Evidence map›Paper›PMID 39719286›Full record

ArticleBMJ open2024

PREVENTion and treatment of incontinence-associated dermatitis through a codesigned manual (PREVENT-IAD): a study protocol for a feasibility cluster randomised controlled trial with a nested process evaluation.

Sue Woodward, Tanya Graham, Sangeeta Sooriah, Dimitri Beeckman, Chris Chatterton, Mandy Fader, Francesca Fiorentino, Joanne M Fitzpatrick, Ruth Harris, Jan Kottner and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. 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
–field-weighted citation impact
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.

  1. Trial
  2. Article
  3. Article
  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

12 authors.

Sue WoodwardFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.ORCID http://orcid.org/0000-0001-5390-7253
Tanya GrahamFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK Tanya.Graham@kcl.ac.uk.ORCID http://orcid.org/0000-0001-7238-4865
Sangeeta SooriahFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.
Dimitri BeeckmanPublic Health and Primary Care, Ghent University, Gent, Belgium.ORCID http://orcid.org/0000-0003-3080-8716
Chris ChattertonFreelance Academic and Researcher, Patient Advocate, London, UK.
Mandy FaderSchool of Health Sciences, University of Southampton, Southampton, Hampshire, UK.
Francesca FiorentinoLICTR, University of Leeds Leeds Institute of Clinical Trials Research, Leeds, UK.ORCID http://orcid.org/0000-0001-9817-6634
Joanne M FitzpatrickFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.ORCID http://orcid.org/0000-0002-6285-180X
Ruth HarrisFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.ORCID http://orcid.org/0000-0002-4377-5063
Jan KottnerInstitute for Clinical Nursing Science, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0003-0750-3818
Christine NortonFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.ORCID http://orcid.org/0000-0003-2259-0948
Peter WorsleySchool of Health Sciences, University of Southampton, Southampton, Hampshire, UK.ORCID http://orcid.org/0000-0003-0145-5042

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIncontinence is commonly experienced by adults who receive care support in a residential facility or in their own home. These individuals are at risk of developing incontinence-associated dermatitis (IAD), which is caused by prolonged and repeated exposure of the skin to urine or faeces. An IAD manual was developed providing an evidence-based clinical algorithm and an e-learning training programme for the prevention and treatment of IAD. The aim of the study is to establish the feasibility of conducting a definitive trial to examine the clinical and cost-effectiveness of the IAD manual. The objectives are to assess recruitment and attrition rates, acceptability of the IAD manual and intervention fidelity. METHODS AND ANALYSIS: A feasibility cluster randomised controlled trial will be conducted in residential nursing homes and in the homes of people receiving formal care support in London and Hampshire, England. A total of six clusters including n=248 participants who are incontinent of urine, or faeces will be included. At each intervention site, care staff will be trained to implement the IAD manual over a 6-month period. Quantitative outcomes include IAD incidence and severity, IAD-related pain, satisfaction with care and mental health. A qualitative evaluation of care staff and care receivers' experiences of participation will be conducted. Rates and proportions of each feasibility outcome will be described informing the sample size estimation for a definitive cluster randomised controlled trial. A thematic analysis of the qualitative data will be guided by a logic model detailing potential factors impacting on both the study methodology and adoption of the IAD manual into routine care. ETHICS AND DISSEMINATION: The study received the approval of the Queens Square Ethics Committee Health Research Authority 23/LO/036, (Project ID 296167). Results will be disseminated through peer-reviewed open-access journals and international conferences TRIAL REGISTRATION NUMBER: ISRCTN70866724.

Indexed as

DermatitisFeasibility StudiesFecal IncontinenceUrinary IncontinenceEnglandHumansNursing HomesRandomized Controlled Trials as TopicClinical TrialDERMATOLOGYFeasibility StudiesUrinary incontinencesWOUND MANAGEMENT

Identifiers

PMID39719286
PMCPMC11667359

What OpenQuestion holds

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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.