eSource Series: How Do RPM Tools Enhance Adverse Event Detection
Remote Patient Monitoring ( RPM) is a healthcare delivery system that works on and with technological advancements well beyond the legacy systems of yesteryears. The number of clinicians and healthcare providers who subscribe to RPM is growing. This ready acceptance amongst professionals makes it more acceptable to the patients, but there has yet to be doubt and skepticism pertaining to the quality of care as compared to in-person visits to the medical facility.
Its reception and acceptance by the patients have been warmer since its widespread usage during the Covid-19 pandemic. Healthcare providers are readily relying on it to keep chronic patients under constant surveillance. Patients suffering from chronic diseases like diabetes, hypertension, congestive heart failure, chronic obstructive pulmonary disease, and asthma have to be monitored for their vitals on a day-to-day basis and sometimes even hourly. There would be times when they could not make it to a medical facility. Under the circumstance, RPM healthcare devices capture physiological data and instantly transfer it to the practitioner/ care provider.
So for patients, too, it is of great comfort to know that help is only a breath away. It alleviates the stress of medical treatment from patients, healthcare providers, and the system as a whole by collecting data at the source without any human intervention. Its benefits range from increasing virtual medical help, a robust communication channel between the patient and the healthcare provider, and proactive patient involvement in self-management during the treatment, thus drastically reducing medical costs.
ePRO Apps Extended With Remote Monitoring Tools
Reporting, tracking, and timely addressing of potentially adverse events are of vital importance with regard to chronically suffering patients. Studies and treatments must rely on safety monitoring through e-PRO (patient-reported outcomes) and its established tools to arrest adverse events for at-risk patients, particularly during care transitions. Remote monitoring tools or devices enable the caregiver to get real-time patient data and accordingly make a quick and prompt decision as to his medical administration. These also facilitate the patient in understanding their health better when they themselves monitor it on a daily basis, resulting in more optimistic outcomes. There are seven most common tools that are commonly used in remote patient monitoring:
1. Bluetooth Blood Pressure Cuff:
It is a wearable device that measures and calculates a patient’s heart rate by measuring the pressure of blood flow in an artery. A Bluetooth cuff would record and send the data in real-time to the patient’s doctor so that he can react without losing time. It is a known fact that blood pressure monitoring is a vital contributor in the treatment of hypertension, diabetes, and kidney dysfunction. A daily monitoring gives an insight into the condition of the heart as opposed to once in a while reading.
It is a meter that gives a reading of the level of glucose in the blood. A drop of blood on the test strip connected to the device measures sugar levels. The reading is sent to the healthcare provider in real-time. Patients with Type 1 and Type 2 diabetes need to use the glucometer almost daily, even multiple times daily, to manage sugar levels effectively. When sent the data, the provider decodes how and which factors are bringing about the adverse events. These factors include medication effect, diet, exercise, stress, concomitant illness, and comorbidities.
3. Pulse oximeter:
It is a clip attached to the patient’s finger or earlobe to determine oxygen levels. The pulse oximeter also takes a patient’s pulse and monitors chronic conditions. The oximeter can detect a change in lung function. For example, for Covid-19, low oxygen levels indicate positivity.
4. ECG & Stethoscope:
This is a relatively new device that patients use to monitor their heart and lung functions virtually at home. It captures the sound of the heart, lungs, and bowels, thus facilitating self-monitoring. The reading can be sent instantly or can be saved and sent later for a clinician’s review.
5. Wearables (Activity Trackers and Continuous Monitoring):
These help the care providers monitor their patient’s steps, heart rate, and sleep. It helps in understanding whether a patient's daily routine is contributing to or affecting his health. Real-time data collected from the tracker helps the practitioner formulate a treatment plan. Common everyday activity trackers are Fitbit or Apple Watch.
6. Bluetooth Thermometer:
This instantaneously transfers the patient’s body temperature data to the healthcare provider and helps take the essential steps to take care of adverse events. High body temperature is one of the vital signs that alert the doctor to the patient's worsening condition. Bluetooth Thermometers available include non-touch digital ones that simply scan the forehead and record the temperature, and the contact ones placed under the tongue.
Observation of weight gain and loss is essential for monitoring a patient’s condition. Weight gain could be due to water retention or medication that might not be helping. For weight management, a Bluetooth scale helps the patient and the provider constantly track weight fluctuations and act accordingly. Patients suffering from obesity need to self-manage and be monitored. For this, a Bluetooth scale can help significantly prevent a heart condition, stroke, or type 2 diabetes, resulting from obesity.
With healthcare becoming increasingly patient-centric, remote patient monitoring dramatically increases a patient’s convenience and reverses an adverse event quickly.
Self-Reporting of Adverse Events (eRAPID)
The use of Electrochemical sensors for testing of blood and body fluids at home has revolutionized electronic systems, which help in real-time symptom control and patient care. By translating the presence of biomolecules in a drop of blood or body fluids into electrical signals that can be read and interpreted, eRAPID has advanced Electronic patient self-reporting of Adverse-events to a level where the patients can self-report symptoms and side effects from home. It is an affinity-based electrochemical sensing platform that detects biomarkers in biological fluids using a single drop of blood. A single sample can test many biomarkers and diagnose diseases and disorders at the point of care. The patient reports his health status and parameters to the healthcare provider through the Electronic Patient Record or EPR for routine treatments. But this system also has a provision for sending out alerts for the medical teams in case of an alarming AE or Adverse events. It can also issue medical advice to patients in case of mild cases of adverse events.
They manually enter data like weight, blood glucose, etc.(patient-generated health data or PGHD). This recording of PGHD is also a part of RPM and includes health histories and reporting of symptoms like heart rate, glucose levels, and weight manually by the patient or his family. It is information that a practitioner could not have obtained by any other means. For example, when a patient talks about the side effects of a changed medical regimen, it helps the care provider update the patient’s EHR with details that help improve care administration to the patient. This exercise often involves incorporating details in the patient’s voice, providing more efficiency and authenticity of data. The PGHD is integrated with the EHR (Electronic health record) via a patient portal. Through the self-reported health parameters, the physician and the patient forge a partnership for creating a health care plan in which the patient has an active role. This patient-generated health data is very different from Personal Health Records or PHRs.
Automatic data collection via connected devices like Fitbit, CGM, connected blood pressure monitors, etc.
Personal Health Records (PHRs) are applications and devices prescribed to and used by patients to create their health records. This data can be uploaded in real-time or stored and shared with the doctor as and when required.
Remote patient monitoring, or RPM, does not use interactive audio-video or virtual visits of the patient to the medical practitioner or vice versa. It simply requires technology that collects, transfers, and interprets physiological data. RPM devices need to be connected via Bluetooth or cellular networking. They are often referred to as connected digital products because they are software-based or sensor-driven while being patient-focused. The most common devices are weight scales, glucose meters, pulse oximeters, blood pressure monitors, and ECG machines. The health data required is captured and transmitted to the healthcare provider for immediate perusal through a mobile app, USB, or Bluetooth.
The RPM devices like blood pressure monitors, CGM (continuous glucose monitoring), or fitbits are integrated with patient health records or the EHR. The device can even issue an alert to the patient if there is something worrisome in his data that should be addressed by a practitioner.
Predict Adverse Events for Pharmacovigilance
Trials and treatments are conducted as a part of the pre-marketing strategy on a large or small scale, depending on the commonality or rarity of a disease. Before going to market, every drug is put through rigorous trials to check and double-check for its efficacy and safety. This step is Pharmacovigilance. It is a process-driven sphere within the pharma industry and practices. Broadly speaking, it oversees the collection, analysis, monitoring, and prevention of adverse effects caused by drugs and therapies under trial or otherwise. Reporting adverse events in clinical trials is mandatory, even if the side effect is suspected and not confirmed. An adverse event is a body’s negative reaction to the administration of a particular drug or treatment therapy. This side effect could be mild, severe, and even life-threatening, requiring hospitalization or life support. With their real-time data generation and recording ability, RPM devices can be used for detecting the presence and predicting the onset of adverse events with high accuracy. Symptom data is collected using e-PRO. This data input is combined with machine learning to help forecast immune-related adverse events or irAE. In a treatment or a trial, a slight change in symptoms or vital signs could signify the beginning of an AE, that if not arrested, can be irreversible. Pharmacovigilance demands that the clinicians or practitioner be up to date with the patient's or participant's health status and predict a serious setback in a patient’s health.
New classes of drugs have to be tested, and with each new trial, a whole range of unknown and unpalatable Adverse effects come to the fore. Decentralization of clinical trials has further made the use of ePRO and RPM technology a boon to sponsors and patients alike. Added to this is the Covid-19 scenario where patient/physician physical interaction had to be kept to the minimum and still administer healthcare.
Monitoring adverse effects is extremely important to calibrate and determine the efficacy and safety of a drug or treatment. Authentic and robust data that faithfully maps the patient's symptoms with the help of patient-reported outcomes complements and improves the trial outcomes. With the integration of technology, data analytics, and digitization, real-time patient self-reporting of adverse events has become feasible. This technological integration, in turn, fulfills the need for careful symptom attribution and the consequent decision-making on the clinician’s part.
Adverse events, if not detected in the nick of time, can end in a result beyond redemption. Remote patient monitoring tools are an answer to this challenge to healthcare administration. These tools continuously monitor a patient’s symptoms and health status without needing a physician’s presence.
The use and utility of these tools are not confined to just detecting adverse events. They also enable patients to afford costly medical treatment by eliminating frequent hospital visits, which can be time-consuming, expensive, and stressful. Patient outcomes are also enhanced due to this technological convenience.
The use of Remote patient monitoring tools has particularly gained traction in the aftermath of the COVID-19 pandemic. Healthcare facilities have been swamped with patients suffering from post-covid symptoms that refuse to abate with the fever. RPM tools have greatly helped healthcare providers deal with patients’ demands without unnecessary exposure to the virus.
Further evolution of RPM tools has contributed to the development of more sophisticated devices like wearable devices, smart sensors, and mobile apps. These tools can capture a wide range of patient data, including vital signs, activity levels, medication adherence, and sleep patterns. The data is then submitted to devices powered with Advanced analytics and machine learning algorithms, which analyzes data to identify patterns and anomalies that indicate adverse events or potential health risks.
With RPM, patients are in the know of things about their health status and can contribute actively to deciding upon the line of treatment and lifestyle pattern. So remote patient monitoring as an exercise coupled with its facilitating tools could be the answer to a healthcare challenge that has been eluding professionals for quite some time.
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