ORIGINAL ARTICLEAccuracy of Clinical Examination of Breast
Lumpsin Detecting Malignancy: A Retrospective StudyChandni Ravi
& Gabriel RodriguesReceived: 4 February 2012 / Accepted: 24
April 2012 / Published online: 22 May 2012#Indian Association of
Surgical Oncology 2012Abstract Clinical examination is a simple
method to detectbreastlumpsand theirnatureasit isinexpensive and
non-invasive and if found to be accurate, might be of great
valueasa diagnostictool. Theaimofthisstudywasto
evaluatetheaccuracyof clinical examinationandits
contributiontowards the diagnosis of a palpable breast lump. The
studywasrecordbasedandconductedat aUniversityMedicalCollege
Hospital and a tertiary referral centre of South India.Patient
filesofthosewomenwhopresentedwithabreastlumpbetweenJanuarytoDecember2011werestudied.
Atotal of 120patients wereobtainedfollowingnecessaryexclusions.
Theaccuracyofclinical assessment at anout-patient facilitywas
determinedbycomparingthephysi-ciansdiagnosiswiththefinal
histopathological diagnosis.The inter-observer agreement (kappa)
for diagnosingabreast lumpwas81%(95%ConfidenceInterval 071%to 92 %)
indicating a good agreement between clinical andpathological
diagnoses. McNemar test also indicated a highdegree of concordance
between the two diagnoses (4.17 %discordance). Sensitivity,
specificity,
positiveandnegativepredictivevaluesofclinicalbreastexaminationincompar-isontohistopathologywere95,
88, 87,
and95%respec-tively,withanoverallaccuracyof90.8%.11lumpswerewrongly
diagnosed at the time of clinical examination. Clin-ical
examination of breast lumps was found to have a highsensitivity
(94.5 %) and specificity (87.7 %) and can be
usedasthediagnostictool toidentifythenatureof thelump,however, its
value in diagnosing breast malignancy
remainscontributoryduetothepossibilitythat malignant
lumpscouldbeoverlookedandpresent asadvancedcancer at alater stage.
Histopathologyis recommendedinall casesunless clinical
examinationis supportedwithstrongevi-denceof
benignitybasedonrepeatedbreast imagingviaultrasound or mammogram
(>35 yrs).KeywordsBreast cancer .Clinical examination .Biopsy
.SurgeryIntroductionBreast cancer is the second most common cancer
(10.4 % ofall cancer incidence, both sexes counted) and the fifth
mostcommoncauseofcancerdeathintheworld[1]. In2005,breast cancer
caused502,000deaths worldwide(7%ofcancer deaths; almost 1 % of all
deaths) [2]. One-fourth ofwomensufferfrombreast
diseaseintheirlifetime[1, 2].Withtheimprovement
inhealthcareandincreasinglifeexpectancy,
moreandmorewomenarebeingexposedtotheriskof developingbreast cancer.
Majorityof womenwhocometothesurgicalOPDcomplainofeitherpainorlump
in the breast or discharge from the nipple [3].There are various
modalities for the diagnosis of a breastlumpsuchasmammography,
ultrasonography,
fineneedleaspirationcytology(FNAC)butnoneofthemarewithoutimpunity[4].
Clinical evaluation, however, is a simplemethod to detect cases as
it is inexpensive and non-invasive and if found to be accurate,
might be of great value[5]. Timelyandaccuratediagnosisof abreast
lumpwithearlyinterventioncanbringdownmorbidityandmortalityof
malignant disease. Clinical evaluation could function as
avaluablediagnostictool. This
wouldprovetobehighlyusefulparticularlyinruralareaswherefundsand/orfacili-ties
may not be available for more sophisticated diagnosticC. Ravi:G.
Rodrigues (*)Department of General Surgery, Kasturba Medical
College,Manipal University,Manipal 576104 Karnataka, Indiae-mail:
[email protected] J Surg Oncol (June 2012)
3(2):154157DOI 10.1007/s13193-012-0151-5methods [6]. The systematic
use of the clinical examinationcriteriaandtheorganizational
platformwouldallowtheclinicianstoselectmalignant
casesandplaninpatient/out-patient surgical treatment so as to avoid
unnecessary admis-sions which will reduce hospital bed occupancy
andexpenditures incurred on the part of the patient.Breast lump is
a very sensitive issue for the patient so areliable, non-invasive
and prompt diagnosis helps to lessenthe associated anxiety and
leads to early definitivetreatment.Review of LiteratureEarly work
by Magarey CJ et al. [7] was concerned with thedevelopment of a
management plan for the outpatient diag-nosisof breast
symptomsandtheyconcludedthat inthemajority of patients the presence
or absence of malignancycanbeestablishedwithahighdegreeof
certaintybeforebiopsy. Several groups of researchers
haveevaluatedthediagnostic efficacy of what is known as the triple
test
score,ortheclinical-radiologic-cytologicaltriad[812].Majorityof
them advocate this system of diagnosis and suggest that
itshouldbefollowedbydefinitivetreatment,
basedonthehighaccuracyvalues obtainedbythestudies. However,Crone P
et al. [9] found that while the diagnostic
sensitivityofclinicalexaminationwashigh, around98%, thespeci-ficity
was rather low, averaging 48 %. In addition, the
studydisclosedastatisticalpossibilityofoverlookingafewma-lignant
tumors when using these three procedures and theyrecommended
excision of all palpable breast lumps.ReevesMJet al.[13] developed
a clinicaldecision rulefor triage of women with palpable
breastmasses into openbiopsy or follow-up and concluded that it
reduced the num-ber of open biopsies performed. There is an overall
consen-sus that clinical breast examination(CBE) is useful
inscreening as well as in evaluation of a lump. About 3 %
to45%ofcancerdiagnosesmissedbymammographywerereportedas
havingbeendetectedbyCBE. Althoughthesensitivityof
mammographyisgreater thanthat of CBE,thereisaresidual
diagnosticvalueofCBEthat favorsitscontinued use in screening
[14].Patients and MethodsThe study design was record based. The
records of womenwhopresentedwithabreast lumpor referredfor
breastexaminationtothis UniversityMedical CollegeHospitaland a
tertiary referral centre of South India, during the timeperiod
January to December 2011 were studied. Structuredperformas
werefilledbasedontheinformationobtainedfromthe individual patient
files. Out of a total of
207womenwhopresentedtoouroutpatientdepartmentwithabreastlump,87exclusionsweremadewhenthediagnosiswas
known prior to examination (For example, if they
werediagnosedelsewhereandhadcomeforasecondopinion),when patients
who were admitted for treatment or follow-upand if the clinical
impression following examination was
notdocumented,orwherepathologicalconfirmationofthedi-agnosis was
absent. Information was obtained regarding theclinical impression
and differential diagnosis as recorded
bythephysicianatthetimeofexamination,
followingwhichhistopathologylabreports of those were patients
wereaccessed to obtain the final/confirmatory
diagnosis.Collecteddata were analyzedusingSPSS16.0. Thesensitivity,
specificity, positivepredictivevalue, negativepredictive values
were calculated. An inter-observer reliabil-ityanalysis usingthe
Kappastatisticwas performedtodetermineconsistencybetweenclinical
andpathologicalfindings. McNemar test wasperformedtotest
thedegreeof discordance between the findings. Sensitivity,
specificity,predictivevalues
andaccuracywerecalculatedbyusingstandard formulae on the 22
table.ResultsAtotal of 120patients
fulfilledtheinclusioncriteriaofwhom clinically, 60 (50 %) were
benign and 60 (50 %) weresuspicious for malignancy. Of the 23
patients that underwentmammography, 9 (39 %) were benign and 14 (61
%) weresuspicious for malignancy. Histopathologyrevealed65(54.2%)
tobebenignand55(45.8%) tobemalignant.Clinical examinationwas
foundtohaveasensitivityof94.5%, i.e., 52out of55malignant
lumpsweredetectedclinically, andaspecificityof 87.7%, i.e., 57out
of 65benignlumpswereclinicallydiagnosedtobebenign.
Thepredictivevalueof apositivewas86.7%, thepredictivevalue of a
negative test was 95 % (Table 1). 109 out of 120lumps were
diagnosed correctly (overall accuracy of90.8%).
Theinter-observeragreement(Kappa)was0.817Table 1 Accuracy of
clinical diagnosis (when compared to histopath-ological
diagnosis)Histopathology Malignant Benign TotalClinical
impressionMalignant 52 8 60Benign 3 57 60Total 55 65 120a)
Sensitivity052/55100094.5 % b) Specificity057/65100087.7 %c)
Positive predictive value052/60100086.7 % d) Negative
predictivevalue057/60100095 %e) Accuracy052+57/120090.8 %Indian J
Surg Oncol (June 2012) 3(2):154157 155(81%) withp
