As the world closed its doors to human interaction earlier this year, our digital platforms like social media, electronic patient data capture technologies, and wearable sensors were put to the test.
No doubt these platforms are functioning in their ability—but are we missing a key element in assessing the patient’s mood? Is this isolation affecting a patient’s mental health? Indeed, if said patient is already emotionally or cognitively compromised, how does this manifest itself in the data we capture during a study?
Research shows that data collected from a patient in a clinical trial can be impacted by mood. As the general population feels locked in and suffers from job insecurity or even job loss, isolation, and weight gain due to lack of mobility, are we accounting for changes in their mental state in our data collection? During this pandemic, it is critical that we capture the remote patient’s voice on a global scale.
The purpose of this blog post is to explore the tools we currently have and uncover the hidden complexities of a patient’s environment that may not have been considered before. We will suggest new strategies and tools to augment and amplify the patient’s voice during this pandemic.
1. Social Listening:
With patient support group meetings halted, where are patients turning for community camaraderie? A research study across 25,000 respondents showed that social media usage increased by 61% over normal usage rates during the first peak of the pandemic. It’s likely that patients are turning to social media platforms like Facebook Groups to discuss their unique challenges with one another. According to Forbes, social listening tools have the ability to collect this publicly available data and drill down to identify themes across discussion threads in multiple languages. We could utilize this dataset to get a temperature check on the mental health impacts of the pandemic.
Social listening is the monitoring of social media channels for any feedback and direct mentions of a study/drug or discussions regarding specific keywords, topics, competitors, or industries, followed by an analysis to gain insights and act on those needs. Is the population in Brazil experiencing a greater change in mood than perhaps a country that is feeling the effects of the pandemic less, e.g., New Zealand? By engaging in social listening, we can uncover what patients care about and what topics are most affecting their experience—especially during lockdown.
2. Electronic Clinical Outcome Assessments:
The most meaningful data is collected from the patiently directly via electronic clinical outcome assessments (eCOAs). These validated questionnaires are made available via mobile apps and tablets. They are already being distributed en masse for remote clinical trials and function to collect the patient’s voice. However, could the nature of the pandemic be impacting the data due to depression, lack of mobility, or mental health acuity?
Subject-matter experts in the field recognize the pandemic’s effects on mental health. Depression compounded with isolation has profound effects on a patient and could impact data collection from patient-reported outcomes. The New York Times interviewed Dr. Luana Marques, a psychologist at Harvard Medical School and the president of the Anxiety and Depression Association of America. According to Marques, “I don’t know anyone right now that’s not having depression-like symptoms It’s hard to keep going when our brains are constantly on fight or flight. It makes people really tired. If you’re having trouble concentrating or getting out of bed, it’s not abnormal. It’s an evolutionary response to a threat.”
If we recognize shifts in mental health are commonplace during the pandemic and know that mental health state affects patient-reported outcomes, then it is critical we utilize questionnaires to determine mental state in a clinical trial setting. If we do not explore this path, data validity may be put into question.
The world has been under a microscope to adhere to social distancing in order to best track and trace the movement of the virus. The European Union has suggested tracking apps (mobile applications and wearable smart watches that monitor biomarkers like mobility, heart rate, and sleep time) to help trace the spread of the virus. As a result, the wearables and mobile industry was tasked to track and monitor mobility and other biometrics.
King’s College London researched the publicly available RADAR-base wearable/mobile application to assess mobility during the pandemic and discovered a number of findings.
“We were able to quantify expected changes in time spent at home, distance traveled, and the number of nearby Bluetooth-enabled devices between pre- and during lockdown periods. We saw reduced sociality as measured through mobility features and increased virtual sociality through phone usage. People were more active on their phones, spending more time using social media apps. Furthermore, participants had lower heart rate and went to bed later.”
The results of the study show that wearables can accurately monitor biometrics such as changes in daily activity, mobility, sociality, and sleep time. These biomarkers can highlight changes in a patient’s mental health. If we implement the use of wearables and eCOA, we can gather insights into a patient’s current mental state while participating in a trial.
In conclusion, we know that mental health, mental acuity, and mental hygiene play an important factor in collecting accurate patient data. There are datasets readily available and functioning to assess mood via social listening, eCOA, and wearables. Though this blog post does not give answers, we can start to question how to best connect these outlets to capture the patient’s voice and ensure data validity.
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