448 - SIRVA, Mediterranean Diet Update, Building a Support Network
Take 3 – Practical Practice Pointers©
Update From the Literature & Vaccine Injury Compensation Program
1) Shoulder Injury Related to Vaccine Administration (SIRVA)
Vaccines, both as a public health measure and as a clinical prevention intervention are very safe, but all interventions have the risk of adverse effects. A relatively newly recognized vaccine adverse event in adults due to vaccination technique is shoulder injury related to vaccine administration (SIRVA). More than just deltoid muscle soreness, this is an inflammation of the subacromial-subdeltoid bursa (SASDB) resulting in shoulder pain and limited range of motion related to vaccine administration.
In 2010, a review of 13 cases of shoulder injury collected from the Vaccine Injury Compensation Program (VICP) was published that documented the predominant clinical factors of the condition the authors named SIRVA: absence of a history of shoulder dysfunction prior to vaccination, restricted range of motion, an absence of neurological symptoms or muscle weakness. Only a minority of patients in this report resolved completely – the rest had persistent symptoms and dysfunction. The authors quoted earlier work suggesting that in adults, the SASDB extended 3-6 cm beyond the edge of the acromion, and the presumed etiology of SIRVA was thought to be vaccine injection “too high” on the shoulder and into the SASDB.
In 2017, SIRVA was added to the VICP “Table” of known adverse events from vaccination, and a study was commissioned to review the VICP claims from 2010-2016, as they were seen to be increasing, especially related to influenza vaccination.
Last summer, that review was published and noted the following:
· Most cases were in adult women (~82%)
· Most cases occurred in pharmacies (35%) and physicians’ offices (31%)
· Most cases occurred with inactivated influenza (84%) and TdaP (12%) vaccines
· The most common presenting symptoms were shoulder pain (94%) and limited range of motion (31%). Most petitioners to the VICP have noted that they thought the injection had been “too high” on the shoulder or “particularly painful.”
· MRI findings frequently show rotator cuff tendon tears and ruptures as well as shoulder arthritis, but these are common in adults and are not necessarily considered indicative of SIRVA. Instead, other common findings – bursitis and tendinopathy – are more consistent with the presumed mechanism of the injury.
· The most common treatments for SIRVA include physical therapy, NSAIDs and corticosteroid injection into the bursa.
Here are some steps recommended to prevent SIRVA (see videos in references):
· Appropriate selection of needle length for age and weight.
· Full exposure of shoulder so all anatomical landmarks are visible (not pulling shirt down over shoulder)
· Appropriate injection site – mid-deltoid, 2-3 finger breadths below the acromion.
· Appropriate angle for intramuscular injection – 90 degrees to skin.
John’s and Mark’s Comments:
We’ve updated this previously published Pointer at the request of our safety and risk management colleagues. With the number of vaccines presently being given, it is essential to ensure that preventable adverse events are minimized. Anyone who administers deltoid injections should watch the two-minute video (2nd reference) and care teams should review together. Having cared for some patients who likely were experiencing SIRVA, the morbidity from it can be quite substantial and healing slow.
The Vaccine Injury Compensation Program is one aspect of an important overall safety program to manage vaccine adverse events in this country. The article by Hesse illustrates the value of programs like this in recognizing and understanding vaccine adverse events.
It should be noted that injuries related to the COVID vaccines are covered by a different HRSA program called the Countermeasures Injury Compensation Program or CICP rather than by the VICP. As such, it is uncertain how SIRVA injuries related to the COVID vaccines will be reimbursed at this time as the standard for coverage under the CICP are “eligible serious injuries.”
· CDC guidance on vaccine administration and a video: Guidance Video
· Video on preventing SIRVA (with soundtrack!): Video
· Health Resources & Services Administration (HRSA): Vaccine Injury Compensation Program (VICP) - Website
· HRSA Countermeasures Injury Compensation Program: Link or toll-free number 1-855-266-2427
· HRSA Vaccine Compensation Program Frequently Asked Questions: LInk
· Hesse EM, et al. Risk for Subdeltoid Bursitis After Influenza Vaccination: A Population-Based Cohort Study. Ann Intern Med. 2020 Jun 23;M19-3176. Link
· Wiesel B and Keeling L. Shoulder Injury Related to Vaccine Administration. J Am Acad Orthop Surg, 2021 Sep 1;29(17):732-739. Abstract
From the Literature
2) More Evidence for the Mediterranean Diet
The Mediterranean diet is holding its ground as the standard for dietary intervention to prevent cardiovascular disease – after studies like the Lyon Heart Study and PREDIMED. A new study compared the recommendation for two different dietary patterns – a Mediterranean diet versus a low-fat diet for secondary prevention in people who had a history of coronary heart disease.
The study was done well – they studied 1002 adults (20-79 years old, 82.5% male, mean age 59.5 years) with stable coronary heart disease (CHD, but no events in the previous six months). The diets compared were a Mediterranean diet which emphasized < 50% carbohydrates and liberal use of extra virgin olive oil and a low-fat diet from the old National Cholesterol Education Project guidelines, which emphasized complex carbohydrates and relatively low fat content (<25% of calories). Each diet restricted total dietary cholesterol to less than 300 mg/day, but there was no prescribed calorie restriction. The study provided either free olive oil or free “healthy food bags” with complex carbohydrates to the two groups. The study randomized patients into strata by age, gender, and history of myocardial infarction. The patients met with dietitians frequently in 1:1 meetings, groups sessions, and by telephone, but this was equalized on both groups. Because this was a diet trial, patients were not masked, but everyone on the research team except for the dietitians were masked to the intervention group. More patients abandoned the low-fat diet (17.2%) than the Mediterranean diet (9.2%). The primary outcome was a composite outcome of myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease, or cardiovascular death.
After seven years of follow up, the investigators found significant reduction in the composite outcome of cardiovascular events in the Mediterranean diet group (different statistical models revealed hazard ratios of 0.719 (95% CI 0.541–0.957) to 0.753 (0.568–0.998). The intervention worked a little better in men and in those who were more adherent to the diet.
This was a pretty strict Mediterranean diet (less than 1 serving per week of red meat, no butter/margarine, 4+ tbsp of olive oil per day), but was apparently more acceptable to participants than the low-fat diet. As one of a handful of controlled, pragmatic, large scale trials of diet, it contributes to the totality of evidence of benefit for the Mediterranean diet in preventing heart disease. This should really be our go-to counseling for heart health at this point.
I asked my Family Medicine research colleague and dietitian, Michelle Rockwell, PhD, RD to weigh in on this study. She notes: Some of the things that make it a remarkable research study (avg. 7-year intervention, good dietary adherence, phone coaching, group sessions, social support, monthly dietitian visits, provision of food, medication support, etc.) are much different from what most patients have access to in real life. At minimum, we should consider that patients taking on a rigorous dietary intervention such as the Mediterranean Diet likely benefit from individualized and ongoing support. But I think the 7-year sustainability statistics are very promising!
Both the Mediterranean and low-fat diets are extremely different from the typical American diet and from on-trend “healthy” diets: low-carbohydrate, keto, etc. When people think of the Mediterranean Diet, they think of fish, nuts, and red wine…not necessarily the full scope of the dietary regimen. Specific examples like this diagram can help.
Delgado-Lista J, Alcala-Diaz JF, Torres-Peña JD, et al. Long-term secondary prevention of cardiovascular disease with a Mediterranean diet and a low-fat diet (CORDIOPREV): a randomised controlled trial. The Lancet. 2022;399(10338):1876-1885. Link
From PeerRxMed ( www.PeerRxMed.org )
3) Hey, I Need Your Help! Who’s Your 2 A.M. Friend?
“I need your help …” Not said by enough of us often enough
On April 26th, 2020, Lorna Breen, MD, an emergency medicine physician, medical director, educator, mentor, daughter, sister, friend and inspiration to many, committed suicide. After weeks of trying to navigate the personal distress brought on by her experience treating patients, often unsuccessfully, on the front lines of the early COVID-19 pandemic in New York City and trying to recover from the illness herself, she apparently reached a point where she felt that she could not go on living. Though she had sought out and received help along the way, on that day she did not reach out to anyone. We will never know what she was thinking, as she left no communication – just a void in many lives and questions that don’t have easy answers … ever.
Almost 2 years later, on March 18, 2022, the Dr. Lorna Breen Health Care Provider Protection Act, which aims to prevent suicide, reduce burnout, and promote emotional health among healthcare professionals, was signed into law. While too late for Lorna and the many other colleagues who have chosen to take their lives through suicide, it is a positive and encouraging indication that perhaps the conversation regarding help-seeking behavior among physicians and other healthcare professionals is moving in the right direction.
While Dr. Breen’s circumstances were quite extreme, none of us are immune from the distressors of this professional (and personal) journey, and like her, we never know when they might exceed our personal coping threshold. We do know that the time to plan for an emergency is not in the middle of it, so what is your plan to deal with overwhelm if (or more likely, when) that time comes? Or, for some of you, for the overwhelm you are in the midst of right now?
I believe that part of your plan needs to include what I call your “2 A.M. friends” – friends (beyond your spouse/partner) who you know you could call any time day or night when your life is crashing or you have exhausted your coping mechanisms and you know they would be there for you.
How do you know they would be there for you? Because you have already talked to them about it. The best way to have 2 A.M. friends is to be one, by explicitly letting close colleagues know you want to be included in their life as someone they could call if they find themselves in a dark place … at any time. Then ask if they would be willing to do the same for you.
Remember, asking for help is not a sign of weakness, but rather wisdom. No one should care alone, ever – and that includes you!
Mark and John
Carilion Clinic Department of Family and Community Medicine
Feel free to forward Take 3 to your colleagues. Glad to add them to the distribution list.