Appealing to Americans' altruism is not enough to nudge them to accept novel vaccines.

BACKGROUND: The role of altruism in the acceptance of novel preventive healthcare technologies like vaccines has not been thoroughly elucidated. METHODS: We 1:1 randomized n = 2004 Amazon Mechanical Turk (MTurk) participants residing in the USA into a control or treatment arm with vaccination decisions framed altruistically, to elicit their preferences for COVID-19 vaccination using web-based discrete choice experiments. We used conditional and mixed logit models to estimate the impact of framing decisions in terms of altruism on vaccination acceptance. RESULTS: Valid responses were provided by 1674 participants (control, n = 848; treatment, n = 826). Framing vaccination decisions altruistically had no significant effect on vaccination acceptance. Further, respondents' degree of altruism had no association with vaccination acceptance. LIMITATIONS: The MTurk sample may not be representative of the American population. We were unable to ascertain concordance between stated and revealed preferences. CONCLUSIONS AND IMPLICATIONS: Framing vaccination decisions in terms of altruism does not appear to significantly influence vaccination acceptance and may not be an effective nudging mechanism to increase the uptake of novel vaccines. Instead, a favorable vaccination profile appears to be the primary driver of uptake.

Dental Protraction Versus Surgery for Cleft Lip and Palate: A Budget Impact Analysis.

Class III malocclusion for individuals with cleft lip and palate has historically been managed with surgery. Orthodontic protraction is a noninvasive alternative that may be associated with lower costs. This analysis investigated the budget impact of protraction versus surgery from an institutional perspective. Using a decision tree, analysis was conducted using costs derived from Medicaid reimbursement codes and using actual institutional reimbursement. Probabilities of success, failure, and complications were based on a clinical trial comparing the 2 treatment modalities. One-way and probabilistic sensitivity analyses tested the robustness of results to model parameters. Based on Medicaid fee schedules and failure rates requiring additional surgery, the total cost of protraction was $79,506 versus $172,807 for surgery, resulting in $93,302 cost-savings per patient. The cost and probability of surgery success, as well as the cost of surgery failure and repeat surgery, had the largest impact on these cost-savings. Probabilistic sensitivity analysis showed cost-savings of nearly $92,000 or higher in >50% of simulations. This study showed that protraction is associated with lower costs than surgery and may present a cost-effective alternative to surgery in eligible, appropriate patients.

Predicting panel attrition in longitudinal HRQoL surveys during the COVID-19 pandemic in the US.

BACKGROUND: Online longitudinal surveys may be subject to potential biases due to sample attrition. This study was designed to identify potential predictors of attrition using a longitudinal panel survey collected during the COVID-19 pandemic. METHODS: Three waves of data were collected using Amazon Mechanical Turk (MTurk), an online crowd-sourced platform. For each wave, the study sample was collected by referencing a US national representative sample distribution of age, gender, and race, based on US census data. Variables included respondents' demographics, medical history, socioeconomic status, COVID-19 experience, changes of health behavior, productivity, and health-related quality of life (HRQoL). Results were compared to pre-pandemic US norms. Measures that predicted attrition at different times of the pandemic were identified via logistic regression with stepwise selection. RESULTS: 1467 of 2734 wave 1 respondents participated in wave 2 and, 964 of 2454 wave 2 respondents participated in wave 3. Younger age group, Hispanic origin (p ≤ 0.001) and higher self-rated survey difficulty (p ≤ 0.002) consistently predicted attrition in the following wave. COVID-19 experience, employment, productivity, and limited physical activities were commonly observed variables correlated with attrition with specific measures varying by time periods. From wave 1, mental health conditions, average daily hours worked (p = 0.004), and COVID-19 impact on work productivity (p < 0.001) were associated with a higher attrition rate at wave 2, additional to the aforementioned factors. From wave 2, support of social distancing (p = 0.032), being Republican (p < 0.001), and having just enough money to make ends meet (p = 0.003) were associated with predicted attrition at wave 3. CONCLUSIONS: Attrition in this longitudinal panel survey was not random. Besides commonly identified demographic factors that contribute to panel attrition, COVID-19 presented novel opportunities to address sample biases by correlating attrition with additional behavioral and HRQoL factors in a constantly evolving environment. While age, ethnicity, and survey difficulty consistently predicted attrition, other factors, such as COVID-19 experience, changes of employment, productivity, physical health, mental health, and financial situation impacted panel attrition during the pandemic at various degrees.

Diagnosing newborns with suspected mitochondrial disorders: an economic evaluation comparing early exome sequencing to current typical care.

PURPOSE: To determine the value of early exome sequencing (eES) relative to the current typical care (TC) in the diagnosis of newborns with suspected severe mitochondrial disorders (MitD). METHODS: We used a decision tree-Markov hybrid to model neonatal intensive care unit (NICU)-related outcomes and costs, lifetime costs and quality-adjusted life-years among patients with MitD. Probabilities, costs, and utilities were populated using published literature, expert opinion, and the Pediatric Health Information System database. Incremental cost-effectiveness ratios (ICER) and net monetary benefits (NMB) were calculated from lifetime costs and quality-adjusted life-years for singleton and trio eES, and TC. Robustness was assessed using univariate and probabilistic sensitivity analyses (PSA). Scenario analyses were also conducted. RESULTS: Findings indicate trio eES is a cost-minimizing and cost-effective alternative to current TC. Diagnostic probabilities and NICU length-of-stay were the most sensitive model parameters. Base case analysis demonstrates trio eES has the highest incremental NMB, and PSA demonstrates trio eES had the highest likelihood of being cost-effective at a willingness-to-pay (WTP) of $200,000 relative to TC, singleton eES, and no ES. CONCLUSION: Trio and singleton eES are cost-effective and cost-minimizing alternatives to current TC in diagnosing newborns suspected of having a severe MitD.

A US Population Health Survey on the Impact of COVID-19 Using the EQ-5D-5L.

BACKGROUND: The COVID-19 pandemic has resulted in negative impacts on the economy, population health, and health-related quality-of-life (HRQoL). OBJECTIVE: To assess the impact of COVID-19 on US population HRQoL using the EQ-5D-5L. DESIGN: We surveyed respondents on physical and mental health, demographics, socioeconomics, brief medical history, current COVID-19 status, sleep, dietary, financial, and spending changes. Results were compared to online and face-to-face US population norms. Predictors of EQ-5D-5L utility were analyzed using both standard and post-lasso OLS regressions. Robustness of regression coefficients against unmeasured confounding was analyzed using the E-Value sensitivity analysis. SUBJECTS: Amazon MTurk workers (n=2776) in the USA. MAIN MEASURES: EQ-5D-5L utility and VAS scores by age group. KEY RESULTS: We received n=2746 responses. Subjects 18-24 years reported lower mean (SD) health utility (0.752 (0.281)) compared with both online (0.844 (0.184), p=0.001) and face-to-face norms (0.919 (0.127), p<0.001). Among ages 25-34, utility was worse compared to face-to-face norms only (0.825 (0.235) vs. 0.911 (0.111), p<0.001). For ages 35-64, utility was better during pandemic compared to online norms (0.845 (0.195) vs. 0.794 (0.247), p<0.001). At age 65+, utility values (0.827 (0.213)) were similar across all samples. VAS scores were worse for all age groups (p<0.005) except ages 45-54. Increasing age and income were correlated with increased utility, while being Asian, American Indian or Alaska Native, Hispanic, married, living alone, having history of chronic illness or self-reported depression, experiencing COVID-19-like symptoms, having a family member diagnosed with COVID-19, fear of COVID-19, being underweight, and living in California were associated with worse utility scores. Results were robust to unmeasured confounding. CONCLUSIONS: HRQoL decreased during the pandemic compared to US population norms, especially for ages 18-24. The mental health impact of COVID-19 is significant and falls primarily on younger adults whose health outcomes may have been overlooked based on policy initiatives to date.

Where Do We Go From Here? A Framework for Using Susceptible-Infectious-Recovered Models for Policy Making in Emerging Infectious Diseases.

OBJECTIVES: Throughout the coronavirus disease 2019 pandemic, susceptible-infectious-recovered (SIR) modeling has been the preeminent modeling method to inform policy making worldwide. Nevertheless, the usefulness of such models has been subject to controversy. An evolution in the epidemiological modeling field is urgently needed, beginning with an agreed-upon set of modeling standards for policy recommendations. The objective of this article is to propose a set of modeling standards to support policy decision making. METHODS: We identify and describe 5 broad standards: transparency, heterogeneity, calibration and validation, cost-benefit analysis, and model obsolescence and recalibration. We give methodological recommendations and provide examples in the literature that employ these standards well. We also develop and demonstrate a modeling practices checklist using existing coronavirus disease 2019 literature that can be employed by readers, authors, and reviewers to evaluate and compare policy modeling literature along our formulated standards. RESULTS: We graded 16 articles using our checklist. On average, the articles met 6.81 of our 19 categories (36.7%). No articles contained any cost-benefit analyses and few were adequately transparent. CONCLUSIONS: There is significant room for improvement in modeling pandemic policy. Issues often arise from a lack of transparency, poor modeling assumptions, lack of a system-wide perspective in modeling, and lack of flexibility in the academic system to rapidly iterate modeling as new information becomes available. In anticipation of future challenges, we encourage the modeling community at large to contribute toward the refinement and consensus of a shared set of standards for infectious disease policy modeling.

Lifetime Burden of Adult Congenital Heart Disease in the USA Using a Microsimulation Model.

Congenital heart defects (CHD) represent a growing burden of illness among adults. We estimated the lifetime health, education, labor, and social outcomes of adults with CHD in the USA using the Future Adult Model, a dynamic microsimulation model that has been used to study the lifetime impacts of a variety of chronic diseases. We simulated a cohort of adult heads of households > 25 years old derived from the Panel Survey of Income Dynamics who reported a childhood heart problem as a proxy for CHD and calculated life expectancy, disability-free and quality-adjusted life years, lifetime earnings, education attainment, employment, development of chronic disease, medical spending, and disability insurance claiming status. Total burden of disease was estimated by comparing to a healthy cohort with no childhood heart problem. Eighty-seven individuals reporting a childhood heart problem were identified from the PSID and were used to generate the synthetic cohort simulated in the model. Life expectancy, disability-free, quality-adjusted, and discounted quality-adjusted life years were an average 4.6, 6.7, 5.3, and 1.4 years lower than in healthy adults. Lung disease, cancer, and severe mental distress were more common compared to healthy individuals. The CHD cohort earned $237,800 less in lifetime earnings and incurred higher average total medical spend by $66,600 compared to healthy individuals. Compared to healthy adults, the total burden of CHD is over $500K per adult. Despite being among the healthiest adults with CHD, there are significant decrements in life expectancy, employment, and lifetime earnings, with concomitant increases in medical spend.

Impact of Confounding on Cost, Survival, and Length-of-Stay Outcomes for Neonates with Hypoplastic Left Heart Syndrome Undergoing Stage 1 Palliation Surgery.

The objective of this analysis was to update trends in LOS and costs by survivorship and ECMO use among neonates with hypoplastic left heart syndrome (HLHS) undergoing stage 1 palliation surgery using 2016 data from the Healthcare Cost and Utilization Project Kids' Inpatient Database. We identified neonates ≤ 28 days old with HLHS undergoing Stage 1 surgery, defined as a Norwood procedure with modified Blalock-Taussig (BT) shunt, Sano modification, or both. Multivariable regression with year random effects was used to compare LOS and costs by hospital region, case volume, survivorship, and ECMO vs. no ECMO. An E-value analysis, an approach for conducting sensitivity analysis for unmeasured confounding, was performed to determine if unmeasured confounding contributed to the observed effects. Significant differences in total costs, LOS, and mortality were noted by hospital region, ECMO use, and sub-analyses of case volume. However, other than ECMO use and mortality, the maximum E-value confidence interval bound was 1.71, suggesting that these differences would disappear with an unmeasured confounder 1.71 times more associated with both the outcome and exposure (e.g., socioeconomic factors, environment, etc.) Our findings confirm previous literature demonstrating significant resource utilization among Norwood patients, particularly those undergoing ECMO use. Based on our E-value analysis, differences by hospital region and case volume can be explained by moderate unobserved confounding, rather than a reflection of the quality of care provided. Future analyses on surgical quality must account for unobserved factors to provide meaningful information for quality improvement.

Behavioral Economics Interventions to Improve Outpatient Antibiotic Prescribing for Acute Respiratory Infections: a Cost-Effectiveness Analysis.

BACKGROUND: Behavioral economics interventions have been shown to effectively reduce the rates of inappropriate antibiotic prescriptions for acute respiratory infections (ARIs). OBJECTIVE: To determine the cost-effectiveness of three behavioral economic interventions designed to reduce inappropriate antibiotic prescriptions for ARIs. DESIGN: Thirty-year Markov model from the US societal perspective with inputs derived from the literature and CDC surveillance data. SUBJECTS: Forty-five-year-old adults with signs and symptoms of ARI presenting to a healthcare provider. INTERVENTIONS: (1) Provider education on guidelines for the appropriate treatment of ARIs; (2) Suggested Alternatives, which utilizes computerized clinical decision support to suggest non-antibiotic treatment choices in lieu of antibiotics; (3) Accountable Justification, which mandates free-text justification into the patient's electronic health record when antibiotics are prescribed; and (4) Peer Comparison, which sends a periodic email to prescribers about his/her rate of inappropriate antibiotic prescribing relative to clinician colleagues. MAIN MEASURES: Discounted costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. KEY RESULTS: Each intervention has lower costs but higher QALYs compared to provider education. Total costs for each intervention were $178.21, $173.22, $172.82, and $172.52, and total QALYs were 14.68, 14.73, 14.74, and 14.74 for the control, Suggested Alternatives, Accountable Justification, and Peer Comparison groups, respectively. Results were most sensitive to the quality-of-life of the uninfected state, and the likelihood and costs for antibiotic-associated adverse events. CONCLUSIONS: Behavioral economics interventions can be cost-effective strategies for reducing inappropriate antibiotic prescriptions by reducing healthcare resource utilization.

United States Valuation of EQ-5D-5L Health States Using an International Protocol.

OBJECTIVE: To derive a US-based value set for the EQ-5D-5L questionnaire using an international, standardized protocol developed by the EuroQol Group. METHODS: Respondents from the US adult population were quota-sampled on the basis of age, sex, ethnicity, and race. Trained interviewers guided participants in completing composite time trade-off (cTTO) and discrete choice experiment (DCE) tasks using the EuroQol Valuation Technology software and routine quality control measures. Data were modeled using a Tobit model for cTTO data, a mixed logit model for DCE data, and a hybrid model that combined cTTO and DCE data. Model performance was compared on the basis of logical ordering of coefficients, statistical significance, parsimony, and theoretical considerations. RESULTS: Of 1134 respondents, 1062, 1099, and 1102 respondents provided useable cTTO, DCE, and cTTO or DCE responses, respectively, on the basis of quality control criteria and interviewer judgment. Respondent demographic characteristics and health status were similar to the 2015 US Census. The Tobit model was selected as the preferred model to generate the value set. Values ranged from -0.573 (55 555) to 1 (11 111), with 20% of all predicted health states scores less than 0 (ie, worse than dead). CONCLUSIONS: A societal value set for the EQ-5D-5L was developed that can be used for economic evaluations and decision making in US health systems. The internationally established, standardized protocol used to develop this US-based value set was recommended by the EuroQol Group and can facilitate cross-country comparisons.

Cost-effectiveness analysis of abiraterone and sipuleucel-T in asymptomatic metastatic castration-resistant prostate cancer.

Of patients diagnosed with prostate cancer, 0% to 20% experience disease progression to metastatic castration-resistant prostate cancer (mCRPC). Recently, 4 novel therapies have been introduced for the treatment of mCRPC; of these, abiraterone and sipuleucel-T have been studied in the asymptomatic, pre-docetaxel population. Both have shown clinical benefits compared with placebo. This study evaluated the cost-effectiveness of abiraterone acetate and sipuleucel-T compared with prednisone in asymptomatic, pre-docetaxel mCRPC from a US societal perspective. A Markov model was constructed to simulate stable disease, progressed disease, and death. Survival and event rates were derived from published clinical trial data. Costs were derived from the literature and government reimbursement schedules. Outcomes were measured as average cost-effectiveness ratios (ACERs), incremental cost-effectiveness ratios (ICERs), and net monetary benefits (NMBs). One-way and probabilistic sensitivity analyses were conducted to test the robustness of the model. The base-case ACER was $114K/quality-adjusted life-years (QALY) for abiraterone, $85K/QALY for sipuleucel-T, and $31K/QALY for prednisone. The base-case ICER was $389K/QALY for abiraterone and $547K/QALY for sipuleucel-T. Prednisone dominates both abiraterone and sipuleucel-T in terms of NMB at willingness-to-pay (WTP) thresholds of $400K or less. One-way sensitivity analyses revealed that the model was most sensitive to overall survival and utility inputs. Probabilistic sensitivity analyses showed abiraterone to be cost-effective 50% or more of the time at a WTP of greater than $400K, whereas sipuleucel-T was cost-effective 50% or more of the time at a WTP of greater than $270K. Neither abiraterone nor sipuleucel-T was found to be cost-effective compared with prednisone in the treatment of asymptomatic, pre-docetaxel mCRPC.

Cost-effectiveness of nirsevimab and palivizumab for respiratory syncytial virus prophylaxis in preterm infants 29-34 6/7 weeks' gestation in the United States.

BACKGROUND: Respiratory syncytial virus (RSV) hospitalizations have increased since the 2014 guideline update recommended against the use of palivizumab for preterm infants born ≥29 0/7 weeks' gestational age (GA) without additional risk factors. A novel drug candidate, nirsevimab, has been developed for this population. We analyzed the cost-effectiveness of palivizumab/nirsevimab vs. no prophylaxis in this population. METHODS: A hybrid-Markov model predicted the RSV clinical course in the first year of life and sequelae in the subsequent four years for preterm infants from the healthcare and societal perspectives. Model parameters were derived from the literature. We calculated costs and quality-adjusted life-years (QALYs) to produce an incremental cost-effectiveness ratio (ICER) evaluated at a willingness-to-pay threshold of $150,000/QALY. Sensitivity analyses assessed model robustness. A threshold analysis examined nirsevimab pricing uncertainty. RESULTS: Compared to no prophylaxis, palivizumab costs $9572 and $9584 more from the healthcare and societal perspectives, respectively, with 0.0019 QALYs gained per patient over five years, resulting in ICERs >$5 million per QALY from each perspective. Results were robust to parameter uncertainties; probabilistic sensitivity analysis revealed that no prophylaxis had a 100% probability of being cost-effective. The threshold analysis suggested that nirsevimab is not cost-effective when compared to no prophylaxis if the price exceeds $1962 from a societal perspective. CONCLUSION: Palivizumab is dominated by no prophylaxis for preterm infants 29 0/7-34 6/7 weeks' GA with no additional risk factors. Relevant stakeholders should consider alternatives to palivizumab for this population that are both effective and economical.

Costs and outcomes associated with the administration of Intravenous Acetaminophen in neonates after esophageal atresia and tracheoesophageal fistula repair.

BACKGROUND: Over the last decade, the intravenous (IV) formulation of acetaminophen (APAP) has gained popularity as a safe and effective first-line analgesic in the neonatal intensive care unit and it is especially useful in peri-operative settings where oral agents are contraindicated. The primary objective was to examine the outcomes and costs associated with the use of IV APAP in combination with opioids versus opioids alone as a pain management strategy after neonatal esophageal atresia (EA) and tracheoesophageal fistula (TEF) repair. METHODS: Data from the Pediatric Health Information System was used to examine 1137 hospitalizations for EA/TEF repair from October 2015 to September 2018. Neonates administered opioids only, or IV APAP in combination with opioids as pain management, were included. RESULTS: Neonates receiving IV APAP experienced a longer median LOS, but a significantly lower mortality rate, a decreased mean daily cost, and reduced opioid use compared to neonates given only opioids. The two groups had no significant differences in pharmacy and total costs. CONCLUSION: Our findings suggest that the use of IV APAP alongside opioids in EA/TEF repair is associated with reduced mortality and opioid use, as well as longer LOS.

Institutional and Regional Variation in Opioid Prescribing for Hospitalized Infants in the US.

Importance: High-risk infants, defined as newborns with substantial neonatal-perinatal morbidities, often undergo multiple procedures and require prolonged intubation, resulting in extended opioid exposure that is associated with poor outcomes. Understanding variation in opioid prescribing can inform quality improvement and best-practice initiatives. Objective: To examine regional and institutional variation in opioid prescribing, including short- and long-acting agents, in high-risk hospitalized infants. Design, Setting, and Participants: This retrospective cohort study assessed high-risk infants younger than 1 year from January 1, 2016, to December 31, 2022, at 47 children's hospitals participating in the Pediatric Health Information System (PHIS). The cohort was stratified by US Census region (Northeast, South, Midwest, and West). Variation in cumulative days of opioid exposure and methadone treatment was examined among institutions using a hierarchical generalized linear model. High-risk infants were identified by International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes for congenital heart disease surgery, medical and surgical necrotizing enterocolitis, extremely low birth weight, very low birth weight, hypoxemic ischemic encephalopathy, extracorporeal membrane oxygenation, and other abdominal surgery. Infants with neonatal opioid withdrawal syndrome, in utero substance exposure, or malignant tumors were excluded. Exposure: Any opioid exposure and methadone treatment. Main Outcomes and Measures: Regional and institutional variations in opioid exposure. Results: Overall, 132 658 high-risk infants were identified (median [IQR] gestational age, 34 [28-38] weeks; 54.5% male). Prematurity occurred in 30.3%, and 55.3% underwent surgery. During hospitalization, 76.5% of high-risk infants were exposed to opioids and 7.9% received methadone. Median (IQR) length of any opioid exposure was 5 (2-12) cumulative days, and median (IQR) length of methadone treatment was 19 (7-46) cumulative days. There was significant hospital-level variation in opioid and methadone exposure and cumulative days of exposure within each US region. The computed intraclass correlation coefficient estimated that 16% of the variability in overall opioid prescribing and 20% of the variability in methadone treatment was attributed to the individual hospital. Conclusions and Relevance: In this retrospective cohort study of high-risk hospitalized infants, institution-level variation in overall opioid exposure and methadone treatment persisted across the US. These findings highlight the need for standardization of opioid prescribing in this vulnerable population.

Estimating the cost of inappropriate antibiotic prophylaxis prior to dental procedures.

Inappropriate dental antibiotic prescriptions to prevent infective endocarditis in the United States results in ∼$31 million in excess costs to the healthcare system and patients. This includes out-of-pocket costs ($20.5 million), drug costs ($2.69 million) and adverse event costs (eg, Clostridioides difficile and hypersensitivity) of $5.82 million (amoxicillin), $1.99 million (clindamycin), and $380,849 (cephalexin).

A cross-country comparison of health-related quality of life in the United States, Sweden, and Norway during the first year of the COVID-19 pandemic.

BACKGROUND: Limited studies have directly compared health-related quality of life (HRQoL) in different countries during the COVID-19 global pandemic. The objective of this study was to evaluate the HRQoL outcomes in the US, Sweden, and Norway during the first year under the pandemic. METHODS: In April 2020, during early phase of the pandemic, separately in the US, Sweden, and Norway, we surveyed 2,734, 1,003 and 1,020 respondents, then again in January 2021, we collected 2,252, 1,013 and 1,011 respondents. The survey was first developed in English and translated into Swedish and Norwegian. Selected variables were used for the current study. We collected respondents' HRQoL using the EQ-5D-5L. Respondents' background information included their sociodemographic data, medical history, and COVID-19 status. We reported the EQ-5D-5L utility, EQ-VAS, and the proportion of problems with each of the EQ-5D-5L health subdomains. Population quality-adjusted life year (QALY) changes based on EQ-5D-5L utility scores were also calculated. Outcomes were stratified by age. One-way ANOVA test was used to detect significant differences between countries and Student's t-tests were used to assess the differences between waves. RESULTS: Respectively for the US, Sweden, and Norway, mean EQ-5D-5L utilities were 0.822, 0.768, and 0.808 in April 2020 (p < 0.001); 0.823, 0.783, and 0.777 in January 2021 (p < 0.001); mean EQ-VAS scores were 0.746, 0.687, and 0.692 in April 2020 (p < 0.001), 0.764, 0.682, and 0.678 in January 2021 (p < 0.001). For both waves, EQ-5D-5L utilities and EQ-VAS scores in the US remained higher than both Sweden and Norway (p < 0.001). Norwegians reported considerably lowered HRQoL over time (p < 0.01). Self-reported problems with anxiety/depression were highest for the US and Sweden, while Norwegians reported most problems with pain/discomfort, followed by anxiety/depression. The population QALYs increased in the US and Sweden, but decreased in Norway. CONCLUSIONS: In the first year of the pandemic, a rebound in HRQoL was observed in the US, but not in Sweden or Norway. Mental health issues during the pandemic warrant a major public health concern across all 3 countries.

Sensory Adaptations to Improve Physiological and Behavioral Distress During Dental Visits in Autistic Children: A Randomized Crossover Trial.

Importance: Autistic children have poorer oral health and greater oral care challenges, which are often associated with sensory overresponsivity, than neurotypical peers. It is important to identify innovative solutions enabling dentists to successfully perform standard clinic-based procedures for this population. Objective: To determine whether a sensory-adapted dental environment (SADE) reduces physiological and behavioral distress in autistic children undergoing dental cleanings, compared with a regular dental environment (RDE). Design, Setting, and Participants: This randomized crossover trial was conducted at a pediatric dentistry clinic in a large urban children's hospital between May 2016 and April 2022. Coders were blinded to study condition for physiological but not behavioral measurements. Autistic children aged 6 to 12 years were identified and invited to participate. Interested families were enrolled consecutively; after confirmation of autism diagnosis, children were randomized. Analysis for this per-protocol study were conducted from April to October 2022. Intervention: Each child underwent 1 RDE and 1 SADE dental cleaning, administered in randomized and counterbalanced order approximately 6 months apart. SADE included modified visual, auditory, and tactile stimuli. Main Outcomes and Measures: The primary outcome was physiological stress, assessed by electrodermal activity. The secondary outcome was behavioral distress measured from video recordings. Results: Among 452 families invited to participate, 220 children were enrolled, and 162 children (mean [SD] age, 9.16 [1.99] years; 136 [84.0%] male) with confirmed autism were randomized, with 83 children receiving RDE first and 80 children receiving SADE first. Most children (94 children [58.0%]) had moderate autism severity. Children had significantly lower physiological stress during dental care in SADE compared with RDE (mean difference in skin conductance level, -1.22 [95% CI, -2.17 to -0.27] µS), suggesting decreased sympathetic activity and increased relaxation during SADE dental care. No significant differences were found in nonspecific skin conductance responses (mean difference, -0.30 [95% CI, -0.86 to 0.25] per min). Video-coded frequency and duration of behavioral distress (but not questionnaire) measures were significantly lower in SADE vs RDE (Cohen d = -0.84 to -1.19). Physiological stress was associated with behavioral distress during the dental cleaning (eg, nonspecific skin conductance responses associated with the Frankl Scale: ß = -0.29; 95% CI, -0.39 to -0.19); age, IQ, and expressive communication moderated the intervention's success. No participants withdrew due to adverse effects. Conclusions and Relevance: In this randomized crossover trial of autistic children, using SADE was safe and efficacious in decreasing physiological and behavioral distress during dental care. This is important because enhancing oral care is critical for autistic children; this intervention may also be beneficial for populations beyond autism. Trial Registration: ClinicalTrials.gov Identifier: NCT02430051.