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Consumer-Generated Clinical Trials? Research Minus Science = Gossip

The internet, in democratizing knowledge, has led a lot of people to believe that it is also possible to democratize expertise.

– Commenter at Science Based Medicine

Regular readers of this blog know how passionate I am about protecting the public from misleading health information. I have witnessed first-hand many well-meaning attempts to “empower consumers” with Web 2.0 tools. Unfortunately, they were designed without a clear understanding of the scientific method, basic statistics, or in some cases, common sense.

Let me first say that I desperately want my patients to be knowledgeable about their disease or condition. The quality of their self-care depends on that, and I regularly point each of my patients to trusted sources of health information so that they can be fully informed about all aspects of their health. Informed decisions are founded upon good information. But when the foundation is corrupt – consumer empowerment collapses like a house of cards.

In a recent lecture on Health 2.0, it was suggested that websites that enable patients to “conduct their own clinical trials” are the bold new frontier of research. This assertion betrays a lack of understanding of basic scientific principles. In healthcare we often say, “the plural of anecdote is not data” and I would translate that to “research minus science equals gossip.” Let me give you some examples of Health 2.0 gone wild:

1. A rating tool was created to “empower” patients to score their medications (and user-generated treatment options) based on their perceived efficacy for their disease/condition. The treatments with the highest average scores would surely reflect the best option for a given disease/condition, right? Wrong. Every single pain syndrome (from headache to low back pain) suggested a narcotic was the most popular (and therefore “best”) treatment. If patients followed this system for determining their treatment options, we’d be swatting flies with cannon balls – not to mention being at risk for drug dependency and even abuse. Treatments must be carefully customized to the individual – genetic differences, allergy profiles, comorbid conditions, and psychosocial and financial considerations all play an important role in choosing the best treatment. Removing those subtleties from the decision-making process is a backwards step for healthcare.

2. An online tracker tool was created without the input of a clinician. The tool purported to “empower women” to manage menopause more effectively online. What on earth would a woman want to do to manage her menopause online, you might ask? Well apparently these young software developers strongly believed that a “hot flash tracker” would be just what women were looking for. The tool provided a graphical representation of the frequency and duration of hot flashes, so that the user could present this to her doctor. One small problem: hot flash management is a binary decision. Hot flashes either are so personally bothersome that a woman would decide to receive hormone therapy to reduce their effects, or the hot flashes are not bothersome enough to warrant treatment. It doesn’t matter how frequently they occur or how long they last. Another ill-conceived Health 2.0 tool.

When it comes to interpreting data, Barker Bausell does an admirable job of reviewing the most common reasons why people are misled to believe that there is a cause and effect relationship between a given intervention and outcome. In fact, the deck is stacked in favor of a perceived effect in any trial, so it’s important to be aware of these potential biases when interpreting results. Health 2.0 enthusiasts would do well to consider the following factors that create the potential for “false positives”in any clinical trial:

1. Natural History: most medical conditions have fluctuating symptoms and many improve on their own over time. Therefore, for many conditions, one would expect improvement during the course of study, regardless of treatment.

2. Regression to the Mean: people are more likely to join a research study when their illness/problem is at its worst during its natural history. Therefore, it is more likely that the symptoms will improve during the study than if they joined at times when symptoms were not as troublesome. Therefore, in any given study – there is a tendency for participants in particular to improve after joining.

3.  The Hawthorne Effect: people behave differently and experience treatment differently when they’re being studied. So for example, if people know they’re being observed regarding their work productivity, they’re likely to work harder during the research study. The enhanced results therefore, do not reflect typical behavior.

4. Limitations of Memory: studies have shown that people ascribe greater improvement of symptoms in retrospect. Research that relies on patient recall is in danger of increased false positive rates.

5. Experimenter Bias: it is difficult for researchers to treat all study subjects in an identical manner if they know which patient is receiving an experimental treatment versus a placebo. Their gestures and the way that they question the subjects may set up expectations of benefit. Also, scientists are eager to demonstrate positive results for publication purposes.

6. Experimental Attrition: people generally join research studies because they expect that they may benefit from the treatment they receive. If they suspect that they are in the placebo group, they are more likely to drop out of the study. This can influence the study results so that the sicker patients who are not finding benefit with the placebo drop out, leaving the milder cases to try to tease out their response to the intervention.

7. The Placebo Effect: I saved the most important artifact for last. The natural tendency for study subjects is to perceive that a treatment is effective. Previous research has shown that about 33% of study subjects will report that the placebo has a positive therapeutic effect of some sort.

In my opinion, the often-missing ingredient in Health 2.0 is the medical expert. Without our critical review and educated guidance, there is a greater risk of making irrelevant tools or perhaps even doing more harm than good. Let’s all work closely together to harness the power of the Internet for our common good. While research minus science = gossip, science minus consumers = inaction.

Major Surgery Versus Ultrasound Treatment: Insurance Makes The Difference

Photo Credit: FUS Foundation

Photo Credit: FUS Foundation

Did you know that one in three women will have a hysterectomy (surgical removal of the uterus) by age 60? It is the second most common surgical procedure among women in the United States. But the question is: are they all necessary? I had a fascinating interview with Dr. Elizabeth Stewart from the Mayo Clinic about some of the reasons behind the potential excess of this type of surgery. You may be surprised to learn that insurance reimbursement guidelines may have something to do with it.

Dr. Val: Women often undergo hysterectomies to treat painful fibroids (benign growths in the uterus). What do women need to know about their fibroid treatment options?

Dr. Stewart: They need to know that they have many different treatment options for uterine fibroids. A hysterectomy is not their only choice. Women should ask their doctor to explain all their options and also make sure that they have the correct diagnosis – menstrual cramping and heavy bleeding doesn’t necessarily mean you have fibroids.

Nowadays we can treat fibroids with hysterectomy, uterine artery ablation, or MRI-guided focused ultrasound surgery (MRgFUS). MRgFUS is a nearly painless procedure where we use focused ultrasound waves to destroy fibroid tissue via heat transfer. I know one woman who went back to work 2 hours after the procedure. Recovery from a hysterectomy or uterine artery ablation can take weeks to months.

Dr. Val: What are some of the advantages and disadvantages of treating fibroids with focused ultrasound?
Read more »

Guest Blog Post At Disruptive Women In Healthcare

Thanks to the ladies at the Disruptive Women In Healthcare blog for hosting me during my period of homelessness. Here’s an excerpt from my post:

Of course, modifying behavior is the holy grail of medicine. We physicians wish that our patients would optimize their diet and exercise choices and become fully compliant partners in managing their chronic diseases. Unfortunately, fifty percent of patients forget to take their meds and over 30 percent don’t refill their prescriptions. Twenty percent say they don’t take the full course of treatment and fifty percent of patients don’t take drugs as directed. What’s a doc to do?…

To read the rest of the post, please click here.

Is The VA Prepared To Handle The Health Needs Of Women Veterans?

Currently, women make up about 15 percent of the active duty forces in Iraq and Afghanistan and by the year 2020 one in five young veterans will be female. Walter Reed and other Veterans Affairs (VA) hospitals are treating more and more injured women than ever before – but are these hospitals prepared to handle all the distinctively female health issues that will be coming their way?

This is the subject of a CBS news segment being released tomorrow night, June 19th. The producers gave me an early head’s up so that I could alert my readers to it, and I immediately reached out to Revolution Health expert, Dr. Iffath Hoskins, for comment.

Dr. Hoskins is well-versed in both military healthcare and women’s health. She completed an obstetrics and gynecology residency at the National Naval Medical Center in Bethesda, Md. and a maternal fetal medicine fellowship at the Uniformed Services University of the Health Sciences. (This includes the National Naval Medical Center and the Walter Reed Army Medical Center in Washington, D.C.). She has been the Chair and Residency Director of the Department of Obstetrics and Gynecology at the New York University Downtown Hospital, and the Chief of Obstetrics at Bellevue Hospital. She currently serves as the Senior Vice President, Chairman and Residency Director in the Department of Obstetrics and Gynecology at Lutheran Medical Center in Brooklyn, N.Y.

Dr. Val: What sort of gaps in care will women military personnel encounter at the VA?

Dr. Hoskins: First of all, the gaps in care are not only for women personnel, but there are gaps in care for all personnel due to resource constraints at the VA hospitals. When the VA system was originally conceived there was no need to support women’s health services as very few women worked as full time military personnel. Now about 15% of military personnel are women. Of course, women have many of the same sorts of health problems as men (migraine headaches, high blood pressure, heart disease, etc.) and the VA system is adept at handling those concerns. But when it comes to female reproductive health, contraception, pregnancy, and disorders of menstruation, the VA system is simply not equiped to handle that.

Dr. Val: How can the VA adapt to serve this influx of women veterans?

Dr. Hoskins: First of all the VA needs to recognize the unique needs of women and identify personnel within the VA system who are capable of meeting these needs. Even in the field some of the rules surrounding uniform requirements have not been adapted to suit the needs of women. During wartime and/or deployments, resources for menstruating women (eg private toiletries, contraception, etc) were scarce. So, the women often bled onto their uniforms and this created problems with personal hygeine.

Dr. Val: Does the VA treat military wives and daughters? What sort of care are they currently getting and could women soldiers benefit from those services?

The VA does not treat dependents because they were designed to meet the healthcare needs of individuals returning from serving their countries in a wartime model. TRICARE is the coverage provided to them and many large hospitals and clinics accept this insurance nationwide.

Dr. Val: Do you think that physical disfigurement affects women differently than men?

Dr. Hoskins: I don’t believe that this is an issue. Women soldiers are tried and true professionals. They know that they are in the military to serve their community, unit, battalion, company, and country and have accepted the potential consequences of death and disfigurement. After working closely with these women for 26 years, I know that they consider themselves soldiers, sailors, marines, and airmen first and foremost and are committed to doing whatever is expected and required of them.

When I was deployed in Operation Iraqi Freedom as one of the highest ranking Reserve Marine physicians, I conducted a research survey to explore the reactions of returning veterans to the large number of women involved in the operation. We asked them how they felt about having women living and working with them shoulder-to-shoulder in times of war, and whether it made a difference to the completion of the mission. We surveyed about 8000 military personnel, and 40% of them expressed concern about having women on the battlefield.

Dr. Val: What specific concerns did they have?

Dr. Hoskins: The respondents believed that the physical load and demand on the young men was greater than on the young women. Sometimes this wasn’t because of differences in physical strength but culturally the men wanted to help the women with their loads, and the women sometimes resented the help.The respondents noted that women who needed to retrieve their fallen comrades behaved differently than their male peers (the women were more likely to cry, which was frowned on by the men). Because the women and men were segregated in their sleeping quarters, accounting for everyone’s whereabouts became more difficult.

Overall the survey clearly showed that there was never a concern about whether or not the women were weapons-qualified. The respondents did not believe that the presence of women affected the success of their mission – but it certainly created distractions.

*Listen To The Podcast With Dr. Hoskins*This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.

New Online Pregnancy Resource For Women

I wanted to let you know about a wonderful new online resource for pregnancy education here at Revolution Health. I helped to develop the Advanced Answers Pregnancy Center along with a team of experts from Columbia University’s Department of Obstetrics and Gynecology. It is a comprehensive, multi-media educational tool to help women (especiallly high risk moms-to-be) learn about their pregnancy and birthing options.

I’m very proud of Dr. Mary D’Alton’s team for their outstanding work on this unique center. Where else on the Internet can you find cutting edge, consumer-friendly pregnancy information written by the top minds in maternal health? I guess you could say that I feel as if I’m the proud new mom of a pregnancy education center!

I also want to tell you about another exciting tool that I helped to build: the momScore. This is the first heatlhcare quality index targeted specifically for women. With the help of an interactive map of the United States, women can compare how their home states stack up against others on women’s health issues. How mom-friendly is your state? View the momScore tool to find out.

Thanks for checking out my two new “babies” – knowledge is power, so go get some!

*Advanced Answers Pregnancy Center*

*The momScore*This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.

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