eSource: How do eCOA and ePRO apps collect better data from the source?
Clinical trials are a way to update medical sciences and products. These trials and their outcomes account for life science sciences that have grown leaps and bounds over the last few years. Research trials, therefore, form the innermost core of medical sciences. For such a vital input, clinical trials must be envisioned so that companies can conduct them without many glitches and costly processes. The most important red flag to a clinical trial is its burgeoning cost. The implication is that the costlier the trial, the fewer the medical products that reach the market for human consumption. Clinical research trials have more to do with collecting and collating information than manufacturing the product. That follows later.
So, in short the latter is information and knowledge activity that gives birth to tangible solutions. The success and relevance of clinical trials are based on the economics of information, and this information-intensive business will succeed only when its processes are based on economical solutions. These innovations can transform and revamp a trial. As is the case with the eSource application.
eSource has changed the face of clinical trials. The source data had been a combination of paper and electronic data taken down by manual resources at the point of generation. It is now in a state where data is recorded in an electronic format at the very beginning, eliminating the need for transcription or transportation of data from paper to digital means. The use of electronic format has increased the efficiency of clinical trials due to quick access to quality research data and consequent prompt action.
eSource allows real-time remote data sharing, due to which eCOA (electronic Clinical Outcome Assessment) and ePRO (electronic Patient Recorded Outcomes) come in handy for immediate collaboration between trial stakeholders regardless of geographical barriers and boundaries. eCOA and ePRO have become two essential features of eSource that bring enhanced speed, clean data, and economical budgets to clinical trials that otherwise could have been long, winding processes and procedures. The following write-up will explain how and why eCOA and ePRO apps are equipped to collect better data from the source - the patient himself.
What is eCOA?
A decade ago, clinical research was solely dependent upon paper-based technology. There would be long, multipart forms that needed to be filled by research assistants and then transferred to a data bank. This process needed support to ensure the data collected was accurate and time relevant. The research model, therefore, demanded a tremendous amount of costly paperwork and labor. Today, legacy business models have been replaced by e-models ( models facilitating the collection of data electronically) that have now become critical to clinical research trials. eCOA is just such a technical innovation that allows direct contact with research subjects and consequent direct data collection from patients.
This method of collecting data enables a direct-to-patient research approach. Electronic Clinical Outcome Assessment or eCOA measures how a patient feels or functions during a clinical trial. The eCOA is carried out using a handheld tablet, home computer, or any other connected device. It works most efficiently in patient retention strategy as its flexibility allows patients and healthcare workers to complete data forms from anywhere. A simulation of a new therapy can be refined and updated with real-time availability of information from participating patients. In an environment dominated by pharmacoeconomics, the patient-centric approach makes eCOA an integral to the cost-effectiveness, action, and return on investment plan analysis.
What is ePRO?
ePRO, or electronic patient-reported outcome, makes the patient actively impact the clinical trial. A new trial or treatment may affect the symptoms positively, but it might not necessarily improve the patient’s quality of life. Recording instant feedback and qualitative answers to the study team’s questions greatly enhances the quality of data and the patient experience. It does not matter how the data is collected; it is patient inclusion that is of pivotal importance in the trial.
The e-PRO technology makes this possible through tools like e-patient diaries, apps, and wearables. The fact that data is harvested straight from the patient without any human intervention makes it high-quality data for quick and prompt decisions. It comes with a timestamp that aids the research team in locating the patient's recorded symptoms or side effects and can be integrated with other trial data for analysis. Another plus for e-PRO is its ability to seamlessly communicate with Electronic Data Capture (EDC) technology and keep all the trial data in one place. Thus ePRO does away with the added burden on on-site coordinators to keep feeding patient data manually.
In a clinical trial, a very critical task is to have valid, correct, and logical data. This requirement demands a data quality plan wherein an edit check is a mechanism that is used to specifically improve data quality within an electronic data capture (EDC) system. It cross-checks the validity of the entered data in a data entry program and creates them into electronic case reports. Forms maximize their utility and benefits.
Edit checks like real-time feedback for site staff as soon as they enter data, immediate resolution of data discrepancies, and automated review - a facility that allows data managers to concentrate on more complex review tasks. It is a process to automatically audit the information entered in the data field to ensure its expected logic, format, and range that works to reduce error percentage. It is a vital part of the clinical data management system, and the specifications required for a trial must be created by the personnel involved in the study. These specifications and the resultant queries are part of the data cleaning that trial personnel must manage.
Types of Edit Checks
1. Univariate edit checks (include range checks)
These are carried out the minute data is entered. They are applicable to a single field or single variable. For example, an edit check for weight will ensure that an unlikely value is not entered. A range check is set up, which will lock the minimum and maximum values. Anything less or more is not acceptable by the computer.
2. Multivariate edit checks
Also called aggregate edit checks are edit checks that audit more than one field for consistency and logic. For example, if the data entered in the gender field is ‘male’, then there should not be any data filled in the field for pregnancy test results. Similarly, if the reason for a participant withdrawal is ‘adverse events,’ then there should be the same entry in the AE data set.
Data validation is the process of double-checking source data for quality. This check is an essential step during the merging and migration of data from various repositories. The clinical data thus collected has to be validated to prevent corruption and inconsistencies due to type or context. Businesses can then evaluate and calibrate how far a medical product investment is worthy of the investment demanded. Data validation tests the quality and integrity of the data against preset documented tests. It checks for the characteristics of good, clean, and reliable data. These are:
- Attributable: The source of the data has to be known such that its origin and time of recording can be traced.
- Legible: The data should be such that humans can read it.
- Contemporaneous: The data should have been instantly recorded as and when the participant gives his response to the medical trial.
- Original: All copies generated should be from the original data, should not have overwriting, and should be complete.
- Accurate: The data should be completely faithful to the original so that its accuracy is not in question.
- Enduring: The data should be recorded and preserved till the entire time of the clinical trial.
- Consistent: The data should not be using terms that are self-contradictory or create a conflict in the information.
Data validation is vital from the perspective of businesses and patient health/ patient population included in the clinical trial.
Min and max values display warnings
ePROs can detect symptoms and occurrence of life-threatening complications earlier, thereby being highly effective in disease management. It can even guide patients/participants who do not have immediate access to a medical practitioner to take measures in case of emergencies. Patient-reported outcomes (PRO) are reports of the patient participant’s health status without the clinician’s interpretation or input. ePRO is a real-time report to healthcare providers on alarming symptoms and complications. The facility provided by ePRO enhances the patient-clinician communication channel and brings immediate medical intervention in emergencies. Physiological, laboratory, and clinical data is integrated to interpret as an early warning of the patient progressing towards a critical point in his health status. The timeliness of the notification is of utmost relevance here.
When multiple signs occur just prior to the critical event, researchers should consider the warning closest to the event and ignore the rest on record. The warning system has three main characteristics that should be considered: multiple warnings per record, warning timeliness, and warning burden ( occurrence of multiple warnings per event/record). The Modified Early Warning Score (MEWS) is a physiological score that enlists specific parameters for the safety of critical and surgical inpatients. The MEWS serves proactively in preventing delays in medical intervention. It helps the health care staff call for the specialist when the MEWS shows an alarming score on the patient’s observation card. MEWS could be a weekly score for data collection during clinical trials to be collated and interpreted.
Full integration of ePRO with electronic hospital records and clinical information systems allows the treatment of patient-reported symptoms immediately without delay. The clinicians and practitioners can also plan an appropriate care strategy when they can access all the data in tandem with each other. An increase in body temperature is the first indication of the prevalent infection in the body. Monitoring body temperatures can help detect a disease that might assume virulent proportions if ignored.
Heart rate example
By measuring heart rate, the health of the heart or a looming health problem can be diagnosed. An RHR or resting heart rate is the number of heartbeats per minute. So an RHR under 60 indicates good health and better heart function. But an RHR above 100 indicates stress or intake of excessive caffeine or a heart problem.
Systolic and diastolic numbers measure blood pressure. Normal blood pressure is 120/80 or a little below it. But higher than this would be the sounding of alarm bells.
High blood pressure consistently above normal puts a patient at risk of heart attack and stroke.
How do they work?
Temperature, heart rate, and blood pressure are vital signs that must be routinely monitored in a patient or participant. They measure a body’s most basic functions, and anything abnormal with them could complicate the issue being treated or researched. All three vital parameters can be checked and monitored at home with devices and software in ePRO.
Does the study need to provide devices for ePRO?
The biggest challenge for a clinical trial is the need to gather, report and analyze clean and faithful data from the source. With this in view often, patients are provided with ePRO tools that facilitate timely data. There are categories of ePROs that a clinical trial/study can consider for their appropriateness vis-a-vis patient’s convenience and the intended use of the data. Also in consideration should be the possibility of using more than one ePRO tool. First is the Interactive Voice Response System (IVRS). It is telephone based and similar to customer care menus used for banking and retail. The IVRS allows patients to record their responses using the touch-tone keypad. The IVRS system works best for trials with a large number of participants or when several trials are going on simultaneously.
ePRO can be used by involving a Screen-Based Reporting Device. It could be an electronic device such as a smartphone, tablet, computer, or wearable medical device. Patients access the software on the device and answer the questions presented to them. They select their answers which are recorded digitally. These could be used as electronic diaries by the patients/participants from easy access to their homes or on a clinical site under the clinician's supervision. But these devices and the training for the patients on how to use them have to be provided by the study sponsor. The participant might even lose a device or damage it. This loss of the device adds to the cost of the study. Another area for improvement is the inability of the patients to use the given device optimally.
Can be BOYD (Bring Your Own Device)
With researchers encountering problems with the dispensed ePRO devices and smartphones being popularly used, BOYD or bring your own device has become the solution for the researchers. An increasing number of trials use this approach to communicate successfully with their participants. For patients, it is most convenient to use their own smartphone to log into an app and fill in the required data. They do not have to invest in decoding a new device; using an app on their phones is more comfortable than using a provisioned device. Along with this is the added inconvenience of keeping track of a new device and then the trips to the study site for picking up and dropping off the device. BOYD significantly does away with the consequent cost associated with provisioning a medical device, reaching it to a participant, and maintaining an inventory tracker. For an extensive study, it could translate into an exponential increase in costs. With BOYD, downloading an app and upgrading a smartphone might be all needed.
eCOA and ePRO are digital solutions that have brought happier ways of collecting patient data right at the source. They use apps that provide several advantages over traditional paper-based methods of collecting data. The procedure involves edit checks, validation rules, and MEWS as a part of the algorithm for collecting data. This procedural algorithm comfortingly ensures that data quality is safe and of sterling quality.
The usage of apps assures real-time data to a researcher or a practitioner. This prompt availability of data on symptoms, medication adherence, and any adverse event helps healthcare professionals respond without losing time. The use of eCOA and ePRO technology has introduced changes in the legacy healthcare system that has considerably reduced response time. The patient participant gains confidence from this promptitude; that they are in safe hands. The consequent satisfaction and comfort encourage the latter to continue with the trial till its completion. All in all, eCOA and ePRO collectively have set off a domino effect in the healthcare system by collecting better data from the source.
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