Literature DB >> 22673094

Participants' experiences of being debriefed to placebo allocation in a clinical trial.

Felicity L Bishop1, Eric E Jacobson, Jessica Shaw, Ted J Kaptchuk.   

Abstract

Participants in placebo-controlled clinical trials give informed consent to be randomized to verum or placebo. However, researchers rarely tell participants which treatment they actually received. We interviewed 4 participants in a trial of acupuncture for irritable bowel syndrome before, during, and after they received a course of placebo treatments over 6 weeks. During the final interview, we informed participants that they had received a course of placebo treatments. We used an idiographic phenomenological approach based on the Sheffield School to describe each participant's experiences of being blinded to and then debriefed to placebo allocation. The participants' experiences of blinding and debriefing were embodied, related to their goals in undertaking the study, and social (e.g., embedded in trusting and valued relationships with acupuncturists). We suggest ways in which debriefing to placebo allocation can be managed sensitively to facilitate positive outcomes for participants.

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Year:  2012        PMID: 22673094      PMCID: PMC3645341          DOI: 10.1177/1049732312448544

Source DB:  PubMed          Journal:  Qual Health Res        ISSN: 1049-7323


  31 in total

1.  Informing participants of allocation to placebo at trial closure: postal survey.

Authors:  Zelda Di Blasi; Ted J Kaptchuk; John Weinman; Jos Kleijnen
Journal:  BMJ       Date:  2002-12-07

2.  Informed consent for population-based research involving genetics.

Authors:  L M Beskow; W Burke; J F Merz; P A Barr; S Terry; V B Penchaszadeh; L O Gostin; M Gwinn; M J Khoury
Journal:  JAMA       Date:  2001-11-14       Impact factor: 56.272

3.  Unblinding of trial participants to their treatment allocation: lessons from the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER).

Authors:  Eleanor M Dinnett; Moira M B Mungall; Jane A Kent; Elizabeth S Ronald; Karen E McIntyre; Elizabeth Anderson; Allan Gaw
Journal:  Clin Trials       Date:  2005       Impact factor: 2.486

4.  Receiving a summary of the results of a trial: qualitative study of participants' views.

Authors:  Mary Dixon-Woods; Clare Jackson; Kate C Windridge; Sara Kenyon
Journal:  BMJ       Date:  2006-01-09

5.  Longitudinal analysis of the illness representation model in patients with irritable bowel syndrome (IBS).

Authors:  Claire L Rutter; Derek R Rutter
Journal:  J Health Psychol       Date:  2007-01

6.  Subjective theories of illness and clinical and psychological outcomes in patients with irritable bowel syndrome.

Authors:  Andrea Riedl; Julia Maass; Herbert Fliege; Andreas Stengel; Marco Schmidtmann; Burghard F Klapp; Hubert Mönnikes
Journal:  J Psychosom Res       Date:  2009-04-01       Impact factor: 3.006

7.  Children's and parents' perspectives on open-label use of placebos in the treatment of ADHD.

Authors:  A Sandler; C Glesne; G Geller
Journal:  Child Care Health Dev       Date:  2008-01       Impact factor: 2.508

Review 8.  Tegaserod for the treatment of irritable bowel syndrome and chronic constipation.

Authors:  B W Evans; W K Clark; D J Moore; P J Whorwell
Journal:  Cochrane Database Syst Rev       Date:  2007-10-17

9.  Reactions to treatment debriefing among the participants of a placebo controlled trial.

Authors:  Zelda Di Blasi; Fay Crawford; Colin Bradley; Jos Kleijnen
Journal:  BMC Health Serv Res       Date:  2005-04-22       Impact factor: 2.655

10.  Revelation of a personal placebo response: its effects on mood, attitudes and future placebo responding.

Authors:  Karen S Chung; Donald D Price; Nicholas G Verne; Michael E Robinson
Journal:  Pain       Date:  2007-03-21       Impact factor: 7.926

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  8 in total

1.  Informed consent and clinical trials: where is the placebo effect?

Authors:  C R Blease; F L Bishop; T J Kaptchuk
Journal:  BMJ       Date:  2017-02-03

2.  Effect of Unblinding on Participants' Perceptions of Risk and Confidence in a Large Double-Blind Clinical Trial of Chemotherapy for Breast Cancer.

Authors:  Ann H Partridge; Karen Sepucha; Anne O'Neill; Kathy D Miller; Christine Motley; Ramona F Swaby; Bryan P Schneider; Chau T Dang; Donald W Northfelt; George W Sledge
Journal:  JAMA Oncol       Date:  2015-06       Impact factor: 31.777

3.  The potential benefit of the placebo effect in sham-controlled trials: implications for risk-benefit assessments and informed consent.

Authors:  Remy L Brim; Franklin G Miller
Journal:  J Med Ethics       Date:  2012-12-13       Impact factor: 2.903

4.  Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial.

Authors:  Sarah Ballou; Ted J Kaptchuk; William Hirsch; Judy Nee; Johanna Iturrino; Kathryn T Hall; John M Kelley; Vivian Cheng; Irving Kirsch; Eric Jacobson; Lisa Conboy; Anthony Lembo; Roger B Davis
Journal:  Trials       Date:  2017-05-25       Impact factor: 2.279

5.  When and why placebo-prescribing is acceptable and unacceptable: a focus group study of patients' views.

Authors:  Felicity L Bishop; Lizzi Aizlewood; Alison E M Adams
Journal:  PLoS One       Date:  2014-07-09       Impact factor: 3.240

6.  Informing Patients About Placebo Effects: Using Evidence, Theory, and Qualitative Methods to Develop a New Website.

Authors:  Maddy Greville-Harris; Jennifer Bostock; Amy Din; Cynthia A Graham; George Lewith; Christina Liossi; Tim O'Riordan; Peter White; Lucy Yardley; Felicity L Bishop
Journal:  JMIR Res Protoc       Date:  2016-06-10

7.  Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers' experiences in a placebo-controlled trial of duloxetine.

Authors:  Isaac N Kwakye; Matthew Garner; David S Baldwin; Susan Bamford; Verity Pinkney; Felicity L Bishop
Journal:  Hum Psychopharmacol       Date:  2016-07       Impact factor: 1.672

8.  Informing Adults With Back Pain About Placebo Effects: Randomized Controlled Evaluation of a New Website With Potential to Improve Informed Consent in Clinical Research.

Authors:  Felicity L Bishop; Maddy Greville-Harris; Jennifer Bostock; Amy Din; Cynthia A Graham; George Lewith; Christina Liossi; Tim O'Riordan; Peter White; Lucy Yardley
Journal:  J Med Internet Res       Date:  2019-01-17       Impact factor: 5.428

  8 in total

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