An updated systematic review and consensus definitions for standardised endpoints in perioperative medicine: patient comfort and pain relief.

BACKGROUND

Improving comfort during and after surgery is a key concern for anaesthetists and other clinicians. With the inclusion of patient and public involvement, we undertook a Delphi consensus process to update previously recommended endpoints to be used in clinical trials evaluating treatments aiming to improve patient comfort after surgery.

METHODS

We undertook a systematic review to identify domains and outcome measures of patient comfort used in perioperative studies. Focus groups, workshops, and a multi-round Delphi consensus process that included clinician-researchers and a patient experience and consumer group updated a recommended list of standardised endpoints focused on patient comfort. Consensus was defined as a median item score of 7 or greater and at least 70% of responses achieving a score of 7 or greater on a 9-point Likert scale. Additional ratings were done to determine validity, reliability, feasibility, and patient-centredness. Qualitative analyses were undertaken to identify themes.

RESULTS

Response rates for each of the Delphi rounds were 100%. A final list of eight defined endpoints was identified: supplementary analgesic use, subjective analgesic effectiveness, pain intensity (at rest, during movement, and at 12, 24, and 72 h), postoperative nausea and vomiting (PONV, at 0-6 h, at 6-24 h, and overall), postdischarge nausea and vomiting (PDNV), severe PONV, quality of recovery (QoR-15), and time to mobilisation. All endpoints were assessed as valid, reliable, and feasible measures of patient comfort and were considered patient-centred. Patient and public involvement highlighted the importance of clear communication and shared decision-making to enhance comfort through the surgical journey.

CONCLUSIONS

We recommend that at least some of these standardised endpoints be included as outcome measures in clinical trials assessing patient comfort and pain after surgery.

SYSTEMATIC REVIEW PROTOCOL: Open Science Framework (10.17605/OSF.IO/DJQFE).