Blog

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

According to the CDC, Heart disease, cancer, and COVID-19 are the leading causes of death in men. 

And due to many societal factors, men often pay less attention to their overall health compared to other genders. 

‍According to Harvard Health, men are more likely to not take part in regular checkups. They’re also more likely to smoke tobacco and drink alcohol - increasing the risk for heart disease.

‍But most of the health problems men face are preventable. 

During National Men’s Health Month we look to spread awareness around men's health and encourage men to take care of themselves by getting regular checkups and take care of themselves through exercise, diet, and disease prevention.

So, how can men take control of their health?

‍What can they do? 

‍What actions should they take?

And what are some of the most common health problems men face?

In today’s article, we’ll be answering all these questions. Keep reading to learn more!

Common health problems men face

What are some of the common health problems men face?

How can they prevent these health problems from happening?

Among all cancers, prostate cancer is the most common among men. It’s said to be the second leading cause of death from cancer for men in the United States. 

Although there are steps you can take to prevent it, some aspects that affect health are out of our control. Age, race, and genetics can all increase the chances of getting prostate cancer. 

But making changes in your lifestyle and diet could help prevent it. Some changes you can make to help prevent prostate cancer include: 

• Eating a healthier diet
• Increasing Vitamin D intake
• Quitting smoking and drinking less
• Staying sexually active (with or without a partner)
• Regular exercise and maintaining a healthy weight

Although prostate cancer is common, the leading cause of death in men in the United States is actually heart disease. In 2019 it caused 1 in 4 male deaths in the United States.

‍But there are steps men can take to reduce their risk of heart disease:‍

• Lower stress levels
• Quit smoking and limit alcohol intake
• Maintain a healthy weight and eat a healthy diet
• Get regular checkups and ask about checking for diabetes and high cholesterol

Men face a lot of physical health problems, but one of the most stigmatized issues men face is mental health. And although the conversation has changed drastically, men, like many others, are still suffering from mental health issues. 

‍Approximately 30.6 percent of men suffer from a period of depression in their life, and the suicide rate in American men is four times higher than it is in women.

But there are steps we can all take to care for our mental health. Self-care is one way we can maintain good mental health. We can practice self-care by:

• Practicing gratitude
• Focusing on positivity
• Getting regular exercise
• Setting goals and prioritizing
• Staying connected with people
• Taking part in a relaxing activity
• Getting an adequate amount of sleep 
• Staying hydrated and eating regular healthy meals

But sometimes self-care isn’t enough. Recognizing the signs that you or a loved one is dealing with mental health issues can help someone take the first steps in treatment.

‍Some signs of depression might include:‍

• Irritability
• Decreased energy or fatigue
• Feelings of guilt, worthlessness, or helplessness
• Loss of interest or pleasure in hobbies and activities 
• Thoughts of death or suicide or even suicide attempts 

There are treatments for mental illness, and if you think you or a loved one are suffering make sure to reach out to a health care provider to get the help needed.

‍If you or someone you know is in crisis, you can call the National Suicide Prevention Lifeline at 1-800-273-8255, or text “HELLO” to the Crisis Text Line at 741741.‍

How to participate

We can all participate in National Men's Health Month in one way or another. 

It’s a great time for men to take a look at their health and start changing their habits and routines to create a healthier lifestyle.

‍Men can take charge of their health by:‍

• Exercising regularly - exercising can help people maintain a healthy weight, fight health conditions and diseases like cancer and depression, promote sleep, and even boost energy. 
• Eating a more balanced and healthy diet - eating a more rounded diet may help to maintain a healthy weight, get the nutrients for optimal health, and even improve your heart health.
• Taking care of their mental health - activities like meditating, yoga, or time spent with hobbies and loved ones are all great ways men can practice self-care and relieve any stress, anxiety, and worry they may be feeling.
• Participating in some activities - spend some time hiking, playing soccer, dancing, or painting with some friends, loved ones, or even co-workers. 

We can also encourage the men in our lives to speak about their mental health issues. Creating a safe place for men to express their concerns is a great way for us all to participate in Men’s Health Month. 

Spreading the word about Men’s Health Month is also a great way to participate. It helps educate people on common issues men face, and it opens the door for more conversations to take place in our communities.

You could even participate in a fundraiser or create your own for men's mental health or even prostate cancer. 

Another way we can participate is by dawning the color of blue during Wear Blue Day. Wear Blue Day is a day people wear the color blue to spread awareness around men’s health month, it takes place each year, on the Friday before Father’s Day.

Closing thoughts - National Men’s Health Month

Men’s Health Month is a time to make changes, spread awareness, and open the conversation about topics that are sometimes stigmatized in today's society.  

We can all do our part during this month either directly by helping the people in our lives or ourselves, or even by participating in fundraisers and events that highlight the common health issues men face every day.

Make sure to share this with a friend or family member who could benefit from some of the information we provided so you can do your part to spread awareness around this important month for men's health!

In the United States alone, over 300 million people have a smartphone. For many, that increase in connectivity through technology has led to becoming disconnected from the outdoors.

During National Great Outdoors Month, we look to celebrate and explore our surroundings and discover the many beautiful sights our world has to offer. 

‍What activities can you take part in to embrace the outdoors?

‍Where should you explore? 

‍How should you celebrate? 

Besides spending time outside, how else can we take part in helping our environment and the many communities that thrive outdoors?

In today’s article, we’ll be touching on the many activities and places you can visit to celebrate Great Outdoors Month. Keep reading to discover more!

What physical activities can we take part in?

There’s no shortage of activities to do outdoors.

From rock climbing to canoeing, with such a diverse landscape across the country, there’s bound to be some kind of activity to enjoy.

We know there are many benefits from exercise itself. It can help control weight, improve mood, and reduce the risk of heart diseases. But combining exercise with spending time outdoors could have a profound impact on your well-being.

But physical activity isn’t the only way to reap the benefits of spending time outside. Just being out in nature is good for us. 

In fact, spending time outdoors may actually reduce stress. 

‍While there are many different outdoor activities you can take part in, some ideas include:‍

• Cycling - this is a great cardio workout that puts minimal stress on our joints yet challenges core muscles and legs. 
• Hiking - explore your local area or a national park while improving your cardiovascular health and decreasing stress.
• Paddling - spending time on the water by kayaking or canoeing with others is a great way to enjoy the weather while working your muscles and cardiovascular system, and it may even help improve stability.
• Rock climbing - challenge your abilities and enjoy the natural landscapes by rock climbing.
• Walking - physical activity doesn’t have to be strenuous to be beneficial. Take a walk in your local park, or a stroll through a zoo or nature preserve.
• Garden - gardening is a great way to reap the benefits of being outside and get some mild exercise. 
• Have a picnic or BBQ - eating outside feels good. Have a picnic with friends or family or invite them over for a BBQ and share the benefits of being together and being outside. 

How to celebrate great outdoors month and where to explore

Getting out and active is a great way to celebrate this June, but there are other ways you can  celebrate Great Outdoors Month by contributing and helping the environment and local communities.

Here are a few ideas:

• Plan a trip - whether traveling solo or with friends and family, planning a trip is a great way to celebrate. 
• Spend some time outdoors - You don’t have to go on a big trip to celebrate this month. Go to the local park and throw the ball around or go on a small hiking trip to explore your local area.
• Visit national parks - with a total of 63 national parks in the United States there are lots of landscapes to explore. From the Grand Canyon in Arizona to Yosemite National Park in California, America has plenty of national parks to discover.
• Conserve the outdoors - Help celebrate this month by cleaning up. Participate with local groups hosting events or host your own. You can even go out and clean up the trails, parks, and other local spots in your area.
• Volunteer as a summer camp counselor - spend some time helping others as a counselor at a summer camp. ‍

Conclusion - Great Outdoors Month

Great Outdoors Month is a time to embrace the surrounding landscapes and nature. 

Whether you decide to take a day trip fishing or to explore a national park you’ve never been to, we encourage you to get outdoors and find some time to get active and enjoy all the beautiful landscapes our country has to offer.

Make sure to share this with a friend or family member who you’d like to take with you on a trip or adventure during Great Outdoors Month!

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. 

‍

‍

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%). 

‍

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. 

‍

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

‍

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

‍

‍

‍

‍

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.‍

What Flu Season in the Southern Hemisphere Can Tell Us

Although flu season in the Northern Hemisphere won’t begin until fall, it’s already underway in the Southern Hemisphere.

In fact, seasonal flu activity is spiking earlier this year when compared to the previous five years! In the graph below, see how the spike in cases at the beginning of 2022 is higher than most spikes during peak flu season in previous years.

Summer Travel Tips for Flu Prevention

Planning to go to the southern hemisphere this summer? The CDC shares these tips to protect yourself and others: 

• Keep up to date on flu trends wherever you’re traveling 
• Wash your hands often with soap and water, or use an alcohol-based hand sanitizer
• Cover your mouth when you sneeze or cough
• Get a yearly flu vaccine 
• If you are sick with flu-like symptoms (fever, cough, sore throat, runny or stuffy nose, muscle or body aches, headache, and fatigue), consider staying home

‍

In 2017, health promotion and wellness programs were offered in almost half of all US worksites. And with over 150 million people spending the majority of their waking hours at work, it’s an encouraging number to see.

Professional Wellness Month looks to shed light on the importance of creating a work culture that emphasizes and creates an environment that encourages wellness in the workplace. 

It also looks to stress the importance of a work-life balance for our health.

From financial well-being to our physical well-being, we can participate and celebrate this month in many different ways.

‍So, how can we celebrate Professional Wellness Month in the workplace?

‍What are steps we can take to improve our wellness at work and at home?

‍And, how can we better balance our work and personal lives?

In today’s article we’ll be breaking down the many options you have to celebrate and take part in during Professional Wellness Month.

How to celebrate professional wellness month in the workplace

According to the American Institute of Stress, 

“83% of US workers suffer from work-related stress.”

But there are steps we can take to create an environment that encourages wellness in the workplace.

‍How can we deal with stress?

Employers and employees can take many different approaches to create a culture that emphasizes the importance of wellness in the workplace. Some ideas include:

• Workshops -  Workshops can be a great way to teach new concepts and ideas to employees. From education around different health exercises to certain habits and actions we can take. Workshops can serve as a great way to build a healthier working environment. 
• Resources - having paid sick days, holidays, and health and dental insurance are some of the many ways to develop a healthy work culture that emphasizes the health of its employees.
• Classes - taking part in different classes may also be a powerful way of creating wellness in the workplace. From meditation classes to fitness circuits, there’s really an endless supply of ideas we can tap into.
• Events - having some sort of event can help us connect with our coworkers and better our overall well-being through socialization. In fact, being social helps us deal with loneliness and may even help improve our cognitive skills and memory. We can take part in online games with coworkers or laid-back meetings talking about our weekends. Events can be a great way to connect and unwind with coworkers in the workplace.
• Wellness challenge - creating a wellness challenge for coworkers to take part in not only encourages people to get active, but it’s a great way for people to connect. Exercise increases the release of endorphins (the feel-good chemical), and it’s a great way to maintain a healthy weight. ‍

Work-Life Balance

Professional Wellness Month is about highlighting the importance of wellness in the workplace. But, it’s also about creating a better work-life balance.

It can be hard to separate the two with the convenience of modern technology and remote work. 

‍How can we make it easier?

Some ways we can create a better work-life balance include:

• Unplugging and relaxing - taking a break to spend some time on our hobbies and passions can help us destress and unwind.
• Detach from work - technology allows us to be constantly connected with work and our duties. If you work at home, try to only work in a dedicated workspace. And when you finish work for the day, make a transition into home life by changing your clothes or going for a walk.
• Managing our time - we should give ourselves enough time to take care of our responsibilities at work. Learning to schedule our time accordingly and avoid taking on too much if we know it’s going to interfere with our work-life balance is a critical skill.
• Develop a support system - we can balance our work and personal lives much easier with support. Whether it's coworkers who can cover for us if needed or family members who can help with responsibilities at home. Having a support system is an effective way to find balance.
• Take some time off - completely shutting off from work and taking time to relax and unwind can be a great way to refocus. It also allows us to mentally and physically recharge.‍

Closing Thoughts

Professional Wellness Month is a time for employers and employees to evaluate the focus they put on health and wellness in the workplace and at home. 

Whether you decide to participate in new workshops or classes or you choose to take some time off from work completely. Every June we’re reminded of the importance of taking care of ourselves in every aspect of our lives. At home and at work.

Make sure to share this with a coworker, friend, or family member that may need the reminder! 

Self-reported migraines and severe headaches affect roughly 1 in 6 Americans.

It’s a common theme, and it happens to many of us. Whether we experience them regularly, or from time to time, headaches present a real problem for many people in their day-to-day lives.

During National Migraine and Headache Awareness month we look to educate and spread awareness around this common condition. We also look to encourage people who experience migraines or chronic headaches to seek help and learn about the treatment options available to them.

‍In today’s article we’ll be exploring:‍

• What migraines and headaches are 
• How and why migraines and headaches occur
• Symptoms and signs 
• Treatment options available
• How to participate in National Migraine and Headache Awareness Month

Keep reading to learn more about migraines and chronic headaches and what you can do to get the help you need.

What are migraines and headaches? How do they happen?

So, what are migraines and headaches?‍

And what’s the difference between a headache and a migraine?

We often associate both with that throbbing, painful feeling we experience in various areas of the head, but there’s actually more to it than just that.

To begin with, headaches are actually just one of the symptoms of a migraine. Headaches can range in severity and length. But they’re actually different from migraines altogether, we sometimes experience them as a result of a migraine or separately on their own.

Some of the most common types of headaches include:

• Sinus headaches - clogged sinuses cause this type of headache to occur. When our sinus passages swell up, we experience a sinus headache.
• Cluster headaches - this type of headache tends to happen daily and sometimes many times per day for several months, and in different areas of the head. When blood vessels become dilated in the brain because of the release of serotonin and histamines we experience this type of headache. Changes in altitude, physical exertion, and bright light may bring on this type of headache. 
• Tension headaches - these are the most common form of headaches we experience. Hunger, excess stress, and eye strain frequently cause this form of headache. Tension headaches are sometimes felt for prolonged periods of time.

‍Now, what differentiates a migraine from a headache?

As we mentioned earlier, a headache is just one symptom someone might experience as a result of a migraine. 

‍Migraines involve nerve pathways and chemicals and they're seen as a neurobiological disease. 

‍Hormones and chemical compounds like serotonin and estrogen often play a role in the pain we experience when a migraine occurs. 

With more research and as better technology comes to the forefront, we’re starting to get a better understanding of migraines and why they occur. 

A new theory suggests waves of activity from excitable brain cells may cause the migraine by triggering chemicals like serotonin, causing it to narrow blood vessels.

The theory states we experience a migraine when the levels of serotonin and/or estrogen change. 

So, now that we know the potential science behind why we experience migraines, what causes them?

It varies from person to person, but triggers for migraines might include:

• Allergies - allergies often cause inflammation and irritation throughout the body. This could result in the inflammation of blood vessels, leading to a migraine. 
• Environments - changes in our stress, diet, or the weather can all trigger the onset of a migraine. 
• Genetics and family history - if members of your family suffer from migraines, you're more likely to experience them as well. 
• Gender and hormonal shifts - women are 3 times more likely to experience migraines compared to men. Changes in hormones and menstrual cycles may affect the probability of women suffering from migraines. 

Symptoms and signs

It’s important to understand the symptoms of headaches and migraines and the treatment options available.

Depending on the type of headache you’re experiencing you may deal with different symptoms. With a tension headache, pain is consistent and it feels mild to moderate. It affects both sides of the head (bilateral) and it can worsen while doing certain activities like running or bending over.

‍Cluster headaches are often intense and have a burning or stabbing-like sensation associated with them. They’re either constant or throbbing. Often, the pain occurs in the eye region or behind one eye and it doesn’t change sides.

Symptoms of sinus headaches may include fever, swelling in the face, bad taste in the mouth, and constant deep pain in the forehead and cheekbones. The pain may get worse with sudden head movements.

‍Migraines follow a different trajectory.

There are actually four stages people may experience with a migraine: 

• Prodrome
• Aura
• Attack
• Postdrome 

Not everybody who suffers from migraines goes through all four stages.

A few days prior to a migraine people might experience symptoms during the prodrome phase that could indicate a migraine is coming. This includes:

• Constipation
• Neck stiffness
• Fluid retention
• Food cravings
• Frequent yawning
• Increased urination
• Mood changes from depression to euphoria 

The aura stage may occur before or even during a migraine. It usually consists of visual symptoms of the nervous system that are reversible, but other irritations may occur as well. Some symptoms include:

• Vision loss
• Difficulty speaking
• Pins and needles sensations in an arm or leg
• Weakness or numbness in the face or one side of the body
• Visual phenomena like seeing bright spots or flashes of light

Now, during the actual migraine (the attack phase) people may experience:

• Nausea and vomiting
• Pain that throbs or pulses
• Sensitivity to light, sound, and sometimes smell and touch
• Pain sometimes on one side of the head but more often on both sides

When a migraine is finally over, we enter the postdrome phase. People might feel drained and confused during this time, and sudden movement of the head may cause migraine pain again briefly.

Treatment options

So, now that we know symptoms to look out for, what about treatment options?

‍What can we do to treat the symptoms we experience? 

‍Over-the-counter medications like aspirin, ibuprofen, and acetaminophen may help alleviate the symptoms we experience with mild migraines and headaches. 

But over-the-counter medications may not be enough for someone who experiences more moderate to severe migraines. Some medications treat symptoms and prevent future migraines from happening. Some of these medications include:

• Antidepressants
• Anti-seizure medications
• Blood pressure medications
• Botulinum toxin A (botox) injections

Making lifestyle changes could also help prevent different forms of migraines and headaches from occurring. 

Exercising regularly, getting better sleep, taking part in relaxing activities such as mediation, and even avoiding certain “trigger” foods may help people prevent the onset of migraines and headaches. 

Conclusion - National Migraine and Headache Awareness Month

Migraines and headaches are often brushed off as insignificant. But they can have a tremendous effect on someone's life. 

During Migraine and Headache Awareness Month it’s important to spread awareness around these common disorders.

And with over 37 million people in the United States suffering from migraines it’s important that we not only spread awareness but also educate ourselves on symptoms and the treatment options available.

If you’re looking to participate, make sure to spread the word, educate, or even take part in events in your community that work to acknowledge the struggles people who suffer from migraines and headaches may experience.

And make sure to share this with a friend or family member that you feel could benefit from what we’ve shared today!

‍

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.

‍

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

‍

‍

According to the CDC, arthritis is one of the most widespread conditions in the United States, affecting about 1 in 4 adults. 

In fact, it’s estimated it affects almost 59 million Americans. 

May is Arthritis Awareness Month, which is the perfect time to learn more and help spread the word.

Arthritis affects older adults, younger adults, and even children. In fact, approximately 300,000 children may have some type of arthritis. 

And while it’s a common condition, it can sometimes be misunderstood. 

In today’s article we’ll be sharing:

• What arthritis is and what causes it
• The different types of arthritis 
• Symptoms to look out for
• Different treatment options available

Keep reading to learn more!

What is arthritis? 

So, what is arthritis?

‍Arthritis is a condition that affects the joints. It usually causes degeneration and inflammation, leading to pain and discomfort.

Because of this, it can sometimes be difficult to stay active and move around. Even simple tasks like sitting, walking, or clenching your fists can become difficult and painful. 

And although it’s often thought of and referred to as a single condition, there are actually more than 100 types of arthritis and conditions related to it.

‍But, what are the distinctions between the many different types of arthritis?

Different forms cause different symptoms and each form might merit distinct approaches to treatment.

What causes arthritis?

To understand what causes arthritis we first need to understand how our joints work.

Soft tissues cushion and protect our joints, this prevents our bones from rubbing against one another. Connective tissue called articular cartilage works to help our joints move with ease and without pain or discomfort.

‍But not all our joints function the same way. 

Some of our joints have something called the synovial membrane, which is responsible for lubricating our joints. 

There are also tendons and ligaments. Tendons attach our muscles to our bones, ligaments attach our bones to one another, and both of them work to support certain joints such as our knees.

While there are many types of arthritis, and many ways they can affect our bodies, we’ll focus here on the most common.

The two most common types of arthritis are osteoarthritis and rheumatoid arthritis. Each affects  joints differently:

• Osteoarthritis - causes wear-and-tear damage to cartilage. Cartilage normally allows for slick movement of our joints, functioning as a protective shield on our bones, preventing bone-on-bone contact. Over time, with enough damage, cartilage will deteriorate to the point that our bones are making direct contact and rubbing against each other.
• Rheumatoid Arthritis - causes the body's immune system to attack the lining of the joint capsule (the synovial membrane). The synovial membrane then becomes swollen and inflamed. With time, this condition can destroy bone and cartilage within the joint.

Although osteoarthritis and rheumatoid arthritis are the most common forms of this condition, there is another form of arthritis that specifically affects children: 

• Childhood or juvenile arthritis - The most common form of childhood arthritis is juvenile idiopathic arthritis which is also referred to as juvenile rheumatoid arthritis. This can cause permanent damage to joints making it difficult for children to go about their day-to-day activities and it could lead to disability. 

Symptoms and treatment options

It’s great to know the science around arthritis, but what are the symptoms?

Understanding and being aware of the symptoms of arthritis can help you better understand if you or your loved ones might be dealing with it.

This can help people get the treatment they need in a timely manner. 

Depending on the type of arthritis, symptoms can vary, but there are some common symptoms, including:

• Soreness
• Stiffness
• Redness
• Swelling
• A decreased range of motion 

If you’re concerned you or someone you know may have arthritis - contact a medical specialist, get a professional opinion, and learn about treatment options.

Treatment options vary depending on the type and severity of arthritis. 

Medications and physical therapy are common forms of treatment. And sometimes if initial treatment doesn’t help, a doctor may suggest surgery. But it depends on how severe the arthritis is and what impact it has on your life.

Some common medications prescribed for arthritis management include: 

• Steroids - Corticosteroid medications are often used to slow joint damage and reduce pain and inflammation. They’re sometimes injected directly into the joint or they’re given in the form of a pill. 
• Counterirritants - Creams and ointments that contain capsaicin or menthol are sometimes used to help with pain and inflammation. The idea is to rub the cream or ointment on the affected joints to help interfere with pain signals.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) -  These medications are used to reduce inflammation and relieve pain. Some common forms include ibuprofen and naproxen sodium. There are even anti-inflammatory topical medications now available.
• Disease-modifying antirheumatic drugs (DMARDs) - these drugs are used to slow the progression of rheumatoid arthritis, in an attempt to protect the joints and other tissues from permanent damage.

‍Physical therapy and exercise can also help. 

Exercising can help strengthen muscles and improve overall range of motion. And physical therapy could help improve mobility and increase strength to support our joints.

For some though, medication and physical therapy may not be enough. In such cases, doctors may suggest surgery, depending on how serious the condition is.

Some forms of surgery include: 

• Joint fusion - this is a more common procedure for smaller joints. It involves the removal of the ends of two bones in the joint. The ends are then locked together until they heal into a single fixed unit.
• Joint repair  - performed through small incisions made over the joints, this surgery involves smoothing out the surfaces of joints to improve function and reduce pain.
• Joint replacement -  the damaged joint is removed completely and then replaced with a manufactured one. ‍

Conclusion - Arthritis awareness month

Arthritis is a common condition that affects many Americans. Although it’s most common in older adults, it can be present in children and young adults as well.

With the variety of different forms out there, it’s important to be aware of the symptoms of arthritis. In doing so, you can help catch this condition before it gets too serious.

There are many treatment options available that can help with the pain, discomfort, and inflammation that arthritis causes.

Be sure to share this article with a friend or family member who you think could really benefit from learning more about arthritis.

‍

‍