- Email: [email protected]
I164 OVERVIEW OF BREAST CANCER EPIDEMIOLOGY AND MAGNITUDE OF THE PROBLEM IN THE DEVELOPING WORLD AND PERU
Invited presentations and presentations by organisations and societies / International Journal of Gynecology & Obstetrics 119S3 (2012) S161–S260
Results: Nearly half of the women were in severe shock, with MAP < 60 mmHg (42.4%). The 182 women (16.4%) who died despite NASG treatment were significantly less likely to have received adequate blood transfusions and significantly more likely to be of higher gravidity (≥6), have a macerated stillbirth, have ruptured uterus as hemorrhage etiology, and had four times the odds of a co-morbidity (anemia, PIH, eclampsia/pre-eclampsia, or sepsis), even when controlling for receipt of blood transfusion and IV fluid (Table). Conclusions: The NASG contributes to the survival of women suffering severe OH and shock; however, efficacy is negatively affected by certain maternal factors, particularly the presence of another life-threatening co-morbidity. Furthermore, although the NASG “buys time”, it does not replace the need for rapid and adequate blood and fluid replacement. I161 MOVING FORWARDS TOWARDS BETTER MATERNAL HEALTH OUTCOMES: EXPERIENCES FROM COUNTRIES – MALAYSIA R. Jegasothy. Department of O&G, Kuala Lumpur Hospital, 50586 Kuala Lumpur, Malaysia The Confidential Enquiries into Maternal Deaths in Malaysia (CEMD) was established in Malaysia in 1991. The essential feature of the enquiry was the independent, multidisciplinary, multisectorial, non-punitive and anonymous review of cases, to identify remediable factors contributing to death and other adverse events. Data collection vastly improved and due to the anonymous nature of the enquiry, more and accurate data on maternal mortality was made available to the CEMD than the vital registration system. The role of nurse coordinators in all the districts of Malaysia to identify possible maternal deaths wherever they occurred was a vital cog in the system. Maternal mortality ratio declined from 44 per 100,000 live births in 1991 to 28.2 in 2008. Direct deaths declined from 81% in 1991 to 48.2% in 2008, while indirect deaths increased from 8.0% to 10.1% and fortuitous deaths increased from 11.0% to 41.7% during the same period of time. The major causes of maternal deaths in 2008 were obstetric embolism, medical disorders, postpartum haemorrhage (PPH) and hypertensive disorders in pregnancy. Training manuals, protocols and guidelines were developed to improve competency in knowledge and skills of health care providers. Numerous case illustrations based on actual maternal deaths were printed to create awareness among health personnel. In 2005, a handbook on ‘Lessons from the Malaysian CEMD’ was distributed to all medical officers. Nurses were empowered to refer cases as first responders to specialist units under the unique Malaysian colour coding system for risk assessment. The training modules for setting up of intravenous lines were incorporated into the basic training programme of community nurses. This was because it was found there were a number of cases in which community nurses were the first health care provider on the scene. Delivery by skilled personnel was maintained at a high 98.5%. Since 1998, maternal mortality has been included as a quality indicator for the health services in Malaysia and various facets of obstetric care as dictated by its prevalence in the CEMD Enquiries have been included in Key Performance Indicators and in the National Indicator Approach for obstetric and labour ward services. Maternal death surveillance is a powerful tool for advocating positive change in the Malaysian experience. I162 TRAINING EXCELLENCE CENTER FOR CAPACITY BUILDING J. Jeronimo Cervical cancer kills close to 300,000 women a year and 85% of those deaths occur in developing countries. The main reason for having high incidence and mortality rates is the lack of access
S201
to screening, ultimately related to the insufficient number of providers trained in new approaches for cervical cancer screening and treatment. Visual inspection with acetic acid (VIA), linked to cryotherapy for women with positive screening result, is a suitable and affordable strategy for developing countries; but broad dissemination of those techniques requires the training of enough master trainers using standard and validated training materials. A Technical Excellence Center (TEC) has the goal of building a sustainable service-delivery platform using VIA and cryotherapy. PATH, in collaboration with Jhpiego and the Peruvian National Cancer Institute, created a TEC in Lima, Peru. The TEC developed and validated training materials, trained master trainers, and trained providers to implement supportive supervision to secure quality of services. The Peruvian TEC expanded and replicated the experience to other two countries in Latin America, Colombia and Nicaragua. Our experience in Latin America shows that the TECs have a pivotal role in the expansion of screening services; the ministries of health of these three countries have used the TECs to increase the capacity for VIA and cryotherapy; now there are more than 100 master trainers in the three countries, and thousands of providers are trained in VIA and cryotherapy. In summary, the TEC model shows promise for building regional capacity to expand cervical cancer prevention services. I163 A CLUSTER SCREEN-AND-TREAT APPROACH FOR ORGANIZING CERVICAL CANCER PREVENTION AT NATIONAL SCALE J. Jeronimo Achieving good coverage of cervical cancer screening is important for reducing the incidence and mortality related to that disease; but it is important to emphasize that screening without completion of treatment of pre-cancerous lesions has very little, if any, benefit. The screen-and-treat approach has been implemented in multiple countries with the goal of securing treatment for women with positive screening results, without the need for final histological diagnosis. This approach has the advantage that treatment can be provided where complex diagnostic services are not available, and even during the same visit the screening is completed. Results show that many women with positive screening accept to be treated during the first visit to the health facility. But we must acknowledge that it is logistically impossible to have cryotherapy units and gas supply in each health facility in developing countries; therefore the single-visit approach can be implemented only in a limited number of facilities. We propose the cluster screen-and-treat approach to expand screening beyond the sites with treatment available. This model is based on implementing VIA in all health centers clustered around a facility offering treatment. Women with a positive screening result can be immediately referred to the nearby treatment site for cryotherapy. Close communication and coordination between screening sites and the treatment facility are required, as well as adequate counseling of women about the need to complete treatment. The cluster screen-and-treat approach has been implemented in low-resource areas in Peru increasing the number of women screened and securing treatment for women who needed it. I164 OVERVIEW OF BREAST CANCER EPIDEMIOLOGY AND MAGNITUDE OF THE PROBLEM IN THE DEVELOPING WORLD AND PERU J. Jeronimo Breast cancer is the most common cancer affecting women worldwide with more than 1.5 million women diagnosed in 2010, more than twice the number of cases diagnosed in 1980. About 500,000 women die due to breast cancer every year, and the number will increase significantly in the next decades, mainly because the incidence rate is currently rising at a pace of 3.1% per
S202
Invited presentations and presentations by organisations and societies / International Journal of Gynecology & Obstetrics 119S3 (2012) S161–S260
year. The incidence of breast cancer is also increasing in Peru, and due to the lack of access to screening, most cases are diagnosed at advanced stages. Even though the incidence of breast cancer is much higher in developed countries, the burden of disease is disproportionally increasing in low-resource countries where the survival rates are much lower. In some parts of Africa women newly diagnosed with breast cancer have 12% likelihood to survive 5 years, compared to 65% in Peru and almost 80% in the United States. The main factors for improving the survival of women with breast cancer are adequate access to screening and diagnosis at early stages, and use of adjuvant therapies. Early detection of breast cancer is important because the cost and success of treatment is directly related to the stage of disease at the time of diagnosis. Unfortunately mammography is not widely available in most developing countries where the scarce resources for screening are limited to some urban areas. Affordable screening, diagnostic and treatment options, and resource-appropriate guidelines offer new opportunities to reach underserved populations with lifesaving screening and treatment approaches that are effective and sustainable. I165 NEW SCREENING ALGORITHMS FOR POPULATION-BASED PROGRAMS J. Jeronimo New cervical cancer screening strategies have been developed in the last decade; some of them are suitable and affordable for developing countries. These new approaches open more opportunities for expanding cervical cancer screening coverage, but create a need to develop comprehensive algorithms that are optimized for different scenarios in developing countries. Between 2009 and 2012 PATH developed field studies using different screening options, including VIA, Pap smear, careHPV™, E6 testing (for genotypes 16/18/45), and DNA genotyping for HPV strains 16/18/45. CareHPV™ testing was done using both a vaginal sample self-collected by women without pelvic evaluation and a cervical sample collected by a health care provider. These studies involved the enrollment of approximately 27,500 women from India (Hyderabad and Delhi), China, Nicaragua, and Uganda. All the evaluations and testing were done using the public health system available in those countries. Colposcopy and biopsy were done for any positive screening result and 10% of randomly-selected women with negative results. Results from these studies show that the best sensitivity for detection of CIN2+ was achieved by careHPV™ using providercollected cervical samples (70–95%), followed by careHPV™ in selfcollected vaginal samples (65–85%). Sensitivity of VIA ranged from 47 to 65%, Pap smear from 40 to 76%, and for the E6 test was 64%. We modeled different screening algorithms starting with careHPV™ as the primary screening tool. When either VIA or Pap smear is used as a second test for HPV+ women, the final sensitivity decreases by half; it is important to consider other possible screening algorithms. I166 THE UTILITY OF COLPOSCOPY IN THE MANAGEMENT OF WOMEN WITH ABNORMAL SCREENING TESTS J. Jeronimo New cervical cancer screening technologies are being developed, bringing changes to the strategies used for the last several decades. In addition, we have population-based programs using HPV vaccines that will eventually reduce the rates of cervical cancer and its precursors within the next decades. Colposcopy is still the main tool for ruling out invasive cancer and guiding the collection of diagnostic biopsies. For decades, cytology was the only screening test for cervical cancer screening and the main test triggering referrals to colposcopy clinics; but with the advent of
new highly sensitive technologies, cases of pre-cancer and lesions are detected much earlier and at smaller sizes. The accuracy of colposcopy has been questioned and options have been proposed in order to increase the sensitivity for detecting CIN2+ cases. These include: taking additional biopsies from different parts of the worst-looking lesion; taking additional biopsies from other abnormal area or areas; or even taking random biopsies from colposcopically normal areas of the epithelium. Fortunately, more research has been done and now we understand that taking additional biopsies from colposcopically abnormal areas could increase the accuracy of colposcopy for detecting CIN2+. Colposcopy is evolving and a new nomenclature has been recently released by the International Federation of Cervical Pathology and Colposcopy (IFCPC) making it simpler and easier to understand. New research is needed to validate whether the new nomenclature is more replicable and accurate, since colposcopy will still a pivotal role in the evaluation of women with abnormalities of the uterine cervix. I167 WHAT WE DON’T KNOW ABOUT ENDOMETRIOSIS: RESULTS FROM A GLOBAL CONSENSUS MEETING N. Johnson. University of Auckland and Repromed Auckland, New Zealand Background: An international consensus meeting on the management of endometriosis, organized by the World Endometriosis Society and attended by experts representing 31 national and international, medical and non-medical organizations, took place on 8 September 2011. Methods: From May to September 2011, a consensus process was followed, to analyze and categorize evidence concerning the management of endometriosis. The consensus meeting took place on 8 September 2011 in Montpellier, France, association with the 2011 World Congress on Endometriosis. A further process was followed after the meeting, including a formal survey of participants, then the consensus statement was drafted, modified and agreed upon by the participants of the consensus meeting. Results: Sixty five consensus statements were developed for which there was majority support for the statement and the categorization of the strength of the statement. In our post-meeting survey, none of the statements made achieved 100% agreement without expression of a caveat about either the statement or the strength of the statement; only seven of our 65 consensus statements were associated with a 0% disagreement rate from the survey respondents. Many of our statements were based on weak evidence; indeed in the case of our good practice points, on no research evidence; however such statements could still be associated with a strong consensus amongst the experts. Some key issues, where research evidence to inform practice remains sparse, are: management of adolescents who have, or might have, endometriosis as well as intervention strategies in the younger age group designed to prevent endometriosis; lifestyle and dietary interventions; standardization of long term strategies for prevention of recurrent endometriosis; clarification of management strategies, both surgical and medical, for women with deep infiltrating endometriosis; development of standards of experience and expertise required for surgeons undertaking advanced laparoscopic endometriosis surgery; standardization of centers/networks of expertise with regard to definition, accreditation and longevity; development of models of care in low resource settings. Conclusion: An attempt to reach consensus on the management of endometriosis has unearthed many areas where research findings are insufficient to inform practice. Research should be geared towards interventional strategies, ideally simple and low cost, designed to bring maximum beneficial impact for a minimal treatment burden for women with endometriosis.
Results: Nearly half of the women were in severe shock, with MAP < 60 mmHg (42.4%). The 182 women (16.4%) who died despite NASG treatment were significantly less likely to have received adequate blood transfusions and significantly more likely to be of higher gravidity (≥6), have a macerated stillbirth, have ruptured uterus as hemorrhage etiology, and had four times the odds of a co-morbidity (anemia, PIH, eclampsia/pre-eclampsia, or sepsis), even when controlling for receipt of blood transfusion and IV fluid (Table). Conclusions: The NASG contributes to the survival of women suffering severe OH and shock; however, efficacy is negatively affected by certain maternal factors, particularly the presence of another life-threatening co-morbidity. Furthermore, although the NASG “buys time”, it does not replace the need for rapid and adequate blood and fluid replacement. I161 MOVING FORWARDS TOWARDS BETTER MATERNAL HEALTH OUTCOMES: EXPERIENCES FROM COUNTRIES – MALAYSIA R. Jegasothy. Department of O&G, Kuala Lumpur Hospital, 50586 Kuala Lumpur, Malaysia The Confidential Enquiries into Maternal Deaths in Malaysia (CEMD) was established in Malaysia in 1991. The essential feature of the enquiry was the independent, multidisciplinary, multisectorial, non-punitive and anonymous review of cases, to identify remediable factors contributing to death and other adverse events. Data collection vastly improved and due to the anonymous nature of the enquiry, more and accurate data on maternal mortality was made available to the CEMD than the vital registration system. The role of nurse coordinators in all the districts of Malaysia to identify possible maternal deaths wherever they occurred was a vital cog in the system. Maternal mortality ratio declined from 44 per 100,000 live births in 1991 to 28.2 in 2008. Direct deaths declined from 81% in 1991 to 48.2% in 2008, while indirect deaths increased from 8.0% to 10.1% and fortuitous deaths increased from 11.0% to 41.7% during the same period of time. The major causes of maternal deaths in 2008 were obstetric embolism, medical disorders, postpartum haemorrhage (PPH) and hypertensive disorders in pregnancy. Training manuals, protocols and guidelines were developed to improve competency in knowledge and skills of health care providers. Numerous case illustrations based on actual maternal deaths were printed to create awareness among health personnel. In 2005, a handbook on ‘Lessons from the Malaysian CEMD’ was distributed to all medical officers. Nurses were empowered to refer cases as first responders to specialist units under the unique Malaysian colour coding system for risk assessment. The training modules for setting up of intravenous lines were incorporated into the basic training programme of community nurses. This was because it was found there were a number of cases in which community nurses were the first health care provider on the scene. Delivery by skilled personnel was maintained at a high 98.5%. Since 1998, maternal mortality has been included as a quality indicator for the health services in Malaysia and various facets of obstetric care as dictated by its prevalence in the CEMD Enquiries have been included in Key Performance Indicators and in the National Indicator Approach for obstetric and labour ward services. Maternal death surveillance is a powerful tool for advocating positive change in the Malaysian experience. I162 TRAINING EXCELLENCE CENTER FOR CAPACITY BUILDING J. Jeronimo Cervical cancer kills close to 300,000 women a year and 85% of those deaths occur in developing countries. The main reason for having high incidence and mortality rates is the lack of access
S201
to screening, ultimately related to the insufficient number of providers trained in new approaches for cervical cancer screening and treatment. Visual inspection with acetic acid (VIA), linked to cryotherapy for women with positive screening result, is a suitable and affordable strategy for developing countries; but broad dissemination of those techniques requires the training of enough master trainers using standard and validated training materials. A Technical Excellence Center (TEC) has the goal of building a sustainable service-delivery platform using VIA and cryotherapy. PATH, in collaboration with Jhpiego and the Peruvian National Cancer Institute, created a TEC in Lima, Peru. The TEC developed and validated training materials, trained master trainers, and trained providers to implement supportive supervision to secure quality of services. The Peruvian TEC expanded and replicated the experience to other two countries in Latin America, Colombia and Nicaragua. Our experience in Latin America shows that the TECs have a pivotal role in the expansion of screening services; the ministries of health of these three countries have used the TECs to increase the capacity for VIA and cryotherapy; now there are more than 100 master trainers in the three countries, and thousands of providers are trained in VIA and cryotherapy. In summary, the TEC model shows promise for building regional capacity to expand cervical cancer prevention services. I163 A CLUSTER SCREEN-AND-TREAT APPROACH FOR ORGANIZING CERVICAL CANCER PREVENTION AT NATIONAL SCALE J. Jeronimo Achieving good coverage of cervical cancer screening is important for reducing the incidence and mortality related to that disease; but it is important to emphasize that screening without completion of treatment of pre-cancerous lesions has very little, if any, benefit. The screen-and-treat approach has been implemented in multiple countries with the goal of securing treatment for women with positive screening results, without the need for final histological diagnosis. This approach has the advantage that treatment can be provided where complex diagnostic services are not available, and even during the same visit the screening is completed. Results show that many women with positive screening accept to be treated during the first visit to the health facility. But we must acknowledge that it is logistically impossible to have cryotherapy units and gas supply in each health facility in developing countries; therefore the single-visit approach can be implemented only in a limited number of facilities. We propose the cluster screen-and-treat approach to expand screening beyond the sites with treatment available. This model is based on implementing VIA in all health centers clustered around a facility offering treatment. Women with a positive screening result can be immediately referred to the nearby treatment site for cryotherapy. Close communication and coordination between screening sites and the treatment facility are required, as well as adequate counseling of women about the need to complete treatment. The cluster screen-and-treat approach has been implemented in low-resource areas in Peru increasing the number of women screened and securing treatment for women who needed it. I164 OVERVIEW OF BREAST CANCER EPIDEMIOLOGY AND MAGNITUDE OF THE PROBLEM IN THE DEVELOPING WORLD AND PERU J. Jeronimo Breast cancer is the most common cancer affecting women worldwide with more than 1.5 million women diagnosed in 2010, more than twice the number of cases diagnosed in 1980. About 500,000 women die due to breast cancer every year, and the number will increase significantly in the next decades, mainly because the incidence rate is currently rising at a pace of 3.1% per
S202
Invited presentations and presentations by organisations and societies / International Journal of Gynecology & Obstetrics 119S3 (2012) S161–S260
year. The incidence of breast cancer is also increasing in Peru, and due to the lack of access to screening, most cases are diagnosed at advanced stages. Even though the incidence of breast cancer is much higher in developed countries, the burden of disease is disproportionally increasing in low-resource countries where the survival rates are much lower. In some parts of Africa women newly diagnosed with breast cancer have 12% likelihood to survive 5 years, compared to 65% in Peru and almost 80% in the United States. The main factors for improving the survival of women with breast cancer are adequate access to screening and diagnosis at early stages, and use of adjuvant therapies. Early detection of breast cancer is important because the cost and success of treatment is directly related to the stage of disease at the time of diagnosis. Unfortunately mammography is not widely available in most developing countries where the scarce resources for screening are limited to some urban areas. Affordable screening, diagnostic and treatment options, and resource-appropriate guidelines offer new opportunities to reach underserved populations with lifesaving screening and treatment approaches that are effective and sustainable. I165 NEW SCREENING ALGORITHMS FOR POPULATION-BASED PROGRAMS J. Jeronimo New cervical cancer screening strategies have been developed in the last decade; some of them are suitable and affordable for developing countries. These new approaches open more opportunities for expanding cervical cancer screening coverage, but create a need to develop comprehensive algorithms that are optimized for different scenarios in developing countries. Between 2009 and 2012 PATH developed field studies using different screening options, including VIA, Pap smear, careHPV™, E6 testing (for genotypes 16/18/45), and DNA genotyping for HPV strains 16/18/45. CareHPV™ testing was done using both a vaginal sample self-collected by women without pelvic evaluation and a cervical sample collected by a health care provider. These studies involved the enrollment of approximately 27,500 women from India (Hyderabad and Delhi), China, Nicaragua, and Uganda. All the evaluations and testing were done using the public health system available in those countries. Colposcopy and biopsy were done for any positive screening result and 10% of randomly-selected women with negative results. Results from these studies show that the best sensitivity for detection of CIN2+ was achieved by careHPV™ using providercollected cervical samples (70–95%), followed by careHPV™ in selfcollected vaginal samples (65–85%). Sensitivity of VIA ranged from 47 to 65%, Pap smear from 40 to 76%, and for the E6 test was 64%. We modeled different screening algorithms starting with careHPV™ as the primary screening tool. When either VIA or Pap smear is used as a second test for HPV+ women, the final sensitivity decreases by half; it is important to consider other possible screening algorithms. I166 THE UTILITY OF COLPOSCOPY IN THE MANAGEMENT OF WOMEN WITH ABNORMAL SCREENING TESTS J. Jeronimo New cervical cancer screening technologies are being developed, bringing changes to the strategies used for the last several decades. In addition, we have population-based programs using HPV vaccines that will eventually reduce the rates of cervical cancer and its precursors within the next decades. Colposcopy is still the main tool for ruling out invasive cancer and guiding the collection of diagnostic biopsies. For decades, cytology was the only screening test for cervical cancer screening and the main test triggering referrals to colposcopy clinics; but with the advent of
new highly sensitive technologies, cases of pre-cancer and lesions are detected much earlier and at smaller sizes. The accuracy of colposcopy has been questioned and options have been proposed in order to increase the sensitivity for detecting CIN2+ cases. These include: taking additional biopsies from different parts of the worst-looking lesion; taking additional biopsies from other abnormal area or areas; or even taking random biopsies from colposcopically normal areas of the epithelium. Fortunately, more research has been done and now we understand that taking additional biopsies from colposcopically abnormal areas could increase the accuracy of colposcopy for detecting CIN2+. Colposcopy is evolving and a new nomenclature has been recently released by the International Federation of Cervical Pathology and Colposcopy (IFCPC) making it simpler and easier to understand. New research is needed to validate whether the new nomenclature is more replicable and accurate, since colposcopy will still a pivotal role in the evaluation of women with abnormalities of the uterine cervix. I167 WHAT WE DON’T KNOW ABOUT ENDOMETRIOSIS: RESULTS FROM A GLOBAL CONSENSUS MEETING N. Johnson. University of Auckland and Repromed Auckland, New Zealand Background: An international consensus meeting on the management of endometriosis, organized by the World Endometriosis Society and attended by experts representing 31 national and international, medical and non-medical organizations, took place on 8 September 2011. Methods: From May to September 2011, a consensus process was followed, to analyze and categorize evidence concerning the management of endometriosis. The consensus meeting took place on 8 September 2011 in Montpellier, France, association with the 2011 World Congress on Endometriosis. A further process was followed after the meeting, including a formal survey of participants, then the consensus statement was drafted, modified and agreed upon by the participants of the consensus meeting. Results: Sixty five consensus statements were developed for which there was majority support for the statement and the categorization of the strength of the statement. In our post-meeting survey, none of the statements made achieved 100% agreement without expression of a caveat about either the statement or the strength of the statement; only seven of our 65 consensus statements were associated with a 0% disagreement rate from the survey respondents. Many of our statements were based on weak evidence; indeed in the case of our good practice points, on no research evidence; however such statements could still be associated with a strong consensus amongst the experts. Some key issues, where research evidence to inform practice remains sparse, are: management of adolescents who have, or might have, endometriosis as well as intervention strategies in the younger age group designed to prevent endometriosis; lifestyle and dietary interventions; standardization of long term strategies for prevention of recurrent endometriosis; clarification of management strategies, both surgical and medical, for women with deep infiltrating endometriosis; development of standards of experience and expertise required for surgeons undertaking advanced laparoscopic endometriosis surgery; standardization of centers/networks of expertise with regard to definition, accreditation and longevity; development of models of care in low resource settings. Conclusion: An attempt to reach consensus on the management of endometriosis has unearthed many areas where research findings are insufficient to inform practice. Research should be geared towards interventional strategies, ideally simple and low cost, designed to bring maximum beneficial impact for a minimal treatment burden for women with endometriosis.