Clinical Efficacy of Combined Surgical Patient Safety System and the World Health Organization's Checklists in Surgery: A Nonrandomized Clinical Trial.

Importance: Checklists have been shown to improve patient outcomes in surgery. The intraoperatively used World Health Organization surgical safety checklist (WHO SSC) is now mandatory in many countries. The only evidenced checklist to address preoperative and postoperative care is the Surgical Patient Safety System (SURPASS), which has been found to be effective in improving patient outcomes. To date, the WHO SSC and SURPASS have not been studied jointly within the perioperative pathway. Objective: To investigate the association of combined use of the preoperative and postoperative SURPASS and the WHO SSC in perioperative care with morbidity, mortality, and length of hospital stay. Design, Setting, and Participants: In a stepped-wedge cluster nonrandomized clinical trial, the preoperative and postoperative SURPASS checklists were implemented in 3 surgical departments (neurosurgery, orthopedics, and gynecology) in a Norwegian tertiary hospital, serving as their own controls. Three surgical units offered additional parallel controls. Data were collected from November 1, 2012, to March 31, 2015, including surgical procedures without any restrictions to patient age. Data were analyzed from September 25, 2018, to March 29, 2019. Interventions: Individualized preoperative and postoperative SURPASS checklists were added to the intraoperative WHO SSC. Main Outcomes and Measures: Primary outcomes were in-hospital complications, emergency reoperations, unplanned 30-day readmissions, and 30-day mortality. The secondary outcome was length of hospital stay (LOS). Results: In total, 9009 procedures (5601 women [62.2%]; mean [SD] patient age, 51.7 [22.2] years) were included, with 5117 intervention procedures (mean [SD] patient age, 51.8 [22.4] years; 2913 women [56.9%]) compared with 3892 controls (mean [SD] patient age, 51.5 [21.8] years; 2688 women [69.1%]). Parallel control units included 9678 procedures (mean [SD] patient age, 57.4 [22.2] years; 4124 women [42.6%]). In addition to the WHO SSC, adjusted analyses showed that adherence to the preoperative SURPASS checklists was associated with reduced complications (odds ratio [OR], 0.70; 95% CI, 0.50-0.98; P = .04) and reoperations (OR, 0.42; 95% CI, 0.23-0.76; P = .004). Adherence to the postoperative SURPASS checklists was associated with decreased readmissions (OR, 0.32; 95% CI, 0.16-0.64; P = .001). No changes were observed in mortality or LOS. In parallel control units, complications increased (OR, 1.09; 95% CI, 1.01-1.17; P = .04), whereas reoperations, readmissions, and mortality remained unchanged. Conclusions and Relevance: In this nonrandomized clinical trial, adding preoperative and postoperative SURPASS to the WHO SSC was associated with a reduction in the rate of complications, reoperations, and readmissions. Trial Registration: ClinicalTrials.gov Identifier: NCT01872195.

[The polypill as cardiovascular prophylactic: clinical trials]. / Polypillen som kardiovaskulær profylakse--kliniske studier.

BACKGROUND: Cardiovascular disease dominates globally as the most common cause of death. This challenge may be countered by employing a combination pill (the «polypill¼) for prophylaxis by everybody above a certain age. The polypill normally contains two to three low-dose antihypertensives, a statin and aspirin. Clinical trials with the polypill are reviewed. METHOD: The databases PubMed and ClinicalTrials.gov were accessed for published, ongoing and planned randomised clinical trials with a polypill, and studies available per June 2013 were identified and evaluated. RESULTS: Six randomised clinical trials with different variations of a polypill have been published. In these, the polypill has been compared either with placebo (n = 3) or other cardiovascularly active pharmacotherapeutic strategies (n = 3). So far, no data on hard endpoints such as morbidity and mortality are available. On the basis of reductions in blood pressure and cholesterol levels, estimated risk reductions for ischemic heart disease and stroke were in the 33-72% and 21-64% ranges, respectively. INTERPRETATION: Additional studies of longer duration and with larger numbers of patients are required to assess the polypill's proposed effects on cardiovascular morbidity and mortality, as well as safety issues.