Archive for the ‘Research’ Category

Simulation Labs: Helping Teach Nurses in Baltimore

Tuesday, September 27th, 2011

From nursing.jhu.edu

Any one who has ever had a hospital stay or knows a loved one or friend who has been in the hospital knows that the nurses play a vital role in caring for patients. Nurses do many of the day-to-day activities of caring for patients in hospitals and clinics. They are also often the first ones at the bedside if a problem arises – so -isn’t it essential that nurses be well trained in all forms of emergency procedures? Even when doctors are present, nurses often play vital roles in assisting the doctors in providing life-saving care to patients.

Law and Medicine Intersect Once Again

I have recently been working on a case in which both doctors and nurses were present during an in-hospital delivery that ended with a significant injury to the child. During the delivery, a problem was encountered that has a low incidence rate during deliveries.  In considering this problem, I wondered just how frequently doctors and nurses are able to practice the skills they would need to successfully and calmly deliver a baby in a situation like this.  Faced with this “emergency” situation, how many of the doctors and nurses in the room had not experienced this problem before? For those who had –  just how much “experience” did they bring to the problem they were facing?

Simulations Rooms and Simulation Patients Provide Training Opportunities

Thankfully, technology is making it more feasible for training healthcare providers to practice handling a myriad of clinical situations during their education process that they might otherwise not experience frequently enough for their skills to develop in real world settings. In Baltimore, the Johns Hopkins University School of Nursing (JHUSON) has simulation rooms in which nursing students are able to practice a variety of procedures and techniques using simulation patients in rooms that are designed to replicate the real patient areas of the hospital. There is also a whole family of simulators to help. This “sim fam” is not like the lifeless plastic dummies you might be imagining. They are a variety of different types of “…life-like practice manikins, including Sim Man, Vital Sim Man, Noelle with newborn, and Sim Baby [that] give nursing students the hands-on experience without the anxiety of working with actual human beings.”

Harvey the Cardiac Sim, SimNewB and Sim Man 3G  - All New Additions to the “Sim Fam”

From nursing.jhu.edu

Just this year, in March, JHUSON added Harvey to its collection of simulators.  While Harvey is new to JHUSON, he is not exactly new technology:

For almost 40 years Harvey, developed in cooperation between Laerdal Medical Corporation and Miami University Miller School of Medicine, has been a proven simulation system teaching bedside cardiac assessment skills that transfer to real patients, and remains the longest continuous university-based simulation project in medical education.

Harvey’s job is to be able to simulate “nearly any cardiac disease at the touch of a button: varying blood pressure, pulses, heart sounds, and murmurs. The software installed in the simulator allows users to track history, bedside findings, lab data, medical and surgical treatment.”  He joins a collection of other sim patients that enable healthcare providers to learn and practice critical life-saving measures such as CPR, defibrillation, intubation and yes – even the proper checking of vital signs. JHSON has adult, child and baby versions of these simulators. Some of them can even “talk” to the practicing nurses. (I wonder if they are programmed to be cooperative and informative or hostile and combative – hmmm.)

New Family Members Arrived this Past August

Even newer, in August, JHUSON added SimNewB and Sim Man 3G to the family. The SimNewB is:

…a 7 pound, 21 inch female baby, with realistic newborn traits. Students will be able to simulate a wide variety of patient conditions with her, including life-threatening ones. The department’s current Sim baby is the size of a 6 month old and is not as conducive to delivery room procedures.

She is also interactive, though she is not wireless like the Sim Man 3G. Some of the new Sim Man’s traits include “…breath sounds both anteriorly and posteriorly, … pupil reactions, [and] skin temperature changes.”

What about Obstetrics Cases?

So, what about the case I was mentioning that involved obstetrical care? Well, JHUSON also has a pregnant simulator, which is can be used to practice a whole host of obstetrically related procedures. These include “Leopold maneuvers, normal vaginal and instrumented delivery, breech delivery, C-section, and postpartum hemorrhaging, among other functions.” The JHUSON sim family also has the new Sim newborn – SimNewB.

The “Jury” Is Still “Out”

Can there be any doubt that additional hands-on practice opportunities with simulators is a good idea for situations that may not come up very often in everyday practice? Won’t it help healthcare practitioners gain skills and keep those skills up-to-date? Any opinion I might have on these issues is not based on evidence….yet. Luckily, JHSON is “…among 10 nursing schools nationwide collaborating on a landmark study to find out just how well patient simulators—high-tech manikins that respond to a nurse’s care—help prepare the nurses of tomorrow.”  I – for one – will certainly be interested in the outcome of that study.

What about you? Do you think that it makes sense for nurses in training to make use of simulation rooms and simulated patients? Would it be better for them to spend more time in real world situations doing real patient care under the supervision of experienced practitioners? What about techniques that might not come up very often?

If any of the readers of this post have used these sim patients in your training and can give us firsthand information as to how, if at all, it carried-over to make you more “experienced and skilled” when facing similar clinical situations with real patients, your comments would be most welcomed as well.

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

Can Copper Surfaces and Duct Tape Reduce Hospital Infections and Deaths?

Thursday, July 7th, 2011

Image from medgadget.com

How many times have you heard about someone entering the hospital healthy, or relatively so, and developing a dangerous infection while hospitalized? What about the number of times that you may have visited your own doctor’s office or your child’s pediatrician’s office and wondered whether the cold you got a few days later was coincidence or the result of having been in the waiting and exam rooms following other sick patients? Have you ever considered what cleaning procedures are done in hospital rooms when one patient is discharged before another takes their place?

In the past, Brian Nash and the other legal bloggers here at Eye Opener have written posts and made mention of the importance of hospital cleanliness and sterility, see the related posts below. We have been involved in cases involving the devastating results of infections. However, everyone knows that there are going to be germs in hospitals. Even the best hospitals have to work to keep the patients, rooms and visitors clean and safe.

Well, there is news that may make keeping hospitals and other health care environments less germy in the future. Two recent articles have focused on seemingly simple solutions, copper and duct tape, that may have major impacts on infection control.

Copper Surfaces Dramatically Reduce Infections by Killing Bacteria

A Reuters’ article reports that a recent study “presented at the World Health Organization’s 1st International Conference on Prevention and Infection Control (ICPIC) in Geneva, Switzerland” shows that “replacing the most heavily contaminated touch surfaces in ICUs with antimicrobial copper will control bacteria growth and cut down on infection rates.” According to the Reuters’ article:

[a]ntimicrobial copper surfaces in intensive care units (ICU) kill 97 percent of bacteria that can cause hospital-acquired infections, according to preliminary results of a multisite clinical trial in the United States. The results also showed a 40 percent reduction in the risk of acquiring an infection.

This news could have a profound impact on health-care costs, disease spread, and most importantly lives lost. If hospitals are able to replace some of their current surfaces with copper surfaces, at least in the parts of the hospital that are most frequently the source of infections, there could be a dramatic improvement in hospital-acquired infections.

Hospital-acquired infections (HAIs) are the fourth leading cause of death in the United States behind heart disease, strokes and cancer.

According to estimates provided by the Centers of Disease Control and Prevention, nearly one in every 20 hospitalized U.S. patients acquires an HAI, resulting in 100,000 lives lost each year.

From Reuters

Perhaps even more infections could be prevented if these changes could be made outside of just ICUs. For instance, perhaps copper surfaces could replace highly touched surfaces on sink handles, the doors to hospital rooms, hospital bed rails, or in out-patient surgery centers and long-term care facilities that are not housed within hospitals.

Duct Tape Warnings Keep Others Far Enough Away from Infected Patients

Image from ducttapesales.com

An article from Medicalnewstoday reports that some hospitals are using plain duct tape – just colored red – to achieve a reduction in infection rates from highly infectious patients without having to deal with the hassle and expense of all visitors or hospital personnel who enter the room having to rescrub and use new gowns every time they enter the room of an infected patient. The study looked at highly infectious diseases like C. diff that require isolation of patients and very careful hand washing to avoid spreading the infection. So how does duct tape help?

The Association for Professionals in Infection Control and Epidemiology (APIC) commissioned a study to corner off a three foot perimeter around the bed of patients in isolation. Medical personnel could enter the room unprotected if they stayed outside the perimeter. Direct patient contact or presence inside the perimeter meant a redo of the cleansing process. The concept, called “Red Box” employs red duct tape, a color used as it provides a strong visual reminder to those who enter the room to be aware.

The study found that 33% of all who entered the rooms could do so without the addition of gowns and gloves, saving the environment, hospital and patient costs, and time without compromising the patient or the medical personnel.

From Medicalnewstoday

How Else Can We Reduce Infections?

What ideas do you have for the use of copper surfaces? Do you think that copper surfaces or duct tape could make a dramatic difference in the safety of hospital admission? What about the cost? Do you think that hospitals would pay the upfront costs of replacing surfaces with copper to be able to dramatically cut infection rates? What about other low cost solutions like duct-tape around the perimeter of the bed? Can you think of other low-cost solutions that could minimize infections and maximize safety?

Related Posts:

New federal study finds ‘lax infection control’ at same-day surgery centers

FDA warning to healthcare professionals: use sterile prep pads!

Week in Review: (June 27 – July 1, 2011) Eye Opener Health, Law and Medicine Blog

Monday, July 4th, 2011

Eye Opener’s Week in Review

From the (guest) editor:  Good morning!  With the morning workout complete, I thought now would be a good time to take a look back.  We had a sneaking suspicion that with the excellent weather forecast you might spend some time outdoors.  Before you do, make sure you read our Summer Series.  This week we gave you what you need to know before you (and your little ones) head to that family BBQ.  Enjoy your Independence Day, drink a tall glass of fresh squeezed lemonade and enjoy!

–Jason Penn, guest editor

Cancer: HIV/AIDS Patients At Increased Risk

By Jon Stefanuca

As if life with HIV/AIDS is not difficult enough, researchers have also found that HIV/AIDS patients are also more prone to developing various malignancies when compared with the non-infected population. In fact, cancer is one of the leading causes ofmortality in the HIV/AIDS  population. It is estimated that 30%-40% of HIV patients will develop some type of cancer during their life time.  Read more

Skin Cancer: Types, Causes and How to Protect Yourself

By Sara Keogh

We can all agree that “skin cancer” is bad.  When we refer to skin cancer, what do we mean?  Most often we are referring to squamous cell, basilar cell or malignant melanoma.  On Tuesday, Sara described the different types of skin cancer and the  associated rates and survival statistics.  Read more

Skin Cancer Prevention: Will new FDA Rules Help?

By Sara Keogh

So Sara’s piece on Tuesday convinced you that sunscreen is necessary?  But how do you pick one?  Last week, the FDA announced new regulations of sunscreen. If sunscreens meet the new legal standards, they can use certain marketing phrases so that consumers know what level of protection will be provided by the product.  Read more

Diseases of Summer: Ticks and Lyme Disease

By Theresa Neumann

Summer is heating up, and there are lots of outdoor activities in which to participate. Along with the thermostat, however, there is also a rise in the deer tick population! This equates to an increase in Lyme disease, the most commonly reported vector-borne illness in America! Maryland, Virginia, Pennsylvania, Delaware and New Jersey all all“hotbeds” for this disease, comprising 5 of the top  12 states comprising 95% of all Lyme disease cases nationwide. Before you leave for the family picnic, you should read more

Skin Cancer Prevention: The Dangers of Tanning Beds

By Sara Keogh

It is popular to “pre-bake” before hitting the beach.  A tanning bed is often the The use of tanning beds or “indoor tanning” greatly increases a person’s risk of developing skin cancer. It is a completely voluntary exposure to UV radiation, and yet many people choose to expose themselves despite all of the risks.  Before you opt to “fake and bake,” you should read more

Sneak Peak of the Week Ahead:

The Eye Opener and its writers are excited about the week ahead too!  Here’s a sneak peak of what’s in store for you:

  • Service dogs for children:  more than just a pet
  • Legal Boot Camp is back in session and Part IV of our Cerebral Palsy tutorial.
  • And more!

 

Images courtesy of:

www.news.getaroom.com

www.topnews.net.nz

www.dsf.chesco.org

www.magazine.ayurvediccure.com

www.frenchtribune.com

 

 

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

Thursday, May 19th, 2011

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.

What is NEC?

Necrotizing enterocolitis. Never heard of it?  It is a frequent cause of mortality and morbidity in very low birth weight (VLBW) infants. The condition is typically seen in premature infants, and the timing of its onset is generally inversely proportional to the gestational age of the baby at birth, i.e. the earlier a baby is born, the later the signs of NEC are typically seen.

Initial symptoms include feeding intolerance, increased gastric residuals, abdominal distension and bloody stools. Symptoms may progress rapidly to abdominal discoloration with intestinal perforation and peritonitis and systemic hypotension requiring intensive medical support.

The diagnosis is usually suspected clinically but often requires the aid of diagnostic imaging modalities. Radiographic signs of NEC include dilated bowel loops, paucity of gas, a “fixed loop” (unaltered gas-filled loop of bowel), pneumatosis intestinalis (gas cysts in the bowel wall), portal venous gas, and pneumoperitoneum (extraluminal or “free air” outside the bowel within the abdomen). The pathognomic finding on plain films is pneumatosis intestinalis . More recently ultrasonography has proven to be useful as it may detect signs and complications of NEC before they are evident on radiographs. Diagnosis is ultimately made in 5-10% of very low-birth-weight infants (<1,500g).

httpv://www.youtube.com/watch?v=ffI5UqLA_74

The role of human milk in both prevention and treatment of NEC has long been recognized. The familiar arguments, cost, inconvenience, etc., are largely inapplicable to the very low birth weight infant. Mothers of very low birth weight infants often experience insufficient milk production, resulting in mixed feedings of human milk and formula.  Moreover, medical complications often limit the volume of feeding these infants can be given.  The analysis shifts, therefore, with the new focus on the medical needs of the child and not simply on whether or not breast feeding is convenient for Mom or whether formula is too expensive for the household budget.

Human milk, whether mother’s own or from a donor, provides significant protection against many of the known risk factors of NEC as well as therapeutic protection for the infant recovering from NEC. The study shows that enteral feeding containing at least 50% human milk in the first 14 days of life was associated with a sixfold decrease in the odds of NEC.  The stark differences in the risk of NEC, its complications and the need for surgery between babies who receive human donor milk and those who get formula signal the need for a change in feeding practices across neonatal intensive care units,” said lead investigator Elizabeth Cristofalo, a neonatologist at the Johns Hopkins Children’s Center.

Those numbers are encouraging, particularly for the vulnerable very low birth weight infant. In the absence of mother’s own milk, donor human milk could be life saving for fragile preterm infants, who are at the highest risk of developing NEC.  Undoubtedly the use of non-human milk (formula) remains an option that many parents may choose to exercise. The study, however, suggests that it is the inappropriate choice for some. I have a sneaking suspicion that they are not interested in participating in the human vs. non-human milk debate.

Question:  Have you made a decision about human vs. non-human milk?  Why did you choose one over the other?

 

Image courtesy of breastfeedingtechniques.com

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?