Development and validation of a labour epidural analgesia documentation instrument for South African hospitals

Abstract

Background: Labour epidural analgesia is the gold standard for intrapartum pain relief, yet documentation practices remain inconsistent, particularly in resource-constrained settings. Inadequate documentation creates patient-safety risk and limits audit and governance. No formally validated labour epidural documentation instrument has been described in the published literature. Aim: This study aimed to develop and content-validate a standardised labour epidural analgesia documentation instrument for the South African health sector. Setting: Study was conducted in the South African health sector. Methods: A two-phase instrument development and content validation study were conducted. In the development phase, a concept instrument was generated from a literature review and refined through expert consensus. In the quantification phase, national anaesthesiology experts independently rated items for relevance and importance using a four-point Likert scale. Item-level and scale-level content validity indices and inter-rater agreement values were calculated using predefined thresholds. Results: The initial 68-item concept instrument was refined to 56 items. Quantitative content validation resulted in a final instrument comprising four domains: pre-procedural assessment, intra-procedural documentation, post-procedural follow-up and chart layout. Most retained items demonstrated high item-level content validity (I-CVI ≥ 0.78), with inter-rater agreement values from 0.80 to 1.00. The layout domain had a borderline scale-level content validity index (S-CVI = 0.79), with all retained items meeting item-level validity criteria. Conclusion: This study presents a content-validated labour epidural analgesia documentation instrument, defining a consensus-based minimum dataset for clinical practice. Contribution: The findings of this research provide a foundation for patient-safety initiatives, audit, training and future electronic anaesthesia record development.