Susannah L. Rose

Relationships Between Authorship Contributions and Authors' Industry Financial Ties Among Oncology Clinical Trials

PURPOSE To test the hypothesis that authors who play key scientific roles in oncology clinical trials, and who therefore have increased influence over the design, analysis, interpretation or reporting of trials, are more likely than those who do not play such roles to have financial ties to industry. METHODS Data were abstracted from all trials (n = 235) of drugs or biologic agents published in the Journal of Clinical Oncology between January 1, 2006 and June 30, 2007. Article-level data included sponsorship, age group (adult v pediatric), phase, single versus multicenter, country (United States v other), and number of authors. Author-level data (n = 2,927) included financial ties (eg, employment, consulting) and performance of key scientific roles (ie, conception/design, analysis/interpretation, or manuscript writing). Associations between performance of key roles and financial ties, adjusting for article-level covariates, were examined using generalized linear mixed models. Results One thousand eight hundred eighty-one authors (64%) reported performing at least one key role, and 842 authors (29%) reported at least one financial tie. Authors who reported performing a key role were more likely than other authors to report financial ties to industry (adjusted odds ratio [OR], 4.3; 99% CI, 3.0 to 6.0; P < .0001). The association was stronger among trials with, compared with those without, industry funding (OR, 5.0 [99% CI, 3.4 to 7.5] v OR, 2.5 [99% CI, 1.3 to 4.8]), but was present regardless of sponsorship. CONCLUSION Authors who perform key roles in the conception and design, analysis, and interpretation, or reporting of oncology clinical trials are more likely than authors who do not perform such roles to have financial ties to industry.

Patient Advocacy Organizations: Institutional Conflicts of Interest, Trust, and Trustworthiness

Patient advocacy organizations (PAOs) advocate for increased research funding and policy changes and provide services to patients and their families. Given their credibility and political clout, PAOs are often successful in changing policies, increasing research funding, and increasing public awareness of medical conditions and the problems of their constituents. In order to advance their missions, PAOs accept funding, frequently from pharmaceutical firms. Industry funding can help PAOs advance their goals but can also create conflicts of interest (COI). Research indicates that bias may occur, even among well-meaning professionals, when people and organizations have financial COI. Industry funding may therefore influence PAOs to act in ways that favor the interests of their donors, which may increase the risk of harm to patients. This article extends the analysis developed in the Institute of Medicine report, Conflicts of Interest in Medical Research, Education, and Practice, and applies the analysis to understand PAOs and their relationships with industry. It argues that the preferred goal of institutional COI policies should not be to promote trust, but to promote trustworthiness and appropriately placed trust.

The Role of Social Work in the ICU: Reducing Family Distress and Facilitating End-of-Life Decision-Making

Abstract The costs associated with Intensive Care Units (ICUs) are high and at times invasive ICU care may not be beneficial, particularly for those patients admitted to ICUs who have little hope of recovery. The process of clarifying medical goals for these patients is often facilitated by addressing psychosocial factors. Social workers in the ICU are uniquely qualified to assess and address many of the complex psy-chosocial circumstances and can clarify potential misperceptions, enhancing communication among patients (if capacitated), their families, and the medical team members. This can not only help improve quality of life for very sick and dying patients in the ICU and their families, but may also reduce the likelihood of decision-making conflicts from arising. Further studies need to be done to investigate the effectiveness of social work interventions in reducing family distress, avoiding care that is unwanted by patients, and demonstrating cost-saving benefits.

Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest.

Importance Patient advocacy organizations (PAOs) are influential health care stakeholders that provide direct counseling and education for patients, engage in policy advocacy, and shape research agendas. Many PAOs report having financial relationships with for-profit industry, yet little is known about the nature of these relationships. Objective To describe the nature of industry funding and partnerships between PAOs and for-profit companies in the United States. Design, Setting, and Participants A survey was conducted from September 1, 2013, to June 30, 2014, of a nationally representative random sample of 439 PAO leaders, representing 5.6% of 7865 PAOs identified in the United States. Survey questions addressed the nature of their activities, their financial relationships with industry, and the perceived effectiveness of their conflict of interest policies. Main Outcomes and Measures Amount and sources of revenue as well as organizational experiences with and policies regarding financial conflict of interest. Results Of the 439 surveys mailed to PAO leaders, 289 (65.8%) were returned with at least 80% of the questions answered. The PAOs varied widely in terms of size, funding, activities, and disease focus. The median total revenue among responding organizations was

Gender Differences in Physicians' Financial Ties to Industry: A Study of National Disclosure Data.

299 140 (interquartile range,

Decision-Making for an Incapacitated Pregnant Patient

70 000-

Use of Visual Decision Aids in Physician–Patient Communication: A Pilot Investigation

1 200 000). A total of 165 of 245 PAOs (67.3%) reported receiving industry funding, with 19 of 160 PAOs (11.9%) receiving more than half of their funding from industry. Among the subset of PAOs that received industry funding, the median amount was

Implementation of Patient and Family Advisory Councils in Primary Care Practices in a Large, Integrated Health System

50 000 (interquartile range,

Patient Perspectives on Clinical Scribes in Primary Care

15 000-

A new survey to evaluate conflict of interest policies at academic medical centers

200 000); the median proportion of industry support derived from the pharmaceutical, device, and/or biotechnology sectors was 45% (interquartile range, 0%-100%). A total of 220 of 269 respondents (81.8%) indicated that conflicts of interest are very or moderately relevant to PAOs, and 94 of 171 (55.0%) believed that their organizations’ conflict of interest policies were very good. A total of 22 of 285 PAO leaders (7.7%) perceived pressure to conform their positions to the interests of corporate donors. Conclusions and Relevance Patient advocacy organizations engage in wide-ranging health activities. Although most PAOs receive modest funding from industry, a minority receive substantial industry support, raising added concerns about independence. Many respondents report a need to improve their conflict of interest policies to help maintain public trust.