Evidence map›Paper›PMID 31564241›Full record

Trial reportInternational journal of stroke : official journal of the International Stroke Society2020

A pragmatic, multi-centered, stepped wedge, cluster randomized controlled trial pilot of the clinical and cost effectiveness of a complex Stroke Oral healthCare intervention pLan Evaluation II (SOCLE II) compared with usual oral healthcare in stroke wards.

Marian C Brady, David J Stott, Christopher J Weir, Campbell Chalmers, Petrina Sweeney, John Barr, Alex Pollock, Naomi Bowers, Heather Gray, Brenda Jean Bain and 3 more

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyPragmatic Clinical Trial
In one paragraph

Trial report in International journal of stroke : official journal of the International Stroke Society, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01954212 (A Multi-centred, Stepped Wedge, Cluster Randomised Controlled Trial to Compare the Clinical and Cost Effectiveness of a Complex Oral Health Care Intervention and Standard Oral Health Care in Stroke Care Settings), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
3.2field-weighted citation impact, top 9% 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.

NCT01954212 phase2completednot on this map

A Multi-centred, Stepped Wedge, Cluster Randomised Controlled Trial to Compare the Clinical and Cost Effectiveness of a Complex Oral Health Care Intervention and Standard Oral Health Care in Stroke Care Settings: a Phase II Pilot Trial.

TypeinterventionalSponsorGlasgow Caledonian UniversityRan2013 to 2016Enrolled437ConditionsCerebrovascular Disorders, Stroke, Pneumonia, Oral HygieneArmsEnhanced complex oral health care
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Interventions for improving oral health in people after stroke.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Review
  4. Article
  5. Article
  6. Observational
  7. Article
  8. 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

13 authors at 4 institutions in 1 country.

Marian C BradyNMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.ORCID 0000-0002-4589-7021
David J StottInstitute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Christopher J WeirCentre for Population Health Sciences, The University of Edinburgh, Edinburgh, UK.ORCID 0000-0002-6494-4903
Campbell ChalmersRoyal National Institute of Blind People, Glasgow, UK.
Petrina SweeneyNMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.
John BarrNMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.
Alex PollockNMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.
Naomi BowersNMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.
Heather GrayNMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.
Brenda Jean BainNMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.
Marissa CollinsNMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.
Catriona KeerieThe University of Edinburgh, Edinburgh, UK.
Peter LanghorneInstitute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Glasgow Caledonian University · GBUniversity of Edinburgh · GBUniversity of Glasgow · GBRoyal National Institute of Blind · GB

Funding

Chief Scientist Office
6 · The paper itself

Abstract

backgroundPatients with stroke-associated pneumonia experience poorer outcomes (increased hospital stays, costs, discharge dependency, and risk of death). High-quality, organized oral healthcare may reduce the incidence of stroke-associated pneumonia and improve oral health and quality of life.

aimsWe piloted a pragmatic, stepped-wedge, cluster randomized controlled trial of clinical and cost effectiveness of enhanced versus usual oral healthcare for people in stroke rehabilitation settings.

methodsScottish stroke rehabilitation wards were randomly allocated to stepped time-points for conversion from usual to enhanced oral healthcare. All admissions and nursing staff were eligible for inclusion. We piloted the viability of randomization, intervention, data collection, record linkage procedures, our sample size, screening, and recruitment estimates. The stepped-wedge trial design prevented full blinding of outcome assessors and staff. Predetermined criteria for progression included the validity of enhanced oral healthcare intervention (training, oral healthcare protocol, assessment, equipment), data collection, and stroke-associated pneumonia event rate and relationship between stroke-associated pneumonia and plaque.

resultsWe screened 1548/2613 (59%) admissions to four wards, recruiting

conclusionsOur stepped-wedge cluster randomized control trial accommodated between-site diversity. The stroke-associated pneumonia event rate did not meet our predetermined progression criteria. We did not meet our predefined progression criteria including the SAP event rate and consequently were unable to establish whether there is a relationship between SAP and plaque. A wide confidence interval did not exclude the possibility that enhanced oral healthcare may result in a benefit or detrimental effect.

trial registrationNCT01954212.

Indexed as

AgedAged, 80 and overCluster AnalysisCost-Benefit AnalysisFemaleHospitalizationHumansMaleMiddle AgedOral HealthOral HygienePilot ProjectsStrokeTreatment OutcomeClinical trialinterventionoral healthcarepilotrandomized controlled trialrehabilitationstroke

Identifiers

PMID31564241
PMCPMC7153219
OpenAlexW2978178917

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.