Abstract
This study examines the prevalence of conflicts of interest among authors of clinical practice guidelines and failure to accurately report financial relationships among authors and industry.
Financial conflicts of interest (FCOI) may unduly influence physician decision-making. For this reason, the Institute of Medicine recommends that guideline development teams be composed of at most 50% authors who have financial relationships to disclose, and recommends abstaining from financial conflicts for a period of 1 year following guideline publication.1 Several studies have evaluated the extent of FCOI between industry and authors of clinical practice guidelines (CPGs) in dermatology,2 oncology,3 and otolaryngology4; however, such an analysis has not been performed in gastroenterology. Our objectives were to evaluate industry payments received by, and FCOI disclosure practices of, authors of 15 gastroenterology clinical practice guidelines.
Methods
We retrieved information about CPGs, including the names of authors and their disclosed FCOIs, from the American College of Gastroenterology (ACG) website.5 Individual payment data was retrieved for each guideline author using the 2014 to 2016 Centers for Medicare and Medicaid Services (CMS) OpenPayments database (OPD) (Table).6 Because the ACG does not clearly delineate a recommended conflict-free interval for its guideline authors, we assessed a period beginning 6 months prior to and ending 6 months following guideline publication, for a total of 12 months, which was the longest possible timeframe permitting analysis of the same number of months of OPD payment records for each ACG guideline published between 2014 and 2016. OpenPayments identifies 4 payment categories: general, research, associated research, and ownership. The general category includes compensation for food/beverage, travel, speaking fees, consulting fees, honoraria and other services. Transactions falling outside the prespecified date range or those categorized as food/beverage were excluded. We calculated medians and interquartile ranges (IQRs) for each guideline for both total and general payments received. We also evaluated, qualitatively, whether authors did or did not disclose any FCOI in a CPG and whether or not any evidence of potential FCOI was found on OPD. All statistical analyses were performed using Microsoft Excel (version 15.38, Microsoft).
Table. Total and General Payments Received by Authors of Gastroenterology Clinical Practice Guidelines, Stratified by Guideline, Received During a 1-Year Period Both Preceding and Following Guideline Development by 6 Monthsa.
| Guideline | Total Authors, No. | Paid Authors, No. (%) | Payments, Median (IQR), $ | |
|---|---|---|---|---|
| Total | General | |||
| Overall | 83 | 44 (53) | ||
| ACG clinical guideline: the diagnosis and management of idiosyncratic drug-induced liver injury (2014) | 6 | 4 (66) | 45 890 (0-200 381) | 139 (0-11 840) |
| Guidelines on genetic evaluation and management of Lynch syndrome: a consensus statement by the US Multi-Society Task Force on Colorectal Cancer (2014) | 15 | 6 (40) | 0 (0-11 401) | 0 (0-11 401) |
| ACG clinical guideline: management of benign anorectal disorders (2014) | 4 | 2 (50) | 263 (0-2681) | 263 (0-2681) |
| ACG clinical guideline: the diagnosis and management of focal liver lesions (2014) | 3 | 3 (100) | 9968 (4615-1 019 954) | 9968 (4615-25 713) |
| Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US Multi-Society Task Force on Colorectal Cancer (2014) | 12 | 5 (42) | 0 (0-30 579) | 0 (0-30 579) |
| ACG clinical guideline: epidemiology, risk factors, patterns of presentation, diagnosis, and management of colon ischemia (2015) | 4 | 2 (50) | 6407 (0-66 440) | 3187 (0-64 115) |
| ACG clinical guideline: genetic testing and management of hereditary gastrointestinal cancer syndromes (2015) | 6 | 0 (0) | 0 (0) | 0 (0) |
| ACG clinical guideline: primary sclerosing cholangitis (2015) | 3 | 2 (66) | 6175 (0-99 289) | 6175 (0-74 318) |
| ACG clinical guideline: diagnosis and management of small bowel bleeding (2015) | 4 | 3 (75) | 38 859 (8160-91 779) | 23 447 (4390-32 833) |
| ACG clinical guideline: diagnosis and management of Barrett’s esophagus (2015) | 4 | 4 (100) | 47 290 (8229-118 483) | 1983 (207-14 124) |
| ACG clinical guideline: liver disease and pregnancy (2016) | 3 | 3 (100) | 148 451 (8484-580 803) | 76 412 (6800-298 323) |
| Colonoscopy surveillance after colorectal cancer resection: recommendations of the US Multi-Society Task Force on Colorectal Cancer (2016) | 10 | 5 (50) | 2478 (0-41 541) | 2478 (0-32 729) |
| ACG clinical guideline: management of patients with acute lower gastrointestinal bleeding (2016) | 2 | 1 (50) | 44 429 (not calculated) | 4842 (not calculated) |
| ACG clinical guideline: nutrition therapy in the adult hospitalized patient (2016) | 4 | 2 (50) | 2007 (0-135 098) | 2007 (0-92 207) |
| ACG clinical guideline: diagnosis, treatment, and prevention of acute diarrheal infections in adults (2016) | 3 | 2 (66) | 8292 (0-9513) | 8292 (0-8292) |
All values are listed in US dollars ($). All guidelines and authorship information was retrieved from the American College of Gastroenterology website and all payment data was extracted using the Centers for Medicare & Medicaid Services OpenPayments website. Years correspond with year of guideline publication.
Results
Among the 15 CPGs identified from the ACG website, there were 83 total authors (median number of authors per CPG, 4; IQR, 3-6). Overall, 44 of 83 (53%) authors received industry payments and the median percentage of guideline authors with FCOIs per CPG was 50% (IQR, 50%-75%). The median total payments received by guideline authors was $1000 (IQR, $0-$39 938). Both the number of authors with industry relationships and the magnitude of those relationships varied greatly between guidelines (Table). Among the 83 authors, only 16 (19%) both disclosed FCOIs in the CPG and had received payments according to OPD or had disclosed no FCOIs and had received no payments according to OPD. Among 146 cumulative FCOIs disclosed by authors and 148 relationships identified on OPD, only 49 (34%) were both disclosed as FCOI and evidenced by OPD payment records.
Discussion
Our investigation sought to understand and characterize the extent of relationships between authors of CPGs in gastroenterology and their efforts to disclose those relationships to relevant stakeholders. Our findings suggest that although almost half of authors have no industry relationships, those who do often receive sizable sums. Our finding that FCOI disclosure only corroborates with OPD payment records between 19% and 34% of the time also suggests that guidance from the ACG may be needed to improve FCOI disclosure efforts in future iterations of gastroenterology CPGs. One limitation of our study is that we were only able to evaluate a period of 12 months for each guideline. The ICMJE advocates for disclosure of relationships for 36 months prior to CPG authorship, so our analysis may underestimate the prevalence of industry relationships among gastroenterology CPG authors. We recommend that the ACG draft new policies with specific expectations for FCOI disclosure among authors of gastroenterology CPGs, and that large-scale efforts be made to improve the comprehensiveness and reliability of the OpenPayments Database.
References
- 1.Institute of Medicine (US) Committee on Standards for Developing Trustworthy Clinical Practice Guidelines In: Graham R, Mancher M, Miller Wolman D, Greenfield S, Steinberg E, eds. Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press (US); 2014. [PubMed] [Google Scholar]
- 2.Checketts JX, Sims MT, Vassar M. Evaluating industry payments among dermatology clinical practice guidelines authors. JAMA Dermatol. 2017;153(12):1229-1235. doi: 10.1001/jamadermatol.2017.3109 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Mitchell AP, Basch EM, Dusetzina SB. Financial relationships with industry among national comprehensive cancer network guideline authors. JAMA Oncol. 2016;2(12):1628-1631. doi: 10.1001/jamaoncol.2016.2710 [DOI] [PubMed] [Google Scholar]
- 4.Horn J, Checketts JX, Jawhar O, Vassar M. Evaluation of industry relationships among authors of otolaryngology clinical practice guidelines. JAMA Otolaryngol Head Neck Surg. 2018;144(3):194-201. doi: 10.1001/jamaoto.2017.2741 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Clinical Guidelines (Sortable List) American College of Gastroenterology. https://gi.org/clinical-guidelines/clinical-guidelines-sortable-list/. Accessed July 23, 2017.
- 6.Open Payments—Centers for Medicare and Medicaid Services CMS.gov. https://www.cms.gov/openpayments/. Published July 11, 2017. Accessed December 4, 2016.