A population‑based screening program for early detection of common cancers among women in India – methodology and interim results.

BACKGROUND: Cancers of the uterine cervix, breast, and oral cavity accounted for 134,420, 115,251, and 24,375 cases, respectively, and were responsible for 52.8% of the total cancers among women in India in 2008. AIM: The major objectives were to create awareness regarding common cancers among women, to detect pre‑cancers of the uterine cervix and oral cavity, and early cancers of the breast, uterine cervix, and oral cavity, by conducting screening with simple, low‑cost technology, within the community, and to facilitate confirmation of diagnosis among the screen positives and treatment and follow‑up among the diagnosed cases. SETTINGS AND METHODS: This is a community‑based screening program for early detection of breast, uterine cervix, and oral cancers, being implemented among the socioeconomically disadvantaged women in Mumbai, India. The process involves selection of clusters, household surveys, health education, and screening the eligible women for breast, uterine cervix, and oral cancers, by primary healthcare workers, at a temporarily set‑up clinic within the community. The program is planned to cover a 125,000 disadvantaged population in five years. RESULTS: Twenty‑one thousand and fifteen people, with 4009 eligible women, have been covered to date. The compliance for screening for breast, cervix, and oral cavity has been 85, 70, and 88% and the screen positivity rates are 3.9, 14.9, and 3.9%, respectively. Twenty‑seven oral pre‑cancers, 25 cervix pre‑cancers, one invasive cancer of the breast, two of the cervix, and one oral cavity cancer have been diagnosed among the screened women and all of them have complied with the treatment. CONCLUSIONS: The program is raising awareness about the common cancers and harms of tobacco among the disadvantaged women population in Mumbai. It is also helping in detecting pre‑cancers and cancers among asymptomatic women and is assisting them in receiving treatment.

Compliance to Gutka ban and other provisons of COTPA in Mumbai.

BACKGROUND: Cigarettes and other tobacco products act 2003 (COTPA) is the principal law governing tobacco control in India. Government of Maharashtra in one of its landmark decisions also banned manufacturing, sale and distribution of gutka and pan masala since July 2012. The desired impact and level of enforcement of the COTPA legislation and the gutka and pan masala ban in Maharashtra State, however, needs assessment. Among the many provisions within COTPA, the present study seeks to assess compliance to implementation and enforcement of Section 5 and 6 of COTPA including compliance to gutka and pan masala ban in Mumbai, India. METHODOLOGY: Six educational institutes (EI) within the Mumbai metropolitan region were selected in a two stage random sampling process. Area around each EI was manually mapped and all the tobacco products selling outlets with in the 100 yards distance were listed by trained Field Social Investigators and were observed to determine compliance for Section 5 and Section 6 of the COTPA legislation and for gutka and pan masala ban. The vendors/shop owners manning these outlets were also interviewed for their personal sociodemographic details, self‑tobacco use, awareness and perception about ill‑effects of tobacco and existing tobacco control legislation in the country. RESULTS: A total of 222 tobacco retail outlets were listed within 100 yards of the EI in violation to the provisions of Section 6 of COTPA, of which 72 (32.4%) were selling tobacco products on mobile structures. About 53.2% of the tobacco vendors were also users of some form of tobacco. Whereas, nearly 217 (97.7%) vendors were aware about the gutka and pan masala ban in the State, only 48.2% were aware about the existence of COTPA legislation. None of the EI had a display board prohibiting the sale of tobacco products within a radius of 100 yards of their EI. Only 56.3% tobacco outlets had complied with the mandatory warning display boards indicating tobacco products will not be sold to people below 18 years of age. With regards to point of sale advertisement only 25.2% compliance was noted for display of health warning boards at the point of sale. Nearly 48.6% tobacco outlets exhibited >2 display boards and another 43.2% exhibited hoardings with brand pack photo, brand name in violation to the provision under Section 5. Violation by visible stacking and open display of tobacco products for sale was observed at 51.3% of tobacco outlets. While 41% of tobacco outlets were found displaying gutka and pan masala packets in violation to the ban. CONCLUSIONS: Enacting of the law without robust measures for enforcement has led to widespread noncompliance to the provisions with in the tobacco control legislation in the metropolitan city of Mumbai. Strong and sustainable measures needs to be incorporated both by civic administration and public health departments for its forceful implementation.

Community-based tobacco cessation program among women in Mumbai, India.

BACKGROUND: Globally tobacco epidemic kills nearly six million people annually. Consumption of tobacco products is on the rise in low‑ and middle‑income countries. Tobacco is addictive; hence, tobacco users need support in quitting. AIMS: Providing tobacco cessation services to women in community enabling them to quit tobacco, identifying factors associated with quitting and documenting the processes involved to establish a replicable “model tobacco cessation program.” SETTINGS AND DESIGN: This is a community based tobacco cessation program of one year duration conducted among women in a low socioeconomic area of Mumbai, India. SUBJECTS AND METHODS: It involved three interventions conducted at three months interval, comprised of health education, games and counseling sessions and a post intervention follow‑up. STATISTICAL ANALYSIS: Uni and multivariate analysis was performed to find out association of various factors with quitting tobacco. RESULTS: The average compliance in three intervention rounds was 95.2%. The mean age at initiation of tobacco was 17.3 years. Tobacco use among family members and in the community was primary reasons for initiation and addiction to tobacco was an important factor for continuation, whereas health education and counseling seemed to be largely responsible for quitting. The quit rate at the end of the programme was 33.5%. Multivariate logistic regression analysis found that women in higher age groups and women consuming tobacco at multiple locations are less likely to quit tobacco. CONCLUSIONS: Changing cultural norms associated with smokeless tobacco, strict implementation of antitobacco laws in the community and work places and providing cessation support are important measures in preventing initiation and continuation of tobacco use among women in India.

Impact of 'gutkha and pan masala ban' in the state of Maharashtra on users and vendors.

BACKGROUND: Gutkha and pan masala contain harmful and carcinogenic chemicals. Hence, Maharashtra Government banned their manufacture, storage, distribution and sale on 19th July 2012 for a year. OBJECTIVES: The objective of this study is to determine the impact of the ban on gutkha and pan masala on its users and vendors. MATERIALS AND METHODS: A cross‑ sectional study was conducted among gutkha and/or pan masala users and tobacco vendors in the selected area of Mumbai city, 4‑6 months after the implementation of the ban. The parameters studied included knowledge regarding the ban, usage or discontinuation of use of the banned products, product availability, withdrawal symptoms among quitters, etc., RESULTS: A total of 68 users and five tobacco vendors were enrolled in this study. Although all users were aware about the ban on gutkha, very few knew about the ban on pan masala. Only 5.9% of users knew that currently the ban had been declared for only 1 year. Electronic media was the main source of information regarding the ban as reported by 45.6% users. All users and vendors were in favor of the ban. After the ban, 23.53% gutkha users quit their habit while 55.88% reduced their gutkha consumption. Non‑availability of gutkha was the most important reason stated by the gutkha users for quitting or reducing the consumption. In spite of the ban, gutkha is still available in the market, but at an increased cost or in a different form. CONCLUSION: Nearly 23.53% of gutkha users have quit their habit post‑ban despite its availability through illegal sources.

Comparative evaluation of human papilloma virus-DNA test verses colposcopy as secondary cervical cancer screening test to triage screen positive women on primary screening by visual inspection with 5% Acetic acid.

INTRODUCTION: Visual inspection with 5% Acetic acid (VIA) as a low cost screening method has good sensitivity with the limitation of low specificity and low positive predictive values. The present study therefore evaluates the performance of secondary testing by human papillomavirus (HPV) test and Colposcopy in a single‑visit screening approach to increase program effectiveness in limited health‑care resources settings. MATERIALS AND METHODS: In a cross‑sectional cervical cancer screening trial, 3629 women (30‑65 years) were screened by primary screening test VIA. VIA test positive women were subsequently tested for the presence of oncogenic HPV types by hybrid capture II and with colposcopy. The reference investigation histopathology was performed for all primary screen positive women. RESULTS: Data for 3613 evaluable women showed 352 (9.7%) women positive on primary screening by VIA. VIA had a sensitivity of 93% (95% confidence interval (CI): 0.76‑0.99) and specificity of 91% (95% CI: 0.90‑0.92) respectively to detect the cervical intraepithelial neoplasia grade 2+ . HPV DNA and colposcopy as secondary tests to triage VIA positive women had a sensitivity of 61% (95% CI: 0.41‑0.78), 43% (95% CI: 0.24‑0.63) and specificity of 99% (95% CI: 0.99‑1.00), 99% (95% CI: 0.99‑0.99) respectively for detecting CIN2+ lesions. CONCLUSION: Two step screening model combining highly sensitive low cost test like VIA for primary screening followed by more specific HPV DNA test as triage test for primary screen positive can be a cost‑effective cervical screening strategy in resource constrained settings.

Determinants of exposure to second-hand smoke at home and outside the home among students aged 11-17 years: Results from the Mumbai Student Tobacco Survey 2010.

Background: While no level of exposure to Second-hand smoke (SHS) is free of risk, 37% of students from South-East Asia region were exposed to SHS. Aims: To estimate the prevalence of exposure to SHS and identify predictors of exposure to SHS at home and outside the home among 1,511 school students aged 11-17 years. Setting: The City of Mumbai. Study Design: This study used a two-stage cluster sampling design. Materials and Methods: Mumbai Student Tobacco Survey (MSTS) was a cross-sectional study, using anonymous self-administered structured questionnaire among students. The probability of schools being selected was proportional to the enrolment into grades 8 to 10. The study aimed to sample around 60 students from selected classes in each chosen school. Statistical Analysis: Proportions, 95% confidence interval and adjusted odds ratios (AOR) were used. Results: About 79.9% students were aware about the current smoking ban at public places and 88.1% were knowledgeable about the deleterious influence of SHS on them. Overall, 16.5% of students were exposed to SHS at home, and 39.9% outside of the home. Students from families where at least one parent used tobacco were at the greatest risk of SHS exposure at home in addition to outside the home exposure. Those students who were not aware about the smoking ban in public places were at a significantly higher risk of SHS exposure outside the home. Conclusion: Self-reported tobacco use status, age, parents' tobacco use, close friends' smoking, and the route they take to school were significant determinants of exposure to SHS at home and outside the home.

Call centre employees and tobacco dependence: Making a difference.

Context : India is known as the Business Process Outsourcing (BPO) capital of the world. Safeguarding health of millions of youngsters employed in this new growing economy is an occupational health challenge. Aims : This study was initiated in June 2007 in India with the objectives to assess the prevalence of tobacco use and study the factors responsible for initiating and continuing its use. The main aim, however, was to assess the effect of different tobacco cessation intervention strategies, thus identifying effective methods to assist these employees to quit tobacco. Materials and Methods : This is a 4-arm cluster randomized trial of 18 months duration among 646 BPO employees, working in 4 different BPO units. The employees were invited to participate in interviews following which tobacco users of each BPO were offered specific tobacco cessation interventions to assist them to quit tobacco use. Results : The prevalence of tobacco dependence is 41%, mainly cigarette smoking. The tobacco quit rate is similar (nearly 20%) in the 3 intervention arms. Significantly higher reduction in tobacco consumption of 45% is seen in Arm 4 with the use of pharmacotherapy. BPO employees change jobs frequently, hence follow-up remains a major challenge. Conclusion : Inaccessibility of pharmacotherapy in the developing countries should not deter tobacco cessation efforts as good tobacco quit rates can be achieved with health education and behavioral therapy. Tobacco cessation should be an integral activity in all BPOs, so that the employees receive this service continuously and millions of our youths are protected from the hazards of tobacco.

Evaluation of colposcopy vs cytology as secondary test to triage women found positive on visual inspection test.

Background: Colposcopic evaluation and guided biopsy is an important diagnostic step and standard of management for abnormal cytology smears in developed countries. Aim: The present study evaluates the performance of colposcopy vs conventional cytology in estimating the presence and grade of cervical disease against the reference standard of histopathology as a secondary test modality to triage women found positive on primary screening by visual inspection with 5% acetic acid (VIA). Settings and Design: Colposcopy and directed biopsy were performed after primary screening for cervical cancer in an urban hospital cancer screening clinic between January 2000 and June 2005, in Mumbai, India. Materials and Methods: Healthy women (8863) in the age group of 35-65 years participated in the cervical cancer early detection program in the hospital and community cancer screening clinics in Mumbai. Women found positive on the primary screening test by VIA underwent diagnostic evaluation by Pap smear cytology and colposcopy evaluation with directed biopsies. Statistical Analysis: Accuracy parameters and their 95% confidence intervals were calculated using 2 Χ 2 tables and standard formulae. Results: The test range of sensitivity of colposcopy for the detection of histologically confirmed cervical intraepithelial neoplasia grade 1+ (CIN1+) or CIN2+ was 58.0-74.7% and that of specificity was 57.5-92.9%. The sensitivity and specificity of cytology to detect CIN2+ was 57.4% and 99.4%, respectively. Conclusion: Colposcopy is a good sensitive test for the detection of CIN and can be considered as a secondary testing tool to triage women found positive on VIA.

Clinical profile and frequency of delta f508 mutation in Indian children with cystic fibrosis.

OBJECTIVE: To document clinical profile of cystic fibrosis (CF) in Indian children and the prevalence of delta F508 mutation in these patients. DESIGN: Observational study. Setting:Pediatric chest clinic in an urban tertiary care center in north India. PERIOD OF STUDY: July 1995 to June 2002. METHODS: Clinical features of 120 children diagnosed as CF by quantitative pilocarpine iontophoresis were recorded. A polymerase chain reaction based test for identification of delta F 508 mutation was performed on all children. RESULTS: Out of 3500 new cases registered in Pediatric Chest Clinic during this period 120, (3.5%) children were diagnosed as CF. Origin of parents of patients traced from almost all the States of north India. Family history suggestive of CF was present in 41 (34%) and consanguinity in 19 (61%) patients. Common clinical manifestations at the time of presentation included recurrent or persistent pneumonia in 118 (98%), failure to thrive in 108 (90%), malabsorption in 96 (80%), history of meconium ileus in 10 (8%), and rectal prolapse was present in 16 (13%). History of salt craving, salty taste on kissing and skin rashes was present in 5 patients each. 49(41%) patients were severely malnourished. Nasal polyposis was present in 5 (4%) patients. Examination of chest revealed evidence of hyperinflation in 100 (83%), kyphosis 20 (17%), crepitations 110 (92%), wheezing 40 (25%) and bronchial breathing in 20 (17%) patients. Average clinical CF scores were 51 (95%; CI 20-80). 48 (40%) patients had a CF score of LT40. Pseudomonas spp was cultured from respiratory secretions of 51 (42%), Staphylococcus spp in 18 (15%), Klebsiella spp in 8 (7%) and Hemophilus influenzae in 2 (2%) patients. Delta F508 mutation was positive in 45 chromosomes out of 240 tested. Patients originated from Pakistan had more frequency of delta F508 mutations. CONCLUSIONS: Cystic fibrosis does occur in Indian children; clinical features are classical. Diagnosis is often delayed and the disease is advanced in most patients at the time of diagnosis. Frequency of Delta F508 mutation is 19% i.e., less than that seen in Caucasian population. There is need to create awareness about occurrence of CF in Indian children.

Early detection of cervical cancer with visual inspection methods: a summary of completed and on-going studies in India

La India es un país de alto riesgo de cáncer cervical, donde se presentan cerca de la cuarta parte de los casos del total mundial (126 000 casos incidentes y 71 000 muertes durante 2000). La tasa de incidencia estandarizada por edad se encuentra en el rango de 16 a 55 por 100 000 mujeres en diferentes regiones con tasas particularmente altas en áreas rurales. El control del cáncer cervical por detección temprana y tratamiento es una prioridad del Programa Nacional de Control de Cáncer y, desafortunadamente, no hay programas organizados de tamizaje citológico en este país. La infraestructura técnica y financiera para organizar tamizaje en este tipo de cáncer, ha promovido la inspección visual como una potencial alternativa de la citología cervical en la India. Se investigan cuatro tipos de opciones de detección visual de neoplasia cervical: a) inspección a ojo desnudo sin la aplicación de ácido acético, opción ampliamente conocida como downstaging; b) inspección de ojo desnudo después de la aplicación de ácido acético de 3 a 5 por ciento (VIA); c) VIA usando un dispositivo de aumento (VIAM); d) inspección visual después de la aplicación de yodo-lugol (VILI). Se ha mostrado que el Downstaging ha sido pobremente sensible y específico para detectar neoplasia cervical y no es considerado ampliamente como una prueba de tamizaje conveniente para cáncer cervical. VIA, VIAM y VILI son frecuentemente investigados en estudios de corte transversal multicéntricos (sin verificación de sesgo), en los que se evalúan simultáneamente la citología y las pruebas del VPH; los resultados de esas investigaciones estarán disponibles próximamente. Estos estudios proveerán información valiosa sobre el desarrollo de pruebas comparativas para detectar lesiones de alto grado precursoras de neoplasia cervical, y cáncer invasor. Los resultados de los análisis de los datos de dos estudios previos indicaron una sensibilidad aproximada de 93.4 por ciento y una especificidad de 85.1 por ciento para VIA en la detección de CIN 2-3 o lesiones invasoras, comparadas con las de citología con 72.1 por ciento y 91.6 por ciento de sensibilidad y especificidad, respectivamente. La eficacia de VIA para la reducción de la incidencia y la mortalidad de cáncer cervical y su costo-efectividad están siendo actualmente investigadas en dos ensayos de intervención aleatorizados controlados en población de la India. Uno de esos estudios es un ensayo con cuatro brazos que establece la eficacia...

An indigenously developed method for sweat collection and estimation of chloride for diagnosis of cystic fibrosis.

An indigenously developed method for sweat collection and titration method for estimation of chloride was validated. The mean difference in estimated chloride value from the known strength of saline in 50 samples was -1.04 +/- 4.13 mEq/L (95% CI: -0.07 to 2.28). The mean difference in the estimated chloride values between two observers when the test was performed on known strengths of saline solution was -2.5 +/- 4.24 mEq/L (95% CI: -3.67 to 1.33). The inter observer variability between two observers when the test was performed on sweat samples obtained from 50 individuals was -1.12 +/- 4.34 mEq/L (95% CI: -2.23 to 0.8 ). Sweat weight of more than 100 mg could be collected in first attempt in 602 of 757 (80%) patient with an average sweat weight of 230 mg. This inexpensive method of sweat collection and chloride estimation has acceptable accuracy and repeatability and can be used in resource poor setting for making a diagnosis of cystic fibrosis.

Prenatal diagnosis of haemoglobinopathies.

BACKGROUND: Haemoglobinopathies constitute a major health problem in the Indian subcontinent. In the absence of any method for achieving complete cure and treatment being expensive, prenatal diagnosis and selective termination of an affected foetus is a feasible option to decrease the disease load. We report our experience with prenatal diagnosis of haemoglobinopathies over a two-and-a-half year period in 257 pregnancies. MEHODS: Amplification refractory mutation system (ARMS) was used to detect beta-thalassaemia, haemoglobin E and sickle cell mutations. RESULTS: Five mutations in the beta-globin gene which are common in the Indian population were detected in 92.3% of mutant chromosomes, whereas 3.1% of chromosomes carried rare mutations followed by 0.8% haemoglobin E and 0.4% sickle cell mutations. Mutations in 3.3% chromosomes were uncharacterized. The prenatal procedure, carried out early in pregnancy, was a chorionic villus sampling in most cases. A confirmed diagnosis based on ARMS-PCR was given in 241 (93.8%) cases. In 10 cases (3.9%) linkage analysis was required to confirm the foetal status, as mutations in both parents were not identified or the chorionic villus sample carried the single identified mutation. Four families with haemoglobin E-beta thalassaemia and one family with sickle cell disease were also included. Of the study population, 91.25% of the couples had a previous child with haemoglobinopathy, whereas 8.75% of the couples came before the birth of the first affected child. CONCLUSION: We conclude that ARMS-PCR is a highly sensitive technique for detecting mutations in the beta-globin gene and its efficacy in the prenatal diagnosis of haemoglobinopathies is proven.

Prenatal diagnosis of Duchenne muscular dystrophy.

BACKGROUND: Duchenne muscular dystrophy (DMD) is one of the most common X-linked genetic disorders seen in children. Mutations in the DMD gene coding for the protein dystrophin causes the severe muscle-wasting disorder leading to death in the second decade of life. In the absence of a cure, prenatal diagnosis (PND) appears to be the best approach to reduce the burden of this disease on the individual family and ultimately on society. There are few published reports worldwide on PND and very few from the developing countries. We report our experience with PND for families with DMD using multiplex polymerase chain reaction (PCR) and microsatellite polymorphic marker analysis. METHODS: From August 1997 to October 1999, PND was offered on request to 23 families with one or two boys affected with DMD. A total of 26 foetuses were screened for DMD. Initially the deletions in the DMD gene in the affected child were identified by multiplex PCR screening for 23 exons in 6 sets. In patients where deletions were not identified, microsatellite repeat analysis was carried out to follow the inheritance of the mutant allele. DNA was extracted from chorionic villus samples obtained by chorionic villus biopsy performed at 10-15 weeks of gestation in 17 families, and at 16-20 weeks in 6 families. RESULTS: Deletions were identified in 20 affected boys. In 2 families, microsatellite repeat analysis was done to identify the mutant allele. Of the 26 foetuses, 5 were found to be affected with DMD and the parents opted for termination of pregnancies. CONCLUSIONS: Multiplex PCR technology and microsatellite repeat analysis can be used effectively for PND of DMD.

Socio-demographic features of cannabis and heroin abuse in Bombay.

A study of socio-demographic features of 680 cannabis and heroin addicts showed that the factors like, age, religion, family structure, peer groups and the easy availability of these drugs contribute to the problem of addiction.