We’ve been asking our members how they feel every day since June, in what was previously called the Daily Mood Survey. We’ve since renamed this offer to the Daily Check-In, and we’re excited to share an update on our findings. 

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In our last community results post, we talked about the connection between how you feel and your activity levels. Since that last post, the percentage of responses for feeling “Good” has gone up—from 57% to 61%. See average results for July and August below:

• Good: 61%
• Okay: 33%
• Bad: 5%

With over 7.7 million responses to-date, today we’ll take a deeper dive to see how things like day of the week, time of day, sleep, and exercise relate to how our members feel day-to-day. 

‍Day of Week & Time of Day

The last community results post showed that when it comes to how members feel, the "best" days were Saturday and Sunday and the "worst" days were Monday and Thursday. 

What has continued to ring true is that people are generally in good spirits on the weekends—Saturday and Sunday remained the "best" days for responses in July and August.

However, alongside Monday (no shock there), Wednesday replaced Thursday as one of the two “worst” days in terms of how people felt.  

But what about time of day? We found that the hours of the day when people respond most optimistically are mornings and early afternoons, specifically:

• 9AM-10AM
• 12PM-1PM 

For the time periods above, Good = 62%.

We can compare this to the least optimistic hours, which are 12AM-4AM (Good = 55%).

‍Amount of Sleep

For members who track their sleep, we took a look at how the amount they sleep in a given night affects how they feel the next day. 

‍We found that when members slept at least 7 hours the night before, they were more likely to respond that they felt good the next day (56% vs. 52%). 

This indicates that people feel better when they get an adequate amount of sleep.

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For example, if Evidation Member "Sally" sleeps less than 7 hours on August 1, and more than 7 hours on August 2 she is more likely to respond that she feels good on August 3, which is the day after she slept more than 7 hours. 

If we combine "Sally's" data with data from all of our members, we find that members are about 7% more likely to feel good on days they slept for more than 7 hours.

‍Exercise

For members who’ve connected their workout data to Evidation, we wanted to see if working out affected how they felt in the 24 hours post-workout. 

‍We found that members who worked out in the 24 hours prior to their response were more likely to respond that they felt good (65% vs. 59%). 

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Additionally, this finding lines up with a survey we shared in August asking our members if they felt better when they were more active. Out of 40,000 responses, 91% of members responded "yes".

Want to receive personalized insights for how things like sleep, exercise, and more affect how you feel? Connect an activity app or wearable to your Evidation account, and be sure to answer the Daily Check-In offer (found on the app home screen) as regularly as possible. 

Better yet, you’ll receive more points to reach your 10k point goal!

‍The Daily Check-In offer is only available in the app at this time. If you typically log in on the web, be sure to download the app.‍

With almost 5 million members, we’ve been able to launch a variety of health research efforts that study topics like chronic pain, how people use their wearable devices, and sleep patterns. 

We've partnered with healthcare and life sciences companies to launch large-scale research programs that look at type 2 diabetes, heart disease, the flu, Alzheimer’s Disease, and most recently COVID-19, to name a few.

With over 77 research publications, we’d like to highlight two notable studies to give you a better idea of the impact our members have when they decide to participate in a study.

DiSCover Program (Digital Signals in Chronic Pain)

About 50 million people in the United States suffer from chronic pain. 

In 2018, Evidation launched the DiSCover Program, a study designed to help us gain a better understanding of what it’s like to live with this condition. More than 10,000 members participated in the program over the course of a year. 

We looked at patterns in activity levels and asked participants to take daily surveys in order to get a better understanding of the day-to-day impact of living with chronic pain. 

Here’s what we learned from these participants:

• Chronic pain had an impact on participants’ physical activity. On average, they were about 25% less active than those without chronic pain.
• Chronic pain affected participants with many different conditions (for example, fibromyalgia, cancer, arthritis, etc.).
• To manage their pain, participants used a wide range of treatment options from over-the-counter pain medications and prescription opioid medications to meditation apps, medical marijuana, and acupuncture treatment.
• Participants with chronic pain reported lower quality of life and had higher rates of depression and anxiety symptoms than those without chronic pain. 

Through their participation, these study participants helped our researchers understand their lived experiences with chronic pain.

COVID Signals Study

At the height of the pandemic in 2020, Evidation and our study partners launched the COVID Signals Study.

Over 800 individuals who were at higher risk of getting COVID-19 (for example, doctors, nurses, and first responders) joined the study. They provided data from wearables, lab tests, and surveys for over 3 months. 

Together, these participants completed: 

• 59,485 daily surveys 
• 7,571 weekly and monthly surveys
• 6,328 weekly COVID-19 test kits
• 841 final surveys

This information is helping us explore if there are ways to predict when someone might be sick, and what their recovery might look like. 

How can I learn more?

These are just a couple examples of how participants like you make research possible. As a result, individuals living with conditions like chronic pain, COVID-19, and others can potentially benefit from this new research. 

Want to know more about any of our Evidation Studies and how to get involved? Check out How to Get Involved in Evidation Studies, or reach out to us at study@evidation.com and one of our friendly team members can help you get started. 

If you want additional general information on health research, we recommend checking out the following public resources: 

• U.S. Department of Health & Human Services, Office for Human Research Protections
• FDA, Clinical Trials and Human Subject Protection
• National Institutes of Health (NIH), Educational Resources
• Clinical Research Resource HUB, Resources for Participants

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Welcome to the next article in our Research 101 series! We're excited to share with you some important information about Institutional Review Boards (IRBs), which are essential to the research process. 

If you’ve ever thought about participating in research, you may have had some questions about how the research could affect you. You may have wondered:

• What are the risks and benefits?
• How will my data be used?
• How do I know I am safe?

Researchers care a lot about providing a safe and ethical study experience. One way we do this is by submitting our research protocols to an Institutional Review Board (IRB). 

What is an IRB?

An IRB is a review board designed to protect the rights and well-being of research participants. It acts as a system of checks and balances for any research involving people. 

IRBs work to ensure the following: 

• Research studies have scientific merit and purpose 
• The activities involved in the research are ethical 
• All regulatory requirements are followed 

Every IRB has at least five members with different backgrounds. The members may have training in scientific areas, have expertise and training in non-scientific areas, or be members of the community who may represent the people who would participate in the research study.

IRBs are the gatekeepers when it comes to being able to conduct research involving human beings. Without IRB approval, researchers are unable to conduct their research.  

History of the Institutional Review Board (IRB)

The idea of an Institutional Review Board (IRB) began in 1974 when President Richard Nixon signed into law the National Research Act. The act led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Events such as the Tuskegee Trials and the Willowbrook Experiments, where research was conducted in an improper manner, proved there was a need for unbiased oversight. 

This commission was in charge of identifying the principles that should underlie the conduct of research. They also created guidelines to make sure research is carried out following those principles. In 1979, the commission published "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," also known as the Belmont Report. 

The Belmont Report is made up of three core principles:

1. Respect for Persons - Giving people the right and capacity to make their own decisions.
2. Beneficence - Minimizing potential harms and maximizing benefits 
3. Justice - Distributing benefits and risks fairly 

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IRBs were founded on these three basic principles which are still referenced when reviewing research proposals. 

What does the IRB review? 

The people who make up the committee carefully consider the following:

• Are procedures in place to reduce any harm or risks to the participants? 
• Do the benefits outweigh the associated risks?
• Is the selection of participants equitable and fair?
• Are potential participants able and willing to give informed consent?
• Will a participant's consent (or permission) be properly documented? 
• Do the researchers have a plan for monitoring the quality of the study data to ensure participant safety?
• Are there adequate procedures in place to protect the privacy of participants? 
• Will the researchers be able to maintain the privacy of study participants?
• Are there protections in place for vulnerable populations? 
• Does the research meet all regulatory requirements? 

Evidation Studies & IRB Oversight 

Research conducted by the Evidation Studies (formerly Achievement Studies) team often requires approval from an IRB. The decision to have a study approved by an IRB is based on the design of the study and what the researchers will use the results for.

At Evidation Studies, we have a dedicated team of researchers who help oversee the protection of our study participants every step of the way. Even when IRB approval is not required. 

Our study participants can be confident that we’re committed to their safety and that our studies are conducted according to the highest standards. 

Want to know more about any of our Evidation Studies and how to get involved? Reach out to us at study@evidation.com and one of our friendly team members can help you get started. 

If you want additional general information on health research, we recommend checking out the following public resources: 

• U.S. Department of Health & Human Services, Office for Human Research Protections
• FDA, Clinical Trials and Human Subject Protection
• National Institutes of Health (NIH), Educational Resources
• Clinical Research Resource HUB, Resources for Participants

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It’s important to understand what Good Clinical Practice is and why it matters. Especially if you are participating (or thinking about participating) in research.

Good Clinical Practice (GCP) is an international guide for how to conduct ethical and good quality research. GCP applies to all stages of research: design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of any research involving people. 

GCP consists of 13 principles focused on the following: 

• Safety 

• You feel protected throughout the entire research study.

• Rights are Protected

• You have the right to information about the research. 
• You decide whether or not you want to participate in the research. 
• You have the right to withdraw from the research at any time without penalty.
• Your privacy and confidentiality will be protected.

• Quality of Research Data

• The data collected from you is for the purpose of the research and is based on a scientific protocol approved by an ethics committee.

Why do we need Good Clinical Practice (GCP)?

The idea of a “good physician” and “good clinical/medical practice” dates back to the Hippocratic Oath from about 400 B.C. This oath represents the earliest idea of medicine being practiced in a just and ethical manner. It established several principles of medical ethics that remain important today. These include the principles of “confidentiality,”  “privacy,” and “doing no harm.” 

While the oath itself was a good start, it was not enough to protect all of the people who participated in research from harm. Additional rules and regulations were necessary to help keep people safe. 

The United States put into place the first legislation to help regulate drugs that are available over the counter, The Food and Drugs Act of 1906. Before this legislation, harmful and deadly drugs could be purchased by anyone, just like any other product. These unsafe products led to serious illness, injury, or death because the ingredients were not tested for safety. 

Well known examples of drugs available at the time include: 

• Kopp’s Baby’s Friend - contained a mixture of morphine and alcohol
• Dr. King’s Consumption Cure - contained a toxic mixture of chloroform, morphine, and pine tar
• Dr. Bull’s Cough Syrup - contained dangerous amounts of opium

In 1938, the Food and Drug Administration (FDA) approved the Federal Food, Drug, and Cosmetic Act. This was the first time manufacturers were required to not only test drugs for safety, but to also provide real-world evidence of that safety to the FDA prior to being available to the public. 

The importance of Real-World Evidence 

Real-world evidence comes from real-world data, and is evidence about the use, risks, and/or benefits of a medication, product, or treatment.  Without real-world safety evidence, the product could not be sold. Companies that broke this rule could now be fined, sued, or even prosecuted by law if their products caused harm. 

While research can be used to help people, the label of “research” has also been used across history to cause harm, particularly in times of war. 

One of the most well-known occurrences was in World War II, when German physicians conducted horrific experiments on individuals in the concentration camps of Europe. These war crimes, performed under the banner of “research,” resulted in the development of the Nuremberg Code in 1947. This code is part of the reason research participants have the right to decide whether or not they want to participate in a research study. 

‍Your voice and your choice matters.

GCP over time 

Over time, new guidelines have been developed to better define the idea of ethical medical practice in clinical research. Unfortunately, nearly all of these guidelines were created in reaction to research that was harmful to participants or was unethical. 

These guidelines include the Declaration of Helsinki (written in 1964, updated in 2013), the Belmont Report (1979), and the International Guidelines for Biomedical Research Involving Human Subjects (1982). 

The primary goals of these guidelines are to protect research participants, allow people to participate in research when it can be helpful to the world, and treat all research participants equally and justly. As new research types emerge, like the use of technology or developments in genetic research, new ethical challenges arise. These documents help guide researchers through ethical challenges and define the principles within GCP guidelines.

How does the team at Evidation Studies ensure Good Clinical Practice?

From the design of our research studies to the final analysis of the information that’s collected, our research team holds each other accountable. 

‍Our team is trained in GCP annually and attends discussions on the importance of Good Clinical Practice in human research studies. It is our guidebook for making sure our research is safe and the rights of our participants are protected. 

Additionally, our research studies are reviewed and approved by an ethics committee called an Institutional Review Board (IRB), whose goal is to keep people safe and make sure research is done ethically. 

‍We feel strongly about the importance of GCP because our participants are top priority to us. 

Our mission is to encourage everyone to participate in better health outcomes. In order to fulfill our mission, we must provide a safe and educational experience for all of our research participants. 

Want to know more about any of our Evidation Studies and how to get involved? Reach out to us at study@evidation.com and one of our friendly team members can help you get started. 

If you want additional general information on health research, we recommend checking out the following public resources: 

• U.S. Department of Health & Human Services, Office for Human Research Protections
• FDA, Clinical Trials and Human Subject Protection
• National Institutes of Health (NIH), Educational Resources
• Clinical Research Resource HUB, Resources for Participants‍

We all know that exercise is supposed to make us feel better. In fact, even mild exercise can increase endorphins or feel good hormones. 

And exercise enthusiasts may know this to be true without needing the science. We’ve all heard of “runner’s high”.

But for some, it may be difficult to see or notice the impact activity has on our mood. And understanding how our mood affects our activity levels adds another layer to consider.

Because day-to-day mood is such an important aspect of our wellbeing, we recently began asking members to keep track of their mood by completing a daily offering asking them how they feel. 

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In the first two weeks we received 743,401 responses from over 131 thousand members!

Overall, the majority of responses indicated that people were feeling good.

• Good: 56.9% (423,268)
• Okay: 37.3% (277,273)
• Bad: 5.8% (42,860)

The “best” days seem to be Saturday (Good = 59.2%) and Sunday (Good = 58.4%), and the “worst” days seem to be Monday (Bad = 6.1%) and Thursday (Bad = 6.14%). 

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In this short time, we noticed a significant connection between those who said they felt “good” and their activity, sleep levels, and resting heart rate. 

More specifically, we took a look at participating members over the first two weeks and examined the relationship between each individual’s self-reported mood and their steps, sleep, and resting heart rate. 

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Members who indicated they had a better mood walked more and slept more, and had a lower resting heart rate. 

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In fact, we observed that "good" days were associated with an increase of nearly 1900 steps when compared to "bad" days

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What does that mean?

Well, it shows that for these members at least, mood and activity levels appear to have some connection. 

It could be that keeping active makes them feel good. Or maybe, feeling good allows them to keep active. 

Curious about how your mood and activity are connected? If you haven’t paired an activity app or wearable to your Evidation app yet, do it today. You’ll earn points for connecting and be eligible to receive more personalized insights.

And stay tuned for more community insights from Evidation!

‍The daily mood survey is a new offer type we’re currently testing and is only available in the app at this time. If you typically log in on the web, be sure to download the app.‍

At Evidation (formerly Achievement) Studies, our primary goal is to put individuals first.

One way we do this is by ensuring the safety, protection, and comfort of the individuals who participate in our studies. 

To make sure we ALWAYS meet this goal, we follow a standard process for outlining important information related to the study and providing that information to potential participants to support knowledgeable, voluntary decision-making. We call that process Informed Consent.

We hope this information helps you better understand the informed consent process and how it fits into health research as a whole.

What is Informed Consent?

Informed consent is both a process and an action.

Researchers use the process of informed consent to give potential participants important information about a study. They do this so an individual understands the purpose of the research, potential risks, benefits, and alternatives available and has the voluntary option to participate based on what is best for them.  

To provide consent, participants sign an Informed Consent Form (ICF). This form guides a person through all the relevant information related to the study and gives them the option to enroll. At Evidation studies, this process is done online through our online platform.

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What information is in an Informed Consent Form? 

It’s important that study participants understand all the important details of a study before providing their consent (in other words, their permission) to participate. To make sure participants have all the information they need, the Informed Consent Form (ICF) includes the following:

• The purpose of the research
• A description of each activity they will need to do and how long each should take to complete
• What data will be collected, who will have access to the data, how the data will be used, and how we will make sure the data stays safe
• Potential risks and benefits of participating in the study
• A statement that participation is voluntary and that participants can withdraw at any time during the study
• If and how they will be compensated for participating in the study (for example, direct deposit, gift card, travel vouchers, products, etc.)

Evidation Studies puts a lot of time and care into developing the Informed Consent Forms for each study. This helps to ensure that we communicate openly, honestly, and clearly with our participants.

Who creates the ICF?

Every study has a team of individuals dedicated to protecting the safety of participants. This team works together to decide what the ICF should include for each study and then submits it to an Institutional Review Board (IRB) for review and approval. An IRB is a group of qualified individuals who work to protect the rights and well-being of research participants. One way they do this is by making sure our ICFs are clear and thorough. 

Why is Informed Consent Important?

Informed consent is important from an ethical point of view, because we need to make sure that everyone who participates in our studies is doing so voluntarily (by choice) and is comfortable with everything the study will involve. 

 Informed consent is also a legal requirement: it has to occur before a participant is enrolled in any clinical research study.  

The guiding principles of the informed consent process are taken from historical documents that focus on respecting the people who participate in research. Documents like the Nuremberg Code and the Belmont Report detail the ethical principles of ‘Respect for Persons’. These principles include:

• Participants have the choice to agree to participate or not (“voluntary consent”).
• Participants have the option to withdraw at any time (that is, they are free to stop at any time).
• People are autonomous and should be treated with respect
• Protected groups like participants who are unable to consent for themselves/require additional protections. (The consent in these cases may be provided by a caregiver or legal guardian.) 

Who do I contact if I have questions about the Evidation Studies informed consent process?

The Evidation Studies Support team is available to answer any and all questions participants may have about a study before signing the informed consent form, as well as any questions that come up throughout their study participation. We have a team of individuals (dedicated to making the experience as easy and comfortable as possible.

Want to know more about any of our Evidation Studies and how to get involved? Reach out to us at study@evidation.com and one of our friendly team members can help you get started. 

If you want additional general information on health research, we recommend checking out the following public resources: 

• U.S. Department of Health & Human Services, Office for Human Research Protections
• FDA, Clinical Trials and Human Subject Protection
• National Institutes of Health (NIH), Educational Resources
• Clinical Research Resource HUB, Resources for Participants

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