Abstract
Objective
To explore the experiences, approaches, and challenges of physicians consulting patients
about experimental stem cell and regenerative medicine interventions (SCRIs).
Participants and Methods
From August 21, 2018, through July 30, 2019, semistructured interviews of 25 specialists
in cardiology, ophthalmology, orthopedics, pulmonology, and neurology were conducted
and qualitatively analyzed using modified grounded theory.
Results
All specialists used informational approaches to counsel patients, especially orthopedists.
Informational approaches included explaining stem cell science, sharing risks, and
providing principles. Several specialists also used relational counseling approaches
including emphasizing that physicians want what is best for patients, acknowledging
suffering, reassuring continued care, empathizing with patients and families, and
underscoring that patients have the final decision. Many specialists reported being
comfortable with the conversation, although some were less comfortable and several
noted challenges in the consultation including wanting to support a patient’s decision
but worrying about harms from unproven SCRIs, navigating family pressure, and addressing
stem cell hype and unrealistic expectations. Specialists also desired that additional
resources be available for them and patients.
Conclusion
Physicians relied more heavily on providing patients with information about SCRIs
than using relational counseling approaches. Efforts should be directed at helping
physicians address the informational and relational needs of patients, including providing
tools and resources that inform physicians about the unproven SCRI industry, building
skills in empathic communication, and the creation and dissemination of evidence-based
resources to offer patients.
Abbreviations and Acronyms:
CAM (complementary and alternative medicine), SCRI (stem cell and regenerative intervention)To read this article in full you will need to make a payment
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References
- Lancet Commission: Stem cells and regenerative medicine [published correction appears in Lancet. 2018;391(10124):e8].Lancet. 2018; 391: 883-910
- Innovation in the time of COVID-19. ARM Global Regenerative Medicine & Advanced Therapy Sector Report H1 2020.(Published 2019. Accessed May 26, 2021)
- Characteristics and scope of training of clinicians participating in the US direct-to-consumer marketplace for unproven stem cell interventions.JAMA. 2019; 321: 2463-2464
- The US direct-to-consumer marketplace for autologous stem cell interventions.Perspect Biol Med. 2018; 61: 7-24
- Challenging misinformation and engaging patients: characterizing a regenerative medicine consult service.Regen Med. 2020; 15: 1427-1440
- A dichotomy of information-seeking and information-trusting: stem cell interventions and children with neurodevelopmental disorders.Stem Cell Rev Rep. 2016; 12: 438-447
- Ecological models of health behavior.in: Glanz K. Rimer B.K. Viswanath K. Health Behavior: Theory, Research, and Practice. 5th ed. Wiley, 2015: 43-64
- The direct-to-consumer market for stem cell-based interventions in Australia: exploring the experiences of patients.Regen Med. 2020; 15: 1238-1249
- Informed consent standard for stem cell-based interventions offered outside of formal clinical trials. Version 1.0.(Published August 12, 2019. Accessed May 26, 2021)
- A professional standard for informed consent for stem cell therapies.JAMA. 2019; 322: 1651-1652
- Global distribution of businesses marketing stem cell-based interventions.Cell Stem Cell. 2016; 19: 158-162
- How to peddle hope: an analysis of YouTube patient testimonials of unproven stem cell treatments.Stem Cell Reports. 2019; 12: 1186-1189
- Fake news portrayals of stem cells and stem cell research.Regen Med. 2017; 12: 765-775
- Open for business: a comparative study of websites selling autologous stem cells in Australia and Japan.Regen Med. 2017; 12: 777-790
- The involvement of Canadian physicians in promoting and providing unproven and unapproved stem cell interventions.BMC Med Ethics. 2018; 19: 32
- Fueling hope: stem cells in social media.Stem Cell Rev Rep. 2015; 11: 540-546
- Selling stem cells in the USA: assessing the direct-to-consumer industry.Cell Stem Cell. 2016; 19: 154-157
- Between hope and evidence: how community advisors demarcate the boundary between legitimate and illegitimate stem cell treatments.Health (London). 2015; 19: 188-206
- Contact us for more information: an analysis of public enquiries about stem cells.Regen Med. 2019; 14: 1137-1150
- Complications from "stem cell tourism" in neurology.Ann Neurol. 2020; 88: 661-668
- Honesty/ethics in professions.https://news.gallup.com/poll/1654/honesty-ethics-professions.aspxDate accessed: May 26, 2021
- Fantasies about stem cell therapy in chronic ischemic stroke patients.Stem Cells Dev. 2013; 22: 31-36
- 'No one here's helping me, what do you do?': addressing patient need for support and advice about stem cell treatments.Regen Med. 2017; 12: 791-801
- Practices to foster physician presence and connection with patients in the clinical encounter [published correction appears in JAMA. 2020;323(11):1098].JAMA. 2020; 323: 70-81
- Communication in cancer care: discussing complementary and alternative medicine.Integr Cancer Ther. 2010; 9: 177-185
- Academic physician specialists’ views toward the unproven stem cell intervention industry: areas of common ground and divergence.Cytotherapy. 2021; 23: 348-356
- Concise review: a comprehensive analysis of reported adverse events in patients receiving unproven stem cell-based interventions.Stem Cells Transl Med. 2018; 7: 676-685
- Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory.2nd ed. Sage Publications, Thousand Oaks, CA1998
- Constructing Grounded Theory.2nd ed. Sage Publications, Thousand Oaks, CA2014
- How patients want their doctor to communicate: a literature review on primary care patients' perspective.Patient Educ Couns. 2013; 90: 297-306
- Four models of the physician-patient relationship.JAMA. 1992; 267: 2221-2226
- The new age of patient autonomy: implications for the patient-physician relationship.JAMA. 2018; 320: 1973-1974
- Patients comment on video-recorded consultations--the "good" GP and the "bad.".Scand J Soc Med. 1992; 20: 213-216
- What women want from their physicians: a qualitative analysis.J Womens Health (Larchmt). 2007; 16: 543-550
- How patients perceive a doctor's caring attitude.Patient Educ Couns. 2008; 72: 359-366
- Physician-patient interaction: what do elders want?.J Am Osteopath Assoc. 2002; 102: 73-78
- Doctor-patient communication: a review.Ochsner J. 2010; 10: 38-43
- The ethics of communication in cancer and palliative care.in: Kissane D.W. Bultz B.D. Butow P. Finlay I. Handbook of Communication in Oncology and Palliative Care. Oxford University Press, 2010: 54-56
- Geriatric patients' expectations of their physicians: findings from a tertiary care hospital in Pakistan.BMC Health Serv Res. 2009; 9: 205
- Implications of placebo and nocebo effects for clinical practice: expert consensus.Psychother Psychosom. 2018; 87: 204-210
- The roles and responsibilities of physicians in patients' decisions about unproven stem cell therapies.J Law Med Ethics. 2012; 40: 122-134
- Therapeutic journeys: the hopeful travails of stem cell tourists.Sociol Health Illn. 2014; 36: 670-685
- Cancer patient disclosure and patient-doctor communication of complementary and alternative medicine use: a systematic review.Oncologist. 2012; 17: 1475-1481
- Complementary and alternative medicine: the importance of doctor-patient communication.Med Clin North Am. 2002; 86: 1-10
- Stem cell tourism and doctors' duties to minors--a view from Canada.Am J Bioeth. 2010; 10: 3-15
- Stem cell-based clinical trials: practical advice for physicians and ethics/institutional review boards.
- Responding to requests of families for unproven interventions in neurodevelopmental disorders: hyperbaric oxygen "treatment" and stem cell "therapy" in cerebral palsy.Dev Disabil Res Rev. 2011; 17: 19-26
- ClinicalTrials.gov, stem cells and ‘pay-to-participate' clinical studies.Regen Med. 2017; 12: 705-719
- Responsibilities of health care professionals in counseling and educating patients with incurable neurological diseases regarding "stem cell tourism": caveat emptor.JAMA Neurol. 2015; 72: 1342-1345
- Medical societies, patient education initiatives, public debate and marketing of unproven stem cell interventions.Cytotherapy. 2018; 20: 165-168
- Unproven stem cell treatments for lung disease—an emerging public health problem.Am J Respir Crit Care Med. 2017; 195: P13-P14
- Position statement on the sale of unproven cellular therapies for spinal cord injury: the International Campaign for Cures of Spinal Cord Injury Paralysis [letter].Spinal Cord. 2009; 47: 713-714
Article Info
Publication History
Published online: August 25, 2021
Footnotes
Potential Competing Interests: Dr Behfar is a cofounder of Rion LLC and owns stock in Sorento Therapeutics, Inc, and Deverra Therapeutics, Inc. Dr. Shane Shapiro is a consultant for Bioventus. The other authors report no competing interests.
Identification
Copyright
© 2021 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.
