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Researchers can often be tripped up by issues they encounter in developing regions and remote areas. Although no definitive answers are provided (there are just too many options and unknowns), the following issues should be considered when planning such a trial. The discussion is based on the African context, but it is felt that it is equally applicable to other developing regions in Asia and the Americas
A defining feature of developing regions is poverty. Things that are taken for granted in developed countries are just not affordable in the developing regions. Let's start with smart-phones. Many posts on the internet ask about using Apple iPhones, iPads or Android devices. As a very rough order of magnitude estimate, I compared the cost of an iPhone 4 with the earning power of a newly qualified doctor or General Practitioner. This doctor works less than 3 hours in the United States to cover the cost of an iPhone 4. A similar doctor in South Africa works 4.5 days and in Kenya he would have to work for about 18 days. If a Malawian doctor bought an iPhone on the grey market (as far as I can see, Apple does not have a representative in Malawi), he would have to work over 200 days to cover this cost. This is a mind blowing figure. I know there are cheaper smart phones than the iPhone, but the costs are of the same order of magnitude and the results should be similar. It is therefore unrealistic to expect the inhabitants of these regions to be able to provide their own devices.
What about PCs and servers? Hardware costs are relatively consistent with most being imported from the Far East. However Windows software can be relatively expensive due to the different licensing and pricing models. Many, if not most, implementations in the health trials area seem to use Linux or other variant of Unix. Support is another issue to be considered - good hardware is available in most countries from local organisations who usually have the expertise to repair when required. So the recommendation here is to buy local - and it might be cheaper than shipping your own hardware.
Network connectivity can be a major factor (see below). And the costs of network connectivity are high, especially relative to the endemic poverty. There is generally minimal fixed line/cable connectivity outside of the major centres and most long distance connectivity is on the mobile phone network. Unlimited bandwidth packages so common in the US and Europe are unknown in Africa and the cost of data transmission is high. One must therefore prepare a realistic network budget when setting up a project in the developing regions.
So having touched on the costs of networking, what are the other networking issues? Network connectivity is slow, unstable and often non-existent in the remote areas of the developing world.
Speed and capacity
While South Africa and a few other African countries have mobile phone networks that reach around 80% of the population, other countries have 10% coverage and less. High speed broadband networking is often available in the major cities and some other areas. For the rest, network coverage is through the mobile phone network which is 2G, or EDGE (2.5G) at best. What do these terms imply? If you can remember the days of dial-up 9600 baud modems, that's about what you can expect on these networks. To put it another way if you're too young to remember the 'good old days', Broadband is defined as better than 1 Mbit/sec , while 2G is about 1/100th of that. Now imagine trying to surf the net at that speed.
Another issue is the reliability of the long distance network. Outages are common, and the networks are often overloaded resulting in dropped calls, lost internet packets and large delays. And even in the major urban areas, outages can be frequent.
Roads are not a technology component but do have an impact on research projects. Roads in the remote areas are generally in a poor to very poor state. This means the researcher has to strike a balance between capturing data at the remote site using a poor computer network and transporting CRFs over a poor road network.
A number of experts have said that networks will be upgraded when the need is there, and so one need not cater excessively for low-speed networks. I believe this to be untrue for Africa. The areas are under-serviced or un-serviced because the potential subscriber base is too poverty stricken to generate sufficient revenue for the networks to consider upgrading these areas. I believe we will not see significant enhancement to the networks for many years.
Satellite communications are an option almost anywhere. But speeds are slow and costs are high.
Africa is notorious for the inefficiency of its power supply. Interruptions can occur at any time, and large parts of many African countries have no formal electric power supply - even large cities. What does this mean for the researcher?
1. Power to central servers must be supplied by a UPS (Uninterruptible Power Supply) - buy one when you buy the server! If there is no formal supply, or if the supply is particularly problematic, also supply your own generator - but this may merely shift the problem from supplying electricity to supplying fuel for the generator. Desktop workstations can be supplied from the same UPS if a sufficiently large one is installed/
2. Case workers using mobile phones will require frequent recharges as apps generally consume far more power than the basic mobile phone. It may be necessary to have a spare battery to get through the working day. If they have power at home, they will need a charger for any spare battery. If not, things become more difficult. Solar chargers are available at a reasonable cost (about $10 in bulk), but then one needs more spare batteries so that one or two can be charged at home (with the solar panel in a sunny window) while the others are being used in the field.
Application type: Web-based or Native App
I have seen more than one solution designed in developed countries that does not work in Africa because it relies on high speed always available networks. This is typical of web-based solutions, as well as some other solutions that are designed as if they were to be used in an office. So they fall flat because the required network connection is not available, or too expensive (see above).
Therefore an application that can store results locally and upload them when a connection is available in a highly compressed format is very desirable.
I do not mean 'can they read and write', but rather 'are they computer literate' type definition. Levels of literacy are low in remote areas, and computer literacy is almost non-existent apart from young urban professionals.
I believe that literacy is a continuum such as illiterate, numerate, literate, speciality literate etc. I have come across people who are functionally illiterate (never went to school) but they can perform quite complex transactions using their mobile phones (in some countries you can buy a goods from your phone airtime). I have also found that people who are used to basic phones struggle to master the virtual keyboard of a smart-phone and vice versa.
Therefore one should assess the probable literacy levels of their staff and study participants before embarking on a research study, and determine how this will impact the study design.
Simple mobile phone apps may be very suitable for care givers in remote areas, provided the requirements are not too onerous. On the other hand, high volume complex studies with follow up visits require a sophisticated data-based app, and staffing for such a study may be problematic outside large urban areas.
The following are the common categories of Apps or applications
This is a point in time study where data is collected once for each participant. There are many such applications available on both PC and mobile phone - I've counted over 35 available on the mobile phone. They are the simplest to deploy and some will tolerate poor or non-existent network connections.
Longitudinal or Observational study without intervention
These studies are more complex technologically as they require one to find previous information about the participant. This means either high quality network in order to query back to the central database in real-time, or the participant visits must be predicted in advance so a copy of the data can be downloaded to the site prior to the visit. Another option is to have multiple synchronised copies of the database, which will allow updating at any device (PC or phone)
Interventional, Diagnostic or Methods study
These are of the same technological complexity as the above studies, but require the rigour of a certified Clinical Data Management System such as openClinica. Because of the requirements of electronic signatures, a centralised database is the only option which then implies good quality network connections are required. This may require satellite communications if performed in the remote areas. As an aside, in one vendor presentation where I asked how they proposed to operate in a poor network environment, I was told "Research projects must be scoped according to the technology available" - a case of the tail wagging the dog.
There are a number of solutions deployed in the first world where one can ask an online panel for advice. However these are invariable web based and require high speed networks. There are applications available where an 'encyclopaedia' is provided on a memory card which slots into most medium quality phones. This means that no network connection is required.
Other social/cultural issues
Strange as it may seem, one should address social and cultural issues and impediments when assessing the technology requirements. The document 'Lessons from mHealth Projects: Tech is the Easy Part' (http://www.ghdonline.org/tech/discussion/lessons-from-mhealth-projects-tech-is-the-easy-par/) says it better than I can.
Personal safety (smartphone mugging)
Finally an issue that is alleged, but no evidence is available to support it. Smartphones, tablets and laptops are highly desired articles in Africa. With the high crime rates that are widespread in Africa, the potential for theft or robbery (theft with violence) is high.
I have heard of a study where case workers were provided with a smartphone to perform a survey. The case workers refused to take them home and would leave them at the office overnight for fear of being mugged. Even so, two were mugged for their smartphones while performing the survey.
The only evidence that somewhat supports this are the recent crime figures for London where it was stated that more than half the cell phone robberies were for smart phones, despite smartphones making up less than 20% of the total phones in use.