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David
B. Spring,
John
R. Akin,
Alexander
‘.
-‘
*.
M.D.
Informed
M.D.
R. Margulis,
M.D.
terms:
Contrast
#{149}
Opinions
Radiology
1
1984;
From
the
toxicity
Informed
#{149}
152: 609-613
Departments
California
School
Letterman
Army
ans Administration
cisco, California.
revision
requested
May3,
media,
of Radiology,
University
of
of Medicine
(D.B.S.,
I.R.A.,
ARM.),
Medical
Center
(D.B.S.),
and VeterMedical
Center
(J.R.A.),
San FranReceived
Nov. 29, 1983; accepted
and
April 9, 1984; revision
received
1984.
Presented
at the Sixty-ninth
Radiological
Society
of North
nois, November
13-18,
1983.
The opinions
and assertions
the private
views
strued
as official
partment
of the
#{176}RSNA1984
of the authors
Annual
America,
contained
for Intravenous
Contrast-enhanced
A detailed
questionnaire
regarding
the
obtaining
of patient
consent
for the administration
of intravenous
contrast
agents
was sent to 3845 radiologists
in
those hospitals
across
the United
States
having
more than 100 beds. The results
represent
the current
community
practice
and opinion
of the 1547 radiologists
(40%)
who answered.
They showed
that 66% of
respondents
obtained
no type of informed
consent
before
injecting
intravenous contrast
agents.
Half of those
who
did obtain
consent
did not inform
their
patients
of possible
specific
major adverse reactions.
Half of those
who did not
obtain
consent
believed
the risk of adverse reaction
was remote.
Another
40%
believed
the consent
procedure
might
heighten
anxiety
and, therefore,
increase
the risk of reaction.
Obtaining
informed
consent,
however,
was not significantly
associated
with an increased
incidence
of
major
reactions.
Since
8% of the respondents
indicated
some involvement
in
malpractice
lawsuits
regarding
the question of informed
consent
for various
procedures,
the obtaining
of informed
consent might
lessen
the risk of exposure
to
malpractice
litigation.
Additional
results
showed
that written
consent
did not appear to lessen
the number
of studies
performed
and that it offered
more specific
information
to the patient
regarding
complications.
Finally,
most radiologists
(80%) requested
a specific
policy
regarding informed
consent
from at least one of
the following
organizations:
the Amencan College
of Radiology
(ACR)
(96%),
the Radiological
Society
of North
Amenca (RSNA)
(26%), state chapters
of the
ACR (15%).
Index
consent
Consent
Meeting
Chicago,
herein
of the
Illiare
and are not to be con-
or as reflecting
the views
of the DeArmy
or the Department
of Defense.
ms
National
Survey
Radiography:
of Practice
A
and
Opinion’
R
ADIOLOGISTS
disagree
regarding
the use of informed
consent
for
the injection
of intravenous
contrast
material,
despite
the small
but significant
and known
risk to patients
that exists
whenever
such
material
is used.
While
there
is agreement
regarding
the need
for
written
informed
consent
for intra-arterial,
catheter-related
angiographic
procedures,
there
is considerable
disagreement
about
the
medical
and legal
appropriateness
of obtaining
the patient’s
written,
informed
consent
for intravenous
procedures.
(1-10).
To determine
the present
standard
of community
practice
in the
United
States
regarding
the use of informed
consent
for intravenous
contrast-enhanced
radiography,
we distributed
a questionnaire
to
radiologists
throughout
the country
during
early
1983.
The results
indicate
the current
practices
and opinions
of these
radiologists.
MATERIALS
AND
METHODS
During
early
1983, we mailed
an eight-page
questionnaire
to the chiefs
of radiology
departments
of the 3845 acute-care
hospitals
in the United
States
that had 100 beds or more. Each questionnaire
asked about
the respondent’s
site of practice,
state, and region
as identified
by the first three
zip code
numbers.
Respondents
were given
the opportunity
to remain
anonymous,
although
names
and addresses
were requested
for forwarding
results
to those
interested
and for follow-up
questioning
as needed.
We asked specifically
about
informed
consent
practice
for the major areas
of intravenous
contrast
material
use (excretory
urography,
CT, and peripheral
venography).
We also asked about any major adverse
reactions
(e.g., shock,
stroke,
cardiac
or respiratory
difficulties,
as well as death)
that occurred
as
a result of these studies.
Radiologists
were then asked to identify
their specific
reasons
for not obtaining
informed
consent.
Respondents
were asked if they and other members
of their groups
carried
malpractice
insurance
and if any of them had been involved
in malpractice
lawsuits
regarding
the question
of informed
consent.
For the purpose
of computer
data entry, we selected
an arbitrary
cut-off
time
of two months
after
mailing,
although
we continued
to receive
questionnaires
after that date. We present
only the answers
to the questions
asked,
although
respondents
were given
the opportunity
to comment
further
regarding
the
dilemma
of obtaining
an informed
consent.
RESULTS
Approximately
40% (1547)
of the
radiologists
responded
to the
questionnaire.
All zip-code
regions
and states
were
represented
in
an approximate
proportion
to their
total
populations
(TABLE
I).
Eighty-one
per cent
of respondents
practice
primarily
in private
hospitals
and
offices,
9.3%
in government
hospitals
(VA,
armed
forces),
4.4% in university
hospitals,
0.7% in HMOs,
and
4.6% with
other
unspecified
hospital
groups.
Respondents
used
a general
range
to indicate
the numbers
of examinations
performed
annually
(TABLE
II) and
estimated
having
609
I:
TABLE
Distribution
of Respondents
1980
Respondents
19.6
30.1
21.1
16.6
7.1
6.8
6.9
10.5
4
168
29.3
5.7
5
6
110
158
131
61
203
1495
13.9
16.2
23.7
10.6
31.8
212.9
7.9
9.8
5.5
5.8
6.4
7.0
Distribution
of Respondents
Studies
During
1982
Quantity
Studies
Performing
of
4
419(30)
1-25
26-50
than
2000
Total respondents
97(6)
141(11)
350(23)
409(27)
413(27)
(
89(6)
79(6)
163(12)
310(23)
144(11)
233(18)
262(21)
148(10)
318(23)
118(9)
1510
1378
Head
Body
1532
Contrast-enhanced
Minimum
urography
263(17)
1285
of Intravenous,
CT
Studies
(%)
Assumes
ment.
venography
72.2%
*
performed
of all head
Maximum
between
intravenous
68.7%
1,204,000(51)
757,000
1,859,000(48)
1,069,000
of all body
2.3 and
3.8 million
studies
1982.
While
large
urograms
are still
contrast-enhanced
the
year
of excretory
being
obtained,
CT equals
or exceeds
urography
as the major
indication
for
use of intravenous
contrast
materials
(TABLE
III). Based
upon
minimum
estimates,
venous
CT accounts
for 51%
contrast-material-enhanced
studies;
excretory
urography
and
peripheral
for 3%.
97,000(3)
3,854,000
CT studies
for
performing
studies
patients
ography
TABLE
intravenous
IV:
Percentage
of Respondents
No.
accounts
Urography
0
1-5
venography
35
60
4
1
0
6-10
11-20
>20
consent
studies.
for
Major
excretory
Contrast
urography
Reactions
Head
Body
CT
CT
34
59
6
1
0
1480
respondents
occurrence,
The radiology
technician
most
often
(59%) obtained
the patient’s
consent
for
the procedure
(TABLE
X). The radiologist,
a nurse,
the referring
physician,
and
the
department
receptionist
or
secretary,
in that
order,
were
the next
most
likely
to obtain
the
patient’s
Reporting
Excretory
Reactions
a rare
IX).
(TABLE
contrast-enhance-
excretory
urography
(TABLE
V). Another
7% told
about
the risk of excretory
urstudies
but
did
not
require
of intra-
Peripheral
Venography
51
46
3
0
0
945
81
19
0
0
0
1433
888
Excretory
Respondents
obtained
approximately
1.0 to 1.9 million
excretory
urograms
in 1982 (TABLE III). Sixty-five
per cent of the respondents
reported
at
least
one major
adverse
reaction
to intravenous
contrast
material
in their
departments
(TABLE
IV).
Sixty-five
per
cent
of the
respondents
did not use informed
consent
for
#{149}
Radiology
involve
of its risks,
78% of the respondents
discussed
the
implications
of that
refusal
with
the
patient,
and
60% documented
this interchange
in
the
patient’s
record
790,000
Total
Practice
Urography
formed
(%)
1,898,000(49)
58,000(3)
2,342,000
CT and
Obtained
1,080,000(46)
447,000
Peripheral
Total
610
387(30)
from
the
stroke,
dif-
ficulties
(TABLE
VI),
and
43%
also
named
death
as a potential
complication
(TABLE
VII). Those
who
obtained
written
consent
from
their
patients
after
giving
specific
written
information
about
excretory
urography
cornplications
were
more
likely
to provide
specific
information
regarding
these
complications
than
those
obtaining
verbal
consent
(70% versus 25%) (TABLE
VI). When
informed
about
the risks
of
intravenous
contrast
materials,
the
majority
of patients
consented
to excretory
urography
studies
(TABLE VIII).
Less
than
1% of those
patients
who
gave
their
informed
consent,
subsequently
refused
to undergo
excretory
urography
procedures.
When
a patient
refused
the excretory
urography
procedure
after
being
in-
,
Study
for 46%;
accounts
Venography
244(16)
490(33)
474(31)
Estimated
Number
During
1982
Excretory
Peripheral
CT
I
(
,
101-250
251-500
501-1000
1001-2000
III:
I
150(10)
51-100
(%)
Body
l
‘1
specific
major
complications
contrast
material,
, shock,
cardiovascular,
or
respiratory
Contrast-enhanced
CT
Urography
0
Specialized
Number
of Respondents
Head
Excretory
Performed
during
numbers
Population
139
205
145
175
II:
TABLE
Million
(Millions)
0
1
2
3
8
9
Totals
any patient
documentation
of this oral
transaction.
Twenty-eight
per cent
of
the respondents
obtained
written
patient
consent
for excretory
urography
studies,
but only
15% of these
provided
written
information
to the
patients
regarding
risks.
Forty-nine
per
cent
of those
obtaming
patient
consent
for excretory
urography
studies
told their
patients
of
Respondents!
Census
of
7
More
to Population
Number
1st digit U.S.
Postal Zone
(ZIP) Code
TABLE
Relative
TABLE
V:
Informed
Percentage
of Respondents
Consent
Excretory
Pattern
Noconsent
65
7
13
0
15
Written-oral
Written-written
Information
given
to patient
orally;
Various
Informed
Head
Urography
Oraloral*
Oral-written
S
Using
patient
consents
Consent
Body
Peripheral
CT
CT
67
6
11
0
16
67
6
12
0
15
orally
Patterns
(i.e..
no written
Venography
48
6
27
0
19
documentation).
September
1984
Practice
for
CT
TABLE
VI:
Respondents
Who
Obtaining
Approximately
studies
and 72%
were
intravenous
and
,
69% of all body
CT
of all head
CT studies
contrast-enhanced,
respondents
performed
Consent
Pattern
of these
Numbers
*
5,
4
of Specific
Respondents
Head
CT
Excretory
Urography
Oral-oral
Oral-written
Written-oral’
Written-written
Totals
in
major
adverse
contrast
a common
occurrence,
were
Patients
Major
they
were
less frequent
with
body
CT
studies
(49%)
than
with
head
CT (66%)
or with
excretory
urography
studies
(65%)
(TABLE
IV).
The patterns
of obtaining
informed
contrast
for CT studies
paralleled
those
for excretory
urography.
Sixty-seven
per cent
of radiologists
employed
no
consent
procedure
for CT studies.
Approximately
24%
obtained
written
consent,
with
11% of these
providing
oral information,
and
15% written
information
(TABLE
V).
Those
obtaining
consent
mentioned
specific
major
complications
in about
half of their
cases for head
and body
CT
studies
(TABLE
VI). Those
providing
written
information
and
obtaining
written
patient
consent
for CT studies
were
far more
likely
to provide
specific
information
regarding
complications
TABLE
25/101(25)
74/194(38)
0/3(0)
150/215(70)
249/513(49)
considered
VII:
too small
Respondents
Obtaining
Body
CT
Numbers
*
TABLE
considered
VIII:
Total
to those
for excretory
urography
and
contrast-enhanced
CT studies.
The rare
patient
who
declined
a CT study
was
informed
about
the implications
of that
refusal
about
77% of the time
(TABLE
Named
Death
Consent
too small
Percentage
Provided
10/56(18)
37/102(36)
1/4(25)
94/181(72)
142/343(41)
Among
Major
Respondents
Head
CT
10/68(15)
40/139(29)
0/2(0)
116/177(66)
166/386(43)
Complications
Who
Discussed
Patient
Refusing
5/40(13)
21/71(30)
1/3(33)
71/110(65)
98/224(44)
Studies
Because
% Respondents
Head
CT
Excretory
Urography
Yes
No
Total
63
27
<5.0
10
17
13
8
3
0
2
0
<10.0
>10.0
respondents
1
0
528
312
Implications
of Study
Refusal
Body
Peripheral
CT
CT
Venography
*
NA
TABLE
respondents
=
X:
79
75
61
39
22
513
80
NA*
NA
21
315
NA
NA
20
696
25
282
not asked.
Identification
of Individual
Excretory
Urography
Title
Radiologist
Radiologist
Obtaining
Informed
Consent
% Respondents
Head
CT
Body
CT
Peripheral
Venography
44
7
46
8
46
10
59
11
X-ray technician
51
65
65
45
Radiology/receptionist/secretary
Nurse
Referring
physician
16
32
20
20
35
17
19
36
18
10
27
15
2
4
4
resident/intern
Another
Volume
152
Number
3
Peripheral
Venography
50
35
Urography
60
40
Body
CT
50
30
Head
78
of Information
51
38
Excretory
Documented
Not documented
11/56(20)
76/254(30)
1/1(100)
129/226(57)
2171537(40)
<0.1
<1.0
% Respondents
Informed
Peripheral
Venography
to be significant.
IX). This
transaction
was documented
in the
patient’s
record
61%
of the
time.
As with
excretory
urography,
the
radiology
technician
was the one who
With
When
Body
CT
most
often
obtained
contrast-enhanced
radiologist
was the
(TABLE
1
2
0
258
752
patient
consent
for
CT studies,
and the
second
most
likely
X).
Practice
for
Venography
Percentage
28/86(33)
151/376(40)
2/3(67)
185/273(68)
366/738(50)
(%)
5/43(12)
24/66(36)
0/2(0)
81/126(64)
1 10/237(46)
of Patients
% Patients
Refusing
those
providing
oral information
obtaining
oral consent
(TABLES
VI
VII).
Nearly
all (99%)
of the
informed
patients
consented
to the study
despite
their
knowledge
of the potential
risks
(TABLE VIII). These
results
were
similar
IX:
Peripheral
Venography
to be significant.
Excretory
Urography
Oral-oral
Oral-written
Writtenoral*
Written-written
Totals
When
(%)
12/57(21)
42/102(42)
0/3(0)
104/146(71)
158/308(51)
Who
Informed
Consent
Pattern
than
and
and
TABLE
Complications
Consent
between
1.2 million
and
1.9 million
1982 (TABLE
III).
Although
reactions
Inform
Informed
Peripheral
Respondents
performed
between
58,000
and
97,000
peripheral
venography
studies
during
1982 (TABLE
III).
Major
contrast
reactions
occurred
infrequently
with
peripheral
venography
studies
(TABLE
IV);
only
19% of
respondents
reported
any major
reaction,
and
those
stated
they
had
seen
fewer
than
five
instances
during
the
whole
of 1982. While
there
were
fewer
major
reactions
with
peripheral
venography
studies
than
with
excretory
urography
and
CT
studies,
written
consent
was
obtained
significantly
more
often
for peripheral
venography
than
for the other
two types
of studies
(TABLE
V). Forty-six
per cent
of respondents
obtained
written
consent,
and
19% of the respondents
also provided
written
information
to their
patients.
Specific
complications
were
named
by 50% of those
obtaining
informed
consent
for
peripheral
venography
Radiology
#{149}
611
XI:
TABLE
Reasons
for Not
Obtaining
Informed
Consent
% Respondents
Head
Body
Excretory
Reason
CT
CT
50
51
52
The level of major risks for each individual
patient
is
usually extremely
low (i.e., rare).
The procedure
is so common
that the risk and benefits
are generally
known.
The informed
consent process may cause the patient to
refuse
a needed
The informed
anxiety
Peripheral
Urography
Venography
51
4
2
2
2
5
7
7
6
40
38
38
40
1
2
1
1
examination.
consent
to point
process
increases
of causing
reaction.
The informed
consent
in a busy department,
Total respondents
a greater
the level
risk
of
of adverse
process
is too time-consuming
making
it impractical.
1 109
871
867
ican College
of Radiology
(ACR)
(96%),
the
Radiological
Society
of
North
America
(RSNA)
(26%),
and state
ACR
chapters
(15%).
Almost
all (97%)
respondents
and
members
of their
groups
were
covered
by malpractice
insurance,
and over
8%
stated
that they
or that
others
in their
group
had been
listed
at some
time
as
a defendant
in a malpractice
lawsuit
involving
the
question
of informed
consent.
922
DISCUSSION
Informed
XII:
TABLE
The Relationship
Reported
between
Reactions
Contrast
Informed
Consent
and
(Excretory
Urography
the Number
of
and CT Studies)
% Respondents
Number
of
Reactions
Obtained
Excretory
Urography
0
1-5
35
60
4
1
0
513
6-10
11-20
>20
Totalrespondents
(TABLE
VI).
also informed
a remote
complication
travenous
VII).
A smaller
patients
contrast
Again,
those
percentage
that
death
related
material
documenting
Consent
Head
CT
34
58
7
1
0
311
(40%)
was
to in(TABLE
the
consent
procedure
in writing
were
far
more
likely
to name
specific
risks,
including
death,
than
those
conducting
only
an
oral
consent
procedure
(TABLES
VI and VII).
Like
those
patients
who
required
excretory
urography
and
contrastenhanced
CT studies,
patients
requiring peripheral
venography
procedures
almost
always
consented
to the studies
after
they
were
informed
of the
potential
risks.
At least
99% of patients
considered
the risks reasonable
(TABLE
VIII).
If a patient
refused
the
procedure
upon
being
told of its risks,
80% of all
radiologists
then
informed
the patient
about
the implications
of not having
the study
(TABLE
IX).
Unlike
the situation
with
excretory
urography
and contrast-enhanced
CT
studies,
it was the radiologist
who
most
often
informed
patients
and obtained
their
consent
(TABLE
X). Radiology
technicians
and/or
nurses,
in
that
order,
were
the next
most
likely
to obtam
consent,
though
they
did so less
frequently.
Opinions
Consent
About
who
did
believed
612
about
half
of
not obtain
that
the
#{149}
Radiology
Informed
those
respondents
informed
consent
individual
level
of
Body
CT
47
49
4
0
0
288
No Consent
Excretory
Urography
34
61
4
1
0
958
Obtained
Head
CT
34
60
5
1
0
624
Body
CT
54
44
2
0
0
595
risk for these
procedures
was
extremely
low (TABLE
XI). Another
40% believed
that
the informed
consent
process
increased
the patient’s
level
of anxiety
to
the point
of causing
a greater
risk
of
adverse
reaction.
Radiologists
strongly
believed
that
the
informed
consent
process
increased
(83%)
anxiety
about
an intravenous
contrast
study
rather
than
decreased
(4%) or left such
concerns
unchanged
(13%).
Most
radiologists,
whether
or not
they
obtained
informed
consent,
believed
that anxiety contributed
to contrast
reactions.
In
fact, 82% of the respondents
believed
that
anxiety
was
the
major
cause
of
minor
contrast
reactions.
Only
37%,
however,
believed
anxiety
to be the
leading
cause
of such
major
reactions
as shock,
stroke,
respiratory
and
cardiovascular
difficulties,
and death.
These
beliefs
notwithstanding,
we
found
no statistical
difference
in the
number
of major
reactions
to urography
and
CT studies
(97%
of intravenous
contrast-enhanced
studies)
between
those
who
did and
those
who
did
not
obtain
informed
consent
(TABLE
XII).
Although
there
have
been
statements
and policies
regarding
informed
consent
procedures,
respondents
are
interested
in some
specific
guidelines
for the
process.
About
80% believed
that an official
group
or society
representing
diagnostic
radiologists
should
enunciate
a specific
policy
about
informed
consent
for the use of intravenous
contrast
media.
The organizations
requested
most
often
were:
the Amer-
consent
procedures
are
now
commonly
used
in the
United
States
for many
higher-risk
diagnostic
radiologic
procedures
such
as arteriography
and
percutaneous
intervention.
However,
the
use
of informed
consent
procedures
for
intravenous
contrast-enhanced
radiography
is
more
controversial.
Since
the law is unclear
in most
jurisdictions
about
the radiologist’s
duty
to inform,
the radiological
community
is not quite
certain
as to its appropriate
course
of action.
Those
who
do not
obtain
consent
wish
to be reassured
that
this
is indeed
correct;
those
employing
consent
procedures
wish
to
know
if they
are doing
so unnecessarily.
Because
of rising
medical
malpractice insurance
costs,
hospital
administrators,
risk management
committees,
malpractice
insurance
carriers,
and
some
radiciogists
have
lobbied
for the
application
of formal
consent
procedures
whenever
intravenous
contrast
material
is injected.
The
majority
of
radiologists,
however,
obtain
no consent
for
excretory
urography
or for
contrast-enhanced
CT
studies.
The
pattern
of non-consent
for excretory
urography
studies
was established
before informed
consent
was a legal
issue
and
before
the incidence
of major
reactions
was known.
We found
that radiologists
who
did
not obtain
cedures
material
informed
consent
using
intravenous
believed:
1) that
the
-4
for procontrast
likelihood
of fatal
reactions
was
remote,
and
2)
that
the consent
procedure
might
increase
patient
anxiety,
thereby
enhancing
the likelihood
of adverse
reactions.
However,
the
present
retrospective
study
of more
than
two
million
contrast-enhanced
examinations
performed
during
1982 did not detect
any significant
difference
between
the
number
of major
reactions
for patients
who
were
informed
than
for those
who
were
not.
The
number
of lawsuits
in which
informed
consent
was
an issue
was
alarmingly
high
(8%)
among
radiological
groups;
however,
any
further
September
1984
I
discussion
trends,
the
of this
and
scope
its
problem,
implications
of this
ysis.
its regional
is beyond
discussion.
The
Acknowledgments:
respondents
questionnaire,
and
not only
but also
interesting
and
We wish to thank all of the
for their
answers
to our
for their encouragement
helpful
comments.
152
Number
3
was
supported
by
the
Education
Foundation,
San Francisco.
and proposals.
Radiology
Curr
Prob Diag Radiol
1979;
8:3-19.
University
7.
Lalli
AF.
analysis
Contrast
and
media
hypothesis.
reactions:
Radiology
data
1980;
134: 1-12.
8.
1.
2.
3.
4.
5.
6.
9.
Lalli AF.
Urographic
contrast
media
reactions
and
anxiety.
Radiology
1974;
112:
267-271.
Ochsner
SF.
Problems
and joys in radiology. AJR 1977; 128:177-179.
Quimby
CW Jr.
Informed
consent:
a dialogue.
Radiology
1977; 123:805-806.
Allen
RW.
Informed
consent:
a medical
decision(II).
Radiology
1977; 123:807.
James
AE Jr. Johnson
BA, Hall
DJ.
Informed
consent:
some
newer
aspects
and
their relation
to the specialty
of radiology.
Radiology
1977; 123:809-813.
Johnson
BA, James
AE Jr. The radiologist
and informed
Webber
MM.
and practice.
References:
Our
thanks
also to Ms. Shirley
Semigran
and Mr.
Richard
Auchmoody
for their
secretarial
assistance
and to Mr. Ronald
Cowen
of the UCSF
Computer
Center
for data compilation
and anal-
Volume
project
high
rate
of response
(40%)
to our
long
questionnaire
and
the
fact that
large
numbers
of respondents
added
additional
comments
attested
to the need
for the development
of a policy
that
protects
both
patients
and
physicians
and
clarifies
the
responsibilities
of
each.
‘I
This
Research
and
of California,
consent:
a review,
comments,
10.
Reuter
Chicago,
Informed
consent
Radiology
SR.
Use of detailed
consent
forms.
IL. American
College
of Radiology.
1983:1-8.
Kassirer
JP.
Adding
insult
urping
patients’
perogatives.
1983; 308:898-901.
David
Spring,
Department
University
in research
1982; 144:939-941.
M.D.
of Radiology
of California
San Francisco,
to injury:
usN Engl J Med
School
of Medicine
CA 94143
Radiology
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