Evidence map›Paper›PMID 34022926›Full record

Trial reportImplementation science : IS2021

OASI2: a cluster randomised hybrid evaluation of strategies for sustainable implementation of the Obstetric Anal Sphincter Injury Care Bundle in maternity units in Great Britain.

Magdalena Jurczuk, Posy Bidwell, Dorian Martinez, Louise Silverton, Jan Van der Meulen, Daniel Wolstenholme, Ranee Thakar, Ipek Gurol-Urganci, Nick Sevdalis

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Implementation science : IS, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
2.4field-weighted citation impact, top 11% 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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

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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

9 authors at 5 institutions in 1 country.

Magdalena JurczukCentre for Quality Improvement and Clinical Audit, Royal College of Obstetricians and Gynaecologists, 10-18 Union Street, London, SE1 1SZ, UK. mjurczuk@rcog.org.uk.ORCID 0000-0001-6915-767X
Posy BidwellCentre for Quality Improvement and Clinical Audit, Royal College of Obstetricians and Gynaecologists, 10-18 Union Street, London, SE1 1SZ, UK.
Dorian MartinezCentre for Quality Improvement and Clinical Audit, Royal College of Obstetricians and Gynaecologists, 10-18 Union Street, London, SE1 1SZ, UK.
Louise SilvertonRoyal College of Midwives, 10-18 Union Street, London, SE1 1SZ, UK.
Jan Van der MeulenDepartment of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.
Daniel WolstenholmeCentre for Quality Improvement and Clinical Audit, Royal College of Obstetricians and Gynaecologists, 10-18 Union Street, London, SE1 1SZ, UK.
Ranee Thakar *Croydon University Hospitals NHS Trust, 530 London Road, Croydon, CR7 7YE, UK.
Ipek Gurol-Urganci *Centre for Quality Improvement and Clinical Audit, Royal College of Obstetricians and Gynaecologists, 10-18 Union Street, London, SE1 1SZ, UK.
Nick Sevdalis *Centre for Implementation Science, Health Service and Population Research Department, King's College London, De Crespingy Park, London, SE5 8AF, UK.
Royal College of Obstetricians and Gynaecologists · GBCroydon University Hospital · GBKing's College London · GBLondon School of Hygiene & Tropical Medicine · GBRoyal College of Midwives · GB

Funding

Department of Health
6 · The paper itself

Abstract

backgroundThe Obstetric Anal Sphincter Injury (OASI) Care Bundle comprises four primary and secondary prevention practices that target the rising rates of severe perineal tearing during childbirth, which can have severe debilitating consequences for women. The OASI Care Bundle was implemented in 16 maternity units in Britain in the OASI1 project (2017-2018), which demonstrated the care bundle's effectiveness in reducing OASI rates. In OASI2, the care bundle will be scaled up to 20 additional National Health Service (NHS) maternity units in a hybrid effectiveness-implementation study that will examine the effectiveness of strategies used to introduce, implement and sustain the care bundle.

methodsOASI2 is a two-arm cluster-randomised control trial (C-RCT) of maternity units in England, Scotland and Wales, with an additional non-randomised study arm. C-RCT arm 1 (peer support, n = 10 units) will be supported by 'buddy' units to implement the OASI Care Bundle. C-RCT arm 2 (lean implementation, n = 10 units) will implement without external support. The additional study arm (sustainability, n = 10 units) will include some original OASI1 units to evaluate the care bundle's sustainability and OASI rates over time, from before OASI1 and through the end of OASI2. Units in all three study arms will receive an Implementation Toolkit with training resources and implementation support. The C-RCT arms will be compared in terms of OASI rate reduction (primary effectiveness outcome) and clinicians' adoption of the care bundle (primary implementation outcome). Clinical data will be collated from maternity information systems; implementation data will be collected through validated surveys with women and clinicians, supplemented by qualitative methods. Descriptive statistics and regression modelling will be used for analysis. Emergent themes from the qualitative data will be assessed using framework analysis. DISCUSSION: OASI2 will study the impact of various implementation strategies used to introduce and sustain the OASI Care Bundle, and how these strategies affect the bundle's clinical effectiveness. The study will generate insights into how to effectively scale-up and sustain uptake and coverage of similar interventions in maternity units. A locally adaptable 'implementation blueprint' will be produced to inform development of future guidelines to prevent perineal trauma.

trial registrationISRCTN26523605.

Indexed as

Anal CanalPatient Care BundlesDelivery, ObstetricFemaleHumansParturitionPerineumPregnancyState MedicineUnited KingdomImplementationOASI Care BundleObstetric anal sphincter injuryQuality improvementScale-upSevere perineal tear

Identifiers

PMID34022926
PMCPMC8140475
OpenAlexW3165694731

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.