Effects of PACK training on the management of asthma and chronic obstructive pulmonary disease by primary care clinicians during two years of implementation in Florianópolis, Brazil: extended follow-up after a pragmatic cluster randomised controlled trial with a stepped wedge design

Background: Training primary care doctors and nurses to use Practical Approach to Care Kit (PACK) improved management of asthma and chronic obstructive pulmonary disease (COPD) in a previous randomised trial. The present study examined the training effects including a second year of follow-up with expanded coverage of repeated training sessions. Methods: Using a stepped wedge cluster randomised trial design, 48 clinics were randomly allocated either to Sequence A: i) no intervention, ii) no intervention, iii) intervention, or Sequence B: i) no intervention, ii) intervention, iii) intervention, during three 12 month periods. Primary outcomes were change in treatment, and spirometry ordering. Effects of any exposure to the training, and of exposure to the first and second years of training, were estimated with mixed effect logistic regression models. Results: Any exposure to training was associated with increased changes in treatment (Odds Ratio adjusted for calendar time (OR) 1.29, 95% confidence interval (CI) 1.02–1.64) and more spirometry ordering (OR 1.55, (1.22-1.97)) in asthma patients, and with more spirometry ordering (OR 1.50, (1.15-1.96)) in COPD patients. Change in asthma treatment was more likely during the first and second year of exposure to training compared with no exposure (ORs 1.43, (1.09–1.87); 1.91, (1.21–3.02)), respectively. Spirometry was more likely during the first and second year of exposure in asthma patients, (ORs 1.76, (1.17–1.93); 2.05 95% (1.32–3.19)), and in COPD patients (ORs 1.57 (1.18–2.10)); 1.71 (1.08–2.70)). Conclusion: Extended follow-up suggested that PACK training continued to be effective in improving chronic respiratory care, and that effective intervention delivery was sustainable for two years

The surgical safety checklist and patient outcomes after surgery: a prospective observational cohort study, systematic review and meta-analysis

© 2017 British Journal of Anaesthesia Background: The surgical safety checklist is widely used to improve the quality of perioperative care. However, clinicians continue to debate the clinical effectiveness of this tool. Methods: Prospective analysis of data from the International Surgical Outcomes Study (ISOS), an international observational study of elective in-patient surgery, accompanied by a systematic review and meta-analysis of published literature. The exposure was surgical safety checklist use. The primary outcome was in-hospital mortality and the secondary outcome was postoperative complications. In the ISOS cohort, a multivariable multi-level generalized linear model was used to test associations. To further contextualise these findings, we included the results from the ISOS cohort in a meta-analysis. Results are reported as odds ratios (OR) with 95% confidence intervals. Results: We included 44 814 patients from 497 hospitals in 27 countries in the ISOS analysis. There were 40 245 (89.8%) patients exposed to the checklist, whilst 7508 (16.8%) sustained ≥1 postoperative complications and 207 (0.5%) died before hospital discharge. Checklist exposure was associated with reduced mortality [odds ratio (OR) 0.49 (0.32–0.77); P\u3c0.01], but no difference in complication rates [OR 1.02 (0.88–1.19); P=0.75]. In a systematic review, we screened 3732 records and identified 11 eligible studies of 453 292 patients including the ISOS cohort. Checklist exposure was associated with both reduced postoperative mortality [OR 0.75 (0.62–0.92); P\u3c0.01; I2=87%] and reduced complication rates [OR 0.73 (0.61–0.88); P\u3c0.01; I2=89%). Conclusions: 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

Prospective observational cohort study on grading the severity of postoperative complications in global surgery research

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