29
Views
0
CrossRef citations to date
0
Altmetric
ORIGINAL RESEARCH

Comparing Methods for Identifying Post-Market Patient Preferences at the Point of Decision-Making: Insights from Patients with Chronic Pain Considering a Spinal Cord Stimulator Device

ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon, ORCID Icon & ORCID Icon show all
Pages 1325-1344 | Received 19 Jul 2023, Accepted 10 May 2024, Published online: 25 Jun 2024

References

  • U.S. Department of Health and Human Services Food and Drug Administration. 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. U.S. Department of Health and Human Services Food and Drug Administration; 2016.
  • National Academies of Sciences, Engineering, and Medicine. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. National Academies of Sciences, Engineering, and Medicine; 2017.
  • Hampton SB, Cavalier J, Langford R. The influence of race and gender on pain management: a systematic literature review. Pain Manag Nurs. 2015;16(6):968–977. doi:10.1016/j.pmn.2015.06.009
  • Hunter NL, O’Callaghan KM, Califf RM. Engaging patients across the spectrum of medical product development: view from the US Food and Drug Administration. JAMA. 2015;314(23):2499–2500. doi:10.1001/jama.2015.15818
  • Benz HL, Lee T-HJ, Tsai J-H, et al. Advancing the use of patient preference information as scientific evidence in medical product evaluation: a summary report of the patient preference workshop. Patient. 2019;12(6):553–557. doi:10.1007/s40271-019-00396-5
  • 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
  • Montori VM, Brito JP, Murad MH. The optimal practice of evidence-based medicine: incorporating patient preferences in practice guidelines. JAMA. 2013;310(23):2503–2504. doi:10.1001/jama.2013.281422
  • van Overbeeke E, Whichello C, Janssens R, et al. Factors and situations influencing the value of patient preference studies along the medical product lifecycle: a literature review. Drug Discov Today. 2019;24(1):57–68. doi:10.1016/j.drudis.2018.09.015
  • 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
  • List of Patient Preference-Sensitive Priority Areas. U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) Patient Science and Engagement Program; 2020. Available from: https://www.fda.gov/about-fda/cdrh-patient-science-and-engagement-program/list-patient-preference-sensitive-priority-areas. Accessed September 11, 2022.
  • Sdrulla AD, Guan Y, Raja SN. Spinal cord stimulation: clinical efficacy and potential mechanisms. Pain Pract. 2018;18(8):1048–1067. doi:10.1111/papr.12692
  • Gildenberg PL. History of Electrical Neuromodulation for Chronic Pain. Malden, USA: Blackwell Publishing Inc; 2006:S7–S13.
  • Clingan JA, Patel A, Maher DP. Survey of spinal cord stimulation hardware currently available for the treatment of chronic pain in the United States. Front Pain Res. 2020;1:572907. doi:10.3389/fpain.2020.572907
  • Deer TR, Mekhail N, Provenzano D, et al. The appropriate use of neurostimulation of the spinal cord and peripheral nervous system for the treatment of chronic pain and ischemic diseases: the neuromodulation appropriateness consensus committee. Neuromodulation. 2014;17(6):515–550. doi:10.1111/ner.12208
  • Bendel MA, O’Brien T, Hoelzer BC, et al. Spinal cord stimulator related infections: findings from a multicenter retrospective analysis of 2737 implants. Neuromodulation. 2017;20(6):553–557. doi:10.1111/ner.12636
  • Celestin J, Edwards RR, Jamison RN. Pretreatment psychosocial variables as predictors of outcomes following lumbar surgery and spinal cord stimulation: a systematic review and literature synthesis. Pain Med. 2009;10(4):639–653. doi:10.1111/j.1526-4637.2009.00632.x
  • Stevenson FA, Barry CA, Britten N, Barber N, Bradley CP. Doctor–patient communication about drugs: the evidence for shared decision making. Soc Sci Med. 2000;50(6):829–840. doi:10.1016/s0277-9536(99)00376-7
  • Burke K. A Grammar of Motives. Prentice Hall; 1945.
  • Kunneman M, Hargraves IG, Sivly AL, et al. Co-creating sensible care plans using shared decision making: patients’ reflections and observations of encounters. Patient Educ Couns. 2022;105(6):1539–1544. doi:10.1016/j.pec.2021.10.003
  • Tannen D. You Just Don’t Understand: Women and Men in Conversation. Virago London: William Morrow; 1991.
  • Leaper C, Ayres MM. A meta-analytic review of gender variations in adults’ language use: talkativeness, affiliative speech, and assertive speech. Pers Soc Psychol Rev. 2007;11(4):328–363. doi:10.1177/1088868307302221
  • Meeuwesen L, Schaap C, van der Staak C. Verbal analysis of doctor-patient communication. Soc Sci Med. 1991;32(10):1143–1150. doi:10.1016/0277-9536(91)90091-p
  • Tait RC, Chibnall JT, Kalauokalani D. Provider judgments of patients in pain: seeking symptom certainty. Pain Med. 2009;10(1):11–34. doi:10.1111/j.1526-4637.2008.00527.x
  • Hoffmann DE, Tarzian AJ. The girl who cried pain: a bias against women in the treatment of pain. J Law Med Ethics. 2001;29(1):13–27. doi:10.1111/j.1748-720x.2001.tb00037.x