clinicaltrials.gov Identifier: NCT00537433.

A large proportion of US parents have limited health-literacy skills. Decreasing literacy demands on parents, including simplification of health insurance and other medical forms, as well as medication and food labels, is needed to decrease health care access barriers for children and allow for informed parent decision-making. Addressing low parent health literacy may ameliorate existing child health disparities.

ImportanceSARS-CoV-2 infection is associated with persistent, relapsing, or new symptoms or other health effects occurring after acute infection, termed postacute sequelae of SARS-CoV-2 infection (PASC), also known as long COVID. Characterizing PASC requires analysis of prospectively and uniformly collected data from diverse uninfected and infected individuals.ObjectiveTo develop a definition of PASC using self-reported symptoms and describe PASC frequencies across cohorts, vaccination status, and number of infections.Design, Setting, and ParticipantsProspective observational cohort study of adults with and without SARS-CoV-2 infection at 85 enrolling sites (hospitals, health centers, community organizations) located in 33 states plus Washington, DC, and Puerto Rico. Participants who were enrolled in the RECOVER adult cohort before April 10, 2023, completed a symptom survey 6 months or more after acute symptom onset or test date. Selection included population-based, volunteer, and convenience sampling.ExposureSARS-CoV-2 infection.Main Outcomes and MeasuresPASC and 44 participant-reported symptoms (with severity thresholds).ResultsA total of 9764 participants (89% SARS-CoV-2 infected; 71% female; 16% Hispanic/Latino; 15% non-Hispanic Black; median age, 47 years [IQR, 35-60]) met selection criteria. Adjusted odds ratios were 1.5 or greater (infected vs uninfected participants) for 37 symptoms. Symptoms contributing to PASC score included postexertional malaise, fatigue, brain fog, dizziness, gastrointestinal symptoms, palpitations, changes in sexual desire or capacity, loss of or change in smell or taste, thirst, chronic cough, chest pain, and abnormal movements. Among 2231 participants first infected on or after December 1, 2021, and enrolled within 30 days of infection, 224 (10% [95% CI, 8.8%-11%]) were PASC positive at 6 months.Conclusions and RelevanceA definition of PASC was developed based on symptoms in a prospective cohort study. As a first step to providing a framework for other investigations, iterative refinement that further incorporates other clinical features is needed to support actionable definitions of PASC.

ObjectiveTo determine whether medical errors, family experience, and communication processes improved after implementation of an intervention to standardize the structure of healthcare provider-family communication on family centered rounds.DesignProspective, multicenter before and after intervention study.SettingPediatric inpatient units in seven North American hospitals, 17 December 2014 to 3 January 2017.ParticipantsAll patients admitted to study units (3106 admissions, 13171 patient days); 2148 parents or caregivers, 435 nurses, 203 medical students, and 586 residents.InterventionFamilies, nurses, and physicians coproduced an intervention to standardize healthcare provider-family communication on ward rounds (“family centered rounds”), which included structured, high reliability communication on bedside rounds emphasizing health literacy, family engagement, and bidirectional communication; structured, written real-time summaries of rounds; a formal training programme for healthcare providers; and strategies to support teamwork, implementation, and process improvement.Main outcome measuresMedical errors (primary outcome), including harmful errors (preventable adverse events) and non-harmful errors, modeled using Poisson regression and generalized estimating equations clustered by site; family experience; and communication processes (eg, family engagement on rounds). Errors were measured via an established systematic surveillance methodology including family safety reporting.ResultsThe overall rate of medical errors (per 1000 patient days) was unchanged (41.2 (95% confidence interval 31.2 to 54.5) pre-intervention v 35.8 (26.9 to 47.7) post-intervention, P=0.21), but harmful errors (preventable adverse events) decreased by 37.9% (20.7 (15.3 to 28.1) v 12.9 (8.9 to 18.6), P=0.01) post-intervention. Non-preventable adverse events also decreased (12.6 (8.9 to 17.9) v 5.2 (3.1 to 8.8), P=0.003). Top box (eg, “excellent”) ratings for six of 25 components of family reported experience improved; none worsened. Family centered rounds occurred more frequently (72.2% (53.5% to 85.4%) v 82.8% (64.9% to 92.6%), P=0.02). Family engagement 55.6% (32.9% to 76.2%) v 66.7% (43.0% to 84.1%), P=0.04) and nurse engagement (20.4% (7.0% to 46.6%) v 35.5% (17.0% to 59.6%), P=0.03) on rounds improved. Families expressing concerns at the start of rounds (18.2% (5.6% to 45.3%) v 37.7% (17.6% to 63.3%), P=0.03) and reading back plans (4.7% (0.7% to 25.2%) v 26.5% (12.7% to 7.3%), P=0.02) increased. Trainee teaching and the duration of rounds did not change significantly.ConclusionsAlthough overall errors were unchanged, harmful medical errors decreased and family experience and communication processes improved after implementation of a structured communication intervention for family centered rounds coproduced by families, nurses, and physicians. Family centered care processes may improve safety and quality of care without negatively impacting teaching or duration of rounds.Trial registrationClinicalTrials.gov NCT02320175.

Medical errors and adverse events (AEs) are common among hospitalized children. While clinician reports are the foundation of operational hospital safety surveillance and a key component of multifaceted research surveillance, patient and family reports are not routinely gathered. We hypothesized that a novel family-reporting mechanism would improve incident detection. OBJECTIVE To compare error and AE rates (1) gathered systematically with vs without family reporting, (2) reported by families vs clinicians, and (3) reported by families vs hospital incident reports. DESIGN, SETTING, AND PARTICIPANTSWe conducted a prospective cohort study including the parents/caregivers of 989 hospitalized patients 17 years and younger (total 3902 patient-days) and their clinicians from December 2014 to July 2015 in 4 US pediatric centers. Clinician abstractors identified potential errors and AEs by reviewing medical records, hospital incident reports, and clinician reports as well as weekly and discharge Family Safety Interviews (FSIs). Two physicians reviewed and independently categorized all incidents, rating severity and preventability (agreement, 68%-90%; κ, 0.50-0.68). Discordant categorizations were reconciled. Rates were generated using Poisson regression estimated via generalized estimating equations to account for repeated measures on the same patient. MAIN OUTCOMES AND MEASURES Error and AE rates.RESULTS Overall, 746 parents/caregivers consented for the study. Of these, 717 completed FSIs. Their median (interquartile range) age was 32.5 (26-40) years; 380 (53.0%) were nonwhite, 566 (78.9%) were female, 603 (84.1%) were English speaking, and 380 (53.0%) had attended college. Of 717 parents/caregivers completing FSIs, 185 (25.8%) reported a total of 255 incidents, which were classified as 132 safety concerns (51.8%), 102 nonsafety-related quality concerns (40.0%), and 21 other concerns (8.2%). These included 22 preventable AEs (8.6%), 17 nonharmful medical errors (6.7%), and 11 nonpreventable AEs (4.3%) on the study unit. In total, 179 errors and 113 AEs were identified from all sources. Family reports included 8 otherwise unidentified AEs, including 7 preventable AEs. Error rates with family reporting (45.9 per 1000 patient-days) were 1.2-fold (95% CI, 1.1-1.2) higher than rates without family reporting (39.7 per 1000 patient-days). Adverse event rates with family reporting (28.7 per 1000 patient-days) were 1.1-fold (95% CI, 1.0-1.2; P=.006) higher than rates without (26.1 per 1000 patient-days). Families and clinicians reported similar rates of errors (10.0 vs 12.8 per 1000 patient-days; relative rate, 0.8; 95% CI, .5-1.2) and AEs (8.5 vs 6.2 per 1000 patient-days; relative rate, 1.4; 95% CI, 0.8-2.2). Family-reported error rates were 5.0-fold (95% CI, 1.9-13.0) higher and AE rates 2.9-fold (95% CI, 1.2-6.7) higher than hospital incident report rates.CONCLUSIONS AND RELEVANCE Families provide unique information about hospital safety and should be included in hospital safety surveillance in order to facilitate better des...