New Brain Death Guidelines for Children Released

Allison Gandey

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August 31, 2011 — New brain death guidelines for infants and children have been issued. Updated for the first time in nearly 25 years, the recommendations provide step-by-step instructions to help guide clinical decision making.

"These revised pediatric death diagnostic guidelines are intended to provide an updated framework in an effort to promote standardization of the neurologic examination and use of ancillary studies," reports the task force, led by Thomas Nakagawa, MD, from Wake Forest University School of Medicine in Winston-Salem, North Carolina.

A standardized checklist, provided to help ensure all components of the examination are carried out, is included as an appendix, the authors note, but they emphasize the importance of supporting families going through the loss of their child.

"Diagnosing brain death must never be rushed or take priority over the needs of the patient or the family," they conclude. "Physicians are obligated to provide support and guidance for families as they face difficult end-of-life decisions and attempt to understand what has happened to their child."

http://pediatrics.aappublications.org/content/early/2011/08/24/peds.2011-1511.full.pdf 

Also involved in the guidelines, published online
August 28 in Pediatrics, is the Society of Critical Care Medicine, the American Academy of Pediatrics, and the Child Neurology Society. The document was also reviewed and endorsed by a number of other societies, including the American Academy of Neurology.

Because of insufficient data in the literature, recommendations for preterm infants younger than 37 weeks' gestational age are not included in these recommendations.

2 Exams

"[B]rain death in term newborns, infants and children is a clinical diagnosis based on the absence of neurologic function with a known irreversible cause of coma," the authors write.

The guidelines state that hypotension, hypothermia, and metabolic disturbances should be treated and corrected. Medications that can interfere with the neurologic examination and apnea testing should be discontinued, allowing for adequate clearance before proceeding.

The task force calls for 2 examinations, including apnea testing, separated by an observation period. They recommend that examinations be performed by different attending physicians. However, apnea testing may be performed by the same physician.

The guidelines recommend an observation period of 24 hours for term newborns to children aged 30 days. For infants and children up to age 18 years, the guidelines call for a 12-hour observation period.

The first examination determines whether the child has met the accepted neurologic examination criteria for brain death, the authors write. The second confirms brain death based on an unchanged and irreversible condition.

The task force suggests that assessment of neurologic function after cardiopulmonary resuscitation or other severe acute brain injuries be deferred for 24 hours or longer if there are concerns or inconsistencies in the examination.

Apnea testing to support the diagnosis of brain death must be performed safely and requires documentation of an arterial PaCO₂ level 20 mm Hg above the baseline and 60 mm Hg or higher, with no respiratory effort, during the testing period. If the apnea test cannot be safely completed, an ancillary study should be performed.

The guidelines state that "[a]ncillary studies (electroencephalogram and radionuclide cerebral blood flow) are not required to establish brain death and are not a substitute for the neurologic examination."

The task force says these studies may be used when components of the examination or apnea testing cannot be completed safely because of the underlying medical condition. They can also be considered if there is uncertainty about the results of the neurologic examination, if a medication effect may be present, or to reduce the interexamination observation period.

When ancillary studies are used, a second clinical examination and apnea test should be performed, and components that can be completed must remain consistent with brain death.

The complete guidelines are available online.

Last June, new brain death guidelines for adults were issued. Unlike these recommendations, the guidelines call for only 1 exam. "The original guideline did not require this either," Gary Gronseth, MD, from the University of Kansas, Kansas City, told Medscape Medical News at the time. "Some people may object, but we found that 1 exam was sufficient."

The guideline authors have disclosed no relevant financial relationships.

Real-World Predictors of Success of Rituximab in RA: Viewpoint

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Highest Clinical Efficacy of Rituximab in Autoantibody-Positive Patients With Rheumatoid Arthritis and in Those for Whom No More Than One Previous TNF Antagonist Has Failed: Pooled Data From 10 European Registries

Chatzidionysiou K, Lie E, Nasonov E, et al
Ann Rheum Dis. 2011;70:1575-1580.

Background

Rituximab is a B-cell-depleting therapy that has been widely used over the past several years for the treatment of rheumatoid arthritis (RA). Typically, rituximab is used for RA after another biologic disease-modifying antirheumatic drug (DMARD) such as an anti-tumor necrosis factor agent has failed to control RA; however, it is still not clear what the optimal treatment strategy for rituximab should be. These authors used a large-scale pooled database of patients with RA in Europe that were treated with rituximab to investigate the real-world predictors of efficacy of this agent.

Study Summary

The authors identified 2019 patients from 10 European countries treated with rituximab at a dose of 2 1000 mg infusions given 2 weeks apart. They evaluated the 3- and 6-month efficacies of this treatment measured by the 28-joint count Disease Activity Score (DAS28).

The mean age of these subjects at the time of rituximab treatment was 54-years-old, 80% were female, the mean duration of RA was approximately 12 years, approximately 86% were rheumatoid factor positive, and approximately 77% were cyclic citrullinated peptide antibody (CCP) positive (although not all patients had CCP assessed). At the time of first use of rituximab, the mean DAS28 at baseline was 5.8, approximately 77% were on concomitant DMARDs, and from data on 1844 patients, 63% had failed at least 1 biologic agent.

Overall, the DAS28 improved in most patients after they received rituximab, and by 6 months, the number of patients with high disease activity (DAS28 > 5.1) had decreased from 73% to 26% (but there were substantial numbers of subjects without available data at the 6-month mark). In multivariate analyses, the predictors of a good EULAR response (DAS improved by > 1.2, and an overall score of ≤ 3.2^[1]) before initiation of rituximab were: (a) use of ≤ 1 biologic DMARD, (b) lower baseline DAS28 level, and (c) and anti-CCP positivity. The authors also found that there was a trend for patients using concomitant oral DMARDs to have improved DAS28 scores at 3 and 6 months when compared with those not taking DMARDs.

The authors conclude that rituximab was most effective in seropositive patients when used as the first biologic agent, or before the failure of > 1 anti-tumor necrosis factor agent.

Viewpoint

Controlled clinical trials can provide only limited amounts of information about drug efficacy; therefore, the approach these authors used to evaluate the "real-world" efficacy of rituximab for RA is to be applauded. Take-home points from their study are that certain patient groups may have better responses to rituximab therapy, including those treated with rituximab as a first-line biologic or before the use of multiple anti-tumor necrosis factor agents, those taking concomitant DMARDs, and those with CCP positivity (supporting findings of other studies^[2,3]; although the improvement seen in this study in patients that were sero-negative suggests that rituximab is still effective even in absence of rheumatoid factor/CCP positivity). However, because this is not a controlled trial, these findings should be interpreted with some caution because there may other factors not accounted for that influence these findings, although this study should help set the stage for additional studies that can provide more specific guidance for the use of rituximab in RA.

Highest clinical effectiveness of rituximab in autoantibody-positive patients with rheumatoid arthritis and in those for whom no more than one previous TNF antagonist has failed: pooled data from 10 European registries.

Ann Rheum Dis.  2011; 70(9):1575-80 (ISSN: 1468-2060)

Chatzidionysiou K; Lie E; Nasonov E; Lukina G; Hetland ML; Tarp U; Gabay C; van Riel PL; Nordström DC; Gomez-Reino J; Pavelka K; Tomsic M; Kvien TK; van Vollenhoven RF
Correspondence to Katerina Chatzidionysiou, Arbetargatan 28A, 1tr, c/o Gunilla Johansson, 11245 Stockholm, Sweden; aikaterini.chatzidionysiou@karolinska.se.

OBJECTIVE: To assess the 6-month effectiveness of the first rituximab (RTX) course in rheumatoid arthritis (RA) and to identify possible predictors of response.

METHOD: 10 European registries submitted anonymised datasets (baseline, 3- and 6-month follow-up) from patients with RA who had started RTX, and datasets were pooled and analysed. Heterogeneity between countries was analysed by analysis of variance. Predictors of response were identified by logistic regression.

RESULTS: 2019 patients were included (mean age/disease duration 53.8/12.1 years, 80.3% female, 85.6% rheumatoid factor (RF) positive and 76.8% (456/594 patients) anti-cyclic citrullinated peptide antibodies (anti-CCP) positive). For these patients an average of 2.7 disease-modifying antirheumatic drugs (DMARDs) (range 0-10) had failed, and RTX was given as the first biological agent in 36.6% of patients. There was significant heterogeneity between countries for several baseline characteristics, including the number of previous biological agents. Disease Activity Score based on 28 joint counts (DAS28) decreased from 5.8±1.4 at baseline to 4.2±1.4 at 6 months (p<0.0001) and 22.2%/42.5% achieved European League Against Rheumatism (EULAR) good/moderate response. Larger 6-month improvement in DAS28 was observed in RF-positive and anti-CCP-positive versus seronegative patients. The following predictors of EULAR good response at 6 months were identified in a multivariate analysis: anti-CCP positivity (OR=2.86, p=0.003), number of previous DMARDs (OR=0.84, p=0.06), ≤1 previous biological agents (OR=1.89, p=0.04), baseline DAS28 level (OR=0.74, p=0.003).

CONCLUSION: In this large observational cohort of patients with RA treated with RTX, seropositive patients achieved significantly greater reductions in DAS28 at 6 months than seronegative patients. Effectiveness was best when RTX was used as the first biological agent or after failure of no more than one anti-tumour necrosis factor agent.

EHRs Improve Care, Outcomes for Patients With Diabetes

Robert Lowes

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August 31, 2011 — Patients with diabetes were more likely to meet care standards, such as annual eye exams, and outcome standards, such as blood glucose control, if their physician used an electronic health record (EHR) instead of a paper chart, according to a study published today in the New England Journal of Medicine.

Such good news about EHR usage has been scarce, comments lead author Randall Cebul, MD, a professor of medicine, epidemiology and biostatistics at Case Western Reserve University, Cleveland, Ohio, and coauthors.

Government efforts to promote EHRs anticipate "a quality-related financial return," they write. However, "available studies have shown few quality-related advantages of [EHRs] over traditional paper records."

To put the question to the test, the authors studied how 46 medical practices in and around Cleveland cared for 27,207 adults with diabetes. The practices, 33 of which relied on EHRs, publicly report their clinical performance in managing chronic illnesses as members of a group called Better Health Greater Cleveland (Dr. Cebul serves as its president). All 13 of the paper-based practices were so-called safety-net providers that serve a high proportion of patients considered vulnerable on account of lower income, lower education, lack of insurance, and other factors. Thirteen of the 33 EHR-based practices also qualified as safety-net providers, although the risk factors for their patients were less pronounced than for those in the paper-based practices.

The different categories of practices were compared on the basis of 4 standards of care and 5 clinical outcomes. The 4 standards of care were:

• Receipt of a glycated hemoglobin value;
• Kidney management, defined as testing for urinary microalbumin or prescription of an angiotensin-converting enzyme inhibitor or an angiotension-receptor inhibitor;
• An eye exam to screen for diabetic retinopathy; and
• Administration of a pneumococcal vaccine.

For the 5 clinical outcomes, the authors chose:

• A glycated hemoglobin value below 8%;
• Blood pressure below 140/80 mm Hg;
• A low-density lipoprotein cholesterol value below 100 mg/dL or documented prescription for a statin medication;
• A body mass index below 30 kg/m²; and
• Nonsmoking status.

EHRs May Not Fully Account for Performance Gap

When the authors looked at composite results, patients in the EHR-based practices scored 35.1 percentage points higher on care standards and 15.2 percentage points higher on outcome standards after an adjustment for income, education, insurance status, ethnic group, and other factors. The digital practices were ahead of the paper ones 25 percentage points on eye exams and nearly 11 percentage points for blood glucose control.

When the paper-based practices were compared to safety-net counterparts equipped with EHRs, the latter still came out on top in terms of composite care and outcome scores, although by smaller margins than when all EHR-based practices were studied.

The authors cautioned that they could not conclude that EHRs were the sole explanation for the quality differences. Causal wildcards include "the participation of exceptional EHR-based organizations, a nonrepresentative sample of paper-based organizations and inadequate adjustment for patient characteristics." They also noted that their study would have provided more compelling evidence for an EHR edge if they had measured before-and-after performance for groups that had switched from hard copy to software.

All authors state that they are active participants in Better Health Greater Cleveland, a regional collaborative supported by the Robert Wood Johnson Foundation and other sources. Their disclosure forms are available with the full text of this article.

  N Engl J Med. 2011;365:825-833. Published online August 31, 2011.

Shopping in Scrubs: OK or Not? Physicians Are Talking

Brandon Cohen

Authors and Disclosures

Posted: 08/26/2011

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Are scrubs only for the operating room, or are they appropriate for everyday use? Should they be worn to the supermarket or a school board meeting? A recent discussion on Medscape's Physician Connect (MPC), an all-physician discussion group, brought out some strong opinions on where scrubs are appropriate and where they are not -- and on what motivates those who wear them in public.

An emergency medicine doctor kicked things off with an eloquent rant: "Is it just me, or is anyone else upset seeing staff wearing scrubs to go shopping? Yesterday, I saw a woman at the supermarket wearing scrubs and her white lab coat on top. Won't this behavior give the public the impression that scrubs aren't clean, but just a fashion statement?"

Should staff be allowed to wear scrubs while shopping?

Yes, it's not a big deal if they carry dirt and germs

Only interns and residents who have no time to do laundry

No, it gives the wrong impression to the public

Many colleagues agreed: "I think the issue is status. You look cool and medical in scrubs," wrote a disparaging general practitioner (GP).

"Some people seem to like the attention that wearing them in public brings: I guess because wearing your stethoscope around your neck is just a bit too obvious?" added another GP.

A third GP continued in this vein: "Are you really so, so busy that you didn't have time to change into street clothes? Really? You couldn't spare that 3 minutes? Most of the time it's a desire to be recognized as a medical professional of some sort. Pretty pathetic in my opinion."

However, some who regularly shop in scrubs, particularly emergency medicine doctors, pushed back. One wrote: "This is ridiculous. I work my butt off. I put on scrubs when I go to work and take them off when I go home. I live 40 miles away "in the middle of nowhere," as my wife likes to say. When I'm coming home, I call her to see if she needs anything -- if so, I stop and buy it."

"Wearing scrubs to go shopping is attention-seeking behavior. However, swinging into the grocery store or popping into a store to get some specific thing that you need after having been at work and, oh by the way, wearing scrubs is just practicality," wrote another emergency medicine doctor.

A third emergency medicine doctor continued this defiant tone, and even expanded the field of acceptable venues for scrubs: "Get a life. I've been to all my kids' programs in scrubs, and because I'm on the school board, I go to the meetings in scrubs before doing my night shifts."

A GP quickly responded: "Alternatively, you could wear jeans and a T-shirt to work, change into scrubs at the hospital, and change back at the end of your shift. Then you don't look like a boob wearing scrubs at a school board meeting. Do the firemen on the board wear their firefighting outfits? Do the farmers wear boots covered in mud? Take an extra 5 minutes a day and just wear scrubs in the hospital, where they belong."

Another GP broke it down even further: "If urgent care is so messy that you need to wear scrubs, you should be changing out of them before you go anywhere else. If not, you might as well dress like the rest of us doing outpatient care."

However, an emergency medicine doctor fired back: "If I crack a chest and get bloody at work, I change -- otherwise, live with it."

"I am not about to go home, change into street clothes, and go back to town to grocery shop. I'm also not going to drag a change of clothes with me to the hospital on the off chance that that shift happens to be on the slow side and I get a chance to make a grocery list," argued another emergency medicine doctor.

A disapproving surgeon, noting the spread of this trend, wrote: "I was once attending my Congressman's birthday party, which was nothing more than a fundraiser. Most were wearing coat and tie, with quite a few in business attire. Next thing I know here comes a local gastroenterologist wearing scrubs. It looked ridiculous."

A pediatrician went further still: "Wearing hospital scrubs away from the hospital is theft."

An ophthalmologist tried to find some middle ground: "I don't go shopping while wearing scrubs, but I have pumped gas on my way home from work with them on."

A mildly conflicted surgeon added: "I understand that I probably make others in the grocery store upset, but they're so comfy and clean that I don't feel too bad about it."

Fifty-one percent of those responding to an accompanying poll objected to wearing scrubs outside the hospital. Fewer than 14% claimed that it was not a big deal, whereas a few crafted their own responses, such as a vote for limiting the practice to Halloween.

Finally, one physician raised a startling possibility: that not all of those wearing scrubs in public may be medical professionals. What if the primary offenders are dressing not for the time crunch of a tough job, but for the demands of fashion? "Scrubs are becoming popular as casual wear, and they are really inexpensive," wrote the physician, who even linked to a site where anyone can easily buy a variety of official-looking hospital scrubs.

The full discussion of this topic is available at: http://boards.medscape.com/forums/.2a0a8300. Note, this is open to physicians only.

The Perils and Pitfalls of Social Networks: Back to the Cases

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The Perils and Pitfalls of Social Networks

Consider the following situations:

1. You maintain a personal Facebook account that identifies you by photograph, name, age, and practice status. You use the highest privacy setting. A patient who lives in your neighborhood and whose children go to the same school as yours makes an online request to "friend" you. You Google the patient and find her social contacts and information about her employment and political opinions. How would you respond to her request?
2. You are in private practice and maintain contact with colleagues through online social networks. You notice a recent tweet from a colleague employed by a prominent local hospital asking for advice from psychiatrists about management of an acutely suicidal patient without explicit patient permission. What, if anything, should you do?

These situations raise some key questions. Can physicians, nurses, pharmacists, and other healthcare professionals separate their personal and professional identities online? What are the duties of healthcare providers to maintain the integrity and status of their respective professions when it comes to other clinicians' use of social media?

A Primer for Responsible Social Networking

What Are Social Networks?

Online social networks are locations on the Internet where one can create a personal profile and connect to others to create a personal network, among the most popular of which are Facebook, Twitter,Friendster, and LinkedIn. Other tools that permit interaction and spread of information include blogs, wikis, and file-sharing sites. Examples of some healthcare-seeking sites used by patients include Medhelp and DailyStrength. Physician rating sites such as123people use a meta search engine to categorize findings from publicly available records and sites (such as licensing agencies and property tax records) into information clusters that include email addresses, phone numbers, and social network profiles. The use of such networks and sites has exploded in recent years to include a substantial proportion of patients and practicing clinicians.^[1]

How Do Physicians Use Social Networks?

A recent study of physician use of Twitter examined the self-identified profiles of 260 physician users and reported that 30% posted 20 tweets within 1 day or less.^[2] An analysis found that 3% of tweets were unprofessional; 0.7% violated patient privacy, 0.6% contained profanities, 0.3% included sexually explicit material, and 0.1% included discriminatory statements. The public profiles posted by physicians in this study included their names in 78% of cases, a photograph of themselves in 78%, and a link to a Website in 92% of cases.

A national, randomly stratified survey conducted earlier in 2011 found that 93.5% of medical students, 79.4% of residents, and 41.6% of practicing physicians used online social networks.^[3] Practicing physicians were most likely among the 3 groups to have visited the profile of a patient or their family member (15.5%). However, a sizeable majority of respondents, 68.3%, indicated that interacting socially with patients was unethical. The survey also found that patient-doctor interactions within social networks were typically initiated by patients.

A 2009 survey conducted in France found that 73% of residents and fellows had Facebook profiles, with over 90% displaying real names, birth dates, and personal photographs.^[4] Among the respondents, 85% reported that they would automatically decline a request by a patient to "friend" them and 15% would decide on an individual basis. Moreover, 76% believed that the patient-doctor relationship would be altered by patients having open access to their doctor's Facebook page.

Landman and colleagues reported that 64% of residents and 22% of faculty in surgical specialties at 1 institution had Facebook accounts, of which half were publicly accessible.^[5] A cross-sectional study conducted in New Zealand of 338 recent medical school graduates revealed that 63% had active Facebook accounts. While a majority, 63%, had activated privacy options, among those with publicly available information, 37% revealed the user's sexual orientation, 16% noted religious views, and 43% indicated their relationship status.^[6] Almost equal numbers displayed photographs of themselves using alcohol (46%) as included photographs of themselves demonstrating healthy behaviors (45%).

One university in the United States reported 44.5% of residents and medical students using Facebook, with over three quarters including at least 1 personally identifiable piece of information and only a third availing themselves of privacy settings.^[7] A significant proportion showed potentially unprofessional behaviors (photographs of intoxication, overt sexuality, and foul language). A 2009 survey of deans at US medical schools found that 60% had experienced incidents of students posting unprofessional content and 13% had found violations of patient confidentiality occurring as a result of online postings by students within the past year.

The Downside to Social Media

Among key concerns about medical professionals' use of online social forums is the lack of guaranteed security, with the possibility of unwitting transmission of sensitive materials despite the use of privacy settings. For example, Facebook users may "tag" or label another Facebook user (pictures or text) by name without the knowledge or consent of the individual involved. A blog leaves a permanent imprint on the Internet because most blogs are searchable by date, name, or keywords, and a blog entry from long ago can quickly be accessed.

There is a considerable bioethical literature base concerning sexual, financial, and gift-giving boundaries within the patient-doctor relationship.^[9] Engaging in friendships with patients has not been a customary part of the relationship. Online friendships are particularly problematic because they do not prioritize the therapeutic interest of the patient and are associated with potentially inappropriate clinician self-disclosure, problems that can be magnified to the detriment of the therapeutic relationship in a mental health encounter.^[10]Therapists also note that the healthcare provider may become privy to patient information not intended for them through social media sites, such as patient smoking, alcohol ingestion, or dating behaviors. This information has the potential to change the framework of the therapeutic relationship.^[1]

Searching for information online without the patient's knowledge may itself violate patient autonomy and dignity, infringing on the trust integral to the relationship. On the other hand, patients are now able to Google their providers and gather data that may well include inaccurate or false information. Healthcare professionals have to rethink the presumption of anonymity now that their private lives are within the reach of their patients, subject to intensification through images and other highly personal content. The traditional information asymmetry between provider and patient is likely to be increasingly equalized, with escalating information access by patients.^[11]

Some examples of unintended consequences of online participation in networking sites could include:

1. A patient loses his life insurance because his primary care provider documents information in the medical record about his lifestyle behaviors obtained through his Facebook account.
2. A nurse practitioner is approached for a date by a male patient on a dating site on which she has a profile.
3. A well-known psychiatrist's online venting about "drug-seeking patients" is widely disseminated through a "friend" who shares it with his friends.
4. A surgeon shares concerns about technical errors he made in a case on a physician blog and becomes the subject of a lawsuit from the patient.

Venting or debriefing are strategies informally adopted by health professionals to relieve stress. While conversations in closed hospital settings and in-person, face-to-face remarks are short-lived and lend some protection to practitioners, the content of blogs and social networks do not afford privacy and are presumed to be a permanent record.^[10] Examples of online violations of patient privacy leading to unintended consequences are widely available in the lay press.^[12] A recent particularly shocking example, as reported by The Boston Globe,occurredin April 2011 when an emergency room physician was fired for posting photos of a patient on her Facebook page.

Professional Associations Respond

Recognizing the need for clinicians to debrief/vent in appropriate contexts, the Australian College of Critical Care Nurses recommends discussion of appropriate methods with trainees with the recognition of the absolute permanence of electronic communications.^[14] The organization also recommends that institutions develop and publish clear institutional criteria for dismissible offenses.

The 2011 summer issue of the Journal of Clinical Ethics focused its attention on the American Medical Association's (AMA's) Council on Ethical and Judicial Affairs (CEJA) recent report on social media and the medical profession. The CEJA report was prepared in response to Policy D-478.985, Physicians and Electronic Social Networking, which was a request from the Medical Students Section that asked the AMA to address the issue of online professionalism. The report recognizes that use of social media can provide benefits, such as an online professional presence, and allows collegial support, fostering of positive relationships, and sharing of views in the public health interest. However, the report also urges physicians to honor the social contract expected of them. The underpinning of the recommendations for physician use of social media is derived from the AMA Code of Medical Ethics, which emphasizes that physicians in positions that do not directly involve patient care should not suspend their ethical obligations.^[15]

The 2011 AMA guidelines for the use of social media provide a compass for physicians' online presence. They urge physicians to:

1. Maintain patient confidentiality and privacy in all environments and refrain from posting identifiable patient information online;
2. Use the highest privacy settings in social networking sites to protect personal information;
3. Monitor their own Internet presence to ensure that information posted is accurate and up to date;
4. Maintain appropriate boundaries with patients online;
5. Separate personal and professional content online;
6. Approach colleagues who post inappropriate content and report colleagues who persist in violations to the appropriate authorities if the content is not removed; and
7. Recognize that online content and actions can impact careers and undermine public trust.^[16]

Similar recommendations have been previously endorsed or suggested by others from disciplines that include surgery, psychiatry, internal medicine, and pediatrics.^[1,5,10,17]

Some Practical Strategies to Maintain a Safe Online Presence

A number of practical suggestions for the social networking savvy professional can be found in the multitude of articles on this topic available in the literature. Some include:

1. Conduct periodic Internet searches, akin to credit checking, to correct any online misinformation.^[18]
2. Maintain a healthy skepticism about privacy settings and assume that settings may be changed without notification or that privacy technology may be compromised or breached by hackers.^[9]
3. Recognize that the unintended audience for online postings is exponentially large and online content is permanent.^[5]
4. Avoid engaging in dual relationships with patients (such as "friending" patients on Facebook), which threaten the therapeutic dynamic of the patient-doctor relationship.^[9,11,19,20]
5. Obtain consent for use of all online patient images regardless of whether they are identifiable.^[19] Include disclaimer language with all posts such as:
   All patient/s names and identifiable information have been changed to protect their privacy. Additionally, this content was viewed and approved for online use by the patient/s described or depicted.
6. Involve regulatory agencies such as state boards as needed.

The majority of current expert opinion advises caution in the use of social media, emphasizing that the risks of interacting with patients in online social forums may outweigh potential benefits. In fact, some contend that absolute separation of personal and professional life is virtually impossible and recommend only a professional presence online.

Vagus Nerve Stimulation Shows Early Promise in Fibromyalgia

Pauline Anderson

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August 26, 2011 — An open-label phase 1/2 trial of patients with treatment-resistant fibromyalgia shows that the therapy is safe and effective and may be a useful treatment addition.

The aim of the uncontrolled single-center pilot study was to determine whether periodic but continuous stimulation of the left vagus nerve is a safe, tolerable, and useful adjunct treatment for patients reporting continued severe pain despite receiving current best medical management.

The research was led by Gudrun Lange, PhD, from the Department of Radiology, New Jersey Medical School, Newark, and carried out at the Pain and Fatigue Study Center, Department of Pain Medicine and Palliative Care, Beth Israel Medical Centre, New York City.

The results were published online August 3 in the journal Pain Medicine.

The study included 14 adult women who had physician-diagnosed fibromyalgia for at least 2 years and were refractory to conventional pharmacological treatment (ie, nonsteroidal anti-inflammatories, tricyclic antidepressants, and anticonvulsants).

The women were surgically implanted with a vagus nerve stimulation (VNS) device. After 2 weeks of recovery, they began a 2-week stimulation adjustment period during which VNS intensity was increased to deliver as high a current as could be comfortably tolerated.

All study participants tolerated the implantation. Of these, 12 patients completed the initial 3-month study, and 11 participated in a longitudinal study lasting an additional 8 months.

Same Adverse Effects

In general, the patients had the same types of adverse effects to VNS as those reported in patients with treatment-resistant epilepsy and depression, including stimulus-bound voice alteration, neck pain, nausea, and dyspnea. In addition, patients reported dry mouth and fatigue. During the study, there were 4 unanticipated/serious adverse events occurring in 4 patients.

The primary efficacy outcome was minimal clinically important difference (MCID+) that includes pain, overall wellness, and physical function. At 3 months, 5 of the14 participants became MCID+, and 2 no longer fulfilled fibromyalgia diagnostic criteria for pain and tenderness.

In addition, the therapeutic effect seemed to increase beyond the acute trial. At the end of 11 months, 7 patients were MCID+, and there was parallel improvement in fibromyalgia caseness, defined as widespread pain and at least 11 tender points, which was added as a secondary outcome.

"[W]e realized that using loss of [fibromyalgia] caseness as an outcome variable might be useful for clinicians in judging the potential efficacy of VNS," the authors write.

The researchers were "surprised" by the robustness and ubiquity of response to the VNS treatment, they note. Although improvement in tender point threshold appears to be a difficult outcome to achieve, "our results suggest that [fibromyalgia] treatment can reduce tender point threshold to the degree that the point treated is no longer tender," they write.

However, they add, tender point count was not a reliable predictor for continued therapeutic success.

An "obvious question" is whether the results represented a placebo effect "related to being in a treatment trial necessitating surgery, feeling a sensory stimulus throughout the day and having high hopes for a good therapeutic outcome," said the authors. The continued improvement shown by some patients and the fact that more patients attained outcome criteria over time argues against a nonspecific or placebo explanation for the therapeutic benefit, they write.

The authors conclude that a controlled trial is needed to better understand the role of VNS in fibromyalgia.

This work was supported by a grant from the National Institutes of Health. Dr. Lange reports a US patent pending in her name for the use of VNS in fibromyalgia.