Bayer US (“Bayer”) appreciates the opportunity to submit comments pertaining to the proposed endorsement of this measure.
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture with nearly 25,000 employees in 300 sites across the United States. Our products and services are designed to benefit people and improve their quality of life. At the same time, we aim to create value through innovation and are committed to the principles of sustainable development and to our social and ethical responsibilities as a corporate citizen.
Bayer is committed to improving patient outcomes and advancing health by closing gaps in care. We recognize the importance of value-based care and quality measurement and are pleased to submit feedback in response to Battelle’s open comment period on the Spring 2023 measure endorsement cycle.
Stroke accounts for a substantial proportion of serious misdiagnosis-related harms and is missed an estimated 17% of the time.1 Focusing on reducing misdiagnosis can help to ensure patients receive timely and effective care and prevent serious harms. Bayer supports the endorsement of this measure to enhance the assessment of stroke care and improve outcomes.
Since sociodemographic factors including female sex and non-white race/ethnicity are associated with higher rates of stroke misdiagnosis, we also encourage the use of measure stratification to identify disparities in care. 1,2,3
1 AHRQ. Diagnostic Errors in the Emergency Department: A Systematic Review. https://effectivehealthcare.ahrq.gov/products/diagnostic-errors-emergency/research. Accessed June 1, 2023.
2 Newman-Toker, D. E., Moy, E., Valente, E., Coffey, R., & Hines, A. L. (2014). Missed diagnosis of stroke in the emergency department: a cross-sectional analysis of a large population-based sample. Diagnosis (Berlin, Germany), 1(2), 155–166. https://doi.org/10.1515/dx-2013-0038
3 Tarnutzer AA, Lee SH, Robinson KA, Wang Z, Edlow JA, Newman-Toker DE. ED misdiagnosis of cerebrovascular events in the era of modern neuroimaging: A meta-analysis. Neurology. 2017;88(15):1468-1477. doi:10.1212/WNL.0000000000003814
I am a practicing emergency physician, and would like to comment on the enormous need to improve care, and improve the measurement of quality, in the workup for dizziness. This is a quite common and high risk complaint across all EDs - rural and urban, academic and community, small and large. Currently, the workup can be quite variable across providers and across settings. It would be a tremendous advance if we could have the tools to measure high risk vs low risk hospitals or practice patterns, then feed that information back to providers, and use this information to improve quality of care.
If there is a reasonable opportunity to control for baseline stroke risk factors (such as cardiovascular risk factors, socioeconomic status, etc) then that would help optimize the value of this measure.
This subject is very close to the intellectual space of great interest to me and about which I frequently speak, write and am involved administratively. I think that the following facts are generally accepted as true:
1. Front line providdrs including emergency physicians, miss stroke/TIA diagoses in a non-trivial minority of patients
2. An acute "dizzy" (or vertigo, lightheadedness, difficulty walking or standing, etc) presentation increases the likelihood of misdiagnosis
3. A substantial group fo the mis-diagnosed patients will be discharged and then return in the near term with recurrent stroke or worsened symptoms from complications of the initial stroke. Because these strokes are almost always wihtin the posterior circulation, many of these pateitns will have serious and sometimes catastrophic outcomes.
4. Early recognition and treatment would have mitigated most of those bad outcomes.
If one accpets those 4 statements, then it is clear that better reserach data about any of these points will help to dissect out the root causes of these issues which in turn opens the door to solutions to the problem. As the committee chair of the Society for Academic Emergency Medicine (SAEM), we just published the first-ever clinical guideline on the managment of acute dizziness & vertigo - the GRACE-3 guideline, published in the May issue of Academic Emergency Medicine. We identified many gaps in the current reality and I think that the proposed research will help to close some of them.
I strongly support this research the findings from which will certainly help front line providers deliver better care and which I believe has the potential to greatly improve patient care for those with this very comon chief complaint.
I am submitting this comment of support for the Avoid Hospitalization After Release with a Misdiagnosis—ED Stroke/Dizziness (Avoid H.A.R.M.) performance measure.
The Vestibular Disorders Association (VeDA) supports people with inner ear disorders that cause dizziness, vertigo and disequilibrium. Because of the many possible causes of dizziness, getting a correct diagnosis can be a long and frustrating experience. Symptoms of chronic dizziness or imbalance can have a significant impact on the ability of a disabled person to perform one or more activities of daily living, such as bathing, dressing, or simply getting around the home. Vestibular patients often find it difficult to engage with groups of people, occupy busy public spaces, or concentrate for long periods, which can result in loss of work and isolation from friends and family. The painful social and economic impacts of vestibular disorders are significantly underestimated.
As many as 35% of adults aged 40 years or older in the United States – approximately 69 million Americans – have experienced some form of vestibular dysfunction. According to the National Institute on Deafness and Other Communication Disorders (NIDCD), a further 4% (8 million) American adults report a chronic problem with balance, while an additional 1.1% (2.4 million) report a chronic problem with dizziness alone. Eighty percent of people aged 65 years and older have experienced dizziness, and benign paroxysmal positional vertigo (BPPV), the most common vestibular disorder, is the cause of approximately 50% of all dizziness in older people. Overall, vertigo from a vestibular problem accounts for a third of all dizziness and vertigo symptoms reported to health care professionals.
Vestibular disorders are under diagnosed and under treated, with devastating results including increased medical costs, loss of time worked, and less quantifiable but equally relevant negative impacts on patient quality of life.
Equally troubling is the lack of clear diagnostic criteria for vestibular disorders, and even more concerning is evidence that even when such criteria exist they are not always followed. For example, BPPV – the most common and easily recognizable vestibular disorder – has clinical practice guidelines published by the American Academy of Otolarynology Head and Neck Surgery. However, patients with BPPV often receive delayed diagnosis, inappropriate testing, and ineffective treatment leading to needlessly prolonged suffering, increased risk of falls, decreased productivity, and higher healthcare costs.
Ensuring accurate and efficient diagnosis for these patients will likely save lives and reduce costs through prompt and appropriate treatments. In addition, patients will be able to get back to work and other normal life activities.
As Executive Director of VeDA I have spoken with hundreds of people who have been negatively impacted by an inaccurate diagnosis resulting in years or a lifetime of challenges, including loss of work, relationships, and the ability to care for themselves. These devastating consequences can be avoided with improved diagnostic outcomes in emergency and urgent care settings.
The dizzy-stroke measure based on SPADE is a critical step to our reducing misdiagnoses of stroke. It is well-known amongst emergency physicians that the complaint that vexes us the most is dizziness. There is a plethora of pathologies that can cause dizziness, from those that are fairly benign to many that are extremely dangerous. Patients who have a posterior stroke may not show any signs of deficits besides dizziness and trouble walking. Because of this, the diagnosis is often missed, which naturally leads to worse outcomes. This, despite the fact that we have highly sensitive and specific maneuvers that can be performed to guide diagnosis. As it stands, we over-image dizzy patients and under-diagnose stroke patients - a double-whammy that not only harms patients but also inflates costs and ED crowding (which leads to yet more patient harm). Simply 'educating' clinicians can only go so far; in order to effect actual change, we need tools to help understand how often physicians err when working up dizziness and how we can make stroke care better for everyone. This measure is one of those important tools.
As a patient that has suffered a delayed diagnosis while presenting at the ER, I know this measure will make a difference for many patients. I presented at my local ER with sudden onset of dizziness only to be released that same evening with a diagnosis of vertigo, with no follow up care suggested. I returned by ambulance about 48 hours later to now be diagnosed with a cerebellum stroke, which has left me with permanent brain damage. Within one month of my event my brother had the same stroke in the cerebellum section presenting with sudden onset of vertigo to a different ED. The physician at this hospital diagnosed without doing any imaging he was having vertigo as well. However my family stepped in this time as his symptoms looked very similar to mine, and asked the attending ED physician to check for stroke. With some hesitation they ordered imaging and found he was having a cerebellum stroke. They administered the correct medications to dissolve the clot and he had and stil, has no lasting effects of his stroke event. So you can see why it’s so important for me as well as hundreds of others that could be possibly saved from going through this life changing challenge. I feel passionate about this measure and hope that we can move forward with these and other life saving measures, to help both patients as well as professionals. I appreciate everyone’s efforts to move this measure forward.
I am a physical therapist with nearly 32 years of experience, having worked the last 30+ at WakeMed, a large tertiary care hospital/trauma center. With a special interest in dizziness/vertigo and having served as the chief vestibular PT at our largest hospital in Raleigh, NC, I have examined and treated hundreds of patients presenting with acute dizziness and vertigo, both in the ED and throughout the hospital. In my own practice, I (and the other physical therapists I have trained) have been able to alert medical staff to findings concerning for stroke/TIA and other central nervous system diagnoses, in patients where the suspected diagnosis initially was benign dizziness. I have multiple case reports demonstrating the effectiveness of an astute physical exam and history taking in assisting with accuracy of diagnosis.
When improved care is largely a matter of realizing that the "old school" method of diagnosing these patients is not accurate, and in fact could cause harm or even death, it seems a logical step to consider evidence-based research demonstrating best practice in these cases. My expertise is even sought by our chief stroke neurologist. Suffice it to say that use of the best practice approach has resulted in the medical staff of our hospital (ED, hospitalists, neurology) recognizing the benefit.
In summary, I strongly urge that the recommended measure be considered to help avoid catastrophic outcomes of missing stroke and TIA, which is more common than many realize.
A challenge clinicians face is ascertaining when a common presenting diagnosis, such as dizziness, heralds the future onset of a more severe condition, such as stroke. This proposed quality measure could positively impact patient care by helping us understand what clinical and patient factors are associated with a complaint of dizziness presaging a stroke. This could promote the development of patient safety systems designed to identify patients who present with high-risk dizziness so that interventions can be taken to reduce the risk of subsequent stroke.
I have been an academic emergency physician for 14 years, and have specialized in teaching about the diagnosis and management of patients in the emergency department with neurologic issues, among them dizziness (or similar) and the diagnosis and treatment of posterior circulation stroke. I have taught this in didactic, simulation and many other formats , including podcasts and publications, and have found that at every level (medical student, resident, fellow, attending physician) there is a significant opportunity for improvement in education. In general, assessment of the dizzy patient is perceived to be complicated and challenging, often missed due to misunderstandings of the issue that have been propagated through the years, starting in medical school. I have been a part of many efforts to close the gap of understanding, and have had some satisfaction in helping people understand the best way to approach, examine and diagnose the patient with dizziness. Having said that, we have much more ground to cover, with patients standing to benefit from earlier diagnosis of this potentially devastating diagnosis. Earlier diagnosis and appropriate treatment can improve the outcome of many patients, if not public health overall.
The SPADE Method & AVOID H.A.R.M. Outcome Measure is a promising tool to help move the needle and further advance our progress in this area. I support the concept and encourage further research in the field.
Please see attachment.