To ultimately reach consensus on a core outcome set for trials relating to childbirth-related perineal trauma we will undertake a Delphi survey. This will be sent to a range of different stakeholders including healthcare professionals, researchers and patients.
The childbirth-related perineal trauma Core Domain Sets identified by the systematic reviews and qualitative interviews will be combined to produce an inventory of a potential CRPT core domain set items. This list will be entered into a Delphi survey.
Potentially relevant core outcome sets:
• The CO-OPT Study: Core Outcomes in First- and Second-degree Perineal Tears Prevention and Treatment.
This study includes women with only first and second degree tears and does not encompass women with third and fourth degree tears or episiotomies.
• A core outcome set development for a French national prospective study about the effect of mediolateral episiotomy on obstetric anal sphincter injury during operative vaginal delivery (INSTRUMODA)
This is developing a core outcome set specifically related to the effect of episiotomy on obstetric anal sphincter injury rates during assisted vaginal births. We aim to develop a core outcome set that can be used in trials aiming to improve outcomes after childbirth-related perineal trauma of any type has been sustained (secondary to spontaneous or assisted vaginal birth).
• The CO-OPT Study: Core Outcomes in Obstetric Anal Sphincter Injury Prevention and Treatment
This focuses on women with third and fourth degree tears only and does not encompass women with other types of perineal trauma.
Prof Katie Morris- University of Birmingham
Prof Stelios Doumouchtsis- Epsom and St Helier University Hospitals NHS Trust
Dr Victoria Hodgetts Morton- University of Birmingham
Prof Cornelia Betschart- University Hospital Zurich
Dr Rebecca Man- University of Birmingham
CHORUS and CHAPTER groups
Disease Category: Pregnancy & childbirth
Disease Name: childbirth perineal trauma
Age Range: 16 - 60
Sex: Female
Nature of Intervention: Any
- Charities
- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- Service providers
- Service users
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
All stakeholder groups, including healthcare professionals, researchers, healthcare regulators and women, will be invited to participate in this process. The Delphi survey will be hosted online. Participants will be asked to register and provide demographic details and commitment to the three-round process. A unique identifier for each participant will allow responses to be anonymised and completion reminders.
Sample size: There is no robust method for calculating the required sample size for such a Delphi survey, although there is a reported typical attrition rate of 20%. We aim to recruit at least 12 representatives from each stakeholder group using established networks to allow our target of 10 per group.
Data collection and analysis: The potential childbirth-related perineal trauma core domain set items will be entered into a Delphi survey pilot to ensure ease of completion using appropriate terminology and phrasing. It will be piloted by the study working group. Following this, a three round Delphi survey will be undertaken.
First and second round: core domain set items will be scored using a Likert type scale ranging from 'not important' (score 1-3), ‘important’ (score 4-6) or 'critical' (score 7 to 9). For each core domain set item, scores will be calculated, summarised graphically with the whole/stakeholder group response. For round two, all outcomes will be carried through. Before scoring of round two, scores from round one will be displayed for participants to consider whilst completing their second round.
Third round: participants will firstly be sent a summary of scores from the previous round. They will be asked to score the outcomes again and asked to indicate whether each specific core domain item should be included the final COS. To establish which outcomes should be included in the COS (‘consensus in’), the threshold of >70% of participants scoring the outcome as critical (7-9), with <15% scoring it as not important (1-3) will be used. For the exclusion of outcomes (‘consensus out’) the inverse will be applied. If there are any outcomes where it is not possible to reach a consensus using these principles, a decision will be made via a consensus meeting.