Development of an inpatient PCDP-COS

• Research type

  Research Study

• Full title

  Development of an inpatient post caesarean delivery pain core outcome set; a scoping review, qualitative interviews and Delphi consensus study.

• IRAS ID

  301924

• Contact name

  Sarah Ciechanowicz

• Contact email

  s.ciechanowicz@nhs.net

• Sponsor organisation

  University College London Hospital

• Clinicaltrials.gov Identifier

  301924, IRAS; ?, REC

• Duration of Study in the UK

  0 years, 6 months, 6 days

• Research summary

  There is no consensus regarding which outcome measures should be used to evaluate interventions to treat or prevent post caesarean delivery pain (PCDP). A core outcome set (COS) is a standardised set of outcomes, which should be measured as a minimum, in all studies for a specific health area/condition, to best evaluate the efficacy of the study intervention. This study aims to develop a consensus-based PCDP-COS for use in research and clinical practice, with an ultimate aim to globally promote the health and well being of people with PCDP by consistent and relevant outcome measurement and reporting in any prevention and management strategy. We will develop this PCDP-COS using a scoping review, patient interviews, a Delphi survey and a face-to-face consensus meeting.

  Further Study Information Method(s)
  -Delphi process
  -Semi structured discussion
  -Systematic review

  Semi-structured interviews: we will interview postpartum women. Data will be collated from each interview and analysed for repetitive responses. Responses will be grouped into themes before applying Delphi methodology to capture consensus of opinion.
  Delphi: We will invite experts in chronic pain, obstetrics, perioperative medicine, nursing and postpartum women to participate in 2 rounds of Delphi questionnaires followed by a "round table" discussion to finalise a core outcome set. We will aim to have at least 20 panellists. Experts will be selected as follows: Investigators Corresponding authors of published PCDP studies from the last 10 years with pain as primary outcome measure. All authors of a recent consensus statement PROSPECT guideline for elective caesarean section: updated systematic review and procedure-specific postoperative pain management recommendations. First and last authors of any published article / review identified in a literature search regarding PCDP with pain as primary outcome measure published in the last 10 years.

• REC name

  South East Scotland REC 02

• REC reference

  22/SS/0084

• Date of REC Opinion

  1 Mar 2023

• REC opinion

  Further Information Unfavourable Opinion