Pneumonia Diagnostic Devices in Ethiopia
An ambitious agenda to design and establish field trial protocols
The management of pneumonia within the community has important benefits. It not only reduces the burden on health facilities but ensures early identification, classification, diagnosis and treatment of children where they need it the most: close to home. Both Integrated Management of Childhood Illness (IMCI) and integrated community case management (iCCM) are therefore central to an integrated approach for prevention and treatment.
Diagnostic innovations designed for community level use such as the acute respiratory infection diagnostic aids (ARIDA) help classify pneumonia easily and portable pulse oximeters that identify children with severe pneumonia in urgent need of oxygen therapy can save lives. Timely and accurate diagnosis is critical to preventing pneumonia deaths.
No child needs to die from pneumonia, yet it was reported that in the year 2015, one out of six childhood deaths were from it. We can end preventable childhood pneumonia deaths and UNICEF’s ARIDA project aims to support just that. Innovative ARIDA devices facilitate appropriate diagnosis of children where they need it most: close to home.
UNICEF developed a Target Product Profile (TPP) for ARIDA devices which outlined ideal performance, functions, and design specifications. The TPP was shared with industry. Industry responded by developing innovative prototypes and devices that meet UNICEF’s described requirements in the TPP. These devices will soon be manufactured and ready to be field trialed. This trip to Addis focused on the field trial preparations, where UNICEF ensures the new devices are fit for purpose. Fit for purpose means devices are appropriate for low-resource settings and use by community and healthcare providers with a broad range of literacy levels and training.
So here we are, in Addis, finally designing the studies to evaluate the different ARIDA devices. It has been a long time coming and a lot of work to get to this stage. Several countries have been approached to host field trials through UNICEF’s Country Offices, and the Ethiopia Federal Ministry of Health (FMOH) expressed significant interest and agreed. Several missions to Ethiopia have taken place to plan for the field trials, ensure alignment with stakeholders, leading to this trip where our objective was to make concrete decisions about field trial design jointly with our Ethiopian stakeholders and our implementing partner, Malaria Consortium (MC).
The team gathered at the Panorama Hotel to tackle an ambitious agenda prepared by MC. Everyone on the team had studied documents on the reading list in advance and were prepared to have fruitful discussions. At the end of the first day, the ARIDA project team had a call with the Advisory Committee (AC) to present different options for the field trial. The AC comprises of experts from the world of pneumonia, research, programme and supply. By sharing options and listening to the AC’s reflections, it helps UNICEF make informed decisions on the different studies.
So, after two days of in-depth discussions and deliberations, we were able to agree on the majority of the study design decisions. MC will outline the plan for each study and the reasoning for why this study design has been chosen over another, pros and cons, etc. MC can now move forward with writing the study protocols.
Looking back at the workshop – it was intense but valuable to have everyone in the same room together to wrestle with important questions. Workshops such as these facilitate fruitful discussions with team members. Asking the right questions is important in product innovation to ensure the new and improved products meet the needs of the end-users and ultimately improve the lives of children by ending those preventable deaths, which are so close within our grasp.
Watch this space for more updates on the ARIDA project and the research associated with it.
Ethiopia ARIDA Stakeholders:
UNICEF Delegation: A mixture of Programme and Supply Division staff, as well as Ethiopia country office representatives. The mix of skills from pneumonia, research, technical, monitoring and evaluation will help influence and shape the study designs.
Malaria Consortium (MC): Again a mixture of people from the headquarters in London, as well as the local country team from Ethiopia. Heavy on expertise in hands on field research, the MC team have been contracted by UNICEF to create the field trial (FT) protocols for the different ARIDA devices here in Ethiopia and other countries. Furthermore, MC will be conducting the field trials themselves.
Armeaur Hansen Research Institute (AHRI): are experienced in working with the local ministries, and one of their tasks is to conduct tests of innovations in health on behalf of the Federal Ministry of Health. AHRI also have an ethics review board that will be reviewing all protocols prior to commencing any field trials in Ethiopia.
Ethiopia Federal Ministry of Health (FMOH): were represented as a key stakeholder – what do key decision makers want to see when evaluating whether a product should be scaled in their health systems?
