Validation of a questionnaire assessing smell loss in an international aspirin-exacerbated respiratory disease population.

Background: Olfactory dysfunction (OD) and smell loss affects aspects of patients' everyday life and lowers their quality of life. OD questionnaires are considered one of the core-outcome measures in chronic rhinosinusitis, but many existing smell loss questionnaires contained pandemic-prohibitive questions on social gatherings or restaurant visits, were too culture specific or gender specific, or were overly long and cumbersome. Objective: We aimed to develop a new brief questionnaire to assess the impact and consequences of smell loss and its burden on daily life. This study validates this new, short, multicultural, dichotomized questionnaire in an international population that has aspirin-exacerbated disease (AERD). Methods: The Consequences of Smell Loss (COSL) questionnaire was developed and content validity was assessed by experts and patients at Brigham and Women's Hospital. The questionnaire, along with other validated quality-of-life surveys, was answered by 853 patients with AERD. We evaluated the factor structure, reliability, validity, and discriminative ability of the COSL questionnaire. Results: The final version of the COSL questionnaire consisted of 13 items divided into three subdomains (emotional distress, food and safety, and physical health) through factor analysis. The Cronbach α for internal consistency was 0.82. Convergent and discriminant validity with the 22-item Sinonasal Outcome Test (SNOT-22), Healthy Days Core Module-4, Patient Health Questionnaire-4, and a specific question on taste and smell were high (p < 0.0001 for all). The COSL questionnaire score was associated with SNOT-22 categories (p < 0.001) and was categorized as follows: normal, 0-1 points; very few consequences, 2-3 points; few, 4 points; moderate, 5-6 points; and severe, 7-13 points. Conclusion: The COSL questionnaire is a new, brief, valid, reliable tool that can effectively screen for a high burden of OD in patients with AERD and has the potential to be used in other patient populations with OD as well.

Loss of smell in patients with aspirin-exacerbated respiratory disease impacts mental health and quality of life.

BACKGROUND: The impact of anosmia on quality-of-life (QoL) for patients with aspirin-exacerbated respiratory disease (AERD) is poorly understood. We aimed to investigate how the severity of smell loss and olfactory dysfunction (OD) in patients with AERD affects their QoL, mental health and physical well-being. METHODS: Five validated QoL questionnaires (Sinonasal Outcome Test-22, Asthma Control Test, Healthy Days Core Module-4, Short Form-36 and Patient Health Questionnaire-4) and two newly developed questionnaires assessing severity and consequences of OD were electronically sent to all 2913 patients in the Brigham and Women's Hospital AERD registry. Responses were received from 853 participants for analysis. RESULTS: Overall, 85% of participants reported a present diminished sense of smell and/or taste, and 30% categorized their OD severity was, "as bad as it can be." There were significant relationships between the severity of self-reported OD and both psychological distress and general health scores, even after adjusting for asthma control. Additionally, incidence rates for physically and mentally unhealthy days in the prior month were higher for patients with moderate or severe OD than for normosmic patients. Patients with diminished smell responded that they could not identify spoiled food (86%), did not enjoy food (71%), felt unsafe (63%) and had encountered dangerous situations (51%) as consequences of their OD. CONCLUSIONS: Anosmia and hyposmia severely impact the physical, emotional and mental health of AERD patients, and lead to safety concerns in their daily lives. The importance of olfaction and the relevance of OD to patients' QoL should be acknowledged and evaluated by clinicians caring for these patients.

Aspirin desensitization and biologics in aspirin-exacerbated respiratory disease: Efficacy, tolerability, and patient experience.

BACKGROUND: Patterns of medication use and efficacy in aspirin-exacerbated respiratory disease (AERD) have not been well characterized, especially since the advent of respiratory biologics. Aspirin therapy after desensitization (ATAD) is efficacious for upper and lower respiratory symptoms for patients with AERD, though aspirin-related adverse effects can limit therapy. The optimal coordination of ATAD and respiratory biologics for the treatment of AERD remains unclear. OBJECTIVE: We aimed to characterize patterns of medication use and treatment experience with biologics and ATAD in AERD. METHODS: We surveyed 98 patients with AERD recruited from the Brigham and Women's Hospital AERD registry. Patients completed an online questionnaire describing their medication history and treatment experience. RESULTS: A total of 52 (53.0%) patients reported a history of use of one or more respiratory biologics (omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab), and 84 (85.7%) reported undergoing aspirin desensitization. There were 24 patients (24.4%) who reported concurrent use of a biologic and ATAD. Compared with those taking ATAD alone, patients taking a biologic and ATAD concurrently were less likely to report that aspirin was effective for their AERD symptoms (odds ratio, 0.161 [95% confidence interval, 0.03-0.76]; P =.02). Whereas patients reported varying efficacy with biologics, dupilumab had the highest odds of patients reporting it worked "very well" (odds ratio, 17.58 [95% confidence interval, 5.68-54.35]; P < .001). CONCLUSION: Biologics are emerging as a treatment option for AERD and are generally well tolerated. Biologic efficacy in AERD is variable by agent, though most patients taking dupilumab found it to be effective. Patients on a biologic in conjunction with ATAD may represent a more severe subset of AERD for which ATAD alone is insufficient.

Ambulatory Virtual Care During a Pandemic: Patient Safety Considerations.

BACKGROUND: The COVID-19 pandemic prompted sudden and fundamental changes in health care, including a rapid rise in the utilization of telehealth services in the ambulatory setting. With the unprecedented and significant decline in traditional office-based visits and procedures, novel patient safety risks and challenges emerged. METHODS: The ambulatory practices at our quaternary care, academic medical center experienced a 200-fold increase in virtual visit volume between February and April 2020. We convened a multidisciplinary working group dedicated to evaluating quality and safety when providing virtual visits during a pandemic. Our primary outcome was patient experience with virtual care delivery, which was assessed by leveraging patient complaint data and patient satisfaction survey data. RESULTS: For our main focus of patient experience and satisfaction, survey data were analyzed from the approximately 76,616 virtual visit encounters that occurred between March 1, 2020, and April 21, 2020. During this period, 5 patient complaints were filed to the Patient Advocacy Department. Overall, patient satisfaction with telehealth remained stable and high at >93% from February to May 2020. As we assessed these data each month, our working group developed risk mitigation strategies in response to the novel challenges presented by the use of telemedicine due to the COVID-19 pandemic while working to maintain patient satisfaction with care. We identified quality and safety issues around patient factors including optimal triage of patients and use of technology. We also evaluated accessibility to virtual platforms and logistics such as coordination of care for diagnostic testing. Finally, a guidance document was created and communicated to our diverse ambulatory practices to support clinicians. CONCLUSIONS: Ambulatory virtual care delivery requires a dynamic, flexible model of care through continuous rapid-cycle process improvement to mitigate patient safety risks during a pandemic, incorporating both provider and patient perspectives.

The immunologic response to severe acute respiratory syndrome coronavirus 2.

Background: The spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has precipitated the worst global pandemic in a century, which has caused millions of infections and deaths as well as massive economic repercussions. Objective: As with any pathogenic virus, it is crucial to understand its unique interactions with the human immune system so that pharmaceutical and prophylactic interventions can be deployed to effectively control the pandemic. Methods: A literature search by using PubMed was conducted in 2020 with variants of the terms "COVID-19," "SARS-CoV-2," and "immunological response." English language articles that presented original data about the immunologic response to coronavirus disease 2019 (COVID-19) were selected for review. This article reviewed the current understanding of the innate and adaptive immune responses to SARS-CoV-2 infection, including their relationship to current therapeutic and diagnostic strategies. Results: SARS-CoV-2 uses several unique molecular techniques to evade detection by the innate immune system early in the course of infection, and upregulation of these innate immune pathways may possibly accelerate the time to recovery and prevent severe disease. Although the majority of cases results in the patients' recovery, a significant proportion of infections result in deaths prompted by the host's inflammatory overreaction to the infection, a response that can be attenuated with corticosteroids and potentially other immune modulators. Conclusion: Current work by the scientific community to further understand how SARS-CoV-2 interacts with the human immune system will be invaluable to our response and preparedness for future coronavirus pandemics.

Quick COVID-19 Healers Sustain Anti-SARS-CoV-2 Antibody Production.

Antibodies are key immune effectors that confer protection against pathogenic threats. The nature and longevity of the antibody response to SARS-CoV-2 infection are not well defined. We charted longitudinal antibody responses to SARS-CoV-2 in 92 subjects after symptomatic COVID-19. Antibody responses to SARS-CoV-2 are unimodally distributed over a broad range, with symptom severity correlating directly with virus-specific antibody magnitude. Seventy-six subjects followed longitudinally to ∼100 days demonstrated marked heterogeneity in antibody duration dynamics. Virus-specific IgG decayed substantially in most individuals, whereas a distinct subset had stable or increasing antibody levels in the same time frame despite similar initial antibody magnitudes. These individuals with increasing responses recovered rapidly from symptomatic COVID-19 disease, harbored increased somatic mutations in virus-specific memory B cell antibody genes, and had persistent higher frequencies of previously activated CD4+ T cells. These findings illuminate an efficient immune phenotype that connects symptom clearance speed to differential antibody durability dynamics.