Literature DB >> 35218599

Therapeutic Misconception about Research Procedures: Does a Simple Information Chart Improve Understanding?

Gavin Campbell1, Margie D Dixon2, Minisha Lohani3, John Cook4, Rachel Hianik5, Mary Catherine Thomson6, Eli Abernethy7, Colleen Lewis8, Jeffrey Switchenko9, R Donald Harvey10, Rebecca D Pentz11.   

Abstract

In phase I trials, some biospecimens are used both for research and patient care and some for research only. Some research participants have therapeutic misconception, assuming all biospecimens are for patient care. This study's aim was to test if a simple information chart would improve understanding of nontherapeutic research procedures. A two-arm study was conducted. Participants in the control group (C) were asked whether biospecimens were for their care, for research only, or for both. The experimental group (E) was asked the same questions but provided with a study-specific information chart labeling the purpose of each biospecimen. One hundred one patients were interviewed. In both arms, understanding that pretreatment blood draws were for patient care and research was moderate (49% for C and 62% for E). Understanding that posttreatment blood draws were for research only was significantly higher in the experimental arm (16% for C and 44% for E; p = 0.002). Providing a simple information chart may help alleviate this aspect of therapeutic misconception.
© 2022 by The Hastings Center. All rights reserved.

Entities:  

Keywords:  biospecimens; informed consent; nontherapeutic procedures; phase I research; research ethics; therapeutic misconception

Mesh:

Year:  2022        PMID: 35218599      PMCID: PMC9069479          DOI: 10.1002/eahr.500120

Source DB:  PubMed          Journal:  Ethics Hum Res        ISSN: 2578-2355


  12 in total

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Authors:  B Freedman; A Fuks; C Weijer
Journal:  Clin Res       Date:  1992-12

Review 2.  Interventions to improve research participants' understanding in informed consent for research: a systematic review.

Authors:  James Flory; Ezekiel Emanuel
Journal:  JAMA       Date:  2004-10-06       Impact factor: 56.272

3.  American Society of Clinical Oncology policy statement update: the critical role of phase I trials in cancer research and treatment.

Authors:  Jeffrey S Weber; Laura A Levit; Peter C Adamson; Suanna Bruinooge; Howard A Burris; Michael A Carducci; Adam P Dicker; Mithat Gönen; Stephen M Keefe; Michael A Postow; Michael A Thompson; David M Waterhouse; Susan L Weiner; Lynn M Schuchter
Journal:  J Clin Oncol       Date:  2014-12-15       Impact factor: 44.544

4.  Rules of the Road for Patient-Driven Consent Processes.

Authors:  Hayden P Nix; Charles Weijer
Journal:  Am J Bioeth       Date:  2020-06       Impact factor: 11.229

5.  Videos improve patient understanding of misunderstood chemotherapy terminology.

Authors:  Rebecca D Pentz; Minisha Lohani; Melissa Hayban; Jeffrey M Switchenko; Margie D Dixon; Richard J DeFeo; Gregg M Orloff; Ashesh B Jani; Viraj A Master
Journal:  Cancer       Date:  2019-08-16       Impact factor: 6.860

6.  Burdensome Research Procedures in Trials: Why Less Is More.

Authors:  Jonathan Kimmelman; David B Resnik; Jeffrey Peppercorn; Mark J Ratain
Journal:  J Natl Cancer Inst       Date:  2017-04-01       Impact factor: 13.506

7.  Ethics of mandatory research biopsy for correlative end points within clinical trials in oncology.

Authors:  Jeffrey Peppercorn; Iuliana Shapira; Deborah Collyar; Teresa Deshields; Nancy Lin; Ian Krop; Hans Grunwald; Paula Friedman; Ann H Partridge; Richard L Schilsky; Monica M Bertagnolli
Journal:  J Clin Oncol       Date:  2010-04-20       Impact factor: 44.544

8.  Research biopsies in phase I studies: views and perspectives of participants and investigators.

Authors:  Rebecca D Pentz; R Donald Harvey; Margaret White; Zachary Luke Farmer; Olga Dashevskaya; Zhengjia Chen; Colleen Lewis; Taofeek K Owonikoko; Fadlo R Khuri
Journal:  IRB       Date:  2012 Mar-Apr

9.  Benefit in phase 1 oncology trials: therapeutic misconception or reasonable treatment option?

Authors:  Franklin G Miller; Steven Joffe
Journal:  Clin Trials       Date:  2008       Impact factor: 2.486

10.  Clinical trials and medical care: defining the therapeutic misconception.

Authors:  Gail E Henderson; Larry R Churchill; Arlene M Davis; Michele M Easter; Christine Grady; Steven Joffe; Nancy Kass; Nancy M P King; Charles W Lidz; Franklin G Miller; Daniel K Nelson; Jeffrey Peppercorn; Barbra Bluestone Rothschild; Pamela Sankar; Benjamin S Wilfond; Catherine R Zimmer
Journal:  PLoS Med       Date:  2007-11-27       Impact factor: 11.069

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