Evidence map›Paper›PMID 30290839›Full record

SynthesisTrials2018

Clinical significance in pediatric oncology randomized controlled treatment trials: a systematic review.

A Fuchsia Howard, Karen Goddard, Shahrad Rod Rassekh, Osama A Samargandi, Haroon Hasan

Open access · goldAbstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 22% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. 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

5 authors at 3 institutions in 1 country.

A Fuchsia HowardSchool of Nursing, The University of British Columbia, T201-2211 Wesbrook Mall, Vancouver, BC, V6T 2B5, Canada. fuchsia.howard@ubc.ca.ORCID http://orcid.org/0000-0001-5704-1733
Karen GoddardDepartment of Radiation Oncology, BC Cancer, Vancouver, BC, V5Z 4E6, Canada.
Shahrad Rod RassekhDivision of Hematology/Oncology, BC Children's Hospital, Vancouver, BC, V6H 3N1, Canada.
Osama A SamargandiDivision of Plastic Surgery, QEII Health Sciences Centre, Halifax, NS, B3H 3A7, Canada.
Haroon HasanDepartment of Radiation Oncology, BC Cancer, Vancouver, BC, V5Z 4E6, Canada.
BC Children's Hospital · CAHealth Sciences Centre · CAUniversity of British Columbia Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical significance in a randomized controlled trial (RCT) can be determined using the minimal clinically important difference (MCID), which should inform the delta value used to determine sample size. The primary objective was to assess clinical significance in the pediatric oncology randomized controlled trial (RCT) treatment literature by evaluating: (1) the relationship between the treatment effect and the delta value as reported in the sample size calculation, and (2) the concordance between statistical and clinical significance. The secondary objective was to evaluate the reporting of methodological attributes related to clinical significance.

methodsRCTs of pediatric cancer treatments, where a sample size calculation with a delta value was reported or could be calculated, were systematically reviewed. MEDLINE, EMBASE, and the Cochrane Childhood Cancer Group Specialized Register through CENTRAL were searched from inception to July 2016.

resultsRCTs (77 overall; 11 and 66), representing 95 (13 and 82) randomized questions were included for non-inferiority and superiority RCTs (herein, respectively). The minority (22.1% overall; 76.9 and 13.4%) of randomized questions reported conclusions based on clinical significance, and only 4.2% (15.4 and 2.4%) explicitly based the delta value on the MCID. Over half (67.4% overall; 92.3 and 63.4%) reported a confidence interval or standard error for the primary outcome experimental and control values and 12.6% (46.2 and 7.3%) reported the treatment effect, respectively. Of the 47 randomized questions in superiority trials that reported statistically non-significant findings, 25.5% were possibly clinically significant. Of the 24 randomized questions in superiority trials that were statistically significant, only 8.3% were definitely clinically significant.

conclusionsA minority of RCTs in the pediatric oncology literature reported methodological attributes related to clinical significance and a notable portion of statistically insignificant studies were possibly clinically significance.

Indexed as

Research DesignAge of OnsetData AccuracyData Interpretation, StatisticalHumansMedical OncologyMinimal Clinically Important DifferenceNeoplasmsPediatricsRandomized Controlled Trials as TopicSample SizeTreatment OutcomeClinical significanceMinimally clinically important differencePediatric oncologyRandomized controlled trials

Identifiers

PMID30290839
PMCPMC6173909
OpenAlexW2895250429

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.