By leveraging leap frog technology and the skills and experience of American Society of Clinical Pathology (ASCP) members in the U. S., clinicians in five Sub-Saharan African countries and Haiti can have access to quality rapid cancer diagnostics. ASCP and a coalition of partners will develop and administer an economical, scalable, secure, and reliable telemedicine solution, that will evolve into a cloud-based system, to register specimens, record findings, and disseminate diagnostic results to local clinicians who can implement patient management. Through this commitment, local clinicians in Sub-Saharan Africa will be able to provide a level of diagnostic care currently scarce or unavailable locally.
The commitment will provide quality diagnostics through three main steps. First, automatic histopathology (tissue examination) equipment and systems for preparing and scanning biopsies will be established in locations with the greatest population density and servers will be placed in laboratories for file transfers. The first sites of deployment and installation will be in Rwanda: the Butaro Cancer Center of Excellence, the University Teaching Hospital of Kigali, and the University Teaching Hospital of Butare. Local clinicians will collect biopsy specimens which will be transported to laboratories to be processed and scanned by locally trained lab technicians. Through the cloud technology, ASCP pathologists will view processed samples, diagnose the patient, and upload their findings. Finally, local clinicians will be able to access the results with 24 to 72 hours after the specimen has been uploaded for reading, and implement patient management.
ASCP anticipates diagnostics will be delivered to more than 156,000 people, 75% of whom will be female. The majority of those served by this commitment currently lack access to diagnostic services. This will bring an incredible increase in the number of patients seen, number of patients diagnosed, and the number of patients treated.
ASCP will draw on its 8,000 anatomic pathologist members to provide diagnostic services and its 91,000 laboratory professional members to provide support and training to laboratory professionals on the ground. Pathologists will be recruited based on anticipated work demand and will be assigned specific days to review cases. ASCP will provide overall oversight and project management, coordinate partners, work with ministries of health, and build capacity through workforce development initiatives.
World-renowned partners will contribute their experience and best-in-class practices to implement this commitment. Sakura Finetek will provide histopathology instruments for preparing biopsies. Omnyx, LLC/GE Healthcare will provide telepathology equipment, supplies, and technical/operational support for the automatic histopathology systems used to scan and display patient biopsy specimens. Roche Diagnostics will provide ancillary equipment (immunohistochemistry). The National Cancer Institute at the National Institutes of Health will supply high-level scientists to determine the best manner of caring for patients identified with malignancies, crafting treatment protocols that are both ethical and effective. Partners in Health, in partnership with the local ministers of health, will coordinate care and treatment in Rwanda and Haiti and care delivery models will be developed in the other four program countries. Pfizer will support the initiative via a philanthropic cash donation. The Institute for Health Measurement and Evaluation will provide data measurement and evaluation of the initiative.
Implementation Timeline: 2015, Botswana; 2016, Rwanda and Haiti; 2017, Swaziland; and 2018, Lesotho and Liberia. Efforts will take place in a rolling fashion, in-country implementation will occur concurrently according to available capacity of partners and country readiness.
Phase 1 (Pre-Analytic): Equipment Acquisition and Sensitization. Efforts will take on average 6-9 months per country.
This phase will include efforts and deliverables that assess cancer treatment capabilities in-country, assess primary care system, examine and address bioethics issues and collect data on disease incidences, number of biopsies currently and targeted to be performed, access to testing, projection of rise in specimens as access to diagnostics and treatment becomes available. This information will inform the site selection for the equipment. Site selection will take into consideration the required infrastructure: electricity, broadband, proximity to clinical sites, and the needed human resources such as laboratory professionals, pathologists, clinicians, and other health care workers. Another aspect of site selection will include meetings with Ministers of Health, laboratory staff, health care providers, and educators. Once these have been completed the diagnostic equipment will be installed and workforce training will begin for both general skills and additional training on specimen grossing, instrument operation, and Laboratory Information Systems integration. During this phase, coordination with care providers will take place to ensure quality specimen collection as well as post diagnostic care and treatment.
Phase 2 (Analytic): Diagnosis, Care, and Treatment. Efforts will take on average 6 months to become operational per country and overlap with Phase 1 efforts by 3 months.
This phase begins when the sites in country are fully operational. Activities include specimen processing, grossing, histopathology slide preparation, slide imaging, and the uploading of images to the cloud where they will be downloaded, reviewed and diagnosed. Once the diagnostic report is prepared it will be uploaded for local review and communication to the patient. This process will take place for each patient specimen. During this phase data will be saved for utilization in monitoring and evaluation.
Phase 3 (Post-Analytic): Monitoring and Evaluation. Efforts will take on average 3 months to become operational per country and overlap with Phase 2 efforts by 2 months.
Given the findings in Phase 1, it will take between 4 and 9 months to analyze and operationalize each country. As a result all Steering Committees will meet, communicate and generate inputs into the system from October 28, 2015 through November 1, 2018. Deliverables for each Committee are included below.
This phase involves delivery of cancer care and follow up with the patient. It also involves monitoring and evaluation of the laboratories based quality indicators (turnaround time, stock outs, and other quality indicators) and continuous improvement cycle to ensure high quality results and evolution of the program. Health outcomes monitoring for patients will be measured and reporting to cancer registries will take place to monitor epidemiology of diversity of cancers. Health outcome indicators for patients with respect to post-cancer care will also be measured. All data collected will be used to train health care workers, monitor disease, assess clinical care and inform and address in-country workforce needs at appropriate levels (college and university).
US-based Steering Committees: Five steering committees will work together to oversee and evaluate country data and support the implementation of this project. Subject matter experts will meet via conference call and in-person meetings to determine country readiness, monitor the project, and determine next steps. Steering committees will form around the following topics.
Diagnostics and Technology: This Steering Committee will determine need for ancillary studies, number of pathologists required, changes in technology, and reporting processes.
Care and Treatment: This Steering Committee will determine treatment regimen, partners to expand care and treatment services, cancer care delivery systems, diagnostic capacity as it relates to existing resources, pathology data needs, use of appropriate clinical guidelines, patient identification systems, and need for specialty referral systems.
Monitoring and Evaluation: This Steering Committee will focus on the following success measures including: implementation plan, country adoption, data output and outcomes, measurable goals, strategies to guide, program design and sustainability.
Bioethics: This Steering Committee will determine care and treatment options, and will evaluate opportunities to expand treatment options in countries with poor access to cancer treatment services.
Medical Education and Training: This Steering Committee will determine partners for sustainable workforce, education and training programs, the need for common curricula, and IT infrastructure needs to support sustainable capacity and continuing medical education.
Non-communicable diseases (NCDs), such as cancer, cardiovascular disease, respiratory disease, and diabetes, are the leading causes of death in Sub-Saharan Africa, with cancer at the forefront (WHO 2008). Additionally, increases in life expectancy, changes in diet and lifestyle, and a reduced incidence of communicable diseases will increase the prevalence of cancer in the future (Council on Foreign Relations 2013).
Alongside the increasing incidence of disease, there is limited availability of screening, laboratories, and pathologists in Sub-Saharan Africa. In most settings, there is less than one pathologist per one million people. The United States, in comparison, has more than 60 pathologists for every one million people (American Cancer Society 2011).
The lack of these vital health services and professionals leads to higher cancer mortality rates in Africa, as compared with other regions of the world (American Cancer Society 2011). In 2008, Africa witnessed approximately 715,000 new cancer cases and 542,000 deaths from cancer. By 2030, those figures are expected to more than double, with 1.28 new cancer cases and 970,000 cancer-related deaths, as a result of population growth and aging. The potential impact of cancer could be even higher in some countries due to changes in behaviors and lifestyles associated with increasing economic development (American Cancer Society 2011).
Lastly, the economic costs associated with cancer, both immediate healthcare costs and loss of productivity, is threatening continued development and prosperity for the continent. Globally, the World Economic Forum projects that the NCD epidemic will inflict $21.3 trillion in losses in developing countries over the next two decades (Daniels).