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    -  Viswanathan V
    -  Ganeshkumar P
    -  Selvam JM
    -  Selvavinayagam T S

 
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ORIGINAL ARTICLE
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Referral mechanism and beneficiary adherence in cervical cancer screening program in Tiruchirappalli district, Tamil Nadu state, India, 2012–2015


1 Department of Epidemiology, Indian Council of Medical Research – National Institute of Epidemiology, Ayapakkam, Chennai, Tamil Nadu, India
2 National Health Mission, Government of Tamil Nadu, Tamil Nadu, India
3 Department of Public Health and Preventive Medicine, Government of Tamil Nadu, Tamil Nadu, India

Date of Submission16-Jun-2020
Date of Decision21-Jul-2020
Date of Acceptance21-Sep-2020
Date of Web Publication21-Jun-2021

Correspondence Address:
Parasuraman Ganeshkumar,
Department of Epidemiology, Indian Council of Medical Research – National Institute of Epidemiology, Ayapakkam, Chennai, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijc.IJC_548_19

  Abstract 


Background: A screening program for cervical cancer was established in 2011 in Tamil Nadu. Since the inception of the program, coverage, and dropout of screening has not been analyzed. We conducted a study to describe the referral mechanism in the cervical cancer screening program implemented in Tamil Nadu, to estimate the level of adherence to the referral process by the beneficiaries, and to identify strengths and weaknesses related to the referral mechanism in the program.
Methods: This descriptive study was conducted during 2015–2016 in the Tiruchirappalli administrative district of Tamil Nadu. All women aged 30 years and above, who were screened in public health facilities, were the participants. Using a structured form, we collected the data maintained in the registers at the district health administration. We estimated the screening coverage, follow-up evaluation, and dropout rates at different stages of the referral mechanism. We used SPSS and Epi Info software for analysis.
Results: Coverage of cervical cancer screening was 4,838(41.6%). We estimated 4,838(41.6%) of screened positives were lost to follow-up for a colposcopy examination. Biopsy samples were obtained from 3425(84%) of those who required a biopsy. Cervical cancer was diagnosed in 159(4.6%) and precancerous lesions in 528(15.4%) women.
Conclusion: More than half of the target population was screened in public health facilities. The dropout rate was less than half of those screened at the colposcopy evaluation level. Major pitfalls of the program were human resource issues at referral centers and poor maintenance of meaningful data.


Keywords: Early detection of cancer, noncommunicable diseases, patient dropouts, program evaluation, referral and consultation, uterine cervical neoplasms
Key Message: The referral mechanism in the cervical cancer program was not implemented at the expected level, and strengthening the program with appropriate resources and data management could improve the referral.



How to cite this URL:
Viswanathan V, Ganeshkumar P, Selvam JM, Selvavinayagam T S. Referral mechanism and beneficiary adherence in cervical cancer screening program in Tiruchirappalli district, Tamil Nadu state, India, 2012–2015. Indian J Cancer [Epub ahead of print] [cited 2021 Jul 27]. Available from: https://www.indianjcancer.com/preprintarticle.asp?id=318900





  Introduction Top


Globally, cancer had caused 213.2 million disability adjusted life-years (DALYs) for both sexes combined in 2016.[1] World Health Organization (WHO) reports that without immediate action, the global number of deaths due to cancer is projected to reach over 13 million by 2030 which is almost twice the 7.8 million deaths that occurred during the year 2008.[2] Similarly, the increase in the incidence of cancers is estimated to be 70% in lower-middle-income countries by 2030.[3] As per the recent report on the burden of cancers, cancers contributed 8.3% of total deaths and 5% of total DALYs in 2016 in India.[4] In India, breast and cervical cancers are the first and second most common cancers with an incidence of 21.6 and 13.5 per 100,000 women respectively of the total cancer cases among women.[4] The proportion of breast and cervical cancers among total cancer deaths was 21.5% and 20.7%, respectively.[5] It is estimated that by the end of 2016, the highest DALYs among women will be contributed by breast cancer (203 per 100,000 women) followed by cervical cancer (88 per 100,000 women).[6] Cervical cancer is largely preventable with effective screening and treatment of early precancerous lesions.[5],[7],[8],[9]

In any population-based screening program, early identification of precancerous and early stage cancer patients requires various stages of screening, confirmation, and treatment. Hence, ensuring proper referral of at-risk individuals at the earliest and adherence to the referral by the beneficiaries decide the success of such a screening program. Across the world, it is evident that the low rate of adherence and poor referral to various stages of diagnosis and treatment of cervical cancer remains a challenge in cancer prevention programs.[10],[11],[12],[13] In India, the National Cancer Control Programme was implemented in 1971.[14] Early detection of cancers was conceptualized in the program during inception apart from health education and legislation against tobacco. However, over the period, state-level initiatives on early detection of breast and cervical cancer have been implemented in a few states. Tamil Nadu, a southern state of India with a population of nearly 72 million, launched a noncommunicable disease (NCD) intervention program during 2011 supported by World Bank. Four diseases targeted under this NCD intervention program were hypertension, diabetes mellitus, breast, and cervical cancer. Since implementation, the referral mechanism of the cervical cancer program has been not reviewed, and thus understanding the strengths and weaknesses of the cervical cancer program would identify the potential areas for improvement.

We conducted this study to address the following questions: What is the referral mechanism in the cervical cancer screening program? What is the level of adherence to the referral process by the beneficiaries in the program? What are the programmatic strengths and weaknesses related to the referral mechanism in the program?


  Methods Top


We conducted a descriptive study between November 2015 and October 2016 in Tiruchirappalli administrative district of the southern state of India, Tamil Nadu. Our study population was all women aged 30 years and above who were screened for cervical cancer between April 2012 and March 2015. We collected data on the available workforce, training, infrastructure, equipment, and logistics using a structured form. We scrutinized the monthly reports from each health facility including monitoring and supervisory reports, concurrent evaluation reports, the supervisory report by the funding agency (World Bank) related to the program. We collected the available line list of women screened positive for cervical cancer maintained on hand-written records from 75 government health facilities. We extracted details of further evaluation, diagnosis, and treatment from the records available in the referral facilities about follow-up evaluation, diagnosis, and treatment. The referral facilities include specialty departments of government-run hospitals in the district and selected private diagnostic and treatment centers empaneled under state government health insurance scheme. Then the line list of screened positives was further matched with those data extracted from referral facilities. Duplicate records were removed using a java program in consultation with a software data analyst. We analyzed the data using Epi Info software version 7 and SPSS version 17. We estimated the screening coverage by using the population data of women aged 30 years and above based on the Census 2011 as the denominator. We estimated the follow-up evaluation and dropout rates at different stages of the referral mechanism. We ensured the quality and strict adherence to study protocol through induction and onsite training of statistical assistants involved in data collection, pilot testing of the tools, and periodic supervisory visits during the study period. Ethical clearance was obtained from the Institutional Human Ethics Committee of ICMR—National Institute of Epidemiology (NIE), Chennai India. We ensured the confidentiality of the collected data by removing personal identifiers from the final dataset before analysis.


  Results Top


Description of the referral mechanism

In the study district, public health service delivery is through three levels of healthcare viz. primary care through 48 rural and 3 urban primary health centers, and 13 community health centers, secondary care through 10 secondary care government hospitals, and tertiary care through one medical college hospital. Under the cervical cancer screening program, opportunistic screening of women aged 30 years and above by visual inspection with acetic acid (VIA) and Lugol's iodine (VILI) was carried out at all levels by trained staff nurses. Screened negative individuals were advised for repeat screening after 2 years. Those who were screened positive were referred to secondary and tertiary care for colposcopy evaluation done by trained gynecologists. Colposcopy-guided biopsies were sent to tertiary care for pathological confirmation. Confirmed cases of cervical intraepithelial neoplasia grade-I (CIN-I) were referred to as secondary and tertiary care for cryotherapy treatment. Cervical intraepithelial neoplasia grade II and grade III (CIN II and CIN III) were referred to the tertiary care center for further evaluation and treatment. Confirmed cervical cancer cases were treated at tertiary care centers based on the staging of the diseases [Figure 1]. At each level, the results of the evaluation of cervical cancer screening were communicated to the patient through a physical report and advised for a referral to the higher facility, if required. Screening details of each patient were maintained at each facility by hand-written registers. Maintaining the screening details in electronic format was tried but discontinued due to operational reasons.
Figure 1: Screening, diagnosis, and treatment protocol at various levels of cervical cancer adopted in the Cancer Screening Program, Noncommunicable Diseases Intervention Program, Tamil Nadu Health Systems Project, Tamil Nadu, India 2015–2016, VIA: Visual Inspection with Acetic acid; VILI: Visual inspection with Lugol's Iodine; TZ: Transformation Zone; ECC: Endo Cervical Curettage; CIN: Cervical Intraepithelial Neoplasia

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Coverage, adherence, and dropouts in cervical cancer screening

The estimated target population of women aged 30 years and above in the study district was 0.7 million. Out of 0.7 million women, 373,643 women were screened under the program, with the coverage of cervical cancer screening as 53.1% for three years. We estimated the yearly cervical cancer coverage and found an increasing trend from 2012 to 2015 [Figure 2].
Figure 2: Screening of cervical cancer by VIA/VILI in Tiruchirappalli district by year, Tamil Nadu India 2012–2015, VIA: Visual Inspection with Acetic acid; VILI: Visual Inspection with Lugol's Iodine

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Out of 373,643 women screened, 11,639 (3.1%) women were found positive and all of them were referred to colposcopy centers at secondary and tertiary healthcare. But only 6801 underwent colposcopy evaluation and thus we estimated 41.6% of screened positives were lost to follow-up for colposcopy examination [Figure 3]. Details regarding repeat screening for those who were screened negative were not available. Colposcopy examination results were available for 6620 (97.3%) out of 6801 women. As per cervical cancer screening and treatment protocol of the program, colposcopy guided biopsy samples were required for 4076 women. However, biopsy reports were available for 3425 (84%) women. Of the 3425 women, cervical cancer was diagnosed in 159 (4.6%) women and was referred to the oncology department of tertiary care. Precancerous lesions were diagnosed in 528 (15.4%) women and referred for appropriate management. No pathological abnormalities were found in 153 (4.5%) women and were advised for follow-up screening after 2 years. Pathological results were recorded as inflammatory cervical lesions for 2210 (64.5%) women. Out of 528 women with precancerous lesions, treatment details were not recorded for 486 (92%) women. Among the 159 women diagnosed with cancer cervix, we could not obtain treatment details for 150 (94.3%) cancer patients. Of the 11,639 screened positive women referred for colposcopy, 4838 didn't turn up for further evaluation. Thus, the dropout rate from VIA/VILI screening to colposcopy was 41.6%.
Figure 3: Coverage, adherence, and dropouts in cervical cancer screening in the cancer screening program, Tiruchirappalli district, Tamil Nadu, India 2015–2016, . VIA: Visual Inspection with Acetic acid; VILI: Visual inspection with Lugol's Iodine; TZ: Transformation Zone;ECC: Endo Cervical Curettage; CIN: Cervical Intraepithelial Neoplasia; NA: Not available

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Colposcopy details and pathological reports were not available for 181 (2.7%) out of 6801 and 375 (10.9%) out of 3425 women, respectively [Figure 3]. Of the 4076 women who required a biopsy, details of 651 were registered as not done but details for nonperformance were not recorded. Due to infirmity in data management at the tertiary level, we could not obtain treatment data of all women diagnosed with cervical lesions.

Strengths of the referral mechanism

Adoption of the field-tested rapid screening method (VIA/VILI) suitable for a low resource setting was a major strength and advantage to the program for wider implementation. The universal presence of screening at all levels of facilities by dedicated trained staff nurses, standardized uniform protocol of diagnostic and treatment services at all centers, utilization of specialists in the existing institutional framework, organized supportive supervision, structured information, education, and communication (IEC) strategy using multiple communication modes and collaboration with community-based civil groups are the major strengths of the program.

Challenges and areas for improvement

Human resource issues such as shortage of gynecologists and utilizing dedicated staff nurses for other services in the hospital posed a challenge to the program. Key stakeholders opined that these human resource issues resulted in a long waiting list for colposcopy evaluation. Deviation from the screening protocol was reported among staff nurses who were later rectified by providing refresher training and supportive supervision to them. The introduction of the electronic data system was delayed due to operational issues which hampered timely and consistent reporting of follow-up and evaluation results at the secondary and tertiary level. Incomplete individual beneficiary records present in most facilities imposed hindrance to generate appropriate reports. This deterred the program managers to make informed decisions in managing the referral mechanism in the program. An inbuilt monitoring mechanism to trace women who dropout from screening and those requiring repeat screening was not functional in the program.


  Discussion Top


We did this evaluation by reviewing the registers maintained across 75 facilities and by interviewing the respective service providers and program managers. We digitized most of the records and used software programmers to match individuals' facility-level screening data with the available follow-up data from various sources viz. secondary, tertiary level government facilities and also from private facilities under the state insurance scheme.

In three years of implementation, we estimated that the program screened more than half of the target population for cervical cancer in the public health facilities. The screening technique used in the program is a well-tested and effective method to identify cervical cancer early, especially in a low resource setting.[15] Evidence strongly supports the cancer screening strategy adopted in the program for reducing mortality due to cervical cancer.[16] Hence this opportunistic screening program is backed by strong scientific evidence and framed with inputs from international experts in cancer epidemiology. Half of the VIA/VILI screening positives were evaluated further in secondary and tertiary care facilities by colposcopy.

A study conducted in Argentina by Paolino et al. estimated that the abandonment rates of women with abnormal  Pap smear More Details at different stages of a cervical cancer screening program were 26.2% at the screening stage, 57.1% at the diagnosis stage.[17] In another study conducted in Latin America by Paolino et al., subjective reasons and organizational problems were the reasons for abandoning the various stages of cervical cancer evaluation from screening to diagnosis and treatment.[18]

Our review highlights two important challenges in this cancer screening program viz. program management and beneficiary compliance. We observed that the major pitfalls in the program management were human resource issues, poor maintenance of meaningful data, weak monitoring, and evaluation system. These may be the possible reasons for shortcomings in coverage, referral, and follow-up. Program data highlighted the poor performance of coverage and dropouts at colposcopy diagnostic evaluation. Scrutinizing the data at different levels suggests that program data management was poor. Initiatives to convert maintenance of records and registers by pen and paper to electronic formats were not successful. Similar situations and challenges were faced in other developing countries.[10],[11],[19],[20],[21] Though program management was well coordinated during the initial implementation phase, difficulties were often expressed in the later stages of implementation.

Despite the hurdles mentioned, the program significantly screened the target population and further referred for evaluation and management. One of the strengths/positive strides in this program was a dedicated staff nurse for the first stage of cancer screening through VIA/VILI. Structured training programs did improve their capacity and refresher training was conducted to sustain the same. Uniform screening protocol across all the levels of a health system with identified health personnel laid clarity in the specific roles for delivering services in this screening program.

Due to its importance, this program was supported initially by World Bank and further continued with the State Health System where services are provided free of cost showing the political will and systems' commitment to bringing down the burden of one of the leading causes of death among women.

Utilization and compliance among the beneficiaries were other major determinants to achieve the intended outcome of the program. Though measures such as information education and communication through mass media communication were attempted, continuous efforts were not made to sustain the same. There is insufficient evidence in determining the interventions to improve compliance among beneficiaries of the cervical cancer screening program.[22]

Identification of the barriers to utilizing the health services especially the cancer screening program would help in choosing the right strategies and intervention to improve compliance. The paucity of literature in this area either for India or similar settings indicates further research is required. Literature suggests that inadequate information about cancer screening to beneficiaries and poor communication on scheduling, referral were major barriers to cancer screening.[10],[23] So, we suggest that evidence on identifying the barriers of utilizing the cancer screening services among beneficiaries and testing strategies to alleviate such barriers are essential to achieve the program objectives. Our study has certain limitations. The review was based on the secondary data analysis of the registers and reports related to the cervical cancer screening program in a district. Interactions with program managers at the state and district were also documented to describe the program implementation. Hence, a structured program evaluation is required to identify the implementation level challenges at all levels involving key stakeholders. This would identify the potential gaps and best practices of the program implementation across all levels to achieve the expected outcomes. The data on repeat screening of those who were negative initially were not available which we believe as a limitation to this study. We conclude that the referral mechanism in the cervical cancer screening program could not be operationalized at the expected level.

We suggest two measures to improve the program management in cancer screening programs based on our review in this setting. First, establishing a robust information system that could document the first stage screening details and has a tracking feature on successive screening evaluation and follow-up. With the advent of mobile technology, geo-location-based recording and registering the screened individuals at the primary care level is possible and could be explored. A well-integrated centralized digital platform connecting all levels of healthcare across the state health system with electronic dashboards would facilitate the program manager to monitor the service delivery. Second, a well-outlined monitoring and evaluation system with predefined indicators built on a logic framework could ensure effective program management. Such a monitoring and evaluation framework with an integrated electronic information system is a basic requirement for any public health program.[24] Thus, we recommend establishing an integrated electronic information system clubbed with robust monitoring and evaluation framework to efficiently manage the program. We also suggest additional research to identify the barriers to utilization and testing new strategies to improve cancer screening program.

Acknowledgments

Mission Director, State Health Mission Tamil Nadu state, India for being supportive since the inception of this study. Director, National Institute of Epidemiology and Course Coordinator of Indian Council of Medical Research School of Public Health, National Institute of Epidemiology Chennai for providing technical inputs for the study.

Financial support and sponsorship

This study was funded by Training Programs in Epidemiology and Public Health Interventions Network (TEPHINET), Atlanta USA under Noncommunicable Diseases Minigrant.

Conflicts of interest

There are no conflicts of interest.



 
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