Determining information for inclusion in a decision-support intervention for clinical trial participation : A modified Delphi approach

Peer reviewedPostprin

Trustworthy Patient Decision Aids: a Qualitative Analysis Addressing the Risk of Competing Interests

OBJECTIVE: Our aim in this study was to examine the competing interest policies and procedures of organisations who develop and maintain patient decision aids. DESIGN: Descriptive and thematic analysis of data collected from a cross-sectional survey of patient decision aid developer\u27s competing interest policies and disclosure forms. RESULTS: We contacted 25 organisations likely to meet the inclusion criteria. 12 eligible organisations provided data. 11 organisations did not reply and 2 declined to participate. Most patient decision aid developers recognise the need to consider the issue of competing interests. Assessment processes vary widely and, for the most part, are insufficiently robust to minimise the risk of competing interests. Only half of the 12 organisations had competing interest policies. Some considered disclosure to be sufficient, while others imposed differing levels of exclusion. CONCLUSIONS: Patient decision aid developers do not have a consistent approach to managing competing interests. Some have developed policies and procedures, while others pay no attention to the issue. As is the case for clinical practice guidelines, increasing attention will need to be given to how the competing interests of contributors of evidence-based publications may influence materials, especially if they are designed for patient use

"It Was as Though My Spirit Left, Like They Killed Me": The Disruptive Impact of an HIV-Positive Diagnosis among Women in the Dominican Republic.

An HIV diagnosis may be associated with severe emotional and psychological distress, which can contribute to delays in care or poor self-management. Few studies have explored the emotional, psychological, and psychosocial impacts of an HIV diagnosis on women in low-resource settings. We conducted in-depth interviews with 30 women living with HIV in the Dominican Republic. Interviews were audio-recorded, transcribed, and analyzed using the biographical disruption framework. Three disruption phases emerged (impacts of a diagnosis, postdiagnosis turning points, and integration). Nearly all respondents described the news as deeply distressful and feelings of depression and loss of self-worth were common. Several reported struggling with the decision to disclose-worrying about stigma. Postdiagnosis turning points consisted of a focus on survival and motherhood; social support (family members, friends, HIV community) promoted integration. The findings suggest a need for psychological resources and social support interventions to mitigate the negative impacts of an HIV diagnosis

Against Fiduciary Utopianism: The Regulation of Physician Conflicts of Interest and Standards of Care

This Article critically examines calls by scholars, legislators, and regulators advocating the imposition of fiduciary duties upon a broad range of actors including judges, jurors, agencies, parents, friends, and even entire countries. The Article examines the physician-patient relationship—an archetypal and frequently cited relationship in which fiduciary duties, administered by courts, are asserted to work well. It argues that some of the most significant problems fiduciary duties are used to address like asymmetry of information, conflicts of interest, and professional conduct have not only been handled badly by courts, but have actually found more effective resolution through legislative fact-finding, acknowledgment of the complexity of medical practice, and ultimately regulatory solutions aimed at sources of conflicts of interest and specific circumstances in which claims for medical malpractice arise. Behind many of these initiatives are physicians themselves—who experience the sources of potential conflicts and endeavor to create self-regulatory and legislative solutions to them. In contrast, court-administered fiduciary duties are often marginalized as judicially manageable claims related to the duties of loyalty and the duty of care converge, litigants focus on settlement, and the high expectations held for fiduciaries are rarely enforced. The Article concludes that not only may imposing more fiduciary duties on more relationships not generate the benefits many scholars suggest, but that doing so will stymie more targeted and effective solutions to problems that occur in trust relationships

HIV and Partner Violence: Implications for HIV Voluntary\ud Counseling and Testing Programs in Dar es Salaam, Tanzania

This study explored the links between HIV infection, serostatus disclosure, and partner violence among women attending a VCT clinic in Dar es Salaam, Tanzania. Men and women both perceive HIV testing as a way to plan for the future but are motivated to undergo testing by a number of different individual, relationship, and environmental factors. The women in our study described more barriers to HIV testing than did men, and women who have communicated with their partners about VCT before seeking services are significantly more likely to share their HIV test results than those who have not talked with their partners. Findings from this study led to a number of recommendations that could reduce the barriers women face in getting tested for HIV and in disclosing their serostatus to their partners, as well as reduce levels of partner violence. These recommendations pertain to VCT services as well as to the wider community and policy environment