#565 - SIRVA, Reducing Sedative Use in the Elderly, Asking for Help

From the Literature and the 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 a prolonged inflammation of the subacromial-subdeltoid bursa (SASDB) resulting in shoulder dysfunction including pain, limited range of motion, and perceived weakness related to vaccine administration.   There has been an increase in reported cases of SIRVA within the literature, particularly in adults, and is likely related to the mass vaccination programs associated with COVID-19 and influenza.

The pathophysiology is not certain, but placement of the vaccination in the subdeltoid bursa or other pericapsular tissue has been suggested to result in an inflammatory capsular process.   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. 

That review was published in 2020 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 was “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.  There is a list of surgical treatments in this article, but most of them are appropriate for the arthritic and mechanical rotator cuff issues that confound the interpretation of these cases.

The articles recommend the following to prevent SIRVA:

• 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 selection of injection site – mid-deltoid, 2-3 finger breadths below the acromion.
• Appropriate angle for intramuscular injection – 90 degrees to skin.

Mark’s Comments:

I recently saw a patient in follow-up who likely had bilateral SIRVA after receiving injections in both arms at the same clinic.  In this case, my history indicated that she (in this case) pulled up her sleeves for the vaccination due to modesty, likely making identification of key landmarks more difficult.  Having cared for some patients who likely were experiencing SIRVA, the morbidity from it can be quite substantial and healing slow.

Anyone who administers deltoid injections should watch the two-minute video (2^nd reference) and care teams should review together. 

References:

• CDC guidance on vaccine administration and a video:  Guidance     Video   
• Video on preventing SIRVA (with soundtrack!):   Video
• 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)  Reducing Sedatives for Sleep in the Elderly

Most of us have encountered the elderly patient who has been on benzodiazepines for sleep for a long time and is very reluctant to change. We know these medications can lead to or worsen cognitive impairment, mood disorder, and fall risk, but changing minds can be challenging. Investigators in Nova Scotia sought to implement a community intervention to reduce benzodiazepine receptor antagonist (BZRA, both benzodiazepines and “z-drugs”) use amongst the elderly in the province. Of note, the article states that approximately 20% of the elderly in Nova Scotia used BZRAs regularly, which seems a very high number, indeed.

The investigators recruited subjects using advertising outreach and random digit phone dialing. The subjects were randomized to one of three groups: Group 1 received a “knowledge mobilization intervention” (booklets and a website from “mySleepwell.ca”) that guided patients through cognitive behavioral therapy for insomnia (CBTi), Group 2 received educational booklets used in the EMPOWER study that showed a decrease in BZRA use, and group 3 got usual care for 6 months, followed by the Sleepwell intervention. Subjects were not blinded but there were independent outcome assessors used. Follow up rates were very good. Decrease in BZRA use was the primary outcome, but the investigators were careful to not count patients who were switched to another sedative, including “trazodone, quetiapine, tricyclic antidepressants, mirtazapine, gabapentin, centrally acting antihistamine, melatonin, or new use of cannabis or cannabinoids” – which is a challenging, yet very useful restriction in the study. Secondary outcomes included sleep and anxiety scales, quality of life, switching to other sedatives, and intervention fidelity measures.

There were 580 subjects were randomized - mean age of 72.1 (SD 5.7) years, 64.1% were female, 35.9% were male, and 88.5% were driving weekly or more. 26.2% of subjects discontinued BZRAs with the Sleepwell intervention, 20.3% with The EMPOWER intervention and only 7.5% with usual care (NNT* for Sleepwell vs. usual care ~ 5.3, NNT for EMPOWER vs. usual care ~ 7.8, there was no significant difference between the two active interventions). The Sleepwell intervention also led to a >=25% reduction in BZRA use over usual care, but the EMPOWER intervention did not. Starting other sedatives (both BZRA and not) was more common in the EMPOWER group, but there was no difference in alcohol consumption. Sleep measure differences were mixed, but not importantly different overall. Quality of life was not different between groups. Subjects stopping their BZRAs had withdrawal symptoms 33% of the time, but mostly insomnia, and none of the symptoms required emergency department visit or hospitalization.

The authors note that the Sleepwell intervention was tailored carefully – it advised against sedative substitution, it had a flexible recommended BZRA tapering schedule, it was more encouraging of education about CBTi, and the booklets had more pictures of people than the EMPOWER intervention. The authors note that the study was limited by lack of blinding and self-reported outcomes.

John’s Comments:

Despite a few quality considerations, this is a pretty remarkable trial result. The investigators had relatively little interaction with patients beyond the mailing and yet were pretty successful. I can imagine doing this at a practice level for patients. You can see some of the material in the Sleepwell intervention at their website.

*In the article, the authors actually used “number needed to mail” (NNM) - meaning the number of intervention packages with booklets and a cover letter that should be mailed to produce an additional outcome. This is technically the more precise measure, but I think it’s easy to get carried away with terminology…

Reference:

·         Gardner DM, Turner JP, Magalhaes S, Rajda M, Murphy AL. Patient Self-Guided Interventions to Reduce Sedative Use and Improve Sleep: The YAWNS NB Randomized Clinical Trial. JAMA Psychiatry. Published online September 18, 2024. Link

From PeerRxMed ( www.PeerRxMed.org )

3) Getting to “Yes, I’d Love Your Help”

“Having a need and needing help is not a sign that you’re weak; it’s a sign that you’re human.” — Kate Northrup, MD

As clinicians, we’re conditioned to be helpers—the ones who provide support, solutions, and care. Rarely do we voluntarily allow ourselves to be on the receiving end. Our training and professional culture often lead us to believe that seeking help is a sign of weakness or incompetence. What if instead of avoiding assistance, we embraced it as an opportunity for growth, connection, and resilience? What if we saw accepting an offer of help and asking for help as strengths rather than shortcomings?

A few years ago, while recovering from a debilitating back injury I was given the opportunity to rethink my beliefs about being helped.  During my healing journey, I engaged in a conversation with a colleague and PeerRx participant that completely shifted my perspective. When I shared my being-helped challenges with her, she smiled knowingly and provided some words of wisdom: “I’ve learned that whenever someone offers to help me, regardless of what it is, I always find a way to say yes, even when I could do it myself. It allows them to feel useful, and it gives us a chance to connect in a way we might otherwise miss.”

Reflecting on her words, I realized how often I had declined help, even when I really needed it, and how well-rehearsed my “having it all together” act had become.  This included seeking help for obvious things such as moving a heavy object (even after my injury!), and professionally for seeking a second opinion or assistance with a procedure.  I used to see these requests as either an inconvenience for the other person or as something that threatened my independence or ego.  But now, thanks to this reframe, I began to view them as opportunities to build relationships and to strengthen bonds with those around me.

This perspective continues to inspire how I approach being helped – both in terms of accepting it when offered and asking for it more often. In addition, it has changed how I help others.  Rather than accepting a “no thanks” or “I’ve got this” response to my offer of help, I find myself saying “let me help you” and just doing it while engaging the other person in a conversation that will enhance our connection.  By doing this, I’ve gained valuable insights and often we’ve ended up talking about things of great importance.  What I once saw as a sign of dependency or even incompetence has instead become a way to enrich both my professional and personal relationships!

So, this week, I challenge you to say “yes” the next time someone offers you help—no matter how small or trivial the offer may seem.  Notice how doing so lightens your day and deepens your connection. Once you get comfortable with this, take a further step and ask for help yourself, even if it feels unnecessary. The goal is to break the habit of mindless isolation and to embrace the connections that can be built through shared support. After all, isn’t that what PeerRx is all about?  And it all can start with the simple act of saying, “Yes, I’d love your help.”

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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.

Email: mhgreenawald@carilionclinic.org