European Journal of Cardiovascular Medicine

Cervical cancer is one of the most prevalent malignancies affecting women worldwide, particularly in developing countries like India. It remains a major public health concern due to its high morbidity and mortality rates^1,2. The disease is largely preventable with early detection and appropriate treatment, as it is preceded by a long pre-invasive phase, known as cervical intraepithelial neoplasia (CIN). Effective screening strategies have significantly reduced the incidence of invasive cervical cancer in developed nations^3,4. However, in India, the burden of cervical cancer remains high due to inadequate screening programs, lack of awareness, and limited access to healthcare facilities.

The most widely used screening methods for cervical cancer include Papanicolaou (Pap) smear and colposcopy, both of which aid in detecting pre-malignant and malignant lesions5. The Pap smear is a cost-effective, non-invasive cytological test that helps identify abnormal squamous cells, while colposcopy provides a magnified view of the cervix to detect abnormal vascular and epithelial patterns6,7. Despite their effectiveness, these methods have limitations, including false-negative and false-positive results. Therefore, histopathological examination (HPE) of biopsy specimens remains the gold standard for confirming cervical pathology.

In this study, we aim to compare the diagnostic accuracy of Pap smear and colposcopy in detecting pre-cancerous and cancerous cervical lesions, using histopathology as the reference standard. By evaluating the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of these screening modalities, this study seeks to enhance cervical cancer screening strategies, ensuring early diagnosis and timely intervention.

Objectives

To study the usefulness of Pap smear and colposcopy in detecting pre-neoplastic and neoplastic cervical lesions.

To correlate Pap smear and colposcopic findings with histopathological examination.

To evaluate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of Pap smear and colposcopy, considering histopathology as the gold standard.

To assess the effectiveness of combining both screening methods in improving diagnostic accuracy.

Study Design

This study is a prospective observational study conducted to evaluate the diagnostic accuracy of Pap smear and colposcopy in detecting cervical lesions, with histopathological examination (HPE) as the gold standard.

Study Setting

The study was carried out at the Department of Obstetrics and Gynaecology, Konaseema Institute of Medical Sciences and Research Foundation, Amalapuram, Andhra Pradesh, over a period from December 2019 to September 2021.

Study Population

A total of 100 women with an unhealthy cervix who attended the outpatient department were included in the study.

Inclusion Criteria

Women aged 20–65 years.

Patients presenting with symptoms such as profuse white discharge, post-coital bleeding, intermenstrual bleeding, or postmenopausal bleeding.

Women with clinically unhealthy cervix on per-speculum examination (e.g., cervical erosion, cervicovaginitis, cervical polyp, condylomas).

Exclusion Criteria

Women with active vaginal bleeding at the time of examination.

Patients with frank invasive cervical cancer.

Women who had previously undergone a total hysterectomy.

Women who had received prior treatment for carcinoma cervix.

Pregnant women.

Study Tools and Data Collection

All participants underwent Pap smear, colposcopy, and colposcopy-guided biopsy for histopathological examination. The following steps were followed:

Pap Smear Collection

Exfoliated cervical cells were collected using Ayer’s spatula and an endocervical brush.

The sample was smeared evenly on a glass slide, fixed with 95% alcohol, and stained using the Papanicolaou staining technique.

The smears were examined under a microscope and classified according to The Bethesda System (2014).

Colposcopic Examination

A video colposcope with up to 40x magnification was used. The cervix was examined under low magnification (10x) to assess surface blood vessels. A green filter was used to visualize vascular patterns. 5% acetic acid was applied to the cervix, and the transformation zone was assessed for acetowhite changes, punctation, mosaic patterns, and abnormal vessels. Lugol’s iodine was applied, and iodine-negative areas were documented.

Colposcopy-Guided Biopsy

Biopsy specimens were taken from suspicious areas using cervical punch biopsy forceps. The specimens were fixed in 10% formalin and sent for histopathological examination.

Statistical Analysis

Data were compiled and analyzed using Microsoft Excel.The diagnostic accuracy of Pap smear and colposcopy was assessed by calculating: Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), Accuracy.The correlation of Pap smear and colposcopic findings with histopathology was determined using statistical comparison methods.

Ethical Considerations

This study was conducted in accordance with the ethical guidelines of the Declaration of Helsinki. Informed written consent was obtained from all participants before enrollment, ensuring voluntary participation and confidentiality. The study was approved by the Institutional Ethics Committee (IEC) of Konaseema Institute of Medical Sciences and Research Foundation, Amalapuram.

A prospective observational study was conducted among 100 women with an unhealthy cervix attending the Out-Patient Department of Obstetrics and Gynaecology, KIMS, Amalapuram, during the study period from 2019 to 2021. The demographic, clinical, and diagnostic findings were analyzed to determine the correlation between Pap smear, colposcopy, and histopathological examination (HPE) findings.

Age Distribution

The majority of the study participants (58%) were in the 40–49 years age group, followed by 30% in the 30–39 years age group and 12% in the 50–59 years age group. The mean age of the study participants was 42.26 ± 6.35 years, ranging from 30 to 59 years. Among patients diagnosed with cervical intraepithelial neoplasia (CIN), 55% belonged to the 40–49 years age group, 35% to the 30–39 years age group, and 10% to the 50–59 years age group (Table 1& Figure No.1). These findings suggest that middle-aged women are at a higher risk of developing cervical abnormalities.

Table 1: Distribution of Age among Study Participants

Figure No:1. Distribution of Age among Study Participants

Educational Status

Regarding educational background, 38% of the women had studied up to 10th grade, 27% had a degree, 24% had completed 11th–12th grade, 8% were illiterate, and 3% had completed post-graduation. Among women diagnosed with CIN, the highest prevalence was observed in those who had studied up to 10th grade (55%), followed by 25% among those with 11th–12th-grade education. Women with a degree (10%) and post-graduation (5%) had lower CIN prevalence (Table 2 & Figure No.2). This highlights the importance of education and awareness in reducing the incidence of cervical lesions.

Table 2: Distribution of Education among Study Participants

Figure No. 2: Distribution of Education among Study Participants

Socio-Economic Status

In terms of socio-economic distribution, 30% of participants belonged to Class IV, 24% to Class III, 20% to Class II, 17% to Class I, and 9% to Class V. The highest CIN prevalence was among Class II women (30%), followed by Class I (20%), Class III (20%), and Class IV (20%), while Class V had the lowest incidence (10%) (Table 3 & Figure No:3). These findings suggest that lower socio-economic status is associated with a higher risk of cervical lesions, possibly due to poor access to healthcare and lack of regular screening programs.

Table 3: Distribution of Socio-Economic Status among Study Participants

Figure No:3. Distribution of Socio-Economic Status among Study Participants

Age at Menarche

Most women (71%) attained menarche between 12–13 years, followed by 17% between 14–15 years and 12% between 10–11 years. Among patients diagnosed with CIN, the highest prevalence was observed in those who had menarche at 12–13 years (65%), followed by 20% at 10–11 years and 15% at 14–15 years (Table 4 & Figure No:4). Early menarche has been associated with a higher lifetime risk of cervical lesions, likely due to longer hormonal exposure.

Table 4: Distribution of Age of Menarche among Study Participants

Figure No:4. Distribution of Age of Menarche among Study Participants

Duration of Marital Life

The majority of participants (63%) had been married for 20–39 years, followed by 34% for less than 19 years and 3% for more than 40 years. Among women diagnosed with CIN, 60% had been married for 20–39 years, while 40% had a marital duration of fewer than 19 years. No cases of CIN were observed among women married for more than 40 years (Table 5). These findings highlight the role of prolonged marital duration and increased exposure to risk factors like persistent HPV infection in the development of cervical lesions.

Table 5: Distribution of Duration of Marital Life among Study Participants

Figure No:5. Distribution of Duration of Marital Life among Study Participants

Pap Smear, Colposcopy, and Histopathology Findings

A comparison of Pap smear, colposcopy, and histopathological examination was conducted to evaluate their diagnostic accuracy. The results are summarized in Table 6:

Pap smear, being the first-line screening tool, had a sensitivity of 44.44% and specificity of 93.90%, indicating a high false-negative rate but high specificity in detecting high-grade lesions.

Colposcopy demonstrated higher sensitivity (95.45%) but lower specificity (84.62%), suggesting that it is more effective in detecting CIN lesions but requires histopathological confirmation.

When correlated with histopathology, colposcopy had an accuracy of 87% compared to 85% for Pap smear, reinforcing that colposcopy enhances the detection of cervical abnormalities.

Combining Pap smear and colposcopy significantly improved screening accuracy, as also observed in previous studies.

Table No:6. Pap Smear, Colposcopy, and Histopathology Findings

Demographic and Clinical Observations

The majority of the study participants (58%) were in the 40–49 years age group, followed by 30% in the 30–39 years group and 12% in the 50–59 years group. These findings align with previous research indicating that cervical intraepithelial neoplasia (CIN) and cervical cancer are most prevalent in middle-aged women (Najib et al8., 2020). Lower educational levels and poor socio-economic status were also associated with a higher prevalence of CIN, which is consistent with studies highlighting the impact of limited awareness and restricted access to screening programs on delayed diagnosis (Kohale et al9., 2024). The highest CIN prevalence was found among women with lower education (1st–10th grade: 55%) and those from lower socio-economic classes (Class II: 30%), emphasizing the need for targeted awareness programs to encourage routine cervical cancer screening (Ansari et al10., 2017).

Diagnostic Accuracy of Pap Smear and Colposcopy

The Pap smear, a widely used cytological screening method, showed a sensitivity of 44.44% and specificity of 93.90%, indicating a high false-negative rate despite its specificity for high-grade lesions (Karimi-Zarchi et al11., 2015). The Bethesda System (2014) was used for classification, revealing cases of ASCUS, LSIL, and HSIL, supporting previous studies on the limitations of cytology-based screening in detecting early CIN lesions (Consul et al12., 2012).

In contrast, colposcopy, a real-time visual examination technique, demonstrated higher sensitivity (95.45%) but lower specificity (84.62%) in detecting CIN lesions. This finding aligns with research showing that colposcopy enhances lesion visualization, particularly after acetic acid and Lugol’s iodine application, improving detection rates (Barut et al13., 2015). The correlation of colposcopic findings with histopathological results confirmed that colposcopy has a higher detection rate for high-grade lesions but requires histopathological confirmation to rule out false positives, as noted in previous comparative studies (Dasgupta14, 2023).

Comparison with Histopathology

Histopathological examination of colposcopy-directed cervical biopsies confirmed the presence of CIN and invasive carcinoma, reinforcing HPE as the gold standard for cervical lesion diagnosis (Najib et al8., 2020). The sensitivity and specificity of Pap smear and colposcopy were calculated and compared with histopathology, showing that:

Colposcopy had a higher sensitivity (95.45%) than Pap smear (44.44%) (Kohale et al9., 2024). Pap smear had a higher specificity (93.90%) compared to colposcopy (84.62%) (Ansari et al10., 2017). Colposcopy was more effective in detecting high-grade CIN lesions, similar to findings by Karimi-Zarchi et al11. (2015). A combined approach (Pap smear + Colposcopy + Histopathology) yielded the highest diagnostic accuracy (87%) (Consul et al12., 2012). These findings are consistent with existing literature, emphasizing that a combination of both screening methods enhances diagnostic accuracy (Barut et al13., 2015). While Pap smear alone is effective in detecting high-grade CIN lesions, colposcopy is more useful for identifying early and low-grade lesions, supporting previous comparative studies (Dasgupta14, 2023).

Clinical Implications and Recommendations

This study reinforces the importance of an integrated approach in cervical cancer screening, which has been strongly recommended in multiple studies (Najib et al8., 2020; Karimi-Zarchi et al11., 2015). A combination of Pap smear, colposcopy, and histopathology provides a comprehensive diagnostic pathway for early detection of pre-malignant lesions (Kohale et al9., 2024). Given that Pap smear alone has limitations, colposcopy should be recommended as a secondary screening method, particularly for women with abnormal Pap smear results or a clinically unhealthy cervix (Ansari et al10., 2017).

Additionally, targeted awareness programs should be implemented to encourage women from lower educational and socio-economic backgrounds to undergo regular cervical screening, as suggested in earlier studies (Consul et al12., 2012; Barut et al13., 2015). Considering the higher prevalence of CIN in middle-aged women, screening efforts should focus on women aged 30–49 years, as recommended by global studies (Dasgupta14, 2023).

These findings emphasize the need for integrating cytology, colposcopy, and histopathology into routine screening programs, particularly in low-resource settings, to improve early detection, timely intervention, and overall patient outcomes (Najib et al8., 2020).

Limitations of the Study

The study was conducted in a single tertiary care hospital, which may limit generalizability to the broader population. A larger sample size would provide more robust statistical comparisons. The subjectivity of colposcopy interpretation may lead to variations in diagnostic accuracy.

This study demonstrates that colposcopy has higher sensitivity (95.45%) than Pap smear (44.44%), while Pap smear has greater specificity (93.90%) compared to colposcopy (84.62%), making histopathology essential for confirmation. The combined approach improved screening accuracy to 87%, reinforcing the need for integrated cervical cancer screening strategies. The findings highlight that lower education and socio-economic status correlate with higher CIN prevalence, emphasizing the necessity of targeted awareness programs. Given the high cervical cancer burden in low-resource settings, integrating Pap smear, colposcopy, and histopathology in routine screening programs is crucial for early detection, timely intervention, and improved patient outcomes, ultimately reducing cervical cancer morbidity and mortality through enhanced screening accessibility.

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