Suchergebnisse

BACKGROUND: The commitment to engage patients as partners in research has been described as a political, moral and ethical imperative. Researchers feel ill-equipped to deal with potential ethical implications of engaging patients as partners. The aim of this study is to identify the ethical considerations related to engaging frail and seriously ill (FSI) patients as partners in research. METHODS: We conducted a sub-analysis of a prior systematic review of 30 studies that engaged FSI patients as partners in research. Studies were included if they reported ethical considerations associated with partnering. We performed deductive content analysis, data were categorized according to Beauchamp and Childress' Principles of Biomedical Ethics (2019): autonomy, non-maleficence, beneficence, and justice. RESULTS: Twenty-five studies were included. Common ethical considerations reported in relation to the principles were: autonomy – promoting desired level of involvement, addressing relational and intellectual power, facilitating knowledge and understanding of research; non-maleficence – protection from financial burden, physical and emotional suffering; beneficence – putting things right for others, showing value-added, and supporting patient-partners; and, justice – achieving appropriate representation, mutual respect for contributions, and distributing risks and benefits. CONCLUSIONS: When partnering with FSI patients, research teams need to establish shared values and ensure processes are in place to identify and address ethical issues. Researchers and patients should work together to clarify the intent and outcomes of the partnership, actively address power differentials, recognize and minimize the potential for unintended harm, and strive to maximize the benefits of partnership. SYSTEMATIC REVIEW REGISTRATION: The protocol for the original systematic review has been registered with the International Prospective Register of Systematic Reviews PROSPERO (CRD42019127994).

Abstract Background Establishing the effectiveness of patient decision aids (PtDA) requires evidence that PtDAs improve the quality of the decision-making process and the quality of the choice made, or decision quality . The aim of this paper is to review the theoretical and empirical evidence for PtDA effectiveness and discuss emerging practical and research issues in the measurement of effectiveness. Methods This updated overview incorporates: a) an examination of the instruments used to measure five key decision-making process constructs (i.e., recognize decision, feel informed about options and outcomes, feel clear about goals and preferences, discuss goals and preferences with health care provider, and be involved in decisions) and decision quality constructs (i.e., knowledge, realistic expectations, values-choice agreement) within the 86 trials in the Cochrane review; and b) a summary of the 2011 Cochrane Collaboration's review of PtDAs for these key constructs. Data on the constructs and instruments used were extracted independently by two authors from the 86 trials and any disagreements were resolved by discussion, with adjudication by a third party where required. Results The 86 studies provide considerable evidence that PtDAs improve the decision-making process and decision quality. A majority of the studies (76/86; 88%) measured at least one of the key decision-making process or decision quality constructs. Seventeen different measurement instruments were used to measure decision-making process constructs, but no single instrument covered all five constructs. The Decisional Conflict Scale was most commonly used (n = 47), followed by the Control Preference Scale (n = 9). Many studies reported one or more constructs of decision quality, including knowledge (n = 59), realistic expectation of risks and benefits (n = 21), and values-choice agreement (n = 13). There was considerable variability in how values-choice agreement was defined and determined. No study reported on all key decision-making process and decision quality constructs. Conclusions Evidence of PtDA effectiveness in improving the quality of the decision-making process and decision quality is strong and growing. There is not, however, consensus or standardization of measurement for either the decision-making process or decision quality. Additional work is needed to develop and evaluate measurement instruments and further explore theoretical issues to advance future research on .