Evidence map›Paper›PMID 35927733›Full record

ArticleTrials2022

Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters: study protocol for the CATHETER II study.

Mohamed Abdel-Fattah, Diana Johnson, Lynda Constable, Ruth Thomas, Seonaidh Cotton, Sheela Tripathee, David Cooper, Sue Boran, Konstantinos Dimitropoulos, Suzanne Evans and 15 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 26% 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

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Review
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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

25 authors at 7 institutions in 2 countries.

Mohamed Abdel-FattahAberdeen Centre for Women's Health Research, University of Aberdeen, Aberdeen, UK. m.abdelfattah@abdn.ac.uk.
Diana JohnsonCentre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
Lynda ConstableCentre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
Ruth ThomasCentre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
Seonaidh CottonCentre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
Sheela TripatheeAcademic Urology Unit, University of Aberdeen, Aberdeen, UK.
David CooperHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
Sue BoranThe Queen's Nursing Institute, London, UK.
Konstantinos DimitropoulosAcademic Urology Unit, University of Aberdeen, Aberdeen, UK.
Suzanne EvansBladder Health UK, Birmingham, UK.
Paraskeve GranitsiotisLothian Health Board, Edinburgh, UK.
Hashim HashimNorth Bristol NHS Trust, Bristol, UK.
Mary KilonzoHealth Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
James LarcombeJMed Limited, Sedgefield, UK.
Paul LittlePrimary Care Research Centre, University of Southampton, Southampton, UK.
Sara MacLennanAcademic Urology Unit, University of Aberdeen, Aberdeen, UK.
Peter MurchieAcademic Primary Care Research Group, University of Aberdeen, Aberdeen, UK.
Phyo Kyaw MyintAgeing Clinical & Experimental Research Team, University of Aberdeen, Aberdeen, UK.
James N'DowAcademic Urology Unit, University of Aberdeen, Aberdeen, UK.
John NorrieUsher Institute, University of Edinburgh, Edinburgh, UK.
Muhammad Imran OmarAcademic Urology Unit, University of Aberdeen, Aberdeen, UK.
Catherine PatersonSchool of Nursing, Midwifery and Public Health, University of Canberra, Canberra, Australia.
Graham ScotlandHealth Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
Nikesh ThiruchelvamCambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Graeme MacLennanCentre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
University of Aberdeen · GBCambridge University Hospitals NHS Foundation Trust · GBNHS Lothian · GBNorth Bristol NHS Trust · GBUniversity of Canberra · AUUniversity of Edinburgh · GBUniversity of Southampton · GB

Funding

Chief Scientist Office HERU1Chief Scientist Office HSRU1Health Technology Assessment Programme 17/30/02
6 · The paper itself

Abstract

backgroundVarious washout policies are widely used in adults living with long-term catheters (LTC). There is currently insufficient evidence on the benefits and potential harms of prophylactic LTC washout policies in the prevention of blockages and other LTC-related adverse events, such as urinary tract infections. CATHETER II tests the hypothesis that weekly prophylactic LTC washouts (normal saline or citric acid) in addition to standard LTC care reduce the incidence of catheter blockage requiring intervention compared to standard LTC care only in adults living with LTC.

methodsCATHETER II is a pragmatic three-arm open multi-centre superiority randomised controlled trial with an internal pilot, economic analysis, and embedded qualitative study. Eligible participants are adults aged ≥ 18 years, who have had a LTC in use for ≥ 28 days, have no plans to discontinue the use of the catheter, are able to undertake the catheter washouts, and complete trial documentation or have a carer able to help them. Participants are identified from general practitioner practices, secondary/tertiary care, community healthcare, care homes, and via public advertising strategies. Participants are randomised 1:1:1 to receive a weekly saline (0.9%) washout in addition to standard LTC care, a weekly citric acid (3.23%) washout in addition to standard LTC care or standard LTC care only. Participants and/or carers will receive training to administer the washouts. Patient-reported outcomes are collected at baseline and for 24 months post-randomisation. The primary clinical outcome is catheter blockage requiring intervention up to 24 months post-randomisation expressed per 1000 catheter days. Secondary outcomes include symptomatic catheter-associated urinary tract infection requiring antibiotics, catheter change, adverse events, NHS/ healthcare use, and impact on quality of life. DISCUSSION: This study will guide treatment decision-making and clinical practice guidelines regarding the effectiveness of various prophylactic catheter washout policies in men and women living with LTC. This research has received ethical approval from Wales Research Ethics Committee 6 (19/WA/0015).

trial registrationISRCTN ISRCTN17116445 . Registered prospectively on 06 November 2019.

Indexed as

Catheter-Related InfectionsCost-Benefit AnalysisUrinary CatheterizationUrinary Tract InfectionsAdultCatheters, IndwellingCitric AcidEquivalence Trials as TopicFemaleHumansMaleMulticenter Studies as TopicPolicyPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicCitric AcidCatheter blockageCatheter maintenance solutionsCatheter washout solutionsIndwelling catheterLong-term catheterSymptomatic catheter-associated urinary tract infection

Identifiers

PMID35927733
PMCPMC9351274
OpenAlexW4289755091

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.