Patients exposed to a surgical safety checklist experience better postoperative outcomes, but this could simply reflect wider quality of care in hospitals where checklist use is routine.
Background The Clavien–Dindo classification is perhaps the most widely used approach for reporting postoperative complications in clinical trials. This system classifies complication severity by the treatment provided. However, it is unclear whether the Clavien–Dindo system can be used internationally in studies across differing healthcare systems in high‐ (HICs) and low‐ and middle‐income countries (LMICs). Methods This was a secondary analysis of the International Surgical Outcomes Study (ISOS), a prospective observational cohort study of elective surgery in adults. Data collection occurred over a 7‐day period. Severity of complications was graded using Clavien–Dindo and the simpler ISOS grading (mild, moderate or severe, based on guided investigator judgement). Severity grading was compared using the intraclass correlation coefficient (ICC). Data are presented as frequencies and ICC values (with 95 per cent c.i.). The analysis was stratified by income status of the country, comparing HICs with LMICs. Results A total of 44 814 patients were recruited from 474 hospitals in 27 countries (19 HICs and 8 LMICs). Some 7508 patients (16·8 per cent) experienced at least one postoperative complication, equivalent to 11 664 complications in total. Using the ISOS classification, 5504 of 11 664 complications (47·2 per cent) were graded as mild, 4244 (36·4 per cent) as moderate and 1916 (16·4 per cent) as severe. Using Clavien–Dindo, 6781 of 11 664 complications (58·1 per cent) were graded as I or II, 1740 (14·9 per cent) as III, 2408 (20·6 per cent) as IV and 735 (6·3 per cent) as V. Agreement between classification systems was poor overall (ICC 0·41, 95 per cent c.i. 0·20 to 0·55), and in LMICs (ICC 0·23, 0·05 to 0·38) and HICs (ICC 0·46, 0·25 to 0·59). Conclusion Caution is recommended when using a treatment approach to grade complications in global surgery studies, as this may introduce bias unintentionally.
Background and Purpose: The treatment of patients with intracerebral hemorrhage along with moderate hematoma and without cerebral hernia is controversial. This study aimed to explore risk factors and establish prediction models for early deterioration and poor prognosis.Methods: We screened patients from the prospective intracerebral hemorrhage (ICH) registration database (RIS-MIS-ICH, ClinicalTrials.gov Identifier: NCT03862729). The enrolled patients had no brain hernia at admission, with a hematoma volume of more than 20 ml. All patients were initially treated by conservative methods and followed up ≥ 1 year. A decline of Glasgow Coma Scale (GCS) more than 2 or conversion to surgery within 72 h after admission was defined as early deterioration. Modified Rankin Scale (mRS) ≥ 4 at 1 year after stroke was defined as poor prognosis. The independent risk factors of early deterioration and poor prognosis were determined by univariate and multivariate regression analysis. The prediction models were established based on the weight of the independent risk factors. The accuracy and value of models were tested by the receiver operating characteristic (ROC) curve.Results: After screening 632 patients with ICH, a total of 123 legal patients were included. According to statistical analysis, admission GCS (OR, 1.43; 95% CI, 1.18–1.74; P < 0.001) and hematoma volume (OR, 0.9; 95% CI, 0.84–0.97; P = 0.003) were the independent risk factors for early deterioration. Hematoma location (OR, 0.027; 95% CI, 0.004–0.17; P < 0.001) and hematoma volume (OR, 1.09; 95% CI, 1.03–1.15; P < 0.001) were the independent risk factors for poor prognosis, and island sign had a trend toward significance (OR, 0.5; 95% CI, 0.16-1.57; P = 0.051). The admission GCS and hematoma volume score were combined for an early deterioration prediction model with a score from 2 to 5. ROC curve showed an area under the curve (AUC) was 0.778 and cut-off point was 3.5. Combining the score of hematoma volume, island sign, and hematoma location, a long-term prognosis prediction model was established with a score from 2 to 6. ROC curve showed AUC was 0.792 and cutoff point was 4.5.Conclusions: The novel early deterioration and long-term prognosis prediction models are simple, objective, and accurate for patients with ICH along with a hematoma volume of more than 20 ml.
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