Effect of monitoring surgical outcomes using control charts to reduce major adverse events in patients: cluster randomised trial

AbstractObjectiveTo determine the effect of introducing prospective monitoring of outcomes using control charts and regular feedback on indicators to surgical teams on major adverse events in patients.DesignNational, parallel, cluster randomised trial embedding a difference-in-differences analysis.Setting40 surgical departments of hospitals across France.Participants155 362 adults who underwent digestive tract surgery. 20 of the surgical departments were randomised to prospective monitoring of outcomes using control charts with regular feedback on indicators (intervention group) and 20 to usual care only (control group).InterventionsProspective monitoring of outcomes using control charts, provided in sets quarterly, with regular feedback on indicators (intervention hospitals). To facilitate implementation of the programme, study champion partnerships were established at each site, comprising a surgeon and another member of the surgical team (surgeon, anaesthetist, or nurse), and were trained to conduct team meetings, display posters in operating rooms, maintain a logbook, and devise an improvement plan.Main outcome measuresThe primary outcome was a composite of major adverse events (inpatient death, intensive care stay, reoperation, and severe complications) within 30 days after surgery. Changes in surgical outcomes were compared before and after implementation of the programme between intervention and control hospitals, with adjustment for patient mix and clustering.Results75 047 patients were analysed in the intervention hospitals (37 579 before and 37 468 after programme implementation) versus 80 315 in the control hospitals (41 548 and 38 767). After introduction of the control chart, the absolute risk of a major adverse event was reduced by 0.9% (95% confidence interval 0.4% to 1.4%) in intervention compared with control hospitals, corresponding to 114 patients (70 to 280) who needed to receive the intervention to prevent one major adverse event. A significant decrease in major adverse events (adjusted ratio of odds ratios 0.89, 95% confidence interval 0.83 to 0.96), patient death (0.84, 0.71 to 0.99), and intensive care stay (0.85, 0.76 to 0.94) was found in intervention compared with control hospitals. The same trend was observed for reoperation (0.91, 0.82 to 1.00), whereas severe complications remained unchanged (0.96, 0.87 to 1.07). Among the intervention hospitals, the effect size was proportional to the degree of control chart implementation witnessed. Highly compliant hospitals experienced a more important reduction in major adverse events (0.84, 0.77 to 0.92), patient death (0.78, 0.63 to 0.97), intensive care stay (0.76, 0.67 to 0.87), and reoperation (0.84, 0.74 to 0.96).ConclusionsThe implementation of control charts with feedback on indicators to surgical teams was associated with concomitant reductions in major adverse events in patients. Understanding variations in surgical outcomes and how to provide safe surgery is imperative for improvements.Trial registrationClinicalTrials.gov NCT02569450.

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PREPARE: protocol for a stepped wedge trial to evaluate whether a risk stratification model can reduce preterm deliveries among women with suspected or confirmed preterm pre-eclampsia

BMC Pregnancy and Childbirth ◽

10.1186/s12884-019-2445-x ◽

2019 ◽

Vol 19 (1) ◽

Author(s):

Marcos Augusto Bastos Dias ◽

◽

Leandro De Oliveira ◽

Arundhanthi Jeyabalan ◽

Beth Payne ◽

...

Keyword(s):

Knowledge Transfer ◽

Adverse Events ◽

Risk Stratification ◽

Risk Reduction ◽

Randomised Trial ◽

Adverse Outcomes ◽

Cluster Randomised Trial ◽

Care Providers ◽

Stepped Wedge ◽

Number Of Patients

Abstract Background Preeclampsia (PE) is a major cause of short and long-term morbidity for affected infants, including consequences of fetal growth restriction and iatrogenic prematurity. In Brazil, this is a special problem as PE accounts for 18% of preterm births (PTB). In the PREPARE (Prematurity REduction by Pre-eclampsia cARE) study, we will test a novel system of integrated care based on risk stratification and knowledge transfer, to safely reduce PTB. Methods This is a stepped wedge cluster randomised trial that will include women with suspected or confirmed PE between 20 + 0 and 36 + 6 gestational weeks. All pregnant women presenting with these findings at seven tertiary centres in geographically dispersed sites, throughout Brazil, will be considered eligible and evaluated in terms of risk stratification at admission. At randomly allocated time points, sites will transition to risk stratification performed according to sFlt-1/PlGF (Roche Diagnostics) measurement and fullPIERS score with both results will be revealed to care providers. The healthcare providers of women stratified as low risk for adverse outcomes (sFlt-1/PlGF ≤38 AND fullPIERS< 10% risk) will receive the recommendation to defer delivery. sFlt-1/PlGF will be repeated once and fullPIERS score twice a week. Rates of prematurity due to preeclampsia before and after the intervention will be compared. Additionally, providers will receive an active program of knowledge transfer about WHO recommendations for preeclampsia, including recommendations regarding antenatal corticosteroids for foetal benefits, antihypertensive therapy and magnesium sulphate for seizure prophylaxis. This study will have 90% power to detect a reduction in PTB associated with PE from a population estimate of 1.5 to 1.0%, representing a 33% risk reduction, and 80% power to detect a reduction from 2.0 to 1.5% (25% risk reduction). The necessary number of patients recruited to achieve these results is 750. Adverse events, serious adverse events, both anticipated and unanticipated will be recorded. Discussion The PREPARE intervention expects to reduce PTB and improve care of women with PE without significant adverse side effects. If successful, this novel pathway of care is designed for rapid translation to healthcare throughout Brazil and may be transferrable to other low and middle income countries. Trial registration ClinicalTrials.gov: NCT03073317.

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A Cluster Randomised Trial of a Multifaceted Quality Improvement Intervention in Brazilian Intensive Care Units

Intensive Care Medicine Experimental ◽

10.1186/2197-425x-3-s1-a24 ◽

2015 ◽

Vol 3 (S1) ◽

Author(s):

AB Cavalcanti ◽

◽

FA Bozza ◽

FR Machado ◽

JIF Salluh ◽

...

Keyword(s):

Intensive Care ◽

Quality Improvement ◽

Intensive Care Units ◽

Randomised Trial ◽

Quality Improvement Intervention ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

Improvement Intervention

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Prolonged Central Venous Desaturation Measured by Continuous Oximetry Is Associated with Adverse Outcomes in Pediatric Cardiac Surgery

Anesthesiology ◽

10.1097/aln.0b013e318233056e ◽

2011 ◽

Vol 115 (5) ◽

pp. 1033-1043 ◽

Cited By ~ 16

Author(s):

Ryan Crowley ◽

Elizabeth Sanchez ◽

Jonathan K. Ho ◽

Kate J. Lee ◽

Johanna Schwarzenberger ◽

...

Keyword(s):

Intensive Care Unit ◽

Cardiac Surgery ◽

Intensive Care ◽

Length Of Stay ◽

Adverse Events ◽

Clinical Outcomes ◽

Pediatric Patients ◽

Adverse Outcomes ◽

Central Venous ◽

Major Adverse Events

Background The role of continuous central venous oxygen saturation (ScvO₂) oximetry during pediatric cardiac surgery for predicting adverse outcomes is not known. Using a recently available continuous ScvO₂ oximetry catheter, we examined the association between venous oxygen desaturations and patient outcomes. We hypothesized that central venous oxygen desaturations are associated with adverse clinical outcomes. Methods Fifty-four pediatric patients undergoing cardiac surgery were prospectively enrolled in an unblinded observational study. ScvO₂ was measured continuously in the operating room and for up to 24 h post-Intensive Care Unit admission. The relationships between ScvO₂ desaturations, clinical outcomes, and major adverse events were determined. Results More than 18 min of venous saturations less than 40% were associated with major adverse events with 100% sensitivity and 97.6% specificity. Significant correlations resulted between the ScvO₂ area under the curve less than 40% and creatinine clearance at 12 h in the Intensive Care Unit (r = -0.58), Intensive Care Unit length of stay (r = 0.56), max inotrope use (r = 0.52), inotrope use at 24 h (r = 0.40), inotrope index score (r = 0.39), hospital length of stay (r = 0.36), and length of intubation (r = 0.32). Conclusions We demonstrate that ScvO₂ desaturations by continuous oximetry are associated with major adverse events in pediatric patients undergoing cardiac surgery. The most significant associations with major adverse events are seen in patients with greater than 18 min of central venous saturations less than 40%. Our results support the further investigation of ScvO₂ as a potential target parameter in high-risk pediatric patients to minimize the risk of major adverse events.

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Interventions to reduce colonisation and transmission of antimicrobial-resistant bacteria in intensive care units: an interrupted time series study and cluster randomised trial

The Lancet Infectious Diseases ◽

10.1016/s1473-3099(13)70295-0 ◽

2014 ◽

Vol 14 (1) ◽

pp. 31-39 ◽

Cited By ~ 216

Author(s):

Lennie P G Derde ◽

Ben S Cooper ◽

Herman Goossens ◽

Surbhi Malhotra-Kumar ◽

Rob J L Willems ◽

...

Keyword(s):

Time Series ◽

Intensive Care ◽

Intensive Care Units ◽

Randomised Trial ◽

Interrupted Time Series ◽

Cluster Randomised Trial ◽

Resistant Bacteria ◽

Time Series Study ◽

Cluster Randomised ◽

Series Study

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Long-Term Surgical Outcomes of Carotid Body Tumors With Pathological Fibrosis: A Cohort Study

Frontiers in Oncology ◽

10.3389/fonc.2021.684600 ◽

2021 ◽

Vol 11 ◽

Author(s):

Hanfei Tang ◽

Xiaolang Jiang ◽

Song Xue ◽

Weiguo Fu ◽

Xiao Tang ◽

...

Keyword(s):

Adverse Events ◽

Nerve Injury ◽

Carotid Body ◽

Surgical Outcomes ◽

Injury Risk ◽

Pathologic Features ◽

Estimated Blood Loss ◽

Clinical Surveillance ◽

Carotid Artery Reconstruction ◽

Major Adverse Events

ObjectiveTo compare the surgical outcomes of carotid body tumor (CBT) with or without pathological fibrosis, and evaluate the associated factors of fibrous CBT (FCBT).Materials and MethodsParaffin-embedded tissues of 236 patients with unilateral CBTs at our center were retrospectively reviewed from January 2008 to May 2020. Based on the pathologic features, CBTs were divided into FCBT and conventional CBT (CCBT) groups. The clinical data and surgical outcomes of the two groups were compared.ResultsOf 236 patients, 53 had FCBT and 183 had CCBT. FCBTs showed higher vascular invasion (24.53%), marked pleomorphism (22.64%), internal carotid artery reconstruction (37.74%), estimated blood loss (559.62 cm3), and postoperative nerve injury (49.06%), with lower 10-year recurrence- (89.2%) and major adverse event-free survival (87.3%) compared to CCBTs. Nerve injury was correlated with the Shamblin grade; major adverse events and nerve injury were both correlated with pathological fibrosis.ConclusionCompared with CCBT, FCBT is prone to increased recurrence, metastasis, major adverse events, and nerve injury risk. Early surgical resection, routine excision of surrounding abnormal lymph nodes, and closer clinical surveillance in FCBT patients are recommended.

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Faculty Opinions recommendation of Interventions to reduce colonisation and transmission of antimicrobial-resistant bacteria in intensive care units: an interrupted time series study and cluster randomised trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718155880.793486683 ◽

2013 ◽

Author(s):

Daniel Diekema

Keyword(s):

Time Series ◽

Intensive Care ◽

Intensive Care Units ◽

Randomised Trial ◽

Interrupted Time Series ◽

Cluster Randomised Trial ◽

Resistant Bacteria ◽

Time Series Study ◽

Cluster Randomised ◽

Series Study

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Continuous enteral nutrition compared with a maximal gastric vacuity strategy at the time of extubation in the intensive care unit: protocol for a non-inferiority cluster randomised trial (the Ambroisie Project)

BMJ Open ◽

10.1136/bmjopen-2020-041799 ◽

2021 ◽

Vol 11 (5) ◽

pp. e041799

Author(s):

Mickael Landais ◽

Mai-Anh Nay ◽

Johann Auchabie ◽

Noemie Hubert ◽

Anne Rebion ◽

...

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Enteral Nutrition ◽

Randomised Trial ◽

Caloric Intake ◽

Nursing Workload ◽

Cluster Randomised Trial ◽

Open Label ◽

Safe Alternative ◽

Cluster Randomised

IntroductionFasting is frequently imposed to patients before extubation in the intensive care unit based on scheduled surgery guidelines. This practice has never been evaluated among critically ill patients and may delay extubation, increase nursing workload and reduce caloric intake. We are hypothesising that continuous enteral nutrition until extubation represents a safe alternative compared with fasting prior to extubation in the intensive care unit.Methods and analysisAdult patients ventilated more than 48 hours and receiving pre-pyloric enteral nutrition for more than 24 hours are included in this open-label cluster randomised parallel group non-inferiority trial. The participating centres are randomised allocated to continued enteral nutrition until extubation or 6-hour fasting (with concomitant gastric suctioning when feasible) prior to extubation. The primary outcome is extubation failure (ie, reintubation within 7 days following extubation).Ethics and disseminationThis study has been approved by the national ethics review board (comité de protection, des personnes Sud Mediterranée III No 2017.10.02 bis) and patients are included after informed consent. Results will be submitted for publication in peer-reviewed journals.Trial registration numberClinicalTrials.gov Registry (NCT03335345).

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