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.
Summary:Background: Statins have been reported to help prevent the development and the recurrence of deep vein thrombosis (DVT). We conducted a prospective randomized clinical trial to compare the effects of rosuvastatin plus a low-molecular-weight heparin (LMWH), bemiparin, with conventional LMWH therapy in the treatment of DVT. Patients and methods: In total, 234 patients were randomized into two groups, 116 in the LMWH group and 118 in the statin plus LMWH group. All patients underwent lower limb duplex ultrasound and analytic markers at diagnosis and three months of follow-up. The fi nal analysis included 230 patients. Results: No signifi cant differences were observed in D-dimer levels after three months of follow-up between patients treated with LMWH+rosuvastatin compared to the LMWH group (802.51 + 1062.20 vs. 996.25 + 1843.37, p = 0.897). The group of patients treated with statins displayed lower levels of CRP (4.17 + 4.27 vs. 22.39 + 97.48, p = 0.018) after three months of follow-up. The Villalta scale demonstrated signifi cant differences between groups (3.45 + 6.03 vs. 7.79 + 5.58, p = 0.035). There was a signifi cant decrease in PTS incidence (Villalta score> 5) in the rosuvastatin group (38.3 % vs. 48.5%, p = 0.019). There were no differences in EuroQol score between groups. Conclusions: Adjuvant rosuvastatin treatment in patients diagnosed of DVT improve CRP levels and diminish PTS incidence.
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.
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