Marketing therapeutic precision

Potential facilitators and barriers to adoption of n-of-1 trials

Richard L Kravitz, Debora A Paterniti, M. Cameron Hay, Saskia Subramanian, Dionne Evans Dean, Thomas Weisner, Sunita Vohra, Naihua Duan

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Background: N-of-1 trials may enhance therapeutic precision by predicting the long-term effectiveness of medical treatment on an individual basis. However, the n-of-1 approach has gained little traction with the clinical community. To learn why, we interviewed physicians and patients, focusing on the perceived benefits and drawbacks of n-of-1 trials and factors influencing these perceptions. Methods: We convened focus groups and individual interviews with 21 physicians and 32 patients, most with chronic conditions. The study employed qualitative interview methods to explore and analyze subjects' views of n-of-1 trials. Analysis involved an iterative process of review and data abstraction after specific topics for coding, definitions of codes, and strategies for abstraction had been established. Previously defined domains and topics were then expanded and enriched, with key themes emerging during the analytic process. Results: Physicians and patients remarked on 4 salient aspects of n-of-1 trials: scientific, relational, clinical, and logistical. Neither physicians nor patients were highly familiar with the n-of-1 concept, but both groups readily grasped the fundamental logic and appreciated the potential scientific benefits. Physicians saw n-of-1 trials as promoting an exciting but possibly threatening paradigm shift in the doctor-patient relationship, while patients viewed the relational consequences as modest. The best n-of-1 candidates were felt to be proactive, cognitively intact, reliable, motivated, and engaged in a trusting physician-patient relationship. Conclusions: Researchers interested in expanding the appeal of n-of-1 trials will need to address these concerns by carefully explaining the approach, emphasizing the benefits, and minimizing the effort required of doctors and patients.

Original languageEnglish (US)
Pages (from-to)436-445
Number of pages10
JournalContemporary Clinical Trials
Volume30
Issue number5
DOIs
StatePublished - Sep 2009

Fingerprint

Marketing
Physicians
Therapeutics
Interviews
Physician-Patient Relations
Traction
Focus Groups
Research Personnel

Keywords

  • Clinical trials
  • Delivery of health care/methods
  • Evidence-based medicine
  • n-of-1 trials
  • Qualitative research

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine(all)

Cite this

Marketing therapeutic precision : Potential facilitators and barriers to adoption of n-of-1 trials. / Kravitz, Richard L; Paterniti, Debora A; Hay, M. Cameron; Subramanian, Saskia; Dean, Dionne Evans; Weisner, Thomas; Vohra, Sunita; Duan, Naihua.

In: Contemporary Clinical Trials, Vol. 30, No. 5, 09.2009, p. 436-445.

Research output: Contribution to journalArticle

Kravitz, Richard L ; Paterniti, Debora A ; Hay, M. Cameron ; Subramanian, Saskia ; Dean, Dionne Evans ; Weisner, Thomas ; Vohra, Sunita ; Duan, Naihua. / Marketing therapeutic precision : Potential facilitators and barriers to adoption of n-of-1 trials. In: Contemporary Clinical Trials. 2009 ; Vol. 30, No. 5. pp. 436-445.
@article{f4c97e84c9b147069e1d32fbd7e78efe,
title = "Marketing therapeutic precision: Potential facilitators and barriers to adoption of n-of-1 trials",
abstract = "Background: N-of-1 trials may enhance therapeutic precision by predicting the long-term effectiveness of medical treatment on an individual basis. However, the n-of-1 approach has gained little traction with the clinical community. To learn why, we interviewed physicians and patients, focusing on the perceived benefits and drawbacks of n-of-1 trials and factors influencing these perceptions. Methods: We convened focus groups and individual interviews with 21 physicians and 32 patients, most with chronic conditions. The study employed qualitative interview methods to explore and analyze subjects' views of n-of-1 trials. Analysis involved an iterative process of review and data abstraction after specific topics for coding, definitions of codes, and strategies for abstraction had been established. Previously defined domains and topics were then expanded and enriched, with key themes emerging during the analytic process. Results: Physicians and patients remarked on 4 salient aspects of n-of-1 trials: scientific, relational, clinical, and logistical. Neither physicians nor patients were highly familiar with the n-of-1 concept, but both groups readily grasped the fundamental logic and appreciated the potential scientific benefits. Physicians saw n-of-1 trials as promoting an exciting but possibly threatening paradigm shift in the doctor-patient relationship, while patients viewed the relational consequences as modest. The best n-of-1 candidates were felt to be proactive, cognitively intact, reliable, motivated, and engaged in a trusting physician-patient relationship. Conclusions: Researchers interested in expanding the appeal of n-of-1 trials will need to address these concerns by carefully explaining the approach, emphasizing the benefits, and minimizing the effort required of doctors and patients.",
keywords = "Clinical trials, Delivery of health care/methods, Evidence-based medicine, n-of-1 trials, Qualitative research",
author = "Kravitz, {Richard L} and Paterniti, {Debora A} and Hay, {M. Cameron} and Saskia Subramanian and Dean, {Dionne Evans} and Thomas Weisner and Sunita Vohra and Naihua Duan",
year = "2009",
month = "9",
doi = "10.1016/j.cct.2009.04.001",
language = "English (US)",
volume = "30",
pages = "436--445",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",
number = "5",

}

TY - JOUR

T1 - Marketing therapeutic precision

T2 - Potential facilitators and barriers to adoption of n-of-1 trials

AU - Kravitz, Richard L

AU - Paterniti, Debora A

AU - Hay, M. Cameron

AU - Subramanian, Saskia

AU - Dean, Dionne Evans

AU - Weisner, Thomas

AU - Vohra, Sunita

AU - Duan, Naihua

PY - 2009/9

Y1 - 2009/9

N2 - Background: N-of-1 trials may enhance therapeutic precision by predicting the long-term effectiveness of medical treatment on an individual basis. However, the n-of-1 approach has gained little traction with the clinical community. To learn why, we interviewed physicians and patients, focusing on the perceived benefits and drawbacks of n-of-1 trials and factors influencing these perceptions. Methods: We convened focus groups and individual interviews with 21 physicians and 32 patients, most with chronic conditions. The study employed qualitative interview methods to explore and analyze subjects' views of n-of-1 trials. Analysis involved an iterative process of review and data abstraction after specific topics for coding, definitions of codes, and strategies for abstraction had been established. Previously defined domains and topics were then expanded and enriched, with key themes emerging during the analytic process. Results: Physicians and patients remarked on 4 salient aspects of n-of-1 trials: scientific, relational, clinical, and logistical. Neither physicians nor patients were highly familiar with the n-of-1 concept, but both groups readily grasped the fundamental logic and appreciated the potential scientific benefits. Physicians saw n-of-1 trials as promoting an exciting but possibly threatening paradigm shift in the doctor-patient relationship, while patients viewed the relational consequences as modest. The best n-of-1 candidates were felt to be proactive, cognitively intact, reliable, motivated, and engaged in a trusting physician-patient relationship. Conclusions: Researchers interested in expanding the appeal of n-of-1 trials will need to address these concerns by carefully explaining the approach, emphasizing the benefits, and minimizing the effort required of doctors and patients.

AB - Background: N-of-1 trials may enhance therapeutic precision by predicting the long-term effectiveness of medical treatment on an individual basis. However, the n-of-1 approach has gained little traction with the clinical community. To learn why, we interviewed physicians and patients, focusing on the perceived benefits and drawbacks of n-of-1 trials and factors influencing these perceptions. Methods: We convened focus groups and individual interviews with 21 physicians and 32 patients, most with chronic conditions. The study employed qualitative interview methods to explore and analyze subjects' views of n-of-1 trials. Analysis involved an iterative process of review and data abstraction after specific topics for coding, definitions of codes, and strategies for abstraction had been established. Previously defined domains and topics were then expanded and enriched, with key themes emerging during the analytic process. Results: Physicians and patients remarked on 4 salient aspects of n-of-1 trials: scientific, relational, clinical, and logistical. Neither physicians nor patients were highly familiar with the n-of-1 concept, but both groups readily grasped the fundamental logic and appreciated the potential scientific benefits. Physicians saw n-of-1 trials as promoting an exciting but possibly threatening paradigm shift in the doctor-patient relationship, while patients viewed the relational consequences as modest. The best n-of-1 candidates were felt to be proactive, cognitively intact, reliable, motivated, and engaged in a trusting physician-patient relationship. Conclusions: Researchers interested in expanding the appeal of n-of-1 trials will need to address these concerns by carefully explaining the approach, emphasizing the benefits, and minimizing the effort required of doctors and patients.

KW - Clinical trials

KW - Delivery of health care/methods

KW - Evidence-based medicine

KW - n-of-1 trials

KW - Qualitative research

UR - http://www.scopus.com/inward/record.url?scp=68349120371&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=68349120371&partnerID=8YFLogxK

U2 - 10.1016/j.cct.2009.04.001

DO - 10.1016/j.cct.2009.04.001

M3 - Article

VL - 30

SP - 436

EP - 445

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

IS - 5

ER -