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Corvallis Clinic Health Information Blog

Informed Consent - My favorite thing!

Jun 27, 10:30 AM

Clinical Research Center

By Julie Carrico, MBA, CCRC

I’ve been  thinking about that amusing anecdote on social media about a typical day in a dog’s life, where for every event the dog proclaims,  “My favorite thing!” For example: 

  • 8:00 a.m. - Dog food! My favorite thing!
  • 9:30 a.m. - A car ride! My favorite thing! And so on, until the day’s final entry:
  • 11 p.m. - Sleeping on the bed! My favorite thing!

This blog is about Informed Consent, which is – you guessed it – my favorite thing! 

One of the first things potential clinical study participants encounter is a document called the Informed Consent.  The following is the official definition of Informed Consent, according to the guideline from the International Conference on Harmonisation, a worldwide advising body for drug research:

A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.

The importance of careful patient review of the Informed Consent document cannot be overstated.  These documents are written in patient-friendly terms so the language is simple and relatively free of medical jargon.  The documents spell out exactly what will happen in the clinical study so there should never be any surprises.  Our site does not allow patients to sign the initial Informed Consent without having a sit-down meeting to discuss it.  If patients are so inclined, we encourage them to share the Informed Consent document with family or trusted friends prior to our sit-down discussion.

And now for my favorite thing!  I love it when patients bring their copy of the Informed Consent to our sit-down meeting and it is a bit battered, has notes scribbled in the margins and maybe a post-it note or two sticking out.  Why is this my favorite thing?  Because it tells me the patient has thoroughly read the Informed Consent, and I know we will have a meaningful discussion about the study, its risks and benefits, and patient responsibilities.  In other words, the patient will make an informed decision about whether or not to participate.  My favorite thing!

The Clinical Research Center is currently seeking volunteer patients in studies for Alzheimer’s disease, Type 2 diabetes, and those with very high triglyceride levels.  Who knows? Being involved in a research study might turn out to be your favorite thing!

If you are interested in learning more about clinical trials, contact the Clinical Research Center at 541-766-2163, or send an email to research@corvallisclinic.com or fill out our Research Study Information Requestform. And, don’t forget to follow us on Facebook at https://www.facebook.com/corvallisclinicresearch.

 - Julie Carrico is Associate Coordinator of The Corvallis Clinical Research Center 

 

Don't wait to check out memory concerns

Jun 10, 08:35 AM

Clinical Research Center

By Julie Carrico, MBA, CCRC

I recently had a conversation with a friend “Jane” who told me she is worried about her mother’s memory issues.  Jane shared these concerns with me because she knows of my work at the Clinical Research Center with Alzheimer’s disease projects and she isn’t sure where to turn.  In fact, Jane said she wasn’t sure she would even want to know if her mother had Alzheimer’s disease.  In this blog we’ll discuss why symptoms of cognitive impairment, such as memory loss, mustn’t be ignored, and why it should be evaluated by medical professionals.

First of all, there are lots of reasons for cognitive impairment, so no one should assume Alzheimer’s disease is the cause. For example, over or under treatment of underlying medical conditions can cause cognitive impairment and that’s why it’s important to start with an evaluation by the patient’s primary care physician.  

In this case, I was concerned because Jane’s mother has Type 2 diabetes and the research is pretty clear on the link between poor blood sugar control and cognitive impairment.  In addition, I knew that Jane’s mother had recently suffered a broken leg from which her recovery was complicated and protracted.  Research has shown a link between stress hormones and blood sugar control, furthering my thoughts that Jane’s mother needed a full evaluation by her physician – one that would undoubtedly include an assessment of the patient’s blood sugar control.  

I encouraged Jane to speak with her mother about the memory issues and perhaps offer to attend the next doctor appointment with her mother so they can discuss it together.  If appropriate, the physician will refer Jane’s mother to a neurologist who can conduct a thorough assessment.

I can sympathize with the position of many people who profess they would rather not be informed of an unfavorable diagnosis such as Alzheimer’s disease.  Now let me tell you why I believe it is better to know.  There are interventions available now that may change the course of the disease.  For example, numerous studies show that a healthy diet, exercise, proper sleep and mental stimulation can be helpful.  And, while there are some medications currently available to boost memory, other treatments that aim to slow and/or halt disease progression are now being tested in large scale clinical trials.

In this case, ignorance is not bliss!  If you or a loved one are experiencing concerning changes in memory, etc., talk with your doctor – you might be able to make adjustments and/or lifestyle changes that will protect your brain health.

The Clinical Research Center is currently seeking volunteer patients in studies for Alzheimer’s disease, Type 2 diabetes, those with very high triglyceride levels, and COPD.  

If you are interested in learning more about clinical trials, contact the Clinical Research Center at 541-766-2163, or send an email to research@corvallisclinic.com or fill out our Research Study Information Request form. And, don’t forget to follow us on Facebook at https://www.facebook.com/corvallisclinicresearch.

 

- Julie Carrico is Associate Coordinator of The Corvallis Clinical Research Center 


The breakdown on adult acne breakouts

Jun 08, 10:53 AM

Kyle M. Van De Graaff, M.D.
Kyle M. Van De Graaff, M.D.

To find out about Dr. Van De Graaff, go to his web page.

By Kyle Van De Graaff, M.D.

You would think that being an adult comes with a clear complexion. However, teenagers aren’t the only ones to experience acne breakouts. Adults get acne, too. Nearly all adults get an occasional blackhead or pimple.  Read further for my breakdown on breakouts.

Why do we get acne?

Despite what your mother may have told you, eating the wrong foods does not trigger acne. In general, acne worsens in response to high stress levels. But there are other triggers.

Blackheads and whiteheads often form when the residue of hair care products finds its way onto the face. Friction on the face can cause acne, such as wearing a chinstrap or a mask.

Hormonal acne is very common, occurring in about 25 percent of adult women. It shows up as tender bumps beneath the skin that take a long time to resolve and hardly ever rise to the skin surface. These lesions usually occur on the lower face or upper neck near the jaw line. They don’t often scar, provided you don’t pick at them. However, they do leave a dark discoloration that can take months to fade.

Hormonal acne can have a sudden onset after discontinuing birth control pills, which normally suppress hormonal acne.

How can breakouts be prevented?

Prevention is the name of the game with acne. Despite what television commercials would have you believe, there is no helping a pimple once it has appeared. All acne treatments are preventive measures.

Over-the-counter acne products are based on salicylic acid or benzoyl peroxide. They come as washes that are rinsed off and as creams that are left in contact with the skin. In general, creams are more effective than washes because they have longer contact time with the skin. This comes at the expense of increased dryness. Salicylic acid tends to be the best non-prescription choice for preventing plugs, while benzoyl peroxide is best for preventing the inflamed pimples. 

What causes acne on the body?

Oily parts of the body including the face, neck, scalp, chest, back, and shoulders are all prone to acne. Acne begins when excess oil mixes with dead skin cells to form a plug at the entrance of the oil gland.

For women, body acne is not common. So if you are a woman and get acne on the body, consider the possibility that it might be something else entirely.

When should adults see their doctor or specialist for acne and what medical treatment is available?

If over-the-counter products haven’t produced the desired effect after 3–4 months, it’s time to see a doctor. Treating acne is a slow process, usually 6–8 weeks before progress is visible.

For women, hormonal acne responds best to estrogen-containing contraceptives, such as birth control pills, and to a drug called spironolactone.

There are very good prescription medications for acne, and most cases of acne can be controlled with today’s treatments.

Dr. Van De Graaff is a dermatologist at The Corvallis Clinic. To schedule an appointment, call 541-754-1252 or contact Find-a-Physician. 


Here's how we keep patients safe during clinical trials

Jun 01, 12:44 PM

Clinical Research Center

When the idea of participating in a research study is first proposed to patients, they naturally have questions about safety. This blog will discuss ways in which clinical studies are designed to make participation as safe as possible.

First, study protocols must undergo a formal review process and receive approval from an independent Investigational Review Board (IRB) before clinical trials can begin.  IRBs are charged with conducting an evaluation to determine if the study protocol has appropriate patient safety and fairness designed in.  It is illegal for the clinical study to commence without this approval.

A second safeguard is that before study volunteers can begin a clinical trial treatment, they must undergo tests designed to help the study doctor assess the following:

  • If the patient is eligible
  • If it would be safe for the patient to participate.

Examples of this type of “eligibility/safety” testing include blood pressure readings, blood work to assess such things as liver and kidney health, EKGs, chest xrays or MRIs.  If the patient does get enrolled, some of this safety testing is repeated at specified intervals. The study doctor will evaluate the test results to determine if the patient can continue in the study.

Once a patient is receiving study treatment, additional safeguards are in place.  Data collected at each visit must be entered into a global database within 48 hours (note: patient-identifying information is not entered).  Even though our site may only enroll a small number of patients, data are being entered for hundreds of patients at hundreds of other clinical study sites.  Analysts evaluate the combined data in real time to look for trends, especially those that might indicate a safety issue.  Any concerning safety data must be reported immediately to the IRB, who will determine if the study can continue.

Some studies take patient safety further and will appoint an Independent Data Monitoring Committee (IDMC) who is charged with ongoing data analysis and who must produce periodic reports on patient safety at specified intervals.  For example, our site is currently participating in a study for a potential new medication for those with mild Alzheimer’s disease, called the Amaranth Study.  When the Amaranth study started, a relatively small number of people (about 250) had taken the drug.    In order to assess ongoing safety of participants in the Amaranth study, the IDMC must produce reports on patient safety at three defined intervals during the study. 

Patient safety is of paramount concern in clinical trial design, but patient volunteers must be well informed of the risks and benefits to participation.  

The Clinical Research Center is currently seeking volunteer patients in studies for Alzheimer’s disease, Type 2 diabetes, those with very high triglyceride levels, and COPD.  

If you are interested in learning more about clinical trials, contact the Clinical Research Center at 541-766-2163, or send an email to research@corvallisclinic.com or fill out our Research Study Information Requestform. And, don’t forget to follow us on Facebook at https://www.facebook.com/corvallisclinicresearch.

- Julie Carrico is Associate Coordinator of The Corvallis Clinical Research Center


Vitamin D: To get adequate amounts, you needn’t follow the sun

May 31, 03:01 PM


Brad Yentzer, M.D.

Get to know dermatologist Brad Yentzer by going to his web page or by viewing his video

By Dr. Brad Yentzer, M.D.

In the past few years, one of the most talked about or written about health-related topic is vitamin D. This fat-soluble vitamin is essential for health, but it is also crucial that we get it from safe sources. Why is vitamin D so essential to one’s health? People need vitamin D to absorb calcium and phosphorus, two minerals that are necessary for healthy bones. Vitamin D not only plays a crucial role in building and maintaining strong bones, it also aids in multiple other metabolic processes in the body.

Some studies have suggested that vitamin D can help prevent and treat certain types of cancers (including skin cancer) along with various neurologic, infectious, autoimmune and cardiovascular diseases.

However, scientists from The Institute of Medicine reviewed more than 1,000 studies on the possible link between vitamin D and other health benefits. Based on this review and expert testimony, it concluded that the evidence for associating vitamin D levels with bone health was strong, but the evidence for other conditions was insufficient to form nutritional requirements.

Don’t rely on sun exposure

Most people have heard that the body makes vitamin D when the skin is directly exposed to sunshine. However, this is not the end of the story. There is also ample evidence of the following:

1) People can have low levels of vitamin D despite adequate sunshine exposure

2) Sunscreens and sun protective measures do not significantly influence one’s vitamin D status

3) Chronic exposure to light increases your risk for skin cancer, including melanoma. So while ultraviolet rays may induce vitamin D production in most individuals, it is inappropriate to discourage the use of sunscreen and sun protective behavior. I advise all of my patients to wear sun protective clothing and use a broad spectrum sunscreen with a sun protection factor (SPV) of at least 50 or higher.

Where to get it?

Vitamin D from food and dietary supplements offers the same benefits — without the danger of skin cancer — as vitamin D obtained from UV light. Vitamin D cannot be used by the body until it is processed by the liver and the kidneys. The usable form of vitamin D created by this process is the same, regardless of how it enters the body. Good sources of vitamin D include fortified milk, cheeses and yogurt, fortified cereal, and oily fish such as salmon and tuna.

Adequate Levels and Supplements

Contact your medical-care provider if you have concerns about your levels of vitamin D. Usually this is determined by taking the 25-hydroxy vitamin D blood test. The normal range is 30.0 to 74.0 nanograms per milliliter (ng/mL).

If it is lower than normal, your provider might suggest taking vitamin D supplements. The recommend allowance by the Insitute of Medicine, Food and Nutrition is 400 IU (international units) for infants and children up to 1 year, 600 IU for children and adults age 1-70, and 800 IU for adults 71 and over. It’s clear that achieving and maintaining an adequate level of vitamin D is vital to one’s health. Just make sure you accomplish this in a responsible manner.

Brad Yentzer, M.D., is a dermatologist at The Corvallis Clinic. He sees patients in Corvallis, Albany and Newport. To schedule an appointment, call 541-754-1252 or contact Find-a-Physician.