Evidence map›Paper›PMID 30081929›Full record

ArticleTrials2018

Statistical analysis plan for the Healthy Hands Project; single centre cluster-randomised clinical trial of a skin care program for the prevention of contact dermatitis in health care workers.

Maryam Soltanipoor, Sanja Kezic, Judith Sluiter, Rebecca Holman

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 39% 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

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Trial
  2. 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

4 authors at 1 institution in 1 country.

Maryam SoltanipoorCoronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Academic Medical Center (AMC), Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. m.soltanipoor@amc.uva.nl.ORCID http://orcid.org/0000-0002-1408-4351
Sanja KezicCoronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Academic Medical Center (AMC), Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
Judith SluiterCoronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Academic Medical Center (AMC), Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
Rebecca HolmanClinical Research Unit, Academic Medical Centre, PO Box 22660, 1100, DD, Amsterdam, The Netherlands.
Amsterdam UMC Location University of Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Healthy Hands Project (HHP) is a randomised clinical trial aiming to determine the effectiveness of an intervention program in the prevention of hand dermatitis in healthcare workers (HCWs). The intervention is comprised of placing dispensers with hand creams on wards combined with continuous electronic monitoring of cream consumption and regular feedback to HCWs. The clinical severity (HECSI score) was used as the primary outcome and natural moisturising factor (NMF) levels as the secondary outcome. The study protocol for the cluster-randomised controlled trial of HHP was published in Trials in 2017. This article describes the detailed statistical analysis plan for the HHP trial. METHODS/

designThe HHP is a single-centre, cluster-randomised controlled trial with two parallel groups and blinded outcome assessment. This update article presents (1) the descriptive statistics of the primary and secondary outcomes, (2) the statistical models used for the analysis of the main outcomes, (3) sensitivity analyses on the effect of observed exposure to wet work, (4) handling of missing data including sensitivity analysis and (5) an updated power calculation. This statistical analysis plan was written prior to unblinding of the study. DISCUSSION: This paper presents a comprehensive statistical analysis plan for the data resulting from the HHP trial. It supports transparency in reporting by clarifying differences between the previously published protocol and the proposed actual statistical analyses.

trial registrationNetherlands Trial Register (NTR), identification number NTR5564 . Registered on 2 November 2015.

Indexed as

Nursing Staff, HospitalOccupational HealthAdministration, CutaneousData Interpretation, StatisticalDermatitis, ContactDermatitis, OccupationalGloves, SurgicalHand DermatosesHand DisinfectionHand HygieneHand SanitizersHumansNetherlandsOccupational DiseasesRandomized Controlled Trials as TopicSeverity of Illness IndexHand SanitizersHCWInterventionOccupational contact dermatitisRCTSkin careStatistical analysis plan

Identifiers

PMID30081929
PMCPMC6080425
OpenAlexW2887580941

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.