Archive for the ‘Medical Research’ Category

Autism and Wandering – a constant struggle

Wednesday, August 3rd, 2011

I have written before in this space about special needs children, including children with autism. This week I want to turn my attention to one aspect of autism – wandering – and some of the ways parents and schools are trying to keep kids safe. Wandering is something I really had not heard of before, but I’ve since learned that it is a serious danger to children with autism or other cognitive deficits. It is also a major source of stress to parents who are constantly worried about their child wandering off.

All children have a tendency to wander away from their parents at times. When my daughter was two, I lost her at Sports Authority. I thought she was standing right next to me while I was looking at something, then I looked down and she was gone. After a few frantic minutes – and with the quick help of the store employees – we found her all the way on the opposite side of the store looking at balls. She was perfectly fine, but it was terrifying for me.

For reasons that are not well understood, children with Autism Spectrum Disorder (ASD) tend to wander more than non-autistic children. As reported by the Child Mind Institute and others, a recent study by the Interactive Autism Network has finally tried to quantify what has traditionally been more anecdotal evidence about wandering.

According to the responses from more than 800 parents, roughly 50 percent of children between the ages of 4 and 10 with an ASD wander at some point, four times more than their unaffected siblings. The behavior peaks at 4, almost four times higher than their unaffected siblings, but almost 30 percent of kids with an ASD between the ages of 7 and 10 are still eloping, eight times more than their unaffected brothers and sisters.

Autistic children seem to wander for two basic reasons. One is to find something they like, such as their favorite pond or playground; and one is to get away from something they don’t like such as a stressful school environment. It’s not really running away, at least as that term is usually used to describe a child who decides to leave home because of some real or perceived injustice at home. A majority of parents in the study described their child as happy and focused when they wandered off. It is usually a matter of the child being drawn to something that he or she likes. One child referenced in the Child Mind story had a fascination with exit signs. One day at school, the boy wandered off through the woods toward the highway to find his favorite exit sign. Thankfully, a good Samaritan picked-up the boy and returned him to where he belonged.

The danger for children is very real. While concrete statistics are difficult to come by, drowning seems to be the biggest danger (there are some who believe that autistic children are drawn to water). Children can also wander into traffic. Of course, when any small child wanders alone there is the risk of getting lost or being abducted. To further complicate matters, thirty-five percent of families in the study reported that their child is never or rarely able to communicate basic identifying information such as name, address and phone number. This obviously makes it harder for a wandering child to get back home. Even older or more high-functioning children may – due to their social anxiety – be reluctant to seek out help or cooperate with someone who is trying to intervene.

Wandering represents a challenge to schools because it can be very difficult to monitor a child all day long, especially during class changes and recess. The problem, however, also occurs at home. Wandering occurs not just during the day; night-time wandering is an especially big fear for parents of autistic children. Some children have been known to get up in the middle of the night, undo the deadbolt on the front door, and walk-off into the night. The terror of finding your child gone in the middle of the night is unimaginable. Some parents have installed deadbolts higher up on the doors, some have installed alarms that go off if the door is opened. Some parents have gone so far as to have their children wear tracking devices that send out a signal that can be pin-pointed. While all of these techniques can help, there are no sure-fire methods of preventing wandering. It is a constant worry for parents.

The autism community has taken action by getting the Center for Disease Control’s safety subcommittee to assign a specific medical code for wandering, which will be in conjunction with the diagnosis of ASD. By doing this, it is hoped that doctors will more readily recognize wandering as a legitimate diagnosis that they can address with the parents or other caregivers (the new code applies to adults with ASD as well). The American Academy of Pediatrics is also preparing a fact sheet to educate doctors on the topic so that they can better work with parents to try to reduce the incidence of wandering. The new code may also make it easier for parents to seek reimbursement from their insurance companies for alarms and tracking devices, and it may make it easier for parents to argue to their schools that a one-on-one monitor is needed as part of the child’s Individualized Education Plan (IEP). The new code takes effect in October 2011.

Lori McIlwain, Chairwoman of the National Autism Association, recently discussed how to deal with wandering:

The best overall strategy is a multi-tiered approach, which includes educating the child about safety and dangers using whatever means of communication works, including social stories, language and/or visual prompts. It’s also important that caregivers—and schools—work to understand what is causing, or contributing to, the wandering or bolting behaviors so that any triggers may be addressed or eliminated.

Have any of our readers had any experience with wandering? I’d like to hear your stories as to how you deal with it and how it affects your life.

Related Nash and Associates Links:

Dogs a Huge Help to Special Needs Kids

The Daily Struggle of Raising a Disabled Child

Many Parents Still Believe Vaccines Cause Autism

 

 

Photo courtesy of: Issueswithautism.com

Asthma News: Parents Underestimate Children’s Symptoms, Placebos Effective in Improving Patient’s Subjective Improvement but Not Objective Health

Monday, July 25th, 2011

image from consumerreports.org

A couple of months ago, one of my colleagues, Jon Stefanuca, wrote a post for Eye Opener entitled Four Tips For Getting the Medical Care You Need When You Are Having An Asthma Problem. In that article, he explained the importance of patients proactively knowing and explaining their asthma symptoms to healthcare providers. He focused on some of the key features of asthma and the unique symptoms that each individual may experience. If you have not already read that article, I highly recommend it as a great way to become a better advocate for yourself or someone in your life that suffers from asthma.

Over the last few months, I have been thinking about Jon’s advice in relation to some work I have been doing. It makes good sense and hopefully will help people receive better care when they are having exacerbations of their asthma. However, I was disheartened to read a recent article from Reuters about how frequently parents underestimate their children’s asthma symptoms.

Parents Underestimate Their Children’s Asthma Symptoms

I am always a little leery of studies that are drugmaker-funded, particularly when the study suggests that perhaps more medications are needed to combat a problem. However, taken at face value, this is a pretty frightening idea given how many children now suffer from asthma and how serious a condition it can be for those children and families. The article points to a disconnect between the parents’ description of their child’s asthma and whether the asthma was actually being adequately treated:

While more than seven out of every 10 parents interviewed described their child’s asthma as “mild” or “intermittent,” the disease was adequately treated in only six in 10 kids.

A doctor who was not involved in the study explained it this way:

“Parents are only aware of asthma when the child is more severely ill,” Dr. Gordon Bloomberg…

“Physicians cannot just ask the parent ‘how is your child doing?’ The physician will get a global answer that doesn’t reflect the child’s quality of life,” said Bloomberg, of Washington University in St. Louis.

Poor treatment may influence asthmatic children’s quality of life, as well as that of their families.

In the survey, more than four in 10 parents reported missing work because of their child’s asthma, and similar numbers of parents regularly lost sleep for the same reason.

Children are Better Reporters Than Their Parents of Symptoms

Interestingly, “[t]he study also found children tended to be better than their parents at determining how well their asthma was being treated.” So, clearly, doctors must take the time to discuss the asthma symptoms and treatments not only with parents but also in a sensitive and appropriate way with the children patients themselves in order to receive a better indication of the disease status. The doctors interviewed for the Reuter’s article had different opinions on what this means for asthma treatment:

According to a new report, this suggests parents need more education about asthma medications.

But one expert said more medication is not the be-all and end-all for children.

“The idea of total control…is not where we should be putting our energy,” Dr. Barbara Yawn from Olmstead Medical Center in Rochester, Minnesota, told Reuters Health in an email.

Instead of just giving children with stubborn breathing problems more medication, she said better communication is needed to determine how children’s lives are affected, and what it will take to prevent their symptoms.

New Study Shows Receiving Treatment, Even with Placebo, Important for Asthma Patients – But Does not Improve Objective Health

image from 123rf.com

In another recent study, reported in the New England Journal of Medicine, researchers looked at how asthma patients responded to a medication (bronchodilator), two different types of placebos (fake inhaler or fake acupuncture), or no intervention at all. An objective measure was taken of the patient’s ability to exhale after each intervention (or lack of intervention) and the patient’s own rating of improvement was noted. What was so interesting about this study were the different outcomes between the objective (spirometry) and subjective (patient’s self-reporting) measurements of improvement.

The bronchodilator provided markedly better objective treatment over the placebos or no treatment – a 20% improvement rather than 7% for the placebos or no treatment. However, the subjective measure of improvement found that patients were almost the same, 45-50% improvement, whether the patients received the actual bronchodilator (50%), the placebo inhaler (45%) or the sham acupuncture (46%).  All of which were higher than the 21% improvement reported by those who did not receive intervention.

An article about the study in medicalnewstoday.com explains the outcome this way:

Now a study of asthma patients examining the impact of two different placebo treatments versus standard medical treatment with an albuterol bronchodilator has reached two important conclusions: while placebos had no effect on lung function (one of the key objective measures that physicians depend on in treating asthma patients) when it came to patient-reported outcomes, placebos were equally as effective as albuterol in helping to relieve patients’ discomfort and their self-described asthma symptoms.

The study’s senior author, Ted Kaptchuk, Director of the Program in Placebo Studies at Beth Israel Deaconess Medical Center and Associate Professor of Medicine at Harvard Medical School explained it this way in the article:

“It’s clear that for the patient, the ritual of treatment can be very powerful…This study suggests that in addition to active therapies for fixing diseases, the idea of receiving care is a critical component of what patients value in health care. In a climate of patient dissatisfaction, this may be an important lesson.”

However, I wonder if it cannot also be understood another way – which is that patients are likely to feel like their symptoms have been improved after a visit to a doctor, even if objectively their airway is still compromised.

How Should this Impact Asthma Treatment?

So what can be done with this new information? I think that Jon’s advice about patient’s knowing their own symptoms and expressing them clearly to their doctors is critical. I also agree completely with his advice that patients should ask for an objective measure of their respiratory improvement before leaving a health care facility. These two steps seem key to making sure that patients objective health is being improved – not just their subjective opinion of improvement. Finally, I think that it is critical that parents act as the best advocates possible for their children – which may include making sure that the children are heard on their own symptoms since parents are not the most reliable reporters.

What do you think? Are there other tips for asthma patients and their parents out there? How do respond to these new studies?

Related Videos:

Videos about Asthma

Related Articles:

Four Tips For Getting the Medical Care You Need When You Are Having An Asthma Problem

Asthma – How to Protect Your Child When the Steroid Inhaler Fails

Use Of Acetaminophen In Pregnancy Associated With Increased Asthma Symptoms In Children

Coming Soon? Restored Breathing for Spinal Cord Injury Patients

Wednesday, July 20th, 2011

image from msstrength.com

The online version of the journal Nature publishes an article today about a potential breakthrough in the treatment of spinal cord patients. While I do not have access to the full article, medicalnewstoday.com provides an overview of the research work. The highlight is that the researchers from Case Western Reserve University School of Medicine were able to restore breathing in rodents with spinal cord injuries.

This research provides optimism for similar success in humans (clinical trials with humans are hopefully forthcoming). In the recently released studies, the scientists combined “…an old technology a peripheral nerve graft, and a new technology an enzyme” to be able to restore 80-100% of breathing function in the rodents.

Using a graft from the sciatic nerve, surgeons have been able to restore function to damaged peripheral nerves in the arms or legs for 100 years. But, they’ve had little or no success in using a graft on the spinal cord. Nearly 20 years ago, [Jerry Silver, professor of neurosciences at Case Western Reserve and senior author,] found that after a spinal injury, a structural component of cartilage, called chondroitin sulfate proteoglycans, was present and involved in the scarring that prevents axons from regenerating and reconnecting. Silver knew that the bacteria Proteus vulgaris produced an enzyme called Chondroitinase ABC, which could break down such structures. In previous testing, he found that the enzyme clips the inhibitory sugary branches of proteoglycans, essentially opening routes for nerves to grow through.

In this study, the researchers used a section of peripheral nerve to bridge a spinal cord injury at the second cervical level, which had paralyzed one-half of the diaphragm. They then injected Chondroitinase ABC. The enzyme opens passageways through scar tissue formed at the insertion site and promotes neuron growth and plasticity. Within the graft, Schwann cells, which provide structural support and protection to peripheral nerves, guide and support the long-distance regeneration of the severed spinal nerves. Nearly 3,000 severed nerves entered the bridge and 400 to 500 nerves grew out the other side, near disconnected motor neurons that control the diaphragm. There, Chondroitinase ABC prevented scarring from blocking continued growth and reinnervation.

“All the nerves hook up with interneurons and somehow unwanted activities are filtered out but signals for breathing come through,” Silver said. “The spinal cord is smart.”

Three months after the procedure, tests recording nerve and muscle activity showed that 80 to more than 100 percent of breathing function was restored. Breathing function was maintained at the same levels six months after treatment”

From medicalnewstoday.com

This could be life-changing for those spinal cord injury patients who currently need ventilators to survive. If human studies prove the efficacy of such treatment, patients would have the hope of being able to breath on their own again. Not only would this dramatically improve these patients’ quality of life, but it would also provide a dramatically improved outcome for these patients. Currently, “[r]estoration of breathing is the top desire of people with upper spinal cord injuries. Respiratory infections, which attack through the ventilators they rely on, are their top killer.”

The BBC is reporting that “[r]esearchers hope to begin trials in humans. They are also investigating whether bladder function can be restored, which can be lost when the lower spine is damaged.”

The CDC’s most recent statistics, which are a few years old, suggest that there are currently about 200,000 people in the United States who are living with spinal cord injuries. This number increases by approximately 12,000-20,000 new patients annually. If some portion of these individuals could be provided hope for breathing on their own and or regaining bladder function, their lives could be dramatically improved.

Related Articles:

Spinal Cord Injury Updates: More Reasons for Optimism?

New Treatment Holds Promise for Patients With Spinal Cord Injuries

New Microchip Promises to Make Life Much Easier for Paraplegic Patients

July 1 – New Residents, New Rules……Again!

Monday, June 13th, 2011

Last year, I wrote a blog on “The July Effect”, a long-observed phenomenon of increased hospital deaths during the month of July that was substantiated by medical data and statistics just last year. These data seemed to specifically relate these deaths to the influx of new medical school graduates into teaching hospitals as first-year residents of those institutions. The conclusions of the study seemed well-substantiated. I further elaborated on some of the potential causes of errors being made that could result in harm to patients; what I didn’t elaborate upon was the rigorous and demanding schedule that residents assume.

In 2003, the Accreditation Council for Graduate Medical Education (ACGME) instituted new policies regarding the time limitations of ALL residents, but specifically focused on the first year resident. These limitations were placed on the number of hours that residents could and should work in any given week or rotation in an effort to safeguard the health of the resident but more so to ensure the safety and well-being of patients being treated by these residents.

It is now 2011, and the ACGME is instituting even stricter limitations affecting both first year and mid-level residents; Nixon Peabody does a great job of delineating the changes in the guidelines. Much information has been published in the last year regarding the continued occurrence of medical errors despite protocols and safety mechanisms in place to protect patients (click on related blogs below). It seems that the ACGME is attempting to address some of these errors by addressing the fatigue factor of medical and surgical residents in training. The overall maximum hours per week will not change; it remains at 80 hours.  Yes, twice that of “normal” jobs. One big change is the limit on the maximum continuous duty period for first year residents; this will be decreased from 24 to 16 hours.  It will remain 24 hours for residents after their first year, but recommendations include “strategic napping.” Another change is the additional duty time, previously allotted as 6 extra hours to perform clinic duty, transfer of care, didactic training, etc.; for first year residents, these duties are to be included in the overall 80-hour work week, but after the first year, the residents will be allowed 4 additional hours. A third big change is the minimum time off between duty periods. Previously, it was noted that all residents “should have” 10 hours between shifts; year 1′s are still recommended to have 10  hours off, but they MUST HAVE AT LEAST 8! Intermediate-level residents should also have 10 hours off, but they also must have at least 8 hours off with a mandatory 14 hours off if they just completed a 24-hour shift. Final year residents are recommended to receive 8 hours off, but this is still being reviewed.  One thing that has not changed is the mandatory 1 day off in 7, averaged over 4 weeks.

Many of us watch the medical TV shows, but none of these shows really paint the true picture of medical residency training. As a Physician Assistant student, I trained alongside medical residents and medical students, alike. My training mirrored theirs in the hospital setting, and it happened well before the 2003 ACGME recommendations. There were times during my surgery rotation in a trauma center during which I worked 36 hours straight, followed by 10 hours off, then back to 10- and 12-hour days. The working hours entailed clinic time, managing daily in-patient care, many hours in the operating room, admitting patients during the overnight hours from the emergency room and emergency surgery for trauma victims, hours and hours at a time, in the overnight hours and during the day.  By the end of 36 hours, the exhaustion was indescribable. It is easy to understand how and why mistakes happen. After these crazy shifts, no one ever looked so glamorous as those who are depicted on television shows…..TRUST ME!

July 1, 2011, marks the date when over 100,000 medical residents across the USA from ACGME-accredited training programs start their training in teaching hospitals/institutions across this great nation. We should applaud the ACGME for looking at the data, analyzing studies regarding sleep deprivation, and putting forth these guidelines, not only to aid in patient safety but also to protect the health and well-being of these doctors in training. The pressures of residency are incredible. It is interesting that there was and still is opposition to the duty-hour limitations, citing oppositional rationale such as the residents do not learn enough in 16 hours, and small institutions do not have the support staff to treat all of the patients without the addition of medical resident hours.

So, who is going to fill those gaps created by the resident-hour restrictions placed by the ACGME come July 1st? Each institution will have to look at its own hospital model and decide according to current standards. In 2003, many of these gaps were filled by Physician Assistants and Nurse Practitioners; I suspect this will again be the case.  These mid-level practitioners are quite capable of providing many of the services necessary in hospital settings; they are a growing and well-respected addition to the healthcare team, and I suspect that their usefulness and potential will be more fully appreciated with the institution of healthcare reform!

For more information and Frequently Asked Questions (FAQs) regarding the ACGME guidelines, please go to the website and click on the links!

And, no matter who is caring for you or your loved one, never be afraid to ask questions about therapies and medications being ordered. Be informed!

Related Posts:

“The July Effect”: Where To Seek Medical Care When The Heat Is On

Medical Malpractice – Serious Medical Errors: Failure of the System or Just Plain Ignorance

Study Finds Regional Hospitals Often Are Better At Preventing Medical Errors Than Academic Centers – Kaiser Health News

Tort Reform or Just Plain Medical Care Reform: the debate continues as thousands are injured annually in US hospitals

 

 

 

 

 

 

Week in Review (April 16 – 20, 2011) The Eye Opener Health, Law and Medicine Blog

Saturday, May 21st, 2011

From the Editor (Brian Nash)

Another week of great posts (IMHO) by our blawgers. Apparently, I’m not the only one who thinks so since we have now surpassed 21,000 page views in the last 30 days. The number keeps rising. Our sincere gratitude to all our readers!

Our topics were once again quite varied. They spanned the law, health, science and medicine. We even had a piece on a local event – Marathon Kids. This piece is part of our new program to promote charities and civic organizations in our own backyard – Baltimore and Washington.

We try week in and week out to find topics of interest for you, our readers. If you ever have any suggestions for topics of interest to you, please leave a comment or send us an email or fill-out the contact form with your thoughts and suggestions. We’d love to hear from you.

Let’s get to it then. What did we cover this past week that you might be interested in reading? Take a look -

Why early settlement is a win-win for all

By: Michael Sanders

There is an old adage in the law that cases settle on the courthouse steps. There is a reason for that. When the parties are actually walking into court to try their case, they seem to suddenly recognize that there are significant risks to going to trial, and that there is serious money at stake. When you go to trial, only one side can win. The other side goes home a loser. Faced with such a stark outcome, both sides tend to become more reasonable in their assessment of their case and more willing to talk settlement. After all, despite all the years of experience that trial attorneys amass, no one can ever predict what a jury is going to do in any specific case. As one mediator I know likes to tell the litigants, going to court is like going to Vegas:  you roll the dice and you take your chances. Read more….

Milk from Mom: Effective in preventing common infant complication (NEC)

By: Jason Penn

The debate among parents regarding the use of human milk vs. formula wages on, but according to a recent study, you can chalk one up for the human body.  That study, headed by the Johns Hopkins University in Baltimore, concluded that premature babies fed human donor milk were less likely to develop the intestinal condition necrotizing enterocolitis (NEC).  Both sides has its advocates, willing to do battle at any time. When it comes to NEC, Mom’s milk has the decided advantage. Read more….

H.I.V. treatment advances, but what are the implications of terminating research early?

By: Sarah Keogh

Last week, I read some exciting news about H.I.V. treatment and transmission. A New York Times article reported that a large clinical trial found that “[p]eople infected with the virus that causes AIDS are far less likely to infect their sexual partners if they are put on treatment immediately instead of waiting until their immune systems begin to deteriorate…” The study found that “[p]atients with H.I.V. were 96 percent less likely to pass on the infection if they were taking antiretroviral drugs…” These findings are overwhelmingly positive and the implication for public health is huge. Read more….

A Windy, Rainy but Fabulous Day in Baltimore: Marathon Kids Final Mile Celebration

By: Rachel Leyko

Despite the wind and rain, this past Saturday I volunteered at the Marathon Kids Final Mile Celebration Event at Western Polytechnic High School in Northwest Baltimore.  I learned of the event through the Junior League of Baltimore and to be honest, prior to Saturday, I did not know much about the organization, its purpose or effect on the children it sought to serve.  However, after Saturday’s event, not only was I impressed with the purpose of Marathon Kids, but I saw firsthand the positive effect this program has had on the children who have participated. Read more….

Acquired Brain Injuries: Causes and Impact

By: Theresa Neumann

On the heels of Jason Penn’s blogregarding calling “911″ for signs of a possible stroke, I decided to introduce a variety of acquired brain injuries for further discussion in future blogs since damage to the brain results in some of the most catastrophic injuries possibly sustained by the human body with significant “collateral damage” for all of the friends and family involved in the individual’s life. Read more….


Sneak Peak of the Week Ahead

Some topics we’ll be covering next week…and then some…

  • You or someone you know has been diagnosed with cancer, now you have to deal with the horror. Jon Stefanuca will be writing a piece based on our experiences with a number of clients “living with cancer.”
  • Mike Sanders and I have both recently resolved cases involving families who have lost a child. Mike’s involved the death of a fetus very near term. He’ll share that story and the experience of the case with you.
  • Maybe those of you who have children with special needs are familiar with the local (Maryland and Washington, D.C.) resources to help you and your child. For those who may not be or just want to learn more, Jason Penn will be providing information on this next week.
  • You may have heard the recent news about labeling of certain medications for children. Sarah Keogh will report on this and also delve into some practical problems and issues that parents face every day in terms of medicating their children.
  • We’re going to begin a new series on exactly what is recoverable in our jurisdictions (Washington, D.C and Maryland) under what is known as the Survival Act and the Wrongful Death Act. We’ll be paying particular attention to issues involving what’s known as pecuniary benefits, loss wages and diminished earning capacity. Should be educational. We hope you enjoy it.

Have a great weekend, Everyone!

H.I.V. treatment advances, but what are the implications of terminating research early?

Wednesday, May 18th, 2011

Scientific Method; image from: scifiles.larc.nasa.gov

Last week, I read some exciting news about H.I.V. treatment and transmission. A New York Times article reported that a large clinical trial found that “[p]eople infected with the virus that causes AIDS are far less likely to infect their sexual partners if they are put on treatment immediately instead of waiting until their immune systems begin to deteriorate…” The study found that “[p]atients with H.I.V. were 96 percent less likely to pass on the infection if they were taking antiretroviral drugs…” These findings are overwhelmingly positive and the implication for public health is huge.

The study details are fascinating, particularly in regards to the results. For example:

The $73 million trial, known as HPTN 052, involved 1,763 couples in 13 cities on four continents. One member of each couple was infected with H.I.V.; the other was not. In half the couples, chosen at random, the infected partner was put on antiretroviral drugs as soon as he or she tested positive for the virus.

In the other half, the infected person started treatment only when his or her CD4 count — a measure of the immune system’s strength — dropped below 250 per cubic millimeter.

In 28 of the couples, the uninfected person became infected with the partner’s strain of the virus. Twenty-seven of those 28 infections took place in couples in which the partner who was infected first was not yet getting treatment.

What I found most interesting, however, was that the study was not completed. The reported findings were the preliminary results from the clinical trials. In fact, the article explained that “[t]he data was so convincing that the trial, scheduled to last until 2015, is effectively being ended early.”

The way these results were discovered and released during the course of the study was what intrigued me. Here’s how the study data was described:

“[U]nblinded” to an independent safety review panel, which is standard procedure in clinical trials. When the panel realized how much protection early treatment afforded, it recommended that drug regimens be offered to all participants. Although participants will still be followed, the trial is effectively over because it will no longer be a comparison between two groups on different regimens.

This means that the clinical trial was stopped before reaching completion so that all of the participating couples could receive treatment.

The implications of ending this trial short are complicated. For the participants, the decision can be nothing but positive since it may provide the study participants with the opportunity to receive treatment that could hopefully lead to a dramatically decreased likelihood of infection with a potentially deadly disease. For many others around the world who have a partner with H.I.V., the implications are likewise a boon for public health. The release of these early results may impact treatment of H.I.V. infected individuals around the world who may now be able to protect their partners from infection. However, the end of this study is not as clear-cut in terms of research and ethical implications as it might seem.

I originally became aware of the idea that clinical studies are sometimes cut short in the mid 1990s. My father, an occupational health doctor who died in 1999, was involved in the CARET studies during the 1990s. This large-scale double blind study was looking at whether beta-carotene and retinyl palmitate would be able to prevent lung cancer in heavy smokers and workers who had been exposed to asbestos.  However, the study was ended prematurely based on interim results that suggested an adverse affect on the study participants. Since I was only a high school student at the time that the trial was ended, I did not know many of the details at the time. I understood the basic idea that if a medical research study was causing harm to the participants, that it must be ended. When I read the recent news about the H.I.V. treatment study, it prompted me to try to learn more about how and when clinical studies are interrupted.

There was an article published called “Stopping the active intervention: CARET” that I found enlightening about how and why the CARET studies were ended.  The article provides an overview that I found helpful in thinking about the current H.I.V. study:

The optimal design of a randomized clinical intervention trial, where the outcome is a disease endpoint, includes a set of criteria for stopping the active intervention before planned. These criteria, called “stopping rules,” guide the review of findings by key study scientists and an independent set of reviewers. If the pattern of outcome, effect or harm, is large enough to be attributed to the intervention, the trial is halted, regardless of the planned completion date or the readiness of staff to end the trial.

While in the H.I.V. study, the impact was positive, rather than negative as in the CARET study, the procedure seems to be similar. A procedure in the study allowed for data to be unblinded and examined by an independent panel which then recommended that the trial be stopped early.

However, this does present two potential problems. One is that the study, scientifically speaking, did not reach its full conclusions. It may not provide as much evidence of implications as it might have if it had continued or if the study population had been larger. For example, the New York Times article mentioned the following:

Although the trial was relatively large, there are some limitations on interpreting the data.

More than 90 percent of the couples in the trial, who lived in Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, the United States and Zimbabwe, were heterosexual.

“We would have liked to have a substantial number of men as potential study subjects, but they just weren’t interested,” Dr. Cohen said.

Although common sense suggests the results would be similar in the contexts of homosexual sex and sex between people who are not couples, strictly speaking, the results apply only to the type of people studied, Dr. Fauci said.

Another implication is that the results may not be as scientifically accurate if the trials are stopped early.  A study published in JAMA entitled “Stopping Randomized Trials Early for Benefit and Estimation of Treatment Effects: Systematic Review and Meta-regression Analysis” explains:

Although randomized controlled trials (RCTs) generally provide credible evidence of treatment effects, multiple problems may emerge when investigators terminate a trial earlier than planned, especially when the decision to terminate the trial is based on the finding of an apparently beneficial treatment effect. Bias may arise because large random fluctuations of the estimated treatment effect can occur, particularly early in the progress of a trial. When investigators stop a trial based on an apparently beneficial treatment effect, their results may therefore provide misleading estimates of the benefit. Statistical modeling suggests that RCTs stopped early for benefit (truncated RCTs) will systematically overestimate treatment effects, and empirical data demonstrate that truncated RCTs often show implausibly large treatment effects.

(internal footnotes omitted)

So, perhaps, if the trial were continued, the results would not have been as overwhelmingly positive. Perhaps the percentage of partners infected in the two groups would not have been as widely divergent. But perhaps they would – and would you want to gamble with someone’s life?

Have you ever been involved in a clinical research study that has been ended early? Was it for positive or negative results? What should be done to maximize public health and safety while still providing the benefits of full blind research studies?

 

Ovarian Cancer – five tips to make sure you get the medical care you need

Wednesday, May 11th, 2011

Did you know that more than 21,000 women are diagnosed with ovarian cancer in the U.S. each year? An astonishing 15,000 women die from ovarian cancer each year. Despite numerous advances in healthcare, the mortality rate for ovarian cancer has not improved in the last 30 years. Simply put, ovarian cancer is the deadliest of all gynecologic cancers. If the cancer is diagnosed in its early stages (i.e. before it spreads to other organs), the five-year survival rate is about 93.8%. However, if it the cancer is diagnosed in its later stages, the five-year survival rate is about 28.2%.

There is no question that ovarian cancer is quite deadly and that early diagnosis and treatment is key for survival. There is an abundance of information about ovarian cancer online and in other written sources. Simply put, take the time to familiarize yourself with the symptoms of this terrible disease. Let’s share with you some information, which I believe can make a difference. Call it a male lawyer’s perspective, if you will. I’ve seen what happens when early detection should have happened, but tragically did not.

1. Examine Your Medical History

Whenever the possibility for ovarian cancer exists, consider your medical history as you discuss your symptoms with your physician. If you are having symptoms consistent with ovarian cancer, take the initiative and discuss your symptoms and history with a gynecologist as opposed to your primary care physician. Make sure to tell your physician if you have any cancer history. Don’t forget to include information about any family history of cancer (parents, siblings, etc.). Of particular importance is any history of breast or ovarian cancer, although any cancer history is relevant. Unfortunately, women with a personal or family history of ovarian cancer or breast cancer are at a higher risk.

2. Understand and Appreciate Your Symptoms

Although your physician is likely to talk to you about ovarian cancer, it is always a good idea to familiarizer yourself with the signs and symptoms of ovarian cancer before your doctor’s appointment. Many of the symptoms of ovarian cancer overlap with the symptoms of cervical cancer. Therefore, if you are experiencing symptoms of cervical cancer, you and your physician should also discuss the possibility of ovarian cancer. We have seen cases were a physician will consider one or the other but not the possibility of both cancers. Here are some of the more common symptoms of ovarian cancer:

-          Irregular uterine bleeding

-          Abdominal  and/or pelvic pain

-          Abdominal fullness or bloating

-          Fatigue

-          Unexpected weight loss

-          Fatigue

-          Headaches

-          Frequent urination

-          Low back pain

Watch this video for more information about symptoms of ovarian cancer:

httpv://www.youtube.com/watch?v=fH9N4auMblE

 

Watch this video for more information about symptoms of cervical cancer:

httpv://www.youtube.com/watch?v=HHA_0HsjeBI&feature=related

3. Is it a solid mass?

If your radiographic studies reveal a mass, make sure that you get a clear answer as to whether the mass is solid or fluid-filled.  A fluid filled mass will typically turn out to be a cyst. It could also be a blocked fallopian tube (i.e., hydrosalpinx, hematosalpinx, pyosalpinx). Generally speaking, a fluid filled mass is less likely to be malignant. However, if your radiographic studies reveal a solid mass, especially one that arises from an ovary, the possibility of ovarian cancer must be seriously considered. If you are found to have a solid mass, talk to your gynecologist or primary care physician about consulting with a surgical oncologist.

4. Should you have a CA 125 blood test?

CA 125 is a protein. It is a tumor marker or biomarker for ovarian cancer because it is more prominent in ovarian cancer cells. The CA 125 test is a test designed to test the levels of CA 125 in a patient’s blood. Elevated CA 125 levels can be indicative of ovarian cancer. If your CA 125 levels are elevated, you and your physician should seriously consider the possibility of ovarian cancer. An elevated CA125 should prompt your physician to order additional radiographic studies, including a CT of the abdomen and pelvis, an ultrasound of abdomen and pelvis, a PET scan or even a CT pyelogram. You should also consider consulting an oncologist or a surgical oncologist. If you are found to have a solid mass and your CA 125 level is elevated, time is of the essence for further investigation and surgical intervention.  Ask your doctor about other tumor markers that can be tested.

5. Who is reading your ultrasound?

Many patients who present to their gynecologist with symptoms of ovarian cancer will initially undergo an ultrasound. A great number of gynecologists will themselves perform and interpret the ultrasound. Here is the problem. With all due respect to gynecologists, they are not trained ultrasonographers or even radiologists! Ultrasounds can be particularly difficult to read. This can be due to the patient’s position and, more frequently, the size of the patient. In heavier patients, a pelvic ultrasound can be quite limited if one is trying to visualize the ovaries, discern the presence of mass, or determine whether the mass is solid or fluid-filled. So, if your gynecologist is the only person to read your ultrasound, the result is potentially quite devastating. The mass could remain undiagnosed, and you may be told to come back if your symptoms get worse. The ultrasound may be interpreted as limited, and, for whatever reason, your gynecologist may simply neglect to order a more sensitive study (i.e. a CT scan). Instead, he or she may choose to monitor you for any further deterioration of symptoms.

In yet another instance, if the ultrasound is limited, a solid mass may be confused for a fluid-filled mass. Under these circumstances, you may be asked to follow-up in six months. The problem with all of these permutations is delay, and you cannot afford delay with ovarian cancer. Make sure that your radiographic studies, whatever they may be, are read by a skilled specialist in the interpretation of whatever study you undergo.

As we always say, be your own patient advocate and be an informed patient. Be an active participant in your medical care by being informed and by demanding the care you require. Having an understating of the types of mistakes that can be made during medical treatment is simply prudent.

Please share your familiarity or experience with ovarian cancer treatment. What do you think women should watch out for should they find themselves afflicted by this terrible disease?

For more information, see our other blogs:

Ovarian Cancer – Early Intervention is Key, What You Must Know…

New study links gene to ovarian cancer and may assist in early detection 

Ovarian Cancer – The Smear Test Won’t Tell You Much

 

Image from cancersyptomspage.com

Week in Review (May 2 – 6, 2011): The Eye Opener Health, Law and Just Interesting Stuff Blog

Saturday, May 7th, 2011

From Brian Nash (Editor)

We appreciate your stopping by to see what this past week’s posts covered in the world of law, medicine, health and safety – and then some.

You’ve been told you need to undergo treatment. The doctor tells you (hopefully) the risks and benefits of what’s being proposed. You’re wondering – “Is this my only choice?” In a non-emergency situation you usually have a choice you may not have considered – a second opinion. Theresa Neumann’s piece this past week addresses this usually available but very under-utilized resource for patient’s facing this situation.

Sarah Keogh writes about a topic that makes a lot of sense – when you stop and think about it. Who are the people on a hospital’s medical team that are with you more than anyone else? Your nurses, of course. Just how does a nurse’s working conditions not only affect him or her – how does it affect your health? Read Sarah’s piece and find out.

Asthma affects the lives of 20 million people in America. It does not discriminate since it affects the young, the old and all in between. This past week, Jon Stefanuca, who has been immersed in a case involving a young man who tragically died as a result of asthma shortly after being discharged from a local hospital, shared his “4 tips” to make sure you get the health care you need when you have an asthma problem. If you or someone close to you has asthma, take the time to consider Jon’s suggestions. As always, if there are some suggestions you could share with others, please do in the comments section.

Recently our firm started using QR Codes on our business cards. I’d heard about them but wasn’t quite sure what they were all about. After a little bit of study and discussion, I was amazed at what they can do – you will be too. So many now use their phones and mobile devices as their primary means for connecting with the world via the internet. Just download a free mobile application, snap a picture using the app and the QR Code will whisk (at a blazingly fast speed) you away to more information than you can imagine. Jason Penn, who was the first to get his QR Code business card, was apparently fascinated by this new technology, so he wrote a post this week about it and shares with you some interesting information about some others who have been using it for some time now.

Our Posts of the Past Week

Medical Second Opinions: An Under-utilized Option for Patients

By: Theresa Neumann

Today’s medical world is vast with various technologies, treatments and options.  So, if a patient is diagnosed with a medical condition, and doctor A recommends treatment A, what keeps the patient from seeking a second opinion? This is an interesting phenomenon.  After performing intake summaries and client interviews for quite a while now, it still amazes me how many people have bad outcomes from surgery simply because they never requested a second opinion. Second opinions are not simply reserved for surgery, though; cancer treatment options, medical therapies for chronic conditions like rheumatoid arthritis or inflammatory bowel disease….read more

 

Working Conditions for Nurses Impact Patient Health

By: Sarah Keogh

I suspect that anyone who has spent even as much as one day or night in a hospital knows just how critical the nursing staff is in the , health, care and comfort of a patient. A compassionate and personable nurse can put a patient at ease and help them feel better in ways that go beyond just medicine.

Recently, I wrote about how different schedules impact nurses’ lives and how they cope with shifting from day to night schedules. This week, I was drawn to write about nurses again after seeing an article on medicalnewstoday.com that spoke about a study done by the University of Maryland School of Nursing.  Read more

Having an Asthma Problem: 4 Tips for you to use to get the medical care you need

By: Jon Stefanuca

Did you know that approximately 20 million Americans suffer from asthma?  Every day, about 40,000 of them miss school or work because of this condition. Each day, approximately 30, 000 experience an asthma attack.  About 5000 patients end up in the emergency room. Asthma is also the most common chronic condition among children. Can there by any doubt it is a very serious and potentially deadly medical condition that needs equally serious understanding and attention? The good news is that with proper education and treatment, most asthmatics have active and productive lives.

Bronchospasm and inflammation: the key features of asthma

This chronic airway disease has two primary features: bronchospasm and inflammation. Bronchospasm refers to the mechanism by which airways become narrower. In asthmatic patients, the muscle within the wall of the airway contracts, thus narrowing the lumen (a cavity or channel within a tubular structure) of the airway and causing respiratory obstruction. Inflammation refers to the process by which the wall of the airway becomes thicker in response to inflammation, which also causes the lumen to narrow and produce respiratory obstruction. Bronchospasm is usually treated with….read more

Bar Codes, QR Codes and More: The Intersection of Life and Technology

By: Jason Penn

The business cards I ordered arrived yesterday.  I tore into the package to do the usual inspection.  Is my name spelled correctly?  Is the card stock heavy enough?  Did they use the desired typeface?  Yes. Yes. And Yes.  But I needed to ask one additional question: Does the QR code link correctly?   I know what you are thinking:  What is a QR Code and why is it on your business card?  Let’s try an experiment. Read more…

Don’t forget, however – you can learn about Jason but just using your QR Code reader right now….

Sneak Peak of the Week Ahead

That was it for last week. What’s coming in the week ahead? Here you go -

  • Mike Sanders has a piece about our wonderful canine friends and how they are being used for those with special needs.
  • Sarah Keogh will be investigate the role and responsibility of our schools to warn parents about potential health problems involving their children
  • Jon Stefanuca will be taking a look at ovarian cancer and suggesting some key issues to discuss with your physician
  • Jason Penn will be telling us more about stroke and a very interesting problem that his research has revealed
  • I will be writing about a brand new project we are starting to take our social networking to a whole new level – stay tuned.

Again – many thanks to all who stopped by. Take a few minutes, read our posts and maybe have some interesting topics for discussion this weekend after reading last week’s Eye Opener.

Have a great weekend, Everyone!



Hungover Surgeons: Watch Out! There Is Nothing Between You and Their Scalpel!

Friday, April 29th, 2011

If you need surgery, you might want to ask your physician not to drink the night before the surgery. According to a recent study, surgeons are a lot more error-prone when operating after a night of drinking.  Sixteen medical student (residents) and eight surgeons participated in the study. They were each asked to perform simulated laparoscopic surgeries without any drinking the night before. Then, they were all invited out to dinner and were asked to drink alcohol as they pleased until they felt intoxicated.  The next day, each participant was asked to perform the same simulated surgeries, and the results were quite surprising.

Each medical student had made an average of 19 errors during surgery.  Their sober counterparts made an average of eight errors. On a side note, the fact that so many errors were made even without any drinking is not making me feel warm and fuzzy at all.  It can take one error, not eight or 19, to seriously injure a patient.

The licensed surgeons did not do much better. The ones who drank had about a 50 % spike in the error rate. Wow!  So, if you see your surgeon ordering yet another Brain Hemorrhage ( 1 part peach schnapps, splash of Irish cream, and a dash of Grenadine) the day before your surgery, you might want to buy him a Virgin Bloody Mary.

Just how prevalent is alcohol abuse among surgeons?

What is the practical importance of this information?  If alcohol impairs surgical performance and alcohol abuse is common among physicians, how safe are we as patients? A number of studies seem to support the conclusion that physicians are more likely to abuse alcohol than other professionals. For example, a study published in the Journal of Addiction, examined trends of alcoholism among male doctors in Scotland. Apparently, as many as 50% of the doctors found to have health problems liable to affect their professional competence were also found to have a drinking problem. According to the same study, the higher rate of liver cirrhosis among doctors suggests that doctors are at a higher risk for alcoholism.  Maybe it has something to do with the wide availability of quality scotch.

Another study published in the Journal of the American Medical Association analyzed the rate of substance abuse among U.S. physicians. Apparently, they are not that different from their Scottish counterparts.  According to this study, U.S. physicians are more likely to consume alcohol than other professionals. I guess one good piece of news for us patients is that, although physicians were as likely to have used illicit drugs in the past, illicit drug consumption was found to be less among practicing physicians. That conclusion, however, may depend on your definition of illicit drug use. According to the same study, physicians are more likely to self-medicate with various drugs that can be just as addictive and impairing as some of the illicit drugs. By the way, it appears that physicians prefer opiates and benzodiazepine tranquilizers to “self-medicate.”

With this in mind, consider the number of surgeries that a surgeon performs a week. While the number may differ depending on the specialty, location, and other factors, many perform multiple surgeries. I have personally met orthopedic surgeons, for example, who perform as many as 5-6 surgeries a day.  If you accept the proposition that surgeons like their booze and that the average surgeon operates multiple times a week, how frequently does a surgeon end operate after a night of intoxicating frivolity?

Should hospitals regulate for patient safety?

This seems to be the ultimate inquiry. Additional research may be necessary to correlate these two variables. After all, no one wants to be operated by a surgeon whose lifestyle makes him 50% more likely to make a mistake. Nevertheless, even absent such information, hospitals and surgeons should take to heart the results of the study.  It might even be prudent for hospitals to enact regulations to prohibit surgeons from drinking the night before scheduled surgeries.

I am unaware of a single hospital that has enacted such a regulation.   Are you aware of hospital regulations designed to prohibit surgeons from drinking the night before scheduled surgeries?  Do you know of any proposed legislation in this regard?  More importantly, if you advocate for such regulations, tell our readers how to get involved. Patients Against Drunk Surgeons (PADS) may be a cause worth fighting for.

 

Image from thegospelcoalition

Week in Review: Miss our posts this past week? Catch-up now!

Saturday, April 16th, 2011

From Eye Opener’s Editor, Brian Nash: Another week gone by – where does the time go? Our bloggers this past week, Theresa Neumann, Jon Stefanuca, Jason Penn, Mike Sanders and Sarah Keogh, were – in addition to practicing law – busy on the keyboard blogging away. In case you missed any posts during the week of April 10th through the 15th, here’s your opportunity to catch-up.

The “Medical Home” – find out what it is and why you should have one!

This past week, Sarah wrote two blogs on a concept that frankly I had not heard of before – the Medical Home. Her follow-up piece on how parents in particular are using emergency departments and clinics was posted yesterday, Friday, April 15th.

In her first piece, Sarah discussed a key issue about continuity of medical care for all of us but particularly our children. While there’s no doubt that there are times when taking your child to an emergency room is the only way to go in a true emergency, is it really the right place for a child to receive primary care? You see a physician or a medical specialist such as a physician’s assistant on a one-time basis. What do they really know about your child’s complete medical history? Do they really address key issues of general health care that is essential to your child’s overall health?

Her second post addresses specifically the topic of how many in this country are using facilities such as in-store clinics and emergency rooms for minor, non-emergency care. While there is no doubt that ED’s and clinics serve a vital role in the providing of healthcare in the United States, are they being used the right way? Are clinics often the only place where many in our country can obtain care for their children? Read Sarah’s posts on What is a medical home? Do your children have one? and her follow-up piece Clinics and Emergency Rooms: Helpful or Barriers to Good Pediatric Care.

A Disturbing Report on Some Area Hospitals and their Complication Rates

Earlier in the week, the new member of our legal team, Jason Penn, wrote about a recent report from the Maryland Health Services Cost Review Commission regarding a continuing failure of several local Maryland and DC hospitals to lessen the number of patients who suffer from complications while in these institutions. P.G. Hospital Center won the dubious distinction of being first in class. Jason reports that this institution, which services many of the area’s population, was fined by the state of Maryland for the number of “complications that are unlikely to be a consequence of the natural progression of an underlying disease.” The “list” includes specified complications such as “bed sores, infections, accidental punctures or cuts during medical procedures, strokes, falls, delivery with placental complications, obstetrical hemorrhage without transfusion, septicemia, collapsed lungs and kidney failure.” For information as to how the local jurisdictions deal with these hospitals in the pocketbook and who made the list, read Jason’s blog post entitled Report Card on Failing Hospitals: Prince George’s Hospital Center Tops “Complications” List.

Learn More about Medicine and Your Health

Theresa Neumann, an in-house medical specialist in our firm, posted Spinal Stroke: An atypical cause of back pain this past week. It’s one thing to have lawyers who live and breath medicine and the law write about medical conditions; it’s quite another to have real medical specialists like Theresa educate all of us on medical matters that affect the lives of so many. Theresa brings to the public’s awareness the signs, symptoms, risks and potential treatment alternatives to a catastrophically disabling condition that many just don’t know about – until it’s too late for them.

We’ve all – unfortunately – heard about or know someone who has suffered a stroke in their brain. Well, as Theresa reports, there’s an equally devastating form of stroke that can hit our spinal cord, which can render the victim paralyzed, without control of bowel or bladder, incapable of feeling sensation and a host of other life-altering consequences. We’re always appreciative of the wonderful, educational pieces Theresa brings to our blog. This piece is no exception.

The War against Super Bugs – MRSA and CRKP – are we losing the fight?

There was a time many months ago where we all became aware of the super bug infection known as MRSA. It was in the news over and over again. Have you heard much about it lately? Silence by news media might make one think that our medical institutions have won the war and the threat of this deadly infection is over. As Mike Sanders tells us – not so quick! In his blog of this past week, Deadly Super Bugs on the rise, Mike tells us who’s winning the MRSA war to and about a newcomer in the Super Bug family – CRKP.

The news is simply not good! See what seems to be working against MRSA and don’t miss the update at the end of Mike’s post about a new prevention method using honey.

Law and Medicine

Well we are lawyers – so why not a piece about our specialty area – representing patients and families of patients against healthcare providers? This past week, Jon Stefanuca wrote what we consider to be a very important piece entitled Should you sue a healthcare provider? Some guidelines to help you decide.

Some may just be surprised about the advice Jon gives in this posting. It is not a call to arms against the medical profession or even a call to our law firm so you can sue the b*****ds! Jon offers some very important advice to those who have been through an experience with a healthcare provider and are considering whether or not they have a potential lawsuit for the injuries they have suffered.

We believe this post encapsulates in large part some principles we have been advocating for a long time. Not every bad outcome means malpractice has occurred. However, how would you – as a lay person – be able to make the distinction between what is and what is not a real medical malpractice case? In addition to Jon’s sage advice, this post links to a White Paper we did on Choosing a Lawyer – a Primer. We hope if you have unfortunately found yourself faced with this issue of whether you should sue or not that you will find this blog by Jon informative and helpful in making your decision.

A Sneak Peak of the Week Ahead

As you can see, our bloggers were quite busy last week. Well, this coming week will be no different. The days ahead will be consumed with representing our clients in depositions, investigations, filing pleadings and court appearances….and writing and posting some interesting, important blogs on aneurysms (did you know they can present as back pain?), laughing gas coming back for moms in labor, sleep deprivation for nurses (and how well that plays out in your healthcare) and some other good stuff our writers are busy working on this weekend and during the week ahead.

Stay tuned – stay informed! Read the Eye Opener and tell your friends about us too! …and don’t forget to join our social networking communities on Facebook and Twitter.