1. What problem were you addressing and why was it important?

● Which problem did you address?

● How did you know it was a problem?
● What data did you use?
● Who was it affecting?
● Why had it not been entered before?

Answer here – 200 words max

The major problem being addressed by our surgical team was the improvement of peri-operative care
and its design to enhance recovery and improve outcomes while maintain safety in patients
undergoing surgeries of the Liver, Pancreas and the Biliary Tract (HPB Surgeries).

The protocol in operation previously had an unacceptably high rate of hospitalization, cost-ineffective
model and an increased physiological stress response to surgery, in addition to other smaller
subjective issues arising out of these main ones.

The inherent complexity of HPB Surgeries mandated an increased risk issue to all patients undergoing
these surgeries, but the most affected patients were the working class population from rural regions
of India, due in part, to their poor educational status, an uninsured economic state and in some cases,
even superstition with regard to surgery which eventually leads to a far lesser advise compliance,
conversions and follow up rates.

From the perspective of any clinical team, the apprehension to adapt newer protocols is fairly
understood as it involves placing their patients on to an un- assessed risk and thereby increasing
morbidity and possibly, even mortality. This may have been a major contributor to the delay in
implementation of a more effective protocol.
2. What did you do to understand the scale of the problem?
● Before you initiated the project, how did you measure the scale of the problem?
● What were your baseline results?
● Ensure you explain what you measured and how you measured it

Answer here - 200 words max

Analysis of the hospital based patient data and protocol was done using the …………………. database.

A variety of factors involved in the peri-operative care of HPB patients were subject to change due to
the lack of objectivity in the previously used protocol.

Therefore, a more evidence based, clinically objective and a patient oriented protocol were composed
that consisted of pre-operative, intra-operative and post-operative factors included in order to
improve the care given in the best interest of the patients.

The basis of our new ‘ERAS-HPB Onco’ protocol was to effectively implement the measurable
variables in the protocol so as to avoid any untoward complication and/or unnecessary maneuver for
the patient/s and consisted of the following parameters:

Figure 1 demonstrates the differences between the traditional protocol that was being used and the new ERAS-HPB Onco Protocol

Figure 1

ERAS-HPB Onco Protocol Traditional Protocol

PRE-OPERATIVE FACTORS

 Education

 Counseling time

 Nutritional optimization
 INTRA-OPERATIVE FACTORS

 Anesthetic regime

 Steroid use

 Fluid Management

 Drains

POST-OPERATIVE FACTORS

 Analgesia

 Early Mobilization

 Oral Intake

 Fluid management

 Ready for Discharge Criteria

3. What did you do?

 ● What was your intervention?
● How did you engage key stakeholders, including patients, both in identifying the problem and
designing the solution?
● Did you consult more widely?
● What was the setting (primary, secondary or community;urban or rural)?
● Who were the subjects of the intervention, and how many were there?
● When did the intervention occur (dates)?
● When the evaluation was performed (dates)?

Answer here - 200 words max

The answer to the challenge posed to us from the patient care perspective was the composition of a
modified, objective, clinically applicable protocol in the best interest of the patient. These patients
were undergoing or had undergone procedures involving the liver, pancreas and/or the biliary tract.

The family of the patient was directly involved in the decision making as well as the management
interests of the patient. Starting from the pre-operative counseling to the ready for discharge criteria
we made sure to actively involve at least two family members one of whom was a male attender.

A well informed and trained critical care team plan was in place to help us effectively execute the new
ERAS-HPB Onco Protocol peri-operatively and was constantly active in management of all HPB
patients before, during and after the surgery.

A fundamental shift in the traditional approach was attempted and a multidisciplinary approach was
being collectively identified and included in the new protocol. Various specialists like the hepatologist,
medical oncologists, radiation oncologists, physiotherapists and nutritionists were involved in the
designing of ERAS-HPB Onco Protocol and were based on the most relevant factors in improving
outcomes in these patients.

The setting was a semi-urban tertiary care Centre with a holistic multimodality infrastructure to
support complex procedures and surgeries including multi-organ transplants. The pilot intervention
was performed in about 20 patients and this intervention included patients diagnosed with
malignancies of the liver, pancreas and the biliary tract to measure the determinants for the main
project most effectively. This preliminary pilot study was designed for duration of 2 months
(November 03 – December 30, 2018), following which the evaluation of the same took place in the
first fortnight of January 02 – January 14, 2019 and a collective decision was taken to begin the main
project by the end of January 2019 and termed it ‘ERAS-HPB Onco Protocol’. This protocol would be
implemented in about three centers in our state and would primarily target the unmet needs of HPB
Surgical patients.
4. What impact did your project have?
● Your results should include measurable variables and outcomes important to patients,
populations or healthcare staff.
● Ensure you explain what you measured and how you measured it
● Variables should have been measured before and after your intervention, as we are interested in
the size of benefit. If you have any tables or figures, you can upload these as supplementary
material but please refer to them and any key points from them within your written answer

Answer here - 200 words max

The primary aim of this project was to standardize the point of care for HPB Surgical patients and to
enable that, we had to select and compose variables that were objective, measurable and most
importantly, result oriented to directly impact the end outcome in each patient.

Figure 2
Traditional Protocol Pilot Phase of ERAS-HPB ERAS-HPB Onco Protocol
Onco Protocol (2019)

Complete Recovery 24 to 40 days 16 to 20 days 14 to 20 days

Hospitalisation 8 to 14 days 6 to 10 days 4 to 10 days

Adverse Effects 32% - Mild complications 21% - Mild complications 20% - Mild complications

02%- Intervention required 00% - Intervention required 00% - Intervention required

Quality of patient care Defined Maintained Maintained

Safety of the patient Defined Maintained Maintained

Need for Medication 22 days post - op 16 days post - op 16 days post - op

Follow up 6 months 6 months 6 months

The results we obtained initially were far better than the traditional mode of management protocol and
this gave us confidence to continue improving patient care and take small steps, one at a time, to
significantly impact end outcomes in HPB Oncology.

5. What lessons have you learnt?

● What feedback - positive and negative did you receive from patients, populations and staff?
 ● What challenges did you face and how did you overcome them?
● If you repeated the project what would you do differently?
● Has your intervention now become routine practice?
● If so will it be sustainable in the long term?
● Are your results generalizable beyond your own project?

Answer here - 200 words max

The feedback obtained from our previous patients who had undergone the traditional management
protocol as well as the patients enrolled on to the pilot intervention of our new ERAS-HPB Onco Protocol
were our primary source of feedback. The results obtained via patient feedback were overwhelmingly
helpful and positive in terms of the aforementioned advantages of recovery, economization and overall
impact on outcomes.

The downside of our project is that we have kept the surgeon-doctor-caregiver related factors out of our
management protocol and have not taken into account the iatrogenic and procedure related variables in
the final product. Although a little early in this project, we aim to incorporate such variables over time,
while maintaining objectivity and evidence basis only for the benefit and improvement in the outcomes
of our patients.

The ERAS-HPB Onco Protocol that we initiated has now become routine in our secondary centers as
well, in addition to our parent hospital located in the city of Bangalore in India. This has been since 15
months now and the study has been designed for a period of 24 months (currently on-going project).

The impact so far seems to be very positively reassuring and we shall continue to study and necessitate
changes in the best interest of the patient. Thus, demonstrating a positive result toward the long term
sustainability of this project. We, as a team, are also confident and positive about the long term
sustainability of this protocol, provided we are ready to modify / change variables as demonstrated by
patient’s peri-operative care requirements.

Such an attitude among surgeons will yield an extremely generalizable and clinically applicable concept
over long term and provide a wider scope of practice for the entire surgical fraternity. Although
applicable in most centers, the best results will be obtained in high volume centers such as ours and an
attitude in considerably updating our approach to the needful practices.

6. Did your project offer value for money?

 ● Please tell us more about the costs and savings involved.
● For costs, we'd like ballpark figures that include staff salaries, equipment and facilities

Answer here - 200 words max

As we are a multi-specialty oncology Centre, catering to all malignancies and including all modes of
treatments including medical, radiotherapy and surgical forms, the hospital staff usually overlaps in the
clerical and clinical departments. Figurative assessment of every single monetary factor involved
becomes very difficult.

Although, as a separate specialty in HPB Oncology, these are the overall approximate figures needed to
support the department, annually.

INR – 70, 00,000/-

USD – 1, 00,000/-

GBP – 78,000/-

As far the patient costs are involved, there has been a drop of over 30% in the expenditure borne by the
patient’s side after implementation of the ERAS-HPB Protocol at our Centre. This has been attributed to
a variety of factors including shorter duration of hospitalization, lesser stay in the ICU, decreased need
for opioid based analgesics as well as medications in general, optimized patients undergoing surgery and
therefore decreased need for post-operative colloid infusions and optimizing solutions and better fluid
management.

Figure 3, explaining the differences in cost-effectiveness of ERAS-HPB Onco Protocol over the Traditional Protocol.

Figure 3
Objective Parameter ERAS-HPB Onco Protocol Traditional Protocol

3 days
ICU Stay 1 day

6 days
Ward Stay 4 days

Fluids
Intra-op medication Fluids Induction and maintenance
Induction and maintenance anesthetics anesthetics
Steroids

Antibiotics
Post-op medication Antibiotics Opioid Analgesia
Non-opioid analgesics Fluids
Fluids

5 days
Drains and Tubes 3 days

Every Day
Need for wound cleaning and dressings Every Day

8 – 10 days
Doctors, Nursing and allied care charges For 5 – 6 days

No change
Follow up costs No change

7. was your project innovative and original?

● Did your intervention offer a new approach, or was it an existing known intervention applied in a
new setting?
● Did it offer any other new benefits, such as improving safety or reducing costs?

Answer here - 200 words max

ERAS, in general, is a concept that heralded in healthcare settings across the first world countries about
a decade ago, in various surgical specialties. But HPB Surgery remained alienated from this concept for a
long time, even in this current era of evidence based surgery, in most regional centers in countries of
South Asia and Africa.

This could have been due to the fact that the risks involved the changing current regimes, even if it
involves modifications only, are extremely high. The clinical repercussions are often difficult to manage
and the consequentiality is most often, a probable increase in mortality and a definite increase in
morbidity. Adding to that, we are probably in an improving state of infrastructure in south Asian
countries, unlike fully operational quaternary healthcare centers of the west.

Therefore, the delayed implementation cannot be attributed to a single factor out there. Multivariable
processes like patient compliance, lack of infrastructure, inadequate training in super-specialty surgery
and a poor economic state of our government and majority of our patients, etc are involved in the
challenges poised to us as a surgical team from India.

Thereby, a generally acceptable and applicable ERAS-HPB Onco Protocol is a modification of the existing
broader concept of ERAS in other surgical specialties.

It is a regime that has added value to the patient in terms of recovery, economy and end outcome. It
has also benefitted patients and the insurers in cost effective management of complex and expensive
HPB Surgeries. We have also noticed a pattern of reduced uncertainty, ambiguity and procrastination
among our patients with the new ERAS-HPB Onco Protocol. Most importantly, it gives surgical teams
involved, the confidence to fundamentally shift approaches from conventional management to state of
the art healthcare.

8. Did you co-produce your project with patients?

● To what extent did your project exemplify the principles of patient partnership and co-production?
● Was the problem your project identified originally highlighted by patients?
● Did you collaborate with patients when designing your project?
● How did you know that the outcomes you measured when evaluating your project were ones
which mattered to patients?
● In what ways did your project change and improve as a result of patient involvement and
feedback?

Answer here - 200 words max

Patient partnership is the epicenter of evidence based surgery and so is for ERAS-HPB Onco Protocol.
The problems were identified by the surgical teams with the help of honest patient feedback, the
change in protocol was explained to all our patients and a fully informed consent was obtained, an
agreement to make the process as cost-effective as possible was settled upon prior to the management
of the malignancy and an active involvement in the designing of the program was sought from patients
and their families (where necessary). This, in combination with the efforts from our paramedical staff to
co-operate with us in carrying out this project is an example of co-production between healthcare teams
and patient families.

Patient involvement made us approach the issues from the other end of the stick and fine tune the
protocol, thus making it far more patient oriented than any other existing peri-operative management
protocol. If this project was the result of a one sided ambitious surgical team, catering to a variety of
clinical problems subject to the specificity of each patient, it would be impossible to obtain results we
have, so far. Therefore, ERAS-HPB Onco Protocol will remain a combined surgeon-patient co-produced
and co-operative project in the best interest of patients undergoing HPB Surgeries.

9. Conflicts of interest
Are there any relevant conflicts of interest (COI) that the judges would expect to be made aware? (NB:
shortlisted candidates will be asked for a more detailed COI declaration)

Yes/No