Evidence map›Paper›PMID 27066461›Full record

ArticleFrontiers in pediatrics2016

From Research Question to Conducting a Randomized Controlled Trial on Continuous Antibiotic Prophylaxis in Prenatal Hydronephrosis: A Rational Stepwise Process.

Luis H Braga, Bethany Easterbrook, Kizanee Jegatheeswaran, Armando J Lorenzo

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Frontiers in pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01140516 (Antibiotic prophyLaxis Versus Placebo in Infants Diagnosed With Hydronephrosis Antenatally), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.3field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01140516 naunknown statusnot on this map

Antibiotic prophyLaxis Versus Placebo in Infants Diagnosed With Hydronephrosis Antenatally

TypeinterventionalSponsorMcMaster UniversityRan2010 to 2024Enrolled160ConditionsHydronephrosis, Urinary Tract InfectionArmsTrimethoprim, Simple Syrup
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Luis H BragaDivision of Urology, McMaster University, Hamilton, ON, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada; Department of Pediatrics, McMaster University, Hamilton, ON, Canada; McMaster Pediatric Surgery Research Collaborative, McMaster University, Hamilton, ON, Canada.
Bethany EasterbrookDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada; McMaster Pediatric Surgery Research Collaborative, McMaster University, Hamilton, ON, Canada.
Kizanee JegatheeswaranMcMaster Pediatric Surgery Research Collaborative, McMaster University , Hamilton, ON , Canada.
Armando J LorenzoDivision of Urology, The Hospital for Sick Children , Toronto, ON , Canada.
McMaster University · CAHospital for Sick Children · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

INTRODUCTION AND

objectivesContinuous antibiotic prophylaxis (CAP) use to prevent urinary tract infections (UTI) in infants with prenatal hydronephrosis (HN) remains controversial. Lack of consensus guidelines and diverse practice patterns for postnatal management of HN highlight the dire need for higher level of evidence studies. Herein, we aim to describe the steps from developing a well-defined research question to execute a multicentered randomized controlled trial (RCT) to address the issue of CAP use in patients with prenatal HN. MATERIALS AND

methodsThe steps involved were (1) choosing the proper research question, (2) survey of practice patterns and establishing clinical equipoise, (3) systematic review of the literature, (4) reviewing own practice, (5) longitudinal prospective study, (6) pilot study, (7) cost-utility analysis, and (8) definitive RCT (clinical trials registry number: NCT01140516). An update of our previous systematic review was conducted using two electronic databases and gray literature from 2010 to 2015. Eligibility criteria included studies of children <2 years old with postnatally confirmed prenatal HN, receiving CAP or not, and reporting on development of UTIs, capturing information on voiding cystourethrogram result and HN grade. Full-text screening was conducted by two independent reviewers. UTI rates in patients with high-grade HN were compared across different study designs. Finally, blinded comparative analysis of UTI rates between placebo and treatment groups was carried out using chi-square test.

resultsUTI rates in patients with high-grade HN by their respective study design were: 25% for systematic review, 20% for retrospective study, 21% for prospective and pilot studies, and 13% for the definitive RCT thus far. Regardless of the type of study design, patients with hydroureteronephrosis had significantly higher (threefold to sixfold) UTI rates than those with isolated HN. Our updated systematic review yielded 486 citations, of which 9 (n = 1987 infants) observational studies met eligibility criteria.

conclusionUTI rates in patients with high-grade HN dropped from 25% in observational studies to 13% in our RCT. This decline in UTI rate demonstrates that study designs lacking strategies to minimize bias are more prone to overestimate treatment effects. These findings highlight the importance of conducting methodologically sound RCTs to answer clinically meaningful questions, such as the one presented here.

Indexed as

antibiotic prophylaxischildrenhydronephrosispilot studyprenatalrandomized controlled trialsurinary tract infections

Identifiers

PMID27066461
PMCPMC4811955
OpenAlexW2327069704

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.