| Literature DB >> 23144816 |
Susan L Norris1, Haley K Holmer, Lauren A Ogden, Shelley S Selph, Rongwei Fu.
Abstract
BACKGROUND: Conflict of interest (COI) is an important potential source of bias in the development of clinical practice guidelines (CPGs) and high rates of COI among guideline authors have been reported in the past. Our objective was to report current rates of disclosure and specific author COI across a broad range of CPGs and to examine whether CPG characteristics were associated with the presence of disclosures and of conflicts. METHODS ANDEntities:
Mesh:
Year: 2012 PMID: 23144816 PMCID: PMC3492392 DOI: 10.1371/journal.pone.0047343
Source DB: PubMed Journal: PLoS One ISSN: 1932-6203 Impact factor: 3.240
Characteristics of the included clinical practice guidelines (n = 250).
| Guideline characteristic | Results |
| Year released or updated [Number (%)] | 2005: 3 (1.2) |
| 2006: 75 (30.0) | |
| 2007: 38 (15.2) | |
| 2008: 74 (29.6) | |
| 2009: 51 (20.4) | |
| 2010: 9 (3.6)* | |
| Number of authors (n = 233) | Range: 1–92; Median: 12; Mean: 15; In 17 guidelines there was no list of authors |
| Country [Number (%)] | US: 149 (59.6) |
| Canada: 38 (15.2) | |
| Western Europe: 47 (18.8) | |
| International: 4 (1.6) | |
| Other: 12 (4.8) | |
| Publication site [Number (%)] | Journal: 155 (62.0) |
| Organization web-site or hard-copy publication: 95 (38.0) | |
| Journal impact factor (n = 112 unique journals) [Number (%)] | <5 or no impact factor: 55 (49.1) |
| ≥5 and <10: 31 (27.7) | |
| ≥10: 26 (23.2) | |
| Developer [Number (%)] | Government: 59 (23.6) |
| Professional organization: 173 (69.2) | |
| Academic institution: 14 (5.6) | |
| More than one type of organization: 4 (1.6) | |
| Relationship between the guideline developerand the funder [Number (%)] | Same: 205 (82.0) |
| Different: 40 (16.0) | |
| Unknown: 5 (2.0) |
n = 250 guidelines unless otherwise indicated.
(*) Includes one guideline from 2011 because at the time of abstraction, one guideline that was initially identified had been removed from the National Guideline Clearinghouse and thus the next guideline in our sequence of random numbers was selected, which was dated 2011.
Figure 1Study flow diagram.
Abbreviations: COI, conflict of interest; CPGs, clinical practice guidelines.
Conflicts of interest among clinical practice guidelines and their authors.
| Characteristic | Result |
| Guideline developer has a CPG-specific COI policy) [Number (%)] (n = 250) | Yes: 217 (86.8) |
| No: 33 (13.2) | |
| Guideline has author disclosures (with or without COI) [Number (%)] (n = 250) | Yes: 150 (60.0) [Publically disclosed: 87 (34.8); Internally disclosed only: 63 (25.2)] |
| No: 100 (40.0) | |
| Proportion of authors of each guideline with COI (%) (n = 87 CPGswith public disclosures for all authors) | Mean (SD): 28.0 (32.3); Median: 11.8; Range: 0 to 100 |
| Guideline has 1 or more authors with COI (%) (n = 87) | Yes: 52 (60.0) |
| No: 35 (40.0) | |
| Types of COI disclosed in CPGs* [Number of CPGs (%)] (n = 52 CPGs with1 or more authors with a disclosed conflict) | Advising/consulting: 49 (94.2) |
| Research: 40 (76.9) | |
| Stocks/equity: 12 (23.1) | |
| Gifts: 4 (7.7) | |
| Patents/royalties: 3 (5.8) | |
| Intellectual: 3 (5.8) | |
| Other: 3 (5.8) | |
| Proportion of authors of each guideline with a conflict (%) (n = 52 CPGswith 1 or more authors with a conflict) | Mean (SD): 46.8 (5.4); Median: 48.9; Range: 4.2–100 |
| Types of COI** disclosed by 325 authors with conflicts [Number (%)](n = 445 unique conflicts) | Advising/consulting: 220 (49.4) |
| Research: 165 (37.1) | |
| Patents/royalties: 3 (0.7) | |
| Stocks/equity: 20 (4.5) | |
| Gifts: 6 (1.3) | |
| Intellectual: 6 (1.3) | |
| Other: 25 (5.6) |
(*) % add to more than 100 because CPG authors can disclose more than one type of COI.
(**) Examples of activities for the types of COI: Advising/consulting: serving on an advisory board and/or executive committee, or receiving consulting fees, honoraria, speaking fees, or providing expert testimony; Research: receiving research grants, salary support; Patents/royalties: receiving income from patents or royalties; Stocks/equity: owning stock or equity in a company; Gifts: receiving gifts, travel, samples, or educational materials; Intellectual: publishing on a topic, providing unpaid advocacy; Other: time devoted to specific procedures, spousal employment.
Abbreviations: COI, conflict of interest; CPG, clinical practice guideline, SD; standard deviation.
Association between clinical practice guideline characteristics and disclosures and conflicts (n = 250 guidelines).
| Presence of any disclosure* | Whether COI could be assessed** | |||
| CPG Characteristic | OR (95% CI) | P-value | OR (95% CI) | P-value |
|
| NA | 0.014*** | NA | 0.0004 |
| Not published in a journal (reference) | ||||
| Published in a journal with IF <5 | 0.311 (0.127, 0.759) | 0.011 | 1.400 (0.604, 3.244) | 0.4308 |
| Published in a journal with IF between 5 and 10 | 2.086 (0.588, 7.399) | 0.254 | 5.873 (1.939, 17.790) | 0.0019 |
| Published in a journal with IF >10 | 2.914 (0.815, 10.422) | 0.0996 | 7.662 (2.495, 23.534) | 0.0004 |
| Whether the organization has a COI policy(Yes vs. No) | 4.932 (1.367, 17.801) | 0.0150 | ||
|
| NA | 0.0214*** | ||
| US (reference) | ||||
| Canada | 5.508 (1.103, 27.496) | 0.0376 | ||
| Europe | 3.570 (1.295, 9.841) | 0.0141 | ||
| International | 0.676 (0.221, 2.062) | 0.4897 | ||
| Others | 2.595 (0.374, 17.994) | 0.3332 | ||
|
| NA | 0.0312* | ||
| 1 (Reference) | ||||
| 2 | 3.903 (0.996, 15.297) | 0.0507 | ||
| 3 | 0.433 (0.141, 1.328) | 0.1423 | ||
|
| 4.141 (1.538, 11.152) | 0.0051 | ||
Abbreviations: CI, confidence interval; COI, conflict of interest; CPG, clinical practice guideline; IF, impact factor; NA, not applicable; OR, odds ratio.
(*) The presence of any disclosure in the clinical practice guideline (including disclosures of no COI, Yes versus No).
(**) Whether the presence of COI could be assessed for the CPG (Yes versus No, the latter including CPGs with no disclosures and CPGs with disclosures that were not publically available).
(***) P-value for the variable overall.