Alone Together: Is Strain Experienced Concurrently by Members of Operating Room Teams?: An Event-based Study

Objective:. To identify which strain episodes are concurrently reported by several team members; to identify triggers of strain experienced by operating room (OR) team members during the intraoperative phase. Summary:. OR teams are confronted with many sources of strain. However, most studies investigate strain on a general, rather than an event-based level, which does not allow to determine if strain episodes are experienced concurrently by different team members. Methods:. We conducted an event-based, observational study, at an academic medical center in North America and included 113 operations performed in 5 surgical departments (general, vascular, pediatric, gynecology, and trauma/acute care). Strain episodes were assessed with a guided-recall method. Immediately after operations, participants mentally recalled the operation, described the strain episodes experienced and their content. Results:. Based on 731 guided recalls, 461 strain episodes were reported; these refer to 312 unique strain episodes. Overall, 75% of strain episodes were experienced by a single team member only. Among different categories of unique strain episodes, those triggered by task complexity, issues with material, or others’ behaviors were typically experienced by 1 team member only. However, acute patient issues (n = 167) and observations of others’ strain (n = 12) (respectively, 58.5%; P < 0.001 and 83.3%; P < 0.001) were often experienced by 2 or more team members. Conclusions and relevance:. OR team members are likely to experience strain alone, unless patient safety is at stake. This may jeopardize the building of a shared understanding among OR team members

Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial

Background: Sparsentan is a novel, non-immunosuppressive, single-molecule, dual endothelin and angiotensin receptor antagonist being examined in an ongoing phase 3 trial in adults with IgA nephropathy. We report the prespecified interim analysis of the primary proteinuria efficacy endpoint, and safety. Methods: PROTECT is an international, randomised, double-blind, active-controlled study, being conducted in 134 clinical practice sites in 18 countries. The study examines sparsentan versus irbesartan in adults (aged ≥18 years) with biopsy-proven IgA nephropathy and proteinuria of 1·0 g/day or higher despite maximised renin-angiotensin system inhibitor treatment for at least 12 weeks. Participants were randomly assigned in a 1:1 ratio to receive sparsentan 400 mg once daily or irbesartan 300 mg once daily, stratified by estimated glomerular filtration rate at screening (30 to 1·75 g/day). The primary efficacy endpoint was change from baseline to week 36 in urine protein-creatinine ratio based on a 24-h urine sample, assessed using mixed model repeated measures. Treatment-emergent adverse events (TEAEs) were safety endpoints. All endpoints were examined in all participants who received at least one dose of randomised treatment. The study is ongoing and is registered with ClinicalTrials.gov, NCT03762850. Findings: Between Dec 20, 2018, and May 26, 2021, 404 participants were randomly assigned to sparsentan (n=202) or irbesartan (n=202) and received treatment. At week 36, the geometric least squares mean percent change from baseline in urine protein-creatinine ratio was statistically significantly greater in the sparsentan group (-49·8%) than the irbesartan group (-15·1%), resulting in a between-group relative reduction of 41% (least squares mean ratio=0·59; 95% CI 0·51-0·69; p<0·0001). TEAEs with sparsentan were similar to irbesartan. There were no cases of severe oedema, heart failure, hepatotoxicity, or oedema-related discontinuations. Bodyweight changes from baseline were not different between the sparsentan and irbesartan groups. Interpretation: Once-daily treatment with sparsentan produced meaningful reduction in proteinuria compared with irbesartan in adults with IgA nephropathy. Safety of sparsentan was similar to irbesartan. Future analyses after completion of the 2-year double-blind period will show whether these beneficial effects translate into a long-term nephroprotective potential of sparsentan. Funding: Travere Therapeutics