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Improving the informed consent process in clinical research is an ongoing concern of the regulatory authorities as well as a challenge for both the specialists and the patients involved. An online training platform designed for obtaining the IC, provides an interactive method for informing the participants about the clinical research, providing the essential information to help them assimilate this knowledge and verifies the level of understanding by providing different types of questionnaires. The main component of this platform consists of a web application that incorporates the multimedia online consent. This application is optimized to run on tablets, taking advantage of the latest innovations in the mobile technology field. Using this online method the patients have an interactive tool to get informed, the content being customized to each research protocol and gives corrective feedback of each concept, information or procedure that that has been misunderstood by the patient.
Keywords: Informed consent, clinical trials, online system
The latest innovations in the information technology and Internet provide the opportunity to develop new methods for getting the informed consent (IC) using an online multimedia training platform in the context of a computerized medical system.
Clinical research has become a complex field with a highly sophisticated activity. It implies various methods of investigation, medical procedures and technologies, as well as a continuously growing amount of information offered to participants. This information is increasing in complexity and sometimes it is exceeding the patient's capability to read it and understand it .
The informed consent document (patient information brochure) offers a review of the clinical trial (CT): purpose and methods of research, estimated timeline of volunteer participation, the benefits that can be reasonably anticipated as a result of research on the patient or on others, any risk associated with the study, maintaining confidentiality of the data recorded, investigators' responsibilities, etc. .
Published studies report that alternative methods for obtaining IC such as multimedia systems are considered to provide substantial benefit to subjects. [M. Paasche-Orlow] Similarly, Eilenberg et al. reported on patients using interactive Web-based IC high satisfaction rates. [KL. Eilenberg]
The information disclosed to the patient from the consent document does not assure the fact that the patient has fully understood what his or her participation in the research involves.
Therefore, we have decided to create a tool to improve the IC process in CT.
This paper will describe the multimedia online training platform and the impact that it has on clinical researches.
Materials and Methods
An online training platform for getting the IC
This tool is an interactive online information system designed to inform the patients about the CT and eventually to get the IC. It trains the patients regarding CT procedures using web-based multimedia content such as: pictures, audio & video content, MS Office presentations etc. Since the competent authorities do not yet regulate its usage, it can be introduced as a supplement to the paper based IC process.
Its development took into consideration the principle of universal accessibility for persons who have limited knowledge using a web system interface. It has been adapted to run efficiently on a tablet that provides simplicity when handled, ideal user friendliness and mobility. Users will be able to access the tool online at home, in the waiting room or in any other designed space within the research center without any keyboard, mouse or other peripherals.
The application is structured as a list of e-learning modules and it will track in real time the progress recorded by each participant in the training process. The program provides the possibility to generate an IC document and IC forms, so the patient will be able to sign&date the IC.
Among the tool's characteristics we listed a few:
Unitary system allowing the usage of a standardized training protocol;
Multicenter consistency - same process is applicable in several medical centers, even if the patients training activity is conducted at the level of the medical centers in which they are enrolled;
Multinational consistency - same process can be implemented in different countries and the patient will be trained in the preferred language;
Data centralization - multiple medical centers will share common data. For example, the info about Sponsors initiating clinical trials (an institution or a person that assumes the responsibility of the clinical research) will be stored in a central repository.
Traceability - any change can be tracked and this info will be accessible online by certain users.
Security - assures data security and confidentiality complying with the laws in force and with the clinical trials regulations.
The web client interface was built using PHP, jQuery, and Adobe Flash technology. The data is stored into a MySQL database. In this way the system can be accessed online and there is no need to install it on the client machine.
As far as the access security into the website is based on username & password and traffic between server and client is encrypted (HTTPS). Each user is assigned to certain user groups (e.g. administrator, Sponsor, monitor, investigator, patient) so he will see only the sections that are allowed for these user groups.
System components: modules and functions
We created the following main modules:
The registration module - every user needs to fill out a registration form as a first step prior to using the system. Afterwards an administrator will accept the registration or not.
The authentication module - every user will access the system using an username & password or via SSO (Single Sign On).
The administrator module - it provides functionalities for User management, CTs management, IC management and Reports management.
The CT admin module - will manage the clinical trials and patients assigned to them.
The interactive training module - it will train the patients regarding a specific clinical trial.
The reporting module - will provide various reports regarding how the clinical trials are coming along. Some of the reports will be geospatial so the data will be presented on a map.
Reports and questionnaires
The program can display the report of a study center (quick statistics related to patients answers). It allows the visualization of the report related to the activity of a patient or of all the patients belonging to that study center. Once the patients completed the training session, the system generates their activity report. This report can be accessed in real time by investigators or other clinical trial managers. The training program integrates two types of questionnaires:
the awareness questionnaire of the presented information,
the satisfaction assessment questionnaire that will get the feedback about the presented training session.
This interactive platform provides researchers, via the patient`s testing session, the acknowledgment of the patients' understanding, approval and acceptance of the clinical trial procedures.
Since the awareness questionnaire represents a key point in the training process, it will be detailed below.
The Awareness Questionnaire
The behavior of potential participants to a CT whether to ask questions or not, as well as their questions' quality, represents the degree of their interest, awareness and understanding of the information disclosed in the IC form. The observations gathered from our analysis on current research practice (using the IC in a printed format), along with the 10-year experience in obtaining consent for clinical trials show that many patients ask too few questions or none, out of which most address the form and not the essence of clinical research.
This behavior can be interpreted as a sign of IC in incomplete awareness. Thus, we suggest using an auxiliary tool integrated in the IC process, that will stimulate the interest of the patients to what will happen during clinical research, that will maintain their attention to the disclosed information and that will evaluate retention, and nonetheless, understanding of the concepts being communicated.
In order to fix this critical problem we introduced "The Awareness Questionnaire" in the online training platform. This questionnaire will allow both the patient to be informed of the most delicate or important aspects of the CT, as well as the physician to seize the aspects poorly understood from the IC document and to identify the areas were more discussions need to happen in order to achieve more comprehensive IC.
The online training material presented to the patient is structured in sections; each section has a multimedia content attached and the awareness questionnaire. We recommend that the questions to be interposed with the sections of the IC document, to keep the patients' attention "awake" during the entire lecture of the document, instead of them being used at the end of the presentation. Once the patient finished visualizing a section, he will have to answer the awareness questionnaire. Depending on the given answers, the system will re-run the current section (if the provided answers were unsatisfactory) or he can move forward (if he gave correct answers to all questions). If the patient provides a wrong answer, the system will provide additional explanations or the patient will be contacted by the investigator in person, via chat or email (see figure 1). In this way the patient will get a better understanding of the matter. A wrong answer will be considered a notion not well understood which requires edification through a targeted explanation of the misunderstood information. The CT team will see these errors by receiving the reports associated to each patient who went through the online training platform.
Using this awareness questionnaire the CT team makes sure the patients have a good level of understanding of the presented notions and in the same time the patient is stimulated to stay connected to the presentation.
View section 1 related MMP
View section 1 related questions
View section 2 related feedback
View final feedback / Consent
View section 1 related feedback
Figure 1- The diagram associated to the patients' multimedia presentation (MMP) and evaluation module.
The interactive multimedia presentation
The multimedia presentation was created as animated slideshows including all the information in the IC document. The standardized information offered to all the patients within a CT is accomplished through a multimedia presentation, identical for all the patients (using the language of the specific country), except for a short introduction clip (welcome clip), specific to each research center, personalized by incorporating some images of the center and of the research team. This will strengthen the bond between patient and investigator, being a tool that favors the maintenance of the subject in the program. The interface communicates information using a calm empathic voice that has the role of increasing the presentation impact. In order to simplify the usage, we have created a minimalist interface, user friendly, having several essential buttons (figure 2). The system will choose the personalized presentation version according to the patient's gender since some information are gender-related (e.g., female patients will be informed about contraceptive precautions during the trials and pregnancy/fetus related risks), thus patients will feel more comfortable and less confused when seeing the appropriate presentation. Patients will have access to the online training system until the CT ends as a source of information. Patients can also receive a printed copy of the clinical trial information as soon as the presentation session ends.
Figure 2- Interface of the interactive multimedia presentation
A multimedia presentation editor was developed for this platform, which can create a new presentation for each CT that requires IC. By text editing, both compulsory information can be added as well as supplementary information that clarify certain terms, medical procedures. Clips that cover information on disease management, background information on clinical trials and other relevant topics can be inserted. It allows managing of words in the glossary, questionnaires and the elements of the multimedia presentation (image, sound, and movie).
The efficacy of this platform has started being evaluated in several feasibility studies with participants from different centers who suffer from various medical conditions. The acceptability of the new technology by the patients and the research teams is verified. At the same time, we have started to estimate the impact of using the new technology on research costs.
Researchers could use this online platform in order to obtain a better valid informed consent regarding clinical research.
There is the physicians and patients request to use new technologies for getting the IC in the context of increasing complexity of CTs and of need to prove without doubt that a person was informed about and understood what their voluntary participation in a clinical trial required.
Since the competent authorities (National Ethics Committees and National Medicine Agencies) didn't regulated the usage of this innovative approach in obtaining the IC, the research centers have to use the program as a supplement to the standard paper based IC.
Even if it`s not yet proved that reduces the clinical research costs comparatively to the usual paper based information, this is a method which increases and verifies the understanding of the patients who took part in these research programs.
This paper is supported by the Sectoral Operation Programme Human Resources Development (SOP HRD), ID76945 financed from the European Social Fund and by the Romanian Government.
To dr. Marius Marginean for his precious advices and guidance in developing an interactive online information system.
To my friends Georgeta and Ionel Popa for their kind support in the style corrections of this paper.