Increasing resident utilization and recognition of the critical viewof safety during laparoscopic cholecystectomy: a pilot studyfrom an academic medical center

Crystal B. Chen1 • Francesco Palazzo1 • Stephen M. Doane1 • Jordan M. Winter1 •

Harish Lavu1 • Karen A. Chojnacki1 • Ernest L. Rosato1 • Charles J. Yeo1 •

Michael J. Pucci1

Received: 15 March 2016 / Accepted: 21 July 2016 / Published online: 5 August 2016

� Springer Science+Business Media New York 2016

Abstract

Background Laparoscopic cholecystectomy (LC) is a

commonly performed surgical procedure; however, it is

associated with an increased rate of bile duct injury (BDI)

when compared to the open approach. The critical view of

safety (CVS) provides a secure method of ductal identifica-

tion to help avoid BDI. CVS is not universally utilized by

practicing surgeons and/or taught to surgical residents. We

aimed to pilot a safe cholecystectomy curriculum to

demonstrate that educational interventions could improve

resident adherence to and recognition of the CVS during LC.

Methods Forty-three general surgery residents at Thomas

Jefferson University Hospital were prospectively studied.

Fifty-one consecutive LC cases were recorded during the

pre-intervention period, while the residents were blinded to

the outcome measured (CVS score). As an intervention, a

comprehensive lecture on safe cholecystectomy was given

to all residents. Fifty consecutive LC cases were recorded

post-intervention, while the residents were empowered to

‘‘time-out’’ and document the CVS with a doublet photo-

graph. Two independent surgeons scored the videos and

photographs using a 6-point scale. Residents were surveyed

pre- and post-intervention to determine objective knowl-

edge and self-reported comfort using a 5-point Likert scale.

Results In the 18-week study period, 101 consecutive LCs

were adequately captured and included (51 pre-intervention,

50 post-intervention). Patient demographics and clinical data

were similar. The mean CVS score improved from 2.3 to 4.3

(p\ 0.001). The number of videos with CVS score [4

increased from 15.7 to 52 % (p\ 0.001). There was strong

inter-observer agreement between reviewers. The pre- and

post-intervention questionnaire response rates were 90.7 and

83.7 %, respectively. A greater number of residents cor-

rectly identified all criteria of the CVS post-intervention

(41–93 %, p\ 0.001) and offered appropriate bailout

techniques (77–94 %, p\ 0.001). Residents strongly agreed

that the CVS education should be included in general surgery

residency curriculum (mean Likert score = 4.71,

SD = 0.54). Residents also agreed that they are more com-

fortable with their LC skills after the intervention (4.27,

r = 0.83).

Conclusion The combination of focused education along

with intraoperative time-out significantly improved CVS

scores and knowledge during LC in our institution.

Keywords Laparoscopic cholecystectomy � Critical viewof safety � Resident education

Laparoscopic cholecystectomy (LC) is one of the most

common surgical procedures with more than 700,000 per-

formed annually in the USA [1]. Despite the clear benefits

of the laparoscopic approach, there appears to be a three-

fold to fivefold increase in the major bile duct injury (BDI)

rate compared to historical open cholecystectomy data

(0.3–0.5 vs. 0.1 %) [2–4]. Although the precise incidence

is challenging to quantify, this equates to approximately

3000 cases of major BDI per year in the USA. Major BDI

is a catastrophic occurrence and is associated with a 1-year

Presented at the SAGES 2016 Annual Meeting, March 16–19, 2016,

Boston, Massachusetts.

& Michael J. Pucci

michael.pucci@jefferson.edu

1 Department of Surgery, Jefferson Pancreas, Biliary and

Related Cancer Center, Sidney Kimmel Medical College,

Thomas Jefferson University, 1100 Walnut Street, 5th Floor,

Philadelphia, PA 19107, USA

123

Surg Endosc (2017) 31:1627–1635

DOI 10.1007/s00464-016-5150-0

and Other Interventional Techniques

mortality rate of 1.7–3.9 % [5, 6], as well as significant

morbidity including increased hospital cost, need for

additional interventions, prolonged hospital stay, and fre-

quent readmissions [7, 8].

The most common cause of major BDI is the misiden-

tification of the common bile duct (CBD) for the cystic

duct [9]. The typical (or ‘‘classical’’) injury occurs as a

result of inadvertent resection of the common hepatic duct

en bloc with the gallbladder, with or without concomitant

vascular injury [10]. This injury occurs as a result of a

misperception of biliary anatomy. Biliary fusion and con-

traction can occur in the setting of acute or chronic

inflammation, leading to subsequent fusing of the lateral

sidewall of the common hepatic duct to the gallbladder. In

this setting, dissection around the lower end of the gall-

bladder to identify the cystic duct (the so-called

infundibular approach) can lead surgeons to misidentify the

common bile duct as the cystic duct, causing major BDI.

Thus, the infundibular approach, while easier to achieve, is

an error trap that surgeons must not rely on for ductal

identification. The critical view of safety (CVS) introduced

by Strasberg et al. [11] in 1995 provides a secure method of

ductal identification by attempting to replicate the method

performed in the open approach. The CVS has three cri-

teria that must be achieved prior to clipping any biliary

structures in order to prevent misidentification. These

include: (1) dissecting within and clearing the hepatocystic

triangle of fat and fibrous tissue, (2) identifying two and

only two structures (cystic duct and cystic artery) entering

the gallbladder, and perhaps most importantly, (3) dis-

secting the gallbladder off and away from the liver

exposing at least the bottom third of the cystic plate

[11, 12]. Accomplishment of the CVS can be documented

and confirmed with a ‘‘doublet photograph’’ which includes

an anterior and posterior (front and back) view of the

gallbladder confirming all criteria have been successfully

achieved. These photographs can be scored via a six-point

scale to objectively correlate with obtainment the CVS (or

if the view has not been adequately demonstrated). A

doublet photograph with a score[4 can be considered an

‘‘adequate’’ surrogate for obtainment of the CVS [12].

While no level I evidence exists to support the efficacy of

the CVS method (as the number of patients necessary to

discriminate between an incidence of 0.4 and 0.1 is almost

prohibitory), there is a large body of literature that supports

the absence of major BDI with CVS achievement [13–15].

These data support the use of the CVS to minimize BDI.

While the CVS method of anatomical (ductal) identifica-

tion is important in prevention of major BDI, it is only one

part of the so-called Culture of Safety of Cholecystectomy.

This culture recognizes the need for putting safety first

when managing benign gallbladder disease. The ‘‘safety

first’’ approach includes appropriately selecting cases to

perform LC, adequately identifying the CVS prior to

ligation of any structures, understanding when danger

exists, and having appropriate ‘‘stop points’’ as well as

reasonable and effective bailout procedures when the CVS

cannot be achieved. Strict adherence to this culture man-

dates putting safety first in all cases of cholecystectomy

[16].

While the CVS approach has been discussed and pop-

ularized since 1995, there still has been no change in BDI

rates. Although speculative, it follows that the higher injury

rate cannot be solely attributed to the ‘‘learning curve’’ of

surgeons [17]. We hypothesize that the CVS is not uni-

versally utilized by practicing surgeons and/or taught to

surgical residents. We suspect this is because the

infundibular approach is much easier to carry out, leading

surgeons to perform ‘‘short cuts’’ in cases without signifi-

cant inflammation. However, this is clearly an error trap; as

many major BDIs occur by the classical injury mechanism

in which the infundibular approach fails to keep patients

and surgeons safe. While the CVS method of ductal iden-

tification is more difficult to achieve, it alerts surgeons

when severe inflammation is present and a bailout proce-

dure should be performed instead [18].

Although the goal of safely performing cholecystectomy

is already a priority in general surgical residency training

programs, we aimed to pilot a safe cholecystectomy cur-

riculum in our surgical residency to demonstrate that

educational interventions and mandated ‘‘time-out’’ during

operations to document the CVS could improve resident

adherence to and recognition of the CVS during LC.

Methods

Study population

Forty-three categorical and preliminary general surgery

residents (ranging from postgraduate year 1 to 6) at the

Thomas Jefferson University Hospital in Philadelphia, PA,

were prospectively studied over a 5-month period in 2015.

General surgery residents routinely perform LC on 5

‘‘services’’, including multiple general surgery, hep-

atopancreatobiliary, and acute care surgery services.

Study design

All cases of LC were attempted to be recorded with video

during the pre-intervention period, while the residents and

attending surgeons were blinded to the outcome measured

(CVS score). These cases were performed per the typical

routine of the attending and resident surgeons. Cases

requiring conversion to an open operation or where ade-

quate video capture was not achieved were excluded. After

1628 Surg Endosc (2017) 31:1627–1635

123

10 weeks of pre-intervention data capture, a comprehen-

sive lecture on the culture of safe cholecystectomy was

given by one author (MJP) to all residents. This lecture

discussed the rationale of utilizing the CVS approach of

ductal identification, as well as other components of safe

cholecystectomy (i.e., anatomy review, bailout operations,

stop points). The residents also watched a video entitled ‘‘A

teaching program for the ‘culture of safety in cholecys-

tectomy’ and avoidance of bile duct injury’’ [16]. Residents

were empowered post-intervention to stop the operation

during LC prior to cystic duct ligation and ‘‘time-out’’ to

document the CVS with a doublet photograph showing

both an anterior and posterior view (Fig. 1) [12]. This

‘‘time-out’’ would include the entire operative team, with

the circulating nurses recording that a CVS occurred (or if

it did not occur). Residents were encouraged to continue

dissection until they felt the CVS was adequately achieved,

and attending surgeons were asked to allow residents time

to dissect. Residents were also given pocket reminder

cards, and ‘‘time-out’’ reminders were posted in the oper-

ating rooms (Fig. 1).

The pre-intervention videos were reviewed and trimmed

to 30 s around the occurrence of cystic duct ligation. The

post-intervention doublet photographs were collected. Two

independent surgeons (FP and MJP) scored the videos and

photographs using a 6-point CVS scale previously pub-

lished by Sanford and Strasberg [12]. Videos were

reviewed from the pre-intervention period and doublet

photographs from the post-intervention period in order to

keep residents in the pre-intervention group blinded to the

purpose of the study. Additionally, the reviewers noted

whether the moment of the cystic duct ligation appeared to

be considered ‘‘unsafe’’ in their opinion. The definition of

‘‘unsafe’’ was that a major BDI could conceivably have

occurred in that scenario. Residents were surveyed pre- and

post-intervention using a 35-item questionnaire to deter-

mine objective knowledge and self-reported comfort, using

a 5-point Likert scale.

Additional data on patient demographics and intraop-

erative variables and outcomes were collected through a

prospectively maintained database.

Outcomes

The primary outcome measured was the overall CVS

scores of the residency before and after the educational

intervention. Secondary outcomes measured included

knowledge scores from the questionnaires, residents’ self-

assessed comfort in performing LC, and compliance rates

during the study.

Statistical analysis

Statistical analyses were performed using Chi-square tests

for categorical variables and t tests for continuous vari-

ables. CVS scores were assessed with kappa coefficient for

Fig. 1 Resident pocket cards

describing the criteria of the

critical view of safety (CVS),

backup measures, and an

example of a doublet

photograph

Surg Endosc (2017) 31:1627–1635 1629

123

inter-observer agreement. p\ 0.05 was considered statis-

tically significant.

Results

In the 18-week study period, 156 consecutive LCs were

attempted. Seven cases were converted to open cholecys-

tectomy (2 pre-intervention, 5 post-intervention), and 48

cases did not have a CVS time-out video or photograph

available (26 pre-intervention, 22 post-intervention). One

hundred and one (101) consecutive cases of LCs were

adequately captured and included (51 pre-intervention, 50

post-intervention). The pre-intervention period had 20

unique residents and 12 unique attending surgeons per-

forming the cases; similarly, the post-intervention period

had 20 unique residents and 13 unique attending surgeons

(Table 1). Patient demographics and clinical data were

similar (Table 2). The operative time (defined as the time

from the beginning to the end of anesthesia) was longer in

the post-intervention period (126-min pre-intervention,

156-min post-intervention, p\ 0.05, Table 2). No major or

minor BDI occurred in the time-span of this study.

CVS Score

The mean CVS score improved from 2.31 to 4.32

(p\ 0.001, Table 1; Figs. 2, 3). The post-intervention

period had more cases achieving adequate CVS scores

(score[4) compared to the pre-intervention period (52.0 %

post-intervention, 15.7 % pre-intervention, p\ 0.001,

Table 1). There were five videos receiving a score of 0 in

the pre-intervention period, compared to only 2 cases in the

post-intervention period (p = 0.436, Table 1). More cases

were marked as ‘‘unsafe’’ in the pre-intervention period

(27.5 % pre-intervention, 10.0 % post-intervention,

p = 0.04, Table 1). ‘‘Unsafe’’ cholecystectomies had a

mean score of 0.61 and 0.80, pre- and post-intervention.

There was no correlation between CVS scores and

postgraduate training year of the resident (p = 0.33). There

was strong inter-observer agreement between reviewers

(Kw = 0.651 pre-intervention, Kw = 0.808 post-inter-

vention) (Table 3).

Questionnaire

The pre-intervention questionnaire response rate was

90.7 % (39/43), while the post-intervention response rate

was 83.7 % (36/43) (Table 4).

Post-intervention a greater number of residents correctly

identified all criteria of the CVS (41–93 %, p\ 0.001,

Fig. 4) and offered appropriate bailout techniques

(77–94 %, p\ 0.001, Fig. 4). Residents strongly agreed

that the CVS education should be included in general

surgery residency curriculum (mean Likert score = 4.71,

SD = 0.54) and that the teaching methods were suitable to

their way of learning (4.36, r = 0.71). Residents also

agreed that they are more comfortable with their LC skills

after the intervention (4.22, r = 0.83) and that they

received adequate feedback from attending surgeons dur-

ing the intervention period (4.16, r = 0.81). Interestingly,

while the residents agreed that the mandated ‘‘time-out’’

and documenting the CVS with a photograph helped them

to perform a safer LC (3.74, r = 1.12; 3.74, r = 1.07),

they were more ambivalent as to whether they felt the

attending surgeons agreed (3.38, r = 0.79; 3.62,

r = 0.84). Even though there was an increase in self-

assessed frequency in documenting CVS with a photograph

(2.08–3.85, p\ 0.001), the residents’ perception of CVS

obtainment did not change (3.68–3.88, p = 0.176, Fig. 5).

Discussion

LC is regarded as the gold standard in the treatment of

benign gallbladder pathology [19]. However, it is associ-

ated with a higher rate of major BDI when compared to

historical controls using open cholecystectomy [20, 21].

Table 1 Study dataSummary Pre-intervention Post-intervention p value

Total number of attempted LC cases 79 77

Cases converted to open 2 (2.5 %) 5 (6.5 %)

Cases captured with video/photo 51 (66 %) 50 (69 %)

Unique attending surgeons 12 13

Unique surgery residents 20 20

Average CVS score 2.31 4.32 p\ 0.001

Median CVS score 2 4.75 p\ 0.001

Videos with CVS score[4 8 (15.7 %) 26 (52 %) p\ 0.001

Videos with CVS score = 0 5 (10.0 %) 2 (4 %) p = 0.436

Number of videos ‘‘unsafe’’ 14 (27.5 %) 5 (10 %) p = 0.040

1630 Surg Endosc (2017) 31:1627–1635

123

Table 2 Patient demographics

and clinical dataPre-intervention (N = 51) Post-intervention (N = 50) p value

Gender p = 0.215

Male 18 (35.3 %) 12 (24.0 %)

Female 33 (64.7 %) 38 (76.0 %)

Age (years) p = 0.829

Median (IQR), SD 50 (37.0–62.0) ± 14.4 49.5 (35.0–63.3) ± 16.6

BMI (kg/m2) p = 0.238

Median (IQR), SD 29.2 (25.5–33.1) ± 8.6 27.0 (24.1–4.1) ± 6.72

Procedure type p = 0.617

Inpatient 14 (27.5 %) 16 (32 %)

Outpatient 37 (72.5 %) 34 (68 %)

Blood loss (mL) p = 0.912

Median (IQR), SD 10.0 (5–20) ± 27.9 12.5 (5–15) ± 7.0

Length of operation (min)a

Median (IQR), SD 126 (118–145) ± 33 156 (127–190) ± 50 p\ 0.05

Diagnosis p = 0.844

Symptomatic gallbladder disease 34 36

Acute cholecystitis 6 5

Symptomatic choledocholithiasis 11 9

a Length of operation is determined by duration of anesthesia

Fig. 2 Scatter plot of the

distribution of critical view of

safety (CVS) scores pre- and

post-intervention

Fig. 3 Critical view of safety

(CVS) scores by postgraduate

year (PGY)

Surg Endosc (2017) 31:1627–1635 1631

123

Table 3 Critical view of safety

score distribution and inter-

observer agreement

Pre-intervention (N = 51) Post-intervention (N = 50)

Reviewer 1 Reviewer 2 Reviewer 1 Reviewer 2

Criteria 1a

0 26 9 7 5

1 13 31 14 15

2 12 11 29 30

Criteria 2b

0 18 12 2 2

1 12 19 5 13

2 21 20 43 35

Criteria 3c

0 40 38 16 21

1 4 11 11 8

2 7 2 23 21

Total

0–2 29 28 9 12

3–4 15 16 14 14

5–6 7 7 27 24

Inter-observer agreement Kw = 0.651 CI = 0.393–0.791 Kw = 0.808 CI = 0.584–0.899

a Criteria 1. Hepatocystic triangle is cleared of fat and fibrous tissueb Criteria 2. Two and only two structures are entering the gallbladderc Criteria 3. Cystic plate is visible in its lower one-third

Table 4 Resident questionnaire pre- and post-intervention results

Pre-intervention

(N = 39)

Post-intervention

(N = 36)

p value

How often do you perceive the CVS is achieved? 3.68 3.88 0.176

How often do you document CVS with a photograph? 2.08 3.58 0.0001

I feel comfortable with my current laparoscopic skills in regards to laparoscopic

cholecystectomy

2.73 3.19 0.296

I feel we have comfortably identified the ductal anatomy when ligation of presumed cystic

duct occurs

4.11 4.36 0.249

I feel we have comfortably identified the arterial anatomy when ligation of presumed cystic

artery occurs

4.08 4.28 0.226

I feel comfortable that my attending will allow me to dissect further to define structures

before ligation (if the anatomy is unclear)

3.71 3.74 0.281

I feel my attending gives me adequate time to identify the structures 3.52 3.87 0.230

I feel my attending is open to my suggestions during LC 3.38 3.83 0.234

I do not feel rushed by my attending during LC 3.15 3.57 0.090

I do not feel rushed by my attending to ligate before I am certain of the anatomy myself 3.64 3.78 0.249

Given the small variations in technique, I feel laparoscopic cholecystectomies are taught

consistently by different attendings

3.09 3.33 0.226

I feel comfortable doing a laparoscopic cholecystectomy by myself with little or no guidance 2.54 2.92 0.334

I feel comfortable teaching a laparoscopic cholecystectomy to a more junior resident 2.26 2.64 0.338

I feel I am adequately taught in performing laparoscopic cholecystectomies safely 3.79 4.33 0.283

I feel I am adequately taught in identifying CVS 3.57 4.36 0.267

I feel I have been adequately exposed to CVS outside of the OR 3.34 4.35 0.269

1632 Surg Endosc (2017) 31:1627–1635

123

While no level I evidence exists currently, expert consen-

sus and a large cohort of approximately 6000 cases without

BDI supports the widespread adoption of the CVS in order

to avoid major BDI in LC [13–15]. Additionally, case

selection, intraoperative bailout procedures, and adjunct

intraoperative imaging techniques are all important com-

ponents to safely performing cholecystectomy and are

considered the ‘‘Culture of Safety’’ where safety comes

before total cholecystectomy [12].

Although widely publicized, evidence exists that the

CVS is not widely adopted or completely understood. We

believe that many surgeons performing LC default to using

the infundibular approach for identification of the cystic

duct, as this method requires less dissection, is quicker to

achieve and is perceived as safe and adequate [24]. How-

ever, this approach is an ‘‘error trap’’ that is unreliable and

fails in the setting of biliary fusion and contraction due to

acute or chronic inflammation or altered anatomy. Thus,

the infundibular method should be completely abandoned,

and the CVS should be the approach to ductal identification

utilized in all cases of total cholecystectomy. Additionally,

when the CVS cannot be safely achieved, total cholecys-

tectomy should be abandoned and a bailout procedure

performed instead. In these difficult operative conditions,

liberal use of intraoperative imaging techniques (ultra-

sound, cholangiography, fluorescence), conversion to an

open operation, and/or utilization of subtotal cholecystec-

tomy should be considered [18].

We have conducted a single-institution prospective

study to assess general surgery residents’ proficiency and

level of improvement in utilizing the CVS technique,

scored using a 6-point scale previously published [12]. The

curriculum successfully showed significant improvement in

the CVS score from 2.31 to 4.32. Pre- and post-intervention

questionnaires also revealed significant improvement in

residents’ knowledge and self-assessed comfort in their

Fig. 4 Resident questionnaire

results of identifying A critical

view of safety (CVS) criteria

and B backup measures

Fig. 5 Post-intervention

resident questionnaire results

Surg Endosc (2017) 31:1627–1635 1633

123

own LC skills. The curriculum was popular among the

residents, as an overwhelming majority agreed that the

education intervention should be included in the future

general surgery curriculum.

This study revealed some interesting pre-intervention

observations. Primarily, it is clear that the majority of LC

performed pre-intervention at our institution did not ade-

quately achieve the CVS. Additionally, although discussed

frequently by some attending surgeons, only 41 % of res-

idents were able to identify the three criteria of the CVS.

Despite this, data from the self-reported questionnaire

reveal that residents’ perception of achieving the CVS and

certainty of anatomy was high pre-intervention. However,

25 % of cases in the pre-intervention group were deemed

‘‘unsafe’’ by two unbiased reviewers (defined as having

serious concern that major BDI could have conceivably

occurred). This distinction was felt necessary because there

are instances where anatomy was clear even if the CVS

criteria were not achieved fully. However, ‘‘unsafe’’ cases

clearly did not achieve the CVS and identification of

anatomy was not clear prior to clip placement. While these

data are worrisome, it is unclear if they reflect local culture

or, more likely we suspect, may reflect the trend in most

teaching hospitals in the USA.

While no major or minor BDI occurred during the study

period, CVS scores significantly improved, as well as

resident understanding of the criteria and other safety

measures during LC. Interestingly, operative time was

significantly longer by 30 min in the post-intervention

cases. It is unclear whether this is an effect of the additional

dissection required to achieve the CVS and/or the time

required to document a doublet photograph. Operative

length is a multifactorial measure that may be affected by

many variables that are not reflected in our data. If this

increase is attributable directly to achieving CVS, one

would suspect this difference in operative time will

decrease with increasing comfort and experience in

obtaining these criteria. However, further investigation will

be necessary.

The design of this project was meant not only as an

observational study to assess changes in resident technique

during LC, but also as an efficient educational tool to instill

the importance of the concept of CVS as a method of safely

approaching LC. The implementation of the study itself

increases the awareness of residents and attendings alike to

the definition of CVS. A safe and systematic way of

approaching LC is certainly needed for young surgical

trainees with limited experience in dealing with variations

in inflammation and anatomy [22–24]. Nevertheless,

approximately 50 % of surgeons report their first BDI after

their first 100 cases, suggesting the potential for enhance-

ment in practice even for experienced surgeons [17].

Countries such as the Netherlands have taken the lead in

successfully adopting the CVS technique into their routine

practice, with 97.6 % of surgeons consistently using the

technique during LC [25].

This study’s major limitations include the small sample

size of residents, the application at a single academic

center, the lack of long-term data, the inability to fully

blind reviewers to pre- and post-intervention groups, and

the use of self-reported questionnaires. Additionally, we

suspect there is some component of the Hawthorne effect

in a study conducted in this manner. Longer-term data are

necessary to study retention. However, the link between the

improvements in CVS score with this direct intervention is

clear. Equally as important as the direct education of the

residents, we believe surgeon ‘‘champions’’ are necessary

to instill the culture of ‘‘safety first, total cholecystectomy

second’’ in training surgeons.

Despite some limitations, this study demonstrates that

the use of focused education, implementation of a time-out

and photograph requirement, and availability of surgeon

champions can achieve a significant improvement in the

obtainment of the CVS during LC at an academic surgical

training institution.

Acknowledgments The authors would like to thank Christian de

Laszlo for his support and assistance in the technical acquisition of

data for this study. Additionally, we would like to thank the nursing

staff at the Thomas Jefferson University Hospitals for their continued

assistance in the excellent and safe care of our patients.

Funding Funding was received from Department of Surgery Pilot

Research Grant, Thomas Jefferson University.

Compliance with ethical standards

Disclosures The authors, specifically Ms. Chen, Doctors Doane,

Palazzo, Winter, Lavu, Chojnacki, Rosato, Yeo, and Pucci, have no

conflicts of interest or financial ties to disclose.

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