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MoynihanR, etal. BMJ Open 2019;9:e025864. doi:10.1136/bmjopen-2018-025864
Open access
Undisclosed nancial ties between
guideline writers and pharmaceutical
companies: a cross-sectional study
across 10 disease categories
Ray Moynihan,1 Alexandra Lai,2 Huw Jarvis,3 Geraint Duggan,3
Stephanie Goodrick,3 Elaine Beller,1 Lisa Bero2
To cite: MoynihanR, LaiA,
JarvisH, etal. Undisclosed
nancial ties between guideline
writers and pharmaceutical
companies: a cross-sectional
study across 10 disease
categories. BMJ Open
2019;9:e025864. doi:10.1136/
bmjopen-2018-025864
►Prepublication history and
additional material for this
paper are available online. To
view these les, please visit
the journal online (http:// dx. doi.
org/ 10. 1136/ bmjopen- 2018-
025864).
Received 7 August 2018
Revised 6 November 2018
Accepted 6 November 2018
1Centre for Research in
Evidence-Based Practice,
Bond University, Gold Coast,
Queensland, Australia
2Charles Perkins Centre and
Faculty of Pharmacy, University
of Sydney, Sydney, Australia
3National Health and Medical
Research Council, Canberra,
Australian Capital Territory,
Australia
Correspondence to
RayMoynihan;
raymoynihan@ bond. edu. au
Research
© Author(s) (or their
employer(s)) 2019. Re-use
permitted under CC BY-NC. No
commercial re-use. See rights
and permissions. Published by
BMJ.
ABSTRACT
Objectives To investigate the proportion of potentially
relevant undisclosed nancial ties between clinical
practice guideline writers and pharmaceutical companies.
Design Cross-sectional study of a stratied random
sample of Australian guidelines and writers.
Setting Guidelines available from Australia’s National
Health and Medical Research Council guideline database,
2012–2014, stratied across 10 health priority areas.
Population 402 authors of 33 guidelines, including up to
four from each area, dependent on availability: arthritis/
musculoskeletal (3); asthma (4); cancer (4); cardiovascular
(4); diabetes (4); injury (3); kidney/urogenital (4); mental
health (4); neurological (1); obesity (1). For guideline
writers with no disclosures, or who disclosed no ties, a
search of disclosures in the medical literature in the 5
years prior to guideline publication identied potentially
relevant ties, undisclosed in guidelines. Guidelines were
included if they contained recommendations of medicines,
and writers included if developing or writing guidelines.
Main outcome measures Proportions of guideline writers
with potentially relevant undisclosed nancial ties to
pharmaceutical companies active in the therapeutic area;
proportion of guidelines including at least one writer with a
potentially relevant undisclosed tie.
Results 344 of 402 writers (86%; 95% CI 82% to 89%)
either had no published disclosures (228) or disclosed
they had no ties (116). Of the 344 with no disclosed ties,
83 (24%; 95% CI 20% to 29%) had potentially relevant
undisclosed ties. Of 33 guidelines, 23 (70%; 95% CI 51%
to 84%) included at least one writer with a potentially
relevant undisclosed tie. Writers of guidelines developed
and funded by governments were less likely to have
undisclosed nancial ties (8.1%vs30.6%; risk ratio 0.26;
95% CI 0.13 to 0.53; p<0.001).
Conclusions Almost one in four guideline writers with no
disclosed ties may have potentially relevant undisclosed
ties to pharmaceutical companies. These data conrm the
need for strategies to ensure greater transparency and
more independence in relationships between guidelines
and industry.
INTRODUCTION
There is global concern about the nature
and extent of financial ties between
pharmaceutical companies and health
professionals, including those who develop
influential clinical practice guidelines.1–3
In 2009, a landmark Institute of Medicine
report on conflicts of interest acknowl-
edged the importance of collaboration with
industry, but warned financial ties to industry
were widespread and risked jeopardising the
integrity of medical education, research and
practice, and called for greater transparency
and independence.1 A subsequent Institute
of Medicine report, titled ‘Clinical prac-
tice guidelines we can trust’, recommended
that groups developing guidelines ‘opti-
mally comprise members without conflict of
interest.’2 Systematic review evidence suggests
most guideline writers disclose some form of
industry affiliation, with estimates between
56% and 87%.3 There are, however, few data
on the extent of undisclosed financial ties of
guideline writers. One study of North Amer-
ican cholesterol and diabetes guidelines esti-
mated 11% of writers had undisclosed ties,4
another study of American head and neck
surgery guidelines found 6% had discrep-
ancies between disclosures and an open
payments database,5 while a Danish study
Strengths and limitations of this study
►Our study is the largest to date to examine undis-
closed ties of guideline writers and includes a broad
sample of guidelines across 10 disease categories.
►Our study includes guidelines with different funding
and development arrangements, enabling compari-
son of guidelines funded and developed by govern-
ment, with other guidelines.
►Our study did not investigate the undisclosed ties
of guideline writers who had disclosed ties in the
sample of guidelines analysed.
►Study results likely underestimate the extent of un-
disclosed nancial ties of guideline writers.
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of 14 specialty society guidelines found 52% had undis-
closed ties.6 (For consistency, the term guideline writer is
used throughout to refer to those who develop, draft and
author guidelines.)
A conflict of interest is defined as “a set of circum-
stances that creates a risk that professional judgement or
actions regarding a primary interest will be unduly influ-
enced by a secondary interest”.1 A primary interest of a
guideline writer may be maximising health outcomes,
and a secondary interest could be personal gain derived
from a financial relationship with a company active in
the relevant therapeutic area. Evidence from other areas,
such as clinical trials, has shown such conflicts of interest
may introduce bias. A recent systematic review found
drug trials sponsored by industry more often have effi-
cacy results and conclusions favourable to the sponsor.7
Similarly, a cross-sectional study of randomised trials
found those authored by principal investigators with
ties to pharmaceutical companies were more likely than
other trials to report favourable results.8 Such evidence
has provoked debate about the optimum constitution of
guideline groups, with calls for chairs and a majority of
writers to be free of financial ties,9 10 as well as recommen-
dations for exclusion of any conflicted writer.2
In Australia, the publicly funded National Health
and Medical Research Council (NHMRC) is currently
engaged in improving standards for guideline develop-
ment, including in relation to transparency and manage-
ment of conflicts of interest. An internal analysis of 9 years
of Australian guidelines made available via the NHMRC
guideline portal, 2005–2013, found only 12% of guide-
lines published declarations of the conflicts of interest
of guideline writers.11 As part of work to improve stan-
dards of guidelines which can have direct impacts on how
clinicians deliver care to their patients, the NHMRC is
developing new ‘guidelines for guidelines’, and a draft
released for public comment in 2017 included the recom-
mendation: “Organisations planning guidelines should
aim to appoint a guideline development group whose
members have no financial or other links with relevant
industry groups”.12 In order to inform ongoing efforts to
improve guideline quality in Australia and internation-
ally, our objective was to investigate the extent of undis-
closed financial ties to industry, for a broad cross-section
of guideline writers from different categories of guide-
line developer, sampled from a comprehensive national
guideline database, across a wide spectrum of diseases.
METHODS
We conducted a cross-sectional study of a stratified
random sample of Australian clinical practice guidelines
and followed the STROBE checklist for reporting obser-
vational studies (see online supplementary file 1).13
Sampling guidelines
We identified a stratified random sample of clinical
practice guidelines from within the NHMRC guidelines
database, across nine government-designated health
priority areas (https:// nhmrc. gov. au/ about- us/ publi-
cations/ nhmrc- corporate- plan- 2017- 2018) plus kidney/
urogenital, published in the years 2012–2014. The
NHMRC database comprised guidelines made available
on the publicly accessible NHMRC guidelines portal,
which aimed to include all Australian guidelines,
defined broadly as published articles making clinical
recommendations. While the NHMRC portal at that
time included all Australian guidelines, it also provided
users of the portal with information on quality indica-
tors for these guidelines, such as whether the guideline
was based on a systematic review of evidence, whether
the authors provided conflict of interest disclosures
and whether or not the guideline had been approved
by NHMRC. From 2015, the NHMRC portal restricted
the inclusion of guidelines to only include guidelines
which met certain quality standards, so to achieve a
representative sample from the comprehensive collec-
tion of widely used Australian guidelines, we analysed
guidelines available on the portal in the 3 years leading
up to the change.
In 2017, NHMRC staff (HJ) identified all guidelines
in the database, published in the years 2012–2014, and
used previous coding by NHMRC to exclude articles
not relevant to the 10 health areas of interest, those
not considered guidelines, including those coded as
Evidence Reviews, Posters/Flowcharts, Standards and
Summary guidelines. Following the initial screen, each
guideline was randomly ordered using Microsoft Excel
within each of the 10 health areas. Two authors (LB,
RM) then assessed each guideline in the order they had
been ranked, against explicit inclusion criteria, and iden-
tified guideline writers to be included in the analysis.
Guidelines were included if they were associated with a
professional organisation or entity and made mention
of medicines in recommendations. They were excluded
if they were a journal article unconnected from an
external organisation, or if no author names or full text
was available. Guideline writers listed in the guideline
were included for analysis if they were explicitly engaged
in developing, preparing or writing the guideline, and
excluded if they were external consultants, members
of oversight committees or staff from a drug company,
NHMRC or administrative staff. Any discrepancies were
resolved by discussion.
The primary unit of analysis was the guideline writer.
Based on assumptions that 10% of guideline writers
might have an undisclosed relevant financial tie, and that
guidelines would have 4–20 writers each, we estimated a
need for a minimum sample of 12 guidelines—aiming for
approximately 140 writers—to produce a CI of a width
of 10% around our estimate of the proportion of writers
with undisclosed ties. In addition, to obtain as broad a
cross-section as possible, we aimed to analyse up to four
guidelines per health priority/disease area, depending
on guideline availability.
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Guideline and author information
One investigator (either AL or RM) extracted all rele-
vant information from each included guideline into
the REDCap electronic data capture tools hosted at
the University of Sydney.14 The extracted information
included the names of all included writers, classified in
one of three ways: disclosure of ties; disclosure of no ties;
no disclosure present. Disclosures were those included in
the guideline document or associated publicly available
documents. Information on whether the guideline had
a statement on conflicts of interest, and the developer/s
and funder/s was also extracted.
Identication of potentially relevant undisclosed nancial ties
For any guideline writer with no declaration present, or
who declared no conflicts of interests, one investigator
(AL or RM) conducted a search of the writer’s publica-
tions in the 5 years before the year of guideline publica-
tion. The period of 5 years was chosen for the following
reasons: many guidelines are estimated to be at least
2 years in development before the year of publication;
disclosures are directly relevant at the start of the process
of guideline development; WHO guidance suggests a
period of 4 years prior to publication is relevant when
disclosing financial ties15; many disclosure policies have
a recall period of 3 to 5 years.16 Publications were also
searched in the 3 years following guideline publication,
as some organisations, including the Institute of Medi-
cine, recommend guideline writers be free of conflicts for
periods of time after guideline publication.17
The Scopus database was used to search for publications
of guideline writers using their names and affiliations.
Full texts were obtained. Searches were conducted from
the earliest date and as per Forsyth et al18 were stopped
once a potentially relevant financial tie was identified. A
potentially relevant tie was defined as a financial tie to
a pharmaceutical company actively marketing or in late
stages of bringing a medicine to market in the therapeutic
area relevant to the guideline, at the time of the guideline
publication, determined through searches of company
websites and relevant product information material. Cate-
gorisation of ties was developed based on criteria set by
the International Committee of Medical Journal Editors,
ICMJE, and based on adaptations of ICMJE criteria
used in a previous study,18 including grants (funding
for research study), personal fees (consulting, advisory,
speakers, honoraria, travel), patents/copyrights/royal-
ties and miscellaneous. Once a potentially relevant tie was
identified by one author (AL or RM), a second author
(RM or LB) double checked the full text of the disclosure
and verified the tie as a potentially relevant tie, and any
discrepancies were resolved by discussion. Searches were
conducted between August and December 2017.
Outcome measures and statistical analysis
The primary outcome measures were specified as the
proportion of guideline writers with potentially rele-
vant undisclosed ties, and the proportion of guidelines
in the sample which included at least one writer with an
undisclosed tie. Secondary outcome measures were the
proportion of writers with disclosed ties, the proportion
of guidelines which have any statement about conflicts
of interest, and the proportion of guidelines developed
and funded by governments (state, federal or territories).
We report data proportions using descriptive statistics
and including 95% CIs. We examined the association
between having statements and the proportion of poten-
tially relevant undisclosed ties of writers, and the associa-
tion between a guideline being developed and funded by
government/s and the proportion of potentially relevant
undisclosed ties of writers. Potential associations were
tested using the χ2 test. CIs were not adjusted for clus-
tering of writers within multiple guidelines or for clus-
tering of guidelines within disease area.
Ethics
As all publications analysed for this study were on the
public record, the chair of Bond University’s Human
Research Ethics committee asserted that the study did not
require ethics review if no individuals were identified or
described.
Patient and public involvement
No patients or members of the public were involved in
this study.
RESULTS
Characteristics of guidelines
There was a total of 347 guidelines in the NHMRC data-
base, published 2012–2014 (figure 1). The initial screen
excluded 11 items not considered guidelines, coded by
NHMRC as Evidence Reviews, Posters/Flowcharts, Stan-
dards and Summary guidelines, 62 because they did not
contain names of those who had developed the guideline
and 129 published outside the 10 health areas in this study.
The remaining 145 guidelines were assigned a random
number to establish a random order for assessment of
the guidelines within each of the 10 health areas. We
continued to assess guidelines within each area in random
order until we had included four for each health area or
had completed assessing all the available guidelines in a
given health area. In total, LB and RM assessed 82 guide-
lines. Forty-nine of those guidelines were excluded after
assessment because they were a publication only with no
affiliation to any external organisation (n=22), had no
recommendations about medications (n=25), or the full
text or author list of the guideline was not publicly avail-
able (n=2). Sixty-three were not assessed.
We included 33 guidelines in our final sample: arthritis/
musculoskeletal (n=3); asthma (n=4); cancer (n=4);
cardiovascular (n=4); diabetes (n=4); injury (n=4); mental
health (n=4); neurological (n=1); obesity (n=1); kidney/
urogenital (n=4) (online supplementary file 2). The 33
guidelines involved a total of 402 guideline writers, with
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individual guidelines having between 2 and 35 writers
included for analysis.
Prevalence of undisclosed ties
Among all 402 guideline writers, 58 disclosed ties (14%;
95% CI 11% to 18%) (table 1). Among the 402 writers,
344 had no disclosed ties (86%; 95% CI 82% to 89%),
including 228 writers where no disclosures appeared
and 116 writers with statements that they had no ties. Of
the 344 writers with no disclosed ties, 83 had at least one
potentially relevant undisclosed tie (24%; 95% CI 20%
to 29%), discovered in the published literature in the
same year as the guideline was published or the previous
5 years. Of those undisclosed ties, the first category of
tie listed in the relevant disclosure was pharmaceutical
company grant (64%) or personal fees (36%). If the time
frame was extended to 3 years after the guideline, the
proportion of potentially relevant undisclosed ties rose
from 24% to 28% (95% CI 23% to 33%).
Of 33 guidelines, 23 included at least one writer with
a potentially relevant undisclosed tie (70%; 95% CI 51%
to 84%) (figure 2). Of those 23 guidelines, 14 guidelines
had 20% or more writers who disclosed no ties, but had
potentially relevant undisclosed ties. Figure 2 also reveals
the proportion of undisclosed ties of guideline writers
who disclosed no ties, per guideline, grouped by disease
category.
Guideline characteristics and undisclosed ties
Guidelines which included any statement about conflicts
of interest were not significantly different from those
without statements: 59 of 223 writers (27%) had poten-
tially relevant undisclosed ties, compared with 24 of
121 writers (20%) (risk ratio 1.33; 95% CI 0.88 to 2.03;
p=0.170) (table 2). Guidelines both developed and
funded by governments, as opposed to non-government
groups (including professional bodies, foundations or
pharmaceutical companies), were significantly less likely
to have authors with potentially relevant undisclosed ties:
8 of 99 writers (8%) compared with 75 of 245 writers
(31%) (risk ratio 0.26; 95% CI 0.13 to 0.53; p<0.001).
Figure 1 Flowchart for sample.NHMRC,National Health and Medical Research Council.
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DISCUSSION
In this broad cross-sectional sample of Australian clin-
ical practice guidelines, 14% of guideline writers had
published disclosures of conflicts of interest. Among
those who either had no disclosures or disclosed they
had no conflicts, 24%—almost one in four—had at
least one potentially relevant undisclosed financial
tie to a pharmaceutical company active in the thera-
peutic area. More than two-thirds, or 70%, of the 33
guidelines in this sample had at least one writer with
an undisclosed tie. Undisclosed financial ties of guide-
line writers appeared to be more common in some
therapeutic areas such as diabetes and cardiovascular
disease, compared with other areas such as injury and
mental health. Guideline writers working on guidelines
developed and funded by government were much less
likely to have undisclosed financial ties: 8% compared
with 31%.
Table 1 Characteristics of guideline writers from a stratied random sample of guidelines, 2012–2014 (n=33)
Therapeutic
area
Clinical practice
guideline (ID
number)
Total number of
writers
Number with
disclosed ties
Number with no
disclosed ties
COI statement
available
Developed
and funded by
government
Arthritis 1 15 0 15 Yes No
2 26 2 24 Yes No
3 6 0 6 No Yes
Asthma 4 14 0 14 No Yes
5 7 0 7 No No
6 6 0 6 No No
7 6 4 2 Yes No
Cancer 8 27 4 23 Yes No
9 6 1 5 Yes No
10 14 0 14 Yes Yes
11 31 0 31 No Yes
Cardiovascular 12 11 4 7 Yes No
13 4 0 4 No No
14 8 1 7 Yes No
15 34 0 34 Yes No
Diabetes 16 4 0 4 No No
17 14 0 14 No No
18 5 5 0 Yes No
19 13 0 13 Yes No
Injury 20 18 0 18 No Yes
21 2 0 2 No Yes
22 35 4 31 Yes No
23 9 0 9 Yes Yes
Kidney 24 7 1 6 Yes No
25 9 2 7 Yes No
26 6 2 4 Yes No
27 13 0 13 No No
Mental health 28 10 10 0 Ye s Ye s
29 11 11 0 Ye s Ye s
30 9 0 9 Yes No
31 8 0 8 Yes No
Neurological 32 2 0 2 No No
Obesity 33 12 7 5 Ye s Ye s
Total 402 58 344
COI, conict of interest.
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There are important limitations to this study. First, the
results likely underestimate the frequency of undisclosed
ties for several reasons: there is a general under-reporting
of ties published in medical journals as many important
transfers of benefits to professionals, such as hospitality
or industry-subsidised education, are not routinely
disclosed; Australia did not at the time have a database
with information on company payments to individuals;
and we did not search for any potentially relevant undis-
closed ties of writers who made disclosures of ties in the
guideline, whether those ties were to pharmaceutical
companies or other groups. Second, our results may tend
to a small degree to overestimate the frequency of undis-
closed ties, through what some may see as a broad defi-
nition of potential relevance; for example, categorising
a co-investigator of a study funded by a pharmaceutical
company active in the therapeutic area as a potentially
relevant tie. Third, the sample of guidelines, while broad
and accessible, comes from 2012 to 2014—the most
recent years available for this sample from a comprehen-
sive collection—admitting the possibility of change since
that time. And fourth, we looked only at financial ties, not
other non-financial conflicts of interest. The strengths
of the study lie in it being the largest to date in terms
of guideline writers and undisclosed ties to industry, as
well as covering a broad cross-section of disease catego-
ries and guideline developers—both government and
non-government—with previous smaller studies limited
to specific therapeutic areas,4 5 or guidelines produced
only by specialty societies.6
Neuman and colleagues investigated the prevalence of
conflicts of interest among panels producing 14 North
American guidelines for high cholesterol and diabetes.4
They reported that among writers who formally declared
no conflicts, 11% had one or more. Looking at a small
sample of 49 writers of head and neck surgery guide-
lines, Horn and colleagues found 6% had discrepancies
between guideline disclosures and information available
in the Open Payments transparency database.5 Analysing
Danish specialty society guidelines, and cross-checking
disclosures against a public register of disclosures, Bind-
sley and colleagues estimated 52% of 254 guideline writers
had not disclosed ties.6 A possible explanation of why our
estimate of 24% sits within these finding is that the North
American studies used narrower timeframes to search for
undisclosed ties, while the Danish study defined a conflict
of interest as any affiliation with any drug company.
As others have stated, guideline writer ties to compa-
nies with interest in the guideline’s outcome raise crit-
ical questions about potential bias in processes that may
have great impacts on the use of healthcare interven-
tions,4 12 disease definitions19 and patient care. Findings
of potentially relevant undisclosed ties compound the
problem further and raise the spectre of hidden bias,
increasing the wariness of guideline users. Contemporary
community standards now demand total transparency,
and our findings of undisclosed ties add weight to calls
for reforms like the Sunshine Act and Open Payments
system in the USA,20 ‘publicly accessible registries of
researcher conflicts of interest’,21 and more immediately,
Figure 2 Proportion of Australian clinical practice guideline writers with undisclosed ties, 2012–2014.
Table 2 Proportion of guidelines writers with undisclosed nancial ties by guideline type
Yes No Risk ratio (95% CI) Pvalue
COI statement in
guideline
59/223 (26.5%) 24/121 (19.8%) 1.33 (0.88 to 2.03) 0.170
Developed, funded by
government/s
8/99 (8.1%) 75/245 (30.6%) 0.26 (0.13 to 0.53) <0.001
Pvalue refers to χ2 test.
COI, conict of interest.
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enforcement of current disclosure policies to minimise
undisclosed ties. In line with repeated recommendations
for greater independence between health professionals
and industry,1 2 12 our incidental finding that almost one
in five of these guidelines had less than 10% of writers
with any ties to industry shows it is possible to assemble
guideline panels almost entirely free of financial conflicts
of interest.
The related reform processes of enhanced transparency
and greater independence underway in many nations
creates clear opportunities for research comparing the
quality of guidelines developed by writers with and without
links to industry, a research question beyond the scope of
this study, and where there are currently limited data.22
Similarly, there is a need for more research investigating
the impacts of links between industry and the professional
organisations which auspice guideline development, with
one recent study suggesting such ties are ‘common and
infrequently disclosed’.23 Given their potential influence
over human health, and health system sustainability, such
vital research on the independence and trustworthiness
of guidelines will be greatly enhanced by complete trans-
parency around the financial conflicts of interest of those
developing them.
Acknowledgements We would like to thank Edward Luca, who helped develop the
search for guideline writer publications.
Contributors RM, AL, HJ, GD, SG and LB conceived and designed the study. RM
and LB supervised the study. RM, AL, EB and LB analysed the data. RM, AL, HJ, GD,
SG, EB and LB interpreted the data. RM wrote the rst draft of the manuscript, and
RM, AL, HJ, GD, SG, EB and LB were involved in revisions of the manuscript. RM and
LB are guarantors. All authors contributed to the planning, conduct and reporting of
this study. All authors had full access to all data and can take responsibility for the
integrity of the data analysis.
Funding RM is supported by a research fellowship funded by NHMRC,
GNT1124207. EB is supported by grants from NHMRC to the Centre for Research in
Evidence-Based Practice, Bond University.
Competing interests HJ was an employee of NHMRC. SG and GD are employees
of NHMRC. LB is an employee of The University of Sydney and had no funding
specically for this work.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement We will share data where possible, within connes of
guidance from Bond University Ethics Committee that the paper does not identify or
describe any individuals.
Open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non-commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the use
is non-commercial. See: http:// creativecommons. org/ licenses/ by- nc/ 4. 0/.
REFERENCES
1. Lo B, Field MJ. Conict of interest in medical research, education,
and practice. Editors: Institute of Medicine (US) Committee on
conict of interest in medical research, education, and practice.
Washington (DC): National Academies Press (US), 2009.
2. Institute of Medicine. Clinical Practice Guidelines We Can Trust,
Report Brief. Washington, DC: The National Academies Press, 2011.
3. Norris SL, Holmer HK, Ogden LA, et al. Conict of interest in clinical
practice guideline development: a systematic review. PLoS One
2011;6:e25153.
4. Neuman J, Korenstein D, Ross JS, et al. Prevalence of nancial
conicts of interest among panel members producing clinical
practice guidelines in Canada and United States: cross sectional
study. BMJ 2011;343:d5621.
5. Horn J, Checketts JX, Jawhar O, et al. Evaluation of industry
relationships among authors of otolaryngology clinical practice
guidelines. JAMA Otolaryngol Head Neck Surg 2018;144:194.
6. Bindslev JB, Schroll J, Gøtzsche PC, et al. Underreporting of
conicts of interest in clinical practice guidelines: cross sectional
study. BMC Med Ethics 2013;14:19.
7. Lundh A, Lexchin J, Mintzes B, et al. Industry sponsorship and
research outcome cochrane database of systematic reviews. First
published 16 February 2017.
8. Ahn R, Woodbridge A, Abraham A, et al. Financial ties of principal
investigators and randomized controlled trial outcomes: cross
sectional study. BMJ 2017;356:i6770.
9. Guyatt G, Akl EA, Hirsh J, et al. The vexing problem of guidelines
and conict of interest: a potential solution. Ann Intern Med
2010;152:738–41.
10. Handbook for Guideline Development. WHO 2nd ed. Geneva, 2014.
11. National Health and Medical Research Council. Annual Report on
Australian Clinical Practice Guidelines. Canberra: National Health and
Medical Research Council, 2014.
12. National Health and Medical Research Council. Identifying and
managing conicts of interest. NHMRC Public Consultation Version
2017 https:// consultations. nhmrc. gov. au/ les/ consultations/ drafts/
iden tify inga ndma nagi ngco ni ctso nt erest. pdf (accessed 12 Apr
2018).
13. STROBE Statement—Checklist of items that should be included in
reports of cross-sectional studies. https://www. strobe- statement. org/
leadmin/ Strobe/ uploads/ checklists/ STROBE_ checklist_ v4_ cross-
sectional. pdf (accessed 12 Apr 2018).
14. Harris PA, Taylor R, Thielke R, et al. Research electronic data capture
(REDCap)-a metadata-driven methodology and workow process for
providing translational research informatics support. J Biomed Inform
2009;42:377–81.
15. World Health Organization. WHO Conict of Interest Guidelines:
declaration of interests for WHO experts, 2010. http:// keionline. org/
node/ 1062. (accessed 12 Apr 2018).
16. Boyd EA, Bero LA. Improving the use of research evidence in
guideline development: 4. Managing conicts of interests. Health Res
Policy Syst 2006;4:16.
17. Institute of Medicine, Board on Health Care Services. Committee on
Standards for Developing Trustworthy Clinical Practice Guidelines.
Clinical Practice Guidelines we can trust. Washington, DC: National
Academies Press, 2011.
18. Forsyth SR, Odierna DH, Krauth D, et al. Conicts of interest and
critiques of the use of systematic reviews in policymaking: an
analysis of opinion articles. Syst Rev 2014;3:122.
19. Moynihan RN, Cooke GP, Doust JA, et al. Expanding disease
denitions in guidelines and expert panel ties to industry: a cross-
sectional study of common conditions in the United States. PLoS
Med 2013;10:e1001500.
20. Centres for Medicare & Medicaid Services, Open Payments
database. https://www. cms. gov/ openpayments/ (accessed 12 Apr
2018).
21. Dunn AG, Coiera E, Mandl KD, et al. Conict of interest disclosure in
biomedical research: a review of current practices, biases, and the
role of public registries in improving transparency. Res Integr Peer
Rev 2019;1:1. Epub 2016 May 3.
22. Cosgrove L, Bursztajn HJ, Erlich DR, et al. Conicts of interest and
the quality of recommendations in clinical guidelines. J Eval Clin
Pract 2013;19:674–81.
23. Campsall P, Colizza K, Straus S, et al. Financial relationships
between organizations that produce clinical practice guidelines
and the biomedical industry: a cross-sectional study. PLoS Med
2016;13:e1002029.
on 6 February 2019 by guest. Protected by copyright.http://bmjopen.bmj.com/BMJ Open: first published as 10.1136/bmjopen-2018-025864 on 5 February 2019. Downloaded from
