OBJECTIVE:Clinical practice guidelines (CPGs) underpin patient care, and ideally authors of these guidelines would be free from outside influence. However, it has been shown many times that authors of professional society CPGs receive large sums of money from industry drug companies, creating financial conflicts of interest. This study investigated industry payments catalogued in the Open Payments Database (OPD) that have been received by authors of the American College of Rheumatology (ACR) CPGs.METHODS:Guidelines on the ACR web site that were published during or after August 2014 were used to retrieve the list of authors. All general, research, associated research, and ownership payments reported on the OPD between the date of publication of the CPG and 12 months prior were extracted in a parallel and blinded manner by 2 investigators.RESULTS:Of the 89 US-based physician-authors from the 5 ACR CPGs identified within the study timeframe, 56 (62.9%) had received at least 1 payment according to OPD records. These 56 authors had received a median of $522 (interquartile range $119-2,500), which, combined, was a total of $9,728,751. Nineteen authors had received at least 1 industry payment relevant to the CPG recommendations, for a median amount of $748 and a total of $1,961,362 in relevant payments. Of the total relevant payments received, a significant proportion was undisclosed (for ACR CPGs during or after August 2014, undisclosed payments were $699,561, or 35.7% of the total).CONCLUSION:Fewer than one-half of the US-based physician-authors of ACR CPGs during or after August 2014 had received guideline-relevant industry payments. Nonetheless, a substantial proportion of the money received was not disclosed. Conflict of interest disclosure is a bare minimum requirement, and more permanent solutions may include divestiture or inclusion of more nonconflicted authors.
We have identified ‘spin’ in abstracts of randomised controlled trials (RCTs) with nonsignificant primary endpoints in psychiatry and psychology journals. This is a cross-sectional review of clinical trials with nonsignificant primary endpoints published in psychiatry and psychology journals from January 2012 to December 2017. The main outcome was the frequency and manifestation of spin in the abstracts. We define spin as the ‘use of specific reporting strategies, from whatever motive, to highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or to distract the reader from statistically nonsignificant results’. We have also assessed the relationship between industry funding and spin. Of the 486 RCTs examined, 116 were included in our analysis of spin. Spin was identified in 56% (n=65) of those included. Spin was found in 2 (2%) titles, 24 (21%) abstract results sections and 57 (49.1%) abstract conclusion sections. Evidence of spin was simultaneously identified in both results and conclusions sections in 15% of RCTs (n=17). Twelve articles reported industry funding (10%). Industry funding was not associated with increased odds of spin in the abstract (unadjusted OR: 1.0; 95% CI: 0.3 to 3.2). We found no relationship between industry funding and spin in abstracts. These findings raise concerns about the effects spin may have on clinicians. Further steps could be taken to address spin, including inviting reviewers to comment on the presence of spin and updating Consolidated Standards of Reporting Trials guidelines to contain language discouraging spin.
Background: The objective of this studywas to evaluate the temporal relationship between clinical practice guideline development and subsequent research performed, with the goal of providing more data on areas of sparse evidence that serve to underlie guideline recommendations. We aimed to assess the quality of current research efforts to address the American College of Emergency Physicians guideline and to provide suggestions for future research of mild traumatic brain injury. Methods: We identified clinical practice guideline recommendations with low levels of underlying evidence and searched ClinicalTrials. gov and the World Health Organization's International Clinical Trial Registry Portal to determine whether subsequent research has reflected an effort to address guideline recommendations. Results: Few currently registered clinical trials attempt to focus on clinical practice guideline recommendations where the basis of evidence is weak, and even fewer might benefit future iterations of the guideline due to multiple problems in study design and reporting. Conclusions: The amount of research dedicated to investigation of mild traumatic brain injury continues to be sparse and of poor quality. Study results should always be posted, even if the null hypothesis is confirmed. Efforts to improve the evidence base of a guideline should be realized by designing studies that directly assess and speak to the questions posed by guideline authors. (c) 2018 Elsevier Inc. All rights reserved.
Purpose Financial conflicts of interest (FCOIs) may influence or undermine the credibility of clinical practice guidelines or society recommendations. Given the wide regard of such publications, understanding the prevalence and extent of FCOIs among their authors is essential. Methods The most current guidelines containing recommendations for breast cancer screening from the US Preventive Services Task Force, American Cancer Society, American College of Obstetricians and Gynecologists, International Agency for Research on Cancer, ACR, and American College of Physicians were retrieved from their respective organizational websites. Industry payments received by authors were then extracted using CMS Open Payments database (OPD), and the values and types of these payments were evaluated. Finally, financial disclosures were compared with open payments. Results Among a total of 43 authors and 7 guideline documents, 14 authors (33%) received at least one industry payment according to OPD payment records, whereas a majority of 29 authors (67%) had none. The median total payment from all sources across all breast imaging guidelines was $0 (interquartile range, $0-$84). Four authors (9%) declared at least one significant FCOI, five (12%) received more than $5,000 from a single company in a single year, and one author had a significant FCOI (2%) identified from OPD records but not disclosed within the guideline document. Conclusions These findings suggest that FCOIs likely have little to no influence on the adoption of consensus recommendations regarding routine screening mammography for all cohorts of women.
An inherent qualification of systematic reviews is that they attempt to collate all relevant empirical evidence. While properly conducted systematic reviews are considered the gold standard for determining health care policy and clinical decision making, they are vulnerable to publication bias1 . Publication bias occurs when statistically nonsignificant data from unpublished literature are omitted from systematic reviews and meta-analyses2 . This article is protected by copyright. All rights reserved.
Financial Conflicts of Interest Among Authors of Clinical Guidelines Related to High-Revenue Medications