BMC Medical Ethics | |
Underreporting of conflicts of interest in clinical practice guidelines: cross sectional study | |
Andreas Lundh1  Peter C Gøtzsche1  Jeppe Schroll1  Julie Bolette Brix Bindslev1  | |
[1] Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark | |
关键词: Transparency; Disclosure; Conflicts of interest; Clinical practice guidelines; | |
Others : 799951 DOI : 10.1186/1472-6939-14-19 |
|
received in 2013-04-24, accepted in 2013-04-25, 发布年份 2013 | |
【 摘 要 】
Background
Conflicts of interest affect recommendations in clinical guidelines and disclosure of such conflicts is important. However, not all conflicts of interest are disclosed. Using a public available disclosure list we determined the prevalence and underreporting of conflicts of interest among authors of clinical guidelines on drug treatments.
Methods
We included up to five guidelines published from July 2010 to March 2012 from each Danish clinical specialty society. Using the disclosure list of the Danish Health and Medicines Authority, we identified author conflicts of interest and compared them with the disclosures in the guidelines. For each guideline we extracted methodological characteristics of guideline development.
Results
Forty-five guidelines from 14 specialty societies were included. Of 254 authors, 135 (53%) had conflicts of interest, corresponding to 43 of the 45 guidelines (96%) having one or more authors with a conflict of interest. Only one of the 45 guidelines (2%) disclosed author conflicts of interest. The most common type of conflict of interest (83 of the 135) was being a consultant, an advisory board member or a company employee. Only 10 guidelines (22%) described the methods used for guideline development, 27 (60%) used references in the text and 11 (24%) graded the types of evidence.
Conclusions
Conflicts of interest were common, but disclosures were very rare. Most guidelines did not describe how they were developed and many did not describe the evidence behind specific recommendations. Publicly available disclosure lists may assist guideline issuing bodies in ensuring that all conflicts are disclosed.
【 授权许可】
2013 Bindslev et al.; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
---|---|---|---|
20140707073143458.pdf | 343KB | download | |
Figure 2. | 51KB | Image | download |
Figure 1. | 55KB | Image | download |
【 图 表 】
Figure 1.
Figure 2.
【 参考文献 】
- [1]Fraser AG, Dunstan FD: On the impossibility of being expert. BMJ 2010, 341:c6815.
- [2]Woolf SH, Grol R, Hutchinson A, Eccles M, Grimshaw J: Potential benefits, limitations, and harms of clinical guidelines. BMJ 1999, 318:527-530.
- [3]Lo B, Field MJ, Institute of Medicine (US) Committee on Conflict of Interest in Medical Research, Education, and Practice (Eds): Conflict of Interest in Medical Research, Education, and Practice. Washington (DC): National Academies Press (US); 2009.
- [4]Tricoci P, Allen JM, Kramer JM, Califf RM, Smith SC Jr: Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA 2009, 301:831-841.
- [5]Stelfox HT, Chua G, O’Rourke K, Detsky AS: Conflict of interest in the debate over calcium-channel antagonists. N Engl J Med 1998, 338:101-106.
- [6]Wang AT, McCoy CP, Murad MH, Montori VM: Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review. BMJ 2010, 340:c1344.
- [7]Taylor R, Giles J: Cash interests taint drug advice. Nature 2005, 437:1070-1071.
- [8]Norris SL, Holmer HK, Ogden LA, Burda BU: Conflict of Interest in clinical practice guideline development: a systematic review. PLoS One 2011, 6:e25153.
- [9]Choudhry NK, Stelfox HT, Detsky AS: Relationships between authors of clinical practice guidelines and the pharmaceutical industry. JAMA 2002, 287:612-617.
- [10]Williams MJ, Kevat DA, Loff B: Conflict of interest guidelines for clinical guidelines. Med J Aust 2011, 195:442-445.
- [11]Neumann J, Korenstein D, Ross JS, Keyhani S: Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study. BMJ 2011, 343:d5621.
- [12]Bundgaard B: [Physicians’ collaboration with the industry - in dry numbers]. Ugeskr Laeger 2011, 173:464.
- [13]The Danish Medicines Agency: List of permissions granted to physicians and dentists affiliated with pharmaceutical companies. [http://ext.laegemiddelstyrelsen.dk/tilladelselaegertandlaeger/tilladelse_laeger_tandlaeger_full_soeg.asp?vis=hele webcite] (Accessed 7 January 2013)
- [14]Godlee F: A sunshine act for Europe. BMJ 2011, 343:d6593.
- [15]Carpenter D, Joffe S: A unique researcher identifier for the Physician Payments Sunshine Act. JAMA 2011, 305:2007-2008.
- [16]Danish Association of Medical Societies: List of Danish Specialty Societies. [http://www.selskaberne.dk/portal/page/portal/LVS/Forside/Medlemsselskaber/Specialebærende%20og%20ikke-specialebærende#speciale webcite] (Accessed 7 January 2013)
- [17]National Board of Health: Danish Authorisation register. [http://www.sst.dk/DS/OpslagAutReg.aspx webcite] (Accessed 7 January 2013)
- [18]International Committee of Medical Journal Editors (ICMJE): Form for Disclosure of Potential Conflicts of Interest. 2009. [http://www.icmje.org/coi_disclosure.pdf webcite] (Accessed 7 January 2013)
- [19]Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L, AGREE Next Steps Consortium: AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ 2010, 182:E839-E942.
- [20]The Danish Medicine Agency: Guidance for physicians and dentists requirement to apply for permission to be affiliated with a pharmaceutical company. [http://laegemiddelstyrelsen.dk/da/service-menu/lovgivning/laegers,-tandlaegers-og-apotekeres-tilkn--virksomhed/laeger-og-tandlaeger/vejledning-om-laegers-og-tandlaegers-pli-virksomhed.aspx webcite] (Accessed 7 January 2013)
- [21]Papanikolaou GN, Baltogianni MS, Contopoulos-Ioannidis DG, Haidich AB, Giannakakis IA, Ioannnidis JPA: Reporting of conflicts of interest in guidelines of preventive and therapeutic interventions. BMC Med Res Methodol 2001, 1:3. BioMed Central Full Text
- [22]Cosgrove L, Krimsky S, Vijayaraghavan M, Schneider L: Financial ties between DSM-IV panel members and the pharmaceutical industry. Psychother Psychosom 2006, 75:154-160.
- [23]Hietanen P: Does the expert panel at the St Gallen meeting provide an unbiased opinion about the management of women with early breast cancer? Ann Oncol 2009, 20:1749-1751.
- [24]Holloway RG, Mooney CJ, Getchius TS, Edlund WS, Miyasaki JO: Invited Article: conflicts of interest for authors of American Academy of Neurology clinical practice guidelines. Neurology 2008, 71:57-63.
- [25]Campbell EG, Gruen RL, Mountford J, Miller LG, Cleary PD, Blumenthal D: A national survey of physician-industry relationships. N Engl J Med 2007, 356:1742-1750.
- [26]Norris SL, Holmer HK, Ogden LA, Burda BU, Rongwei F: Characteristics of physicians receiving large payments from pharmaceutical companies and the accuracy of their disclosures in publications: an observational study. BMC Med Ethics 2012, 13:24. BioMed Central Full Text
- [27]Chimonas S, Frosch Z, Rothman DJ: From disclosure to transparency: the use of company payment data. Arch Intern Med 2011, 171:81-86.
- [28]Cosgrove L, Bursztajn HJ, Krimsky S, Anaya M, Walker J: Conflicts of interest and disclosure in the American Psychiatric Association's Clinical Practice Guidelines. Psychother Psychosom 2009, 78:228-232.
- [29]Campbell EG, Rao SR, DesRoches CM, Iezzoni LI, Vogeli C, Bolcic-Jankovic D, Miralles PD: Physician professionalism and changes in physician-industry relationships from 2004 to 2009. Arch Intern Med 2010, 170:1820-1926. Erratum in: Arch Intern Med 2010, 170:1966
- [30]Physician Financial Transparency Reports (Sunshine Act): American Medical Association. [http://www.ama-assn.org/ama/pub/advocacy/topics/sunshine-act-and-physician-financial-transparency-reports.page webcite] (Accessed 27 March 2013)
- [31]Rasmussen LI: [In the future everyone will be able to see what physicians earn from industry]. Ugeskr Laeger 2013, 175:618.
- [32]Nissen SE: Can We Trust Cardiovascular Practice Guidelines? Arch Intern Med 2011, 171:584-585.
- [33]Guyatt G, Akl EA, Hirsh J, Kearon C, Crowther M, Gutterman D, Lewis SZ, Nathanson I, Jaeschke R, Schünemann H: The vexing problem of guidelines and conflict of interest: a potential solution. Ann Intern Med 2010, 152:738-741.
- [34]Oxman AD, Guyatt GH: The science of reviewing research. Ann N Y Acad Sci 1993, 703:125-133. discussion 133–134
- [35]Panagiotou OA, Ioannidis JP: Primary study authors of significant studies are more likely to believe that a strong association exists in a heterogeneous meta-analysis compared with methodologists. J Clin Epidemiol 2012, 65:740-747.
- [36]Gøtzsche PC, Ioannidis JPA: Content area experts as authors: helpful or harmful for systematic reviews and meta-analyses? BMJ 2012, 345:e7031.