The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 93, Issue 13

The Orthopaedic Forum | July 06, 2011

Substantial Variation in the Interpretation of Financial Disclosure Policies for Orthopaedic Society Meetings

Kolawole Jegede, MD¹; Peter Whang, MD¹; Jonathan N. Grauer, MD¹

¹ Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, P.O. Box 208071, New Haven, CT 06520. E-mail address for J.N. Grauer: jonathan.grauer@yale.edu

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Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by the authors of this work are available with the online version of this article at jbjs.org.

Disclosure statement for author(s): PDF

J Bone Joint Surg Am, 2011 Jul 06;93(13):e75 1-6. doi: 10.2106/JBJS.J.01411

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Abstract

Background:

Physician disclosure of potential conflicts of interest is currently controversial. To address this issue, orthopaedic societies have implemented a variety of guidelines related to potential conflict-of-interest disclosure. Transparency is crucial to address the concerns about potential conflict-of-interest disclosure. Nonetheless, prior studies have noted substantial discrepancies in disclosures to societies for individual authors who present their research work at multiple conferences. Our goal was to evaluate the ability of orthopaedic surgeons to interpret disclosure policy statements regarding project-specific or global disclosure instructions.

Methods:

The disclosure policy statements of the ten conferences most frequently attended by this group were collected, and selected statements were compiled into a questionnaire survey that was administered to orthopaedic faculty and trainees at our institution. Subjects were asked to read each statement and identify whether they interpreted the policy to be requesting project-specific disclosures (potential conflict of interest related to the research work in the abstract being submitted) or global disclosure (inclusive of all potential conflicts of interest, including those not associated with the abstract being submitted). The correct responses were identified by communicating with the individual societies and determining the responses desired by the society.

Results:

The study had a 100% return rate from seventeen orthopaedic faculty, twenty-five orthopaedic residents and fellows, and twenty-five medical students. The average number of incorrect responses to the ten questions was 2.8. Forty-six percent of respondents had three or more incorrect responses, 24% had two incorrect responses, 19% had one incorrect response, and 10% had no incorrect responses. There was no significant difference in responses between those of different training levels. Subjects were no more likely to answer a project-specific question incorrectly than they were to answer a global question incorrectly.

Conclusions:

This study clearly demonstrated a discrepancy between what societies intend to identify with disclosure policies and what the orthopaedist interprets is intended. Almost half of those completing the survey did not correctly understand the intention of three or more of the policies, even with expected study intent bias. This study showed that the language used in disclosure policy statements and the lack of a uniform policy may be a cause of substantial discrepancies in potential conflict-of-interest disclosure.

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Introduction

Despite the potential benefits that can result from working collaborations between orthopaedic surgeons and industry, there is a growing concern that these relationships can influence the judgment of clinicians and scientists. Commercial involvement has the potential to compromise scientific research on various levels including project design¹ and the interpretation of the data^2,3. A conflict of interest is considered any relationship a physician has with industry that may undermine his or her impartiality.

This topic of disclosure of potential conflict of interest has been under growing scrutiny by both the lay press^4-7 and the scientific community. Promoting transparency of industry relationships and authors by requiring them to disclose these relationships is an accepted approach to limit the negative effects of these relationships⁸. Most medical journals and societies have adopted comprehensive disclosure policies that continue to evolve^9-12. A study conducted in 1997 found that only 16% of 1396 journals had disclosure policies¹³ compared with a similar study from 2008, in which 89% of the sampled journals had some disclosure policies⁹.

Currently, two types of disclosure standards are used by journals and societies¹³. Authors may be asked to disclose any financial relationship they have, regardless of whether it is associated with the active topic (a so-called global disclosure). Alternatively, authors may be asked to disclose any financial relationship that is directly related to the research being presented (a so-called project-specific disclosure).

Although most agree that there is a need for disclosure policies, the efficacy of these statements by the authors is still unknown. Despite the widespread adoption of disclosure policies by various medical societies, discrepancies in disclosure reporting are prevalent. Studies quantifying variability in the financial disclosures of authors presenting at multiple orthopaedic conferences during the same calendar year revealed common authors to have multiple disclosure discrepancies between the various conferences^14,15. Jegede compared the financial disclosure of the same authors who gave podium presentations at three sports medicine conferences and found up to 40% had some discrepancy in what was disclosed¹⁵. Ju et al. also compared the disclosures of authors presenting at three different spine conferences and found similar rates in disclosure discrepancy¹⁴.

As the magnitude of author disclosure discrepancies became known, our group became concerned that this discrepancy may be partially because authors simply do not understand the instructions for global disclosure compared with project-specific disclosure. The purpose of the current study was to evaluate the level of understanding of orthopaedic attending surgeons and trainees as to what was being asked of them by disclosure policy guidelines from orthopaedic society meetings.

Materials and Methods

A questionnaire was generated after obtaining from ten orthopaedic societies the requested disclosure information to be provided by authors of research work being presented at the society meetings. The disclosure policy statements of the ten most frequently attended conferences with the highest number of abstract submissions by the orthopaedic faculty and trainees at our institution were collected. Excerpts that contained the most relevant information regarding the desired method of financial disclosure were taken from each policy statement. The statements were chosen from the following societies (see Appendix):

American Academy of Orthopaedic Surgeons (AAOS), February 2008
American Association of Hip and Knee Surgeons (AAHKS), July 2009
American Society for Surgery of the Hand (ASSH), July 2009
Scoliosis Research Society (SRS), February 2008
Arthroscopy Association of North America (AANA), July 2009
American Spinal Injury Association (ASIA), July 2009
Orthopaedic Trauma Association (OTA), July 2009
American Orthopaedic Society of Sports Medicine (AOSSM), July 2009
Cervical Spine Research Society (CSRS), February 2008
North American Spine Society (NASS), July 2009

Subjects were asked to read each disclosure policy statement and identify whether they interpreted the policy to be requesting project-specific disclosure or global disclosure. Project-specific disclosure was selected if the reader thought the statement required financial disclosure only for the research work being presented. Global disclosure was selected if the reader interpreted the statement as requiring disclosure of all financial relationships, regardless of the research work being presented.

The questionnaire was circulated to seventeen academic orthopaedic attending surgeons, twenty-five orthopaedic residents, and a representative twenty-five medical students (chosen from those attending a medical education ethics class, to match the number of residents surveyed). Names were crossed off a list of those to whom the survey had been given to ensure that all surveys were returned, but no identifying information was included for the survey analysis other than the level of training.

The "correct" responses were identified by communicating with the individual societies and requesting the responses they desired to the statements. Of the ten policy statements used in the survey, seven selected societies (AAOS, AAHKS, ASSH, SRS, AANA, ASIA, and OTA) had project-specific disclosure policies, and the other three (AOSSM, CSRS, and NASS) had global disclosure policies for the year the statements were taken.

The average number of incorrect responses was determined and analyzed for all training levels. Differences in the rate of incorrect responses for project-specific disclosure policies and global disclosure policies were also compared.

Results

The survey had a 100% return rate. The sixty-seven subjects who completed the ten-question survey had an average of 2.8 incorrect responses. Only 10% of the subjects had no incorrect answers. Nineteen percent had one incorrect answer; 24%, two incorrect responses; 13%, three incorrect responses; 12%, four incorrect responses; and 22%, five or more incorrect responses (Figs. 1-A and 1-B). Overall, 47% had three or more incorrect responses.

Fig. 1-A Fig. 1-B

Fig. 1-A Frequency of incorrect responses for all training levels (orthopaedic attending surgeons, orthopaedic residents or fellows, and medical students) stratified by none, one, two, and three or more incorrect responses. Fig. 1-B Frequency of incorrect responses for all training levels (attending orthopaedic surgeons, residents or fellows, and students) stratified by none, one, two, three, four, and five or more incorrect responses.

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Differences in responses by training level did not show a trend (Figs. 2-A, 2-B, and 2-C). Among attending surgeons, 46% answered three or more questions incorrectly. Among residents, 40% answered three or more questions incorrectly (Fig. 2-B). Among students, 52% answered three or more questions incorrectly (Fig. 2-C).

Fig. 2-A Fig. 2-B

Fig. 2-A Frequency of incorrect responses for orthopaedic attending surgeons. Fig. 2-B Frequency of incorrect responses for orthopaedic residents or fellows.

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Fig. 2-C

Frequency of incorrect responses for medical students in the Yale School of Medicine.

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A chi-square analysis was performed to determine if there was a difference in the probability of subjects answering a global question incorrectly compared with answering a project-specific question incorrectly. The results showed that subjects were no more likely to have an incorrect answer for a project-specific question than for a global disclosure question.

Discussion

Relationships between surgeons and industry in scientific research have led many orthopaedic societies and publications to adopt author disclosure policies to promote transparency about these relationships. Although these disclosure polices are now common practice, there continues to be a paucity of data on the usefulness of these disclosures. It has been demonstrated that there are inconsistencies in disclosure reporting consistency by authors among various conferences at which the same research work is presented^14,15. The data from this questionnaire study demonstrate that there is a disparity between the information that societies intend to gather with their disclosure process and the information that the authors interpret they need to disclose. Almost half of those completing the survey incorrectly identified three or more of the ten policies, whether they were faculty or students. Each incorrect policy can be seen as a potential source of erroneous disclosure reporting. For example, if an author with multiple industry affiliations interpreted a global disclosure policy as a project-specific disclosure policy, incorrect information would be provided.

If error was introduced by the study design, the authors should have been more attuned to the true intention of the disclosure statements being reviewed, as the respondents were alerted to the importance of differentiating the different types of disclosure policies. Despite this observation bias, high error rates were often noted in identifying the types of disclosure being reported.

During the recent period of increased emphasis on disclosure reporting, society and publication policies continue to evolve. Nonetheless, the policy statements used in this survey were selected from the previous year or two and are believed to reflect a common list of disclosure policies that colleagues in the orthopaedic field have been encountering over the previous few years.

The lack of uniformity and varied interpretation of the language used in the request of societies for disclosure information has been shown to lead to confusion among those completing the potential conflict-of-interest disclosure forms. The inherently busy schedule of a physician scientist may not leave time for cautious interpretation of policy language. In the absence of a uniform disclosure policy that is widely adopted by all societies, our findings suggest that the disclosure process will continue to have inconsistent reporting of potential financial and other conflicts of interest by the authors of research reports.

Appendix

Questionnaire on the Disclosure Policy Statements of the Ten Most Frequently Attended Orthopaedic Conferences*

□ Attending

□ Fellow

□ Resident

□ Student

Below are excerpts of financial disclosure policy statements from ten orthopaedic societies. Please read each statement in its entirety.

Check Project-Specific Disclosure if the statement requires financial disclosure only for the project being presented.

Check Global Disclosure if all financial relationships are required to be disclosed.

Please do not leave any items blank.

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Disclosure Policy Statements	Please Check One
1. Obligation to disclose all potentially conflicting interests. Each participant must disclose relevant activities or relationships through the AAOS mandatory disclosure program. (AAOS)	Project-Specific Disclosure	Global Disclosure
2. Required to disclose if individual either has no relevant financial relationship or any financial relationship with the manufacturer(s) of any commercial product(s) and/or providers of commercial services discussed in CME activities. (AOSSM)	Project-Specific Disclosure	Global Disclosure
3. Each participant has been asked to disclose if he or she has received something of value (any item, payment, or service valued in excess of $500) from a commercial company or institution, which relates directly or indirectly to the subject of their presentation. (AAHKS)	Project-Specific Disclosure	Global Disclosure
4. Instructions, planners, and managers who affect the content of a CME activity are required to disclose to the ASSH financial relationships or relationships to products or devices they have with commercial interest associated with this CME activity of any amount over the past 12 months ONLY. (ASSH)	Project-Specific Disclosure	Global Disclosure
5. The actions and expressions in providing education of the highest quality must be as free of outside influences as possible. Therefore, any relevant, potentially conflicting interests and all commercial relationships must be disclosed. (CSRS)	Project-Specific Disclosure	Global Disclosure
6. All faculty will disclose to the audience any real or apparent conflict(s) of interest related to the content of their presentation(s). Faculty relationships with companies whose products and/or services may be mentioned in their presentations will be indicated in the program. (SRS)	Project-Specific Disclosure	Global Disclosure
7. The disclosure policy requires that faculty submit all financial relationships that create a potential conflict. Each participant in the Annual Meeting has been asked to disclose if he or she received something of value from a commercial company or institution, which relates directly or indirectly to the subject of their presentation. (AANA)	Project-Specific Disclosure	Global Disclosure
8. I (or a member of my immediate family) have a financial interest or relationship with a commercial company related directly or indirectly to the subject of my presentation. (ASIA)	Project-Specific Disclosure	Global Disclosure
9. Members participating in an activity should disclose all financial relationships that have occurred during the prior calendar year with an estimated value of greater than one hundred dollars ($100), using the estimated dollar amount to the nearest one thousand dollars ($1,000). (NASS)	Project-Specific Disclosure	Global Disclosure
10. Paper authors whose presentations have an asterisk by the title have indicated they or their co-authors (department) received something of value (in excess of $500) from a commercial company or institution which relates directly or indirectly to the subject of their presentation. (OTA)	Project-Specific Disclosure	Global Disclosure

*The correct answers are Global Disclosure for questions 2, 5, and 9 and Project-Specific Disclosure for questions 1, 3, 4, 6, 7, 8, and 10. CME = continuing medical education.

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Disclosure Policy Statements	Please Check One
1. Obligation to disclose all potentially conflicting interests. Each participant must disclose relevant activities or relationships through the AAOS mandatory disclosure program. (AAOS)	Project-Specific Disclosure	Global Disclosure
2. Required to disclose if individual either has no relevant financial relationship or any financial relationship with the manufacturer(s) of any commercial product(s) and/or providers of commercial services discussed in CME activities. (AOSSM)	Project-Specific Disclosure	Global Disclosure
3. Each participant has been asked to disclose if he or she has received something of value (any item, payment, or service valued in excess of $500) from a commercial company or institution, which relates directly or indirectly to the subject of their presentation. (AAHKS)	Project-Specific Disclosure	Global Disclosure
4. Instructions, planners, and managers who affect the content of a CME activity are required to disclose to the ASSH financial relationships or relationships to products or devices they have with commercial interest associated with this CME activity of any amount over the past 12 months ONLY. (ASSH)	Project-Specific Disclosure	Global Disclosure
5. The actions and expressions in providing education of the highest quality must be as free of outside influences as possible. Therefore, any relevant, potentially conflicting interests and all commercial relationships must be disclosed. (CSRS)	Project-Specific Disclosure	Global Disclosure
6. All faculty will disclose to the audience any real or apparent conflict(s) of interest related to the content of their presentation(s). Faculty relationships with companies whose products and/or services may be mentioned in their presentations will be indicated in the program. (SRS)	Project-Specific Disclosure	Global Disclosure
7. The disclosure policy requires that faculty submit all financial relationships that create a potential conflict. Each participant in the Annual Meeting has been asked to disclose if he or she received something of value from a commercial company or institution, which relates directly or indirectly to the subject of their presentation. (AANA)	Project-Specific Disclosure	Global Disclosure
8. I (or a member of my immediate family) have a financial interest or relationship with a commercial company related directly or indirectly to the subject of my presentation. (ASIA)	Project-Specific Disclosure	Global Disclosure
9. Members participating in an activity should disclose all financial relationships that have occurred during the prior calendar year with an estimated value of greater than one hundred dollars ($100), using the estimated dollar amount to the nearest one thousand dollars ($1,000). (NASS)	Project-Specific Disclosure	Global Disclosure
10. Paper authors whose presentations have an asterisk by the title have indicated they or their co-authors (department) received something of value (in excess of $500) from a commercial company or institution which relates directly or indirectly to the subject of their presentation. (OTA)	Project-Specific Disclosure	Global Disclosure

*The correct answers are Global Disclosure for questions 2, 5, and 9 and Project-Specific Disclosure for questions 1, 3, 4, 6, 7, 8, and 10. CME = continuing medical education.

References

Shah RV; Albert TJ; Bruegel-Sanchez V; Vaccaro AR; Hilibrand AS; Grauer JN. Industry support and correlation to study outcome for papers published in Spine. Spine (Phila Pa 1976). 2005;30:1099-105.[PubMed][CrossRef]

Lu-Yao G; Albertsen P; Shih W; Yao SL. Failure to report financial disclosure information. JAMA. 2009;301:35-6.[PubMed]

Tomaszewski C. Conflicts of interest: bias or boon?J Med Toxicol. 2006;2:51-4.[PubMed][CrossRef]

Boyd EA; Bero LA. Assessing faculty financial relationships with industry: a case study. JAMA. 2000;284:2209-14.[PubMed][CrossRef]

Kubiak EN; Park SS; Egol K; Zuckerman JD; Koval KJ. Increasingly conflicted: an analysis of conflicts of interest reported at the annual meetings of the Orthopaedic Trauma Association. Bull Hosp Jt Dis. 2006;63:83-7.[PubMed]

Okike K; Kocher MS. The legal and ethical issues surrounding financial conflict of interest in orthopaedic research. J Bone Joint Surg Am. 2007;89:910-3.[PubMed][CrossRef]

Okike K; Kocher MS; Mehlman CT; Bhandari M. Industry-sponsored research. Injury. 2008;39:666-80.[PubMed][CrossRef]

Weinfurt KP; Friedman JY; Dinan MA; Allsbrook JS; Hall MA; Dhillon JK; Sugarman J. Disclosing conflicts of interest in clinical research: views of institutional review boards, conflict of interest committees, and investigators. J Law Med Ethics. 2006;34:581-91, 481.[PubMed][CrossRef]

Blum JA; Freeman K; Dart RC; Cooper RJ. Requirements and definitions in conflict of interest policies of medical journals. JAMA. 2009;302:2230-4.[PubMed][CrossRef]

Conflicts of interests and investments. CMAJ. 2004;171:1313.[PubMed][CrossRef]

Drazen JM; Curfman GD. Financial associations of authors. N Engl J Med. 2002;346:1901-2.[PubMed][CrossRef]

Flanagin A; Fontanarosa PB; DeAngelis CD. Update on JAMA's conflict of interest policy. JAMA. 2006;296:220-1.[PubMed][CrossRef]

Krimsky S; Rothenberg LS. Financial interest and its disclosure in scientific publications. JAMA. 1998;280:225-6.[PubMed][CrossRef]

Ju BL; Miller CP; Whang PG; Grauer JN. Quantifying the variability of financial disclosure information reported by authors presenting at annual spine conferences. Spine J. 2011;11:1-8.[PubMed] [CrossRef]

Jegede K. Inconsistencies in authors financial disclosure information reported by authors at annual spine conferences. Am J Orthop. In press.

Topics

conflict of interest ; disclosure ; students, medical ; medical residencies

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Kolawole Jegede, Peter Whang, Jonathan N. Grauer; Substantial Variation in the Interpretation of Financial Disclosure Policies for Orthopaedic Society Meetings. The Journal of Bone & Joint Surgery. 2011 Jul;93(13):e75 1-6.

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