Evidence map›Paper›PMID 23843589›Full record

Trial reportPeritoneal dialysis international : journal of the International Society for Peritoneal Dialysis

The HONEYPOT randomized controlled trial statistical analysis plan.

Elaine Mary Pascoe, Serigne Lo, Anish Scaria, Sunil V Badve, Elaine Mary Beller, Alan Cass, Carmel Mary Hawley, David W Johnson

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 19% 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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Honey as a topical treatment for wounds.The Cochrane database of systematic reviews · 2015
    Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
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

8 authors at 5 institutions in 2 countries.

Elaine Mary PascoeSchool of Medicine, University of Queensland, Brisbane, Australia.
Serigne Lo
Anish Scaria
Sunil V Badve
Elaine Mary Beller
Alan Cass
Carmel Mary Hawley
David W Johnson
Translational Research Institute · AUUniversity of Queensland · AUUniversity of Sydney · AUBond University · AUPrincess Alexandra Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe HONEYPOT study is a multicenter, open-label, blinded-outcome, randomized controlled trial designed to determine whether, compared with standard topical application of mupirocin for nasal staphylococcal carriage, exit-site application of antibacterial honey reduces the rate of catheter-associated infections in peritoneal dialysis patients.

objectiveTo make public the pre-specified statistical analysis principles to be adhered to and the procedures to be performed by statisticians who will analyze the data for the HONEYPOT trial.

methodsStatisticians and clinical investigators who were blinded to treatment allocation and treatment-related study results and who will remain blinded until the central database is locked for final data extraction and analysis determined the statistical methods and procedures to be used for analysis and wrote the statistical analysis plan. The plan describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues, and the specific statistical procedures for analyzing the primary, secondary, and safety outcomes.

resultsA statistical analysis plan containing the pre-specified principles, methods, and procedures to be adhered to in the analysis of the data from the HONEYPOT trial was developed in accordance with international guidelines. The structure and content of the plan provide sufficient detail to meet the guidelines on statistical principles for clinical trials produced by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

conclusionsMaking public the pre-specified statistical analysis plan for the HONEYPOT trial minimizes the potential for bias in the analysis of trial data and the interpretation and reporting of trial results.

Indexed as

HoneyPeritoneal DialysisCatheter-Related InfectionsCatheters, IndwellingFemaleHumansIntention to Treat AnalysisMaleNoseResearch DesignStaphylococcal InfectionsStaphylococcus aureuscatheter-associated infectionsintention-to-treatInternational Conference on Harmonizationoutcome reporting biaspre-specified statistical analysesRandomized controlled trialstatistical analysis plan

Identifiers

PMID23843589
PMCPMC3707722
OpenAlexW2083132277

What OpenQuestion holds

Textmetadata
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.