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GUIDELINES FOR
CERVICAL CANCER SCREENING
in the State of Qatar
V1.2016
Guidelines for Cervical Cancer Screening
in the State of Qatar
V1.2016
Guidelines for Cervical Cancer Screening in the
State of Qatar
This guideline provides an overview of the cervical cancer screening pathway conducted
in the State of Qatar. The cervical cancer screening services are delivered by primary and
secondary healthcare providers, and regulated by the Ministry of Public Health. This guideline
is adapted from the following organisations: Primary Health Care Corporation (PHCC),
Hamad Medical Corporation (HMC), National Institute for Health and Care Excellence (NICE),
the National Comprehensive Cancer Network (NCCN), Scottish Intercollegiate Guidelines
Network (SIGN), London Quality Assurance Reference Centre (LQARC) and World Health
Organisation (WHO).
This guideline is subject to ongoing review on a 12-monthly basis in order to ensure
that they reflect any changes in practice and emerging clinical evidence.
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Contents
1Introduction
4
2
General Principles of Care
7
3
Health Promotion
10
4
Screening Invitation and Stratification
11
5
Screening Clinical Team
14
6
Referral Guidelines and Patient Pathway
17
7
Investigations and Diagnosis
23
8
Quality Assurance
29
9References
30
10
34
The Guideline Development Group (GDG)
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INTRODUCTION
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INTRODUCTION
Guidelines for Cervical Cancer Screening in the State of Qatar | 5
Guidelines for Cervical Cancer Screening in the State of Qatar | 4
1.
Introduction
In 2014, there were 18 confirmed cervical cancer cases and no recorded cervical
cancer related deaths registered with the Qatar National Cancer Registry1. This
appears to be in line with the current estimates from the ICO (Institut Català
d’Oncologia) Information Centre on HPV and Cancer which indicate that every year
15 women are diagnosed with cervical cancer and 4 will potentially die from the
disease2,3. From 1970 to 2015, Qatar National Cancer Registry has a total of 60
Qatari women recorded to have been diagnosed of cervical cancer as the primary
site with variable age distribution from an onset age of 26 to 96 and classical peaks at
ages 42 and 62. Human papillomavirus (HPV) is a common virus transmitted through
sexual contact but in most cases, the infection completely subsides without requiring
treatment. However, certain HPV subtypes cause cervical cancers4 and are known
to be high risk HPV (HR-HPV) subtypes, examples include HPVs 16 and 18. If left
untreated, these subtypes could develop into cervical cancers.
Cervical cancer currently ranks as the fifth most common cancer among women in
Qatar and one of the top 5 causes of cancer deaths in women in countries without
cervical screening programme. Most cases of cervical cancer occur in women who
were either never screened or were screened inadequately5,6. Estimates suggest
50% of the women in whom cervical cancer is diagnosed never had cervical cytology
testing, and another 10% had not been screened within the 5 years before diagnosis7-9.
Additional public health measures remain critical to improving access to screening to
this group of women.
Screening is a process of identifying individuals who appear healthy but may be at
increased risk of a disease or a condition. The screening process may not adequately
identify cervical lesions as in every screen there can be a number of false positives
and false negatives. The screening test is rather a method of preventing cancer
by detecting, identifying and treating abnormalities (i.e. early epithelial changes)
in the cervix of women. However, when cervical cancer screening programs have
been introduced into communities, marked reductions in cervical cancer incidence
have followed10-11.
A population-based screening is a process where all eligible population are invited
to routine screening at a specific screening interval. This is an organised integrated
process where all activities along the screening pathway are planned, coordinated,
monitored and evaluated through a quality improvement framework with adequate
resources to ensure benefits are maximised. Management and monitoring of the
screening programme should follow an agreed set of quality assurance standards
including implementation of service’s performance indicators. Adequate staffing and
facilities for calling and/or recalling eligible women, testing, diagnosis, treatment and
programme management should be agreed and established. Healthcare professionals
in cervical screening programme should ensure that correct protocols and processes
are followed for the safety of the screening participants and the entire programme.
Evidence-based information, explaining the purpose and potential consequences of
screening, investigation, and preventative intervention or treatment should be made
available to eligible participants to assist them in making an informed decision.
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The cervical screening programme is about preventing cervical cancer through the
detection and treatment of incipient, superficial, precursor lesions or changes in the
cervix, also known as cervical intraepithelial neoplasia (CIN). The UK NHS Cervical
Screening Programme recommends that asymptomatic women aged 25 to 64
years should undergo a routine cervical screening at specific screening intervals12.
These cervical screening intervals are supported and assessed by the UK National
Screening Committee13. In the United States, the American Cancer Society for
Colposcopy and Cervical Pathology recommends cervical screening for ages 21 to
65 year and the recommended screening method is HPV and Cytology cotesting14.
Women aged 21-29 years should be tested with cervical cytology alone and screening
should be performed every 3 years. Cotesting should not be performed in women
younger than 30 years. For women aged 30-65 years, cotesting with cytology and
HPV testing every 5 years is preferred; screening with cytology alone every 3 years
is acceptable. In all countries, women are continuously encouraged to participate in
screening irrespective of their sexual history. In 2011, joint ACS, ASCCP, and ASCP
guidelines and the USPSTF guidelines, it has been recommended that cotesting is
not for women younger than 30 years because of the very high prevalence of the
high-risk HPV infections and the low incidence of cervical cancer in sexually active
women in this age group15,16.
The introduction of a Qatar national cervical cancer screening programme will aid
the early detection of CIN and timely management with optimal outcomes for all
women. The cervical cancer screening service will aim to screen at least 70% of the
entire eligible population who are unaware of the disease (healthy people). Although
screening is aimed to test healthy population, in practice, it is often extended to patients
who may have presented to medical providers for other reasons other than for testing
especially during medical encounters where no symptoms are present unaware that
they may have cervical disease, and therefore considered as asymptomatic. This is
sometimes referred to as case-detection or as case finding.
The national cervical screening programme recommends a screen-and-treat
programme17 in which the treatment decision is based on a screening test and
treatment is provided soon or, ideally, immediately after a positive screening test. The
screening programme will aim to use liquid based cytology (LBC) to collect samples
of cells from the cervix and then use the HPV Testing dependent on the results of
LBC. This is because HPV testing has high sensitivity in detecting CIN III+ lesions18
however, it has a known disadvantage which is less specificity than cervical cytology19.
The introduction of HPV testing will have resource implications for all providers who
are currently using LBC only. LBC and HPV testing detect precancerous changes of
the cervix, known as cervical intraepithelial neoplasia (CIN).
1.1
Purpose of the Guideline
This guideline is intended to aid the screening of asymptomatic women in the general
population of Qatar from age 25 and sexually active to age 64. It is recommended that
women aged 25 to 49 are screened every 3 years whilst women aged 50 to 64 are
screened every 5 years12. For women above age 64 years, they will only be invited
if they have not been screened since age 50 or have recently had abnormal tests.
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Aims of the guideline are:
• To ensure early detection and diagnosis of cervical cancer;
• To promote an organised, systematic and culturally appropriate population-based
screening service across an integrated screening pathway;
• To improve all aspects of the screening pathway and guide more consistent referrals.
• To reduce the incidence of cervical cancers in Qatar and improve mortality.
• To generate statistical and epidemiological data to inform the Ministry of Public
Health’s National Cancer Screening Registry.
This guideline also covers the stratification of symptomatic women who had signs
and symptoms of the cervical cancer at time of presentation.
1.2
End Users of the Guideline – Professionals and Individuals
This guideline is relevant to all healthcare professionals (i.e. physicians, nurses,
diagnostic cytologists, social counsellors, and others) who manage asymptomatic
and symptomatic women in the cervical screening journey.
It is also expected that this guideline will be of value to those involved in clinical
governance in both primary, secondary, tertiary care and private healthcare to help
ensure that arrangements are in place to deliver appropriate diagnostic care to this
group of women.
1.3
Target Areas
This guideline is intended as a reference for the following departments in any
organisation involved in the cervical screening pathway: administration, nursing,
diagnostic radiology, pathology/cytopathology, gynaecology, assessment clinic
and oncology.
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GENERAL PRINCIPLES
OF CARE
GENERAL PRINCIPLES OF CARE
Guidelines for Cervical Cancer Screening in the State of Qatar | 8
2.
The General Principles of Care
• All eligible and asymptomatic women aged 25 to 64 years and sexually active
should be invited for routine cervical screening at given age ranges and
screening intervals:
• Women aged 25 to 49 years should be screened every 3 years.
• Women aged 50 to 64 years should be screened every 5 years.
• Cervical screening method will be Liquid-Based monolayer Cytology, also known
as LBC. Depending on the cervical screening result, human papillomavirus test
(HPV Test) will be conducted.
• Asymptomatic women with any of the following factors may require more frequent
cervical cancer screening than recommended:
• Women who are infected with HIV
• Women who are immunocompromised (such as those who have received
solid organ transplants)
• Women who were exposed to diethylstilbestrol (DES) in utero
• Women previously treated for CIN2, CIN3 or cancer
• Women with history of CIN2, CIN3 or adenocarcinoma in situ should continue
screening for a total of 20 years after spontaneous regression or appropriate
management of CIN2, CIN3 or adenocarcinoma in situ, even if it extends
screening past age 65 years.
• Women over 64 years old will only be invited for cervical screening if they have not
been screened since age 50 or have recently had abnormal tests. Women with
a history of CIN2 or a more severe diagnosis should continue routine screening
for at least 20 years14.
• Women who had hysterectomy should be excluded from cervical screening. This
applies to women without a cervix and without a history of CIN2 or a more severe
diagnosis in the past 20 years or cervical cancer ever14.
• Screening procedure, treatment and care should take into account women’s
needs and preferences.
• Women undergoing cervical cancer screening should have the opportunity to
make informed decisions about
• their acceptance of the invitation or not on each occasion the screening is
offered and
• their care and treatment, in partnership with their healthcare professionals.
• Cervical cancer screening should be accessible to women with additional needs
such as physical, sensory, learning disabilities and mental health.
• Healthcare providers should also be prepared to respond to the discussion of
risks and consequences of having cervical cancer screening.
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• The information given to individuals presenting for screening and/or their families
are governed by the DISCERN Quality Criteria20. This instrument should be used
in conjunction with the following discussion points with the individual for screening:
○ What to expect from the service if willing to attend screening.
○ The importance of informed consent.
○ The process of cervical screening.
○ What type of tests may be carried out, and what will happen during cervical
screening i.e. Liquid Based Cytology (LBC), HPV Testing, etc.
○ Understanding the benefits of cervical screening and potential risks.
○ What is the process if the individual is being referred for further assessment
○ How long they will have to wait for the appointment.
○ Whether they can take someone with them to the appointment.
○ The cervical assessment procedures and treatment choices based on
evidence of clinical effectiveness.
○ The benefits and risks of each treatment.
○ How treatment choices would affect the overall quality of life.
○ How long it will take to get the results.
○ Who to contact if they do not receive confirmation of an appointment.
○ Any other sources of support and information
• Informed consent will be required from the individual before cervical screening.
The healthcare providers should ensure that the DISCERN Quality Criteria is
adhered to before an individual arrives at an informed decision to screening.
• A woman presenting with symptoms and/or signs suggestive of cervical cancer
should be assessed through a detailed history and examination, irrespective of
the presence of risk factors.
• A person presenting with symptoms and/or signs suggestive of cervical cancer
requires urgent referrals and investigation in the symptomatic service.
• An explanation needs to be given to any person being referred with suspected
cancer that they are being referred to a cancer service.
• Information provided should be appropriate for the person in terms of language
and likely awareness of cervical cancer. All information shall be sensitive
considering culturally-variable perceptions of cancer overall.
• Information on screening should be available in a variety of formats on both local
and national sources of information.
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• When referring a woman for further assessment to a specialist service, assess
their need for continuing support while waiting for their referral appointment. This
should include inviting the person to contact their healthcare professional again
if they have more concerns or questions before they see a specialist.
• If the woman has additional support needs because of their personal
circumstances, inform the specialist (with the person’s agreement).
• Include all appropriate information in referral correspondence, including whether
the referral is urgent or non-urgent.
• Once the decision to refer to assessment after all co-testing results have been
read and documented, ensure that appropriate time referrals are discussed and
made. Use local referral proformas if these are in use.
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HEALTH PROMOTION
HEALTH PROMOTION
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3.
Health Promotion
Health promotion in cancer screening provides initiatives in the early detection of
cervical lesions through the timely delivery of the awareness messages. Robust health
promotion could potentially impact behaviour and expedite the early presentation of
women with cervical intraepithelial neoplasia (CIN) or cervical cancers and increase
the screening coverage and uptake.
Health promotion is driven by marketing campaigns in community groups and
activities, media, advertisements, promotions and leaflets/flyers distribution. The
DISCERN quality criteria20 for consumer health information should be applied
in order to ensure that the aim of the health promotion is achieved and that the
message is clear and explicit to the targeted audience. Health promotion should
also provide unbiased information especially on the risks and benefits of cervical
screening supported by evidence-based research and studies.
Primary and secondary healthcare providers should deliver robust promotions and
education to encourage participation and maximum population coverage. They should
welcome questions and queries related to screening and advice should be provided.
Discussion of risks and consequences of having screening should be prepared by
the healthcare providers. As health centres are the first point of contact for patients
for medical consultations, they should make every effort to raise people’s awareness
of all the services they offer and how they could avail of these services. Information
on any treatments and follow-up procedures after cervical screening assessment
should be discussed with the woman.
Obtaining informed consent from women before undergoing cervical screening is a
mandatory requirement in order for them to make their own informed decision. This
process of obtaining informed consent will help the women to:
• decide if they will proceed with cervical screening and
• weigh the benefits against the potential risks from cervical screening.
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SCREENING INVITATION
AND STRATIFICATION
SCREENING INVITATION
AND STRATIFICATION
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4.
Screening Invitation and Stratification
4.1
Invitation (Call/Recall)
‘Call/Recall’ is the process of inviting asymptomatic eligible women for cervical cancer
screening at given screening intervals. Women aged 25 to 49 years old and sexually
active should be invited for routine cervical screening every 3 years whilst women
aged 50 to 64 years should be invited for routine cervical screening every 5 years.
The ‘Call/Recall’ office will invite the eligible women for screening via the telephone.
Women who decide to decline the screening invitation would either be deferred (if
they wish) or removed from the screening register. Consent should be recorded if
they choose to be deferred or removed from screening register. Call/Recall Database/
Information System would require updating regularly to ensure that all eligible women
are invited within the recommended screening interval.
Call and recall systems are necessary for the successful operation of population
screening programmes. There is a need:
•
to provide a system with failsafe, active personalized invitation of eligible participants.
• that invitation to participate in cervical cancer screening should be a single
intervention and not be part of a multi-intervention health preventive programme.
• to provide a reminder system for screening appointments.
• that preference for communication should be elicited from those invited for
screening and that reminders to attend should be tailored to their stated
preference. These could be either by email, telephone or text messages.
• for the use of educational materials explaining the key facts concerning the pros
and cons of screening required for informed consent should be included with the
phone invitation to attend the cervical cancer screening.
• to advise the patient that more than one investigation may be necessary to
confirm or exclude a diagnosis of cervical cancer.
• to ensure that the cervical cancer screening provider’s database has linkage to
the Qatar National Cancer Screening Registry with the Ministry of Public Health.
4.2
Initial Appointment at the Health Centre
Women invited for screening at the primary health centre will be registered and
assessed by qualified case managers who will decide on whether they will undergo
cervical cancer screening, or be referred directly to a symptomatic clinic in order
to see a specialist. Stratification of women for screening ensures that women are
directed to the proper route for investigation and diagnosis. Stratification criteria for
screening individuals discussed in the next section (section 4.3) would be useful for
case managers in primary healthcare to manage the screening participants.
Asymptomatic women (i.e. healthy women) would undergo the cervical screening;
while symptomatic women would be referred directly to the secondary healthcare
provider’s symptomatic clinic. Results from either cytology or HPV testing or both will
be finalized and provided by primary healthcare provider to the women.
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The case manager will be providing the women with all cervical screening information
including the aims and purpose, screening pathway, benefits, signs and symptoms of
cervical cancer. Treatment and referral processes will also be discussed in order to
reassure that the screening process is safe and that the results are reliable.
The case manager should be prepared to respond to the individuals in discussion
of risks and consequences of undergoing cervical screening process. The inclusion
of the DISCERN quality criteria in the discussion of screening information to the
individuals should include the following points:
○ what to expect from the service if willing to attend screening.
○ the importance of informed consent.
○ the process of cervical screening.
○ what type of tests may be carried out, and what will happen during cervical
screening i.e. Liquid Based Cytology (LBC), HPV Testing, etc.
○ understanding the benefits of cervical screening and potential risks.
○ what is the process if the individual is being referred for further assessment
○ how long they will have to wait for the appointment.
○ whether they can take someone with them to the appointment.
○ the cervical assessment procedures and treatment choices based on
evidence of clinical effectiveness.
○ the benefits and risks of each treatment.
○ how treatment choices would affect the overall quality of life.
○ how long it will take to get the results.
○ who to contact if they do not receive confirmation of an appointment.
○ any other sources of support and information
4.3
Clinical Stratification
Management of women for cervical cancer screening involves stratification of eligible
population of women through to either asymptomatic or symptomatic. It is important
to stress that women may take more than one visit to the screening service due to
series of tests and treatments.
Eligible population who attend call/recall appointment at cancer screening healthcare
centers and those women who are self-referrals will be managed by qualified case
managers and will be stratified into the following clinics – asymptomatic or symptomatic.
• Symptomatic patients would be referred directly to the symptomatic clinic without
conducting LBC/HPV Testing at the primary healthcare center.
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• Asymptomatic women would undergo LBC/HPV Testing first at the primary
healthcare center, then depending on the result; they will be referred for
further assessment (tests, treatments) at the primary and/or secondary
healthcare provider/s.
4.3.1 Stratification Criteria
A.
Symptomatic women, signs and symptoms21 include:
○ Inter-menstrual bleeding (IMB)
○ Post-coital bleeding (PCB)
○ Post-menopausal bleeding (PMB)
○ Abnormal appearance of the cervix (suspicion of malignancy)
○ Vaginal discharge (blood-tinged)
○ Pelvic pain
B.
Asymptomatic women with no manifestation of signs and symptoms,
screening would be conducted straightaway.
○ Women will undergo LBC and/or HPV Test and a report will be given within 2
weeks (re-testing excluded in this timeline of 2 weeks).
○ Women with negative LBC and/or HPV Test outcome would be sent back to
routine screening (call/recall) after the required screening interval.
○ All findings requiring further investigation would need further examination at
cervical assessment clinic for final outcome. Diagnosis, referral and treatment
would be agreed and finalized by the members of the cervical screening
multidisciplinary team (MDT).
○ Colposcopy must be completed within 3 weeks from the date of the woman’s
screening attendance.
○ Treatment and follow-up for all confirmed cervical cancer patients after final
diagnosis would be managed by the treating MDT.
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SCREENING CLINICAL TEAM
SCREENING
CLINICAL TEAM
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5.
Screening Clinical Team
The clinical team will be composed of qualified clinical experts from healthcare
organisations in the State of Qatar:
• The primary healthcare provider with the responsibility of providing the call/recall,
health promotion and LBC and HPV analyses/results; and
• The cervical cancer clinic within the secondary healthcare provider with the
responsibility of providing further clinical assessment (such as cervical histology
and colposcopy services), diagnosis, treatment and follow-ups.
5.1
Primary Healthcare Provider
5.1.1 The Case Manager
A case manager should be a qualified nurse with the relevant experience in assessing
the woman’s eligibility to screening. The case manager will stratify the women into
screening pathway to the asymptomatic or symptomatic. Part of the role of case
manager is the health promotion of cervical cancer screening. The case manager
will provide all the necessary information to the women about cervical cancer
screening program including the eligibility criteria, benefits of screening, screening
frequency, liquid-based cytology, HPV Testing, referral process, and the woman’s
informed consent to screening. Please refer to section 4.2 for further details about
the accountabilities of the case manager.
5.1.2 The Physician
Women stratified by case managers to the asymptomatic pathway would undergo
cervical cancer screening - liquid-based cytology and/or HPV testing. HPV Testing
should be performed to detect the presence of high-risk HPV, to determine the
requirement for colposcopy, and as an adjunct to LBC (cotesting). There is no
role for testing low-risk genotypes, and tests for low-risk HPV should not be
performed according to American Society for Colposcopy and Cervical Pathology,
American Society for Clinical Pathology and American Congress of Obstetricians
and Gynecologists.
Women stratified by case managers to the symptomatic pathway would be referred
by the physicians to the symptomatic clinic of the secondary healthcare provider
through the HMC RMO using the 48 hour referral pathway.
5.1.3 The Lead Cytopathologist
The Lead Cytopathologist will supervise the screening of cervical samples and
examination of abnormalities. Accuracy in examining the cervical samples is vital
and paramount to establish the result of the samples.
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5.2
Secondary Healthcare
5.2.1 The Consultant Obstetric-Gynaecology Lead
The consultant Obstetric-Gynaecology lead is a member of the cervical screening
MDT which will decide on the final diagnosis, treatment and follow-up of the patient
after Colposcopy. Cervical cancer should be decided by the treating MDT as the
screening MDT will not necessarily have the staging information.
5.2.2 The Colposcopist
The Colposcopist conducts the colposcopy of the patients referred from primary
healthcare after cervical cytology and/or HPV testing. Colposcopy is clinical process
of investigating abnormal changes in the cells of the cervix using a special magnifying
device called a colposcope. Biopsy may be performed at the time of colposcopy.
5.2.3 Lead Colposcopy Nurse
The Lead Colposcopy Nurse has key roles in cervical cancer screening program as
clinical support during colposcopy and as a counsellor for new patients before they
schedule an initial appointment and before they undergo the procedure. They also
help in explaining the importance of colposcopy and benefits from the procedure with
equal emphasis on some disadvantages as well. Information and facts discussed
with the lead colposcopy nurse help reduce any fears or anxieties brought by the
procedure. Part of their role is to call and follow up patients for follow ups and
assessment appointments.
5.2.4 The Lead Histopathologist22
The Lead Histopathologist provides the final diagnosis which serves as the basis of
the treatment plan and also as the gold standard for quality control of cytology and
colposcopy. Histopathologists should be aware of, and be familiar with the nature
of cytological changes that may be relevant to their reports. The accuracy of the
histopathological diagnosis of tissue specimens depends on adequate samples,
obtained by colposcopically directed punch biopsies or excision of the transformation
zone or conization. An accurate histological diagnosis depends on appropriate
macroscopic description, technical processing, microscopic interpretation and quality
management correlating cytological and histological diagnosis.
5.2.5 The Pathology Department
The department provides quality prognostic and predictive information in pathological
reports and helps minimise the number of unnecessary surgical operations. The
department also provides laboratory services to the cervical screening programme
for the biopsy result provision and timely issue of results to minimise delay.
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5.2.6 The Screening Multi-Disciplinary Team (MDT)
The Screening MDT discusses discordant cases and women who have CIN and
colposcopy findings. The group also discuss the final diagnosis following colposcopy,
histopathology results, patient’s history and diagnosis after careful examination of
the all evidence-based tests and results. For those patients, with confirmed cases
of cervical cancers, the screening MDT decides on the referral to the treating MDT.
Screening MDT should have a quorum of all the leads mentioned above under
‘secondary healthcare’. For an organised population-based screening, this MDT
should ensure that each case has
• reached a definitive diagnosis,
• been referred to have the most appropriate treatment.
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REFERRAL GUIDELINES
AND PATIENT PATHWAY
REFERRAL GUIDELINES
AND PATIENT PATHWAY
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6.
Referral Guidelines and Patient Pathway
6.1
Patient Referral pathway for Screening in Qatar
Invitation (Call/Recall) in two stages:
1) Telephone 2) Health Centre Visit
Negative
result
Asymptomatic (1)
Symptomatic (3)
Cervical Cytology
(with HPV Testing,
as req’d)
Referred to
Secondary Care (4)
Positive Result
Referred to
Secondary Care (2)
Referral time requirement from stratification of screening women to referral:
• From Asymptomatic (1) to Referral to Secondary Care (2) = 3 Weeks
• From Symptomatic (3) to Referral to Secondary Care (4) = 48 hours
6.2
The Referral Process
6.2.1 For Asymptomatic Referral
Patients with abnormal cervical cytology and/or HPV testing results would be
referred to the cervical assessment clinic (secondary healthcare provider) within 3
weeks from the date of screening attendance. Final screening outcome and final
diagnosis (including staging) should be decided within 31 days from the date of
screening attendance.
Patients with confirmed cervical cancer cases would have their first definitive treatment
within two weeks from the date of referral to surgeon (secondary healthcare provider).
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6.2.2 For Symptomatic Referral23
Symptomatic patients after stratification must be referred to secondary care within 48
hours. Patients with confirmed cervical cancer cases would have their first definitive
treatment within 14 days from the date of referral to Gynaecology Oncology Surgeon
(secondary healthcare provider).
Please refer to the document – ‘Guidelines for Management of Cervical Cancer in the
State of Qatar’ on Chapter 4.
6.3
Presentation of Symptoms and Clinical Assessment
6.3.1 Symptomatic Patients
Clients classified as symptomatic patients could present with the following signs
and symptoms:
A.
Post-Coital Bleeding (PCB): Postcoital bleeding (PCB) is a non-menstrual
bleeding that occurs immediately after sexual intercourse. This is a symptom
that requires further assessment for suspected gynaecological cancers.
Unexpected bleeding causes anxiety and concern because it can be a symptom
for gynaecological cancer particularly cervical cancer24.
The causes of post-coital bleeding includes infection, cervical ectropion (for
women taking combined oral contraceptive pill), cervical polyps, vaginal cancer,
cervical cancer (evident on speculum examination) and trauma.
B.
Post-Menopausal Bleeding (PMB): Post-menopausal bleeding (PMB) is a
vaginal bleeding occurring after 12 months of amenorrhoea (abnormal absence
of menstruation) when menopause can be expected25. This kind of bleeding is
not expected for young women who had amenorrhea from anorexia nervosa, or
a pregnancy followed by lactation. However, this can occur in younger women
following premature ovarian failure or premature menopause.
The causes of PMB include vaginal atrophy (common cause)26, endometrial
hyperplasia, endometrial cancer, endometrial polyps or cervical polyps, cervical
cancer, uterine sarcoma, ovarian cancer, vaginal cancer (very uncommon),
vulvar cancer and non-gynaecological causes (which could include trauma or
bleeding disorder).
C.
Abnormal appearance of the cervix (suspicion of malignancy)
Visualization of the cervix is an important factor in order to identify cervical
abnormalities. In most women, this is a straightforward process but for others it
present challenges for an adequate cervical examination. Cervical lesions that
may or may not be associated with cytological abnormalities such as ectropion,
Nabothian cysts, and small cervical polyps are usually benign but abnormalities
associated with exposure to diethylstilbestrol and abnormalities with history
of cervical inflammation should undergo additional evaluation. Another set of
challenges for adequate cervical examination presents for those women who
are nulliparous or postmenopausal; who have retroverted uterus resulting in an
anterior cervical displacement; and who had prior vaginal surgery, pelvic mass
and scarring or high body mass index.
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I. Potential abnormal appearances of the cervix include:
1. Nabothian Cysts also called mucinous retention cysts or epithelial cysts, are
common and benign and considered to be a normal feature of an adult cervix.
These could occur after childbirth or minor trauma. A woman with several
Nabothian cysts (very rarely) may develop gross enlargement of the cervix.
Nabothian cysts are usually asymptomatic and have no need for treatment.
However for those women who experience fullness or pain from these cysts,
they can be treated by electrocautery ablation or excision.
2. Leiomyoma: Cervical myomas are solitary firm masses of smooth muscle
usually small, asymptomatic and arising from lower uterine segment. Myomas
may cause symptoms related to mechanical pressure, dysuria, urethral or
ureteral obstruction, dyspareunia, and obstruction of the cervix. In some
instances, menorrhagia and dysmenorrhea also occur. Pelvic examination
usually identify cervical myomas but sometimes additional imaging is
required such as ultrasonography in order to delineate size, location and
monitor growth.
3. Ectropion: Cervical ectropion is the eversion of the endocervix to expose
columnar epithelium to the vaginal milieu. This process is known to be a
cervical ectopy. The eversion usually results in a reddish appearance of the
epithelium and appears similar to granulation tissue. Vaginal discharge is the
most common symptom.
4. Cervical Polyps (endocervical polyps): These polyps may present with
postcoital, intermenstrual or postmenopausal bleeding but most often
found during pelvic examination. The aetiology of cervical polyps is unclear.
Most polyps are benign and the incidence of malignancy is 1:100027. Small
asymptomatic polyps less than 5 mm in diameter do not necessitate removal
but should be monitored. Larger polyps on the other hand, should be evaluated
and removed. Removal of large polyps is a straightforward procedure.
II. Cervical abnormalities for further examination includes:
1. Endometriosis and Adenomyosis: Symptoms from endometriosis may
present as red, blue or black cervical lesions (known as “powder burns”)
that do not blanch on compression. The woman may be asymptomatic or
may report symptoms of discharge, dysmenorrhea, pelvic pain, or deep
dyspareunia. Adenomyosis occurs when the inner lining of the uterus
(endometrium) breaks through the muscle wall of the uterus (myometrium). It
may involve endocervical canal or form a polypoid mass protruding into the
endocervical canal28.
2. Cervicitis: Cervicitis can be acute or chronic with an infectious or noninfectious nature. It usually presents as vaginal discharge or postcoital
bleeding. Cervical edema, cervical friability and mucopurulent discharge
characterize gonococcal and asymptomatic chlamydial cervicitis29.
D.
Vaginal discharge (blood tinged): Blood-tinged or brown vaginal discharge
could be early symptoms of cervical cancer. It could be a result of an irregular
menstrual cycles or an infection. This is often continuous and the discharge may
be pale, watery brown and foul-smelling.
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E.
Screening Pathway for Asymptomatic Individuals
The pathway below demonstrates the services that will be delivered by Primary Health
Care Providers (all services outside the dotted box) and Secondary Health Care
Providers (services inside the dotted box). The cervical cancer screening waiting
time of 31 days (max.) starts from cervical cytology date (1) until referral to surgeon
(2) followed by 2 weeks (max.) for first definitive cancer treatment (3).
Screening Report
HPV Testing
Cervical Cytology
(LBC) (1)
Negative
Screening Report (Positive HPV and BorderlineSquamous/Borderline-Endocervical)
Colposcopy
Pathology Result
CIN 1/2/3 and AGC
Multidisciplinary Team (MDT)
Confirmed
Cancer
Cases
Routine
Recall
Communication
of Results to
Women via Primary
Healthcare provider
31 days
Negative
1 week
Negative
2 weeks
Administration
Process
Cancer Cases Referral to
Gynae Oncology Surgeon (2)
First Definitive
Treatment
of Cancer (3)
2 weeks
6.4
Pelvic Pain: Pelvic pain is characterised as more advanced and intense symptom
that arises in later stages of cervical cancer. Other symptoms associated with
pelvic pain include difficulty in urinating, swelling of one or both legs, fatigue
and weight loss.
Definition:
• Administration process – composed of the 3-year and 5-year screening plans,
invitation process and clinical preparation.
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6.5
Human Papillomavirus (HPV)
Human Papillomavirus (HPVs) are composed of more than 200 related viruses where
40 HPV types easily spread through direct sexual contact from skin and mucous
membranes of infected people to the skin and mucous membranes of their partners.
These viruses can be transferred through vaginal, anal and oral sex30.
There are two sub-categories of HPV viruses: (a) low-risk genotypes; and, (b) highrisk HPV genotypes. Epithelial infections associated with low-risk HPV are typically
self-limiting, regressive, and do not cause cervical cancer in the immuno-competent
individual; but, can cause warts on or around the genitals, anus, mouth or throat. The
low-risk HPV category includes types 6 and 11, which may cause up to 90% of all
genital warts and recurrent respiratory papillomatoses. Respiratory papillomatosis is
a less common disorder in which benign neoplasms may appear in the air passages
leading from the nose and mouth into the lungs. Conversely, cervical epithelial lesions
associated with high-risk HPV may persist and pose a substantially increased risk of
progression to either squamous or glandular malignancy if left untreated. High-risk
HPV cervical epithelial infections can lead to invasive cervical cancer when involved
with two globally-prevalent genotypes: 16 and 1831,32; however, other genotypes are
also thought to be involved. These risk genotypes are linked to the development and
uncontrolled replication of abnormal cells reflecting DNA aberrations caused by viral
DNA integration into the human genome. The HPV genome appears to be the most
important determinant of persistence and progression. Human papillomavirus-16
has the highest carcinogenic potential and accounts for approximately 55-60% of
all cases of cervical cancer worldwide. Human papillomavirus-18 is the next most
carcinogenic genotype and is responsible for 10-15% of cases of cervical cancer.
Approximately 12 other genotypes are associated with the remainder of cases of
cervical cancer.
Epithelial cells organised in layers are prone to HPV infection because it covers
the inside and outside surfaces of the body including genital tract, anus, skin and
throat. When the HPV enters an epithelial cell, the virus begins to produce encoded
proteins E6 and E7. These proteins interfere with cell functions enabling the cell
to grow in an uncontrolled manner. Sometimes these activities are recognised by
the body’s immune system and eventually eliminated. However, if the infected cells
are not identified and destroyed, infection persists. As the infected cells continue
to grow exponentially and uncontrolled, they develop mutations in cellular genes
that promote even more abnormal cell growth leading to the formation of an area of
precancerous cells or cancerous tumour.
A sexually active individual (or one who has previously been) can get HPV with
easy transmission between partners through sexual contact (i.e. skin-to-skin sexual
conduct, vaginal, anal or oral sex). HPV infections are more likely in those who may
have many sexual partners or at least have sex with someone who has had many
partners. Someone can have infections even if they have no symptoms and their only
sexual contact with a HPV-infected person happened many years ago.
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HPV infections can be reduced through HPV vaccination before sexual activity and
proper use of barrier contraceptives. Condoms for example are unable to cover
areas exposed during sexual activity therefore condoms are unlikely to provide
complete protection against the infection. Western countries have approved the use
of three vaccines to provide protection against HPV infections however, these are
ineffective for treatment of disease caused by HPV33,34. Although HPV vaccination is
an important step toward cervical cancer prevention, it does not remove the need for
routing cervical cancer screening. The debate on whether to offer HPV vaccination
is still ongoing in Qatar. Other methods to reduce HPV infections35 include smoking
or chewing tobacco cessation, immune system strengthening, ceasing long term oral
contraceptive use and good oral hygiene.
Evidence suggests that it can take between 10 to 30 years for an initial HPV infection
to form a tumor. It has been reported that the percentage of CIN3 lesions that
progress to invasive cervical cancer has been estimated to be 50% or less36. In a
cohort of untreated patients with CIN3, the cumulative incidence of invasive cancer
was reported to be 30.1% at 30 years, which is evidence that CIN3 poses a significant
risk of progression to cancer37.
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INVESTIGATIONS AND DIAGNOSIS
INVESTIGATIONS
AND DIAGNOSIS
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7.
Investigations and Diagnosis
7.1
Cervical Cytology (Liquid-based monolayer cytology, LBC)
Liquid-based cytology is a technique based on placing the sample collected from the
cervix into a vial containing a liquid medium that preserves the cells for microscope
examination. The liquid media currently being used are ethanol and methanol.
The sample is processed at the laboratory into a cell thin-layer and then stained.
After staining, it is examined through a light microscopy. The liquid sample has the
advantage of supporting co-testing for HPV involvement, may reduce unsatisfactory
specimens38 and may be used for testing gonorrhea and chlamydial infection.
LBC Results and Colposcopy referral
7.2
Results
Repeat LBC?
When?
Routine
Recall?
Colposcopy Referral?
Inadequate
Yes, repeat at 3 No
months
No
Glandular Neoplasia (non-cervical)
or Negative (Not HPV Tested)
No
Yes
No
Borderline-Squamous/BorderlineEndocervical or Low Grade SIL
(HPV Tested)
No
No
Yes, for HPV Positive and
inadequate or unreliable
HPV test.
Cytology = Low grade SIL
High grade SIL or Worse or
other indication for referral
(without HPV Test)
No
No
Yes
HPV Testing and HPV Test of Cure
HPV Test of Cure (TOC) uses high risk HPV testing to assess women who have
received treatment for cervical intra epithelial neoplasia (CIN) and atypical glandular
cells (AGC). Healthcare professionals should use the TOC pathway to decide if the
woman needs either referral for further assessment or recall for cervical screening
in 3 or 5 years depending on age. It is now understood that persistent cervical
infection with high-risk human papillomavirus (HPV) genotypes is necessary for the
development of cervical cancer and its immediate precursor lesion.
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HPV Triage and Test of Cure Protocol (For women aged 24 to 64 years)39
1
MODERATE
or WORSE
with treated CIN
2
BORDERLINE or LSIL
HPV Negative
HPV Positive
COLPOSCOPY
No repeat cytology
CIN1
CIN2/3
No treatment
TREATMENT
Cytology at 12
months with or
without colposcopy
Cytology
at 6 months
BORDERLINE/Low
grade with negative
colposcopy, no biopsy
or biopsy with no CIN
3
4
Normal
HPV Negative
Routine 3 or 5 year recall
(depending on age < 65)
3 or 5 year recall
(depending on age < 65)
5
Abnormal
HPV Positive
COLPOSCOPY
Cytology follow
up according to
national guidelines
6
1 If sample is unreliable/inadequate for the HPV test, refer mild and recall borderline for 6
month repeat cytology. At repeat cytology HPV test if Negative/ Borderline/ Low Grade. If HPV
negative return to routine recall, refer if HPV positive. Refer moderate or worse cytology.
2 Untreated CIN1 should be managed as per untreated CIN1 following borderline/mild.
3 Follow up of 12 month cytology only should follow normal protocols.
4 Women in annual follow up after treatment for CIN are eligible for the HPV test of cure at their
next screening test.
5 Women ≥ 50 who have normal cytology at 3 years will then return to 5 yearly routine recall.
6 Women referred due to borderline/low grade cytology or normal cytology/HPV positive, who
then have a satisfactory and negative colposcopy can be recalled in 3 years.
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7.3
Colposcopy
Colposcopy is a diagnostic procedure to examine an illuminated, magnified view of
the cervix and the tissues of the vagina and vulva40. Premalignant and malignant
lesions in these areas can be detected through colposcopy. The instrument used for
colposcopy is called a colposcope which provides an enlarged view of the areas under
investigation. A colposcopist identifies the abnormal tissues and biopsy may be taken
for further pathological examination. Colposcopy aims to detect precancerous lesions
at an early stage in order to provide immediate and relevant treatment and most
importantly to stop precancerous/ cancerous cells from spreading in the cervical area.
7.3.1 Colposcopy Results41
Uterus
Cervical Changes
Normal
LSIL
HSIL
Cervical
cancer
Cervix
Vagina
© 2014 Terese Winslow LLC
U.S. Govt. has certain rights
I.
Low-Grade Squamous Intraepithelial Lesions (LSIL)
LSIL are also called cervical intraepithelial neoplasia (CIN1). CIN are abnormal
cells found on top of the surface of the cervix. LSIL means that there are low grade
abnormal changes in cervical cells. LSIL changes are usually caused by HPV
infection. Although the changes may disappear on their own, further diagnostic
tests (LBC, colposcopy, biopsy or TOC) are usually done to find out whether there
are more severe changes that need to be treated. Abnormal cells are typically
superficial in the squamous epithelium.
II.
High-Grade Squamous Intraepithelial Lesions (HSIL)
HSIL are also cervical intraepithelial neoplasia 2, 2/3 or 3 (CIN2, CIN2/3 or
CIN3). CIN are abnormal cells found throughout the thickness of the squamous
epithelium of the cervix. HSIL means that there are more serious changes than
LSIL in cervical cells. These changes are caused by HPV and may turn into
cervical cancer if not treated. Further diagnostic tests (LBC, colposcopy, biopsy
or TOC) are usually done to find out whether there are more severe changes that
need to be treated.
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III. Glandular epithelial cell abnormalities
Atypical Glandular cells (AGC) refer to abnormal glandular cells that line the inside
of the cervix. AGC is classified as either low grade or high grade.
IV. Squamous Cell Carcinoma or Adenocarcinoma
Sometimes cervical cancer cells (squamous cell carcinoma or adenocarcinoma)
are found during cervical screening especially after colposcopy and biopsy.
7.4
Treatment Options for HPV-infected Individuals
Abnormal cell changes due to HPV infections include genital warts, benign respiratory
tract tumors and precancerous changes at the cervix can be treated. Treatment for
precancerous cervical changes include cryosurgery (freezing to destroy tissues),
LEEP (loop electrosurgical excision procedure or the removal of cervical tissue
using a hot wire loop), surgical conization (surgery with a scalpel, a laser, or both
to remove a cone-shaped piece of tissue from the cervix and cervical canal), and
laser vaporization conization (use of laser to destroy cervical tissue). Other types
of precancerous changes caused by HPV include vaginal, vulvar, penile and anal
lesions. For these types and genital warts, treatment include topical chemicals or
drugs, excisional surgery, cryosurgery, electrosurgery and laser surgery
7.5
Communication of Results to Women via the Primary Healthcare
The Primary healthcare provider is tasked with the provision of cervical screening
results to the women:
• Within 2 weeks from the date of cervical screening.
• Within 3 weeks from the date of cervical to colposcopy42.
• Negative results (normal) should be sent through text message with a reminder
for the next routine recall cervical screening appointment.
• Patients with abnormal results must be contacted via phone and register an
appointment with the Case Manager in PHCC centre (Cerner open appointment
slots with the family physician) both on the same appointment date. Details
of abnormal results must not be divulged on the phone or through SMS to
the participants.
• A reminder message would be sent to patients with positive results to remind them
of their appointment with Primary Healthcare Physician to receive the results. The
reminder message should be sent one working day prior to the appointment date.
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Final colposcopy results from the secondary healthcare provider would be sent to
PHCC via agreed and secured IT systems. Patients with negative results for routine
recall would receive their result through text message from primary healthcare
provider as stated above. However, colposcopy results of patients with cancer
would follow an MDT discussion to finalise the diagnosis and treatment plan before
referral to first definitive treatment of cancer case. Final diagnosis and referral
must be completed within 31 days from the date of screening and results must be
communicated to the patients through an assessment clinic appointment with the
secondary healthcare provider.
7.6
Surveillance and Follow-Up43
Following a routine cervical screening, women should be continuously recalled for
LBC or LBC and HPV Testing every 3 or 5 years depending on age44 and diagnostic
findings. Women who had abnormal results from routine screening and who were
found with abnormal results from colposcopy and HPV Triage (at any stage of
screening and/or HPV triage) should be returned back to routine screening and
invited every 3 years. However, for women who had abnormal results and referred
for treatment are to be under the management of the secondary healthcare provider.
Surveillance and follow-up algorithm for HPV Triage and Test of Cure (TOC) are
outlined below:
7.6.1 7.6.1 Follow up after LBC
Result
Test/Treatment
Repeat Recall
Inadequate
LBC + HPV Test (as required)
3 months (Early Repeat)
7.6.2 Follow up after LBC + HPV Tested with Borderline-Squamous/BorderlineEndocervical or Low Grade Squamous Intraepithelial Lesion (LSIL)
Result
Test/Treatment
Repeat Recall
HPV Negative
None
Routine Recall in 3 or 5 years
HPV Test Inadequate
or Unreliable; and
Cytology is Borderline
HPV Test only (if Neg/Borderline/
Low Grade SIL)
6 months (Early Repeat)
HPV Test Inadequate
or Unreliable; and
Cytology is LSIL
Colposcopy
Recall depending on CIN/AGC result
HPV Positive
Colposcopy
Recall depending on CIN/AGC result
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7.6.3 Follow up after Colposcopy and HPV Positive
Result
Test/Treatment
Repeat Recall
Cytology Neg/
Borderline/Low Grade
SIL
None
Routine recall in 3 or 5 years
Untreated CIN 1
Cytology Follow-up
12 months
CIN 1/2/3
Test of Cure and/or treatment option 6 months
as per 7.3
Atypical Glandular
Cells (AGC)
Test of Cure and/or treatment option 6 months
as per 7.3
<CIN 1
7.6.4 Follow up after LBC with High Grade Squamous Intraepithelial Lesion
(HSIL) or Worse or other indication for referral
Result
Test/Treatment
Repeat Recall
<CIN 1 or Untreated
CIN
Cytology Follow-Up or Recall
6-12 months or as appropriate
CIN 1/2/3
Test of Cure and/or treatment option 6 months
as per 7.3
Atypical Glandular
Cells (AGC)
Test of Cure and/or treatment option 6 months
as per 7.3
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QUALITY ASSURANCE
QUALITY ASSURANCE
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8.
Quality Assurance
8.1
Standards
ISO 9001:2008 (version 2015) will be used as the international standard to regulate
processes and documentation of the cervical cancer screening programme. This
standard would ensure that the programme meets the minimum quality requirements
to deliver an efficient, accurate and safe service to the women.
Agreed Key Performance Indicators (KPIs) will also be implemented to ensure that
the programme is achieving the minimum performance targets.
8.2
Audits
Two sets of audit will be implemented for cervical cancer screening programme:
• Right Results Walkthrough – audit for management of patient’s results across
the screening pathway.
• Quality Assurance Visit – audit of the entire screening programme.
8.3
Adverse Incidents
Incidents and errors may arise in a screening programme, and these must be recorded
as ‘Near Misses’ or ‘Serious Untoward Incidents’ (SUIs).
Near Misses are incidents which have no impact on activity beyond the programme
and Serious Untoward Incidents (SUIs) are those of a more serious nature which
might affect the population. These incidents must be recorded in an electronic
database (i.e. DATIX) for easy collation of data and trends.
8.4
User Feedback
Comments or feedback are always encouraged from all users in order to improve
the quality of the service/s delivered. These are received through the following
communication streams:
• Participants who call or write to the screening programme.
• Post clinical investigation questionnaire given to subjects attending the
screening programme.
• In-house questionnaires sent from the screening programme.
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41.http://www.cancer.gov/types/cervical/understanding-cervical-changes
42.Delivering Cancer Waiting Times: A Good Practice Guide. http://www.england.
nhs.uk/wp-content/uploads/2015/03/delivering-cancer-wait-times.pdf. Pp 7-8.
Accessed 11 October 2015.
43.Screening Protocol Algorithm for HPV Triage and Test of Cure, NHS Cervical
Screening Programme, Public Health England. July 2014.
44.Cervical Cancer Screening, NCCN Clinical Practice Guidelines in Oncology
(NCCN Guidelines). National Comprehensive Cancer Network. 2012: Version
2.2012. Available at: www.NCCN.org.
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THE GUIDELINE DEVELOPMENT GROUP
(GDG)
THE GUIDELINE
DEVELOPMENT GROUP
(GDG)
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Guidelines for Cervical Cancer Screening in the State of Qatar | 43
10.
The Guideline Development Group (GDG)
The cervical cancer screening clinical guidelines have been produced with the
assistance of a multidisciplinary group of clinicians and healthcare professionals to
provide a comprehensive overview of the cervical cancer screening patient’s journey
from call/ recall to referral and support.
The guideline development process was supported by staff from Ministry of Public
Health (MOPH), Primary Health Care Corporation (PHCC), Hamad Medical Corporation
(HMC) and SIDRA Medical and Research Center. The draft of the guideline was
prepared by SCH staff. This draft was then discussed with various stakeholders and
subsequently forwarded to the national stakeholders for consultation.
Following the consultation period, staff from SCH finalized the recommendations and
the final document was sent to the National Cancer Committee (NCC) for approval.
On receipt of the NCC approval, publication and dissemination occurred in the
state of Qatar.
Primary Health Care Corporation:
Dr. Shaikha Abu Shaikha
Manager, Special Care Program
Hamad Medical Corporation:
Dr. Afaf Ali Hassan Mohd Al-Ansari
Senior Consultant, Clinical Lead –
GynaeOncology and OB-Gynecology,
Gynecologic Oncology MDT
Supreme Council of Health
Mrs Fiona Bonas
Director, National Cancer Program
Mr Vernon Recreo
Cancer Screening Program Manager
Mrs Nneka Onwuachu Cancer Research and Education
Program Observer
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Guidelines for Cervical Cancer Screening in the State of Qatar | 44
Updating the Guideline
One year after publication of the screening guideline, members of the guideline development
group will review this document to determine whether the evidence base has progressed
significantly to alter the guideline recommendations and warrant an early update.
Disclaimer
The GDG assumes that healthcare professionals will use clinical judgment, knowledge
and expertise when deciding whether it is appropriate to apply these guidelines. The
recommendations cited here are a guide and may not be appropriate for use in all situations.
The decision to adopt any of the recommendations cited here must be made by the practitioner
in light of individual patient circumstances, the wishes of the patient and clinical expertise.
The MOPH disclaims any responsibility for damages arising out of the use or non-use of
these guidelines and the literature used in support of these guidelines.
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