By: Aimee Edell, MD
Gratefully returning to daylight after a two-week stint assigned to the night float service, I’ve been observing the week’s events with great mirth. It seems bedbugs have continued on their squirm-inducing rise to power and glory, causing panic on Park Avenue; the iPhone design flaw, dubbed “antennagate”, has threatened to undermine Apple’s ultimate superiority on the smartphone front (1); and Sarah Palin has found herself in yet another public snafu, this time mixed up with the unlikely likes of William Shakespeare. (2) Things look like they are progressing nicely in the Gulf and in Washington, for a change. BP is reportedly “days away” from finishing the highly-anticipated relief well that will – cross your fingers – kill its most unseemly gusher (although what’s with that brewing tropical storm?), and Obama has finally signed the sweeping financial regulation bill designed to protect main street consumers. (3)
Medical news this week has been equally interesting, and arguably as entertaining. An anti-HIV microbicide shows exciting potential; doctors muse on what would happen if they open up their notes to patients’ scrutiny; pregnant closet coffee drinkers can breathe a sigh of relief (in moderation!); and a bit of light has been shed on the best therapy for ACL tears in young athletes. Enjoy!
An ounce of prevention is worth a pound of cure, and nowhere is this more a propos than in the world of HIV. A source of frustration for many, HIV infection prevention strategies have repeatedly come up short over the past several decades, and the few modalities that have been successful (male circumscision, vaccine combinations, and STI treatment clinics) have failed to squarely capitalize on that most explosive potential resource – women – with their efforts. That is, until now. Enter the CAPRISA 004 trial and its tenofovir 1% vaginal gel, recently made public in ScienceExpress. (4) It was destined to be unique from the start, as one of the first gels to include an antiretroviral agent, and the results so far are making headlines around the world. In a double-blind, randomized, placebo-controlled study of 889 HIV-uninfected sexually active women ages 18 to 40, researchers found that when applied within 12 hours of a sex act, the tenofovir gel reduced the incidence of new HIV infection by 39%. In women whose adherence was considered high, using the gel decreased HIV acquisition by 54%. To put that in perspective, the effectiveness of male circumcision in preventing HIV acquisition was found to be 57% (5,6,7), while an HIV vaccine combination tested in Thailand amounted to a 39% reduction in acquisition. The numbers are promising, but alone do not tell the whole story; in a world where women often have no control over condom use or the fidelity of their sexual partners, tools like microbicides afford them a viable means of self-protection, and become a powerful addition to the anti-HIV arsenal that could well change the landscape of future HIV control strategy. The study needs to be repeated on a larger scale to further assess safety, acceptability, and the role of varying adherence, but the results are encouraging and this is an area to keep an eye on.
In the Spirit of Patient Partnership
Now imagine yourself in a busy primary care practice. Your 9:30 patient has arrived for his blood pressure follow-up visit and you enter the room to find him holding a copy of your note from his initial appointment. You notice that beside most of the bulleted recommendations in your plan, he has written a checkmark. He looks up as you enter and asks, “Doc, I’ve been watching sodium in my diet like you said, and taking walks everyday too, but my blood pressure at home is still running 145/90’s . . . I saw that you wrote about starting hydrochlorothiazide if diet and exercise don’t work. Is it time for that now? Also, would you mind going over the results of my urinalysis? I want to make sure my kidneys are okay.” In this scenario, your patient has had access to your clinic note so he understands your plan for treating his blood pressure and has signed on to do his part, in this case, participate in lifestyle changes in earnest and monitor his blood pressure at home. You astutely realize that by giving your patients easy access to their own clinic notes, you have at once improved the health-literacy of your patients and heightened the efficiency and productivity of your clinic. This dreamy scenario is what some researchers hope they might achieve with the OpenNotes project, a year-long observational study taking off in three hospitals in Massachusetts, Pennsylvania, and Washington state. (8)Giving patients access to their medical records is not a new concept, but giving them easy access, and encouraging them to do so, is new. The primary care physicians involved in the study hope it will improve patient-doctor communication, and ultimately clinic productivity, but at the same time voice concerns ranging from how the change will affect their time as administrative staff field calls from patients with numerous questions and corrections, to medicolegal implications, to how patients will react when called “SOB [short of breath].” Some physicians question whether their notes will ever be fully understandable to patients. At the end of the study, participants on both sides of the stethoscope will be asked about their experiences. If the idea is palatable, the technology to make medical records widely and easy accessible through online portals is already in place. The study is scheduled to begin this summer, and when the results come in, we may find ourselves entering into a new era of unprecedented patient-physician partnership.
A Cup a Day . . . Appears Okay in Pregnancy
I remember looking at one of my clerkship preceptors one morning. She was bleary-eyed as she stared at her schedule, her right arm protectively held close to her 4-month pregnant belly. “Is everything alright?” I asked. “Yes,” she said with a sigh, “it’s just -” and she looked at the ceiling, as if searching for some source of strength there, “ – no caffeine in pregnancy.” Well, I hope she’s reading this next report! This month in Obstetrics & Gynecology, the American College of Obstetricians and Gynecologists has released a committee opinion on the effects of caffeine consumption on spontaneous miscarriage and preterm birth. (9) After reviewing four large studies on the subject, the committee found no evidence to support an effect of moderate caffeine intake (less than 200 mg daily – a cup of coffee delivers 137 mg) on spontaneous miscarriage and preterm birth. There were discrepancies in outcomes with regards to higher caffeine intake (> 200 mg), possibly due to differences in patient population and study design, so the committee stopped short of commenting on the effects of larger amounts of caffeine, but today the take home message is that pregnant women can enjoy their morning cup of joe with peace of mind.
“Doc, do I need surgery?”
Musculoskeletal complaints are one of the most commonly cited reasons for outpatient provider visits. As the quality and intensity of elite and non-elite athletic programs increases, the primary care physician will be faced with a growing number of athletes presenting with injuries sustained on the field. This month in New England Journal of Medicine, a study by Frobel and colleagues sheds light on the proper management of anterior cruciate ligament (ACL) tears in young nonelite athletes. (10) In this randomized, controlled trial, 121 young, healthy adults with acute ACL injuries were entered into treatment regimens consisting of either structured rehabilitation plus early reconstruction of the ACL, or structured rehabilitation with the option of surgical repair if needed. Investigators followed the young athletes for two years, assessing their status in terms a predetermined scale called the Knee Injury and Osteoarthritis Outcome Score designed to assess pain, functionality, symptoms, and knee-related quality of life. At the end of the study, consistent with prior studies, early surgical reconstruction was not shown to be superior to rehabilitation with optional delayed surgery, and as only 40% of the delayed optional surgery group ever went on to seek surgical correction in the 2-year study period, a trial of rehabilitation prevented 60% of surgeries. As surgery is expensive and the gateway to numerous complications, it would seem that the study would favor initial nonoperative management over early surgery. However, the study does have some important limitations. For one, the follow up period only lasted 2 years. It is possible that some participants may have elected to have surgery after the 2-year period due to persistent disability, thus reducing the magnitude of surgeries avoided. Secondly, there was no sham surgery control group, so neither the subjects nor their assessors were blinded, potentially introducing bias. And finally, the authors themselves note that the generalizability of this study is limited by the specificity of the rehabilitation program used. It is possible that the results might not be reproducible with different rehabilitation programs. In summary, this study shows that early reconstruction is likely not superior to initial nonoperative management with rehabilitation, and that the latter is a worthy therapeutic option when assessing patients.
Aimee Edell is a first year internal medicine resident at NYU Langone Medical Center
Peer Reviewed by Danise Schiliro, Contributing Editor, Clinical Correlations
Picture Courtesy of Wikimedia Commons
4 Karim Q, Karim S, Frolich J, et al. Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women. Sciencexpress. 19 July 2010. Available from: http://www.sciencemag.org/cgi/gca?gca=science.1193748v1&sendit.x=64 &sendit.y= 8&sendit=Get+all+checked+abstract%28s%29
5 Auvert B, et al. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med 2. 2005 e298.
6 Bailey RC, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007 369, 643-656.
7 Gray RH, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007 369, 657-666.
8 Delbanco T, et al. Open notes: doctors and patients signing on. Ann Int Med. 2010. 153:121.
9 Committee on Obstetric Practice. Committee Opinion. Moderate caffeine consumption during pregnancy. Obstectrics and Gynecology. 2010. 116:467.
10 Frobell RB, et al. A randomized trial of treatment for acute anterior cruciate ligament tears. NEJM. 2010. 363:331.