Development and Psychometric Validation of the Olfactory Dysfunction Outcomes Rating.

Importance: Olfactory dysfunction (OD) is an increasingly common and morbid condition, especially given the ongoing COVID-19 pandemic. Thus, the ability to reproducibly measure smell loss-associated quality of life (QOL) and its response to treatment is paramount. Objective: To develop and validate a concise and visually appealing smell loss-associated QOL patient-reported outcome measure for OD. Design, Setting, and Participants: A secondary analysis of comments to an online survey by 1000 patients with olfactory dysfunction published in 2013 was used as the primary source to generate items of the Olfactory Dysfunction Outcomes Rating (ODOR). In addition, 30 patients with OD enrolled in 2 clinical studies at a tertiary care medical center (Washington University) were asked to identify their main concerns associated with smell loss. And finally, 4 otolaryngologists reviewed the items generated from the online survey and the patients' interviews to identify any additional items. Prospective study design was used for data collection from the 30 patients and 4 otolaryngologists. Prospective study design was used for survey validation. Validation of the ODOR was performed with 283 patients enrolled in several prospective studies at a single institution that completed the ODOR as an outcome measure. Main Outcomes and Measures: Item generation and selection were the outcomes of ODOR development. The psychometric and clinimetric measures evaluated for validation were internal consistency, test-retest reliability, face and content validity, concurrent validity, and discriminant validity. Minimal clinically important difference was also determined. Results: The ODOR is a 28-item instrument with each item scored as either no difficulty or very rarely bothered (0) to complete difficulty or very frequently bothered (4) with a total instrument score range of 0 to 112 points. Higher scores indicate higher degree of dysfunction and limitation. Validation in the cohort of 283 patients (mean [SD] age, 47.0 [14.4] years; 198 female participants [73%]; 179 White participants [80%]) revealed that the instrument has high internal consistency (Cronbach α = 0.968), test-retest reliability (r = 0.90 [95% CI, 0.81-0.95]), face validity, content validity, concurrent validity (r = 0.87 [95% CI, 0.80-0.91] compared with the Questionnaire of Olfactory Disorders-Negative Statements; ρ = -0.76 [95% CI, -0.81 to -0.71] compared with a patient-reported symptom severity scale), and divergent validity (mean score difference, -33.9 [95% CI, -38.3 to -29.6] between normosmic patients and hyposmic/anosmic patients). The minimal clinically important difference was 15 points. The estimated time for survey completion was approximately 5 minutes. Conclusions and Relevance: In this survey creation and validation study, the ODOR was shown to be a novel, concise, reliable, and valid patient-reported outcome measure of OD-associated QOL. It can be used to measure physical problems, functional limitations, and emotional consequences associated with OD and how they change after a given intervention, which is clinically applicable and particularly pertinent given the growing burden of OD associated with COVID-19.

Smell Changes and Efficacy of Nasal Theophylline (SCENT) irrigation: A randomized controlled trial for treatment of post-viral olfactory dysfunction.

OBJECTIVE: To evaluate the efficacy and safety of intranasal theophylline saline irrigation on olfactory recovery in patients with post-viral olfactory dysfunction (PVOD). METHODS: Between May 2019 and April 2020, we conducted a double-blinded, placebo-controlled randomized clinical trial of adults with 6-36 months of PVOD. Patients were randomized to nasal theophylline saline irrigation or placebo saline irrigation twice a day for 6 weeks. The primary outcome was the Global Rating of Smell Change. Secondary outcomes were changes in the University of Pennsylvania Smell Identification Test (UPSIT) and Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS). RESULTS: Twenty-two patients (n = 12, theophylline; n = 10, placebo) completed the study. Slightly more patients in the theophylline group (33%) reported improved smell compared to the placebo group (30%, difference 3.3%, 95% CI -35.6% to 42.3%). The median differences in pre- and post-treatment UPSIT and QOD-NS change between the two groups were 1 (95% CI -3 to 5) and -10 (95% CI -15 to -4), respectively in favor of theophylline. Three patients receiving theophylline and 2 receiving placebo had clinically meaningful improvements on the UPSIT (difference 5%, 95% CI -30% to 40%). There were no adverse events, and serum theophylline levels were undetectable in 10/10 patients. CONCLUSIONS: While safe, there were no clinically meaningful differences in olfactory change between the two groups except for olfaction-related quality of life, which was better with theophylline. The imprecise estimates suggest future trials will need substantially larger sample sizes or treatment modifications, such as increasing the theophylline dose, to observe larger treatment effects.

Preliminary results from the COVID caregiving project

Background In the United States, family caregivers are the cornerstone of the support system for persons living with dementia (PLWD). This study examined how the coronavirus disease 2019 (COVID-19) pandemic challenged caregivers? capacity to deliver long term care services and supports to PLWD. Method Participants (expected N=40) in this qualitative study are family caregivers for PLWD who reside in either the community or a long-term care facility. Family caregivers participate in semi-structured, hour-long telephonic interviews covering: (1) adequacy of caregiving supports;(2) social, emotional, physical, financial, and other effects of caregiving during the COVID-19 pandemic on the caregiver;and (3) effects of the COVID-19 pandemic on the person with dementia. Interviews are audio-recorded, transcribed, and coded in NVivo. The University of Pennsylvania IRB approved this study. Results Preliminary results show that social distancing measures disrupted services and supports for PLWD (e.g., closure of adult day centers). Efforts to minimize the risk of COVID-19 disease or death for the person with dementia increased caregiver work and feelings of burden. Many caregivers described making difficult tradeoffs. Some reduced their utilization of supports (e.g., forgoing having paid aides come into the home, limiting visits from other family members), but this has increased workload and limited opportunities for respite. Other caregivers reduced work hours or left the workforce entirely (e.g., because they deemed their risk of SARS-CoV-2 exposure on the job too high), but this has increased financial vulnerability and social isolation. A majority of caregivers expressed concern that social distancing has negatively affected the person in their care;many perceive a hastening of cognitive decline and feel their time with the person with dementia has been limited by the pandemic. Caregivers for long-term care facility residents reported frustration with limited visitation opportunities as well as a perceived decrease in quality of care and lack of transparency. Conclusion Our results will help characterize the impact of the COVID-19 pandemic on PLWD and their caregivers. They will inform ethical guidelines and policies to improve the delivery of services and supports for PLWD and the ability of people to perform the work of caregiving.

Public attitudes toward allocating scarce resources in the COVID-19 pandemic.

The general public is subject to triage policies that allocate scarce lifesaving resources during the COVID-19 pandemic, one of the worst public health emergencies in the past 100 years. However, public attitudes toward ethical principles underlying triage policies used during this pandemic are not well understood. Three experiments (preregistered; online samples; N = 1,868; U.S. residents) assessed attitudes toward ethical principles underlying triage policies. The experiments evaluated assessments of utilitarian, egalitarian, prioritizing the worst-off, and social usefulness principles in conditions arising during the COVID-19 pandemic, involving resource scarcity, resource reallocation, and bias in resource allocation toward at-risk groups, such as the elderly or people of color. We found that participants agreed with allocation motivated by utilitarian principles and prioritizing the worst-off during initial distribution of resources and disagreed with allocation motivated by egalitarian and social usefulness principles. At reallocation, participants agreed with giving priority to those patients who received the resources first. Lastly, support for utilitarian allocation varied when saving the greatest number of lives resulted in disadvantage for at-risk or historically marginalized groups. Specifically, participants expressed higher levels of agreement with policies that shifted away from maximizing benefits to one that assigned the same priority to members of different groups if this mitigated disadvantage for people of color. Understanding these attitudes can contribute to developing triage policies, increase trust in health systems, and assist physicians in achieving their goals of patient care during the COVID-19 pandemic.