Patient and psychiatrist ratings of hypothetical schizophrenia research protocols: assessment of harm potential and factors influencing participation decisions.

Full Abstract

OBJECTIVE:
A central ethical issue in schizophrenia research is whether participants are able to provide informed consent, particularly for protocols entailing medication washouts or placebo treatments. Few data show how patients with schizophrenia and psychiatrists assess such scientific designs regarding potential harm, willingness to participate, and the relative influence of clinicians, family members, and financial incentives upon participation decisions.

METHOD:
In this preliminary study, structured interviews were conducted with schizophrenia patients (N=59), and parallel surveys were completed by attending and resident psychiatrists (N=70). Four hypothetical research protocols were rated. Patients were asked about their own views; psychiatrists provided both their personal views and predictions of patient views.

RESULTS:
Patients and psychiatrists both perceived substantially different levels of harm across the four protocols, identifying significantly greater harm for medication washouts or placebo treatments. Participants were less willing to enroll in protocols perceived as more harmful. Schizophrenia patients found enrollment decisions relatively easy. Patients and psychiatrists indicated that doctor recommendations, monetary incentives, and, to a lesser extent, family preferences had a mild influence on participation decisions.

CONCLUSIONS:
Given hypothetical protocols with variable design elements, schizophrenia patients and psychiatrists made meaningful and discerning harm assessments and participation decisions. These findings suggest that schizophrenia patients may have strengths in the research consent process that may not be fully recognized. The impact of outside influences upon research enrollment decisions remains uncertain. While psychiatrists were often accurate in predicting patient responses, data suggest the importance of clarifying views of individual patients regarding specific protocols.

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Author information

Author/s: Roberts, Laura Weiss (LW); Warner, Teddy D (TD); Brody, Janet L (JL); Roberts, Brian (B); Lauriello, John (J); Lyketsos, Constantine (C);

Affiliation: Empirical Ethics Group, University of New Mexico School of Medicine, Albequerque 87156-5326, USA. lroberts(-atsign-)salud.unm.edu

Grants: MH-01918 (Agency:NIMH NIH HHS)

Journal and publication information

Publication Type: Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.; Research Support, U.S. Gov't, P.H.S.

Journal: The American journal of psychiatry (Am J Psychiatry), published in United States. (Language: eng)

Reference: 2002-Apr; vol 159 (issue 4) : pp 573-84

Dates: Created 2002/04/01; Completed 2002/04/18; Revised 2007/11/15;

PMID: 11925295, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Motivation
Patient Education as Topic
Patient Participation
Physician-Patient Relations
Placebos - therapeutic use
Problem Solving
Questionnaires
Risk Assessment
Schizophrenia - diagnosis; drug therapy
Schizophrenic Psychology

Associated Chemicals: Placebos (0)

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