The Ethiopia Experience Dr Julia Palmer Dr Anni

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The Ethiopia Experience Dr Julia Palmer, Dr Anni Innamaa, Mr John Tidy, Mr Tom

The Ethiopia Experience Dr Julia Palmer, Dr Anni Innamaa, Mr John Tidy, Mr Tom Farrell. Sheffield Teaching Hospitals NHS Foundation Trust.

Cervical cancer in Ethiopia: • Ethiopia has a population of 20. 90 million women

Cervical cancer in Ethiopia: • Ethiopia has a population of 20. 90 million women aged 15 years and older who are at risk of developing cervical cancer. • Current estimates indicate that every year 4648 women are diagnosed with cervical cancer and 3235 die from the disease. • Cervical cancer ranks as the 2 nd most frequent cancer among women in Ethiopia, and the 2 nd most frequent cancer among women between 15 and 44 years of age. [WHO/ICO Information Centre on HPV and Cervical Cancer (HPV Information Centre). Human Papillomavirus and Related Cancers in Ethiopia. Summary Report 2010. [Date accessed 11/12/2011]. Available at www. who. int/ hpvcentre]

Cervical cancer in Ethiopia: HOWEVER: These figures are probably significantly lower than the actual

Cervical cancer in Ethiopia: HOWEVER: These figures are probably significantly lower than the actual number of cases, given: - • the low level of awareness, • cost, • limited access to screening services • lack of a national cancer registry. Women therefore present at advanced stage of disease.

Most Vulnerable: Poor Rural HIV Positive Often kills women at young age when still

Most Vulnerable: Poor Rural HIV Positive Often kills women at young age when still raising their families.

 Cervical cancer mostly affects women in Ethiopia over 30 years old and peaks

Cervical cancer mostly affects women in Ethiopia over 30 years old and peaks in the 40 -45 year old age group according to local statistics. The consequences of the death in Ethiopia of a mother, still rearing her children, are catastrophic. Without her the family usually disintegrates and the significant economic contribution that her labour provides is lost.

Cervical cancer in Ethiopia: • Projected number of new cervical cancer cases in 2025*

Cervical cancer in Ethiopia: • Projected number of new cervical cancer cases in 2025* - 7700 • Projected number of cervical cancer deaths in 2025* - 5421 WHO/ICO Information Centre on HPV and Cervical Cancer (HPV Information Centre). Human Papillomavirus and Related Cancers in Ethiopia. Summary Report 2010. [Date accessed 11/12/2011]. Available at www. who. int/ hpvcentre

HPV Burden in Ethiopia: • Data is not yet available on the HPV burden

HPV Burden in Ethiopia: • Data is not yet available on the HPV burden in the general population of Ethiopia. • However, in Eastern Africa, the region Ethiopia belongs to, about 33. 6% of women in the general population are estimated to harbour cervical HPV infection at a given time. WHO/ICO Information Centre on HPV and Cervical Cancer (HPV Information Centre). Human Papillomavirus and Related Cancers in Ethiopia. Summary Report 2010. [Date accessed 11/12/2011]. Available at www. who. int/ hpvcentre

Global HPV Vaccination: WHO indicate that a 5 year vaccination initiative could prevent 1

Global HPV Vaccination: WHO indicate that a 5 year vaccination initiative could prevent 1 million deaths from cervical cancer. Most of these deaths would be prevented in resourcepoor settings. BUT Are we targeting the correct HPV types? Can we ensure effective coverage? Costs – are they prohibitively high Problems with need for future cervical screening [WHO/ICO Information centre on HPV and cervical cancer (HPV information centre). HPV and related cancers in World. Summary report 2010. Crosbie EJ. Global human papillomavirus vaccination: can it be cost effective? BJOG 2012; 119: 125 -128. ]

HPV Vaccination Quadrivalent Vaccine Licensed BUT NOT AVAILABLE HPV vaccination needs modifying for lowresource

HPV Vaccination Quadrivalent Vaccine Licensed BUT NOT AVAILABLE HPV vaccination needs modifying for lowresource settings: Low cost Single dose. Schiffman M, Castle PE. The Promise of Global Cervical-Cancer Prevention. n engl j med 2005; 353: 2101 -2104

HIV Rates in Ethiopia: 534, 000 women over age 15 living with HIV in

HIV Rates in Ethiopia: 534, 000 women over age 15 living with HIV in Ethiopia • More readily infected with certain types of HPV, • More likely to develop precancerous lesions, • More vulnerable to rapid development of these lesions than HIV-negative women. Pathfinder International Ethiopia: Combating Cervical Cancer in Ethiopia Addis Tesfa. April 2010. Available at URL >http: //www. pathfind. org/site/Doc. Server/Ethiopia_CC_launch_brief. pdf? doc. ID=18441< Accessed 30 th January 2012.

BUT Cervical cancer is preventable and, in most cases, curable, if identified in its

BUT Cervical cancer is preventable and, in most cases, curable, if identified in its early stages. Anorlu RI. Cervical cancer: the sub-Saharan African perspective. Reproductive Health Matters 2008; 16 (32): 41 -9.

Cervical Screening: In 2006 WHO identified cervical screening coverage as a crucial component for

Cervical Screening: In 2006 WHO identified cervical screening coverage as a crucial component for providing effective prevention for cervical cancer. Interestingly in resource poor settings this is a strategy open for question. World Health Organization (2006)Comprehensive cervical cancer control: A guide to essential practice. Available: http: //www. who. int/reproductive-health/ publications/cervical_cancer_gep/index. htm. Accessed 11 th Dec 2011.

Cervical Screening in Ethiopia • 0. 6% (All women aged 18 -69 yrs screened

Cervical Screening in Ethiopia • 0. 6% (All women aged 18 -69 yrs screened every 3 yrs; WHS Ethiopia) • 1. 6% (Urban women aged 18 -69 yrs screened every 3 yrs; WHS Ethiopia) • 0. 4% (Rural women aged 18 -69 yrs screened every 3 yrs; WHS Ethiopia) WHO/ICO Information Centre on HPV and Cervical Cancer (HPV Information Centre). Human Papillomavirus and Related Cancers in Ethiopia. Summary Report 2010. [Date accessed 11/12/2011]. Available at www. who. int/ hpvcentre

Problems with Screening: Repeated Testing Laboratory Analysis / Established Lab WHY? ? Proper Diagnostic

Problems with Screening: Repeated Testing Laboratory Analysis / Established Lab WHY? ? Proper Diagnostic Protocols Proper Treatment Protocols Proper Follow-up Protocols

Problems with Screening: Infrastructure Little Investment in: Training Laboratory Capacity Costs of Lab equipment

Problems with Screening: Infrastructure Little Investment in: Training Laboratory Capacity Costs of Lab equipment & Supplies Transportation of Specimens Administration / Program-related Activities Sue J. Goldie, et al. Cost-Effectiveness of Cervical-Cancer Screening in Five Developing Countries. N Engl J Med 2005; 353: 2158 -68.

Makele: Mekelle (Makelle, Mek’ele) • Founded in the 13 th century, Makele is the

Makele: Mekelle (Makelle, Mek’ele) • Founded in the 13 th century, Makele is the capital of the Tigray region & the largest city in northern Ethiopia, having a population of 261, 200. • Makele is fast becoming an economic hub and educational centre, boasting a new airport, teaching hospital and university. • The city, like the region, faces an increasingly severe water crisis, producing less than half the amount its citizenry consumes each day. [Central Statistical Agency of Ethiopia (CSA)-2011]

The Team: Mike Critchley – ST 5 O&G Anni Innamaa – Subspecialty Trainee Gynaecological

The Team: Mike Critchley – ST 5 O&G Anni Innamaa – Subspecialty Trainee Gynaecological Oncology Julia Palmer – Consultant Gynae Oncologist Charlotte Kenyon – Senior Lecturer Tom Farrell – Consultant O&G

Ayder Hospital: The hospital serves as the tertiary hospital for Tigray region's residents, who

Ayder Hospital: The hospital serves as the tertiary hospital for Tigray region's residents, who number >4 million. • Opened in September 2008 • 450 beds in the hospital

Hospital Set Up: Wokro Hospital Ayder Hospital Makelle Hospital Health Centres (10) Hut /

Hospital Set Up: Wokro Hospital Ayder Hospital Makelle Hospital Health Centres (10) Hut / Village – (Traditional Birth Attendants) 24% of deliveries attended by health extension workers who are trained in obstetric emergencies – other deliveries by relatives / traditional birth attendants.

Makelle Hospital Staffing: Specialist (1) – (7 years postgraduate) General Practitioners (3) – SHO

Makelle Hospital Staffing: Specialist (1) – (7 years postgraduate) General Practitioners (3) – SHO grade Interns (10) – FY 1 grade MSC (2) – non-clinician physician Midwives (3) Gynaecology Nurses • Trained to perform surgical procedures e. g. CS, Ectopic pregnancy. • 4 years of training then work in health centres. In 2011 Makelle Hospital had 2, 500 deliveries.

The Cytology Set Up: There is presently no cervical screening service in Makelle There

The Cytology Set Up: There is presently no cervical screening service in Makelle There are no cyto-screeners The pathologist would potentially read any cervical cytology.

The QA Office: Mmmmm !!

The QA Office: Mmmmm !!

The Pathology Set Up:

The Pathology Set Up:

The Pathology Set Up Currently a single pathologist serves the entire Tigray region (population

The Pathology Set Up Currently a single pathologist serves the entire Tigray region (population 4 - 4. 5 million). The pathology service has only been fully functioning for 1 -2 years and covers all pathology requests. The pathologist is supported by six lab technicians. BUT can obtain a second opinion via a postal service to Addis Ababa.

The Colposcopy set Up:

The Colposcopy set Up:

The Colposcopy Set Up:

The Colposcopy Set Up:

Colposcopy Set Up: A functioning colposcope – no one trained to use it A

Colposcopy Set Up: A functioning colposcope – no one trained to use it A ? functioning diathermy machine – no one trained to use it, no loops / balls, cutting facility on machine faulty, Suction machine available but broken. Limited biopsy reporting service. No Acetic Acid / No Lugol’s / No Cryo Therefore all we could offer was radical diathermy as treatment (We provided acetic acid / loops & balls)

What can we do ? ? ? 1) How to motivate women to actively

What can we do ? ? ? 1) How to motivate women to actively seek screening and preventative care; 2) How to alleviate stress imposed on the healthcare system by the attrition of physicians in the public sector. 3) How to develop a national tumour registry;

1) How to motivate women to actively seek screening and preventative care; Essentially a

1) How to motivate women to actively seek screening and preventative care; Essentially a public health issue Access to hospitals / doctors is limited, women need to travel many miles for hospital-based healthcare & trained medical staff are lacking. Need a method that achieves the fewest amount of visits. Method that does not require follow-up.

What do they need Method that achieves the fewest amount of visits. i. e.

What do they need Method that achieves the fewest amount of visits. i. e. Screen, diagnose & treat Reduce costs Reduce loss to follow-up ? ? Discharge HPV negative Consider cryotherapy for low grade (cheap, extensively available) Severe / Extensive CIN or Cancer refer to gynae. Schiffman M, Castle PE. The Promise of Global Cervical-Cancer Prevention. n engl j med 2005; 353: 2101 -2104

In view of the failure of cytology screening programmes for cervical cancer in developing

In view of the failure of cytology screening programmes for cervical cancer in developing countries, the World Health Organization suggested unaided visual inspection of the cervix after an application of acetic acid (VIA) and Lugol's iodine (VILI) as alternative screening methods. [World Health Organization. Cervical cancer screening in developing countries. Report of a WHO consultation. Geneva: World Health Organization, 2003. ]

Limitations of VIA: Low specificity (generally <85%), which can lead to over investigation and

Limitations of VIA: Low specificity (generally <85%), which can lead to over investigation and overtreatment of screenpositive women, lack of standardised methods of quality control, training and competency evaluation. It is limited in its ability to detect endocervical disease Miller, A. B. , Sankaranarayanan, R. , Bosch, F. X. et al, Can screening for cervical cancer be improved, especially in developing countries? . International Journal of Cancer, 2003; 107: 337– 340.

Strengths of VIA: Simplicity and low cost, real-time availability of results potential for immediate

Strengths of VIA: Simplicity and low cost, real-time availability of results potential for immediate linkage with investigations /treatment, consistent estimates of accuracy, feasibility to be offered in low-resource settings and the possibility of rapid training of providers. a major advantage of VIA has been the possibility of treatment (cryotherapy) in the same session as an abnormality is detected, this obviating the need to bring women back for diagnosis and treatment, with the associated costs and risk of failure to attend. Miller, A. B. , Sankaranarayanan, R. , Bosch, F. X. et al, Can screening for cervical cancer be improved, especially in developing countries? . International Journal of Cancer, 2003; 107: 337– 340.

 Efficacy and cost-effectiveness of VIA-based populationscreening programmes in reducing the incidence of and

Efficacy and cost-effectiveness of VIA-based populationscreening programmes in reducing the incidence of and mortality from cervical cancer remains to be established, VIA has shown inconsistent in its performance across different settings, and within the same setting – variously been shown to reduce or have no effect at all on cervical cancer mortality rates in large prospective trials. Miller, A. B. , Sankaranarayanan, R. , Bosch, F. Xet al. Can screening for cervical cancer be improved, especially in developing countries? . International Journal of Cancer, 2003; 107: 337– 340. / Sankaranarayanan R, Esmy PO, Rajkumar R, et al. Effect of visual screening on cervical cancer incidence and mortality in Tamil Nadu, India: a cluster-randomisedtrial. Lancet. 2007 Aug 4; 370(9585): 398 -406. Sankaranarayanan R, Nene BM, Shastri SS, et al. HPV screening for cervical cancer in rural India. N Engl . J Med. 2009 Apr 2; 360(14): 1385 -94

HPV DNA Testing: Disadvantages of HPV DNA testing: Relatively high costs compared to cytology

HPV DNA Testing: Disadvantages of HPV DNA testing: Relatively high costs compared to cytology and VIA; Dependence on reagents currently produced by only a single commercial manufacturer; Requirement for a molecular diagnostic laboratory; Low specificity in younger women and questionable in populations with significant rates of HIV seropositivity; Miller, A. B. , Sankaranarayanan, R. , Bosch, F. X. et al, Can screening for cervical cancer be improved, especially in developing countries? . International Journal of Cancer, 2003; 107: 337– 340.

care. HPV Test (QIAGEN): April 2009, a study (NEJM) showed that in low-resource settings,

care. HPV Test (QIAGEN): April 2009, a study (NEJM) showed that in low-resource settings, a single round of HPV testing significantly reduced the number of advanced cervical cancers and deaths, compared with either Pap testing (cytology) or visual inspection with acetic acid (VIA). Sankaranarayanan, R. et al. HPV screening for cervical cancer in rural India. N. Engl. J. Med. 2009; 14: 1385.

care. HPV Test: The test can be run by a healthcare worker with minimal

care. HPV Test: The test can be run by a healthcare worker with minimal lab training. The test can be performed in any setting (neither running water nor mains electricity is required). Cervical cell samples can be collected by a healthcare worker or self-collected by the patient herself. Results are available within two-and-a-half hours, allowing both screening and follow-up treatment of precancerous lesions, if required, to take place during a single visit. http: //www. qiagen. com/about/Who. We. Are/QIAGENcares/The-care. HPV-Test. pdf

care. HPV Test: Trial demonstrated that the care. HPV Test had a 90% clinical

care. HPV Test: Trial demonstrated that the care. HPV Test had a 90% clinical sensitivity for identifying moderate or severe cervical disease (CIN 2+) Higher sensitivity than either VIA or liquid-based Pap testing. VIA and Pap testing had clinical sensitivities of 41% and 85%, respectively. Qiao, Y. L. et al. A new HPV-DNA test for cervical-cancer screening in developing regions: a cross-sectional study of clinical accuracy in rural China. Lancet Oncol. 2008; 10: 929.

Zilico Epitheliometer Sheffield research group - investigating the use of electrical impedance spectroscopy (EIS)

Zilico Epitheliometer Sheffield research group - investigating the use of electrical impedance spectroscopy (EIS) as a tool to identify CIN. EIS can be measured across a range of current frequencies and used to identify tissue types. Impedance is influenced by cell layering, intra and extracellular spaces and the capacitance of the cell membranes. We have previously evaluated the ability of EIS to discriminate different cervical tissues by developing a 3 dimensional cellular model of the cervical epithelium. Walker DC, et al. A study of the morphological parameters of cervical squamous epithelium. Physiol Meas 2003; 24: 121– 35

Zilico Epitheliometer We have published a series of papers evaluating EIS in detecting CIN.

Zilico Epitheliometer We have published a series of papers evaluating EIS in detecting CIN. Our current device the APX 100 consists of a battery driven hand held unit, a base station to allow data to be downloaded to a laptop and for re-charging of the device, a disposable single-use sheath that covers the snout of the hand held unit, and associated software. Before clinical use a sheath is placed over the snout of the device. The device is robust and simply needing a power source to charge the unit and laptop. Up to 12 EIS measurements are taken from the cervix after application of acetic acid. Brown BH, et al. The relationship between tissue structure and imposed electrical current flow in cervical neoplasia. Lancet 2000; 355: 892– 95. Balasubramani L, et al. The detection of cervical intraepithelial neoplasia by electrical impedance spectroscopy: The effects of acetic acid and tissue homogeneity. Gynecol Oncol; 2009; 115: 267– 71

Zilico Epitheliometer The EIS data is then analysed, in real time, by comparing the

Zilico Epitheliometer The EIS data is then analysed, in real time, by comparing the measured spectra with templates corresponding to normal squamous epithelium, columnar epithelium, immature metaplasia and high grade CIN generated from 3 -D finite elements models of the four tissue types. Using a cut off value the device will provide a result of HG-CIN present or absent. Using this type of result would there permit immediate management decisions. The performance of VIA is variable with a low specificity. To date our studies have been performed in colposcopy clinics in the UK. We now plan to evaluate the APX 100 in low resource settings as adjunct to VIA or HPV testing

2) How to alleviate stress imposed on the healthcare system by the attrition of

2) How to alleviate stress imposed on the healthcare system by the attrition of physicians in the public sector. EDUCATION TRAINING

2) How to alleviate stress imposed on the healthcare system by the attrition of

2) How to alleviate stress imposed on the healthcare system by the attrition of physicians in the public sector. WHO SHOULD WE EDUCATE WHO SHOULD WE TRAIN Everyone Specialists GP’s Nurses Health Extension Workers Fundamental problems with retention of medical staff Therefore nurse led training may be the best way forward.

3) the need to develop a national tumour registry; A long-term goal to be

3) the need to develop a national tumour registry; A long-term goal to be revisited

The Result: A Happy Trainee:

The Result: A Happy Trainee:

The Future: We are planning to return to Makelle in 2013. Interim Plan –

The Future: We are planning to return to Makelle in 2013. Interim Plan – distance learning for medical staff. BSCCP Certification for a fully trained Colposcopist from Overseas – absconding visitors !! Discussion with QIAGEN re care. HPV test ? Trial of John Tidy’s probe ?

Thankyou:

Thankyou: