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Effect of a risk-stratified intervention strategy on surgical complications: experience from a multicentre prospective study in China.

ABSTRACT: OBJECTIVES:To develop a risk-stratified intervention strategy and evaluate its effect on reducing surgical complications. DESIGN:A multicentre prospective study with preintervention and postintervention stages: period I (January to June 2015) to develop the intervention strategy and period II (January to June 2016) to evaluate its effectiveness. SETTING:Four academic/teaching hospitals representing major Chinese administrative and economic regions. PARTICIPANTS:All surgical (elective and emergent) inpatients aged ?14 years with a minimum hospital stay of 24?hours, who underwent a surgical procedure requiring an anesthesiologist. INTERVENTIONS:Targeted complications were grouped into three categories (common, specific, serious) according to their incidence pattern, severity and preventability. The corresponding expert consensus-generated interventions, which focused on both regulating medical practices and managing inherent patient-related risks, were implemented in a patient-tailored way via an electronic checklist system. PRIMARY AND SECONDARY OUTCOMES:Primary outcomes were (1) in-hospital death/confirmed death within 30 days after discharge and (2) complications during hospitalisation. Secondary outcome was length of stay (LOS). RESULTS:We included 51 030 patients in this analysis (eligibility rate 87.7%): 23 413 during period I, 27 617 during period II. Patients' characteristics were comparable during the two periods. After adjustment, the mean number of overall complications per 100 patients decreased from 8.84 to 7.56 (relative change 14.5%; P<0.0001). Specifically, complication rates decreased from 3.96 to 3.65 (7.8%) for common complications (P=0.0677), from 0.50 to 0.36 (28.0%) for specific complications (P=0.0153) and from 3.64 to 2.88 (20.9%) for serious complications (P<0.0001). From period I to period II, there was a decreasing trend for mortality (from 0.64 to 0.53; P=0.1031) and median LOS (by 1?day; P=0.8293), without statistical significance. CONCLUSIONS:Implementing a risk-stratified intervention strategy may be a target-sensitive, convenient means to improve surgical outcomes.

SUBMITTER: Yu X

PROVIDER: S-EPMC6561454 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Effect of a risk-stratified intervention strategy on surgical complications: experience from a multicentre prospective study in China.

Yu Xiaochu X Jiang Jingmei J Shang Hong H Wu Shizheng S Sun Hong H Li Hanzhong H Xin Shijie S Zhao Shengxiu S Huang Yuguang Y Wu Xinjuan X Zhang Xu X Wang Yaolei Y Xue Fang F Han Wei W Wang Zixing Z Hu Yaoda Y Wang Lei L Zhao Yupei Y

BMJ open 20190609 6

<h4>Objectives</h4>To develop a risk-stratified intervention strategy and evaluate its effect on reducing surgical complications.<h4>Design</h4>A multicentre prospective study with preintervention and postintervention stages: period I (January to June 2015) to develop the intervention strategy and period II (January to June 2016) to evaluate its effectiveness.<h4>Setting</h4>Four academic/teaching hospitals representing major Chinese administrative and economic regions.<h4>Participants</h4>All s ...[more]

PMID: 31182441

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Project description:IntroductionSurgical safety has emerged as a crucial global health issue in the past two decades. Although several safety-enhancing tools are available, the pace of large-scale improvement remains slow, especially in developing countries such as China. The present project (Modern Surgery and Anesthesia Safety Management System Construction and Promotion) aims to develop and validate system-based integrated approaches for reducing perioperative deaths and complications using a multicentre, multistage design.Methods and analysisThe project involves collection of clinical and outcome information for 1?20?000 surgical inpatients at four regionally representative academic/teaching general hospitals in China during three sequential stages: preparation and development, effectiveness validation and improvement of implementation for promotion. These big data will provide the evidence base for the formulation, validation and improvement processes of a system-based stratified safety intervention package covering the entire surgical pathway. Attention will be directed to managing inherent patient risks and regulating medical safety behaviour. Information technology will facilitate data collection and intervention implementation, provide supervision mechanisms and guarantee transfer of key patient safety messages between departments and personnel. Changes in rates of deaths, surgical complications during hospitalisation, length of stay, system adoption and implementation rates will be analysed to evaluate effectiveness and efficiency.Ethics and disseminationThis study was approved by the institutional review boards of Peking Union Medical College Hospital, First Hospital of China Medical University, Qinghai Provincial People's Hospital, Xiangya Hospital Central South University and the Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences. Study findings will be disseminated via peer-reviewed journals, conference presentations and patent papers.

Project description:BackgroundFindings of observational studies investigating the impact of transfusions are at odds with those of randomised controlled trials, raising concern that observational studies may be inappropriate to inform transfusion decisions. We examined whether observational data could replicate evidence from randomised controlled trials on restrictive transfusion in cardiac and orthopaedic surgery, and be generalised to broader specialties as well as to a lower haemoglobin transfusion threshold (7 g/dL).Material and methodsA multicentre, prospective cohort study was performed at three representative regional hospitals in China between 2015 and 2016. Participants were surgical inpatients (≥18 years; hospital stay ≥24 h) in six specialties: cardiac, cerebral, vascular (CCV), and orthopaedic, general, thoracic (non-CCV). Patients with a stable haemoglobin (7-10 g/dL) constituted the primary analytic sample, while patients with ≥500 mL intra-operative bleeding were analysed separately to avoid haemoglobin instability. The association of transfusion with surgical outcomes (death, in-hospital complications) was evaluated.ResultsThe transfusion rate was 10.7% in 36,607 patients (mean age, 52.5±14.3 years; 52.3% female). After restriction, stratification, and propensity score matching to reduce patients' heterogeneity, transfusion was unrelated to death (CCV: odds ratio [OR]=0.74, 95% confidence interval [CI]: 0.16-3.39; non-CCV: OR 0.83, 95% CI: 0.36-1.94) and the composite complication (CCV: OR 1.31, 95% CI: 0.63-2.72; non-CCV: OR=1.24, 95% CI: 0.81-1.90). The results were consistent in subgroups (elderly, coronary heart disease, malignant tumour, severe illness) and applicable to patients with significant bleeding after restoration of a stable haemoglobin.DiscussionTransfusion at a stable haemoglobin concentration of 7-10 g/dL did not alter surgical outcomes. Our results show the feasibility of observational data to expand restrictive transfusion to broader specialties and a lower transfusion threshold in surgical practice.

Project description:BackgroundSurgical site infection (SSI) is the most common postoperative complication worldwide. WHO guidelines to prevent SSI recommend alcoholic chlorhexidine skin preparation and fascial closure using triclosan-coated sutures, but called for assessment of both interventions in low-resource settings. This study aimed to test both interventions in low-income and middle-income countries.MethodsFALCON was a 2 × 2 factorial, randomised controlled trial stratified by whether surgery was clean-contaminated, or contaminated or dirty, including patients undergoing abdominal surgery with a skin incision of 5 cm or greater. This trial was undertaken in 54 hospitals in seven countries (Benin, Ghana, India, Mexico, Nigeria, Rwanda, and South Africa). Patients were computer randomised 1:1:1:1 to: (1) 2% alcoholic chlorhexidine and non-coated suture, (2) 2% alcoholic chlorhexidine and triclosan-coated suture, (3) 10% aqueous povidone-iodine and non-coated suture, or (4) 10% aqueous povidone-iodine and triclosan-coated suture. Patients and outcome assessors were masked to intervention allocation. The primary outcome was SSI, reported by trained outcome assessors, and presented using adjusted relative risks and 95% CIs. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03700749.FindingsBetween Dec 10, 2018, and Sept 7, 2020, 5788 patients (3091 in clean-contaminated stratum, 2697 in contaminated or dirty stratum) were randomised (1446 to alcoholic chlorhexidine and non-coated suture, 1446 to alcoholic chlorhexidine and triclosan-coated suture, 1447 to aqueous povidone-iodine and non-coated suture, and 1449 to aqueous povidone-iodine and triclosan-coated suture). 14·0% (810/5788) of patients were children and 66·9% (3873/5788) had emergency surgery. The overall SSI rate was 22·0% (1163/5284; clean-contaminated stratum 15·5% [454/2923], contaminated or dirty stratum 30·0% [709/2361]). For both strata, there was no evidence of a difference in the risk of SSI with alcoholic chlorhexidine versus povidone-iodine (clean-contaminated stratum 15·3% [223/1455] vs 15·7% [231/1468], relative risk 0·97 [95% CI 0·82-1·14]; contaminated or dirty stratum 28·3% [338/1194] vs 31·8% [371/1167], relative risk 0·91 [95% CI 0·81-1·02]), or with triclosan-coated sutures versus non-coated sutures (clean-contaminated stratum 14·7% [215/1459] vs 16·3% [239/1464], relative risk 0·90 [95% CI 0·77-1·06]; contaminated or dirty stratum 29·4% [347/1181] vs 30·7% [362/1180], relative risk 0·98 [95% CI 0·87-1·10]). With both strata combined, there were no differences using alcoholic chlorhexidine or triclosan-coated sutures.InterpretationThis trial did not show benefit from 2% alcoholic chlorhexidine skin preparation compared with povidone-iodine, or with triclosan-coated sutures compared with non-coated sutures, in preventing SSI in clean-contaminated or contaminated or dirty surgical wounds. Both interventions are more expensive than alternatives, and these findings do not support recommendations for routine use.FundingNational Institute for Health Research (NIHR) Global Health Research Unit Grant, BD.

Project description:ObjectivesThe provision of complex surgery is increasingly centralised to high-volume (HV) specialist hospitals. Evidence to support nephrectomy centralisation however has been inconsistent. We conducted a systematic review and meta-analysis to determine the association between hospital case volumes and perioperative outcomes in radical nephrectomy, partial nephrectomy and nephrectomy with venous thrombectomy.MethodsMedline, Embase and the Cochrane Library were searched for relevant studies published between 1990 and 2016. Pooled effect estimates for nephrectomy mortality and complications were calculated for each nephrectomy type using the DerSimonian and Laird random-effects model. Sensitivity analyses were performed to examine the effects of heterogeneity on the pooled effect estimates by excluding studies with the heaviest weighting, lowest methodological score and most likely to introduce bias from misclassification of standardised hospital volume.ResultsSome 226 372 patients from 16 publications were included in our review and meta-analysis. Considerable between-study heterogeneity was noted and only a few reported volume-outcome relationships specifically in partial nephrectomy or nephrectomy with venous thrombectomy.HV hospitals were correlated with a 26% and 52% reduction in mortality for radical nephrectomy (OR 0.74, 95% CI 0.61 to 0.90, p<0.01) and nephrectomy with venous thrombectomy (OR 0.48, 95% CI 0.29 to 0.81, p<0.01), respectively. In addition, radical nephrectomy in HV hospitals was associated with an 18% reduction in complications (OR 0.82, 95% CI 0.73 to 0.92, p<0.01). No significant volume-outcome relationship in mortality (OR 0.84, 95% CI 0.31 to 2.26, p=0.73) or complications (OR 0.85, 95% CI 0.55 to 1.30, p=0.44) was observed for partial nephrectomy.ConclusionsOur findings suggest that patients undergoing radical nephrectomy have improved outcomes when treated by HV hospitals. Evidence of this in partial nephrectomy and nephrectomy with venous thrombectomy is however not yet clear and could be secondary to the low number of studies included and the small patient number in our analyses. Further investigation is warranted to establish the full potential of nephrectomy centralisation particularly as existing evidence is of low quality with significant heterogeneity.

Dataset Information

Effect of a risk-stratified intervention strategy on surgical complications: experience from a multicentre prospective study in China.

Publications

Effect of a risk-stratified intervention strategy on surgical complications: experience from a multicentre prospective study in China.

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