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ORIGINAL ARTICLE
Year : 2019  |  Volume : 7  |  Issue : 4  |  Page : 143-147

Diagnostic accuracy of triple test in breast pathologies of women above 20 years of age


1 Department of General Surgery, Government Medical College, Ratlam, Madhya Pradesh, India
2 Department of General Surgery, SAIMS and RC, Indore, Madhya Pradesh, India

Date of Submission26-Mar-2019
Date of Acceptance16-Sep-2019
Date of Web Publication12-Dec-2019

Correspondence Address:
Anurag Jain
Associate Professor, Department of General Surgery, Government Medical College, Ratlam - 457 001, Madhya Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ssj.ssj_15_19

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  Abstract 

Background: This study is to establish the diagnostic accuracy of triple test in assessing breast pathologies in women above 20 years of age taking their histopathological report as standard.
Patients and Methods: In our analytical study, we included women presenting with a complaint of breast lump or change in breast texture in an age group of above 20 years. Systematic clinical examination was done followed by mammography and finally fine-needle aspiration cytology (FNAC) for tissue sampling. Lesions were considered triple test positive, if lesions were FNAC positive and any one of the remaining two modalities also gave a positive (malignant) interpretation, supporting FNAC, but each of three components must be negative for labeling triple test as negative. Postoperatively, cumulative results were compared with histopathology reports and statistical parameters such as specificity, sensitivity, positive predictive value, negative predictive value, and accuracy of triple test were calculated.
Results: We have obtained 100% sensitivity using triple test in all age groups when each element was interpreted as malignant and 100% specificity (P < 0.001) when each element was interpreted as benign with diagnostic accuracy of almost 100% in concordant cases. It was recommended that in cases, where all three modalities are not in agreement for benign pathology and in FNAC positive cases where other two parameters are not in agreement, and lesion is interpreted as suspicious on triple test, the nature of the lesion must be ascertained by excision biopsy.
Conclusion: Triple test of breast pathologies is a reliable method and allows detection of breast pathologies in an effective manner, and undue delay in treatment can be minimized by using this modality in limited resource country.

Keywords: Breast cancer, clinical examination mammography, fine-needle aspiration cytology, triple test


How to cite this article:
Jain A, Jain R. Diagnostic accuracy of triple test in breast pathologies of women above 20 years of age. Saudi Surg J 2019;7:143-7

How to cite this URL:
Jain A, Jain R. Diagnostic accuracy of triple test in breast pathologies of women above 20 years of age. Saudi Surg J [serial online] 2019 [cited 2020 May 30];7:143-7. Available from: http://www.saudisurgj.org/text.asp?2019/7/4/143/272844


  Introduction Top


Breast (mammary gland) is a distinguishing feature of class Mammalia; from puberty to death, the breast is subjected to constant physical and physiological alteration that relates to menses, pregnancy, gestation, and menopause.

Nearly, half of the population is of females, and they are likely to suffer from diseases of breast any time after puberty. Breast problems make up to 20% of the workload of a surgical outpatient department in the UK.[1] Patients commonly present, complaining of lump in the breast, pain, and nipple discharge. Although the most common cause of symptoms is benign breast diseases. But as the life expectancy is increasing incidence of carcinoma breast is also increasing.

Many times, it becomes difficult to clinically differentiate between benign and malignant lesions, especially in early stages. Furthermore, cancer awareness has created phobia in minds of most of women, and they want to be sure that they are not suffering from cancer breast, as name itself is taken, by general masses to be a forebearer of death. In many countries, increasing numbers of women now undergo screening for malignant breast disease and ask for further management of their asymptomatic breast disease. Previously for clinically suspicious lesions biopsy was only reliable tool but with newer imaging and pathological evaluation techniques, the field of diagnosis has been revolutionized. However, main problem is none of the tools, for diagnosis is 100% accurate. Hence, to minimize delay in treatment and to avoid unnecessary outpatient follow-up and open biopsy, many breast clinics have evolved a policy of “triple test” with immediate reporting to provide a “One Stop diagnostic Service"[2] where patients are evaluated by history and physical examination, imaging (mammography, breast USG, and MRI) and FNAC or core needle biopsy to establish a diagnosis and management plan for each patient on the day of the clinic visit.


  Patients and Methods Top


This analytical study was conducted in the Department of Surgery, Ruxmaniben Deepchand Gardi Medical College and Allied Hospitals, Ujjain, in collaboration with Pathology and Radiology departments. Women presenting with breast lump or change in the nature of breast with the age above 20 years were selected. Diagnosed cases of breast abscess, antibioma, and malignancy were not included in study. We have included 420 patients in our study.

Relevant history was taken and clinical examination done. Mammography included two standard views, i.e., mediolateral oblique and a craniocaudal view. After imaging patients were evaluated by FNAC for cytology. Interpretations of clinical examination, mammography, and FNAC were tabulated as benign, malignant, and suspicious, respectively. The triple test assessment was done and interpretation drawn. Lesions were considered triple test positive if lesion was FNAC positive with any one of remaining two modalities was also positive (malignant), but each of three components must be negative for labeling triple test as negative. Finally, results were compared with histopathological reports.

Statistical calculation comprised of sensitivity, specificity, positive predictive value, negative predictive value and accuracy of triple test, for evaluating breast pathology, considering histopathology as standard.


  Results Top


The age group of patients (n = 420) observed in this series ranged from 20 to 72 years. Number of malignant cases were 138(32.8%) whereas benign cases reported were 282 (67.2%), [Table 1] and [Figure 1]. With mean age at presentation of benign diseases was 29.86 years and for malignancy was 51.84 years' youngest patient who was detected malignancy was 28 years, and the oldest patient was 72 years old. The most common age group of incidence for malignancy was 36-45 years (34.69%) and the most common age group in benign pathology was 20–26 years (47.06%) [Table 2] and [Figure 2].
Table 1: Histopathological distribution of breast masses

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Figure 1: Pie chart showing histopathological distribution of sample

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Table 2: Histopathological distribution of breast lumps in various age groups

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Figure 2: Bar chart for age group distribution of histopathological lesions

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Present study shows that clinical assessment alone was having sensitivity of 69.39% and specificity of 83.12% with overall diagnostic accuracy of 72%, results of mammography alone showed sensitivity of 62.79%, specificity of 85.13% with overall diagnostic accuracy of 75.27%, FNAC alone have given sensitivity of 94.25% and specificity of 85.92% with overall diagnostic accuracy of 78.47%. When two elements were, combined for assessment results obtained were as; combination of clinical assessment and FNAC yielded sensitivity of 96% and specificity of 86.95% with overall accuracy of 80.60%, whereas, combined assessment with clinical assessment and mammography yielded sensitivity of 65.81% and specificity of 82.86% with overall accuracy of 78.57% [Table 3] and [Figure 3]. The accuracy of triple assessment in concordant cases was 100%, with overall test accuracy of 82.15%. Triple test showed a positive and negative predictive value of 100% with sensitivity of 97.17% and specificity of 86.96% which was greater than individual test or two modalities used in combination [Table 3], [Table 4] and [Figure 3].
Table 3: Statistical comparison of diagnostic modalities

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Figure 3: Graphical depiction of statistical parameters of diagnostic modalities alone and in combination. SENSI: Sensitivity, CE: Clinical examination, SPECI: Specificity, MG: Mammography, PPV: Positive predictive value, FNAC: Fine-needle aspiration cytology, NPV: Negative predictive value, TT: Triple test, ACCUR: Accuracy

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Table 4: Triple test result compared with histopathology in concordant and nonconcordant cases

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  Discussion Top


The accurate diagnosis of breast lump through cost-effective and less time-consuming manner should be of top priority in a country like India where health care facilities are not at par with developed world. Being the most common cause of malignancy in female's timely diagnosis and treatment is of paramount importance. The diagnosis of breast pathology can be done by various modalities namely clinical examination, radiological examination (USG, mammography, and MRI), and pathological examination (FNAC, trucut biopsy, core needle biopsy, and incisional biopsy). The accuracy of each test varies when used individually whereas the combination of all the three modalities enhances accuracy significantly. The triple assessment or triple test which includes clinical examination, mammography, and FNAC yields superior results [Table 5], [Table 6], [Table 7], [Table 8].
Table 5: Comparative study chart for triple assessment

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Table 6: Comparative study chart for FNAC (cytological) assessment

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Table 7: Comparative study chart for imaging assessment

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Table 8: Comparative study chart for clinical assessment results

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We have identified studies from the literature that addressed the same research question as this study [Table 5], [Table 6], [Table 7], [Table 8].

Our results support the findings of other studies that combined clinical, imaging, and cytological (FNAC) assessment is diagnostically more accurate than individual or combination of two diagnostic modalities [Table 3].

In our study, the clinical assessment was found to have sensitivity of 69.39% and specificity of 83.12% with overall diagnostic accuracy of 72%. Sensitivity and specificity of clinical examination in our study is less that the most of the available literature [Table 8].

This difference in sensitivity may be due to the fact that few of the patients in our study were found to have malignant lesion in very younger age group with the youngest female being 28 years of age; and there is always an unavoidable bias toward benign pathology in younger age group.

In our study, results of imaging of breast gave sensitivity of 62.79% and specificity of 85.13% with overall diagnostic accuracy of 75.27%, which are on the lower side of the available literature [Table 7].

The reason may be breast imaging is an operator-dependent process[17] and technical team expertise can significantly change quality of film and reporting process other reason may be technically related to resolution of the machine.

FNAC results in our study have given sensitivity of 94.25% and specificity of 85.92% with overall diagnostic accuracy of 78.47%, which is in accordance with most of the available literature.

In our study, combined assessment with clinical examination and FNAC yielded sensitivity of 96% and specificity of 86.95% with overall accuracy of 86.60% which is in agreement with Kulkarni et al.[6] sensitivity 93.33% specificity 87.50% in the view of higher diagnostic accuracy than single diagnostic modality. Morris et al. used a scoring system for triple test;[7] in their study, they have included 113 patients. Benign lesions were given a score of 1, suspicious lesions 2, and malignant lesions 3 on each modality. The final score was obtained by adding individual scores. Results were then compared with histopathological reports. The triple test was found to have an accuracy of 100%. They suggested that breast pathologies with score less than four are benign, those with score of five should undergo biopsy and lesions with six and higher score can undergo definitive treatment. Thus unnecessary biopsies can be avoided. Morris et al.[4] also supported this fact in their study on 261 female patients with breast lesions with diagnostic accuracy of 100% results were obtained by Mansoor and Zahrani.[18] Kachewar and Dongre in their study of 200 female patients obtained sensitivity of 97.44% and specificity of 100% for triple test[19] Similar results were obtained by Ghafouri et al.[8] and Ghimire B et al.[10] Kaufman et al. in their study of 234 patients also concluded that triple test was more sensitive (100%) and specific (57%)[17] as compared to individual test used alone, thus unnecessary biopsies could be avoided saving time and money of patient.


  Conclusion Top


The triple test for assessment of breast lesions is a reliable method and allows the detection of breast pathologies in an effective manner, and undue delay in treatment can be minimized using this modality in limited resource country.

Three potential sources of error are suggested

  • Interobserver variation in clinical assessment, breast imaging, and cytological analysis[20]
  • Unavoidable bias toward benign pathology in younger age groups
  • Histopathology was considered gold standard in this study and all other studies. However, in accuracies and possibility of human errors are always there
  • In the present study, all patients presented with breast lump so our study have a limitation that no comments could be given on triple assessment of impalpable malignant/benign breast lesions.


Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

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Kerlikowske K, Hubbard RA, Miglioretti DL, Geller BM, Yankaskas BC, Lehman CD, et al. Breast Cancer Surveillance Consortium. Comparative-effectiveness of digital vs film-screen mammography in community practice in the US. Ann Intern Med 2011;155:493-502.  Back to cited text no. 15
    
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Rahman MZ, Sikder AM, Nabi SR. Diagnosis of breast lump by fine needle aspiration cytology and mammography. Mymensingh Med J 2011;20:658-64.  Back to cited text no. 16
    
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Kaufman Z, Shpitz B, Shapiro M, Rona R, Lew S, Dinbar A, et al. Triple approach in the diagnosis of dominant breast masses: Combined physical examination, mammography, and fine-needle aspiration. J Surg Oncol 1994;56:254-7.  Back to cited text no. 17
    
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Mansoor I, Zahrani I. Analysis of inconclusive breast FNA by triple test. J Pak Med Assoc 2002;52:25-9.  Back to cited text no. 18
    
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Kachewar SS, Dongre SD. Role of triple test score in the evaluation of palpable breast lump. Indian J Med Paediatr Oncol 2015;36:123-7.  Back to cited text no. 19
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Martin JE, Moskowitz M, Milbrath JR. Breast cancer missed by mammography. AJR Am J Roentgenol 1979;132:737-9.  Back to cited text no. 20
    


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