Recruiting both pediatric and adult participants for clinical trials in CF is currently of paramount importance as numerous new therapies are being developed. However, recruitment is challenging as ...parents of children with CF and adults with CF cite safety concerns as a principal barrier to enrollment. In conjunction with the CF Foundation (CFF) Data Safety Monitoring Board (DSMB), a pilot brochure was developed to inform patients and parents of the multiple levels of safety monitoring; the CFF simultaneously created an infographic representing the safety monitoring process. This study explores the attitudes and beliefs of CF patients and families regarding safety monitoring and clinical trial participation, and elicits feedback regarding the educational materials.
Semi-structured interviews were conducted using a pre-tested interview guide and audio-recorded during routine CF clinic visits. Participants included 5 parents of children with CF <16years old; 5 adolescents and young adults with CF 16–21years old; and 5 adults with CF ≥22years old from pediatric and adult CF centers. The study team performed systematic text condensation analysis of the recorded interviews using an iterative process.
Four major thematic categories with subthemes emerged as supported by exemplar quotations: attitudes toward clinical trials, safety values, conceptualizing the safety monitoring process, and priorities for delivery of patient education. Participant feedback was used to revise the pilot brochure; text was shortened, unfamiliar words clarified (e.g., “pipeline”), abbreviations eliminated, and redundancy avoided.
Qualitative analysis of CF patient and family interviews provided insights into barriers to participation in clinical trials, safety concerns, perspectives on safety monitoring and educational priorities. We plan a multicenter study to determine if the revised brochure reduces knowledge, attitude and practice barriers regarding participation in CF clinical trials.
Subspecialty consultation is a frequent, consequential practice in the pediatric inpatient setting. Little is known about factors affecting consultation practices.
To identify patient, physician, ...admission, and systems characteristics that are independently associated with subspecialty consultation among pediatric hospitalists at the patient-day level and to describe variation in consultation utilization among pediatric hospitalist physicians.
This retrospective cohort study of hospitalized children used electronic health record data from October 1, 2015, through December 31, 2020, combined with a cross-sectional physician survey completed between March 3 and April 11, 2021. The study was conducted at a freestanding quaternary children's hospital. Physician survey participants were active pediatric hospitalists. The patient cohort included children hospitalized with 1 of 15 common conditions, excluding patients with complex chronic conditions, intensive care unit stay, or 30-day readmission for the same condition. Data were analyzed from June 2021 to January 2023.
Patient (sex, age, race and ethnicity), admission (condition, insurance, year), physician (experience, anxiety due to uncertainty, gender), and systems (hospitalization day, day of week, inpatient team, and prior consultation) characteristics.
The primary outcome was receipt of inpatient consultation on each patient-day. Risk-adjusted consultation rates, expressed as number of patient-days consulting per 100, were compared between physicians.
We evaluated 15 922 patient-days attributed to 92 surveyed physicians (68 74% women; 74 80% with ≥3 years' attending experience) caring for 7283 unique patients (3955 54% male patients; 3450 47% non-Hispanic Black and 2174 30% non-Hispanic White patients; median IQR age, 2.5 (0.9-6.5 years). Odds of consultation were higher among patients with private insurance compared with those with Medicaid (adjusted odds ratio aOR, 1.19 95% CI, 1.01-1.42; P = .04) and physicians with 0 to 2 years of experience vs those with 3 to 10 years of experience (aOR, 1.42 95% CI, 1.08-1.88; P = .01). Hospitalist anxiety due to uncertainty was not associated with consultation. Among patient-days with at least 1 consultation, non-Hispanic White race and ethnicity was associated with higher odds of multiple consultations vs non-Hispanic Black race and ethnicity (aOR, 2.23 95% CI, 1.20-4.13; P = .01). Risk-adjusted physician consultation rates were 2.1 times higher in the top quartile of consultation use (mean SD, 9.8 2.0 patient-days consulting per 100) compared with the bottom quartile (mean SD, 4.7 0.8 patient-days consulting per 100; P < .001).
In this cohort study, consultation use varied widely and was associated with patient, physician, and systems factors. These findings offer specific targets for improving value and equity in pediatric inpatient consultation.
Individuals with CF and their parents cite safety concerns as barriers to participating in clinical studies. We assessed whether a brochure/infographic describing patient safety monitoring processes ...could reduce knowledge and attitude barriers regarding safety monitoring. We also identified factors associated with likely participation in future CF studies.
Respondents from three CF centers in the U.S. were randomly assigned to receive the safety monitoring brochure/infographic or an unrelated brochure. Fifty parents of children with CF <16, 50 adolescents with CF 16–21, and 50 adults with CF ≥22 years old were recruited to complete the study survey. Factors associated with survey responses and with reported likelihood of participating in future studies were assessed.
Overall the safety monitoring brochure/infographic was associated with increased likelihood of future participation in non-drug studies (aOR 2.30, CI95 1.01–5.28), but not in drug studies. Non-Hispanic respondents reported greater likelihood of participating in a future drug study than Hispanic respondents (aOR 3.18, CI95 1.30–7.74). Adults with CF (aOR 2.62, CI95 1.05–6.51) and parents (aOR 4.49, CI95 1.66–12.15) were more likely than adolescents to report they would ask their care team about clinical trials. Confidence in safety monitoring was associated with reported likelihood of future participation in drug studies.
Potential future participation in CF drug and/or non-drug studies was associated with respondent age and ethnicity, receiving the safety monitoring brochure/infographic, and confidence in safety monitoring. Our findings underscore the need for education about safety monitoring, with targeted approaches for the Hispanic CF population and adolescents.
•Safety concerns are a barrier to clinical trial participation in the CF community•A safety brochure did not increase reported future participation in clinical trials•Hispanic individuals were less likely to report future drug study participation•Adolescents reported lower likelihood of asking the care team about clinical trials•Confidence in safety monitoring predicts likelihood of drug study participation
Consumer home monitors (CHM), which measure vital signs, are popular products marketed to detect airway obstruction and arrhythmia. Yet, they lack evidence of infant death prevention, demonstrate ...suboptimal accuracy, and may result in false alarms that prompt unnecessary acute care visits. To better understand the hospital utilization and costs of CHM, we characterized emergency department (ED) and hospital encounters associated with CHM use at a children's hospital.
We used structured query language to search the free text of all ED and admission notes between January 2013 and December 2019 to identify clinical documentation discussing CHM use. Two physicians independently reviewed the presence of CHM use and categorized encounter characteristics.
Evidence of CHM use contributed to the presentation of 36 encounters in a sample of over 300 000 encounters, with nearly half occurring in 2019. The leading discharge diagnoses were viral infection (13, 36%), gastroesophageal reflux (8, 22%) and false positive alarm (6, 17%). Median encounter duration was 20 hours (interquartile range: 3 hours to 2 days; max 10.5 days) and median cost of encounters was $2188 (interquartile range: $255 to $7632; max $84 928).
Although the annual rate of CHM-related encounters was low and did not indicate a major public health burden, for individual families who present to the ED or hospital for concerns related to CHMs, there may be important adverse financial and emotional consequences.
National guidelines recommend against continuous pulse oximetry use for hospitalized children with bronchiolitis who are not receiving supplemental oxygen, yet guideline-discordant use remains high.
...To evaluate deimplementation outcomes of educational outreach and audit and feedback strategies aiming to reduce guideline-discordant continuous pulse oximetry use in children hospitalized with bronchiolitis who are not receiving supplemental oxygen.
A nonrandomized clinical single-group deimplementation trial was conducted in 14 non-intensive care units in 5 freestanding children's hospitals and 1 community hospital from December 1, 2019, through March 14, 2020, among 847 nurses and physicians caring for hospitalized children with bronchiolitis who were not receiving supplemental oxygen.
Educational outreach focused on communicating details of the existing guidelines and evidence. Audit and feedback strategies included 2 formats: (1) weekly aggregate data feedback to multidisciplinary teams with review of unit-level and hospital-level use of continuous pulse oximetry, and (2) real-time 1:1 feedback to clinicians when guideline-discordant continuous pulse oximetry use was discovered during in-person data audits.
Clinician ratings of acceptability, appropriateness, feasibility, and perceived safety were assessed using a questionnaire. Guideline-discordant continuous pulse oximetry use in hospitalized children was measured using direct observation of a convenience sample of patients with bronchiolitis who were not receiving supplemental oxygen.
A total of 847 of 1193 eligible clinicians (695 women 82.1%) responded to a Likert scale-based questionnaire (71% response rate). Most respondents rated the deimplementation strategies of education and audit and feedback as acceptable (education, 435 of 474 92%; audit and feedback, 615 of 664 93%), appropriate (education, 457 of 474 96%; audit and feedback, 622 of 664 94%), feasible (education, 424 of 474 89%; audit and feedback, 557 of 664 84%), and safe (803 of 847 95%). Sites collected 1051 audit observations (range, 47-403 per site) on 709 unique patient admissions (range, 31-251 per site) during a 3.5-month period of continuous pulse oximetry use in children with bronchiolitis not receiving supplemental oxygen, which were compared with 579 observations (range, 57-154 per site) from the same hospitals during the baseline 4-month period (prior season) to determine whether the strategies were associated with a reduction in use. Sites conducted 148 in-person educational outreach and aggregate data feedback sessions and provided real-time 1:1 feedback 171 of 236 times (72% of the time when guideline-discordant monitoring was identified). Adjusted for age, gestational age, time since weaning from supplemental oxygen, and other characteristics, guideline-discordant continuous pulse oximetry use decreased from 53% (95% CI, 49%-57%) to 23% (95% CI, 20%-25%) (P < .001) during the intervention period. There were no adverse events attributable to reduced monitoring.
In this nonrandomized clinical trial, educational outreach and audit and feedback deimplementation strategies for guideline-discordant continuous pulse oximetry use among hospitalized children with bronchiolitis who were not receiving supplemental oxygen were positively associated with clinician perceptions of feasibility, acceptability, appropriateness, and safety. Evaluating the sustainability of deimplementation beyond the intervention period is an essential next step.
ClinicalTrials.gov Identifier: NCT04178941.
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