Introduction:
Completeness and accuracy of clinical data are critical requirements for meaningful interpretation in clinical research. Centrally linked clinical and laboratory databases are either unavailable or have restricted reach in most of the developing world. Therefore, there is a need of innovative strategies to ensure completeness of clinical data collection in such settings. Over last decade, our team has established the multi-centric Indian Chronic Kidney Disease (ICKD) cohort study of patients with early chronic kidney disease (CKD). The lack of central mechanisms of data collection across centers prompted us to develop a database model where we have expanded the patient’s role from just being a ‘participant’ to ‘participant contributor’ of her data.
Methods:
In the absence of a structured and interconnected referral system or centralized system, collating clinical information about one patient from different sources is almost impossible. Such information in resource-poor settings is captured manually and not stored on electronic systems. All such information converges at the patient i.e. the patient is the owner of and has sole access to all information related to her clinical status – viz. clinical notes or prescription, surgical notes or results of biochemical, pathology or radiology investigations, irrespective of whether these are generated at different clinics, hospitals or laboratories. With the widespread availability of low-cost mobile phones and internet in countries like India and advantage of portability, a mobile based smartphone application seemed to be the most appropriate platform for this purpose.
Results:
The ICKD study team coordinated with its software developer team to develop the workflow.
A customized mobile application has been created and integrated with the study database. For every participant, a mobile-like chat interface is automatically created between the participant and study staff upon the addition of participant to the study. Both participants and study staff can upload data related to that participant. The uploaded data can be in pictures, pdf files, plain text, or soundbites. All such uploaded files constitute source documentation for that participant. Centrally, all data become indexed to the participant as soon as it is captured in the mobile application linked to the study database at the backend. The participant always has complete access to her data in the mobile application. The mobile application is also linked to participant’s follow-up schedule in the study. We have developed two similar applications; one is integrated with the ICKD cohort study (as mentioned above) and the other one is integrated with the Clinical Trial Database Management System (CTDMS). CTDMS database has been developed for running clinical trials within the ICKD cohort. The team has secured software copyright for the CTDMS software (including its integrated mobile application) in India (7331/2021-CO/SW). As of now, the mobile application has been rolled out to 500 participants in the ICKD study and CTDMS clinical trials. The clinical database-linked mobile application has interfaces for the study participant and staff. Once uploaded by the study staff, the clinical data or source documentation generated at the study site also becomes available to the participant. So, in a way it becomes a digital repository of clinical data of the participant.
Conclusions:
Though challenging, the scope for digital, mobile technology-based solutions in clinical research is immense. We have shown that it is feasible to develop and run patient centered mobile application linked clinical research databases with patient as contributor as well as manager of her data. The concept is simple yet innovative. This model promises to fill the most important gaps in conduct of clinical research studies in low resource settings i.e. real time documentation of changes in clinical status of study participants and provision of a dedicated, secure communication interface.
I have no potential conflict of interest to disclose.
I did not use generative AI and AI-assisted technologies in the writing process.