Nirmatrelvir/ritonavir and remdesivir against symptomatic treatment in high-risk COVID-19 outpatients to prevent hospitalization or death during the Omicron era: a propensity score-matched study.

Background: Even though worldwide death rates from coronavirus disease 2019 (COVID-19) have decreased, the threat of disease progression and death for high-risk groups continues. Few direct comparisons between the available severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antivirals have been made. Objective: We aimed to compare two SARS-CoV-2 antivirals (nirmatrelvir/ritonavir and remdesivir) against all-cause hospitalization or death. Design: This is a propensity score-matched cohort study. Methods: We included all high-risk outpatients with COVID-19 in a tertiary referral center in Mexico City from 1 January 2022 to 31 July 2023. The primary outcome was all-cause hospitalization or death 28 days after symptom onset. The secondary outcome was COVID-19-associated hospitalization or death 28 days after symptom onset. Logistic regression analysis for characteristics associated with the primary outcome and a multi-group comparison with Kaplan-Meier survival estimates were performed. Results: Of 1566 patients analyzed, 783 did not receive antiviral treatment, 451 received remdesivir, and 332 received nirmatrelvir/ritonavir. The median age was 60 years (interquartile range: 46-72), 62.5% were female and 97.8% had at least one comorbidity. The use of nirmatrelvir/ritonavir was associated with an absolute risk reduction of 8.8% and a relative risk reduction of 90% for all-cause hospitalization or death. The use of remdesivir was associated with an absolute risk reduction of 6.4% and a relative risk reduction of 66% for all-cause hospitalization or death. In multivariable analysis, both antivirals reduced the odds of 28-day all-cause hospitalization or death [nirmatrelvir/ritonavir odds ratio (OR) 0.08 - 95% confidence interval (CI): 0.03-0.19, remdesivir OR 0.29 - 95% CI: 0.18-0.45]. Conclusion: In high-risk COVID-19 outpatients, early antiviral treatment with nirmatrelvir/ritonavir or remdesivir was associated with lower 28-day all-cause hospitalization or death.

Nirmatrelvir/ritonavir and remdesivir against symptomatic treatment in high-risk COVID-19 outpatients In this study, we included high-risk non-hospitalized patients with confirmed mild COVID-19. We compared those who received antiviral treatment (nirmatrelvir/ritonavir or remdesivir) against those who only received symptomatic treatment. The aim was to detect differences in hospitalization or death 28 days after symptom onset. We analyzed 1566 patients: 783 did not receive antiviral treatment, 451 received remdesivir, and 332 received nirmatrelvir/ritonavir. Most patients were female and over 60 years old. The most common comorbidities were chronic hypertension (44%), diabetes mellitus (26%), and autoimmune diseases (25%); systemic immunosuppression was registered in 35% of patients. Hospitalization or death 28 days after symptom onset occurred in 168 patients (136 in the symptomatic treatment group, 27 in the remdesivir group, and 5 in the nirmatrelvir/ritonavir group). Considering multiple variables like age, sex, comorbidities, and previous vaccination, both antivirals significantly reduced the odds of hospitalization or death (nirmatrelvir/ritonavir odds ratio 0.08, 95% confidence interval 0.03-0.19; remdesivir odds ratio 0.29, 95% confidence interval 0.18-0.45).

Quality-of-life concerns differ among patients, parents, and medical providers in children and adolescents with congenital and acquired heart disease.

OBJECTIVES: Mortality rates in pediatric patients with heart disease have decreased dramatically in recent decades, resulting in an increasing number of survivors with morbidities that impact quality of life. The purpose of this study was to assess and compare how heart disease affects the quality of life of the pediatric cardiac patient from the perspectives of the patient, parent, and health care provider. METHOD: Individual focus groups were conducted with children (8-12 years of age) with heart disease, adolescents (13-18 years of age) with heart disease, parents of children with heart disease, parents of adolescents with heart disease, and health care providers of pediatric patients with heart disease. A structured focus group technique was used to develop a list of potential items that might affect quality of life. Participants chose the 5 most important items from the list. These items were then categorized into preidentified dimensions (physical, psychological, social, school, and other). The percentages of the total votes for all items were calculated and distributions of responses across dimensions within group and within dimension across groups were reported and compared qualitatively. RESULTS: Patient and parent groups identified similar items as important. Providers identified different items. The physical limitation item received the largest percentage of total votes in all groups (9%-20%). Analysis across dimension revealed that those items related to the physical dimension received the highest percentage of total votes among all groups (30.2%-51.2%). Analysis within dimension revealed that patients endorsed items in the physical dimension more frequently than parents or providers. Within the psychological dimension, the children selected the fewest items relative to all other groups (7.2% vs 21.3%-37.8%), whereas health care providers endorsed these items more frequently than patients or parents (child or parent of child groups 7.2%-21.3% vs health care provider group 28.8%; adolescent or parent of adolescent groups 29.6% vs health care provider group 37.8%). Differences were noted between the child and adolescent groups in the psychological (child versus adolescent: 7.2% vs 29.6%) and school (child versus adolescent: 11.2% vs 2.1%) dimensions. CONCLUSIONS: Patients and parents generally agreed on how heart disease affects the quality of life of children and adolescents, whereas health care providers had a different opinion.

Adapting a patient satisfaction instrument for low literate and Spanish-speaking populations: comparison of three formats.

OBJECTIVE: To compare responses to print versions of the Consumer Assessment of Healthcare Providers and Systems 2.0 survey (CAHPS) to those for an illustration enhanced format and a telephone based interactive voice response format. METHODS: First, 2015 adult patients awaiting primary care visits completed: demographic information, Test of Functional Health Literacy (S-TOFHLA), CAHPS in one of three formats: print, illustrated, or interactive voice. A second sample of 4800 active patients was randomized to receive alternative formats. RESULTS: Response rates for the illustrated (31.3%) and print (30.4%) formats were significantly higher than for the interactive voice format (18.1%). The results of the illustrated format were comparable to the traditional text version, but required about 2 min more to complete by both low and high literacy groups. There were almost no invalid responses for the interactive voice format, but the format was associated with lower CAHPS satisfaction scores. CONCLUSION: Despite extensive efforts to produce formats tailored to individuals with limited literacy, surprisingly we found no consistent advantages to either alternative format. In fact, the interactive voice format yielded lower satisfaction scores and lower response rates. PRACTICE IMPLICATIONS: Practitioners need to ensure the health instruments they use are aligned with literacy skills and delivery preferences of their consumers. The lack of benefit of the illustrated form does not support investment of resources in these formats to measure satisfaction. The interactive voice response deserves more study--do lower scores register limited access to or use of telephones, irritation or true signal?

The development of the pediatric cardiac quality of life inventory: a quality of life measure for children and adolescents with heart disease.

OBJECTIVE: Mortality after surgery for congenital heart disease (CHD) has decreased. Quality of life (QOL) assessment in survivors has become increasingly important. The purpose of this project was to create the Pediatric Cardiac Quality of Life Inventory (PCQLI). METHODS: Items were generated through nominal groups of patients, parents, and providers. The pilot PCQLI was completed by children (age 8-12), adolescents (age 13-18), and their parents at three cardiology clinics. Item reduction was performed through analysis of items, principal components, internal consistency (IC), and patterns of correlation. RESULTS: A total of 655 patient-parent pairs completed the pilot PCQLI. Principal components identified included: impact of disease (ID); psychosocial impact (PI); and emotional environment (EE). After item reduction ID and PI had excellent IC (ID = 0.88-0.91; PI = 0.78-0.85) and correlated highly with each other (0.81-0.90) and with the total score (TS) (ID = 0.95-0.96; PI = 0.87-0.93). EE was not correlated with ID, PI, or TS and was removed from the final forms. Two-ventricle CHD patients had a higher TS than single-ventricle CHD patients across all forms (P < 0.001). CONCLUSION: The PCQLI has patient and parent-proxy forms, has wide age range, and discriminates between CHD subgroups. The ID and PI subscales of the PCQLI have excellent IC and correlate well with each other and the TS.

'Breaking it down': patient-clinician communication and prenatal care among African American women of low and higher literacy.

PURPOSE: Low literacy has been associated with poor medical adherence, but its role in maternal care utilization has not been explored. METHODS: We undertook a concurrent mixed methods study among 202 African American women of low (< or = 6th grade) and higher literacy receiving Medicaid. Poor use of prenatal care was defined by (1) starting care after the first trimester and (2) inadequate care utilization according to the Adequacy of Prenatal Care Utilization Index (APNCU). Participant-derived themes regarding prenatal care and care utilization were identified and explored through individual interviews (free listing and cultural consensus analysis; n = 40), and 4 confirmatory focus groups stratified by literacy. RESULTS: Thirty-three women (16%) had low-literacy levels, 120 (61%) women started prenatal care after the first trimester, and 101 (50%) had inadequate utilization of prenatal care. Neither measure varied by literacy (P >.05). Cultural consensus analysis identified a single prenatal care factor that was comprised of 9 items, shared by women of low and higher literacy (eigenvalue 0.881, SD 0.058). Focus groups confirmed these items among participants from both literacy groups. Communication with clinicians was a central theme linking all of the factor items. Effective communication, exemplified by "breaking it down," was described as encouraging, whereas ineffective communication discouraged use of care. CONCLUSION: Women who had both low- and higher-literacy skills had high rates of poor prenatal care utilization and reported that communication with clinicians influenced their use of prenatal care. Improving the clarity of communication by breaking down information into simple parts should be a priority for prenatal clinicians.

The effect of a simple educational intervention on interest in early abortion training among family medicine residents.

OBJECTIVES: We aimed to assess the effect of an educational intervention on the interest in and support for abortion training among family medicine residents. METHODS: We conducted a cross-sectional survey before and after an educational lecture on medical and surgical abortion in primary care among 89 residents in 10 New Jersey family medicine programs. RESULTS: Before the lecture, there was more interest in medical abortion training than surgical abortion. Resident interest in surgical abortion and overall support for abortion training increased after the educational intervention (p<.01). CONCLUSIONS: Efforts to develop educational programs on early abortion care may facilitate the integration of abortion training in family medicine.

Developing an illustrated version of the Consumer Assessment of Health Plans (CAHPS).

BACKGROUND: The most commonly used tool for assessing member satisfaction with health plans in the United States is the Consumer Assessment of Health Plans (CAHPS). Yet its complexity exceeds the abilities of many patient populations. An illustrated version of the CAHPS instrument was designed for low-literacy audiences; the illustrations were tested and were then revised toreflect respondents' feedback. METHODS: Ilustrattions were developed to support the central themes in each of 63 CAHPS text items. The cognitive testing approach was used to create a systematic method to analyze key features of an item and develop the corresponding interview procedure. RESULTS: Following cognitive interviews on subsets of illustrations and items with more than 900 patients, all but 7 (11%) of the 63 items met the criterion that no more than 25% of the sample who saw the illustration could be rated as having "limited/no understanding." By the final pilot, a median of 66% had "full understanding," 20% had "partial understanding," and 14% had "limited/no understanding" of the 43 illustrations needing revision. CONCLUSIONS: The protocol helped improve the respondents' understanding of the illustrations. The experiences and lessons learned can guide design of illustration-enhanced materials for low-literacy populations.

Performance of the English and Spanish S-TOFHLA among publicly insured Medicaid and Medicare patients.

The objective of this study was to analyze the psychometric properties of the English and Spanish S-TOFHLA for three patient populations of interest. Despite being widely used, little is written about psychometric properties of the S-TOFHLA, particularly the Spanish version. Participants were Medicaid and Medicare patients: 936 non-Hispanic and 368 Hispanic patients completed the English S-TOFHLA; 1066 Hispanics completed the Spanish S-TOFHLA. Validity of both versions of the S-TOFHLA was supported by strong positive relationships with education and inverse relationships with age. Significant differences between scores for men and women remained after adjusting for level of education. Score differences occurred across numerous items. More research is needed on the S-TOFHLA and other health literacy instruments to determine why women score differently than men. Variability in literacy skills within subgroups of patients highlights the importance of healthcare providers being sensitive to patients' literacy levels in both spoken and written communications.

Designing an illustrated patient satisfaction instrument for low-literacy populations.

Up to 25% of adults in the United States have difficulty with everyday reading tasks. As patients, adults with low literacy may not be able to complete many self-administered written questionnaires, which often are used to obtain information from patients and to gauge their satisfaction with care. We developed an illustrated version of a patient satisfaction instrument used by the Veterans Health Administration. This paper describes the extensive design process used to develop, pilot-test, and revise this 63-item illustrated instrument. A total of 438 patients were interviewed over a 1-year period to obtain feedback on illustrations, with at least 15 people viewing and commenting on each picture and revision. All pictures were revised, with the majority revised at least 4 times. We report on this iterative design process as well as on lessons we learned in illustrating questions for low-literacy populations.