Drug Trials - The results are not always what they seem
A new drug was being studied by its manufacturer. This study included 12,000 patients and was stopped before the end. The new drug, evacetrapib showed no benefit, yet it did what it was designed to do and looked to be a hopeful alternative to drugs currently on the market that some patients were not tolerating well. I am sharing this story about a new cholesterol lowering drug to make a point about effectiveness, NOT about the drug itself. The tested drug reduced bad cholesterol and raised good cholesterol - which sounds like what everyone would want. But in the end, it did not change the occurrence rate of heart attacks or strokes in a large study.
What is important to understand is that when we look at pharmaceuticals, it is critical to ask if the drug is actually achieving the benefit that we are looking for. According to a NY Times article, "Participants taking the drug saw their LDL levels fall to an average of 55 milligrams per deciliter from 84. Their HDL levels rose to an average of 104 milligram per deciliter from 46. Yet 256 participants had heart attacks, compared with 255 patients in the group who were taking a placebo. Ninety-two patients taking the drug had a stroke, compared with 95 in the placebo group. And 434 people taking the drug died from cardiovascular disease, such as a heart attack or a stroke, compared with 444 participants who were taking a placebo." How can a drug that lowers something that is associated with benefit not show any benefit? One theory about the result was that it may be HOW the cholesterol is lowered, not just if it is lowered.
As with much of health care, it is very important to ask the question that goes beyond the immediate results of an intervention, be it medication or a procedure. It is important to determine how the end result of whatever you are doing will impact your life. Everything has possible risks and this question of real benefit must be answered so that patients can make better, more informed choices in their health care.
A Throwback to the Days of House Calls
There is a "new" approach to healthcare as a result of the emphasis and financial incentives to reduce hospital readmissions that is popping up around the country. We are hearing about the use of non-medical workers who are reaching out to recently discharged patients identified at risk of suffering setbacks that will force them to return to the hospital.
A program in Missouri is pairing patients and community health workers who can connect them "with resources like housing, transportation and other government benefits - factors that influence health but aren't the doctor's focus." The key is that these workers know the communities that they are serving and they are trusted by the people who they are there to support.
For years, community health workers have been used to fill the needs of public health initiatives and now they are being used to broaden the way patient care is being delivered. Health systems, insurers and even state and local governments are recognizing the impact of a community's health on the well-being of patients and they recognize there are "non-health care related variables that have a profound impact."
We are seeing an appreciation that health is about more than the medical conditions that are treated in the physician's office and hospitals of our communities.
Effective delivery of health care is a big picture issue that requires "outside of the box" approaches and solutions in addition to the best that medicine has to offer to improve during these times of major change and fiscal cutbacks. Examples of innovative approaches across the country show that there are ideas that are working and there are always new options that our system can try.
May Health Hint
SAVE LIVES: World Hand Hygiene Day May 5 2016
According to the Centers for Disease Control and Prevention, practicing hand hygiene is a simple yet effective way to prevent infections. Handwashing prevents the spread of germs, including those resistant to antibiotics which are becoming difficult, if not impossible, to treat. On average, healthcare providers clean their hands less than half of the times they should. On any given day, about one in 25 hospital patients has at least one healthcare-associated infection.
As a patient in a healthcare setting, you are at risk of getting an infection while you are being treated for something else. Patients and their loved ones should be proactive by reminding healthcare providers to clean their hands. Patient's hands can spread germs too, so protect yourself by cleaning your hands often.
Hand hygiene quick facts:
- Alcohol-based hand sanitizer kills most of the bad germs that make you sick.
- Alcohol-based hand sanitizer does not kill C. difficile, a common healthcare-associated infection that causes severe diarrhea and is on the rise.
- Alcohol-based hand sanitizer does not cause antibiotic resistance.
You should clean your hands:
- Before preparing or eating food
- Before touching your eyes, nose, or mouth
- Before and after changing wound dressings or bandages
- After using the restroom
- After blowing your nose, coughing, or sneezing
- After touching hospital surfaces such as bed rails, bedside tables, doorknobs, remote controls, or the phone
How should you clean your hands:
With an alcohol-based hand sanitizer:
- Put product on hands and rub hands together
- Cover all surfaces until hands feel dry
- This should take around 20 seconds
With soap and water:
- Wet your hands with warm water. Use liquid soap if possible. Apply a nickel- or quarter-sized amount of soap to your hands.
- Rub your hands together until the soap forms a lather and then rub all over the top of your hands, in between your fingers and the area around and under the fingernails.
- Continue rubbing your hands for at least 15 seconds. Need a timer? Imagine singing the "Happy Birthday" song twice.
- Rinse your hands well under running water.
- Dry your hands using a paper towel if possible. Then use your paper towel to turn off the faucet and to open the door if needed.
Please MARK YOUR CALENDARS! This year the Connecticut Center for Patient Safety asks you to join others in supporting our work through our participation in the Community Foundation for Greater New Haven's Great Give. The Great Give is a 36 hour day of giving from May 3-4. With everyone's donation of $10 (or more if you wish), we will continue to expand all of the work that we do, including our patient education and empowerment project, on behalf of patients in Connecticut .
We thank you for your contributions and maintain our commitment to be the voice of patients and family members and to work for safe, high quality health care for everyone in our state.
On a beautiful sunny day in October, I walked very pregnant into the hospital after being diagnosed with preeclempsia. I remember vividly that I wore a pair of brown flip-flops, thinking they'd be easy to slip on and off throughout my stay. My son was born the next day. But long after the epidermal wore off, my right leg and foot were still numb. A neurologist at the hospital where I delivered said that my nerves had been compressed at the level of my right knee because of the stirrups used during labor.
Over the long week I stayed at the hospital, the staff appeared unfamiliar and uncomfortable with my condition. I was confined to bed - and learned later that I should have been up moving and doing physical therapy immediately. I was told I might not walk again - no more flip-flops for me. The whole experience was incredibly upsetting as it was not how my husband and I pictured the post-delivery experience and the first few months with our baby.
Several days later I was discharged, carried out by my husband because I had foot drop. The correct diagnosis took several more days. I underwent a full body exam and a painful nerve conduction study (EMG) by another neurologist, not affiliated with the hospital. Finally I was diagnosed with lumbosacral plexopathy-my baby's head had compressed the nerves in my pelvis (L4, L5, S1); the consulting neurologist sees about two cases a year.
Of course, every woman experiences a challenging time after birth. And every woman should receive the help she needs. Although rare, any numbness of the legs and/or feet should be promptly addressed. Some patients could be among the 1% of new mothers who suffer from a complication, and I was one of those unlucky few.
Several months after my delivery, The Connecticut Center for Patient Safety facilitated a meeting with hospital administration that led to an informational seminar for staff so that I could have the reassurance that future moms there would be cared for in the best way possible. The conversation also gave me emotional closure.
The Connecticut Center for Patient Safety gave me invaluable tools to help raise awareness of this condition and other neurological disorders that can occur as a result of childbirth. The reality is that this condition should have been diagnosed earlier and correctly, as the prognosis is usually good.
Fortunately I'm almost 100% recovered. My nerves have regrown. I can walk (though no stilettos, thanks). More important, I can carry and even run after my baby, who's grown into a beautiful, healthy toddler.
I want to thank Anne for bravely sharing her story with us. We are pleased that her medical situation is resolving and that she had personal resolution, as well. We have always believed in the power of sharing stories and in this particular case, Anne's story was used to meaningfully educate doctors at the hospital where her missed/delayed diagnosis occurred. Hopefully, her sharing this will also empower other patients to speak up and to help improve our healthcare system. ~Lisa
|Advancing Safety for Elders - The Most Important Conversation You'll Ever Have|
Jim Kinsey, Director Planetree Member Experience
A crisis is not the time to make critical healthcare decisions, however many people find themselves in that very predicament. The predicament is avoidable through one vital conversation; that conversation however is one of the more challenging and complex discussion for many people.
Admittedly there is a healthcare crisis in the United States, not only issues surrounding safety and quality, one where the voice of the patient-the person is often not heard and the individual preferences, choices and values are often misunderstood.
This is avoidable, but it requires people to discuss, determine, and document their choices, values and preferences. Many individuals avoid these conversations because they are often introduced in the context of end of life or catastrophic illness; however, let us begin to think differently about these discussion!
Any one of us wants what healthcare that is in our best interest and
represents what is important to our values and our preferences. Think back to a time where success in a healthcare encounter wasn't necessarily decided by you, but by others around you representing good intention, but often a differing perspective that may not be representative of your choice. The gap between good intentions and meaningful individual outcomes comes at a cost and that cost is to become active in the discussions of our treatment to be sure that our preferences, values and choices are clearly represented. This self-advocacy sets the stage for being able to make more challenging decisions regarding our healthcare as we age or find ourselves living with a chronic disease. It also demonstrates the importance of our values and preferences in that decision making process.
One may be wondering what this has to do with that crisis I referenced at the beginning, if we become habitual in defining what is important to us as we experience healthcare outside of crisis-having the most important conversation will be less stressful and more clearly understood by our families, friends and care providers.
To be sure that our wishes are honored when we can no longer make them known to others, we each should select a Healthcare Proxy. This is an individual that you have confidence in and a relationship with that you feel will honor and advocate for your choices and preferences. This is an important role and should not just be delegated to an eldest child or closest relative by default; this role should be accepted by the individual and they need to be comfortable asking questions and discussing your choices so that they are able to advocate on your behalf when necessary.
This is only one step in the Advanced Care Planning process for individuals. Over the coming months we will explore the different choices that can be made, how to make those choices understood by your Healthcare Proxy, how to document those choices and how to integrate those preferences into your care encounters now, before a crisis.
But one mustn't wait to make their preferences known, begin by defining success with your provider, ensuring that he or she is aware of your preferences and values and most importantly partners with you on defining success!
How People Differ from Airplanes
In Connecticut, hospitals are searching for ways to improve patient outcomes. As we have discussed in prior issues, according to the 2015 CT Department of Public Health Adverse Event report there were 471 reports of preventable adverse events resulting in serious patient harm in the state's hospitals in 2014. These included 24 cases of retained foreign objects, 15 cases of surgery performed on the wrong body part and 12 cases where the patient died or suffered serious injury associated with surgery. One approach to improve this statistic has been for hospitals to look to "high reliability" industries, complex high-stakes industries such as the airline and nuclear industries, which have exceptionally low accident and failure rates, to learn from their practices and strategies and use the similar tools to make health care safer as well.
Over the years, certain aspects of health care safety have improved. For instance, nationwide, hospitals have reduced the occurrence of specific hospital acquired infections by focusing on evidence based practices and other strategies that research demonstrated accomplishes this. Nationally, a number of infection rates have gone down however, while there has also been improvement in Connecticut hospitals, they have not experienced the same rate of improvement as the national average and don't forget, additionally, we still had 471 adverse events in CT hospitals.
According to an article I read in Becker's Hospital Review
, there are five characteristics of a high reliability organization:
- High reliability organizations are sensitive to operations (processes and systems).
- High reliability organizations are reluctant to accept "simple" explanations for problems.
- High reliability organizations have a preoccupation with failure.
- High reliability organizations defer to expertise.
- High reliability organizations are resilient (relentlessness until solutions are found).
This sounds good. So why has this approach not brought the number of medical harm events closer to zero? In a piece authored by Suneel Dhand, MD he speaks to
Why You Can't Compare Healthcare to the Airline Industry.
He first points out that patients are people, they are not machines. They have emotions, and need human contact and they want to be involved in their care and one person differs from the next. He points out that checklists can improve care that essentially needs to be done the same way every time, but the clinician needs to add their human qualities to patient care.
Dr. Dhand goes on to point out that flying has always been relatively safe compared to healthcare. Airplanes are engineered to be able to fly as efficiently as possible. Patients coming into the hospital are usually not in the best condition, vary from one to another and medicine itself if more variable in outcomes.
The third point that Dr. Dhand makes is that staffing levels on airplanes are heavily regulated and the pilot will be totally dedicated to flying the plane and won't do so without the appropriate crew to support him/her. In the hospital setting, clinicians are often focused on multiple patients and the workflow is very different, with healthcare tasks frequently interrupted with new clinical issues and emergency situations.
Perhaps, recognizing these and other points, our healthcare leaders will continue to take strategies from these high reliability industries, but will also address the importance of good, patient-centered medicine. Patient-centered medicine, where our doctors get to know the patient, listen to the patient, welcome a partnership between the patient and the entire healthcare team, consider the whole person in their care and also consider their environment as a component of healthcare.