Background: Studies of cesarean delivery pain report different outcomes, restricting data pooling. This study aimed to develop a core outcome set for inpatient postoperative pain assessment after cesarean delivery to use for research and clinical practice, using the Delphi consensus methodology.
Methods: A scoping review identified 37 initial outcomes, with 2 additional outcomes developed from a patient focus group. These were rated in a two-round Delphi survey process completed by a panel consisting of authors of studies identified from a scoping review (n = 9), supplemented with other experts (n = 5) and patients with recent lived experience of post cesarean delivery pain (n = 7). Scores were collected usinga 1-5 Likert scale, 1-2 being 'critical for inclusion'; 3 being 'important but not critical', and 4-5 of 'limited importance/invalid'. Outcomes were included if recommended by =70% of stakeholders after voting. A third-round virtual meeting determined domains, and several further rounds of online surveys finalizedthe specific measures.
Results: Round one included 14 experts and 7 patients (100% response). Round two included 12 experts and 4 patients (76% response). The virtual meeting was attended by 11 experts and 3 patients (67%), and the 4 online surveys were completed by 67%, 52%, 67%, and 76%. The final domains included pain intensity: at rest, movement-evoked, and pain relief; pain interference; total consumption of opioids; and maternal adverse effects. 12 measures for domains were agreed upon. Getting out of a hospital bed was selected as the most relevant functional activity for movement-evoked pain after cesarean delivery.
Conclusions: This core outcome set may be applied to future research and clinical practice initiatives to evaluate post cesarean delivery pain.
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.
S Ciechanowicz, B Carvalho, J S Berger, P Duch, P Flood, R Ffrench-O'Carroll, H Sviggum, S Hakimi, D Jethava, M Mieszkowski, A Merriam, S Osmundson, U Ituk, J Wagner Kovacec, P Sultan
Disease Category: Anaesthesia & pain control
Disease Name: Post caesarean delivery pain
Age Range: 18 - 50
Sex: Female
Nature of Intervention: Surgery
- Clinical experts
- Consumers (patients)
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Delphi process
- Focus group(s)
- Interview
- Literature review
- Semi structured discussion
- Systematic review
We will develop this PCDP-COS using a systematic 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.