacock SJ. Health-related quality of life in oncology drug reimbursement submissions in Canada: a review of submissions to the pan-Canadian oncology drug review. Cancer. 2020;126(1):148–155. doi:10.1002/cncr.32455
  • Hailey D, Nordwall M. Survey on the involvement of consumers in health technology assessment programs. Int J Technol Assess Health Care. 2006;22(4):497–499. doi:10.1017/S0266462306051427
  • Janssens R, Huys I, van Overbeeke E, et al. Opportunities and challenges for the inclusion of patient preferences in the medical product life cycle: a systematic review. BMC Med Inform Decis Mak. 2019;19(1):1–16. doi:10.1186/s12911-019-0875-z
  • Shah SGS, Robinson I. Benefits of and barriers to involving users in medical device technology development and evaluation. Int J Technol Assess Health Care. 2007;23(1):131–137. doi:10.1017/S0266462307051677
  • Parvizi N, Woods K. Regulation of medicines and medical devices: contrasts and similarities. Clin Med. 2014;14(1):6–12. doi:10.7861/clinmedicine.14-1-6
  • Pope C, Mays N. Qualitative research: reaching the parts other methods cannot reach: an introduction to qualitative methods in health and health services research. BMJ. 1995;311(6996):42. doi:10.1136/bmj.311.6996.42
  • Danner M, Hummel JM, Volz F, et al. Integrating patients’ views into health technology assessment: Analytic Hierarchy Process (AHP) as a method to elicit patient preferences. Int J Technol Assess Health Care. 2011;27(4):369–375. doi:10.1017/S0266462311000523
  • Soekhai V, Whichello C, Levitan B, et al. Methods for exploring and eliciting patient preferences in the medical product lifecycle: a literature review. Drug Discov Today. 2019;24(7):1324–1331. doi:10.1016/j.drudis.2019.05.001
  • Boulkedid R, Abdoul H, Loustau M, et al. Using and reporting the delphi method for selecting healthcare quality indicators: a systematic review. PLoS One. 2011;6(6):e20476. doi:10.1371/journal.pone.0020476
  • Ho MP, Gonzalez JM, Lerner HP, et al. Incorporating patient-preference evidence into regulatory decision making. Surg Endosc. 2015;29(10):2984–2993. doi:10.1007/s00464-014-4044-2
  • E2263-12, A. Standard test method for paired preference test; 2018. Available from: www.astm.org. Accessed June 16, 2022.
  • Villegas‐ruiz X, Angulo O, O’mahony M. Hidden and false “preferences” on the structured 9‐point hedonic scale. J Sens Stud. 2008;23(6):780–790. doi:10.1111/j.1745-459X.2008.00184.x
  • Xia Y, Zhong F, O’Mahony M. Paired preference testing: false preferences and disruptive protocols. Food Sci Biotechnol. 2016;25(1):1–10. doi:10.1007/s10068-016-0001-2
  • Solutions, R.-H.H. Patient preferences considered for the first time in FDA decision to approve first-of-kind obesity device; 2015. Available from: https://www.rtihs.org/news-and-events/patient-preferences-considered-first-time-fda-decision-approve-first-kind-obesity. Accessed June 16, 2022.
  • Medtronic. Medtronic study shows patients with high blood pressure are interested in an interventional procedure treatment option; 2021.
  • Zahnd D, Aebi S, Rusterholz S, et al. A randomized crossover trial assessing patient preference for two different types of portable infusion-pump devices. Ann Oncol. 1999;10(6):727–729. doi:10.1023/A:1008334313918
  • Nobili F, Arbizu J, Bouwman F, et al. European Association of Nuclear Medicine and European Academy of Neurology recommendations for the use of brain 18 F-fluorodeoxyglucose positron emission tomography in neurodegenerative cognitive impairment and dementia: delphi consensus. Eur J Neurol. 2018;25(10):1201–1217. doi:10.1111/ene.13728
  • Janssens R, Russo S, van Overbeeke E, et al. Patient preferences in the medical product life cycle: what do stakeholders think? Semi-structured qualitative interviews in Europe and the USA. Patient-Patient-Centered Outcomes Res. 2019;12(5):513–526. doi:10.1007/s40271-019-00367-w
  • King PH, Fries RC. Design of Biomedical Devices and Systems. Second ed. Crc Press; 2008.
  • Niederberger M, Spranger J. Delphi technique in health sciences: a map. Public Health Front. 2020;8:457. doi:10.3389/fpubh.2020.00457
  • Taylor E. We agree, don’t we? The Delphi method for health environments research. HERD. 2020;13(1):11–23. doi:10.1177/1937586719887709
  • Morgan DL, Ataie J, Carder P, et al. Introducing dyadic interviews as a method for collecting qualitative data. Qual Health Res. 2013;23(9):1276–1284. doi:10.1177/1049732313501889
  • Trochim W, Kane M. Concept mapping: an introduction to structured conceptualization in health care. Int J Qual Health Care. 2005;17(3):187–191. doi:10.1093/intqhc/mzi038
  • Flynn TN, Louviere JJ, Peters TJ, et al. Best–worst scaling: what it can do for health care research and how to do it. J Health Econ. 2007;26(1):171–189. doi:10.1016/j.jhealeco.2006.04.002
  • Flynn TN. Valuing citizen and patient preferences in health: recent developments in three types of best-worst scaling. Expert Rev Pharmacoecon Outcomes Res. 2010;10(3):259–267. doi:10.1586/erp.10.29
  • Cross RM. Exploring attitudes: the case for Q methodology. Health Educ Res. 2005;20(2):206–213. doi:10.1093/her/cyg121
  • Henrikson NB, Davison BJ, Berry DL. Measuring decisional control preferences in men newly diagnosed with prostate cancer. J Psychosoc Oncol. 2011;29(6):606–618. doi:10.1080/07347332.2011.615383
  • Alex G, Wyrwich KW. Wyrwich, health utility measures and the standard gamble. Acad Emerg Med. 2003;10(4):360–363. doi:10.1111/j.1553-2712.2003.tb01349.x
  • Yen Z-S, Davis MA, Chen S-C, et al. A cost–effectiveness analysis of treatment strategies for acute uncomplicated pyelonephritis in women. Acad Emerg Med. 2003;10(4):309–314. doi:10.1111/j.1553-2712.2003.tb01341.x
  • Hauber B, Coulter J. Using the threshold technique to elicit patient preferences: an introduction to the method and an overview of existing empirical applications. Appl Health Econ Health Policy. 2020;18(1):31–46. doi:10.1007/s40258-019-00521-3
  • Devereaux PJ, Anderson DR, Gardner MJ, et al. Differences between perspectives of physicians and patients on anticoagulation in patients with atrial fibrillation: observational study. BMJ. 2001;323(7323):1218–1222. doi:10.1136/bmj.323.7323.1218
  • Tervonen T, Gelhorn H, Sri Bhashyam S, et al. MCDA swing weighting and discrete choice experiments for elicitation of patient benefit-risk preferences: a critical assessment. Pharmacoepidemiol Drug Saf. 2017;26(12):1483–1491. doi:10.1002/pds.4255
  • Sutherland HJ, Lockwood GA, Minkin S, et al. Measuring satisfaction with health care: a comparison of single with paired rating strategies. Soc Sci Med. 1989;28(1):53–58. doi:10.1016/0277-9536(89)90306-7
  • Prosser LA. Statistical methods for the analysis of discrete-choice experiments: a report of the ISPOR conjoint analysis good research practices task force. Value Health. 2016;19(4):298–299. doi:10.1016/j.jval.2016.05.002