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Cervical cancer is the second most common cancer in women worldwide and is the principal cancer of women in developing countries. Worldwide, cervical cancer claims the lives of an average of 231,000 women annually, over 80% of whom live in developing countries 3. Molecular evidence indicates that certain strains of the human papilloma virus (HPV), a sexually transmitted virus, are the principal cause of invasive cervical cancer as well as the precancerous lesions known as cervical intraepithelial neoplasia 4. About 80 HPV strains can infect the genital tract but recent research evidence suggests HPV types 16 and 18 are human carcinogens and hence the strains that cause cancer of the cervix 4. If not detected early, cervical cancer is a fatal disease and as such, prevention through early detection of pre-cancerous lesions is the main strategy for prevention.
In developed countries like the United Kingdom, initiation and sustenance of regular cervical cytology screening by way of the papanicolaou smear annually or once in 2 to 5 years in sexually active women has resulted in a huge decline in cervical cancer incidence and mortality over the last 40 to 50 years 3. These screening programs detect precancerous lesions and treat them before they progress to invasive cancer. However, due to inadequate provision for routine screening as well as lack of awareness of the disease in developing countries, the risk of disease and death from cervical cancer has been on the increase.
A two year health promotion program was set up in January 2008 in Lagos state, Nigeria by the Lagos state ministry of health. This was prompted by the fact that the burden of cervical cancer was very large and the cost of the disease to the government was very high. A health needs assessment done prior to planning and setting up the health promotion intervention showed that the population of women within the high-risk age group for developing cervical cancer was estimated to be 5 million. WHO 2006 estimate had shown that of all new cases of cervical cancer diagnosed in Nigerian women, 80% died of the disease within one year. Estimates had also shown that 24.8% of women in the general population in Nigeria were estimated to harbor cervical HPV infection at a given time 5. Prior to this program, cervical screening was not done in the community health care centers and was only carried out in the 2 state government hospitals as well as in the teaching hospitals. Despite the fact that cervical screening has proven to be associated with a huge decline in incidence and mortality in developed countries, the uptake by Nigerian women in the 15 to 44 year old age group had been very low and this was reflected in a survey conducted in 2006 which showed that among women who worked in the healthcare sector, only 5.7% had ever undergone screening 6.
The program was set up with the aim of reducing the incidence and mortality of cervical cancer among women in Lagos state. Its objectives were:
To increase the competence level and skill of community health care staff to perform cervical screening (collection of cervical smears).
To ensure active participation of all 10 community health centers in Lagos state, in the cervical screening program.
Increase the awareness to 80%, of women within the age group at risk (15 to 44 years) to cervical cancer and screening by 2011.
To increase uptake of cervical screening among 15 to 44 year old women by 25% by 2011.
The primary targets of this intervention are all women resident in Lagos state between the age of 15 and 44 years. For the sake of the program, the primary targets were all women attending antenatal as well as postnatal clinics (because they are a good representation of sexually active women in the age group at risk). Other stakeholders involved in this intervention are the health trainers, health care staff in the community health centers, health care staff in the state government hospitals and those in the teaching hospital. Key stakeholders include the Lagos state ministry of health, hospital management as well as hospital administrators.
Evaluation design and perspective
The evaluation would be based on the Before-After (Type 3) design using the logic model. The Before-After design makes use of comparison of measured states taken before the program and after implementation of the program. This design is being used because it is relatively quick and it would need fewer resources to perform the evaluation compared to the comparative-experimentalist (Type 4) or the randomized controlled experimentalist (Type 5) 7.
The evaluation would take the Managerial perspective because the outcome would be used by the health-funding body to ensure the set objectives are met, assess whether the service is reaching the people for whom it was intended and for performance improvement. It would however, also take account of other stakeholders.
The interventions involved in the implementation of the program were:
Organize training workshops on cervical cancer and screening for the nurses and midwives in the community health centers twice a year (in June and December).
Set up a confidential advisory service in each of the community health centers manned by a trained healthcare worker.
Awards of non-financial incentives to the community health centers that achieve a target number of cervical screening over the period, based on periodical progress reviews.
Delivery of 15 minute health talks/sessions on cervical cancer and screening to all women during their antenatal and postnatal visits to health centers and hospitals.
Distribution of leaflets on “cervical cancer facts” to all women in antenatal and post natal clinics, door to door distribution as well as distribution into market places.
Media campaign through radio broadcasts, to increase awareness of women who are not directly accessible to the program.
Provision of free cervical screening services at all health care centers in the state.
Incentives to women by way of ‘certificates’ after a negative smear test. These would be validated to a certain period, when the next screening is due and may act as an incentive for other unscreened women to want to get certificates.
Setting up a regular notification/recall system to enable all women who have been screened in the program to receive notification when they are due for their next screening.
Short term outcomes expected from this program were achievement of the target objectives.
The Long term consequences expected from this program are a reduction in the incidence of cervical cancer cases as well as reduced mortality due to cervical cancer.
Data collection involves would involve qualitative and quantitative methods. These include:
Observation: Participant observation to measure the cervical screening competence level of the nurses and midwives prior to completion of the training workshops. This is however not a very valid method of data collection because the observer’s presence may have an influence on the nurses or midwives. There is also risk of observer bias in this method but this would be minimized by ensuring the evaluation is carried out by more than one observer providing factual detailed description of the screening procedure.
Data would also be obtained from the community health centers to provide information on the number of cervical screening done per trained nurse or midwife. This measure would be used to ensure that the baseline number of screening required to be done to maintain competence is being done.
Data would be collected from records in the community health centers, to provide information on the number of cervical screening done within each of the health centers. This acts as a measure of level of participation of the health centers. These data would also measure the age groups and social classes of women that were screened in order to ascertain whether certain age groups and social classes are taking up screening more than others.
Community surveys through questionnaires: This would be done through self-completed questionnaires mailed to homes located in the different local government areas of the state, before and after the program. Questionnaires would also be sent to schools for the 15 to 18 year olds who may want to maintain confidentiality from their parents. These questionnaires would be mailed with stamped addressed envelopes to ensure they are returned for analysis. Questionnaires that were filled prior to the program had established the age, sex and sexual activity (if they are or have ever been sexually active) of respondents and collected information on awareness of cervical cancer and screening. After the program, questionnaires would in addition, collect information about awareness of the program, acceptability of the service, accessibility to screening centers as well as uptake of screening by the respondent. Questions would need to be carefully worded to ensure validity 7 and would consist of pre-coded questions with additional provision for responses or comments. In the case of respondents who refuse to undergo screening despite awareness, reasons for such refusal are expected to be collected in the questionnaire.
Hospital records to measure uptake of cervical screening before and after the program. This is a valid and reliable measure of uptake because all cervical smear samples collected in the community health centers as well as those collected in the hospitals, are sent for laboratory analysis in either one of the state government hospitals or the teaching hospital. Therefore collection of data from the hospitals give a measure of the uptake in the state.
Cost of resources used in providing the service in terms of financial costs, human resources and other indirect costs.
In performing the evaluation, measures obtained from the data collected after the program would be compared with measures collected before the evaluation.
Increased competence by the community nurses and midwives would be evaluated through the participant observation of the competence level of the nurses/midwives after the training workshops. Maintenance of competence would be evaluated through the number of screening done by the staff in comparison with the baseline number required to ensure sustained competence.
Since the community health centers did not perform cervical smears prior to this program, there would be no data with which to measure against and to evaluate active participation of these health centers, it would be based on data showing the total number of women screened in each health center since the program started.
To evaluate the increase in awareness level of cervical screening among 15 to 44 year olds, the questionnaire surveys done before the program and after the program would be used to measure the level of increase in awareness. Since the objective is to increase awareness level among 15 to 44 year olds to 80%, this measure would be evaluated against this standard to monitor if the achievement is on track. These surveys would also inform about the accessibility, acceptability and equity of the service.
Increased level of uptake of cervical screening among 15 to 44 year olds would be evaluated using the before-after data from hospital records.
Economic evaluation would be carried out using the cost-effectiveness analysis. Deciding on this method of economic analysis, the limitations of the other methods were taken into consideration.
The cost minimization ascertains the less costly option out of two interventions or treatments with similar outcomes. In the screening program being evaluated, there is no other service in place for the prevention of cervical cancer so this is unsuitable.
Cost utility on the other hand, objectively measures the value received from a treatment or service for the money spent. It incorporates the patient’s preference for a particular health state as the outcome measure, valued in terms of quality of life measures or length of life measures. In the cervical screening program, the benefits of screening can not be objectively measured because the effect of not having cancer is normally accrued over the long term.
Lastly, cost benefit analysis measures the costs and outcomes of alternative intervention in terms of resources. It therefore compares the resources spent to resources created by the intervention. The effects of screening i.e not having cancer, can not be quantified in monetary terms and therefore, this method can not be applied.
Cost-effectiveness analysis measures the ratio of the cost of providing this service to the net effects of the service, which in this case is the number of cases detected by the screening program. It represents this measure as a ratio known as the incremental cost effectiveness ratio (ICER). This ratio is usually measured against a standard in order to establish the cost-effectiveness of a service. The acceptability of the screening program would be based on comparison of the ICER against the national ICER threshold (acceptable cost-effectiveness ratio) in Nigeria.
In the interpretation of the result of the evaluation, it is important to consider the alternative interpretations of the findings bearing in mind other factors that may influence the outcome. These confounding variables need to be adjusted for before conclusive inferences can be made.
OUTCOME OF PEER REVIEW
After peer review of the draft of the protocol for the cervical screening program evaluation, a few points were raised and these have been taken account of in the final protocol for the program evaluation. These include:
In the protocol draft, I planned to collect data through community surveys using self-completed questionnaires mailed to homes before and after the program. This was to evaluate the effectiveness of the program based on awareness level after the program, also to evaluate acceptability, accessibility and uptake.
The peer review comment questioned the issue of confidentiality in the case of young girls whose parents don’t know they are sexually active. It was considered that getting questionnaires at home may be problematic for such girls.
I took note of that and included surveying in schools for the benefit of 15 to 18 year olds who may want to maintain confidentiality from their parents.
In measuring the competence level of the health care staff that perform the cervical screening (smear sample collection), based on current practice in the UK, it was suggested that competence could be maintained by ensuring the staff perform a set number of smear collection within a time frame.
Following that, the number of cervical screening performed per nurse or midwife was added to my data collection, as a means of ensuring that the baseline number required, is being achieved in order to maintain competence.
Lastly, the reason for my choice of cost-effectiveness as method of economic analysis was said to be unclear in the draft. As a result, I expatiated on the reasons why the other methods were unsuitable for my economic evaluation of a cervical screening program.
1. Green J, South J. Evaluation: Open University Press; 2006.
2. Smith S, Sinclair D, Raine R, Reeves B. Health Care Evaluation. Open University Press, 2005.
3. Caldwell JC. Population health in transition. Bulletin of the World health Organisation. Volume 79. Geneva: World Health Organisation, 2001.
4. Munoz N, Bosch X, Sanjose S. New England Journal of Medicine. 2003;348:518-27.
5. Castlellsague X, Sanjose S, Aguado T, Louie K, Bruni L. WHO Report 2007 (HPV and Cervical Cancer in the World 2007 Report), 2007.
6. Udigwe GO. Nigerian Journal of Clinical Medicine. 2006;9(1):40-3.
7. Ovretveit J. Evaluating Health Interventions. Berkshire: Open University Press; 2003.
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