Conflict of Interest Policies for Organizations Producing a Large Number of Clinical Practice Guidelines

Conflict of interest (COI) of clinical practice guideline (CPG) sponsors and authors is an important potential source of bias in CPG development. The objectives of this study were to describe the COI policies for organizations currently producing a significant number of CPGs, and to determine if these policies meet 2011 Institute of Medicine (IOM) standards.We identified organizations with five or more guidelines listed in the National Guideline Clearinghouse between January 1, 2009 and November 5, 2010. We obtained the COI policy for each organization from publicly accessible sources, most often the organization's website, and compared those polices to IOM standards related to COI. 37 organizations fulfilled our inclusion criteria, of which 17 (46%) had a COI policy directly related to CPGs. These COI policies varied widely with respect to types of COI addressed, from whom disclosures were collected, monetary thresholds for disclosure, approaches to management, and updating requirements. Not one organization's policy adhered to all seven of the IOM standards that were examined, and nine organizations did not meet a single one of the standards.COI policies among organizations producing a large number of CPGs currently do not measure up to IOM standards related to COI disclosure and management. CPG developers need to make significant improvements in these policies and their implementation in order to optimize the quality and credibility of their guidelines

Conflict of Interest in Clinical Practice Guideline Development: A Systematic Review

Background: There is an emerging literature on the existence and effect of industry relationships on physician and researcher behavior. Much less is known, however, about the effects of these relationships and other conflicts of interest (COI) on clinical practice guideline (CPG) development and recommendations. We performed a systematic review of the prevalence of COI and its effect on CPG recommendations. Methodology/Principal Findings: We searched Medline (1980 to March, 2011) for studies that examined the effect of COI on CPG development and/or recommendations. Data synthesis was qualitative. Twelve studies fulfilled inclusion criteria; 9 were conducted in the US. All studies reported on financial relationships of CPG authors with the pharmaceutical industry; 1 study also examined relationships with diagnostic testing and insurance companies. The majority of guidelines had authors with industry affiliations, including consultancies (authors with relationship, range 6–80%); research support (4–78%); equity/stock ownership (2–17%); or any COI (56–87%). Four studies reported multiple types of financial interactions for individual authors (number of types per author: range 2 to 10 or more). Data on the effect of COI on CPG recommendations were confined to case studies wherein authors with specific financial ties appeared to benefit from the related CPG recommendations. In a single study, few authors believed that their relationships influenced their recommendations. No studies reported on intellectual COI in CPGs

Characteristics of physicians receiving large payments from pharmaceutical companies and the accuracy of their disclosures in publications: an observational study

Abstract Background Financial relationships between physicians and industry are extensive and public reporting of industry payments to physicians is now occurring. Our objectives were to describe physician recipients of large total payments from these seven companies, and to examine discrepancies between these payments and conflict of interest (COI) disclosures in authors’ concurrent publications. Methods The investigative journalism organization, ProPublica, compiled the Dollars for Docs database of payments to individuals from publically available data from seven US pharmaceutical companies during the period 2009 to 2010. We examined the cohort of 373 physicians in this database who each received USD $100,000 or more in the reporting period 2009 to 2010. Results These physicians received a total of$52,600,624 during this period (mean payment per physician $141,020). The predominant specialties were internal medicine and psychiatry. 147 of these physicians authored a total of 134 publications in the first quarter of 2011 and 77% (103) of these publications provided a COI disclosure. 69% of the 103 publications did not contain disclosures of the payment listed in the Dollars for Docs database. Conclusions With increased public reporting of industry payments to physicians, it is apparent that large sums are being paid for services such as consulting and peer education. In over two-thirds of publications where COI disclosures were provided, the disclosures by physician authors did not include industry payments that were documented in the Dollars for Docs database.</p

Conflicts of interest among authors of clinical practice guidelines for glycemic control in type 2 diabetes mellitus.

BACKGROUND:Conflict of interest (COI) is an important potential source of bias in the development of clinical practice guidelines (CPGs). OBJECTIVES:To examine rates of disclosure of COI, including financial interests in companies that manufacture drugs that are recommended in CPGs on glycemic control in type 2 diabetes mellitus, and to explore the relationship between recommendations for specific drugs in a guideline and author COI. METHODS:We identified a cohort of relevant guidelines from the National Guideline Clearinghouse (NGC) and abstracted COI disclosures from all guideline authors for this observational, cross-sectional study. We determined which hypoglycemic drugs were recommended in each guideline, and explored the relationship between specific disclosures and whether a drug was recommended. RESULTS:Among 13 included guidelines, the percentage of authors with one or more financial disclosures varied from 0 to 94% (mean 44.2%), and was particularly high for two US-based guidelines (91% and 94%). Three guidelines disclosed no author financial COI. The percentage of authors with disclosures of financial interests in manufacturers of recommended drugs was also high (mean 30%). On average, 56% of manufacturers of patented drugs recommended in each guideline had one or more authors with a financial interest in their company. We did not find a significant relationship between financial interests and whether a drug was recommended in our sample; US-based guidelines were more likely to make recommendations for a specific drug compared to non-US based guidelines. DISCUSSION:Authors of this cohort of guidelines have financial interests directly related to the drugs that they are recommending. Although we did not find an association between author COI and drugs recommended in these guidelines and we cannot draw conclusions about the validity of the recommendations, the credibility of many of these guidelines is in doubt

Quality of Clinical Practice Guidelines for Glycemic Control in Type 2 Diabetes Mellitus

<div><p>Background</p><p>Several studies have reported that clinical practice guidelines (CPGs) in a variety of clinical areas are of modest or variable quality. The objective of this study was to evaluate the quality of an international cohort of CPGs that provide recommendations on pharmaceutical management of glycemic control in patients with type 2 diabetes mellitus (DM2).</p> <p>Methods and Findings</p><p>We searched the National Guideline Clearinghouse (NGC) on February 15th and June 4th, 2012 for CPGs meeting inclusion criteria. Two independent assessors rated the quality of each CPG using the Appraisal of Guidelines for Research & Evaluation II (AGREE II) instrument. Twenty-four guidelines were evaluated, and most had high scores for clarity and presentation. However, scope and purpose, stakeholder involvement, rigor of development, and applicability domains varied considerably. The majority of guidelines scored low on editorial independence, and only seven CPGs were based on an underlying systematic review of the evidence.</p> <p>Conclusions</p><p>The overall quality of CPGs for glycemic control in DM2 is moderate, but there is substantial variability among quality domains within and across guidelines. Guideline users need to be aware of this variability and carefully appraise and select the guidelines that they apply to patient care.</p> </div

Standardized domain scores for rigor of development and editorial independence.

<p>Scores are obtained from two of the domains of AGREE II (Appraisal of Guidelines for Research and Evaluation) <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0058625#pone.0058625-Brouwers1" target="_blank">[11]</a> Guidelines: American Association of Clinical Endocrinologists (AACE), American College of Physicians (ACP), American Diabetes Association (ADA), American Medical Directors Association (AMDA), Canadian Agency for Drugs and Technologies in Health (CADTH), European Society of Cardiology (ESC), Institute for Clinical Systems Improvement (ICSI), International Diabetes Center (IDC), International Diabetes Federation (IDF), Joslin Diabetes Center (JDC), National Kidney Foundation (KDOQI), National Collaborating Centre for Acute and Chronic Conditions (NCC-ACC), National Collaborating Centre for Women's and Children's Health (NCC-WCH), National Health Care for the Homeless Council (NHCHC), National Institute for Health and Clinical Excellence (NICE), New York State Department of Health (NY DoH), Qatif Primary Health Care (QPHC), Scottish Intercollegiate Guidelines Network (SIGN), University of Michigan Health System (UMHS), Department of Veterans Affairs/Department of Defense (VA/DoD), Wisconsin Diabetes Prevention and Control Program (WDPCP).</p

AGREE II Instrument for the Quality Assessment of Clinical Practice Guidelines.

<p>AGREE II, Appraisal of Guidelines for Research and Evaluation II <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0058625#pone.0058625-Brouwers1" target="_blank">[11]</a>.</p

Financial interests in specific drugs among three selected guidelines.

<div><p>Percent of authors of three clinical practice guidelines with disclosures of financial interests in the manufacturers of specific drugs. </p> <p>Abbreviations. See list for <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0075284#pone-0075284-t001" target="_blank">Table 1</a>.</p></div

Disclosure requirements and conflict of interest management strategies for organizations (n = 17).

*<p>Disclosure management strategy goes beyond simply requiring clinical practice guideline members to disclose conflicts of interest (COI). Management strategies include, for example, descriptions of who assesses and/or manages the disclosures, penalties for non-disclosure, detailed decision-making processes, limitations placed on individuals with COI, or prohibition from participation.</p><p>Abbreviations: COI, conflict of interest; NR, not reported; see <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0037413#pone-0037413-t002" target="_blank">Table 2</a> for abbreviations of the guideline organizations.</p

Guideline authors with financial interests in recommended drugs.

<div><p>Percentage of authors of clinical practice guidelines with a financial interest in one or more of the manufacturers of patented drugs recommended in each guideline. </p> <p>Abbreviations. See list for <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0075284#pone-0075284-t001" target="_blank">Table 1</a>.</p></div