Screening and management of preinvasive lesions of the cervix: Good clinical practice recommendations from the Federation of Obstetrics and Gynaecologic Societies of India (FOGSI).

In India, there are marked variations in resources for cervical cancer screening. For the first time, resource-stratified screening guidelines have been developed that will be suitable for low middle-income countries with similar diversities. The current article describes the process and outcomes of these resource stratified guidelines for screening and treatment of preinvasive lesions of cervix. Evidence from literature was collated and various guidelines were reviewed by an expert panel. Based on the level of evidence, guidelines were developed for screening by human papillomavirus (HPV) testing, cytology and visual inspection after application of acetic acid (VIA), and management of screen positive lesions in different resource settings. Expert opinion was used for certain country-specific situations. The healthcare system was stratified into two resource settings - good or limited. The mode of screening and treatment for each was described. HPV testing is the preferred method for cervical cancer screening. VIA by trained providers is especially suitable for low resource settings until an affordable HPV test becomes available. Healthcare providers can choose the most appropriate screening and treatment modality. A single visit approach is encouraged and treatment may be offered based on colposcopy diagnosis ('see and treat') or even on the basis of HPV test or VIA results ('screen and treat'), if compliance cannot be ensured. The Federation of Obsterician and Gynaecologists of India Good Clinical Practice Recommendations (FOGSI) GCPR are appropriately designed for countries with varied resource situations to ensure an acceptable cervical cancer prevention strategy.

New Paradigms in Cervical Cancer Prevention.

Cervical Cancer prevention is a relatively new concept in Medicine. Since mid-twentieth century, diagnosis of Precancerous phase became possible thus outcome of invasive cervical cancer could be avoided. The dawn of this new era began with the research on HPV infection, being the causative factor. Clinical use of vaccines made it possible to start primary prevention by the year 2006. There has been a paradigm shift in this field and some of the important shifts will be discussed. The 1st paradigm is to better understand "Cancer Prevention". Cytology or the "Pap Smear" as it is commonly known is a simple low cost, low technology test. Combining it with biomarker test gives it more validity. Angiogenesis of cervical neoplasia was based on colposcopy. Angiogenesis inhibitor was discovered on this concept which improved treatment results. Incidence and mortality of cervical cancer shows a global disparity. For this, we have to study the social determinants. Some of the causes leading to high mortality are delay in diagnosis and reaching healthcare facility. UN's SD goal has suggested 30% reduction to be achieved. HPV is the cause of many other cancers apart from cervical cancer which may lead to suffering and mortality. The most deadly genotypes of HPV are 9 which form the NONAVALENT Vaccine. Introduction of vaccine made in India may be a game changer. A new "Ray of Hope" was the introduction of therapeutic vaccines in 2020. It will reduce human suffering and prolong life. As research advances, many more new Paradigms will evolve.

Accreditation of ethics committees: experience of an ethics committee.

Many ethics committees (ECs) approving clinical trials in India have got themselves registered with the Drugs Controller General of India as per regulatory requirements. However, there is still scope to improve their functioning. Accreditation, which entails adherence to national and international standards, helps an EC to protect the rights, safety and well-being of research participants. The National Institute for Research in Reproductive Health (NIRRH) ethics committee for clinical studies has received recognition, or accreditation, from the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER). An EC receives recognition from SIDCER if it meets five standards related to its structure and composition; adherence to specific policies; completeness of the review process; after-review process; and documentation and archiving. The extent to which these standards have been met is assessed in various ways, such as review of the EC's records, interviews of selected EC members and observation of a full board meeting of the EC. This paper describes the experiences of the NIRRH EC during and after the process of receiving recognition.

Preventable but not prevented: the reality of cervical cancer.

INTRODUCTION: The incidence of invasive cervical cancer has decreased in the last 50 years in the developed countries substantially due to the use of routine pap smears. However, in the Asia-Oceanic region it continues to be high as screening programs are not established. Credit for starting cytology services in India goes to Professor P.N. Wahi of Agra. He became Founder President when about 34 cytologists got together in 1970 to form the Indian Academy of Cytologists. Since then cytology has spread through all parts of India. The Cytology Clinic in Cama & Albless Hospital was started in the same year. Since then over 100000 women have been screened. Approximately 1200 cases of pre- and early cancers have been detected and treated. Since 1982 we are aware of the important role of human papillomavirus infection. We diagnose it by cytology and colposcopy and histology. Facilities for polymerase chain reaction, in-situ hybridization and other virology studies are not available to us. CO2 laser treatment is found particularly useful in multicentric human papillomavirus disease. SCREENING FOR THE STATE OF MAHARASHTRA: Since 1984 we have planned for a screening program for our State. We have a population of 78.9 million. Approximately 15 million women in the age group of 35-64 years have to be screened. The health care infrastructure is good with 36 medical colleges and over 35 district hospitals. Screening is planned in phases. Trained personnel are the key to a successful program. In the final analysis, cervical cancer is not just a biomedical disease. It has socio-cultural and economic implications.