The document describes a study that investigated how patients react to information about their physicians' conflicts of interest (COI). Participants were randomly assigned to one of three disclosure conditions (no, partial, or full disclosure) and asked their treatment preference. Increased disclosure significantly increased the likelihood patients would reject the physician's recommendation and choose drug therapy instead of an invasive procedure. On average, participants felt confident in their treatment choices across all disclosure levels.

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On average, participants were between
“Confident” and “Very Confident” in their
treatment choice.
Participants were asked how confident they were with
their treatment choice on a 6-point Likert scale (Not at all
confident, Only slightly confident, Moderately confident,
Confident, Very confident, Absolutely confident). After
performing a Chi-squared test, Figure 2.1 shows no
significant difference (p=.29) between the levels of
disclosure when patients are asked how confident they
are in their treatment choice. Basically, all the patients felt
that they had made the correct decision based on the
information they received. This indicates that participants
were not confused by the disclosure information that they
were confronted with despite the medical jargon and
increased information that increased disclosure entailed.
Effects of Conflict of Interest on Patient Action and Attitude
Roy Spece, Andrea-Gale Okoro, Ryan Keim
1 University of Arizona, James E. Rogers College of Law, 2 University of Arizona, Honors College
Introduction
Several studies show that physician financial conflicts of interest
(“COI”) significantly increase the likelihood that conflicted physicians will
order diagnostic and treatment modalities, including invasive procedures
such as surgery. Many court decisions and regulations mandate
disclosure of any and all information that a reasonable patient would
consider material to his medical choices. Disclosure is often suggested
as a remedy in the medical and other contexts, but current literature
leaves uncertain disclosure’s effects on patient attitudes and action.
Some studies suggest that disclosure does not change patients’
acceptance of physician recommendations, while others claim
disclosure can have perverse effects such as giving patients a false
sense of security. Central to court or legislative decisions whether
disclosure of COI must or should be made to patients is whether
disclosure does affect patients’ decisions. If it does, then that is strong
evidence that patients in fact consider COI to be material information.
This study investigates how patients react when confronted with
information about their physicians’ COI’s in the form of ownership
interests in facilities where recommended procedures will be done.
Using participants from all over the country to experience our vignettes
involving physician recommendations and patient choices between drug
therapy or an invasive procedure for coronary artery disease, we were
able to evaluate, through survey questions and scales, exactly how
patients are affected by disclosure. Especially important is our finding
that disclosure does significantly increase the probability that patients’
will reject their physicians’ recommendations.
.
Methods
Logistic Regression Model of Treatment Choice
Ordinal Regression Model of Confidence in Physicians
On average, participants
were between
“Confident” and “Very
Confident” in their
treatment choices. .
Likelihood of Seeking a Second Opinion
Discussion
Acknowledgments
Though there was a significant difference in likelihood of
seeking a second opinion between the levels of disclosure,
patients were generally leaning towards a 2nd opinion. When
asked to rank “likeliness” of seeking a second opinion on a 6pt, fully
anchored Likert scale (1=Very Unlikely, 6= Very Likely), participants were
generally between “Somewhat Likely” and “Very Likely” (88%). Thirty-
seven percent of participants who received Full Disclosure were “Very
Likely” to seek a second opinion, versus 27% of those who received No
Disclosure.. (X2 (10)= 25.793, p = 0.004)
Federalandstatestatutes,regulations,andcommonlawopinionsgoverninformation
transferfromphysicianstopatients. Thefindingsheremightinformwhetherandhowthese
legalmandatesshouldbealteredorbroadened,particularlyinthecurrentlyuncertaincontext
ofdisclosureoffinancialconflictsofinterest.Therearethreegeneralrulesadoptedincases
andregulationsconcerningdisclosurerequiredunderthedoctrineofinformedconsent:one
mustdisclosethatwhichwouldbethoughtreasonablebyphysiciansgenerally,onemust
disclosewhatareasonablepatientwouldconsidermaterialtohisdecisionmaking,andwhat
theparticularpatientwouldconsidermaterialtohisdecisionmaking.Applicationofthebasic
doctrinallawinthosejurisdictionthatrequiredisclosureofwhatareasonablepatientwould
considermaterialdepends,inwholeorpart, onanempiricalquestionastowhatreasonable
personswouldconsidermaterialinspecificscenarios. Thelatterquestiondepends
substantiallyonwhatinfactaffectspatients’actualdecisions. Thispaperexaminesthelatter
questionby,inturn,askingwhetherpatients’decisionsareaffectedbydisclosure—atdifferent
levelsofdetail—ofphysicians’financialconflictsofinterestintheformofownershipinterestsin
hospitalswhererecommendedprocedureswouldtakeplace.Ourfindingsintheclinical
practicecontextarethatthefactofdisclosure,butnotanincreasedlevelofdisclosure,does
significantlyaffectpatients’propensitytorejectfinanciallyconflictedphysicians’
recommendations.Therefore,itlogicallyfollowsthatsuchconflictsofinterestareinfact
materialtopatientdecisionmaking. Onecanarguethatsuchproofshowsthatlegalbodies
shouldadoptthepatient-orienteddisclosurerule,atleastinthecontextoffinancialconflictsof
interest.Othershaveobjectedthatsuchdisclosuresmightconfusepatientsorgivethema
falsesenseofsecurityabouttheirdoctors’fealty. Anotherobjectionisthatsuchdisclosures
areunwarrantedbecausetheywillnotaffectpatients’decisions. Thefindingsherecontradict
alltheseargumentsagainstdisclosure. Ourfindingsarenotonlythatdisclosureincreases
patients’propensitytorejectphysicianadvice,butalsothat,withdisclosure,patientsare
confidentintheirdecisions,aremorewaryoftheirphysicians,andmorelikelytoseeksecond
opinions.
Subjects were given one of three different vignettes either
as a high risk patient (someone who has had a heart
attack previously and therefore at higher risk of having
another) or a low risk patient (someone who has not
previously had a heart attack). The three vignettes varied
by disclosure, ranging from “No Disclosure” to “
Disclosure” to “Enhanced Disclosure”, but all ended with
the same two doctor recommendations and patient
choices. After reading their vignettes, participants were
asked a series of questions in order to measure changes
in their medical choice, opinion of the doctor’s fealty, and
understanding of the situation.
Participants
777 subjects, recruited online via Amazon Mechanical
Turk with a $0.75 incentive, consented to participate; 34
did not complete the entire experiment and 64 were
excluded for not complete the survey in a timely manner,
bringing the final sample to 691 subjects. The sample
was predominantly white (78%) and male (61%), with
some college (35%) or a Bachelor’s degree (35%), and
an average age of 28 years.
Figure 1| Note: Model χ2 (2) = 11.4, p = .003.
Full disclosure
basically inverted
treatment choice
against the doctor’s
recommendation.
Shown in both Figure 1
and Figure 1.4,
increased disclosure
significantly increased
the likelihood that
patients would ignore
the doctor’s
recommendation and opt
for drug therapy.
Figure 1.4 This figure shows the percent
change, or uptake, in respondents who
chose the recommended PCI treatment
across the levels of disclosure and risk
Figure 6. 2x3 Factorial
Design for the
experiment show all
possible options for
participants, assigned
randomly.
Figure 3.1 This figure shows
how respondents differed in
Q27, stratified by risk and
separated by disclosure level.
Figure 3| Note: Model χ2 (10) = 98.102, p < .001.
Understanding the Treatment Choice
Despite increased information with increased
disclosure, participants understood their choices
across all levels.
A simple visual and statistical comparison of responses to the
statement "I fully understand the treatment choices presented to
me by the cardiologist“ demonstrates that despite conclusions of
past literature, disclosing COI does not overwhelm patients or
impair their ability to make decisions. In a fully anchored 6pt-
Likert scale (Strongly Disagree – Strongly Agree), participants in
all levels generally fell into the “Agree” category (47%).
Figure 5.1 Given a fully
anchored 6pt-Likert scale
(1= Strongly Disagree and
6= Strongly Agree) this figure
illustrates how respondents,
separated by risk and
disclosure, felt they
understood the information
given to them.
X2 (10)= 5.716,
p = 0.839
Confidence in Treatment Choice
Figure 2.1 This figure
shows the average
confidence levels of
respondents, in their
treatment choice, in terms
of risk level and
disclosure level.
Thanks to Dr. Charles Okoro for medical accuracy review. Thanks to Christopher
Robertson and David Yokum for research guidance. Thanks to the James E. Roger Law
School and University of Arizona Honors college for financial and educational support.
Future Directions
Given that our findings contradict those in a few other somewhat
analogous investigations, we invite others to attempt to duplicate
our findings. There is also need for studies that investigate the
effects of other financial conflicts of interest such as fee-for-
service payment, receipt of monies or other perks from
pharmaceutical companies, and HMO financial incentives (be
they carrot or stick).
*
Figure 4.1 Subjects’
likelihood of seeking a
second opinion after
receiving the
information on their
treatment options from
the doctor, separated
by levels of disclosure
and risk. *
Which course of treatment do you want to select?”)
Q21
Disclosure Drug Therapy PCI Treatment Row Total
----------------------- ----------- ----------- -----------
Full Count 146 91 237
Row % 61.60% 38.40% 34.30%
Column % 38.42% 29.26%
----------------------- ----------- ----------- -----------
None Count 110 127 237
Row % 46.41% 53.59% 34.30%
Column % 28.95% 40.84%
----------------------- ----------- ----------- -----------
Partial Count 124 93 217
Row % 57.14% 42.86% 31.40%
Column % 32.63% 29.90%
----------------------- ----------- ----------- -----------
Column Total 380 311 691
Column % 54.99% 45.01%
========== Table: Disclosure by Q27 ==========
Q27 "The cardiologist had only my interests in mind in making his recommendation."
Disclosure Strongly Disagree Disagree Somewhat Disagree Somewhat Agree Agree Strongly Agree Row Total
----------------------- ----------- ----------- ----------- ----------- ----------- ----------- -----------
Full Count 13 40 56 78 38 12 237
Row % 5.49% 16.88% 23.63% 32.91% 16.03% 5.06% 34.30%
Column % 41.94% 43.96% 44.09% 37.50% 21.35% 21.43%
----------------------- ----------- ----------- ----------- ----------- ----------- ----------- -----------
None Count 1 8 28 72 94 34 237
Row % 0.42% 3.38% 11.81% 30.38% 39.66% 14.35% 34.30%
Column % 3.23% 8.79% 22.05% 34.62% 52.81% 60.71%
----------------------- ----------- ----------- ----------- ----------- ----------- ----------- -----------
Partial Count 17 43 43 58 46 10 217
Row % 7.83% 19.82% 19.82% 26.73% 21.20% 4.61% 31.40%
Column % 54.84% 47.25% 33.86% 27.89% 25.84% 17.86%
----------------------- ----------- ----------- ----------- ----------- ----------- ----------- -----------
Column Total 31 91 127 208 178 56 691
Column % 4.49% 13.17% 18.38% 30.10% 25.76% 8.10%
No Disclosure Full Disclosure Partial Disclosure
High Risk Previous MI
No Disclosure
Previous MI
Disclosure
Explanation of Disclosure
Previous MI
Disclosure
Low Risk No MI
No Disclosure
No MI
Disclosure
Explanation of Disclosure
No MI
Disclosure
Understandingofchoices