Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Norris SL

PROVIDER: S-EPMC3796568 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Publications

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

Norris Susan L SL Holmer Haley K HK Ogden Lauren A LA Burda Brittany U BU Fu Rongwei R

PloS one 20131014 10

<h4>Background</h4>Conflict of interest (COI) is an important potential source of bias in the development of clinical practice guidelines (CPGs).<h4>Objectives</h4>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.<h4>Methods</h4>We identified a cohort of releva ...[more]

PMID: 24155870

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Project description:BackgroundAuthors of clinical practice guidelines (CPGs) disclose financial conflicts of interest (FCOIs) to promote transparency ethics. Typically, they do so on standard declaration forms containing generic open-ended questions on FCOIs. Yet, the literature is scant on the format and effect of alternative disclosure forms. Does supplementing a standard form with subsequent detailed disclosure forms tailored to the context of the CPG improve the yield or accuracy of FCOIs declarations?MethodsFor an international CPG in gastroenterology on the endoscopic surveillance for colorectal neoplasia in inflammatory bowel disease, we compared the use of a standard FCOIs disclosure form with a contextual FCOIs disclosure form that detailed commercial relations related to the CPG topic. This included manufacturers of endoscopes, endoscopy equipment and accessories. Participants completed the generic form early, and the supplementary contextual form six months later. We then compared the FCOI disclosures obtained.Findings26 participants provided FCOIs disclosures using both disclosure forms. We found discrepancies regarding (1) the disclosure of FCOIs (presence/absence), and (2) the listing of financial entities. While the number of participants who disclosed a FCOI remained the same (30.8%) using the two forms, disclosures were not from the same individuals: two additional participants disclosed a FCOI, whereas two participants withdrew previous disclosures. Among those who reported a FCOI in either form, we noted inconsistencies in disclosures for 70% of the participants. This included changes in FCOIs disclosure status or modifications of "their commercial relations".DiscussionAccurate reporting of FCOIs advances the transparency and ethical integrity of CPGs. Our experience suggests that a contextual FCOIs disclosure form tailored to content of the CPG with narrow, detailed questions provides supplementary, more complete FCOIs declarations than generic forms alone. The finding raises challenges on how forms are best written and formatted, optimally timed, and more effectively processed with sensitivity to professional behaviour, so as to heighten transparency.

Project description:BackgroundVeterans with evidence of homelessness have high rates of mental health and substance abuse disorders, but chronic medical conditions such as diabetes are also prevalent.ObjectiveWe aimed to determine the impact of homelessness on glycemic control in patients with type 2 diabetes mellitus.DesignLongitudinal analysis of a retrospective cohort.SubjectsA national cohort of 1,263,906 Veterans with type 2 diabetes. Subjects with evidence of homelessness were identified using a combination of diagnostic and administrative codes.Main measuresOdds for poor glycemic control using hemoglobin A1C (HbA1C) cutoff values of 8 % and 9 %. Homeless defined as a score based on the number of indicator variables for homelessness within a veterans chart.Key resultsVeterans with evidence of homelessness had a significantly greater annual mean HbA1C?? 8 (32.6 % vs. 20.43 %) and HbA1C?? 9 (21.4 % vs. 9.9 %), tended to be younger (58 vs. 67 years), were more likely to be non-Hispanic black (39.1 %), divorced (43 %) or never married (34 %), to be urban dwelling (88.8 %), and to have comorbid substance abuse (46.7 %), depression (42.3 %), psychoses (39.7 %), liver disease (18.8 %), and fluid/electrolyte disorders (20.4 %), relative to non-homeless veterans (all p?<?0.0001). Homelessness was modeled as an ordinal variable that scored the number of times a homelessness indicator was found in the Veterans medical record. We observed a significant interaction between homelessness and race/ethnicity on the odds of poor glycemic control. Homelessness, across all racial-ethnic groups, was associated with increased odds of uncontrolled diabetes at a cut-point of 8 % and 9 % for hemoglobin A1C ; however, the magnitude of the association was greater in non-Hispanic whites [8 %, OR 1.55 (1.47;1.63)] and Hispanics [8 %, OR 2.11 (1.78;2.51)] than in non-Hispanic blacks [8 %, OR 1.22 (1.15;1.28)].ConclusionsHomelessness is a significant risk factor for uncontrolled diabetes in Veterans, especially among non-Hispanic white and Hispanic patients. While efforts to engage homeless patients in primary care services have had some success in recent years, these data suggest that broader efforts targeting management of diabetes and other chronic medical conditions remain warranted.

Dataset Information

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

Background

Objectives

Methods

Results

Discussion

Publications

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

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