ICU-related Out of Pocket Expenses (ICOPE) - A Multinational Prospective Study In African And Asian Countries.
Conditions: Cost of ICU, Out of Pocket Expenses
Sponsor: Nat Intensive Care Surveillance - MORU

ICOPE study protocol version 1.0
RESEARCH PROTOCOL
ICU-related Out of Pocket Expenses (ICOPE) – a
multinational prospective study in African and
Asian countries
Short title
Out of Pocket Expenses in Asian and African ICUs
Version
1.0 - September 8th, 2023
OxTREC reference number
554-23
Steering Committee
Luigi Pisani, Mahidol Oxford Research Unit, Bangkok, Thailand*
Bharath K.T. Vijayaraghavan, Department of Critical Care Medicine, Apollo Hospitals, Chennai,
India*
Diptesh Aryal, Nepal Mediciti, Nepal
Wangari Waweru Siika, Aga Khan University, Nairobi, Kenya
Rashan Haniffa, Mahidol Oxford Research Unit, Bangkok, Thailand*
Maryam Shamal, Afghanistan team, NICS-MORU collaboration, Kabul, Afghanistan
Aniruddha Ghose, Chattogram Medical Centre, Chattogram, Bangladesh
Swagata Tripathy, Department of Anaesthesia & Critical Care, All India Institute of Medical*
Sciences, Bhubaneswar, India
Madiha Hashmi, Department of Critical Care, Ziauddin University, Karachi, Pakistan
Basri Nor, Department of Anaesthesiology and Intensive Care, Kulliyyah (School) of Medicine,
International Islamic University Malaysia (IIUM)
Yen Lam Minh, Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam
Hem Paneru, Department of Critical Care Medicine, Tribhuvan University Teaching Hospital,
Kathmandu, Nepal
Arishay Hussaini, Department of Critical Care, Ziauddin University, Karachi, Pakistan
Louise Thwaites, Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam*
Thuong Nguyen Thuy, Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam
Sutharshan Vengadasalam, Department of Surgery, Jaffna Teaching Hospital, Jaffna, Sri Lanka.
Iqbal Hussain, Pakistan Registry of Intensive Care (PRICE)
John Amuasi, Kumasi Center for Collaborative Research In Trop. Med., Ghana
Thomson David, University of Cape Town, Cape Town, South Africa
Adam Hewitt Smith, Mbale Hospital, Mbale, Uganda
Cornelius Sendagire, Makerere University College of Health Sciences, Kampala, Uganda
Arthur Kwizera, Makerere University College of Health Sciences, Kampala, Uganda
Abi Beane, CIR, University of Edinburgh, Scotland & Mahidol Oxford Research Unit, Bangkok,
Thailand*
Ronnie Kaddu, Aga Khan Hospital, Mombasa, Kenya*
Jorge Salluh, D’Or Insitute (IDOR), Rio de janeiro, Brazil
Itimayee Panda, Indian Registry of IntenSive care, IRIS, Chennai, India & All India Institute of
Medical Sciences, Bhubaneswar, India
Arjen Dondorp, Mahidol Oxford Research Unit, Bangkok, Thailand*
Statisticians
Mavuto Mukaka, Mahidol Oxford Research Unit, Bangkok, Thailand*
Atanu Bhattacharjee, Mahidol Oxford Research Unit, Bangkok, Thailand*
Health Economists
Abdur Sarker, Mahidol Oxford Research Unit, Bangkok, Thailand*
Yoel Lubell, Mahidol Oxford Research Unit, Bangkok, Thailand*
Hung Trinh Manh, Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam*
* Members of Protocol Writing group.
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ICOPE study protocol version 1.0
TABLE OF CONTENTS
1. STUDY SUMMARY
3
2. BACKGROUND AND JUSTIFICATION
4
3. STUDY AIMS AND HYPOTHESIS
6
3.1 Aims
6
3.2 Hypothesis
6
4. METHODS
6
4.1 Study design and duration
6
4.2 Population
6
4.3 Sample size calculation
6
4.4 Study parameters/endpoints
7
4.5 Study procedures
7
4.6 Data to be collected
7
4.7 CRF testing and refining
9
4.8 Statistical analysis
9
5. DATA MANAGEMENT
10
6. PROJECT MANAGEMENT
10
7. ETHICS AND INFORMED CONSENT
11
7.1 Regulation statement
11
7.2 Recruitment and consent
11
7.3 Benefits and risks assessment
11
8. FUNDING
11
9. REFERENCES
11
10. APPENDIX
13
LIST OF ABBREVIATIONS
ICU, intensive care unit
OOPE, out of pocket expenses
CHE, catastrophic health expenditure
LMIC, low and middle income country
ACCCOS, African COVID-19 Critical Care Outcomes study
CRF, case report form
ICF, informed consent form
PIS, patient information sheet
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ICOPE study protocol version 1.0
1. STUDY SUMMARY
Title
ICU-related
Out
of
Pocket
Expenses
(ICOPE)
–
a
multinational
prospective study in African and Asian countries
Sponsor
Mahidol Oxford Tropical Research Unit
Collaboration for Research, Implementation and Training in Critical Care
in Asia and Africa (CCAA)
Funder
Wellcome
Trial design
Prospective observational study
Trial
Participants
All patients admitted to the participating ICUs during a predefined window
of 14 days and expected to have a duration of stay >24 hours. Exclusion
criteria is lack of informed consent.
Sample size
at least 354 patients (at least 212 non-ventilated & 142 ventilated
patients)
Planned study
period
Recruitment during 14 days
Follow up until ICU discharge for each recruited patient, at 30 days after
admission and 6 months after admission.
Total study duration: 18 months
Planned
recruitment
period
From 01 Dec 2023 to 30 June 2024
Objectives
Endpoints
Timepoint(s) of
evaluation
Primary
objective
To quantify ICU care
related OOPE in African
and Asian LMICs and
the proportion of
patients/families facing
CHE, comparing patients
receiving invasive
ventilation to
non-ventilated patients.
1.Costs per complete patient
episode, as actually spent in
US dollars and International
dollars (purchasing power
parity exchange rate) in
ventilated versus
non-ventilated groups.
2.Relative risk of CHE in
ventilated versus
non-ventilated groups.
During ICU
stay, average
1 week
Secondary
objectives
To identify risk factors for
CHE.
Risk factors for CHE
Not applicable
To identify coping
strategies for OOPE and
CHE
Frequency of different coping
strategies for financial
coverage of ICU costs
During ICU
stay and follow
up, 6 months
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2. BACKGROUND AND JUSTIFICATION
2.1
Increasing availability and access to ICU care in LMICs
Availability and utilization of intensive care unit (ICU)-level care is increasing in low and
middle income countries (LMICs). In parallel, there is a rise in the financial burden for service
providers, but also for patients and their families. Even in LMIC healthcare systems which
offer government funded healthcare, ICU is associated with considerable costs which impact
patients’ households. As such, stakeholders seeking to expand access to health services
must consider the financial burden associated with critical care becoming routinely available.
In fact, increasing health coverage is paradoxically associated with worsening out of pocket
expenses.1 Achieving universal health coverage, including financial risk protection, is a target
of the 3rd Sustainable Development Goal.2,3 Critical care relates both to acute conditions
(injury, trauma, infection, etc.) and chronic diseases. Return on investment for these
conditions may be different leading to cost-effectiveness considerations.
2.2
ICU costs
ICU admission is often unexpected, the treatment and interventions needed are usually
unpredictable and length of stay frequently prolonged. In fact, a single ICU admission can
cost from few hundreds to more than one hundred thousand US dollars.4 Thus ICU care
often results in spiraling costs, which if not absorbed by welfare or insurance systems,
directly fall on the patient and family. Costs can be classified as direct and indirect costs, with
direct cost further divided in ‘medical’ and ‘non-medical’ domains. Direct medical costs
include any daily fixed costs for the ICU bed, consumables (eg. medications, laboratory tests,
nutrition, fluids, bandaging, ventilation circuits) which often fall at the pocket of patients and
families. Studies assessing ICU direct costs are available from LMICs such as Brazil,
Thailand,
Vietnam
and
India.5–8 Direct non-medical costs include transportation and
accommodation. In addition, indirect costs arise such as loss of income for patients,
especially ones employed without sick leave cover. For families and caregivers, income loss
and productivity loss are associated with time spent being at the hospital with their relatives.
2.3
Out of pocket and catastrophic health expenditure
ICU care in LMICs is mostly funded by a mixed system of public welfare, insurance coverage
and out of pocket expenditure (OOPE). Insurance penetration and government support
remains low in most LMICs. OOPE in healthcare is defined as any direct outlay by
households, including gratuities and in-kind payments, where the primary intent is to
contribute to the restoration or enhancement of an individual's health. OOPE can include
direct medical and direct non-medical costs, but does not include pre-paid fees for
health-related taxes or insurance.2 OOPEs constitute around 60% of total health expenditure
in India9 and 67% in Bangladesh.10 Yet, while some data is available on cost burden of
specific conditions such as chronic liver failure11 or organophosphorus poisoning,12 data on
ICU-related OOPE in LMICs remains extremely scarce.
ICU-related OOPEs may rapidly lead to household debt and for some families, cross
the threshold into catastrophic health expenditure (CHE).13,14 The incidence of catastrophic
spending on health is reported on the basis of out-of-pocket expenditures exceeding
conventional thresholds of 10% or 25% of household total annual income.15 CHE thus refers
to any expenditure for medical treatment that can pose a threat towards a household’s
financial ability to maintain its subsistence needs.3 Across countries, the mean incidence of
catastrophic out-of-pocket payments at (considering the 10% threshold) is 9.2%.15 This
incidence was already increasing before the COVID-19 pandemic, with more than one in ten
care episodes resulting in catastrophic spending in South Asia in 2010.16,17 At the global level
in 2010 some 808 million people incurred CHE, with a great concentration in Asia and Africa.
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ICOPE study protocol version 1.0
CHE calculation allows to capture financial tensions in households that arise when
OOPEs are compensated by selling or mortgaging households assets, borrowing money
from lenders, banks, black market, friends or relatives during ICU care. Forty-seven percent
of patients with septic shock incurred CHE in a Vietnam hospital, against 13% of patients
admitted with dengue shock.5 In an Indian neonatal ICU, 56% of families incurred CHE, with
one out of five families spending more on a single neonatal ICU admission than their monthly
income.18
2.4
Risk factors and coping mechanisms for OOPE and CHE
Coping mechanisms for critical care-related OOPE have been inadequately investigated and
are largely unknown for adult ICU patients admitted to LMICs hospitals. Many studies focus
on non-ICU populations, limit their scope to direct medical costs or are performed in
high-income countries. A study on 3100 households in Dhaka, found that marital status,
religion, source of care, access to safe water, income quintile and even the location of
households had a significant relationship with OOPE.10 In a study from Thailand performed
on 897 ICU patients with severe sepsis or septic shock, age, nosocomial or ICU infection,
admission from the emergency department, number of organ failures, ICU length of stay, and
fluid balance the first 72 hours were independently associated with ICU costs, although
OOPE were not analyzed.19 Mechanical ventilation was found to be a factor increasing
OOPEs in LMICs for pediatric20 patients and total ICU costs in adult patients.4,19 Yet, the
influence of the initiation of invasive ventilation on CHE remains to be described.
2.5
Impact of costs on ICU care
Financial costs are a barrier to both access and continuation of critical care. In a survey of
1465 ICU physicians from 466 ICUs in 16 Asian countries, those from LMICs (notably China,
the Philippines, and Bangladesh) reported as more likely to accede to families’ requests to
withdraw life sustaining treatments in a patient with an otherwise reasonable chance of
survival, so as to avoid further medical bills, than those from high-income economies.18 The
large ACCCOS study on COVID-19 ICU African patients reported 9% of treatment limitation
with 3% of withdrawal of therapy, although it was not assessed whether the limitation was
influenced by financial motives.21 A study in India suggested up to 9% of discharge against
medical advice patients are due to financial constraints.22
2.6
The knowledge gap
In LMICs, where ICU care is increasingly available with limited financial risk protection, there
remains limited robust quantitative data linked to OOPEs. Particularly, the actual burden that
critical illness has on direct and indirect costs to the patients and their families is unknown.
While some data on direct costs is starting to be available,5–8 there is limited insight into the
magnitude of OOPEs and rates of CHE. We also lack robust data on risk factors for CHE due
to ICU admissions and coping mechanisms in terms of sources of funding for patient families.
Organ support, and especially mechanical ventilation that affects almost one out of two
patients in the ICU, may be a key driver of OOPEs and CHE rates.
2.7
The present project
This study seeks to to precisely quantify ICU care related OOPEs in several LMICs in both
the private and public sector. Context-specific drivers of OOPEs and CHE rates will also be
established, while defining coping mechanisms and sources of funding. The impact of organ
support, especially invasive mechanical ventilation, will be analyzed as a key potential driver
of CHE.
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ICOPE study protocol version 1.0
3. STUDY AIMS AND HYPOTHESIS
3.1 Aims
The OOPE study has the following aims:
1.
To quantify ICU care related OOPE in African and Asian LMICs and the proportion of
patients/families facing CHE, comparing patients receiving invasive ventilation to
non-ventilated patients.
2.
To identify risk factors for CHE.
3.
To identify coping strategies for OOPE and CHE
3.2 Hypothesis
The following exploratory hypothesis are formulated:
-
Mechanical ventilation has a doubling effect on CHE incidence.
-
The risk of CHE and magnitude of OOPE can be predicted by distinct patient-,
disease-, household- and organizational-related factors.
-
Distress financing by borrowing from family members is the most frequent coping
mechanism both in Asia and Africa.
4. METHODS
4.1 Study design and duration
Observational prospective cohort study.
The recruitment period for each site will be consecutive 14-30 days, based on site feasibility.
Daily follow up until death or ICU discharge.
4.2 Population
All patients admitted to the participating ICUs during a predefined window of 14 days and
expected to have a duration of stay >24 hours will be eligible for the study. Exclusion criteria
is lack of informed consent. For unconscious or unwell patients the primary caregiver will be
approached to answer the interview questions.
4.3 Sample size calculation
Anticipating the following assumptions:
-
an expected proportion of ventilated patients of 40% in the study cohort, derived from
the aggregate proportion of ventilated patients across CCAA registries in 6 Asian
countries (64327 patients across Pakistan, India, Nepal, Malaysia, Vietnam and
Bangladesh – of 40.4% and the proportion of ventilated patients in Kenya in 2021-22
(47%, unpublished data).
-
expected CHE incidence among ventilated patients of 30%
-
expected CHE incidence among non-ventilated patients of 15% (i.e. relative risk of
CHE of 0.50)
A sample size of at least 307 patients (at least 184 non ventilated and at least 123 ventilated
patients) is needed to verify the expected difference in CHE incidence. Considering a 15%
loss to follow-up or incomplete patient episodes, we intend to recruit a total of at least 354
patients (at least 212 non-ventilated and at least 142 ventilated patients). Assuming each
ICU will recruit an average of 12 patients, we seek to enroll at least 30 ICUs in the study,
from at least 5 different countries.
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ICOPE study protocol version 1.0
4.4 Study parameters/endpoints
Primary endpoints:
-
Costs per complete patient episode, as actually spent in US dollars and International
dollars (purchasing power parity exchange rate) in ventilated versus non-ventilated
groups.
-
Relative risk of CHE in ventilated versus non-ventilated groups.
Secondary endpoints:
-
Risk factors for CHE (presumptive list in section 4.6)
-
Frequency of different coping strategies for financial coverage of ICU costs
Tertiary endpoints
-
Proportion of direct medical versus direct non-medical costs in the total OOPEs
-
Patient family socio-economic status (SES) or income
-
Paying structures, models by country.
4.5 Study procedures
Screening
Initial screening of study participants will be done by the research assistant on patients
admitted to the ICU. Expectation of a length of stay >24 hours will be discussed with the
treating team. If a patient fulfills inclusion criteria the research assistant will perform the
consenting procedure with the patient or with the primary caregiver in case the patient is
unconscious or unwell. After informed written consent is obtained from the patient or primary
caregiver, the patient will be recruited in ICOPE.
Recruitment
Once eligibility is confirmed, the study will be explained to the patient or their primary
caregiver. The research assistant will then conduct the consent procedure, which involves
providing information about the study through the participant information sheet and obtaining
written informed consent. Any reasons for exclusion, such as refusal to provide informed
consent, will be recorded in the 'Screening and Enrolment Log'. After obtaining consent, the
patient will be enrolled in the study.
Informed Consent
The participant or legally authorized person or primary caregiver must personally sign and
date the latest approved version of the Informed Consent Form (ICF) before any study
interview is performed. A written version of the Participant Information Sheet (PIS) and ICF
will be presented and verbally explained to the patients, legal guardian or primary caregiver.
Written Informed Consent will be obtained by means of participants (or witness if illiterate)
dated
signature
(or
thumb
print
plus
dated
signature
of
literate
witness
if
legal
guardian/primary caregiver unable to write) and a dated signature of the person who
presented and obtained the Informed Consent. A copy of the signed Informed Consent will
be given to the participant.
4.6 Data to be collected
CRF structure and timeline is detailed in Table 1 and comprises sequential domains from A
to F. Daily follow up will run until ICU discharge or death, whichever occurs first. An additional
telephone follow up at 30 days and 6 months will be used in survivors.
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Table 1. CRF structure and timepoints for data collection
ICU
Admission
day
Daily
(max
every 72h)
ICU
Discha
rge
30
days
6
months
Responder
A Socioeconomic status
and admission costs
X
Patient or
caregiver
B Relative Wealth tool
X
C Costs form
X
X
D Discharge form
X
E Follow up form
☎
☎
Patient or
caregiver
(telephone)
F Clinical registry
Admission form (core)
Daily processes of care
Discharge (core)
X
X
X
Extracted
from patient
file
*In some instances daily followup may not be feasible due to unavailability of family members or
unwillingness to discuss the study. Therefore a maximum interval of 72h is granted between two daily
forms.
#A. Socioeconomic status and admission costs
Absolute household estimated yearly and monthly income will be collected in order to
calculate CHE. Household consumption expenditure (food and non-food expenditure) will
also be collected in order to minimize recall bias and potential missing income data. This
information on expenditure will be used as a proxy of income, in cases where the income
information is missing.
The following potential risk factors for CHE will be investigated: household income
status, patient occupation; marital status; religion; access to safe water; educational status;
ownership and location of households (urban vs. rural vs. slum); female-headed households;
household size and age/gender of members; geographical location.10
#B. Relative wealth
Relative wealth will be quantified using the Equity tool (www.equitytool.org), consisting of a
short survey of 11-12 questions allowing to compare the wealth of the respondents to the
national or urban population in over 60 countries.
#C. Costs form
Granularity on direct medical and non-medical costs will be sought. Family members
(supported by research assistants) will be asked to provide information about expenditure on
each visit to ICU. The data collection will ideally be daily, but time window is extended to
maximum every 72h as we acknowledge several barriers to daily collection e.g. family
members may not visit each day, the research assistant may face conflictual family meetings
and some family members assisting a severe kin may not be comfortable with a daily visit.
The form will be administered until patient discharge from ICU or death, whichever occurs
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ICOPE study protocol version 1.0
first. Direct medical and direct non-medical costs categories and operational definitions are
defined in Appendix 1.
#D. Discharge form
The discharge form will comprise ICU and hospital discharge outcome and the MRC and
EQ5D-3L functional outcome status. The EQ5D-3L is validated to monitor changes in
self-reported health status through time in a given patient group.23
#E. Follow up form
The follow-up form to be collected by telephone outreach will contain the vital status,
EQ5D-3L functional outcome status. The telephone version of EQ5D-3L will be used.24
#F. Registry variables
Patient characteristics, severity of illness, case-mix information and outcomes will be
captured using the existing Critical Care Asia Africa (CCAA) network core registry data set.
This dataset contains the following features on admission: demographics information, reason
of admission, severity score on admission (eTROPICs and/or SOFA and/or APACHE II) and
comorbidities. Clinical data points collected daily include variables used for the derivation of
process-measures, organ support features and quality indicators. The following data will be
collected:
-
ventilation status and execution of spontaneous breathing trials;
-
sedation status;
-
use of renal replacement therapy;
-
use of cardiovascular support such as vasopressors or inotropes;
-
use of deep venous thrombosis prophylaxis and stress ulcer prophylaxis;
-
infection and antimicrobial treatment status i.e. documented infections and number of
antibiotics received during stay.
4.7 CRF testing and refining
The case report forms (including expenditure categories) were reviewed by a stakeholder
group with representation from participating registries. The stakeholders were asked to
contextualize the categories with examples relevant for their healthcare setting and to agree
on operational definitions for spending as described above, including relevant source data
documents. Expenditure will be recorded in local currency and then converted to USD using
a single time point exchange rate (xe converter, xe.com).
4.8 Statistical analysis
Normally distributed continuous variables will be summarized using means and standard
deviations while ordinal variables and skewed continuous data will be expressed as median
with interquartile range. For categorical variables, percentages will be calculated and tests of
significance between categorical variables will be done using a Fisher’s exact or a
Chi-square test as appropriate. Student’s t-test will be used to compare normally distributed
numerical variables between factors and a linear regression model will be fitted where
applicable. Mann Whitney U-tests and Kruskal-Wallis tests will be used to compare numerical
variables when normality cannot be assumed.
Analysis of the primary endpoint
a.
Quantification of ICU OOPEs
The primary endpoint will be summarized by reporting overall income group quintiles.
Information on direct medical costs, including ICU bed charges, laboratory costs, medication
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ICOPE study protocol version 1.0
costs, procedure costs, consumables, medical nutrition, and other related costs will be
obtained and summarized.
b.
Calculation of CHE
The best method for CHE calculation for single patient episodes is debated in the literature.
For the purpose of this study ICU episodes causing CHE will be defined as the calculated
total episode OOPE divided by total yearly household income exceeding 10%.2
Other applicable definitions that are justified in literature will also be considered and clearly
documented in the Statistical Analysis Plan prior to statistical analysis.
c.
CHE Sensitivity analysis
The primary analysis regarding CHE will be repeated using a variety of other considerations
as a form of sensitivity analysis. These sensitivity analyses will be clearly outlined in the
Statistical Analysis Plan prior to database lock and statistical analysis.
Analysis of risk factors for CHE
We will use mixed effects logistic regression models to investigate the relationship between
risk factors and CHE. The multivariable mixed effects logistic regression model will then be
used to simultaneously estimate the effects of multiple explanatory variables on CHE while
controlling for the effects of other covariates. The mixed-effects models will help to account
for clustering of the patient level, ICU level and country level data. Tests of significance will
be performed at 5 % significance level. Where appropriate, the 95% confidence intervals will
be calculated and reported. A detailed Statistical Analysis Plan will be developed for the
primary and the secondary outcomes. The Statistical Analysis Plan will be finalized and
signed by key investigators after database lock prior to statistical analyses.
5. DATA MANAGEMENT
5.1 Data management
All patients will be identified with a unique study identification code. A logbook with the
matching between patient number and name will be stored in the study site. The logbook will
be the only document containing patient identifier information. Data will be stored an
additional 10 years after the study’s completion.
5.2 Data capture
Data will be collected from patients or caregivers interviews, or from the patient's medical
chart and transcribed onto an Internet–based electronic CRF. Access to the data–entry
system is protected by a personalized username and password. Patients are identified with a
study identification code.
5.3 Data sharing
After publication of the primary results, on request a FAIR-compliant pooled dataset will be
available for secondary analysis, after judgment and approval of scientific quality and validity
of the proposed analysis by the CCAA Data Access Committee (email: dac@nicslk.com).
6. PROJECT MANAGEMENT
6.1 Dissemination of results and publication policy
The results of this study will be published in a peer–reviewed medical journal. We have no
restrictions in publication of outcomes of this study.
6.2 Timeline of project
Ethical Clearance: Sep 23 - Nov 23
Data Collection period: Dec 23 - Jun 24
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ICOPE study protocol version 1.0
Data analysis: Jun 24- Aug 24
Preliminary results: Sep 24
Final report: Dec 24
7. ETHICS AND INFORMED CONSENT
7.1 Regulation statement
This study will be conducted according to the principles of the Declaration of Helsinki
(revision Fortaleza, Brazil, October 2013). Approval to carry out this study will be sought from
the relevant National and local Ethical Review Boards, as mandated by the country
legislation. Ethical review will be requested from the Oxford Tropical Research Ethics
Committee (OxTREC) and from relevant National Ethics bodies and Institutional review
boards, as mandated by national and site regulations.
7.2 Recruitment and consent
Family members and primary caregivers will be invited to participate in the study and written
consent obtained. If eligibility is confirmed, the study will be explained to the patient or patient
relative/legal guardian, including detailed explanation of the participant information sheet and
informed consent form.
7.3 Benefits and risks assessment
The participation in this observational study will not bring direct benefits to the patient or
family. However the findings of the OOPE study will provide important information for
policymakers on the burden of OOPE/CHE and potential solutions. No safety concerns are
envisaged for this observational study based on information collected from patients or
caregivers, with no influence on patient treatment or procedures.
8. FUNDING
The
study
will
be
supported
by
the Wellcome award, Collaboration for Research,
Implementation
and
Training
in
Critical
Care
in
Asia
and
Africa
(Grant
number:
224048/Z/21/Z).
9. REFERENCES
1 World Health Organization, World Bank. Tracking Universal Health Coverage 2021 Global
Monitoring report. 2021.
2 Headley J, Swanson K, Baumgartner JN. Measuring Household Out-of-Pocket Health
Expenditure Considerations for Healthcare Social Enterprises and Organizations in Low-
and Middle-Income Countries. 2016.
3 World Health Organization. Monitoring Sustainable Development Goals – Indicator 3.8.2.
www.who.int. https://www.who.int/health_financing/topics/financial-protection/
monitoring-sdg/en/.
4 Karabatsou D, Tsironi M, Tsigou E, Boutzouka E, Katsoulas T, Baltopoulos G. Variable
cost of ICU care, a micro-costing analysis. Intensive Crit Care Nurs 2016; 35: 66–73.
5 McBride A, Thuy Duong B, Chau Nguyen VV, Thwaites CL, Turner HC, Hao Nguyen V.
Catastrophic health care expenditure due to septic shock and dengue shock in Vietnam.
Trans R Soc Trop Med Hyg 2019; 113: 649–51.
6 Sogayar AMC, Machado FR, Rea-Neto A, et al. A multicentre, prospective study to
evaluate costs of septic patients in Brazilian intensive care units. PharmacoEconomics
2008; 26: 425–34.
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7 Chatmongkolchart S, Chittawatanarat K, Akaraborworn O, Kitsiripant C. Cost of Critically
Ill Surgical Patients in Thailand: A Prospective Analysis of a Multicenter THAI-SICU Study.
J Med Assoc Thail Chotmaihet Thangphaet 2016; 99 Suppl 6: S31–7.
8 Kulkarni AP, Divatia JV. A prospective audit of costs of intensive care in cancer patients in
India. Indian J Crit Care Med Peer-Rev Off Publ Indian Soc Crit Care Med 2013; 17:
292–7.
9 National Health Systems Resource Centre. National Heath Accounts Estimates for India
(2014-15). Ministry of Health and Family Welfare, 2017.
10Sarker AR, Ali SMZ, Ahmed M, Chowdhury SMZI, Ali N. Out-of-pocket payment for
healthcare among urban citizens in Dhaka, Bangladesh. PloS One 2022; 17: e0262900.
11 Prinja S, Bahuguna P, Duseja A, Kaur M, Chawla YK. Cost of Intensive Care Treatment for
Liver Disorders at Tertiary Care Level in India. PharmacoEconomics - Open 2018; 2:
179–90.
12Nambiar R, Dae D, Anjali S. Burden of poisoning on a critical care unit in southern India.
Natl Med J India 2019; 32: 197–9.
13Saleem S, Jan S. Modified Kuppuswamy socioeconomic scale updated for the year 2021.
Indian J Forensic Community Med 2021; 8: 1–3.
14Booysen F, Van der Berg S, von Maltitz M, du Rand G. Using an asset index to assess
trends in poverty in seven sub-Saharan African countries. World Dev 2008; 36: 1113–30.
15World Health Organization. Tracking Universal Health Coverage: 2017 Global Monitoring
Report. https://doi.org/ISBN 978-92-4-151355-5.
16Wagstaff A, Flores G, Smitz M-F, Hsu J, Chepynoga K, Eozenou P. Progress on
impoverishing health spending in 122 countries: a retrospective observational study.
Lancet Glob Health 2018; 6: e180–92.
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18Agrawal R, Negi R, Kaushal SK, Misra SK. Out of pocket expenditure and its associated
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hospital of Agra District, Uttar Pradesh. Indian J Public Health 2020; 64: 60–5.
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20Kaur A, Jayashree M, Prinja S, Singh R, Baranwal AK. Cost analysis of pediatric intensive
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with COVID-19 infection admitted to African high-care or intensive care units (ACCCOS):
a multicentre, prospective, observational cohort study. The Lancet 2021; 397: 1885–94.
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10.
APPENDIX
Appendix 1. Operational definitions
Term
Definition
OOPE
Defined as the cost incurred by individuals or households at the time of receiving
any healthcare services in the ICU, including the component of cost-sharing (the
part not covered by a third party like, an insurer) and informal payments (e.g., tips
and under-the-table payments), but excluding insurance premiums and any
reimbursements from the third-party payers (e.g., the government, a health
insurance fund or a private insurance company).
OOPE includes direct medical and direct non-medical costs, but excludes indirect
costs (such as income/productivity loss).
Catastrophic
health
expenditure
(CHE):
For CHE incidence estimation, there is no single agreed threshold. In this study
CHE will be defined as OOPEs exceeding 10% of the household budget (yearly
income or consumption expenditure). In sensitivity analysis, we will apply the
higher threshold level of 25%.
Direct costs
Direct costs are expressed as expenditure during ICU treatment by households
and consist of two main categories: direct medical cost and direct non-medical
cost.
Direct
medical costs
Subcategory of ‘direct costs’ referring to direct payments made by individuals to
healthcare providers at the time of service use. These include those costs that are
consumed for healthcare resources during ICU care and will be classified across 7
categories.
-
Facility/provider fees, e.g. ICU bed charges, hospital daily rates, theater
fees.
-
Laboratory costs
-
Medication costs e.g. drugs, fluids, nutrition solutions, bandages
-
Procedure
costs
e.g . diagnostic imaging procedures, mechanical
ventilation, dyalisis
-
Consumables e.g. (ventilator circuits, infusion sets, ventilation masks,
gloves, alcohol rub, etc.)
-
Medical nutrition
-
Other costs
These exclude any prepayment for health services, for example in the form of
taxes or specific insurance premiums or contributions and where possible, net of
any reimbursement to the individual who made the payments.
Direct
non-medical
costs
Subcategory of ‘direct costs’ including transportation, lodging, food items, informal
payments and tips, payments incurred by caregivers and family for helping the
patients during treatment.
Yearly/
Annual
Income
Annual income refers to the total amount of money earned by a household over
the course of a year (i,.e. last 12 months preceding this survey time). This income
can come from various sources, such as salary or wages from employment,
profits from a business, rental income, investment income, land, or any other
source of income received over the course of a year.
Yearly/
Annual
Expenditure
Annual expenditure refers to the total amount of money spent by a household
over the course of a year (i.e., last 12 months preceding this survey). This
includes all expenses such as rent or mortgage payments, utilities, groceries,
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transportation costs, insurance, taxes, entertainment, food and any other
expenses incurred during the year.
Family
caregivers
Defined as any family member, relative, partner or friend of the ICU patient, who
were caring for the patient while he or she stayed in the ICU with or without
remuneration.
-
Primary family caregiver:
is the family caregiver with the most patient
contact.
-
Secondary family caregivers: defined as any other family member or
friend over the age of 18 involved in patient care and listed along with
their time commitment by the primary family care-giver.
Coping
strategies
Any mechanisms for OOPE coverage by patient or family member, including:
-
Savings: own income.
-
Medical
debt:
defined
as
personal
debt
derived
from
healthcare
expenditures or paying for medical OOPE by borrowing money from
friends or family, institutional loans (banks, etc) or non institutional loans
(borrowing from black market).
-
selling of personal property
-
limitation to procurement of medical services or drugs
-
other
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