Design Gisborne Cervical Screening Inquiry
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National Cervical Screening Programme (NCSP) Questions and Answers

1. What is the National Cervical Screening Programme (NCSP)?

2. What can a cervical screening programme do?

3. Why screen?

4. Who needs cervical screening?

5. How effective is the NCSP?

6. What is the National Cervical Screening Programme-Register?

7. How have cervical cancer rates changed since the NCSP began?

8. What actions have been taken to strengthen the NCSP?

9. What is the National Screening Unit (NSU)?

10. How are women informed about the NCSP?

11. What monitoring is in place for the NCSP?

12. What is the Cancer Registry?

13. What was the Gisborne Cervical Screening Inquiry?

14. What has the Ministry of Health done to date to implement recommendations from the Cervical Screening Inquiry?

15. What are the Kaitiaki Regulations and the National Kaitiaki Group?

16. What is the current audit of invasive cervical cancer?

17. What are the aims of the audit and slide re-read?

18. What work has been done so far on the audit?

19. Why is the audit proceeding carefully?

20. Are women supporting the audit?

21. What will the Audit find?

1. What is the National Cervical Screening Programme (NCSP)?

The National Cervical Screening Programme (NCSP) was the first organised cancer-screening programme in New Zealand. It was established in 1990 to reduce the incidence and mortality rate of cervical cancer through a nation-wide ongoing organised screening programme that would detect the majority of cases in the early pre-cancerous curable stage.

The NCSP is managed by the National Screening Unit of the Ministry of Health and encompasses health promotion, smear taking, laboratory analysis of cervical smears and cervical biopsies, and the management of women with abnormal smear results. The NCSP is delivered to New Zealand women by a range of providers including health promoters, general practitioners, gynaecologists, nurse smear takers, family planning centres, midwives and laboratories. Regional co-ordination of the NCSP, which includes the data-entry of laboratory results onto the National Cervical Screening Programme-Register (NCSP-Register), is managed through eight NCSP Regional Services linked to a central database.

The focus of the NCSP is on women aged 20-69 years who have never had a smear or whose previous smear was more than five years ago. Women aged over 40 years and Maori and Pacific women are priority groups in the NCSP.

 

2. What can a Cervical Screening Programme do?

International evidence suggests that morbidity and mortality from invasive cervical cancer can be reduced with organised screening that aims to detect and treat pre-cancerous changes to the cervix.

Screening for a disease reduces the risk of developing and/or dying from that disease. It does not eliminate that risk entirely. Therefore a cervical screening programme can only reduce the risk of a woman developing and dying from cervical cancer. It cannot eliminate it for all women.

As it can take as long as 10 or more years for invasive cervical cancer to develop, and assuming ALL women aged between 20 and 69 years were routinely screened every three years, a cervical screening programme could theoretically achieve a 91% reduction in the incidence and mortality rate of squamous cell carcinoma over time.

Even with 100% coverage, a cervical screening programme is unlikely to be 100% effective for a number of reasons;

  • The screening test, the cervical smear, categorises women into those who have a relatively high risk of developing cervical cancer, and those who have a relatively low risk at a particular point in time. That is, it does not clearly divide women into those who will and those will not develop cervical cancer.
  • The limitations of smear taking mean that there will always be a proportion of smears that are difficult to classify even in the presence of rigorous quality assurance programmes.
  • The limitations of smear taking and reading also mean that there will always be a proportion of "false negatives" (or "false positives)", even in the presence of rigorous quality assurance programmes.

The validity of a screening test is measured by its ability to do what it is supposed to do, i.e. that it correctly categorises persons who have preclinical disease as test-positive (sensitivity) and those without the preclinical disease as test negative (specificity)2

It would be desirable to have a screening test that was both highly sensitive and highly specific. Usually this is not possible and there is generally a trade-off between the sensitivity and specificity of a given screening test. The sensitivity of the cervical smear is quoted most frequently as 55-80%.

In the case of the cervical smear test, this trade-off has to do with the fact that there are some smears that are clearly normal, some clearly abnormal, and some, which fall into the grey zone between the two.

The cervical smear test is a screening test that involves subjective interpretation by a cytoscreener or pathologist of the 50,000 to 100,000 cells that are present on a typical cervical smear slide. There is an irreducible false negative rate of up to 20%. Although rescreening can reduce the false-negative rate, zero-error performance can never be obtained.

 

3. Why screen?

Unlike most cancers the most common type of cervical cancer, squamous cell carcinoma, is largely preventable. Cells in the cervix undergo changes, which if not detected and treated may develop into cervical cancer in some women. Cervical cancer can take as long as 10 or more years to develop. A cervical smear test checks for abnormal cell changes before they become cancer. Treatment will remove abnormal cells more than 90 percent of the time. Occasionally further treatment will be needed. As with all screening tests there is a small chance that some abnormalities may not be detected at a single screen. This is why it is important for women to have regular three-yearly cervical smear tests.

 

4. Who needs cervical screening?

All women aged 20-69 years who have ever been sexually active. The usual screening interval is every three years for women with normal smear results. The women most likely to develop cervical cancer are those not regularly screened.

 

5. How effective is the NCSP?

 The NSU has established a range of quality activities that help ensure the safety and effectiveness of the NCSP for women currently. One of the most important indicators of overall programme effectiveness is disease incidence and mortality. The NCSP has achieved a 39 percent reduction in incidence and a 44 percent reduction in mortality from cervical cancer under the current enrolment system.

Coverage is another indicator of NCSP effectiveness. The NCSP target for programme coverage is that the proportion of all 20-69 year old women who have had a cervical smear recorded on the NCSP-Register in the previous 36 months is 85% (adjusted for hysterectomy). Currently, approximately 73 percent of eligible women have had a smear in the last three years. This compares favourably with the three-year coverage rates from the UK (66%) and the New South Wales (73%). As of May 2003, 1,084,592 women or 99.14 percent of the eligible population were enrolled on the NCSP-Register.

 

6. What is the National Cervical Screening Programme-Register?

The National Cervical Screening Programme-Register (NCSP-Register) is an important management tool for the NCSP. It holds details of women enrolled on the Programme (such as their name, address, age and ethnicity); smear results, their histology results and details of smear takers, health centres and laboratories. Provided women do not 'opt-off' the information held on the NCSP-Register allows the programme to fulfil its role of providing a backup recall and management system for women enrolled on the NCSP.

 

7. How have cervical cancer rates changed since the NCSP began?

Since the NCSP began there have been significant reductions in both the rates of disease and deaths from cervical cancer. Age-standardised incidence rates for cervical cancer have declined from 12.7 per 100,000 in 1990 to 8.2 per 100,000 in 1999. Age-standardised mortality rates for cervical cancer have declined from 5.0 per 100,000 in 1990 to 2.7 per 100,000 in 1999.

 

8. What actions have been taken to strengthen the NCSP?

The HFA's National Screening Team took over the management of the NCSP in May 1998. Following a review, an additional $1.4 million was injected into the NCSP during the 1999/2000 year to strengthen elements of the programme. These areas included improved quality standards, new independent monitoring processes, improved co-ordination between providers, and better information for women and training for health educators. The National Screening Team transferred to the Ministry of Health as a separate unit, the National Screening Unit (NSU), within the Public Health Directorate in January 2001.

 

9. What is the National Screening Unit (NSU)?

The National Screening Unit (NSU) in the Ministry of Health is responsible for the national operational and strategic management of the two current cancer screening programmes, the National Cervical Screening Programme (NCSP) and BreastScreen Aotearoa (BSA). These functions include: providing national leadership, strategic direction, advice to Government, the development and management of nationally consistent policy and quality standards for the national programmes, prioritising the improvement of Maori health outcomes in screening, providing national monitoring and evaluation and quality improvement processes, purchasing provider services in accordance with provider agreements and robust financial and contract management.

 

10. How are women informed about the NCSP?

The NCSP works with health sector organisations, women's groups and national focus groups to develop information resources to assist women to understand the nature of cervical screening and the National Cervical Screening Programme. Communication resources outline the benefits and potential harms of cervical screening to enable women to give their informed consent to participation in the NCSP.

Resources include

A comprehensive cervical screening information booklet - "Cervical Screening: A guide for women in New Zealand."
This booklet provides detailed information to inform women about the cervical smear test, cervical screening, cervical cancer and the NCSP. It is endorsed by The Royal New Zealand College of General Practitioners and by The New Zealand Committee of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

A general pamphlet - "Cervical smear tests: What women need to know"
The general pamphlet provides women with key messages about the cervical smear test, cervical screening and the NCSP to inform their participation in the screening pathway.

A pamphlet about cervical smear test results - "Cervical Screening: Understanding Cervical Smear Test Results"
This pamphlet assists women to understand what their cervical smear test results mean and what further action may be required in the event that changes are detected on their cervix. It describes key terms in relation to test results, colposcopy and treatment.

A pamphlet explaining colposcopy - "Colposcopy: Information for women who have abnormal cervical smear results"
This pamphlet provides a step-by-step introduction to colposcopy including all stages in the colposcopy treatment pathway

Havas MediMedia tear-off information sheets
These information sheets are designed to assist smear takers when they are discussing cervical screening, the NCSP and the NCSP-Register with women

In addition to the above printed information resources the NCSP makes information available to women on its website www.healthywomen.org.nz through interactive, touch-screen information kiosks, through smear takers and by the efforts of health promoters in local settings.

All resources are available free of charge from local authorised providers of health education resources.

 

11. What monitoring is in place for the NCSP?

An Independent Monitoring Group was contracted in September 2000. It commenced routine monitoring of the NCSP and provides quarterly monitoring reports. As at the end of March 2003, ten reports had been published. These reports are distributed to providers and are publicly available providing statistical data on the performance of the NCSP and NCSP providers. Routine monitoring of the NCSP ensures providers are meeting standards and are able to identify and resolve problems at an early stage. These reports show that the national indicators and targets of performance are largely being met; where there are recommendations to follow up with providers, the NSU addresses these directly with the service provider concerned. They also identify the need to increase NCSP participation rates among under and unscreened women.

The NSU is also receiving valuable external advice and input from a number of advisory groups. This will include input from consumers, Maori, and health professional representation on the current breast and cervical screening programmes, as well as focusing on wider screening issues.

 

12. What is the Cancer Registry

The NZ Cancer Registry is a population based register of all primary malignant diseases diagnosed in New Zealand (excluding squamous cell and basal cell skin cancers). The Cancer Registry is a generic register of all primary malignant diseases diagnosed in New Zealand and the data is a useful surveillance tool to evaluate and monitor various cancer programmes. The Registry was established in 1948 using information sent by public hospitals to the National Minimum Data Set. The Cancer Registry Act 1993 and Cancer Registry Regulations 1994 were introduced to increase reporting of primary cancers in New Zealand. Laboratories are required to report all primary cancers including cervical cancer and CIN3 to the Cancer Registry.

The NCSP-Register is different from the Cancer Registry held by the New Zealand Health Information Service. More information on the Cancer Registry is available on the New Zealand Health Information Service website www.nzhis.govt.nz

 

13. What was the Gisborne Cervical Screening Inquiry?

In October 1999 the then Minister of Health established an Inquiry into the apparent under reporting of abnormal smears in the Gisborne region. The Inquiry also examined whether there was evidence of wider systemic issues for the NCSP that needed to be addressed.

The Inquiry found that during the 1990s the National Cervical Screening Programme in New Zealand lacked the necessary organisation, coordination and some of the constituent parts required for safe and effective screening programmes. Overall 46 recommendations were made by the Inquiry. Four of these recommendations are addressed by the Health (National Cervical Screening Programme) Amendment Bill, and in fact one of the key findings of the Inquiry was the need for the Health Act 1956 to be amended to enhance the capacity to monitor, audit and evaluate the NCSP.

 

14. What has the Ministry of Health done to date to implement recommendations from the Cervical Screening Inquiry?

The Ministry of Health has reported regularly on progress to implement the CSI recommendations. These reports are published on the CSI website www.csi.org.nz. Significant progress has been made in a number of areas:

  1. The NCSP is able to demonstrate reducing incidence and mortality from cervical cancer, increasing programme participation, and good results from the monitoring with the introduction of quality standards. Dr McGoogan does stated in her report that current monitoring of the NCSP suggests an acceptable standard is being achieved.
  2. Improvements continue to be implemented, and in 2003/04 there was the introduction of new and revised standards for colposcopy and NCSP Regional Services, the development of the Framework for Provider Compliance Audits, a new Complaints System, and a range of workforce development and training initiatives. In addition, a number of evaluation activities aimed at investigating where further improvements may be made are planned or underway.
  3. Phases 1 to 7 (of 9 Phases) of the Audit of Invasive Cervical Cancer are completed or underway (Recommendations 1, 2 and 3).
  4. Independent monitoring of national indicators and targets of NCSP and provider performance has been in place since October 2000. Ten Quarterly IMG Reports have been published covering the period October 2000 to March 2003. The NCSP Statistical Report for 1996-98 has also been published and Statistical Reports for further years are in the process of finalisation. (Recommendations 7 and 8)
  5. The NCSP Operational Policy and Quality Standards were introduced from November 2000 across the programme. These mandate standards for laboratory and publicly funded colposcopy services. Since mid 2003, 758,585 women have had one or more cervical smears in the NCSP in accordance with the new standards.
  6. New resources for informing women and health professionals have been produced and distributed. (Recommendations 38 and 39)
  7. Commenced implementation of a Workforce Development Strategy, including implementation of a Nurse Smear Taker training fund, and work to review workforce development options for all health professionals, with an emphasis on laboratories. (Recommendations 28, 40, 41, 42)
  8. The Health (National Cervical Screening Programme) is before Parliament, whilst the Health Practitioner Competency Assurance Bill has been passed. (Recommendations 14, 15, 16, 17, 29, 30, 33, 34, 35, 44)
  9. Progress has been made in a number of other areas, including:
    1. Changes to the operation of the NCSP-Register at the regional level introduced and in the process of being implemented.
    2. Review of smear taker laboratory referral forms completed.
    3. Commencement of work on the introduction of the new Bethesda 2001 laboratory coding for cervical cytology.

 

15. What are the Kaitiaki Regulations and National Kaitiaki Group?

The Health (Cervical Screening (Kaitiaki)) Regulations 1995 established the National Kaitiaki Group (NKG). NKG governs access to the use and publication of Maori women's aggregate data from the NCSP.

The Gisborne Inquiry recommended that the Kaitiaki Regulations be reviewed to allow independent teams to have ready access to Maori women's data on the Register (without the need for Kaitiaki approval), for the purposes of monitoring and evaluating the NCSP. Consultation with Maori women on these regulations began in early 2002, and in September 2002 Cabinet announced its decision to retain the system under the regulations with improved processes for the NCSP to access data.

 

16. What is the current audit of invasive cervical cancer?

The Cervical Screening Inquiry committee recommended that an audit of women with invasive cervical cancer be undertaken as a priority. The current audit of women with invasive cervical cancer involves collating, analyzing and interpreting the screening histories of over 450 women diagnosed with invasive cervical cancer (ICC) between 1 January 2000 and 30 September 2002. The audit has been designed to ensure it includes approximately 100 Maori women. The audit is being carried out by the Ministry of Health in partnership with the University of Auckland. A multidisciplinary advisory group meets quarterly to provide advice to the project sponsor and the audit team.

The overarching goals of the audit are to provide information to support improvements to the NCSP and to provide information to support elimination of disparities between Maori and non-Maori women in the incidence and mortality from ICC.

The current audit project commenced early in 2001. Most of that calendar year was spent developing the methodology and infrastructure for the audit. Ethics approval was obtained in May 2002 and contacting and interviewing women commenced in June 2002. At this stage data collection is well advanced and will be largely complete by the end of this year. A slide re-read was undertaken by an Australian laboratory.

 

17. What are the aims of the audit and slide re-read?

There are a number of aims of the audit, but one very important one is to determine areas where the NCSP could operate more effectively including identifying possible systemic failures. The aim of the slide re-reads is to provide information that will contribute to the overall aims of the audit.

 

18. What work has been done so far on the audit?

The current audit project commenced early in 2001. Most of that calendar year was spent developing a methodology that was feasible in the current legal environment and establishing a project infrastructure for the audit. An ethics application was submitted to all 13 ethics committees in February 2002 and ethics approval was obtained in May 2002. Contacting and interviewing women commenced in June 2002 and is close to completion. A slide re-read was conducted by an Australian based laboratory and was completed by the end of 2003.

 

19. Why is the audit proceeding carefully?

In general, the audit has taken the time that would be expected for a project of this size and complexity being conducted for the first time in the New Zealand health service.

 

20. Are women supporting the audit?

The response rate to the audit has been excellent with 84% of women overall and 87% of Maori women consenting to be interviewed. The success of this Audit relies on women agreeing to take part, and women have responded positively.

 

21. What will the audit find?

It is too early at this stage to say what the audit may find as data analysis has not commenced. However, the audit team has commenced planning the audit reports. The aim is for the audit team to complete the main audit report by the end of September 2004. This report will be publicly available.

Further information on the Health (National Cervical Screening Programme) Amendment Act Questions and Answers is available online.

Further information can be found on our website http://www.healthywomen.org.nz

 

  1. US Preventive Services Task Force. Guide to Clinical Preventive Services. 2nd edition. Washington: USPSTF; 1996.
  2. Hennekens,C H, Buring JE. Epidemiology in Medicine. Little, Brown.1987
  3. US Preventive Task Force. Guide to Clinical Preventive Services. 2nd edition. Washington: USPSTF; 1996
  4. Hennekens,C H, Buring JE. Epidemiology in Medicine. Little, Brown.1987
  5. Fitzgibbons PL. Austin M. Expert Review of Histologic Slides and Papanicolaou Tests in the Context of Litigation or Potential Litigation. Archives of Pathology and Laboratory Medicine - Volume 124, November 2000.

 

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