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Several of my friends hate flossing their teeth. They go months without flossing, which I think is pretty gross. But then an odd thing happens. About a week before their dental appointment, these same friends will start flossing. By the time they reach their appointment, they have unusually clean gums (though dentists can see through this fairly well, I’m told). On a different tone, some family members have a condition called White Coat Syndrome. When they go to the doctor’s office, their nervousness causes a spike in blood pressure or heart rate, giving deceptively high readings. What’s going on? Can psychological effects like these be used to our advantage?


The Hawthorne Effect is a term used to describe a very beneficial effect seen in clinical trials. This is named after a productivity study in Hawthorne Works, a Western Electric factory in the 1920s and 30s. The study was attempting to discover a link between the amount of light and productivity of workers. When increasing the amount of light, productivity increased. Strangely, when lowering the amount of light, productivity also increased! Researchers attributed the increase in productivity to the workers simply being observed. In research, we tend to see increased positive results for patients simply because we are observing them in a study.


Hawthorne Works


Let’s analyze a 2014 sleep study. Researchers measured 195 patients’ amount and quality of sleep at night. 81 days later, before any medical intervention, researchers measured the patients again. They found that patients slept an average of 30 minutes longer per night and had an increased quality of sleep. This was before any medication or intervention! The change was attributed to the Hawthorne Effect.

Patients at ENCORE Research Group comment on the excellent quality of care they receive during clinical trials. Instead of seeing a doctor for a few minutes once a year, patients see doctors and medical staff for much longer and are encouraged or required to call and report changes in health. Quality of care is increased and makes for a pleasant and healthful patient experience. Patients in clinical trials may also experience more observation time from medical professionals due to the attention to detail that clinical trials require for data integrity in studies.

Finally, patients are found to have better adherence to medication requirements while undergoing clinical trials. The increased emphasis on accuracy and adherence results in better patient outcomes, even when they are part of a placebo or standard-of-care group.

In clinical trials, we see these benefits and must account for them. Randomization of patients helps spread the effect. Everyone sees increased baseline results on average; we are interested to find out if those receiving investigational treatment do even better. Join a clinical trial today and experience the Hawthorne Effect for yourself… and floss your teeth!

Written by Benton Lowey-Ball, BS Behavioral Neuroscience



Sources:

Benedetti, F., Carlino, E., & Piedimonte, A. (2016). Increasing uncertainty in CNS clinical trials: the role of placebo, nocebo, and Hawthorne effects. Lancet Neurol, 15, 736-47. http://dx.doi.org/10.1016/S1474-4422(16)00066-1

Cizza, G., Piaggi, P., Rother, K. I., Csako, G., & Sleep Extension Study Group. (2014). Hawthorne effect with transient behavioral and biochemical changes in a randomized controlled sleep extension trial of chronically short-sleeping obese adults: implications for the design and interpretation of clinical studies. PLoS One, 9(8), e104176. https://doi.org/10.1371/journal.pone.0104176

ENCORE Research Group. (2020, October 14). Hawthorne effect.[Video]. Youtube. https://www.youtube.com/watch?v=1DH7jwqFlyw

Mayo, E. (1993). The human problems of an industrial civilization. The Macmillan Company. 

McCarney, R., Warner, J., Iliffe, S., Van Haselen, R., Griffin, M., & Fisher, P. (2007). The Hawthorne Effect: a randomised, controlled trial. BMC medical research methodology, 7(1), 1-8. https://doi.org/10.1186/1471-2288-7-30




In this episode, Dr. Michael Koren and Michelle McCormick wrap up their discussion on how clinical trials find the truth as well as truth vs. faith and the conclusion of lady tasting tea. Could she actually tell whether the milk or tea was put in first?

Dr. Michael Koren is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.


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In this episode, Dr. Michael Koren and Michelle McCormick walk through the history of Clinical Trials. From Biblical stories of Daniel through the smallpox pandemic to our present COVID pandemic. How far have we come and where do we go from here?

Some of what you will learn:

  • History of Clinical Research
    • Daniel and King Nebuchadnezzar
    • Newgate Prison
    • Cotton Mather & Onesimus
  • Current Vaccine Trials
    • Chickenpox
    • Shingles
    • Covid
    • Flu
    • RSV
  • Future of COVID

Dr. Michael Koren is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.


Prefer to listen to the podcast without video? You can do that below!





In this second episode, Dr. Michael Koren, New York Central High School alumni, and Michelle McCormick take us back to high school minus having that awkward conversation about asking your date to prom.  Listen to find out what your high school classes have to do with clinical trials.

Some of what you will learn:

  • What makes a good hypothesis
  • Statistical concepts
  • Statistical methods involved in carrying out a study
  • The vocabulary of clinical research
  • History of clinical research
    • Newgate Prison
    • Daniel and King Nebuchadnezzar
    • Pepsi vs. Coke

Dr. Michael Koren is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.


Prefer to listen to the podcast without video? You can do that below!





In a four-part series on What are Clinical Trials & Why are they important, in this first episode Dr. Michael Koren and Michelle McCormick talk about The Science of Clinical Trials, What makes a good Clinical Trial, good?

What do these things have in common?

  • R.A. Fisher
  • Lady Tasting Tea
  • Truth vs Faith
  • Experiments
  • Clinical Trials

Dr. Michael Koren, is a practicing cardiologist and CEO at ENCORE Research Group. He has been the principal investigator of 2000+ clinical trials while being published in the most prestigious medical journals. Dr. Koren received his medical degree cum laude at Harvard Medical School and completed his residency in internal medicine with a fellowship in cardiology at New York Hospital / Memorial Sloan-Kettering Cancer Center/ Cornell Medical Center.


Prefer to listen to the podcast without video? You can do that below!



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Alzheimer’s Disease is devastating. An estimated 6.2 million Americans age 65 and older are living with Alzheimer’s dementia in 2021. Alzheimer’s is a brain disease that causes a slow memory decline. It can also affect your thinking, problem-solving, and reasoning skills. There are ten signs that you or a loved one may be experiencing early stages of Alzheimer’s Disease. If any of these signs persist, you should schedule an appointment with your doctor and come in for a free memory screening at Jacksonville Center for Clinical Research (JCCR).

1.Memory Loss that Disrupts Daily Life 

A critical factor in spotting Alzheimer’s Disease’s early stages is noticing the memory loss of recently learned information. The memory loss examples include forgetting dates and events and asking the same questions multiple times. 

2. Difficulty Completing Normal, Daily Tasks

It can be difficult for a person in the early stages of Alzheimer’s to complete daily tasks. For example, they may find it difficult to find familiar locations or do simple things such as making a grocery list or remembering the rules to a favorite game.

3. Trouble with Planning or Problem Solving 

It can sometimes become difficult for those with Alzheimer’s to work with numbers. Tasks such as paying bills may get swept under the rug or have excessive errors. They also have difficulty planning things as simple as everyday errands.

4. Confused about the Current Time or Place

Alzheimer’s Disease can cause confusion and result in anxiety or panic. Frequently, they can forget where they are or how they got there. 

5. Trouble with Vision and Depth Perception 

Alzheimer’s Disease and vision issues can go hand-in-hand. For example, they may show difficulty reading, balancing, or distinguishing the depth and color of objects. 

6. Difficulty Pronouncing Words or Writing 

It can be difficult for someone with Alzheimer’s to join a conversation. They may stumble on their words. They may have trouble remembering names and often repeat themselves. 

7. Losing Important Items Often

Everyone loses their keys, remote, or wallet every once in a while. However, someone suffering from the early stages of Alzheimer’s may often lose these things or put them in strange places. For example, they are putting their keys in the fridge. 

8. Poor Judgement

Someone who has Alzheimer’s Disease may have poor judgment. Examples of this can be poor hygiene, trouble dealing with money, or acting irrationally.

9. Becoming Socially Distant

It can become difficult for people with Alzheimer’s to work or interact socially. You may notice them pulling away from normal social activities. They may start to have trouble keeping up with their favorite activity. 

10. Mood Swings 

Suffering from Alzheimer’s Disease can be extremely frustrating. It is common to experience sudden mood changes and sometimes act irrationally. They can quickly become confused, suspicious, depressed, or even fearful.

It is important to remember that we can have a natural decline in cognitive ability as we age. However, when that decline disrupts daily life, it is time to see a doctor for a memory screening. 

Thankfully, there have been many breakthroughs in memory research, although there is still no cure for Alzheimer’s. Clinical trial studies are the only way to continue to learn about this disease in hopes of and finding a cure. If you or a loved one is currently experiencing any of these early symptoms of Alzheimer’s Disease, we encourage you to get a memory screening. ENCORE Research Group offers free memory screenings at our Jacksonville Center for Clinical Research location and has several studies enrolling for Alzheimer’s Disease.

For more information, visit encoredocs.com or call 904-730-0166.


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November 17, 2021 BlogClinical Trials

The Hawthorne Effect is an interesting phenomenon where people alter their behavior due to the awareness of being observed. This effect was first discovered in the 1950s outside of Chicago. The experiment was done on factory workers, and it found that workers had a positive response to the extra attention given by managers who cared about them.

This same phenomenon has been noticed in clinical trials as well. “When you’re doing a clinical trial, and you’re involved with something that is being observed, your patients tend to do better regardless of how they are being medically treated.” Dr. Michael Koren, CEO of ENCORE Research Group, says. For example, if a patient is in a clinical trial for weight management, they may be more likely to lose weight if they must keep a log of everything they eat and present it to their study coordinator. 

So what does that mean for you? It means that you have the chance to improve your health just by participating in a clinical trial, even if you happen to be on a placebo. Studies have shown that patients in clinical studies are more adamant and knowledgeable about their health in the first place. It is safe to say your health will likely improve no matter what study you participate in! To see what studies are available right now, visit our enrolling studies page!


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We asked, “What motivates you to participate in clinical trials?” With over 160 responses, the answer is clear. People who participate in clinical trials are dedicated to helping others by improving medicine for future generations.

We also found that very few were participating in order to receive the stipend for time and travel. This says a lot about the type of people who are willing to participate in clinical trials. They are in it for the cutting edge treatment, and the need to help others.

There is truly only one way to improve healthcare, and that is to participate in clinical trials. Thank you to everyone who responded to our survey, and everyone who participates in these trials.


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On a sailing ship in 1747, twelve sailors who had begun the voyage feeling fine were overcome with fatigue.  Their gums were swollen and sore, making it difficult to eat.  Their teeth were falling out.  Their legs were swollen and purple from bruising.

 

Dr. James Lind was a passenger on that ship, and he set out to find the cause.  He set up what may have been the first clinical nutrition experiment.  He decided on six groups of treatments, 2 sailors in each group:

 

  1. drank one quart of cider a day
  2. gargled with sulfuric acid
  3. had two spoonfuls of vinegar, 3 times a day
  4. drank ½ pint seawater a day
  5. drank barley water
  6. ate two oranges and 1 lemon a day

 

Within six days, the sailors who ate the oranges and lemon felt better and were able to work again.  The other sailors in the experiment felt worse.  The ill sailors were suffering from a lack of vitamin C, now known as Scurvy. They had plenty of fresh fruits and vegetables when they first set out on the voyage.  But fresh foods ran out on the long voyage, and they suffered symptoms from this lack. After this finding, sailors often brought lime juice aboard ship because it could be stored longer. This is how sailors earned the nickname “limey”.

 

1747 was well before the requirement of informed consent of the patient, detailed eligibility criteria, protocols and regulations, which are a foundation of today’s clinical research.  Nevertheless, it is an interesting example of a method of discovering the best treatment for a disabling condition.

 

Scientific minds are still seeking solutions for medical problems.  Modern clinical research is strictly regulated for the safety and well-being of the research volunteer.  Great progress has been made in medical science over the last decades.  This progress could not happen without dedicated volunteers. Participation in clinical trials can be a rewarding endeavor for both investigators and volunteers alike.

 

Written by: Julia Baker, RN, CCRC

Resources:
https://askabiologist.asu.edu
https://www.umass.edu/nibble/infofile/limey.html

 

 

 


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Why do our volunteers want to participate in clinical trials?  Volunteers are often motivated by a combination of several reasons. Here are 6 of the top reasons to participate.

  1. The potential of finding relief from their symptoms

We can’t promise relief from symptoms due to placebo and efficacy of the medication being tested.  However, the Hawthorne Effect proves that patients who participate in a research trial have better outcomes than those not participating.

  1. To learn more about their condition

You might argue that to learn about a condition you can just look it up on the web, and we all do that.  However, often these websites can be misleading or provide the worst-case scenario results, which don’t apply to most of us. Another option is to ask your primary physician, and that is a good thing to do.  Unfortunately, physicians are often rushed or running behind and questions are forgotten.  Participating in a clinical trial provides you ample one on one time with a research professional and physician so that all your questions can be answered.

  1. Access to new cutting-edge treatments

When participating in a clinical trial, there is access to new cutting edge treatments that are not available yet to the public. There can even be access to medications that have been newly FDA approved, but are much too expensive to afford.  Study required medications are most often provided at no cost!

  1. Receiving medical care at no cost

Sponsors such as pharmaceutical companies, governments and foundations fund medical research through study grants. The grants fund local research sites for conducting the study so you don’t pay a thing.  In fact, we don’t even ask you for your insurance information!  Can you believe most studies compensate patients for time and travel?

  1. Making a difference

Clinical Trials help shape the future of medicine and healthcare.   Volunteer participation helps researchers discover more about health conditions and find better ways to treat them!

  1. Moral and emotional support

Having medical conditions that others don’t necessarily understand can make some people feel alienated.  When involved in research, support staff understand the patient’s condition and what they may be experiencing and can provide moral and emotional support.

We will do everything we can to help find a trial that is a good fit for interested volunteers.  New clinical trials are constantly enrolling so do not be discouraged if we don’t currently have the perfect trial for you.  The majority of volunteers who completed a clinical trial are interested in participating in another one, so call us and find out your reason to participate!

 


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At ENCORE Research Group it is our mission to help every patient that walks through our doors qualify for the clinical trial of their choice. Often times we get to experience the thrill of telling our patients that they successfully qualified and will soon enroll in the study. However, this is not always the case and we understand our patients’ frustration when they decide to commit to a trial only to later find out that they do not qualify. Here at ENCORE Research Group we were curious how this situation affected their thoughts about applying for future studies. This month, curiosity got the best of us and we reached out to some of our community members to find out!

Thomas recently came to Jacksonville Center for Clinical Research (JCCR) to have an evaluation for a high triglyceride and weight loss study.  Fortunately for Thomas, he was not eligible for the trial because his triglyceride level was too low.  Thomas stated “it’s good that I am healthy enough not to be in this research study.  But they are looking at another study that I may be interested in.” As you can see, Thomas was not discouraged that he did not qualify, but optimistic that he may qualify for a different study.

We also reached out to Latasha, who is new to research, and may qualify for a study that has a waiting list for interested participants.  When discussing with her how some patients are not eligible to join a trial, she stated “I would want to know why I did not qualify, but that would not prevent me from trying to get in another trial.” Fortunately for Latasha and all of our participants, ENCORE Research Group is very transparent about the screening process and explains exactly why they may have been ineligible. Hopefully she will receive a spot in the study she applied for!

Mark was passionate about participating in a Sjogren’s research trial but did not qualify.  He said “it’s not unusual for someone with Sjogren’s Disease not to qualify for studies with systemic therapies if they do not have the antibodies. But when you’re sick, your driving force is to get better for yourself and your family.  I tried the conventional way but it did not work for me.”  After doing more research on the specific clinical trial, Mark decided to pursue the FDA Expanded Access program. “It’s a relatively new program to help people get access to new medications.” Fortunately for Mark, he had the resources and insight to look into alternative treatment options.

We also asked an experienced researcher how she saw things. Linda Gray, site manager of the Nature Coast Clinical Research site in Inverness, Florida, has many gastrointestinal (GI) studies currently enrolling.  Linda acknowledges that “some of our patients are not eligible for a study because they have mild disease, and the sponsors are looking for moderate to severe disease.  If the disease is not measurable enough for objective data, we will not be able to tell if we’ve reversed it or slowed the progression.  Our NASH studies include a liver biopsy to determine the extent of the disease to see if the patient is eligible.” It is unfortunate that this can limit access to drugs for those in need, but we have to believe that obtaining clear and objective data will help a greater number of people in the future.

The reality is, every clinical trial is different and has unique qualifying criteria. The pharmaceutical companies that sponsor clinical trials create the criteria in order to make the strongest case possible to the FDA on the drug’s safety and efficacy. While we would love to involve every one of our community members that are interested, it is just not always possible. The good news is that all seven of our research sites are always getting new clinical trials to enroll in! So, just because you didn’t qualify the first time doesn’t mean you won’t qualify for the next one! We look forward to working with you in the ENCORE community.

 

 


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The practice of medicine has changed in major ways in recent years. Though many of these changes reflect good intentions, the real world consequences to patients often don’t match expectations. To understand this divide between reasonable intentions and the less salubrious reality from which we may collectively suffer, I’d like to share a recent anecdote that occurred at the airport when regulations ran amok.

During recent travel, I witnessed an unfortunate incident that you may have seen before. An airline gate agent stopped a member of our party and reprimanded her for carrying a small overnight suitcase, a computer bag and her pocketbook. The gate agent, working on behalf of the airline, stated that she had to follow FAA (Federal Aviation Authority) rules and only allow two bags on board even though the computer bag and pocket book were small. Unfortunately, when asked to “consolidate” the three bags into two, we had a problem. No bag really fit into any of the other bags. The agent wouldn’t “gate check” any of the bags so that we could pick it up when exiting the plane and running off to our next flight. Further, our discussion with the gate agent failed to alleviate our concern that, if checked to its “final destination,” we wouldn’t see a checked piece of luggage any time soon given the shortness of time for our connection.

The solution that followed satisfied no one. Over the next 10 minutes, embarking passengers stepped around the contents of the three bags which littered the entrance to the Jetway. At first, the gate agents ignored the situation, but as tempers flared due to the obstruction of foot traffic, an agent “helped” by aggressively stuffing the computer bag into the overnight bag. A busted zipper later, the bulging overnight bag limped down the Jetway led by a very unhappy customer.

Does this scenario prove airline excellence because the agents showed how well they can comply with government rules? Hardly! Most folks would conclude that this messy scenario wasn’t necessary. In complex situations, the empowerment of professionals to act judiciously given a set of circumstances leads to excellence. The above scenario required the gate agents to apply context while making an overall effort to comply with government regulations. Unfortunately an excellent result didn’t happen in this case.

Similarly, we face the issue of context and judicious interpretation every day in medicine. As a common example, computerized medical records, a well-intended effort to characterize complex information, often fail to convey the true story of a patient or the nuances that make each of us unique. Summarized, bullet point information can easily miss the point. The great composer Mozart famously observed that musical excellence doesn’t lie in the notes but actually in the space and timing in between the sounds. Medical excellence involves a similar concept. Health care providers must read “in between the lines” and understand and respond both to what is and isn’t stated.

What this concept means to the average patient depends on the circumstances. For example, some people with neck pain may need consideration for a heart condition (angina) whereas others should check in immediately for an MRI of the spine and others should book a massage. Distinguishing the underlying cause of the neck pain relies on both a description of the nature of the symptom and on understanding the quiescent pauses of relief between episodes of pain. Excellent clinicians make this distinction by asking the right questions. Excellence during the medical evaluations of headaches, arthritis, and memory problems, among other things, also require this same commitment to careful questioning.

Clinical research promotes excellence by demanding great attention to detail.  During research programs, physician investigators and their staff members must extensively analyze many aspects of our patients’ health.  This thorough analysis usually exceeds that which occurs at the time of general physician visits, a setting during which time pressed clinicians must limit their focus and move on to the next patient. Research also requires the deployment of state of the art technology. The combination of technology and attention to detail of symptoms, signs and lab values leads to an experience which most patients highly value and describe as a demonstration of medical excellence.

In sum, medical excellence involves more than compliance or automatically matching a disease with a drug. Medical excellence is a philosophy of understanding the needs of a patient and putting those needs in context through the development of an individual treatment plan. Clinical research promotes medical excellence by demanding a culture of detail and caring.


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As a proven clinical research organization, we take every precaution to assure the safety of and maximize the value for our research volunteers. Qualified doctors, nurses and study coordinators on staff provide support and care throughout the research trial. Participation is always voluntary. We appreciate the time and effort that research volunteers bring to this important process.

Copyright 2021 ENCORE Research Group