The rapid expansion of the programme, and therefore the need to deal with a vast amount of clinical data, has led to the creation of specific software in order to manage the patients' medical files and their diagnostic data, called DREAM Software (Figure shows the Home page of the software). Below we show the challenges involved in designing this software, how it has become an essential instrument for treatment and for epidemiological analyses and how it can, like DREAM as a whole, become an instrument that can be used in similar contexts.
A Screenshot of the DREAM Software's Main Form.
DREAM Software was born of the need to computerise the management of the clinical files of DREAM patients.
This need envelops three main objectives:
i. Optimising access of the patients to the clinic so as to guarantee the highest possible number of daily visits;
ii. Having at one's disposal a database with information on the clinical history of individual patients and on the overall running of the DREAM centre, which is useful for refining therapies and for the sound running of the centres;
iii. Providing researchers with a useful database, by making use of the experience accumulated over the years.
The first objective of DREAM, and consequently for DREAMS (DREAM Software), is to guarantee a standard of quality comparable with that of developed countries. In this sense, the genesis of the software is strictly related to that of DREAM.
It has been recognised [8
] that developing computer projects for application in the health services sphere is a very complex activity, which must necessarily take into account the perspective of the end user, who is involved in the iterative process for the development of software tools [10
]. DREAM Software was created and developed to respond to the needs which emerged in the field and has been elaborated with experience. Hence the end users were extensively involved, and they gave a fundamental contribution to the creation of the tool which they themselves would be using. In fact, during the development of the project, a selected group of users (including doctors, nurses, biologists and technicians) had access to a website specially developed to collect comments and requests regarding the software. This way the team of developers were able to receive suggestions and indications from users in various countries, coordinating the modifications and improvements to the software. The users classified all the comments they made by giving them a priority value in order to direct the software designers towards the most urgent matters.
For example, one important aspect of the treatment of AIDS, as already mentioned, is the fact that it will last the whole of the patient's life. From the beginning of the therapy, the patient may have dozens of medical examinations and tests, which it is important to evaluate as a whole, in order to have an overall vision of the treatment of the patient. This is why the software includes a form, called Synopsis, in which the doctor has a complete and synoptic view of the various events that have occurred over the whole period during which the patient has been in treatment. This function was not present in the first version of the software and has been added thanks to the indications of the doctors who use it (Figure ).
A Screenshot of the DREAM Software's Synopsis Form.
Moreover, the expansion of DREAM to several countries (with different languages) introduced a further level of complexity, that of sharing data [12
]. In this sense, DREAM Software was also born of the need to introduce uniformity in the gathering of data by different centres in different countries, for the monitoring of centres and for the refining of therapies. Often, in fact, integrating data coming from heterogeneous sources is a problem which may require a somewhat complex solution [8
]. The need to collect and share data for subsequent analysis required a solution to the communication problems often encountered in African countries.
The typical architecture of DREAM centres is illustrated below and then the solutions adopted to solve the problems of communication and information sharing is presented. The question of data management is then dealt with and this also plays a very important role in the treatment of patient and in epidemiological research.
Architecture of the centres
This section briefly presents the typical architecture of a DREAM centre.
The DREAM database and Software are on the computer server in every DREAM centre. For security reasons, access to the database can take place only indirectly through the DREAM Software: the users (the coordinator, doctors, nurses and operators) do not have the privilege of direct access to the database. This precaution is to prevent a malicious (or inexpert) user from damaging the database or from deliberately spreading sensitive information. Moreover, sharing the same software on the server simplifies the configuration of the computers used. The architecture of a DREAM centre is illustrated in Figure .
As may be seen, every service within the DREAM centres (the examination room, the pharmacy and so on) has a computer, which is linked to the server and to the rest of the computers through a LAN, giving individual operators the possibility of following the patient for his/her entire course of treatment in the centre, with the most updated data always at hand, without having to refer to files on paper.
Communication between the various centres is guaranteed by an Internet connection, and through satellite in those places where it has proved impossible to get connected through an already existing cable network. Communication has turned out to be of considerable importance for two fundamental reasons, namely the centralised compilation of data and communication/consultation with specialised personnel. Through Internet communication (instant messaging or VoIP), every user can communicate with the personnel of other African or European centres. This has made the extensive use of teleconsultation possible (with no additional cost save that of the Internet connection), and this is very useful when the doctor feels the need to interact with colleagues about more complex clinical cases.
Difficulties in the setting and proposed solutions
When situated in a complex environment like the African reality, a structure of this kind is naturally subject to different kinds of problems: power surges, disruptions in network connections, both LAN and Internet and low bandwidth. Years of experience in this field have led to the identification of simple solutions to these problems. Clearly, a distinction needs to be drawn between the big centres, found in large cities where the problem is usually just of an economic/financial nature, and rural centres where the challenges are of a technical nature. The most pressing problem was undoubtedly that of power current; we can list three types of solutions of increasing complexity: i) using a UPS, ii) using a system of (rechargeable) batteries and of inverters, iii) using solar panels and batteries. The first method is obviously effective only in those cases where the power supply is present but erratic, and the dimensions of the UPS may be measured on the basis of the estimated quality of the connection. The second system is used in centres which are open only on some days, and it is possible to recharge the batteries in backup/support centres. The last is the latest method and allows for the continual use of our centres.
The problem of the quality of the LAN is fundamentally linked to the quality of the planning and implementation of the installation process. By consulting engineers, it has been possible to equip local technicians with the necessary know-how to create installations of a quality comparable to Western structures.
As for Internet connections, especially regarding bandwidths that are not always adequate, the matter is tackled in different ways. Careful enquiries made to local Internet service providers (ISP) have allowed many centres to have good quality Internet access at an accessible price. In cases where this was not an option, the problem has been resolved by using satellite connections, usually installed in our laboratories. For all the rural centres that are not connected to the Internet, it has been possible to transfer requests for tests via flash disk from the centre to the laboratory. The same applies to the transfer of backup of the centres. Once the backup reaches the laboratory, the software makes it possible to send all the backup of the satellite centres to a centralised server. Another important point: the size of files sent is reduced, to make them as robust as possible, so as not to be vulnerable to possible loss of data. An incremental backup system with especially strong redundancy was designed in order to achieve this.
Testifying to the quality of the networks (electrical as well as computer) of DREAM centres, VoIP communication systems have been introduced (at times supplied by the operators), which have allowed for the reduction in intercontinental teleconsultation costs.
As already mentioned, data management is an extremely important aspect. Not only because by computerising the medical files the work in the centres is carried out more efficiently. In fact the data collected make up a real mine of information that is useful for operational research, in order to make not only the work of the individual health centres more efficient, but also DREAM as a whole. This means that there has to be a reliable database and that the data collected in the various countries where DREAM is active have to be homogenous.
A large part of the work on DREAM Software has been dedicated to the design of a relational database for the management of data contained in clinical files. The database consists of 42 tables, which contain data relative to the topics presented in Table . This is an important resource both for the management of the clinical data of patients, as well as for the possibility it gives to analyse information found therein, from a clinical and organisational point of view.
Typology of data represented in the database
As has already been acknowledged [15
], creating a dictionary of terms used is of crucial importance for the management of the database. In particular, a need was seen for encoding the most important information - pathologies and drugs although not exclusively - as this has the capacity of making such information usable in an epidemiological context while maintaining a friendly approach towards clinical users. ICD X and ATC codifications in particular were used. The transcoding dictionaries compile 2,700 items for pathologies in the following languages: English, French, Portuguese and Italian. This feature is all the more useful in the case of DREAM, where the presence of many centres spread across different countries makes the homogenisation of terminology necessary. In the DREAM Software, pre-codified data is consequently used for the specification of symptoms, of diagnoses and of drugs, to avoid the possibility of inserting free text which would lead to non-homogeneity of data.
The registration of test results coming from laboratories (which have specific software for the administration of tests) has been automated too, to prevent mistakes in copying values [18
]. In fact, it has been noted that the quality of data (accuracy and completeness) is fundamental, among other things, to enable the integration of a support tool with decisions in the system [19
]. We thus chose to use an established terminology, in order to create structured records that could be used towards this end. On the other hand, the input of the patients in supplying information about themselves has been recognised as very useful in several cases [20
]. Consequently, the Software provides the option to add notes in fields for free text, apart from the codified data to be filled for each patient, so that news (possibly supplied by the patients themselves), which cannot be committed to memory in any other way, may be recorded there.
It has been noted [9
] that the preservation of data relating to electronic health records (EHR) is a critical issue, even if at times the staff may adopt an attitude of mistrust with regard to computerized systems for patient management [21
]. The security of data is consequently a fundamental aspect of the programme, bearing in mind that frequently data pertaining to DREAM patients on treatment is the only clinical data which exists about them. Hence, the database is equipped with a sophisticated backup and recovery system which guarantees the reliability of the system and the persistence of data.
Further, since the system handles sensitive, private information about the patients on treatment, we have sought to make the data secure on various levels, preventing its malicious diffusion or loss due to technical malfunctions. Despite the fact that many African countries have no specific regulations governing privacy, the data are dealt with according to the European regulations on privacy and electronic communications.
As already mentioned, a fundamental aspect of DREAM Software is that it links tools for epidemiological investigation to the automatic management of the patients' clinical files. A database containing the clinical data of patients on treatment provides the opportunity to use these data to conduct large-scale epidemiological investigations. This required the creation of a centralized database, in which to merge the data of the various databases of the DREAM centres. In order to keep this database updated, an additional backup procedure has been installed and it periodically (according to the settings) sends new data to the central database. A copy of this centralised database is then used for the analysis of data, through the use of specific tools.
Only the director and the scientific managers' medical staff have access to the central database, managed in the DREAM project's data processing centre in Rome. This way the data collected are used in an anonymous and assembled way for epidemiological research and for the evaluation of the therapy in the various countries' centres.
Some of the software's features
Some instruments have been implemented in the software to make the staff's work quicker and more accurate.
This section intends to only describe some of the functions of the software but they are extremely important for its effectiveness. In fact every function has a crucial role for the success of the therapy and for the excellent management of the resources (human and economic).
- Management of the appointments. This function is very important because it makes it possible to rationalise the centres' work. It is therefore considered an organisational aspect.
- Management of the drug storeroom and drug handover. This part of the software is of paramount importance, since precision in administrating the therapy and in taking the drugs is fundamental for the success of the therapy. The drugs are also a very important resource from an economic point of view.
- Managment of the languages. Great attention has been paid to the creation of a multilingual environment, because of the possible presence of international staff collaborating in the same health centre.
These functions, which have been developed to respond to the requirements of the DREAM health centres, are briefly explained below.
The appointments with the patients are managed by the software, in order to help with coordinating the health centre, which often look after thousands of patients. There are also some automatic warnings to highlight certain situations regarding patients who need particular care. This way one has not only a complete view of every patient's situation, but it is also possible to monitor how the centre is doing as a whole.
Managing the drug storeroom, the prescriptions and the deliveries is all dealt with by the software. This makes it possible to rationalise one of the project's very important and expensive resources, the drugs, particularly the antiretroviral drugs. The efficient management of the drugs has turned out to be a fundamental aspect of a project like DREAM, for at least two reasons: (i) it improves adherence to the therapy by monitoring the patients' use of the medicines; (ii) it helps avoid any waste in using the drugs. In particular the first aspect is crucial, given the complexity of the AIDS treatment because of the difficulty in substituting the therapy in the case of resistance to the drugs.
Figure shows two screenshots of the Drugs (prescriptions and handover) section of the software.
A Screenshot of the DREAM Software's Drugs Management Form.
A very important function of the software is to be able to change the language used quickly, without having to reinstall the programme. In contexts like the one in which DREAM is active, where people of different nationalities (and languages) find themselves working together, this has turned out to be an essential instrument for overcoming errors and misunderstandings caused by the language used. Figure shows how in the programme's status bar (at the top on the right) there is an option for the choice of language, which makes it possible to change from one language to another instantly without having to start the programme again, or even worse reinstall it.
A Screenshot of the DREAM Software's Status Bar.