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A multi-centre quality improvement project to reduce the incidence of obstetric anal sphincter injury (OASI): study
Posy Bidwell1, Ranee Thakar2, Nick Sevdalis3
1Royal College of Obstetricians and Gynaecologists, London, UK. pbidwell@rcog.org.uk.
Insights
Obstetric anal sphincter injuries (OASI) can cause lifelong issues. A new care bundle aims to prevent OASI by standardizing practices like perineal protection and timely episiotomies during childbirth. This study evaluates its effectiveness and acceptability.
Area of Science:
- Obstetrics and Gynecology
- Surgical Safety
- Quality Improvement in Healthcare
Background:
- Third and fourth-degree perineal tears, or obstetric anal sphincter injuries (OASI), lead to significant maternal morbidity, including anal incontinence and psychosocial distress.
- Reported rates of OASI have been increasing within the English National Health System (NHS).
- A collaborative quality improvement project developed an OASI Care Bundle to address this rise.
Purpose of the Study:
- To evaluate the effectiveness of a newly developed OASI Care Bundle in reducing OASI rates.
- To assess the feasibility and acceptability of integrating the OASI Care Bundle into routine maternity care.
- To identify barriers and enablers for upscaling the OASI Care Bundle across maternity units.
Main Methods:
- A stepped-wedge design will be employed across 16 maternity units in England, Wales, and Scotland from January 2017.
- The primary outcome is the OASI rate, analyzed using regression to adjust for covariates.
- Qualitative methods, including focus groups and interviews with clinicians and women, will assess implementation feasibility and acceptability.
Main Results:
- The study protocol outlines the evaluation of a quality improvement project.
- The primary clinical outcome measured is the rate of OASI.
- Regression analysis will be used to adjust for organizational characteristics and obstetric risk factors.
Conclusions:
- The OASI Care Bundle integrates evidence-based interventions to standardize practice and prevent OASI.
- The project aims to ensure the interventions are acceptable to both clinicians and women.
- Successful implementation could lead to wider dissemination of the OASI Care Bundle within the NHS and beyond.
Background:
Third and fourth degree perineal tears, or obstetric anal sphincter injuries (OASI), sustained during childbirth can result in anal incontinence and psychosocial problems which require ongoing treatment. Within the English National Health System (NHS) reported rates of OASI have gradually increased. In response, a care bundle was developed incorporating four elements: 1) antenatal information to women, 2) manual perineal protection during all vaginal births, 3) episiotomy to be performed with a 60° mediolateral angle at crowning (when clinically indicated) and 4) perineal examination (including per rectum) after childbirth. Implementation of the OASI Care Bundle is aided by a skills development module and an awareness campaign. The project is a collaboration between two national professional bodies, an NHS hospital trust and an academic institution.
Methods:
Implementation of the OASI Care Bundle will be evaluated using a stepped-wedge design. From January 2017 sixteen maternity units across England, Wales and Scotland will participate in the study over a 15-month period, with sequential roll-out of the intervention in four blocks (regions) of four units. The primary clinical outcome is OASI rate. Regression analysis will adjust for differences in organisational characteristics and obstetric risk factors in women who gave birth before and after implementation of the care bundle. Focus group discussions and in-depth interviews with clinicians will evaluate the feasibility of integrating the care bundle into routine practice. Interviews with women will explore the acceptability of the intervention.
Discussion:
This protocol outlines the evaluation of our quality improvement project which aims to prevent OASI using a bundle of evidence-based interventions that are each widely used in practice. The OASI project aims to 1) standardise practice to prevent OASI in a way that is acceptable to clinicians and women and 2) identify the barriers and enablers associated with upscaling interventions within maternity units. If found to be effective, feasible and acceptable, the OASI Care Bundle will be shared with a range of audiences using the communication channels available to the professional bodies.
Trial Registration:
The OASI Project was retrospectively registered on the ISCTRN12143325 database date assigned 03/10/2017.
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