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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. V1.2016 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) V1.2016 INTRODUCTION V1.2016 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 5 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 6 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 7 V1.2016 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 9 • 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 10 • 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 11 HEALTH PROMOTION HEALTH PROMOTION V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 12 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 13 SCREENING INVITATION AND STRATIFICATION SCREENING INVITATION AND STRATIFICATION V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 14 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 15 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 16 • 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 17 SCREENING CLINICAL TEAM SCREENING CLINICAL TEAM V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 18 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 19 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 20 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 21 REFERRAL GUIDELINES AND PATIENT PATHWAY REFERRAL GUIDELINES AND PATIENT PATHWAY V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 22 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). V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 23 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 24 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 25 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 26 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 27 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 28 INVESTIGATIONS AND DIAGNOSIS INVESTIGATIONS AND DIAGNOSIS V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 29 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 30 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 31 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 32 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 33 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 V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 34 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 V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 35 QUALITY ASSURANCE QUALITY ASSURANCE V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 36 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 37 REFERENCES REFERENCES V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 38 9. References 1. Qatar National Cancer Registry. 2. Qatar’s Ministry of Development, Planning and Statistics. Available at: http:// www.mdps.gov.qa. 3. ICO Information Centre on HPV and Cancer. Qatar Human Papillomavirus and Related Cancers, Fact Sheet 2014 (15 December 2014). Available at http://www. hpvcentre.net/statistics/reports/QAT_FS.pdf. 4. Criteria for appraising the viability, effectiveness and appropriateness of a screening programme. Public Health England. Updated 23 October 2015. Available at: www.gov.uk/government/publication/. 5. Sung HY, Kearney KA, Miller M, Kinney W, Sawaya GF, Hiatt RA. Papanicolaou smear history and diagnosis of invasive cervical carcinoma among members of a large prepaid health plan. Cancer 2000; 88:2283-9. 6. Leyden WA, Manos MM, Geiger AM, Weinmann S, Mouchawar J, Bischoff K, et al. Cervical cancer in women with comprehensive health care access: attributable factors in the screening process. J Natl Cancer Inst 2005; 97:675-83. 7. Freeman HP, Wingrove BK. Excess cervical cancer mortality: a marker for low access to health care in poor communities. NIH Pub. No. 05-5282. Rockville (MD): National Cancer Institure, Centre to Reduce Cancer Health Disparities; 2005. Available at: http://www.cancer.gov/about-nci/organisation/crchd/abouthealth-disparities/resources/excess-cervical-cancer-mortality.pdf. Retrieved 3 September 2015. 8. Centers for Disease Control and Prevention. Cervical Cancer. Available at: http:// www.cdc.gov/cancer/cervical/. Retrieved 2 August 2012. 9. Spence AR, Goggin P, Franco EL. Process of care failures in invasive cervical cancer: systematic review and meta-analysis. Prev Med 2007; 45:93-106. (Metaanalysis). 10.Gustafsson L, Ponten J, Bergstrom R, Adami HO. International incidence rates of invasive cervical cancer before cytological screening. Int J Cancer 1997; 71:159-65. 11.Gustafsson L, Ponten J, Zack M, Adami HO. International incidence rates of invasive cervical cancer after introduction of cytological screening. Cancer Causes Control 1997; 8:755-63. (Level II-3) Int J Cancer 1997; 71:159-65. 12.UK NHS Cervical Screening Programme. Public Health England. Available at: https://www.gov.uk/guidance/cervical-screening-programme-overview. 13.UK National Screening Committee (UK NSC). Available at: http://legacy. screening.nhs.uk/screening-recommendations.php. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 39 14.Saslow D, Solomon D, Lawson HW, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. American Journal of Clinical Pathology 2012; 137:516-542. 15.Saslow D, Solomon D, Lawson HW, Killackey M, Kulasingam SL, Cain J, et al. American Cancer Society, American Society of Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. ACS-ASCCP-ASCP Cervical Cancer Guideline Committee. CA Cancer J Clin 2012; 62:147-72. 16. Vesco KK, Whitlock EP, Eder M, Lin J, Burda BU, Senger CA. et al. Screening for cervical cancer: a systematic evidence review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 86. AHRQ Publication No. 11-05156- EF-1. Rockville (MD): Agency for Healthcare Research and Quality; 2011. Available at: http://www.ncbi.nlm.nih.gov/books/NBK66099/pdf/Bookshelf_nBK66099.pdf. Retrieved 4 September 2015. 17. WHO Guidelines for screening and treatment of precancerous lesions for cervical cancer prevention. WHO Guidelines. 2013. Page xii. 18.Ahti Anttila et al. Rate of cervical cancer, severe intraepithelial neoplasia, and adenocarcinoma in situ in primary HPV DNA screening with cytology triage: randomised study within organised screening programme, BMJ 2010; 340: c1804. 19.Arbyn M, Sasieni P, Meijer CJ, Clavel C, Koliopoulos G, Dillner J. Chapter 9: Clinical applications of HPV testing: a summary of meta-analyses. Vaccine 2006; 24(suppl 3):S3/78-89. 20.DISCERN. Quick reference guide to the DISCERN criteria. Available at: www. discern.org.uk/quick_reference_guide.php. Accessed 11 October 2015. 21.Management of Cervical Cancer, A national clinical guideline. Scottish Intercollegiate Guidelines Network (SIGN). January 2008. Page 4. 22.M. Arbyn, et. al. European Guidelines for QA in Cervical Cancer Screening 2nd Ed. Summary Document, Ann Oncol. 2010 March; 21(3): 448-458. Available at: www.ncbi.nlm.nih.gov/pmc/articles/PMC2826099/ 23.Guidelines for Management of Cervical Cancer in the State of Qatar V1.2015. Pages 9-11. 24.Lumsden MA, Gebbie A, Holland C; Managing unscheduled bleeding in nonpregnant premenopausal women. BMJ. 2013 Jun 4;346:f3251. doi: 10.1136/ bmj.f3251 25.Investigation of post-menopausal bleeding. Scottish Intercollegiate Guidelines Network - SIGN (2002). 26. Munot S, Lane G: Modern management of post menopausal bleeding. Trends in Urology, Gynaecology and Sexual health. Vol 13. Issue 5. Sept 2008. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 40 27. Schnatz PF, Ricci S, O’Sullivan DM. Cervical polyps in postmenopausal women: is there a difference in risk? Menopause. 2009;16(3):524-528. 28.Okamoto Y, Tanaka YO, Nishida M, Tsunoda H, Yoshikawa H, Itai Y. MR imaging of the uterine cervix: imaging-pathologic correlation. Radiographics. 2003;23(2):425-445. 29.Bax CJ, Oostvogel PM, Mutsaers JA, et al. Clinical characteristics of Chlamydia trachomatis infections in a general outpatient department of obstetrics and gynaecology in the Netherlands. Sex Transm Infect.2002;78(6):E6 30.American Cancer Society. Cancer Facts & Figures 2014. Atlanta: American Cancer Society; 2014. Accessed February 25, 2015. 31.Lowy DR, Schiller JT. Reducing HPV-associated cancer globally. Cancer Prevention Research (Philadelphia) 2012;5(1):18-23. 32.Centers for Disease Control and Prevention. Human papillomavirus-associated cancers—United States, 2004-2008. Morbidity and Mortality Weekly Report 2012; 61(15):258-261. 33. Hildesheim A, Herrero R, Wacholder S, et al. Effect of human papillomavirus 16/18 L1 viruslike particle vaccine among young women with preexisting infection: A randomized trial. JAMA 2007; 298(7):743–753. 34.Schiller JT, Castellsague X, Garland SM. A review of clinical trials of human papillomavirus prophylactic vaccines. Vaccine 2012; 30 Suppl 5:F123-138. 35.Shi R, Devarakonda S, Liu L, Taylor H, Mills G. Factors associated with genital human papillomavirus infection among adult females in the United States, NHANES 2007-2010.Biomed Central Research Notes 2014; 7:544. 36.McCredie MR, Sharples KJ, Paul C, et al. Natural history of cervical neoplasia and risk of invasive cancer in women with cervical intraepithelial neoplasia 3: A retrospective cohort study. Lancet Oncology 2008; 9(5):425-434. 37.McCredie MR, Sharples KJ, Paul C, Baranyani J, Medley G, Jones RW, et al. Natural history of cervical neoplasia and risk of invasive cancer in women with cervical intraepithelial neoplasia 3: a retrospective cohort study. Lancet Oncol 2008; 9:425-34/ 38.Ronco G, Cuzick J, Pierotti P; et al. (2007). “Accuracy of liquid based versus conventional cytology: overall results of new technologies for cervical cancer screening randomised controlled trial”. BMJ 335 (7609): 28.doi:10.1136/ bmj.39196.740995.BE. PMC 1910655. PMID 17517761. 39.HPV Triage and Test of Cure Protocol. NHS Cancer Screening Programmes. United Kingdom: April 2010. 40.Chase DM, Kalouyan M, DiSaia PJ (May 2009). “Colposcopy to evaluate abnormal cervical cytology in 2008”. Am. J. Obstet. Gynecol. 200 (5): 472–80. doi:10.1016/j.ajog.2008.12.025. PMID 19375565. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 41 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. V1.2016 Guidelines for Cervical Cancer Screening in the State of Qatar | 42 THE GUIDELINE DEVELOPMENT GROUP (GDG) THE GUIDELINE DEVELOPMENT GROUP (GDG) V1.2016 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 V1.2016 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. V1.2016