CURRENT BEST EVIDENCE

Translating Best Evidence into Best Care - Jan 2023

EDITOR’S NOTE: Studies for this column are identified using the Clinical Queries feature of PubMed, searching The Journal
of Pediatrics, JAMA, JAMA Pediatrics, Pediatrics, The New England Journal of Medicine, and from customized EvidenceAlerts.

EBM PEARL: Cluster Randomized Trial (CRT): A CRT is a randomized trial of groups, as opposed to individuals (in a
traditional randomized control trial [RCT]). CRTs answer questions that apply to groups, such as questions relating to policy
and protocol. CRTs can also avoid interaction (also known as contamination) among randomized individuals within a group,
e.g., a specific provider’s control patients take on treatment aspects of the provider’s intervention patients. There may be prac-
tical reasons to choose CRT methodology. For example, a study comparing adolescent-patient nursing care between a pediatric
unit and an adult unit would be cumbersome or nearly impossible to conduct as a standard individual-based RCT. A CRT
would also limit contamination among patients in the two units. Also, CRTs are often less costly to run. A notable disadvantage
of CRTs is the need to include many patients within each group to achieve adequate statistical power. Another challenge with
CRTs is interclass correlation, where statistical adjustment is needed to account for patients in a group tending to behave simi-
larly, thereby also affecting statistical power. Finally, CTRs are not typically blinded. An example of a CRT is the Pedersen et al
study, below.

EBM HYPER-BRIEF-ABSTRACT CHART: RCT, randomized controlled trial.

Description Study Type Primary Results

and Citation and Location Age Outcome Favor Statistics
Multicenter, Randomized Trial of a Bionic Pancreas RCT 6 - 79 years Glycated Bionic HgB A1c decreased -0.5 percentage
in Type 1 Diabetes. N Engl J Med 2022;387:1161-72. US hemoglobin pancreas points (95% CI) -0.6 to -0.3)
level at
13 weeks
Effects of an Exercise RCT 8 - 11 years Crystallized Exercise Difference between groups, 0.72 SDs
Program on Brain Health Outcomes for Children Spain intelligence intervention (95% CI, 0.46-0.97), P< 0.001
With Overweight or Obesity: The Active Brains
Randomized Clinical Trial. JAMA Netw Open.
2022;5:e2227893.
Effect of Topical Antibiotics on Duration of Acute RCT 0.5 - 7 years Time to Moxifloxacin 3.8 vs 5.7 days, difference, -1.9 days
Infective Conjunctivitis in Children: A Randomized Finland clinical cure eye drops (95% CI, -3.7 to -0.1)
Clinical Trial and a Systematic Review and
Meta-analysis. JAMA Netw Open. 2022;5:e2234459.

Screen use limitation increases physical Setting 10 Danish municipalities.

activity Participants 181 children (boys and girls equally
represented), ages 6 - 10 years and 164 adults (89 families
Pedersen J, Rasmussen MGB, Sørensen SO, Mortensen SR,
randomized).
Olesen LG, Brønd JC, et al. Effects of Limiting Recreational
Screen Media Use on Physical Activity and Sleep in Families Intervention Screen media reduction versus usual routine.
With Children: A Cluster Randomized Clinical Trial. JAMA Outcomes Difference in physical activity, as measured by
Pediatr. 2022;176:741-9. combined thigh and waist accelerometry.
Main Results The mean difference in physical activity
Question Among children, what is the therapeutic efficacy of between the intervention versus the control group was
screen media use limitation, compared with usual routine, on 45.8 minutes per day (95% CI, 27.9-63.6 minutes per day,
physical activity? P < .001).
Design Cluster randomized, controlled trial. Conclusions Screen use limitation increased physical activity.

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Commentary In this well-designed RCT, Pedersen et al Outcomes An encounter occurring within 30 days of the in-
showed that reducing screen time significantly increased dex admission discharge date to admission hospital.
device-measured physical activity in children. This is a novel
finding as previous literature mainly relies on observational Main Results 1 189 140 procedures were identified, with 88 796
studies showing that the group with high screen time also revisits, 7.46% (95% CI, 7.42%-7.51%). Tonsillectomy/
had lower physical activity and fitness levels.1 Considering adenoidectomy, appendectomy, central-venous catheter/port
the large proportion of children not meeting the physical insertion, gastrostomy, myringotomy/tympanostomy, and
activity recommendations of 60 minutes of moderate-to- circumcision accounted for 67.77% of all revisits. Tonsillec-
vigorous physical (MVPA) per day,2 limiting screen time tomy/adenoidectomy had the highest number of revisits
could be a potential strategy to increase physical activity (18 279), and central-venous catheter/port insertion had the
levels. In the present study, the mean time spent in MVPA highest revisit rate 41.45%; (95% CI, 40.93%-41.97%).
at baseline was below the physical activity recommendations. Conclusions 6 of 26 reviewed procedures accounted for
Therefore, it is promising that screen time was replaced by more than 40% all revisits.
MVPA and non-sedentary activities rather than sedentary
time, especially in children with low physical activity levels. Commentary This analysis provides important, albeit prelim-
The World Health Organization emphasizes that even a small inary, epidemiological data for hospital revisits associated with
increase in physical activity for inactive children will improve commonly performed pediatric surgical procedures. Neither
their health.3 However, it should be noted that the length of preventability nor relatedness were assessed, both of which
the intervention was short, so the feasibility of a longer are likely to vary considerably among procedures and influ-
intervention should be investigated. Further, the study was ence prioritization efforts. This is perhaps most notable for
conducted in younger children and physical activity levels central intravenous access procedures, where revisits are
tend to decrease with age.2 Therefore, similar interventions more likely to be associated with indications for placement
should be evaluated in older children and adolescents. rather than technical or infectious complications. Despite
these limitations, the analysis does provide much needed
Karin Kjellenberg, MSc, PhD candidate insight into where further efforts should be focused across
Swedish School of Sport and Health Sciences, GIH each surgical specialty. Mitigating preventable revisits will
Stockholm, Sweden need to address relevant elements of care before and following
discharge, tailored to each procedure and condition. Use of
evidence-based operative technique and care pathways to
References
optimize pain management and reduce complications (e.g.,
€ St
opioid-sparing adjuncts) should be obligatory.1,2 Comprehen-
1. Kjellenberg K, Ekblom O, alman C, Helgad ottir B, Nyberg G. Associa-
tions between Physical Activity Patterns, Screen Time and Cardiovascular sive, procedure-focused, discharge educational resources and
Fitness Levels in Swedish Adolescents. Children (Basel) 2021;8:998. proactive follow-up to both manage caregiver expectations
2. Cooper AR, Goodman A, Page AS, Sherar LB, Esliger DW, van Sluijs EM, and identify complications at an early stage have shown prom-
et al. Objectively measured physical activity and sedentary time in youth: ise in reducing unplanned revisits.3 Finally, active involvement
the International children’s accelerometry database (ICAD). Int J Behav
of specialty organizations to endorse and promote compliance
Nutr Phys Act 2015;12:113.
3. WHO guidelines on physical activity and sedentary behaviour: at a glance. with such interventions will be essential to move the needle on
Geneva: World Health Organization; 2020. revisit rates for high-priority procedures.2

Shawn J. Rangel, MD, MSCE

High pediatric post-surgical revisit rate Michael J. Cunningham, MD
Harvard Medical School
De Boer C, Ghomrawi H, Zeineddin S, Linton S, Tian Y, Boston, Massachusetts
Kwon S, et al. Pediatric Surgical Revisits by Specialty and
Procedure Across US Children’s Hospitals, 2016-2020.
JAMA. 2022;328:774-776. References

Question Among common pediatric surgical procedures, 1. Parikh SR, Archer S, Ishman SL, Mitchell RB. Why Is There No Statement
which are the most likely to lead to revisiting the admitting Regarding Partial Intracapsular Tonsillectomy (Tonsillotomy) in the New
hospital within 30 days? Guidelines? Otolaryngol Head Neck Surg 2019;160:213-4.
2. Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA,
Design Secondary analysis of the Pediatric Health et al. Clinical Practice Guideline: Tonsillectomy in Children (Update)-
Information System administrative database. Executive Summary. Otolaryngol Head Neck Surg 2019;160:187-205.
3. Berman L, Hronek C, Raval MV, Browne ML, Snyder CL, Heiss KF, et al.
Setting 52 US tertiary children’s hospitals. Pediatric Gastrostomy Tube Placement: Lessons Learned from
Participants Children £18 years old. High-performing Institutions through Structured Interviews. Pediatr
Qual Saf 2017;2:e016.
Intervention Any 1 of 26 inpatient or ambulatory proced-
ures, 2016 - 2020.
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Neuromuscular training prevents post- Neurally-adjusted ventilation superior to nasal

concussion subsequent injury CAP in preventing extubation failure
Howell DR, Seehusen CN, Carry PM, Walker GA, Reinking Shin SH, Shin SH, Kim SH, Song IG, Jung YH, Kim EK,
SE, Wilson JC. An 8-Week Neuromuscular Training Program et al. Noninvasive Neurally Adjusted Ventilation in
After Concussion Reduces 1-Year Subsequent Injury Risk: A Postextubation Stabilization of Preterm Infants: A
Randomized Clinical Trial. Am J Sports Med. 2022;50:1120-9. Randomized Controlled Study. J Pediatr. 2022;247:
53-9.e1.
Question Among post-concussion children, what is the ther-
apeutic efficacy of neuromuscular training (NMT), Question What is the therapeutic benefit of noninvasive
compared with standard care, in reducing subsequent injury? neurally-adjusted ventilatory assist (NIV-NAVA) compared
with nasal continuous positive airway pressure (NCPAP),
Design Randomized, controlled trial (RCT).
in preventing extubation failure?
Setting Sports medicine clinic of Children’s Hospital
Design Randomized controlled trial.
Colorado.
Setting Single NICU center in Seoul, Republic of Korea.
Participants 12 - 18 years of age £14 days post-concussion.
Participants Infants born at <30 weeks gestation.
Intervention NMT for 8 weeks; frequency, 2 times per week,
or standard care. Intervention NIV-NAVA compared with NCPAP.
Outcomes Primary outcome: extubation failure within 72
Outcomes Acute, sports-related, time-loss injury over the
hours.
subsequent year.
Main Results Extubation failure was higher in the NCPAP
Main Results Sports-related, time-loss injuries were more
group than in the NIV-NAVA group, 28.6% vs 8.6%,
common among standard care relative to NMT intervention,
P = .031; absolute risk reduction and number needed to treat,
75% (95% CI, 48%-93%) vs 36% (95% CI, 11%-69%).
20.0% (95% CI, 2.4%-37.6%) and 5.0 (95% CI, 2.7-41.8),
Adjusted hazard ratio of subsequent injury in the standard
respectively. The two groups demonstrated similar
care group was 3.56 (95% CI, 1.11-11.49).
respiratory support duration and severe bronchopulmonary
Conclusions NMT prevents post-concussion subsequent dysplasia incidence.
injury. Conclusions NIV-NAVA more effectively prevented
Commentary Howell et al conducted a well-designed RCT as- extubation than NCPAP.
sessing whether youth athletes who recently sustained a concus- Commentary Extubation failure in preterm infants is a
sion could reduce the risk of a subsequent sports-related time- daily concern in the NICU and was significantly reduced
loss injury by performing a NMT program consisting of 20 in the NIV-NAVA group at 72h in this study. Findings at
minute, twice-weekly sessions for 8 weeks. Despite a small sam- 7 days were consistent, although not statistically
ple size, the investigators reported a lower incidence of injury significant, possibly due to lack of power. In addition,
after concussion in the NMT group, with the most pronounced swing electrical activity of the diaphragm (Edi) – a proxy
effects in the first 90 days post-concussion. While there were for the work of breathing - was decreased in the
some inherent differences between groups, with 1) a 16-day NIV-NAVA group during the 24 hours following
symptom-free waiting period prior to return to play clearance extubation, which could contribute to the observed result.
in the standard of care group compared to just 5 days for the A study limitation was that continuous positive airway
NMT group, and 2) a higher proportion of the NMT group pressure (CPAP) was delivered with a constant flow
were already physically active prior to the initial evaluation, ventilator (Servo i), whereas variable flow CPAP is often
the findings are still significant and clinically relevant. A 20 preferred. However, it has been found that swing Edi is
minute, twice weekly training session is a feasible in-season significantly reduced, and synchrony significantly
intervention and does not appear to have much risk for improved when NIV-NAVA using Servo-n was compared
harm. Further investigation as to whether these results can be to sigh-positive airway pressure using a variable flow
replicated with the intervention implemented by school athletic driver.1 Thus, the present results might be extrapolated
trainers or remotely via telehealth is important to understand to other CPAP generators. Much research has to be done
for health equity. If replicated, this would increase training to improve our use of NAVA in neonates, especially
accessibility and allow athletes who do not have easy access regarding the validity of Edi recording during invasive
to a specialized clinic to benefit from the training program. ventilation, to better assess “extubation-readiness”,
optimal back up settings (apnea time, positive inspiratory
Adam Pfaller, MD pressure) and assessment of interfaces used to deliver
Alison Brooks, MD MPH NIV-NAVA. While future studies are awaited, this trial
University of Wisconsin-Madison encourages the use of NIV-NAVA as a first line respiratory
Madison, Wisconsin support or in case of NCPAP failure after extubation in
preterm infants.
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February 2023 CURRENT BEST EVIDENCE

Xavier Durrmeyer, MD, PhD Reference

Fabrice Decobert, MD
Universite Paris Est Creteil 1. Treussart C, Decobert F, Tauzin M, Bourgoin L, Danan C, Dassieu G, et al.
Creteil, France Patient-Ventilator Synchrony in Extremely Premature Neonates during
Non-Invasive Neurally Adjusted Ventilatory Assist or Synchronized Inter-
mittent Positive Airway Pressure: A Randomized Crossover Pilot Trial.
Neonatology 2022:386-93.

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