Elsevier

The Lancet

Volume 370, Issue 9585, 4–10 August 2007, Pages 398-406
The Lancet

Articles
Effect of visual screening on cervical cancer incidence and mortality in Tamil Nadu, India: a cluster-randomised trial

https://doi.org/10.1016/S0140-6736(07)61195-7Get rights and content

Summary

Background

Cervical cancer is the most common cancer among women in developing countries. We assessed the effect of screening using visual inspection with 4% acetic acid (VIA) on cervical cancer incidence and mortality in a cluster randomised controlled trial in India.

Methods

Of the 114 study clusters in Dindigul district, India, 57 were randomised to one round of VIA by trained nurses, and 57 to a control group. Healthy women aged 30 to 59 years were eligible for the study. Screen-positive women had colposcopy, directed biopsies, and, where appropriate, cryotherapy by nurses during the screening visit. Those with larger precancerous lesions or invasive cancers were referred for appropriate investigations and treatment. Cervical cancer incidence and mortality in the study groups were analysed and compared using Cox regression taking the cluster design into account, and analysis was by intention to treat. The primary outcome measures were cervical cancer incidence and mortality.

Results

Of the 49 311 eligible women in the intervention group, 31 343 (63·6%) were screened during 2000–03; 30 958 control women received the standard care. Of the 3088 (9·9%) screened positive, 3052 had colposcopy, and 2539 directed biopsy. Of the 1874 women with precancerous lesions in the intervention group, 72% received treatment. In the intervention group, 274 430 person years, 167 cervical cancer cases, and 83 cervical cancer deaths were accrued compared with 178 781 person-years, 158 cases, and 92 deaths and in the control group during 2000–06 (incidence hazard ratio 0·75 [95% CI 0·55–0·95] and mortality hazard ratio 0·65 [0·47–0·89]).

Interpretation

VIA screening, in the presence of good training and sustained quality assurance, is an effective method to prevent cervical cancer in developing countries.

Introduction

Cervical cancer is the most common cancer among women in many developing countries, where 85% of the estimated 493 000 new cases and 273 000 deaths in 2002 occurred worldwide.1 Although population-based cervical cytology screening has resulted in a substantial reduction in cervical cancer burden in developed countries, lack of screening or inefficient cytology screening programmes contribute to the high risk seen in sub-Saharan Africa, south and southeast Asia, Oceania, Central and South America, and the Caribbean.2, 3, 4

The difficulties in organising cytology screening in developing countries have prompted the assessment of alternative methods like visual inspection with 3–5% acetic acid (VIA) for prevention of cervical cancer. In several studies, VIA had an acceptable sensitivity in detecting cervical intraepithelial neoplasia (CIN).4, 5, 6, 7, 8, 9, 10, 11 Although model-based studies suggest that low-intensity, single-round of VIA screening once a lifetime is a cost effective method to reduce disease burden,12, 13, 14, 15 whether it can achieve a significant reduction in cervical cancer incidence and mortality in real programme settings is unclear. The Christian Fellowship Community Health Centre, India, and the International Agency for Research on Cancer (IARC) of WHO, France, jointly did a cluster randomised trial to assess the efficacy of VIA screening to reduce cervical cancer incidence and mortality in a high-risk population in India.16 The results, after 7 years from the beginning of the screening, in terms of reduction in cervical cancer incidence and mortality are described in this paper.

Section snippets

Design

The study design and methods of this trial were described in detail in a baseline paper.16 Clusters (panchayaths or municipal units) were first assigned numbers, and a statistician in IARC, not involved in the project, randomly assigned these numbers into two groups using computer-generated random numbers. Of the 114 clusters in seven subdistricts of the Dindigul district randomly chosen for the study, 57 were randomised to each group. The two groups were then randomly assigned either to an

Results

Figure 1 shows the flow of study clusters and eligible women throughout the trial. All 49 311 eligible women in the intervention and the 30 958 in the control groups were interviewed. The study groups were well balanced for distribution of religion, occupation, income, and menopause, but some differences were observed for age, education, marital status, and parity (table 1). Only two of the eligible women had ever had previous cervical screening.

Enumeration of households and eligible women

Discussion

Successful screening leads to reduction in cervical cancer incidence by detection and treatment of CIN. Strategies involving cytology screening and multiple visits for diagnosis and treatment are impractical in low-resourced and most medium-resourced developing countries. We show that cervical cancer burden can be reduced by a single round of VIA screening. Our findings indicate that VIA is a simple, feasible, and effective method to prevent cervical cancer and death among deprived populations

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