Effectiveness, safety and acceptability of ‘see and treat’ with cryotherapy by nurses in a cervical screening study in India

British Journal of Cancer (2007) 96, 738 – 743 & 2007 Cancer Research UK All rights reserved 0007 – 0920/07 $30.00 www.bjcancer.com Effectiveness, safety and acceptability of ‘see and treat’ with cryotherapy by nurses in a cervical screening study in India Clinical Studies R Sankaranarayanan*,1, R Rajkumar2, PO Esmy3, JM Fayette1, S Shanthakumary4, L Frappart5, S Thara6 and J Cherian3 1 Screening Group, International Agency for Research on Cancer, 150 cours Albert Thomas, Lyon 69008, France; 2Preventive Medicine Department, PSG Medical College, Coimbatore, 641004 Tamil Nadu, India; 3Department of Radiotherapy, Christian Fellowship Community Health Centre, Ambillikai, Dindigul District, Tamil Nadu 624612, India; 4Department of Pathology, PSG Institute of Medical Sciences and Research, Coimbatore 641 004, Tamil Nadu, India; 5Laboratoire d’Anatomie et de Cytologie Pathologiques, Hôpital Edouard Herriot, Lyon 69003, France; 6Department of Pathology, Regional Cancer Centre, Medical College Campus, Trivandrum, Kerala 695011, India We evaluated a ‘see and treat’ procedure involving screening, colposcopy, biopsy and cryotherapy by trained nurses in one-visit in field clinics in a cervical screening study in South India for its acceptability, safety and effectiveness in curing cervical intraepithelial neoplasia (CIN). Women positive on visual inspection with acetic acid (VIA) were advised colposcopy, directed biopsies and cryotherapy if they had colposcopic impression of CIN in one visit by nurses in field clinics supervised by a doctor. Side effects and complications were assessed and cure rates were evaluated with VIA, colposcopy and biopsy if colposcopic abnormalities were suspected. Cure was defined as no clinical or histological evidence of CIN at X6 months from treatment. Of the 2513 women offered ‘see and treat’ procedure, 1879 (74.8%) accepted. Of the 1397 women with histologically proved CIN treated with cryotherapy, 1026 reported for follow-up evaluation. Cure rates were 81.4% (752 out of 924) for women with CIN 1; 71.4% (55 out of 77) for CIN 2 and 68.0% (17 out of 25) for CIN 3. Minor side effects and complications were documented in less than 3% of women. ‘See and treat’ with cryotherapy by nurses under medical supervision is acceptable, safe and effective for cervical cancer prevention in low-resource settings. British Journal of Cancer (2007) 96, 738 – 743. doi:10.1038/sj.bjc.6603633 www.bjcancer.com Published online 20 February 2007 & 2007 Cancer Research UK Keywords: cervical cancer; screening; early detection; cervical intraepithelial neoplasia; ‘see and treat’; cryotherapy Cryotherapy offers an effective and simple outpatient treatment for women with cervical intraepithelial neoplasia (CIN) (Alliance for Cervical Cancer Prevention, 2003; Sellors and Sankaranarayanan, 2003). The currently available data on its effectiveness, safety and acceptability are based on treatment provided by medical doctors in developed countries (Alliance for Cervical Cancer Prevention, 2003). The evidence from such published studies indicate that cryotherapy is an effective, safe and acceptable treatment and cure rates exceed 86% for women with CIN confined to the ectocervix (Alliance for Cervical Cancer Prevention, 2003). However, it is not clear if similar cure rates can be achieved for cryotherapy provided by trained nurses in field conditions in less developed countries. ‘See and treat’ usually involves a loop electrosurgical excision procedure (LEEP) simultaneously to diagnose and to treat premalignant cervical disease in screen-positive women in one visit thereby eliminating the need of a second visit for treatment (Ferris et al, 1996). We adapted the ‘see and treat’ principles to achieve maximum compliance of screen-positive women for diagnosis and *Correspondence: Dr R Sankaranarayanan, Screening Group, International Agency for Research on Cancer, 150 cours Albert Thomas, 69372, Lyon cedex 08, France; E-mail: Received 27 November 2006; accepted 20 January 2007; published online 20 February 2007 cryotherapy in one visit within the context of a randomised controlled screening trial in South India designed to evaluate the impact of visual inspection with acetic acid (VIA) on cervical cancer incidence and mortality (Sankaranarayanan et al, 2004). The screening trial, a collaborative research project of the Christian Fellowship Community Health Centre (CFCHC), Ambillikai, in Dindigul district, Tamil Nadu, India and the International Agency for Research on Cancer (IARC), Lyon, France, was reviewed and approved by the institutional ethical review committees of both CFCHC and IARC. The design, methodology and the preliminary results of the trial have been published elsewhere (Sankaranarayanan et al, 2004, 2005). In this paper, we describe the acceptability, safety and effectiveness of ‘see and treat’ procedure involving screening, colposcopy, directed biopsy and double-freeze cryotherapy by trained nurses in a single-visit in field clinics supervised by a doctor. MATERIALS AND METHODS Participants Apparently healthy women aged 30 – 59 years, with an intact uterus and no past history of cervical neoplasia in clusters of villages randomised to the screening group were identified by active enumeration of households. Female health workers explained Effectiveness of ‘see and treat’ with cryotherapy by nurses R Sankaranarayanan et al 739 Training of nurses in VIA, colposcopy and cryotherapy Eight registered nurses with 3 years’ nursing education learned VIA, colposcopy and cryotherapy in a 3-week intensive training course, using manuals prepared by the IARC (Sankaranarayanan and Wesley, 2003; Sellors and Sankaranarayanan, 2003). Training included lectures, discussions, review of photographs of normal and abnormal cervix, and clinical sessions to observe and practice VIA, colposcopy, directing biopsy and cryotherapy, initially under the supervision of the teaching faculty and then independent assessment with the findings checked by the faculty. The training allowed the nurses to develop skills in obtaining gynaecological history, visualising the cervix to recognise the squamocolumnar junction (SCJ), transformation zone (TZ), assessing the TZ with acetic acid and Lugol’s iodine, in recognising acetowhite and mustard-yellow lesions, directing biopsies, in discussing results and management plans with women, in performing cryotherapy and in counseling women on follow-up care. Their performance was routinely monitored by regular review of screen-positive rates, correlation between colposcopy and histology findings, and routine medical supervision in the field. Refresher courses were conducted every 3 months to maintain competency. Screening, colposcopy and directed biopsy The women were invited for VIA screening in field clinics organised in village primary health centres, municipal offices, schools, or women’s club buildings. A medical doctor (gynaecologist or clinical oncologi (...truncated)