Open access
Original article
Quality improvement initiative using
transcutaneous bilirubin nomogram to
decrease serum bilirubin sampling in
low-risk babies
Muhammad Hussain Shah,1 Shabina Ariff,1 Syed Rehan Ali,2
Rayaan Asad Chaudhry,1 Maryam Pyar Ali Lakhdir,3 Fatima Qaiser,4
Simon Demas,1 Ali Shabbir Hussain 1
To cite: Shah MH, Ariff S,
Ali SR, et al. Quality
improvement initiative using
transcutaneous bilirubin
nomogram to decrease serum
bilirubin sampling in low-risk
babies. BMJ Paediatrics Open
2019;3:e000403. doi:10.1136/
bmjpo-2018-000403
ABSTRACT
Background Screening for neonatal hyperbilirubinaemia
1
in the postnatal ward has traditionally been performed
using serum bilirubin sampling, but this has significant
drawbacks such as risk of infection and slower reporting
time.
Objective We aimed to assess the impact of introducing
transcutaneous bilirubin (TcBR) testing using TcBR
nomogram on the number of serum bilirubin samples sent.
Methods A before-and-after study was performed
following the introduction of a protocol integrating the use
of the Dragger JM-105 transcutaneous bilirubinometer
in the postnatal ward. Only babies born at ≥37 weeks of
gestation, weighing ≥2500 g who presented with jaundice
after the first 24 hours and within the first 7 days of life
were included in the study. The number of total serum
bilirubin samples (TSBRs) sent were compared for the
6-month periods before and after (a total of 12 months)
implementation of the new protocol.
Results In the pre-implementation phase, a total of 882
(49%) out of 1815 babies had at least one serum bilirubin
sample taken as opposed to a total of 236 (17%) out of
1394 babies in the post-implementation phase. The odds
of performing TSBRs at least one time among babies in
post-implementation phase were 79% lower than in preimplementation phase (OR 0.21, 95% CI 0.18 to 0.25). We
also estimated a significant cost saving of approximately
US$1800 over a period of 6 months
Conclusion TcBR testing used in conjunction with our
proposed nomogram significantly reduces the need for
serum bilirubin sampling.
Correspondence to
Dr Ali Shabbir Hussain, The Aga
Khan University; ali.hussain@
aku.edu
INTRODUCTION
Jaundice in the neonatal period is a very
common cause of concern for both parents
and healthcare providers. Clinically, it is
subjectively determined by an observer as a
yellow discolouration of the skin or sclera. It
usually presents after the first 24 hours of life
and spontaneously resolves over the next few
days. If jaundice remains unrecognised for a
prolonged period of time, there is a high risk
Received 2 November 2018
Revised 4 January 2019
Accepted 7 January 2019
© Author(s) (or their
employer(s)) 2019. Re-use
permitted under CC BY-NC. No
commercial re-use. See rights
and permissions. Published by
BMJ.
Department of Paediatrics and
Child Health, The Aga Khan
University, Karachi, Pakistan
2
The Indus Hospital, Karachi,
Pakistan
3
Department of Community
Health Sciences, The Aga Khan
University, Karachi, Pakistan
4
Department of Pediatrics, Dow
University of Health Sciences,
Karachi, Pakistan
What is already known on this topic?
► Jaundice is a common newborn problem. Early rec-
ognition and treatment play a key role in preventing
bilirubin-induced neurological dysfunction.
► Transcutaneous bilirubin (TcBR) measurement
provides a reliable screening tool for detection of
neonatal jaundice; however, its widespread use
in low- and lower middle-income countries is still
limited.
► Significant differences in TcBR nomogram exist
across populations based on ethnicity, race and bilirubin kinetics.
What this study hopes to add?
► A TcBR measurement protocol that significantly re-
duces serum sampling in healthy, full-term and lowrisk babies.
► A TcBR nomogram which is easy to use and reliable.
► This TcBR nomogram and screening protocol can
be used at a larger scale in similar settings for improvement in quality and reduction in cost of care
for babies with neonatal jaundice in low- and lower
middle-income countries.
of bilirubin-induced neurological dysfunction and irreversible neurological damage.1
Traditionally, babies are screened using
the Kramer’s Scale which divides the body
into five different quadrants for rapid visual
assessment of jaundice.2 Total serum bilirubin (TSBR) levels are done to confirm the
diagnosis and commence treatment.3 This
not only leads to excessive blood sampling
but also predisposes to infections and causes
significant pain to the child. Obtaining blood
samples also requires trained personnel and
clinical expertise.4 Laboratory testing is also
expensive and time-consuming, which may
cause delays in initiation of treatment.5
Shah MH, et al. BMJ Paediatrics Open 2019;3:e000403. doi:10.1136/bmjpo-2018-000403
1
Open access
in TcBR group compared with non-TcBR group.9 Implementation of TcBR in hospital or community-screening
programme is associated with a reduction in the incidence of severe neonatal jaundice, readmission for
phototherapy and lower duration and rate of phototherapy.10 Despite its utility, very few hospital wards in
low- and lower middle-income countries are using TcBR
as a screening tool. Hence TSBR remains the gold standard for commencement of phototherapy.11
Although several TcBR nomograms have been evaluated, significant differences exist across populations
based on ethnicity, race and bilirubin kinetics.12 Studies
from Pakistan have also shown encouraging results,13 but
the widespread use of the transcutaneous bilrubinometer
has still not been adopted. In addition, there has never
been any study that looked to establish a TcBR nomogram for Pakistani population. This study would allow
us to develop a protocol for initiation of phototherapy
that could be used in various neonatal healthcare settings
and might reduce the complications and delay of blood
sampling.
Our aim was to implement a quality improvement
initiative to reduce the number of blood sampling for
jaundice in low-risk well babies using a TcBR nomogram.
Figure 1 Pre-implementation phase flowchart. TSBR, total
serum bilirubin .
The transcutaneous bilirubin (TcBR) meter presents us with a viable solution to these problems. It uses
multi-wavelength spectral reflectance from the skin to
estimate TSBR and hence avoid blood sampling. TcBR is
an inexpensive ‘point of care’ test that can be performed
by any health caregiver in the hospital or community
setting.6 It is used as a quick, non-invasive, screening tool
for neonatal hyperbilirubinaemia.7 Over time, various
studies have demonstrated its reliability and validity.8 9
One randomised controlled trial done in the Netherlands
showed significant reduction in blood bilirubin samples
METHODOLOGY
Setting
Our methods followed the framework that was described
in our protocol.14
The study was carried out in the postnatal well-baby
wards of The Aga Khan University Hospital (AKUH),
Karachi. AKUH is a JCI-accredited, 600-bedded large
private sector tertiary care hospital that contributes to
healthcare needs of the largest city of Pakistan and adjacent areas within the province of Sindh. It has two wellbaby wards with a total capacity of around 60 patients at
any given time. There are on average around 6000 babies
born at the hospital every year. Cost of care is born by the
patient. Mostly women belonging to upper middle socioeconomic class deliver here, although we offer welfare to
those who are in need. Well babies are kept for approximately 48–72 hours and followed up based on the risk
assessment usually within a week from discharge.
Duration
The study was divided into two distinct 6-month phases,
a retrospective pre-implementation phase and a prospective post-implementation phase, with a 1- month implementation phase in between. The overall duration of the
study was 12 months from 1st September 2016 to 30th
September 2017.
Figure 2 TcBR nomogram. (TcBR transcutaneous bilirubin.)
2
Study population
All babies that were admitted in the postnatal ward during
this period with a gestational age greater than 37 weeks and
birth weight greater than 2500 g were enrolled. However,
any patients that presented with clinical jaundice within
Shah MH, et al. BMJ Paediatrics Open 2019;3:e000403. doi:10.1136/bmjpo-2018-000403
Open access
Figure 3 Post-implementation phase
flowchart. (G6PD, glucose-6-phosphate dehydrogenase;
TcBR, transcutaneous bilirubin; TSBR, total serum bilirubin.)
the first 24 hours of life or after 7 days were excluded.
Those at high risk for neonatal jaundice such as babies
born at less than 37 weeks of gestation, with birth weight
less than 2500 g, with a positive direct Coombs test or
whose mothers had a positive anti-red blood cell antibody
screening test were also not eligible for the study. Any
baby with a history of a sibling with glucose-6-phosphate
dehydrogenase deficiency, kernicterus or requiring
exchange transfusion for neonatal hyperbilirubinaemia
were also excluded from the cohort.
Patient involvement
Patients were not directly involved in the design of this
study.
Pre-implementation phase
Data of all eligible babies during this phase were extracted
from the electronic medical records. Flow chart for
pre-implementation phase is shown in figure 1.
checked, calibrated and serviced by the staff from the
biomedical department. TcBR measurements were taken
over the mediastinum as studies suggest that it is better
than forehead measurements.16 Three consecutive readings were taken and the average result was recorded. As
per our study protocol (figure 3), if TcBR level fell on or
over the phototherapy (red) line, serum TSBR was sent
and phototherapy was also started. If TcBR level fell on
or over the TcBR (blue) line, then serum TSBR was sent;
however, phototherapy was started only if TSBR levels fell
on or over the phototherapy (red) line. All babies that
tested below the TcBR line were followed with serial TcBR
testing every 8 hours until resolution of clinical jaundice.
Prior to the implementation phase, a hands-on training
and competency certification of all neonatal healthcare
providers were done. During this phase, all components
of the study protocol were explained and the protocol
flow chart (figure 3) and TcBR nomogram (figure 2)
were handed over to them. The same were also pasted
across all postnatal ward areas for reference. Monthly
refreshers were also conducted.
Data collection
Data from the two distinct phases were collected from
the electronic medical records for all neonates during
both phases of the study. Demographics, including gestational age, chronological age, gender and birth weight,
were obtained. TcBR levels were obtained for patients
suspected of having hyperbilirubinaemia as determined
by trained physicians or nurses. All data were recorded in
the predesigned study proforma.
Analysis and ethics
Analysis was done using Stata V.12. Demographic factors
were measured to ensure that children in both phases
had similar attributes. Comparisons between the percentages of babies that required TSBR in the two phases were
made using a χ2 test with a p value less than 0.05 indicating
significance. Mean peak TcBR and mean peak TSBR in
post-implementation phase were compared to look for
differences. Crude sampling cost was calculated to look
for any meaningful savings between the two phases.
Intervention and post-implementation phase
TCBR nomogram
We used the American Academy of Paediatrics (AAP)
phototherapy guidelines to make a modified TcBR nomogram (figure 2). The high-risk and intermediate-risk lines
from the AAP nomogram were removed and the low-risk
line was renamed and colour coded as the phototherapy
(red) line. A new TcBR (blue) line was drawn 2 mg/dL
(34.2 µmol/L) below the phototherapy (red) line. This
was done because various published articles and the
device manufacturer reported a variation of ±1 mg/dL
(17.1 µmol/L) in the values of TcBR and TSBR.15
Equipment and training
Two Dragger JM-105 TcBR metres were used, one for
each well-baby nursery. Both devices were routinely
Shah MH, et al. BMJ Paediatrics Open 2019;3:e000403. doi:10.1136/bmjpo-2018-000403
Table 1 Demographic data for the live inborn non-high-risk
babies >37 weeks of gestation in both phases of the study
Demographic data of term well babies eligible for study
Number of term well
babies
Mean gestational
age±SD (weeks)
Phase 1
Phase 2
1815
1394
38.0 (±1.0)
38.0 (±1.0)
Mean birth weight±SD 3092.0 (±371.9)
(g)
3133.0 (±374.91)
Male n (%)
Female n (%)
696 (50%)
698 (50%)
875 (48%)
940 (52%)
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Table 2 Outcome data for two distinct implementation phases
Primary and secondary outcome data of eligible cases
Phase 1 (n=1815)
Phase 2 (n=1394)
P value
Number of babies whose TSBR was sent at least one time (%)
Number of TSBR performed
882 (48.60%)
1022 (56%)
236 (16.93%)
437 (31%)
<0.001
<0.001
Mean number of TSBR performed per baby
1.2 (0.5)
1.9 (1.2)
>1.000
Number of babies requiring >1 TSBR (%)
99 (11%)
104 (44%)
<0.001
Mean peak TSBR (SD) (mg/dl)
9.22 (2.59)
10.22 (3.25)
<0.001
Phototherapy number (%)
70 (4%)
85 (6%)
0.0017
Number of babies whose TcBR was done at least one time
0
1125 (81%)
–
Number of TcBR performed
0
2956
–
Mean number of TcBR performed per babies
0
2.6 (1.2)
Number of babies requiring >1 TcBR (%)
0
847 (75%)
–
Mean peak TcBR (SD) (mg/dL)
Total number of tests performed (TSBR+TcBR)
0
1022
8.94 (2.29)
437+2956=3393
–
NA
In the post-implementation phase, 2956 TcBRs were performed. The mean peak TcBR among babies in phase 2 was 9.0±2.3 mg/dL.
TcBR, transcutaneous bilirubin; TSBR, total serum bilirubin.
The study was presented to and approved by the Hospital's Ethics Review Committee (Ref # 4742-PED-ERC-17).
RESULTS
There were a total of 2286 and 1705 babies born in the
hospital during the two phases. Of these, 1815 and 1394
babies were recruited, respectively, in each phase based
on the exclusion criteria. There was no significant difference in the demographics of the babies for the two time
phases (table 1).
The results showed that a total of 1022 TSBR samples
were sent in phase 1, whereas 437 in phase 2. There were
around 49% (n=822) of the 1815 term well babies in
phase 1 whose TSBR was performed at least one time,
whereas in phase 2, around 17% (n=236) of the 1394
term well babies whose TSBR was performed at least
one time (z=18.6; p value <0.001). This represents an
OR of 0.21 (95% CI 0.18 to 0.25) for babies in phase 2
whose TSBR was performed at least one time compared
with babies in phase 1. The odds of performing TSBRs
at least one time among babies in phase 2 were 79%
lower as compared with phase 1. The mean peak
TSBR (9.2±2.6 mg/dL) among babies in phase 1 was
significantly lower as compared with mean peak TSBR
(10.22±3.3 md/dL) among babies in phase 2 (t=−5.0; p
value <0.001) (table 2).
There was significant difference between rates of
phototherapy in both phases. Around 4% (n=70) of
babies in phase 1 were given phototherapy on the basis
of TSBR, whereas around 6% (n=85) of babies in phase 2
were given phototherapy (z=2.93; p value =0.0017). Out
of 85, around 60% (n=51) were given phototherapy on
the basis of TcBR. This represents an OR of 1.61 (95%
CI 1.17 to 2.24) for babies given phototherapy in phase
2 compared with babies given phototherapy in phase 1.
4
The odds of a baby receiving phototherapy in phase 2
were 61% higher as compared with phase 1 based on
tests.
DISCUSSION
To the best of our knowledge, this is the first Pakistani
study to incorporate the effectiveness of TcBR nomogram in managing neonatal jaundice. We report a
significant reduction in the percentage of babies who
required TSBR in the post-implementation phase. Our
finding of a 79% reduction is comparatively higher than
other similar studies.17–20 den Boer found a reduction of
46.9% and Maisels showed a 40% decrease in serum bilirubin sampling. We estimate that this large decrease in
our study was due to excessive sampling that was being
previously performed at our centre. This was likely done
keeping in mind the high (15%) incidence of severe
neonatal jaundice in the South Asian population.21
Although in comparison with phase 1, where serum
samples of about half of the babies were sent, the serum
samples in phase 2 were significantly less (17%). Mean
number of TSBR performed per baby (whose TSBR was
sent at least one time) in phase 2 was higher (1.9) as
compared with phase 1 (1.2). This is probably because a
significantly lesser number of babies had blood samples
in phase 2, but all those who had blood samples were
either at or near the phototherapy threshold and
probably required more frequent TSBR sampling as
compared with those babies who had blood samples for
TSBR in phase 1. TcBR, on the other hand, in phase 2
was performed in about 80% of the eligible babies. This
may be because TcBR was relatively easy to perform,
available at bed side, free of cost at that time and made
the assessment of the bilirubin extremely rapid. It was
also observed that the threshold for performing a TcBR,
Shah MH, et al. BMJ Paediatrics Open 2019;3:e000403. doi:10.1136/bmjpo-2018-000403
Open access
based on clinical judgement, was lower and that more
tests in total were done in phase 2 compared with phase
1. This was also due, in part, to the fact that our initial
protocol demanded that TcBR be repeated every 8 hours
until resolution of symptoms.
The study was not designed to assess the accuracy
of TcBR readings as this has already been well established internationally and22 23 in Pakistan also.8 22Nahar
et al calculated a mean difference of 0.97±1.01 mg/dL
between the TSBR and TcBR readings. This was in line
with the difference of 1.28 mg/dL illustrated in our data
between the mean peak TSBR and TcBR readings, with
the latter being lower which is consistent with international data. Foreseeing this underestimation, we established a serum sampling cut-off that was 2 mg/dL below
the phototherapy line (red line) in our nomogram. This
allowed us to account for the variation in readings that
may have arisen between TcBR and TSBR and maintain a margin of safety during the study to ensure that
no infants were missed.24It is also in accordance with the
nomogram established by Wainer et al who used a similar
lower threshold to begin serum sampling.
Mean peak TSBR in phase 1 was significantly lower in
comparison to phase 2. This was because in phase 1 serum
TSBR was sent on many babies based purely on clinical
judgement, whereas in phase 2 TSBR was only performed
on babies who met the criteria for serum sampling based
on the TcBR nomogram.
In the pre-implementation phase, 49% of babies
underwent blood sampling in order to give phototherapy
to only 4% babies, whereas in phase TSBR samples of
17% babies were sent to administer phototherapy to 6%
babies. A higher percentage of babies’ receiving phototherapy in phase 2 (6%) than in phase 1 (4%) were probably due to early detection of babies at risk for developing
jaundice by TcBR who may have been missed in phase 1.
Crude cost savings were estimated using the assumption
from phase 1 that around 50% of the babies would have
been pricked in the absence of this protocol. This means
that from the total eligible babies in phase 2 (1394), half
of them (697) would require at least one serum sampling
for TSBR. Because we actually performed TSBR on 437
babies, we saved around 260 samples from being sent.
One TSBR sample costs around $7 at our institute and
based on the number of samples saved we estimate a
total crude cost savings of around $1800 in just 6 months.
This figure does not include extra saving incurred such
as the cost of antiseptic measure (gloves, swabs), storage
containers, syringes, time, requirement of skilled individuals and risk of hospital-acquired infections etc.
Based on the above-mentioned figure, the cost of device
can be recovered in 2 years, whereas the service life of
the device as quoted by the manufacturer is 150 000
measurements, enough for a 25-year service at The Aga
Khan University Hospital.25This supports the substantial
savings demonstrated by Mcclean et al who also observed
the difference in smaller community settings. In a lowto lower middle-income country such as Pakistan, this
is especially significant and can benefit a large population. The nomogram also proved easy to understand
and implement by all involved healthcare professionals,
making the transition faster and more efficient.
Along the course of our study, we came across some
shortcomings which we would like to report. First, our
study is a small, single-centre study, with a study duration
of only 12 months. We feel that during the post-implementation phase, TcBR may have been used more than
that reported because of convenience, rapid results and
easy availability. In addition, we did not do TcBR and
TSBR simultaneously. Doing this would have allowed us
to eliminate any further discrepancy in between the two
readings. We did not include babies at high risk for developing jaundice for which further studies can be planned.
Although there were no cases of exchange transfusion
during the study period, we did not specifically record
duration of phototherapy and hospitalisation in our data.
We would also like to look at frequency of babies in both
phases who were readmitted for phototherapy.
CONCLUSION
We conclude that TcBR screening in conjunction with
our nomogram provides a rapid and useful tool for
screening low-risk babies for neonatal jaundice. It is a
safe, easy to use, cost-effective method and also prevents
unnecessary painful pricks. Furthermore, large population-based trials are required to look at the efficacy, safety
and cost-effectiveness of the nomogram so that it can be
instituted at a larger scale throughout Pakistan.
Acknowledgements We would like to acknowledge the staff of well-baby
nursery, all physicians involved in well-baby care. n Rukhsana, Naureen Lalani,
Khalil Ahmad and Sohail salat.
Contributors SRA, ASH and MSA planned, conducted the study and reviewed the
manuscript. RA, MA, ASH helped in analysis and wrote the initial draft. FQ and MHS
helped in conducting, analysis and manuscript writing. SD helped in conducting the
study. All authors contributed equally in finalising the manuscript.
Funding The authors have not declared a specific grant for this research from any
funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval This study was approved by the AKU ethical review committee
ERC number :4742-ped-ERC-17.
Provenance and peer review Not commissioned; externally peer reviewed.
Open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non-commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the
use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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Shah MH, et al. BMJ Paediatrics Open 2019;3:e000403. doi:10.1136/bmjpo-2018-000403