In this double-blind, randomized trial in Bangladesh, maternal vitamin D supplementation from midpregnancy until birth or 6 months post partum did not improve fetal or infant growth.
In this randomized trial comparing delivery strategies in women with twin gestation, planned cesarean section did not significantly increase or decrease the risk of fetal or neonatal death or serious ...neonatal morbidity, as compared with planned vaginal delivery.
Because of assisted reproductive technologies, twin pregnancy occurs more frequently now than in the past, and it complicates 2 to 3% of all births.
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Twins are at higher risk for an adverse perinatal outcome than singletons.
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Planned cesarean section, as compared with planned vaginal delivery, may reduce this risk.
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Although a small, randomized, controlled trial did not show better perinatal outcomes with planned cesarean section than with planned vaginal delivery,
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several cohort studies have shown a reduced risk of adverse perinatal outcomes for both twins, or for the second twin, when twins at or near term were delivered . . .
Restoring intestinal flora may improve outcomes in children with acute gastroenteritis. In this multicenter trial, the administration of lactobacillus for 5 days in children with acute ...gastroenteritis was not associated with clinical benefit.
IMPORTANCE: Gastroenteritis is a common pediatric illness. Electrolyte maintenance solution is recommended to treat and prevent dehydration. Its advantage in minimally dehydrated children is ...unproven. OBJECTIVE: To determine if oral hydration with dilute apple juice/preferred fluids is noninferior to electrolyte maintenance solution in children with mild gastroenteritis. DESIGN, SETTING, AND PARTICIPANTS: Randomized, single-blind noninferiority trial conducted between the months of October and April during the years 2010 to 2015 in a tertiary care pediatric emergency department in Toronto, Ontario, Canada. Study participants were children aged 6 to 60 months with gastroenteritis and minimal dehydration. INTERVENTIONS: Participants were randomly assigned to receive color-matched half-strength apple juice/preferred fluids (n=323) or apple-flavored electrolyte maintenance solution (n=324). Oral rehydration therapy followed institutional protocols. After discharge, the half-strength apple juice/preferred fluids group was administered fluids as desired; the electrolyte maintenance solution group replaced losses with electrolyte maintenance solution. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of treatment failure defined by any of the following occurring within 7 days of enrollment: intravenous rehydration, hospitalization, subsequent unscheduled physician encounter, protracted symptoms, crossover, and 3% or more weight loss or significant dehydration at in-person follow-up. Secondary outcomes included intravenous rehydration, hospitalization, and frequency of diarrhea and vomiting. The noninferiority margin was defined as a difference between groups of 7.5% for the primary outcome and was assessed with a 1-sided α=.025. If noninferiority was established, a 1-sided test for superiority was conducted. RESULTS: Among 647 randomized children (mean age, 28.3 months; 331 boys 51.1%; 441 (68.2%) without evidence of dehydration), 644 (99.5%) completed follow-up. Children who were administered dilute apple juice experienced treatment failure less often than those given electrolyte maintenance solution (16.7% vs 25.0%; difference, −8.3%; 97.5% CI, −∞ to −2.0%; P < .001 for inferiority and P = .006 for superiority). Fewer children administered apple juice/preferred fluids received intravenous rehydration (2.5% vs 9.0%; difference, −6.5%; 99% CI, −11.6% to −1.8%). Hospitalization rates and diarrhea and vomiting frequency were not significantly different between groups. CONCLUSIONS AND RELEVANCE: Among children with mild gastroenteritis and minimal dehydration, initial oral hydration with dilute apple juice followed by their preferred fluids, compared with electrolyte maintenance solution, resulted in fewer treatment failures. In many high-income countries, the use of dilute apple juice and preferred fluids as desired may be an appropriate alternative to electrolyte maintenance fluids in children with mild gastroenteritis and minimal dehydration. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01185054
These investigators followed a large birth cohort with the use of questionnaires, lung-function tests, and allergy skin tests from the age of 3 to 26 years. Almost three quarters of the study ...participants had wheezing at one point in the follow-up, and 15 percent had wheezing at all points in the follow-up.
Clinical data on a large birth cohort.
The increase in the prevalence of wheezing disorders, whether or not they are labeled as asthma, could be related to an increased incidence or an increased persistence of asthma.
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Studies of the natural history of asthma have often focused on selected populations. However, the outcomes in children referred to university clinics
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or selected in high-risk cohorts
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may not reflect the outcomes in the general population, since the initial selection criteria may predetermine the risk factors for persistence or relapse.
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Most children attending asthma specialty clinics who have been followed have had atopy, with frequent symptoms and airway hyperresponsiveness, . . .
Bayesian methods for pilot studies Willan, Andrew R; Thabane, Lehana
Clinical trials (London, England),
08/2020, Letnik:
17, Številka:
4
Journal Article
Recenzirano
Background/aims:
The use of pilot studies to help inform the design of randomized controlled trials has increased significantly over the last couple of decades. A pilot study can provide estimates of ...feasibility parameters, such as the recruitment, compliance and follow-up probabilities. The use of frequentist confidence intervals of these estimates fails to provide a meaningful measure of the uncertainty as it pertains to the design of the associated randomized controlled trial. The objective of this article is to introduce Bayesian methods for the analysis of pilot studies for determining the feasibility of an associated randomized controlled trial.
Methods:
An example from the literature is used to illustrate the advantages of a Bayesian approach for accounting for the uncertainty in pilot study results when assessing the feasibility of an associated randomized controlled trial. Vague beta distribution priors for the feasibility parameters are used. Based on the results from a feasibility study, simulation methods are used to determine the expected power of specified recruitment strategies for an associated randomized controlled trial.
Results:
The vague priors used for the feasibility parameters are demonstrated to be considerably robust. Beta distribution posteriors for the feasibility parameters lead to beta-binomial predictive distributions for an associated randomized controlled trial regarding the number of patients randomized, the number of patients who are compliant and the number of patients who complete follow-up. Ignoring the uncertainty in pilot study results can lead to inadequate power for an associated randomized controlled trial.
Conclusion:
Applying Bayesian methods to pilot studies’ results provides direct inference about the feasibility parameters and quantifies the uncertainty regarding the feasibility of an associated randomized controlled trial in an intuitive and meaningful way. Furthermore, Bayesian methods can identify recruitment strategies that yield the desired power for an associated randomized controlled trial.
IMPORTANCE: Children with medical complexity (CMC) have chronic conditions and high health needs and may experience fragmented care. OBJECTIVE: To compare the effectiveness of a structured complex ...care program, Complex Care for Kids Ontario (CCKO), with usual care. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial used a waitlist variation for randomizing patients from 12 complex care clinics in Ontario, Canada, over 2 years. The study was conducted from December 2016 to June 2021. Participants were identified based on complex care clinic referral and randomly allocated into an intervention group, seen at the next available clinic appointment, or a control group that was placed on a waitlist to receive the intervention after 12 months. INTERVENTION: Assignment of a nurse practitioner–pediatrician dyad partnering with families in a structured complex care clinic to provide intensive care coordination and comprehensive plans of care. MAIN OUTCOMES AND MEASURES: Co-primary outcomes, assessed at baseline and at 6, 12, and 24 months postrandomization, were service delivery indicators from the Family Experiences With Coordination of Care that scored (1) coordination of care among health care professionals, (2) coordination of care between health care professionals and families, and (3) utility of care planning tools. Secondary outcomes included child and parent health outcomes and child health care system utilization and cost. RESULTS: Of 144 participants randomized, 141 had complete health administrative data, and 139 had complete baseline surveys. The median (IQR) age of the participants was 29 months (9-102); 83 (60%) were male. At 12 months, scores for utility of care planning tools improved in the intervention group compared with the waitlist group (adjusted odds ratio, 9.3; 95% CI, 3.9-21.9; P < .001), with no difference between groups for the other 2 co-primary outcomes. There were no group differences for secondary outcomes of child outcomes, parent outcomes, and health care system utilization and cost. At 24 months, when both groups were receiving the intervention, no primary outcome differences were observed. Total health care costs in the second year were lower for the intervention group (median, CAD$17 891; IQR, 6098-61 346; vs CAD$37 524; IQR, 9338-119 547 US $13 415; IQR, 4572-45 998; vs US $28 136; IQR, 7002-89 637; P = .01). CONCLUSIONS AND RELEVANCE: The CCKO program improved the perceived utility of care planning tools but not other outcomes at 1 year. Extended evaluation periods may be helpful in assessing pediatric complex care interventions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02928757
IMPORTANCE: There is limited evidence that the use of severity of illness scores in pediatric patients can facilitate timely admission to the intensive care unit or improve patient outcomes. ...OBJECTIVE: To determine the effect of the Bedside Paediatric Early Warning System (BedsidePEWS) on all-cause hospital mortality and late admission to the intensive care unit (ICU), cardiac arrest, and ICU resource use. DESIGN, SETTING, AND PARTICIPANTS: A multicenter cluster randomized trial of 21 hospitals located in 7 countries (Belgium, Canada, England, Ireland, Italy, New Zealand, and the Netherlands) that provided inpatient pediatric care for infants (gestational age ≥37 weeks) to teenagers (aged ≤18 years). Participating hospitals had continuous physician staffing and subspecialized pediatric services. Patient enrollment began on February 28, 2011, and ended on June 21, 2015. Follow-up ended on July 19, 2015. INTERVENTIONS: The BedsidePEWS intervention (10 hospitals) was compared with usual care (no severity of illness score; 11 hospitals). MAIN OUTCOMES AND MEASURES: The primary outcome was all-cause hospital mortality. The secondary outcome was a significant clinical deterioration event, which was defined as a composite outcome reflecting late ICU admission. Regression analyses accounted for hospital-level clustering and baseline rates. RESULTS: Among 144 539 patient discharges at 21 randomized hospitals, there were 559 443 patient-days and 144 539 patients (100%) completed the trial. All-cause hospital mortality was 1.93 per 1000 patient discharges at hospitals with BedsidePEWS and 1.56 per 1000 patient discharges at hospitals with usual care (adjusted between-group rate difference, 0.01 95% CI, −0.80 to 0.81 per 1000 patient discharges; adjusted odds ratio, 1.01 95% CI, 0.61 to 1.69; P = .96). Significant clinical deterioration events occurred during 0.50 per 1000 patient-days at hospitals with BedsidePEWS vs 0.84 per 1000 patient-days at hospitals with usual care (adjusted between-group rate difference, −0.34 95% CI, −0.73 to 0.05 per 1000 patient-days; adjusted rate ratio, 0.77 95% CI, 0.61 to 0.97; P = .03). CONCLUSIONS AND RELEVANCE: Implementation of the Bedside Paediatric Early Warning System compared with usual care did not significantly decrease all-cause mortality among hospitalized pediatric patients. These findings do not support the use of this system to reduce mortality. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01260831
IMPORTANCE: Routine use of pulse oximetry has been associated with changes in bronchiolitis management and may have lowered the hospitalization threshold for patients with bronchiolitis. OBJECTIVE: ...To examine if infants with bronchiolitis whose displayed oximetry measurements have been artificially elevated 3 percentage points above true values experience hospitalization rates at least 15% lower compared with infants with true values displayed. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, parallel-group trial conducted from 2008 to 2013 in a tertiary-care pediatric emergency department in Toronto, Ontario, Canada. Participants were 213 otherwise healthy infants aged 4 weeks to 12 months with mild to moderate bronchiolitis and true oxygen saturations of 88% or higher. INTERVENTIONS: Pulse oximetry measurements with true saturation values displayed or with altered saturation values displayed that have been increased 3 percentage points above true values. MAIN OUTCOMES AND MEASURES: The primary outcome was hospitalization within 72 hours, defined as inpatient admission within this interval or active hospital care for greater than 6 hours. Secondary outcomes included the use of supplemental oxygen in the emergency department, level of physician agreement with discharge from the emergency department, length of emergency department stay, and unscheduled visits for bronchiolitis within 72 hours. RESULTS: Forty-four of 108 patients (41%) in the true oximetry group and 26 of 105 (25%) in the altered oximetry group were hospitalized within 72 hours (difference, 16% 95% CI for the difference, 3.6% to 28.4%; P = .005). Using the emergency department physician as a random effect, the primary treatment effect remained significant (adjusted odds ratio, 4.0 95% CI, 1.6 to 10.5; P = .009). None of the secondary outcomes were significantly different between the groups. There were 23 of 108 (21.3%) subsequent unscheduled medical visits for bronchiolitis in the true oximetry group and 15 of 105 (14.3%) in the altered oximetry group (difference, 7% 95% CI, −0.3% to 0.2%; P = .18). CONCLUSIONS AND RELEVANCE: Among infants presenting to an emergency department with mild to moderate bronchiolitis, those with an artificially elevated pulse oximetry reading were less likely to be hospitalized within 72 hours or to receive active hospital care for more than 6 hours than those with unaltered oximetry readings. This suggests that oxygen saturation should not be the only factor in the decision to admit, and its use may need to be reevaluated. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00673946
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