1

Synopsis
Accuracy of clinical pallor to detect anemia among
female patients presenting to outpatient
department of a tertiary care hospital

Proposed By
Dr. Hira Bashir
Postgraduate student of FCPS
(Obstetrics and gynecology)

Under Supervision of
Prof. Shireen Zulifqar Bhutta
FRCOG, FCPS.
Department Of Obstetrics and gynecology. Jinnah
Postgraduate Medical Centre, Karachi

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The Director,
Research Training and Monitoring Cell,
College of Physicians & Surgeons, Pakistan,
7th Central Street Phase II, DHA, Karachi 75500

Dear Sir,
Please find herewith enclosed copy of synopsis titled Accuracy of clinical pallor
to

detect

anemia among

female

patients

presenting

to

outpatient

department of a tertiary care hospital prepared by Dr. Hira Bashir, as a prerequisite for FCPS-II in Obstetrics and gynecology. RTMC allotted registration number
is OBG-2014-175-13031.
My praiseworthy supervisor is Professor Dr. Shireen Zulifqar Bhutta, FRCOG, FCPS.
Serving as Professor, department of Obstetrics and gynecology, Jinnah Post
Graduate Medical Centre, Karachi.

Yours truly,

Dr. Hira Bashir

(Signature)

Supervisor

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TO WHOM IT MAY CONCERN

It is to certify that Hira Bashir is working as a postgraduate trainee leading to

FCPS-II Examination under my supervision. She is submitting the synopsis titled
Accuracy of clinical pallor to detect anemia among female patients
presenting to outpatient department of a tertiary care hospital. To the
best of my knowledge she is the only trainee working on this topic in this institute
within the period of five years.

Supervisors signature

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Prof. Shireen Zulifqar Bhutta
Professor of Obstetrics and gynecology
Jinnah postgraduate medical center, Karachi

Date: 18 June, 2016

Non-Ethical Consideration
This is to certify that the study being conducted by Dr. Hira Bashir titled
Accuracy of clinical pallor to detect anemia among female patients
presenting to outpatient department of a tertiary care hospital has no
ethical issues.

Signature

Accuracy of clinical pallor to detect anemia among female patients

presenting to outpatient department of a tertiary care hospital

Introduction:
Anemia is a common disorder, affecting a third of the world population most
of whom live in resource poor countries.1 Anemia is very common in
pregnant patients; one study estimates that 90.1 % pregnant Pakistani
patients are anemic.2
Signs traditionally used in the physical diagnosis of anemia are pallor of the
conjunctivae, nail beds, face, palms, and palmar creases. 3 Of these, only
pallor of the conjunctivae, nail beds, and palms can be used in patients of
any race. Current evidence suggests that conjunctival pallor may be a more
accurate indicator of the presence or absence of anemia than pallor of the
palms or nail beds.4 In addition, conjunctival pallor has been documented to
appear more frequently in patients with severe anemia, and hence may be
more sensitive than other signs.
Although diagnosis of anaemia can easily be done by traditional Sahli's
haemoglobinometer, or more recently by electronic cell counters, yet
physicians and healthcare workers try to detect anaemia by looking at
conjunctival, tongue, palmer, or nailbed pallor. 5 Often physicians use clinical
assessment of pallor as a screening test, and order haemoglobin test if one
or more sites suggest presence of pallor. This is especially true of crowded
outpatients departments of public hospitals, where most doctors either
believe that accurate estimation of haemoglobin is either not worth the time
and effort needed to obtain it or do not have access to facilities to measure
haemoglobin.6 clinical assessment of cunctival palor is useful test for
estimation of anemia. It has sensitivity of 91.3% and specificity of 69.9% .7
There are situations, however, in which the presence of pallor may be more
helpful. For example, clinicians in the office often see patients whose

probabilities of anemia are too low to justify ordering a hemoglobin

determination to search for it. However, the presence of conjunctival pallor in
such a patient can raise the probability of anemia high enough to make a
hemoglobin determination worthwhile. For example, when a clinician initially
assesses a patient's probability of having anemia and then finds pale
conjunctivae on physical examination, the probability of anemia increases.
Rationale:
Blood hemoglobin level though standard for diagnosis and assessment of
severity of anemia yet it is both time consuming and costly. Testing for
conjunctival pallor on contrary is very easy, quick and cost effective method.
It is important for health-care workers to know the accuracy of pallor in
detecting anemia. The aim of the present study will be to determine
accuracy of clinical pallor to detect anemia among pregnant patients
presenting to outpatient departments of a tertiary care hospital.

Objective: to determine accuracy of clinical pallor to detect anemia among

female patients presenting to outpatient department of a tertiary care
hospital.

Operational definitions:
Clinical pallor: will be considered as positive if the color of the anterior rim
of conjunctiva is same as that of the posterior pale rim. Assessed on clinical
examination.
Anemia: anemia will be considered positive if serum Hb < 7mg/dl.
Sensitivity
The ability of conjunctival pallor to detect anemia, positive in patients who
actually have anemia.

Specificity
The ability of conjunctival pallor to identify the patients who do not have
anemia.

Positive predictive value (PPV)

It is the percentage of patients who are predicted as having anemia by
conjunctival pallor
Negative predictive value (NPV)
It is the percentage of patients who do not have anemia as predicted by
conjunctival pallor.
True Positive
These will be the patients who will be having conjunctival pallor and will have
anemia on blood testing.
True Negative
These will be the patients who will be having conjunctival pallor and will not
have anemia on blood test.
False Positive
It means positive conjunctival pallor but patient does not have anemia on
blood test.
False Negative
It means negative conjunctival pallor but blood tests shows anemia.

MATERIAL AND METHODS

Study Design: Cross sectional Validation Study

Study Settings:

Study will be conducted at Gastroenterology and

Hepatology division of the Medical unit I, Holy Family Hospital, Rawalpindi.

Duration of Study: 06 Months after the acceptance of synopsis.

Sample Size.
Sample size will be calculated by sensitivity, specificity calculator using
statistics7
Expected sensitivity 91.3%
Expected specificity 69.9%
Confidence interval 95%
Expected prevalence 0.90
Absolute precision required 0.05
Sample size 137
Inclusion Criteria:

All pregnant, female patients, aged 18-60 attending antenatal care

OPD.
All having conjunctival pallor on general physical examination,

Exclusion Criteria:

Patients on long-term transfusion therapy (for more than 10 years)

Patients who had received a blood transfusion within three months

prior to the study

Patients with a history of other critical illness such as heart failure
(diagnosed on EF < 25%, COPD (diagnosed on FEV < 70% predicted),
CKD (diagnosed on S. Cr > 3mg/dl or malignancy (confirmed biopsy
report)

Data collection procedure:

This study will be conducted after the approval from college of physicians &
surgeons Pakistan and Jinnah Postgraduate Medical centre, Karachi ethical
review committee. The patients will be enrolled from medical unit I of Jinnah
Postgraduate Medical centre, Karachi. Those patients who fulfill the
inclusion/exclusion criteria of the study will be asked for written consent at
the time of admission. The investigator will collect the data on a prescribed
questionnaire which will include baseline characteristics of patient. The
reference variable will be hemoglobin concentration in blood which was
noted from the investigation chart of the patient. On the same day five
milliliters of blood will be drawn from a convenient peripheral vein into plain
tubes for assessment of iron deficiency anemia. Tubes will be transported to
the laboratory of the hospital. Results of the laboratory tests will be
evaluated when available. Anemia will be labeled as per operational
definition and will be noted in proforma by researcher.

Data Analysis procedure

Data will be analyzed by using SPSS Version 20.In descriptive statistics
frequencies will be calculated for variables like TP, TN, FP, FN,DA and parity.
In addition percentages, mean values, and standard deviations will be
calculated for all variables like maternal age, gestational age and Hb level.
2X2 table will be constructed to calculate sensitivity, specificity, PPV, NPV
keeping anemia as gold standard. Stratification will be done with respect to
maternal age, gestational age and parity. post stratification chi square test
will be applied. P > 0.05 will be taken as significant
Anemia
+ve

-ve

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Conjuncti

+ve

TP

FP

-ve

FN

TN

val
pallor

PPV (positive predictive value) = PV= TP/TP+FP100

NPV (negative predictive value) = NP= TN/ TN+FN100
Sensitivity = TP/FN+TP100
Specificity = TN/ FP+TN100
Diagnostic Accuracy = TP+TN/TP+TN+FP+FN100

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References:
1. Kassebaum NJ, GBD 2013 Anemia Collaborators. The Global Burden of
Anemia. Hematol Oncol Clin North Am. 2016 Apr;30(2):247308.
2.Baig-Ansari N, Badruddin SH, Karmaliani R, Harris H, Jehan I, Pasha O, et al.
Anemia prevalence and risk factors in pregnant women in an urban area of
Pakistan. Food Nutr Bull. 2008 Jun;29(2):1329.
3. Collings S, Thompson O, Hirst E, Goossens L, George A, Weinkove R. NonInvasive Detection of Anaemia Using Digital Photographs of the Conjunctiva.
PloS One. 2016;11(4):e0153286.
4. Kalantri A, Karambelkar M, Joshi R, Kalantri S, Jajoo U. Accuracy and
reliability of pallor for detecting anaemia: a hospital-based diagnostic
accuracy study. PloS One. 2010;5(1):e8545.
5. Buttarello M. Laboratory diagnosis of anemia: are the old and new red cell
parameters useful in classification and treatment, how? Int J Lab Hematol.
2016 May 16;
6. Sharawy N, Hussein A, Hossny O, Refaa A, Saka A, Mukhtar A, et al. Effects
of haemoglobin levels on the sublingual microcirculation in pregnant women.
Clin Hemorheol Microcirc. 2016 May 30;
7. Butt Z, Ashfaq U, Sherazi SFH, Jan NU, Shahbaz U. Diagnostic accuracy of
pallor for detecting mild and severe anaemia in hospitalized patients. JPMA
J Pak Med Assoc. 2010 Sep;60(9):7625.

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PERFORMA
Accuracy of clinical pallor to detect anemia among female patients
presenting to outpatient department of a tertiary care hospital

Name_______________
Age_____________________
Reg NO._________________
No___________________

Ph

Address____________________________________________________________

Hb____________________
Gestational age
Parity

Clinical pallor
Anemia

1) nulliparous

1) Yes
1) Yes

2) multiparous

2) No
2) No