Pulse Oximeter Evaluation-Call For Comments
Pulse Oximeter Evaluation-Call For Comments
Pulse Oximeter Evaluation-Call For Comments
pulse oximetry as
a tool to prevent childhood pneumonia
related morbidity and mortality
Study Report
In Collaboration with
September 2019
Evaluation of Pulse Oximetry as a
Tool to Prevent Childhood
Pneumonia Related Morbidity and
Mortality
In collaboration with
September 2019
1
List of Contributors:
Dr. Hisham Moosan, Technical Expert – Epidemiology & Project Lead, Regional
Technical Resource Centre for HTA (RTRC-HTA), Achutha Menon Centre for Health
Science Studies, SCTIMST Trivandrum
Dr. Antony Stanley, Research Associate, RTRC-HTA, Achutha Menon Centre for Health
Science Studies, SCTIMST Trivandrum
Dr. Raman Kutty V., Principal Investigator, RTRC-HTA Chief & Emeritus Professor,
Achutha Menon Centre for Health Science Studies, SCTIMST Trivandrum
Dr. Biju Soman, Co-Principal Investigator, RTRC-HTA & Professor, Achutha Menon
Centre for Health Science Studies, SCTIMST Trivandrum
Ms. Priya Abraham, Data Manager, RTRC-HTA, Achutha Menon Centre for Health
Science Studies, SCTIMST Trivandrum
Dr. Malkeet Singh, Junior Health Economist, HTAIn Secretariat, Department of Health
Research, MoHFW, Govt. of India
Suggested citation:
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Acknowledgements
We would like to extend our sincere gratitude to the Secretaries of DHR, for selecting
SCTIMST, Trivandrum as an HTA Resource Hub, assigning projects and building the
team’s capacity to carry out the work of HTAIn, DHR.
We are also deeply thankful to the Additional Secretary, Joint Secretary and Deputy
Secretaries of the DHR for the continuous administrative support.
We gratefully acknowledge the work of our former Additional Chief Secretary, Sri Rajeev
Sadanandan IAS, for his unwavering commitment to establish a centre for HTA in Kerala.
We would like to thank Dr. Rajan N. Khobragade, Principal Secretary, Health and Family
Welfare, Government of Kerala for his unconditional motivation and support for the
centre and its activities.
We would also like to thank Sri Keshvendra Kumar IAS, State Mission Director, National
Health Mission, Kerala for his continued support and partnership with the Regional
Technical Resource Centre.
We thank the members of the Technical Appraisal Committee, HTA In, for their
constructive suggestions throughout this study.
We sincerely thank Dr. Santhosh Kumar, Professor and Head, Department of Paediatrics
and Dr. Purushothaman K K, Paediatrician, Government Medical College, Thrissur, for
their valuable inputs related to the protocol of diagnosing and management of childhood
pneumonia.
We would also like to thank Dr. Nita Vijayan, State Programme Manager (RCH) for taking
the time to discuss concerns on childhood pneumonia, current standards of prognostic
tools available in India, and the issues around the treatment and length of stay for
children with severe pneumonia.
We express our sincere thanks Dr. Sreehari M. State Nodal Officer, CH & RBSK for his
inputs on the different types of oximetry devices used to treat and monitor different
stages of pneumonia.
3
We would like to thank Dr Malkeet Singh, Junior Health Economist, Department of Health
Research, for his technical support in developing the decision tree model for this study.
We would like to express our heartfelt gratitude to Dr Kavitha Rajsekar, Scientist E, DHR
& HTAIn Co-Ordinator, without whose feedback and constant encouragement this report
could not have been completed. And finally we would like to express our sincere thanks
and acknowledgement to the team at Department of Health Research (DHR) especially
Dr. Oshima Sachin (Scientist D) and Ms. Jyotsna Naik (Scientist C), Government of India,
for their unwavering support and guidance throughout the study.
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Table of Contents
i Executive Summary 8
1 Introduction 11
a. Objectives 13
b. The PICO 13
a. Search Results 16
b. Risk of Bias 16
c. Disease Progression 16
e. Prognostic parameters 17
f. Sensitivities and specificities based on thresholds of
18
hypoxemia
g. Cost parameters 20
b. Results 26
a. Methodology 27
5
b. Results 28
8 Economic Evaluation 29
b. Sensitivity analysis 31
Discussion (based on decision model and budget impact
9 33
analysis)
10 Conclusions and Recommendations 35
12 References 36
13 Addendum 40
6
List of tables
List of figures
7
Executive Summary
Introduction:
Globally, pneumonia is the leading cause of death in children <5 years of age. Despite
interventions being available, it is estimated that pneumonia is responsible for 15% of
childhood deaths worldwide. In the absence of appropriate prognostic tools at the
frontline, currently recommended World Health Organization (WHO) guidelines for
integrated management of childhood illness (IMCI) often lead to an overuse of antibiotics
and the under-referral of patients with severe pneumonia who require hospital care.
The present recommended strategy for diagnosis and prognosis of pneumonia is IMCI
tool for professional health workers at health facilities and iCCM tool for community
health workers. Currently, identification of these IMCI symptoms remains inconsistent
and unreliable among health-care personnel. The use of pulse-oximetry devices (used to
measure the oxygen level in the blood) in community health-care settings has been
proposed as a method to identify hypoxic children at risk of treatment failure.
Objectives:
Methods:
A systematic literature review (SLR) was conducted with PICO as population consisting
of patients aged 0-5 years with pneumonia in LMIC’s, Intervention was IMCI +Pulse
Oximetry and the comparator was IMCI alone. The outcomes was diagnostic accuracy of
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pulse oximetry, cost per QALY gained, and incremental deaths averted with the
introduction of pulse oximetry. The SLR was conducted using electronic databases such
as Database of Cochrane, PubMed, Web of Science, ProQuest, Google Scholar and WHO
Global Health Library, with no language restrictions. A decision tree model was
developed for estimating the Incremental Cost Effectiveness Ratio (ICER). For populating
the model we required data pertaining to disease progression, care-seeking, health-care,
prognostic and cost parameters. In addition to data gathered from SLR, we did a scoping
review wherever necessary to extract data for the decision model.
We extracted the costs of the IMCI implementation in Indian primary healthcare settings
from previous studies. The average number of hospital visits (outpatient and inpatient)
were calculated including the associated out of pocket health expenditure for each
category. We indexed the amount to the current INR rate using inflation tools. Pulse
oximeters which fit the predefined specifications were shortlisted and their net average
cost was taken for costing purposes. The training cost is derived from consultation with
the program implementers.
Results:
The evidence from the systematic review was overwhelmingly in favour of the use of
pulse oximetry along with the existing guidelines. Out of the seven studies which were
eventually shortlisted, 6 of them favoured the use of PO. When it came to costing, the cost
of Pulse oximetry per patient per year is INR 0.36. We did a budget impact analysis, which
showed that if we were to provide a pulse oximeter to all the PHC’s in India, the cost of
the roll-out of pulse oximeters would be INR 64,125,000. The cost of training frontline
health workers to use PO is INR 26,334,000. The overall cost of roll-out of pulse oximeters
in PHC’s would amount to INR 90,459,000. In absolute terms, the introduction of pulse-
oximetry devices to IMCI is estimated to result in annual reductions in pneumonia deaths
in India. The deaths averted per year for PO2 within a cohort of 10000 pneumonia cases
would be 367 if the sensitivity is 85% and 213 if the sensitivity is 70%. Owing to the large
under-five populations (128 million) India could significantly reduce the mortality due to
childhood pneumonia by the introduction of PO into the existing IMCI.
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Recommendations:
IMCI+PO is a cost saving prognostic tool as compared to IMCI alone provided there
is supplementary oxygen availability.
IMCI should be the basic prognostic tool for childhood pneumonia but PO is
beneficial in the referral of cases.
Pulse oximetry in general may be used to measure oxygen saturation in cases
wherever required. Among outpatients with pneumonia, oxygen saturations
<90% were associated with increased morbidity and mortality.
A hospital admission threshold of <92% would be safer and clinically better
justified.
All severe cases, irrespective of availability of Pulse oximeter, should be referred
to a tertiary care facility for expert management.
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Evaluation of pulse oximetry as a tool to prevent
childhood pneumonia related morbidity and mortality
1. Introduction
Pneumonia is an infection of the lower respiratory tract that involves the airways and
parenchyma with consolidation of the alveolar spaces. Lobar pneumonia describes
pneumonia localized to one or more lobes of the lung. Atypical pneumonia describes
patterns typically more diffuse or interstitial than lobar pneumonia. Infectious agents
that commonly cause community-acquired pneumonia vary by age1. Most common
causes are respiratory syncytial virus (RSV) in infants, other respiratory viruses
(parainfluenza viruses, influenza viruses, human meta-pneumovirus, adenoviruses) in
children younger than 5 years old, and Mycoplasma pneumonia in children older than age
5 years. Streptococcus pneumonia is the most common bacterial cause of lobar
pneumonia, and occurs in children of any age outside the neonatal period1. M.
pneumoniae and Chlamydophila pneumoniae are principal causes of atypical pneumonia.
Globally, pneumonia is the leading cause of death in children <5 years of age 2. Despite
interventions being available, it is estimated that pneumonia is responsible for 15% of
childhood deaths worldwide. Reductions in annual mortality remain modest, with nearly
950,000 under-5 year olds dying of pneumonia in 2013. Immunizations have brought
down the incidence of pneumonia caused by Haemophilus influenza type b, and S.
pneumoniae. But despite the unprecedented rate of Haemophilus influenzae type B (Hib)
and pneumococcal vaccine (PCV) introduction, achieving high levels of coverage in
developing countries is still challenging. Therefore, in regions where vaccine introduction
and scale-up lags behind other countries, improved access to diagnosis and treatment is
crucial.
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of childhood illness (IMCI) often lead to an overuse of antibiotics and the under-referral
of patients with severe pneumonia who require hospital care4,5.
The use of pulse-oximetry devices (used to measure the oxygen level in the blood) in
community health-care settings has been proposed as a method to identify hypoxic
children at risk of treatment failure. Unfortunately, current treatment coverage remains
low, and, more importantly, most childhood pneumonia deaths result from a lack of, or
delay in, accurate diagnosis. These devices may be particularly beneficial at the frontline
given that they require little training and reduce the reliance on clinical symptoms. The
current pulse-oximetry systems are also quick, non-invasive and require minimal
infrastructure. As international organisations are investing in programmes to increase
pulse oximeter use in low-income settings, more research is needed on the optimal use
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of pulse oximeters (eg, appropriate oxygen saturation thresholds), and how pulse
oximeter use affects referral and admission rates, length of stay, resource utilisation and
health outcomes. We therefore reviewed the evidence on the effectiveness, and cost-
effectiveness of pulse oximetry devices introduction alone and when combined with the
existing IMNCI guidelines.
2. Methods:
a. Objectives
b. The PICO
Population
Patients aged 0-5 years with pneumonia
Intervention
IMCI + Pulse Oximetry
Comparator
IMCI
Outcome
Diagnostic Accuracy of Pulse Oximetry
o (Sensitivity, Specificity, Positive and Negative Predictive Values)
Referral and admission rates, length of stay, resource utilisation and health
outcomes
Cost per QALY gained/ DALY averted
Incremental deaths averted with the introduction of pulse oximetry by
community health workers in community settings
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c. Types of studies considered
The types of studies considered for the review included the following:
For the effectiveness we considered randomized controlled trials, field/ community trials
and quasi-randomized trials. The cost effectiveness data was extracted from full
economic evaluations (studies in which both the costs and outcomes of the alternatives
were examined and in which a comparison of two or more interventions or case
alternative was undertaken) including trial-based, non-trial based (i.e. observational
studies), simulation-based, decision model, trial-based model and partial economic
evaluations such as cost analysis, costing of interventions with or without comparator.
The population selected were patients aged 0-5 years with pneumonia in LMIC’s.
Intervention was the use of Pulse oximetry alone or in combination with the existing
IMNCI guidelines. The comparators were IMCI alone or the existing local pneumonia
management guideline. In other words, we included studies with at least one intervention
group in which a pulse oximeter reading was taken and at least one control group in
which pulse oximetry was not used.
The outcomes of interest included diagnostic accuracy of pulse oximetry, referral and
admission rates, and length of stay, resource utilisation and health outcomes, cost per
QALY gained/ DALY averted, incremental deaths averted, difference in mortality and
morbidity, referral rates and length of stay in critical care where pulse oximeters are used
to inform diagnosis and treatment compared with where pulse oximeters are not used.
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a meta-analysis. However, due to the small number of studies and the study
design/outcome variability this was not possible. Instead we narratively describe the
evidence using a structured approach while drawing insights where possible, a standard
strategy in such situations.
Inclusion/Exclusion
criteria applied
204 studies
removed
50 studies after screening of
based on
Title & Abstract
incl/excl
criteria
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3. Results of the Systematic Review
a. Search Results
We found 361 reports initially, which underwent removal of duplicates and application
of the inclusion and criteria, followed by screening of all titles and abstracts. The
shortlisted potentially relevant studies amounted to 50. They were divided into three
categories based on their relevance to the PICO. Studies with serious and critical level of
risk of bias were not included in the final summary. Most of the studies fell into the
moderate risk category. Seven studies, were closely aligned (see PRISMA flow diagram)
to the PICO, and thirteen studies were relatively associated with the PICO. Finally 20
studies were considered for inclusion. We’ve added them to the analysis as supportive
evidence (see Table 2).
b. Risk of Bias
Table 6 and 7 in the addendum of this document demonstrates the risk of bias for each
study included.
c. Disease Progression
In 2013, Rudan et al.9 estimated that in India alone, the number of new episodes
(incidence) of community–acquired pneumonia in children 0–4 years of age is
127,960,004. The number of new severe episodes (according to WHO's definition) that
required hospitalizations was 4,066,541. The estimates of the number of child deaths
attributable to pneumonia was 388,144.
By 2015, Farooqui et al.10 projected that there were 3.6 million (3.3–3.9 million) episodes
of severe pneumonia and 0.35 million (0.31–0.40 million) all cause pneumonia deaths in
children younger than 5 years in India. In addition, to the overall figure, state-wise
breakup of data suggested that the states that merit special mention include Uttar
Pradesh where 18.1% children reside but contribute 24% of pneumonia cases and 26%
pneumonia deaths, Bihar (11.3% children, 16% cases, 22% deaths) Madhya Pradesh
(6.6% children, 9% cases, 12% deaths), and Rajasthan (6.6% children, 8% cases, 11%
deaths). In the latest Pneumonia and Diarrhoea Progress Report 2018, the number of
Pneumonia deaths in children under 5 years has come down to 158,176.
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The proportion of pneumonia severe on day 1 was 5% (2–10%) according to Pitt et al.11
The mean duration of non-severe illness before recovery was 3 days (2–4 days)12. The
mean duration of non-severe illness before progression to severe illness was 10 days (9–
11 days)12. The mean duration of severe illness before recovery was 4 days (3–5 days)13.
Mean duration of severe illness before death was 7 days (6–8 days)14. The proportion of
bacterial versus viral infection was 15% bacterial (10-25%) and 85% viral (75–90%)15.
The mean duration of illness before care seeking in the case of non-severe illness was 3
(2–4) days and 0.75 (0.5–1) days in the case of severe illness14. Foran M et al.16 found
that oximetry data changed clinical management in all observed cases of hypoxemia and
several cases of normoxemia, leading to application of supplemental oxygen, initiation of
further diagnostic testing, prolongation of inpatient stay, or expedited discharge home.
According to McCollum et al., the availability of oximetry appeared to have increased the
referral rate for severely hypoxaemic children without chest indrawing or danger signs
from 0% to 27.2%. In the absence of oximetry, if the relevant World Health Organization
(WHO) guidelines published in 2014 had been applied, 390/568 (68.7%) severely
hypoxaemic children at study health centres and 52/84 (61.9%) severely hypoxaemic
children seen by community health workers would have been considered ineligible for
referral17,18.
The Pneumonia & Diarrhea Progress Report 2018 states that in India, 73% of patients
with pneumonia were taken to an appropriate healthcare provider. The probability of
community-based treatment curing non-severe bacterial case was 0.925 (0.90–0.95)19
and the probability of treatment with amoxicillin curing severe case if it adhered to the
prescription (based on treatment failure rates of patients with hypoxia at baseline) was
0.65 (0.6–0.7). However the optimal dosing recommendation for amoxicillin remains
unclear with limited pharmacological and clinical evidence20.
e. Prognostic parameters
Clinical signs alone or in combination are not suitable to diagnose hypoxaemia 21.
According to Fu LY et al.22 the inclusion of oximetry data improved the predictive ability
at baseline, 12 hours, and 24 hours. The ability to predict failure after 12 hours of
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observation with oximetry data was similar to the predictive ability after 24 hours
without pulse oximetry data.
The sensitivity of IMCI was 0.55 (0.5–0.6)23 whereas the sensitivity of pulse oximetry
with IMCI was 0.85 (0.8–0.9)24. Pulse oximetry misclassified notably fewer well children
than did the WHO algorithm (4% vs 35%)24. Pulse oximetry and the WHO algorithm
together (SATWHO) detected 99% and 87% of pneumonic ALRI and radiologic
pneumonias, respectively, and both methods detected 94% of all cases of pneumonic and
non-pneumonic ALRI diagnosed clinically. No single clinical sign can perform as well as
pulse oximetry for predicting hypoxia in children with severe pneumonia25.
Hypoxaemia definitions varied from <92% to 95%. According to Majumdar et al., raising
the admission threshold to 92% entails 1 additional hospitalization for every 14 patients
discharged. Among outpatients with pneumonia, oxygen saturations<90% were
associated with increased morbidity and mortality28. Their results indicated a hospital
admission threshold of <92% to be safer and clinically better justified.
18
SpO2 (n=131) 29.8 2.7 46.4 76.0 29.8 86.6
≤90% (1.7-
4.5)
SpO2 (n=187) 26.7 2.6 59.5 64.2 26.7 87.9
≤92% (1.6-
4.3)
SpO2 (n=271) 22.5 2.2 72.6 45.2 22.5 88.3
<95% (1.3-
3.7)
** Adapted from Thomas Bewick et al. 2010
Among outpatients with pneumonia, oxygen saturations <90% were associated with
increased morbidity and mortality. A hospital admission threshold of <92% would be
safer and clinically better justified7,28.
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g. Cost parameters
The cost of Amoxicillin treatment per child is INR 47.77 as per Jan Aushadi rates
(http://janaushadhi.gov.in/old-data/New_MRP_Oct15.pdf). The average hospital cost
per episode is INR 207 if it’s a primary healthcare facility, INR 293 when it is a secondary
healthcare facility and INR 437 when the referral is to a tertiary healthcare facility (WHO
CHOICE database). The cost of a USFDA approved Life Box Pulse oximeter is $250. 30 Each
set of batteries can be used for approximately 840 readings. The lifetime of device is 2
years.31 There are ISO certified finger pulse oximeters available in the GeM which cost
anywhere between INR 1800 – 4000. The number of devices needed is 1 per 1,000
children under 5 (0.8–1.2). The DALY’s lost due to pneumonia32 in young children amount
to 121·15 (105·92 to 138·3) * 10^5.
Ginsburg AS et al., reported that healthcare professionals and caregivers viewed the pulse
oximeter and breath counter favourably. Challenges included electricity requirements for
charging and the time needed to complete the application. Some caregivers saw it as a
sign of modernity, increasing their trust in the care received. Other caregivers were
hesitant or confused about the new technology. Overall, this technology was valued by
users and is a promising innovation for improving quality of care in frontline health
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facilities34. In Spence et al., community health workers (CHW) and national stakeholders
across the four countries perceived the acute respiratory infection (ARI) timer and
fingertip pulse oximeter as highly scalable and easy for CHWs to use. CHWs placed greater
priority on device acceptability to caregivers and children. Both groups felt that heavy
reliance on electricity reduced potential scalability and usability in rural areas. Device
simplicity, affordability and sustainability were universally valued35.
In general, the states having a high prevalence of pneumonia risk factors and poor access
to health services had a higher burden of pneumonia cases and deaths10. Although
hypoxemia is common, the absence of routine pulse oximetry results in most hospitalized
hypoxemic children not receiving available oxygen treatment. It is important to recognize
that referral/ admission rates is dependent on the thresholds for oxygen therapy. Setting
a uniform threshold for a country as geographically varied as India is complicated
because pulse oximeter results may not be considered in isolation from clinical findings,
SaO2 can naturally fluctuate over a day, and studies show that ‘healthy’ SaO2 differs by
age and altitude.
Clinical signs alone are poor predictors of hypoxemia, and using pulse oximetry in
resource-poor health facilities to target oxygen therapy is likely to save costs. The relative
ease of implementation of a pulse oximetry-based intervention (even with the
assumption of perfect availability) compared with the elimination of low birth weight or
malnutrition makes it an important candidate for an intervention against pneumonia in
resource-poor settings. Many of these studies considered have not taken into account the
positive impact pneumococcal vaccine would have for infants. In Sinha et al. 13, it is seen
that the vaccine has the potential to directly avert around 262,000 deaths in under-5s
across 72 countries. Taking that vaccine into consideration might decrease the cost-
effectiveness of pulse oximetry. Still it should compare favourably with the pneumococcal
vaccine.
The breadth of different views on pneumonia diagnostic aids emerging from the research
activities can be seen amongst the different participant groups. The fingertip pulse
oximeter was deemed the most usable and scalable in most of the studies. There is
evidence to indicate that pulse oximetry may lead to improved health outcomes, with
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lower mortality rates (when combined with improved/adequate oxygen administration);
pulse oximetry may change physicians’ decisions regarding illness severity, and increase
hospital admissions related to previously unrecognised hypoxaemia. Routine pulse
oximetry may also influence diagnostic tests and treatments used. Pulse oximetry could
facilitate swifter diagnosis, so effective treatment starts earlier and recovery likelihood
increases, reducing future resource use. Oximetry can reduce resource waste by
indicating when to end treatment, and by decreasing false positives. The emphasis should
be to ensure all aids are accurate, affordable and acceptable to the communities where
they will be used.
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d. Audio-visual alarms required: high and low
SpO2 and pulse rate; operator variable settings;
sensor disconnected, sensor failure, low battery
e. Pulse rate range at least 30 to 240 bpm,
minimum gradation 1 bpm
Power consumption 1.5 Watt
Power input and frequency 220 to 240V, 50 Hz
Display type Color OLED
23
Memory Minimum 24 hour trend memory for SpO2 & PR
Sell in addition:
-Adult prone
-Pediatric probe
The Public Health Standards of India which was published in 2012 detailed the minimum
expected infrastructure and human resources needed to run the country’s healthcare
services, from sub-centres to district hospitals. These standards apply to government-run
healthcare facilities. As per the document, oxygen is an essential commodity for any
maternal birthing unit, including sub-centres, the most ‘peripheral’ of India’s rural health
facilities, and that all district hospitals should have piped oxygen to their sickest patients
(intensive care units and casualty). It is important to make sure that the procurement is
done by appropriately by fairly awarding contracts, payments without delay, and
prevention of theft of procured stocks. The challenge is to create a system which makes
these outcomes more likely and limits harm to patients from almost inevitable human
and other error.
Oxygen therapy must be more widely available; in many remote settings, this can be
achieved by use of oxygen concentrators, which can run on regular or alternative sources
of power. Several conditions must be met for hypoxemic children to receive appropriate,
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uninterrupted oxygen therapy for as long as is necessary to save their lives. A 2016 gap
analysis of gas use in the Armed Forces Medical College Hospital in Pune found limited
documentation from the oxygen supplier and major gaps in pipeline maintenance,
particularly in the lack of alarm mechanisms to alert staff to shortages. Medical oxygen
comes under the National List of Essential Medicines (NLEM) of India, one of the key
instruments in a balanced healthcare delivery system. Medical oxygen is also on the
World Health Organization’s (WHO) list of essential medicines. No ICU or hospital for that
matter can run without a smooth supply of oxygen as medical oxygen comes under
essential medical list.
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6. Costing of incorporation of Pulse-oximeter to IMCI guidelines in
Indian primary healthcare
a. Methodology
We extracted the costs of the IMCI implementation in Indian Primary healthcare settings
from previous studies37. The average number of hospital visits (outpatient and inpatient)
were calculated including the associated out of pocket health expenditure for each
category. We indexed the amount to the 2019 INR rate using inflation tools. Pulse
oximeters which fit the predefined specifications were shortlisted and their net average
cost was taken for costing purposes. The cost for the equipment (pulse oximeters) were
derived from the Government e-Marketplace. The power consumption for the finger
pulse oximeter was negligible. The training cost is derived from consultation with the
program implementers. We assumed the life of a training to be two year (similar to the
lifespan of the device) and therefore dealt with the training cost as capital in nature. The
life of training was considered to be 2 years, based on a need for retraining health
workers after an interval of 2 years. Since the PO’s will be handled by the frontline health
workers, no additional human resources will be required to implement this project.
b. Results
Per patient cost of treatment of non-severe pneumonia (home based) before recovery
came to INR 1117 (Table 12). This figure was arrived at by assuming that the patient had
to make at least 1 OPD Visit and the associated OOP. Per patient cost of treatment of non-
severe pneumonia (home based) before progression to severe illness came to INR 2234
taking into account 2 OPD visits and OOP. Per patient cost of treatment for severe
pneumonia (hospital based) is INR 10592. Per infant cost of general health system
administration and program cost (IMCI) came to INR 16137. The average cost of a pulse
oximeter in GeM portal with the required specification is INR 2500. The cost of training
one frontline health worker is INR 513.33 (Table 13). This takes into account the cost of
trainer honorarium, stationery, and reimbursements for trainee, infrastructure and
logistics, and travelling costs. We want to train two frontline health worker per facility.
Hence the cost per facility will be INR 1026.66. Summing up the common expenses for
training two health workers per facility and the instrument cost, the total cost to install
pulse oximeter in a PHC will be INR 3526.67. The expected life of the equipment is 2 years.
26
The annualization factor was taken 0.5226 and the discount rate was 3% (Table 11).
Therefore, per year cost of PO will come to INR 1833.52 (3526*0.522). The number of
patients in the 0-5 age group with acute respiratory infection visiting a PHC OPD (other
than immunisation) in a day is around 10-15, which may increase up to 25 depending on
the availability of the paediatrician. This indicator when extrapolated to a year comes to
around 5040. The cost of Pulse oximetry per patient per year is INR 0.36
a. Methodology
The Ayushman Bharat targets operationalizing 1.5 lakh Health and Wellness Centres in
India. Each centre is expected to have at least one functioning pulse oximeter and two
trained staff. The cost of PO was gathered from the finger pulse oximeters available in the
GeM portal. The net average cost of all the oximeters which had the recommended
specifications were taken. This was multiplied by the number of proposed Health and
Wellness Centres. One year warranty and three free servicing was included in the
recommended terms and conditions. Training of frontline health workers formed
another major part of the budget. The training was planned in a phased manner. Costs for
central level, state level and district level training for trainers was budgeted. This was
followed by training of frontline health workers at the CHC/ PHC levels. The common
27
expenses for the training included trainer honorarium, stationary items, trainee
reimbursement (TA+DA), infrastructure and logistics.
The health system already has a functioning IMCI unit. The pulse oximetry is an add-on
to the existing IMCI. Hence, no additional human resources will be required to implement
it.
b. Results
The cost of roll-out of pulse oximeters for 1.5 lakh health and wellness centres
Number of health and wellness centres: 150000
Cost of PO: 2500
Overall cost of PO: 150000*2500 = INR 375,000,000
But, as on 31st March 2017, there were only 25650 Primary Health Centres (PHCs)
functioning in India38. If we were to provide a pulse oximeter to all the PHC’s in India, the
cost of the roll-out of pulse oximeters would be INR 64,125,000 (25650*2500). The cost
of training frontline health workers to use PO is INR 26,334,000. The overall cost of roll-
out of pulse oximeters in PHC’s would amount to INR 90,459,000.
The number of functioning Community Health Centres (CHCs) in India was 5510 as on
31st March, 201639. Each community health centre would require at least 4 finger-tip
pulse oximeters which should ideally be placed in the casualty, OP and inpatient ward. If
there are dedicated structured pulmonary rehabilitation programme like SWAAS40 an
additional pulse oximeter might be needed in the specific clinic as well. The cost of
equipping all the CHC’s with specified number of pulse oximeters amount to INR
55100000 (5510*2500*4).
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8. Economic Evaluation
A lifetime study horizon starting from base year of 2019 was considered appropriate to
cover all costs and effects comprehensively. Pneumonia have a predominant risk within
the first 5 years of life, with gradually declining risk till about 15 years.
We evaluated the costs and effects from both health system and societal perspective.
Effect was measured in terms of illness episodes averted, child deaths prevented, life
years gained and quality-adjusted life years (QALY) gained. Costs were discounted at 3%
and an annualization factor of 0.52 was added for time preference of cost. We estimated
the standardized unit cost from health system and societal perspective. We report our
findings as incremental cost of implementing IMCI + PO for infants per QALY gained and
per infant death averted as compared to IMCI alone.
The cost data for analysis was extracted from previous costing studies done with IMNCI
and pulse oximetry33,37. The parameters used for the economic model are shown in the
input parameter table. The sensitivity of ‘IMCI’ and the sensitivity of ‘IMCI + PO’ were
taken from previous studies23,24. We started with an initial base cohort of pneumonia
patients of same size for both interventions. Using the abovementioned sensitivity for
IMCI and IMCI+PO respectively, we screened both groups of severe and non-severe
pneumonia. Per patient cost of treatment of non-severe pneumonia (home based) before
recovery, per patient cost of treatment of non-severe pneumonia (home based) before
progression to severe illness, and per patient cost of treatment for severe pneumonia
(hospital based) were calculated from previous studies conducted in India 37. The mean
duration of non-severe pneumonia before recovery, the mean duration of non-severe
illness before progression to severe illness, the mean duration of severe illness before
recovery and the mean duration of severe illness before death were computed from
secondary data12,14.
29
Table 5. Results of Cost effectiveness of IMCI + PO as compared to IMCI Alone
Intervention Cost LY QALY ICER
IMCI (0.55) 32247526 601736.1 601736.1 -117.32
IMCI+PO (0.85) 29503112 625127.9 625127.9
Intervention Cost LY QALY ICER
IMCI (0.55) 32247526 601736.1 601736.1 -18.7521
IMCI+PO (0.7) 31993096.31 615304.17 615304.17
*Number given in brackets in the first column is the sensitivity of each intervention
30
Figure 3: Decision Model – IMCI + PO
b. Sensitivity Analysis
We did one-way sensitivity analysis by varying costs of all input parameters from their
lower limit to upper limit and ascertained their effect on ICER of intervention. We finally
selected input parameters which had maximum impact on cost-effectiveness of
introduction of Pulse-oximeter in IMCI guidelines. We plotted these parameters and
variation in ICER attributed to them in tornado chart as given in Figure 4.
31
We also conducted a probabilistic sensitivity analysis to ascertain the variation in ICER
which may arise from uncertainty in input parameters and all assumptions we took
during the process of this evaluation. In Microsoft excel, we used Visual Basics to run PSA
where ICER was calculated for 1000 times by randomly varying the values of input
parameters, taking any random value from their lower to upper bound.
All these 1000 iterations were plotted against base case to present the variation and
proportions of ICER falling in different quadrants. We can see, that all values fall in right
upper and right lower quadrant; out of which majority (97.4) of values are in right lower
quadrant, signifying ICER to be negative with gain in QALYs and less cost incurred in
intervention scenario as presented in Figure 5.
1,000,000.00
0.00
0 5000 10000 15000 20000 25000 30000 35000 40000 45000 50000
-1,000,000.00
-2,000,000.00
-3,000,000.00
-4,000,000.00
-5,000,000.00
-6,000,000.00
Incremental
QALYs
Basecase Joint incremental cost and LYs
PSA Joint incremental cost and LYs
32
ICER was also compared to the willingness to pay threshold (which is considered to be
one times per capita GDP of the country) and results of PSA were presented in the form
of Cost-Effectiveness Acceptability Curve (CEAC) to compare ICER values with
willingness to pay threshold as presented in Figure 6.
1
PROBABILITY OF COST-EFFECTIVENESS
0.995
0.99
0.985
0.98
0.975
0.97
0 20000 40000 60000 80000 100000 120000 140000
COST-EFFCTIVENESS/WILLINGNESS TO PAY THRESHOLD
From the evidence brought forth by our systematic review, it seems that pulse oximetry,
used in conjunction with clinical guidelines like the IMCI, is beneficial in screening and
diagnosis of pneumonia in the community. It is important to note here that such
diagnoses have to be coupled with prompt provision of oxygen therapy at the community
level institutions, in order to reap the benefits of a more early and accurate diagnosis. The
deaths averted due to childhood pneumonia when IMCI+PO is used instead of IMCI alone
is 21 and 36 per 1000 patients when the sensitivity is 70% and 85%. When we take a
lifetime horizon this results in a QALY gain of 1356 and 2339 years respectively.
33
The ICER for both sensitivities show a negative value suggesting that PO when added to
the existing IMCI would become a cost saving intervention. The costing and budget
impact analysis showed that the introduction of pulse oximeter along with existing IMNCI
will increase the cost per patient per year by INR 0.36 only. The overall cost of roll-out of
pulse oximeters in PHC’s would amount to INR 90,459,000. The cost of equipping all the
CHC’s with specified number of pulse oximeters amount to INR 55,100,000. The overall
domestic general government health expenditure per capita for India is US$61.4041. For
a three trillion dollar economy which spends 1% of its GDP on healthcare, the
implementation of the IMNCI+PO would cost only 0.003% of its annual budget.
It is important to know how to interpret the information received from oximetry. The
inherent limitation of being a non-invasive technology makes it all the more important
for proper training to be given to frontline health workers. The technical specifications
of Finger Pulse Oximeter for use in Health and Wellness Centres (Table 4) should be
maintained and updated at regular intervals. The relative ease of implementation of a
pulse oximetry-based intervention (even with the assumption of perfect availability)
compared with the elimination of low birth weight or malnutrition makes it an important
candidate for an intervention against pneumonia in resource-poor settings. The decision
tree was able to show that on top of the large reduction in deaths due to pneumonia, the
addition of pulse oximetry to IMCI has the potential to increase the correct treatment of
severe cases. Thus, pulse oximetry appears to be both an effective and cost-effective
option for the government to contemplate implementation of the same in the primary
healthcare institutions.
In the case of IMNCI+PO, the value of ICER was less than the GDP per capita in all
simulations as part of the probabilistic sensitivity analysis. The sensitivity analysis also
showed that majority of the values fell into the right lower quadrant, signifying ICER to
be negative with gain in QALYs and less cost incurred in the intervention scenario. The
implementation of IMNCI+PO imposes only a small increase in the overall budget. With
an overall health system spending of US$61.40 per capita per year 41, this implies a
0.003% increase in budget which appears reasonable, considering the Government of
India’s strong commitment to raise resource allocation to health for achieving universal
health care. Recommending a program or strategy for scale-up merely on grounds of cost-
effectiveness may not be prudent.
34
10. Conclusions and Recommendations
1. IMNCI+PO is a cost saving prognostic tool as compared to IMNCI alone provided
there is supplementary oxygen availability.
2. IMNCI should be the basic prognostic tool for childhood pneumonia but PO is
beneficial in the referral of cases. Pulse oximetry in general may be used to measure
oxygen saturation in cases wherever required.
3. Among outpatients with pneumonia, oxygen saturations <90% were associated with
increased morbidity and mortality. A hospital admission threshold of <92% would
be safer and clinically better justified. All severe cases irrespective of availability of
Pulse oximeter will be referred to a tertiary care facility for expert management.
4. In tertiary care, when SpO2 ≥ 80%, pulse oximetry has high accuracy in estimating
SaO2 and may be used instead of ABG; in patients with SpO2 < 80%, however, the
exact estimation of SaO2 and the evaluation of oxygenation by pulse oximeter is not
a good substitute for ABG analyzer.
5. Pulse oximeter specification may be as mentioned in Table 4.
6. In tertiary care hospitals, especially in ICU’s Parameters multipara monitors which
measures ECG, Respiration, Pulse Rate, Temperature, SPO2, NIBP suitable for adult
and neonates should be used.
There were several limitations to our analysis. One major limitation of the study was a
lack of data on the availability of oxygen support and how it is distributed throughout the
health system. The IMNCI was functional (at least on paper) in most of the states in India.
But the mortality rate of children in the age group 0-5 is different for different states.
There is still no good quality evidence as to why there is a disparity in the death rates due
to pneumonia despite most states opting to implement IMNCI. So, the question of whether
it is the poor implementation of IMNCI or whether IMNCI as a tool is unsatisfactory is not
conclusively proven. The assumptions made for the decision model and the economic
evaluation is given in Table 14.
35
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39
13. Addendum
Summary of findings
Table 6: Evidence Summary
No. Title/ Authors/ Journal/ Type of study and Overall outcome Risk of Remarks
Year/ Country number of bias
participants rating -
overall
Evaluating the impact of Modelling study The cost-effectiveness of implementing pulse oximetry in India Moderate Favouring the
pulse oximetry on childhood with PO1 and PO2 are US$11.84 and US$9.56 per DALY, use of pulse
pneumonia mortality in Continuous-time respectively. oximetry
resource-poor settings. deterministic
1
compartmental model.
Floyd J et al.
Nature.
2015 Dec 3
The Role of Pulse Oximetry: Comparative study. Children with pneumonic and non-pneumonic ALRI (59%, Moderate Favouring the
Its Use as an Indicator of 160/269) had a mean (+/- SD) arterial oxygen saturation use of pulse
Severe Respiratory Disease 162 well children significantly lower than well children (93.8% +/- 3.5% vs 98.7% oximetry
in Peruvian Children Living 269 children with ARI +/- 1.51%; P < .01).
at Sea Level
Pulse oximetry misclassified notably fewer well children than did
2 Madico et al. the WHO algorithm (4% vs 35%).
Archives of Pediatrics and
Adolescent Medicine Pulse oximetry and the WHO algorithm together (SATWHO)
1995 detected 99% and 87% of pneumonic ALRI and radiologic
Peru pneumonias, respectively, and both methods detected 94% of all
cases of pneumonic and non-pneumonic ALRI diagnosed
clinically.
Emergency triage Validation study Hypoxemia was strongly associated with inpatient mortality (age- Moderate Favouring the
assessment for hypoxaemia adjusted risk ratio: 4.5; 95% confidence interval, CI: 3.8-5.3). use of pulse
in neonates and young Hypoxemia was found oximetry
3
children in a Kenyan in 977 of 15289 5-15% of the children who had hypoxaemia on admission were
hospital: an observational (6.4%) of all missed, and 18% of the children were incorrectly identified as
study. admissions hypoxaemic.
40
Mwaniki MK et al. Clinical signs are poor predictors of hypoxemia, and using pulse
Bull World Health Organ. oximetry in resource-poor health facilities to target oxygen
2009 Apr therapy is likely to save costs.
Kenya
Hypoxaemia in Mozambican Hospital-based survey The prevalence of hypoxemia on admission was 27.9%, and Moderate Favouring the
children <5 years of age 19.8% of these children died (OR compared with non-hypoxaemic use of pulse
admitted to hospital with 825 children children 3.22, 95% CI 1.98-5.21, P < 0.001). oximetry
clinical severe pneumonia:
clinical features and None of the models performed well when tested in different case
performance of predictor scenarios of oxygen availability through mathematical modelling,
4
models. with over 50% of hypoxaemic children not receiving oxygen even
Bassat Q et al. in favourable case scenarios.
Trop Med Int Health.
2016 Sep 21 Clinical signs alone or in combination are not suitable to diagnose
Mozambique hypoxaemia. The use of pulse oximeters should be strongly
encouraged.
Prevalence of undiagnosed Cross-sectional Oximetry data changed clinical Moderate Favouring the
hypoxemia in adults and analysis management in all observed cases of hypoxemia and several cases use of pulse
children in an under- of normoxemia, leading to application of supplemental oxygen, oximetry
resourced district hospital in 192 patients initiation of further diagnostic testing, prolongation of inpatient
Zambia. stay, or expedited discharge home.
5
Foran M et al.
Int J Emerg Med.
2010 Nov 11
Zambia
Pulse oximetry for children Survey-based The availability of oximetry appeared to have increased the Moderate Favouring the
with pneumonia treated as assessment referral rate for severely hypoxaemic children without chest use of pulse
outpatients in rural Malawi. indrawing or danger signs from 0% to 27.2% (P < 0.001). In the oximetry
N= 14092 absence of oximetry, if the relevant World Health Organization
6 McCollum ED et al. (WHO) guidelines published in 2014 had been applied, 390/568
Organ. (68.7%) severely hypoxaemic children at study health centres
2016 Dec 1 and 52/84 (61.9%) severely hypoxaemic children seen by
Malawi community health workers would have been considered ineligible
for referral.
41
The Use of Pulse Oximetry to Retrospective The median pulse oximetry reading of children with radiographic Moderate Do not favour
Exclude Pneumonia in comparison study. pneumonia was 97% (interquartile range 95th- 98th percentile) the use of pulse
Children In our study compared with 98% (interquartile range 96th-99th percentile) in oximetry
population of children the control group.
The American Journal of under the age of 24 Forty-five percent (35 of 78) of children with radiographic
Emergency Medicine months, 803 chest pneumonia showed oxygen saturations of 98% or higher with
2002 Oct radiographs were greater than 10% (8 of 78) displaying oxygen saturations of
USA obtained and 100%.
7 analyzed.
By using logistic regression, pulse oximetry was not found to be a
statistically significant predictive variable for radiographic
pneumonia.
42
Table 7: Summary of studies with supportive evidence for pulse oximetry
No. Title/ Authors/ Year/ Country Type of study Overall outcome Risk of Bias - Remarks
and number of Overall
participants
1. Beyond Critical Congenital Heart Comparative The sensitivity and specificity of pulse Moderate Favours
Disease: Newborn Screening Using cross-sectional oximetry screening for non-cardiac diseases expanded use of
Pulse Oximetry for Neonatal Sepsis study. were 42% and 99.9% respectively, and pulse oximetry.
and Respiratory Diseases in a Middle- 100% and 99.7% for CCHD, respectively.
Income Country. N = 5247 Expanded use of pulse oximetry has
immediate implications for low- and middle-
Jawin V et al. income countries contemplating strategies
PLoS One. to reduce neonatal mortality and morbidity.
2015 Sep 11
Malaysia
2. What is the role of pulse oximetry in Prospective cohort SpO₂ ≤ 90% has good specificity but low Moderate Pulse oximetry
the assessment of patients with study sensitivity for adverse outcomes in CAP. complements
community-acquired pneumonia in rather than
primary care? N = 467 replaces clinical
severity scoring.
Bewick T et al.
Prim Care Respir J.
2010 Dec
UK
3. Adoption of paediatric and neonatal Mixed-methods Prior to our intervention, 3.3% of children Moderate Favouring the
pulse oximetry by 12 hospitals in realist evaluation. and 2.5% of neonates had oximetry use of pulse
Nigeria: a mixed-methods realist documented on admission. oximetry
evaluation. Between January
2014 and April In the 18 months of intervention period, all
Graham et al. 2017, 38525 hospitals improved oximetry practices,
BMJ Glob Health. children (38% typically achieving oximetry coverage on
2018 Jun 26 aged ≤28 days) >50% of admitted children after 2-3 months
Nigeria were admitted to and >90% after 6-12 months.
participating
hospitals (23401
43
pre-training; However, oximetry adoption varied in
15 124 post- different contexts.
training).
4. Brief hospitalization and pulse Post-hoc cohort The inclusion of oximetry data improved the Moderate Favouring the
oximetry for predicting amoxicillin analysis was predictive ability at baseline, 12 hours, and use of pulse
treatment failure in children with nested within a 24 hours. The ability to predict failure after oximetry
severe pneumonia. previously 12 hours of observation with oximetry data
completed, was similar to the predictive ability after 24
Fu LY et al. randomized trial hours without pulse oximetry data.
PEDIATRICS
2006 Dec
9 locations in
8 countries
5. Multi-center study of hypoxemia Prospective, No hospital used pulse oximetry routinely, Low Favouring the
prevalence and quality of oxygen multicenter and only 9 of 40 (22.5%) patients<15 years use of pulse
treatment for hospitalized Malawian observational old with SpO2<90% were treated with oximetry
children. study. oxygen by hospital staff. Study personnel
using WHO criteria for children<5 years old
McCollum ED et al. N= 761 achieved a higher sensitivity (40.0%) and
Trans R Soc Trop Med Hyg. lower specificity (82.7%) than Malawian
2013 May clinicians (sensitivity 25.7%, specificity
Malawi 94.1%).
44
significant number of children with hypoxia
not receiving oxygen.
8. mPneumonia, an Innovation for Qualitative study HCPs and caregivers viewed the pulse Low Favouring the
Diagnosing and Treating Childhood based in ground oximeter and breath counter favorably. use of pulse
Pneumonia in Low-Resource Settings: theory methods Challenges included electricity oximetry
A Feasibility, Usability and requirements for charging and the time
Acceptability Study in Ghana. needed to complete the application. Some
caregivers saw mPneumonia as a sign of
Ginsburg AS et al. modernity, increasing their trust in the care
PLoS One. received. Other caregivers were hesitant or
2016 Oct 27 confused about the new technology. Overall,
Ghana this technology was valued by users and is a
promising innovation for improving quality
of care in frontline health facilities.
45
9. Childhood pneumonia diagnostics: Qualitative CHWs and national stakeholders across the Low Favouring the
community health workers' and methodology, four countries perceived the acute use of fingertip
national stakeholders' differing combination of respiratory infection (ARI) timer and pulse oximetry
perspectives of new and existing aids. pile-sorting fingertip pulse oximeter as highly scalable
activities and and easy for CHWs to use.
Spence H et al. focus group
Glob Health Action. discussions National stakeholders were less receptive to
2017 (FGDs). new technologies. CHWs placed greater
Cambodia, Ethiopia, Uganda and South priority on device acceptability to caregivers
Sudan. and children.
46
J Pediatr.
1991 Dec Radiographic pneumonia was not a sensitive
Peru predictor of hypoxemia or clinically severe
illness. In contrast, the presence of
hypoxemia was a useful predictor of
radiographic pneumonia, with both
sensitivity and specificity of 75% in infants.
47
Both single nor combined symptoms and
signs have satisfactory performance in
predicting hypoxaemia among young
children with ARI. Improved access to pulse
oximetry is needed in developing countries.
13. Does pulse oximeter use impact health Systematic Review The evidence is low quality and hypoxaemia Low Favouring the
outcomes? A systematic review definitions varied across studies, but the use of pulse
5 studies included evidence suggests pulse oximeter use with oximetry
Enoch AJ et al. children can reduce mortality rates (when
Arch Dis Child. combined with improved oxygen
AUG 2016 administration) and length of emergency
department stay, increase admission of
children with previously unrecognised
hypoxaemia, and change physicians'
decisions on illness severity, diagnosis and
treatment. Pulse oximeter use generally
increased resource utilisation.
48
Table 8 A: Parameters of Disease Progression
49
Table 8B: Care-seeking and health-care parameters
50
Table 9: Prognostic parameters
Acácio, S. et al.
Under treatment of pneumonia among
children under 5 years of age in a malaria-
endemic area: population-based surveillance
study conducted in Manhica district- rural,
Mozambique.
Int. J. Infect. Dis. 36, 39–45 (2015).
Adherence to severe 0.65 (0.6–0.7) Chinbuah, M. A. et al.
prognosis (IMCI) Assessment of the adherence of community
health workers to dosing and referral
guidelines for the management of fever in
children under 5 years: a study in Dangme
West District, Ghana.
Int. Health 5, 148–156 (2013).
Adherence to non-severe 0.55 (0.5–0.6) Assumed to be similar to IMCI
prognosis
Adherence to severe 0.85 (0.8–0.9) Assumed to be high for the purpose of this
prognosis analysis
51
Table 10: Cost parameters
52
Table 13: Cost of training frontline health-worker42
Table 14: Assumptions made for the decision tree in the study
Assumption
Once a patient is diagnosed with pneumonia, he/ she gets full treatment. Dropout/
poor compliance has not been factored.
The sensitivity and specificity of diagnosing any severity of pneumonia is the same.
Due to lack of availability of transition probabilities (for e.g.: percentage of
patients going back into non-severe state and not complete cure from severe state
after treatment) some of the intermediate states have been merged.
Proportion of patients with non-severe pneumonia who develop severe
pneumonia, if not given proper treatment
Proportion of patients with non-severe pneumonia who get cured and survive, if
not given proper treatment.
The proportion of children reaching an appropriate health facility may vary
significantly between various states and so having one single parameter for all the
28 states could result in inaccurate estimates
53
Search strings: Pulse oximetry for the diagnosis of pneumonia in children
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