A mixed method realist evaluation of the implementation of an Enhanced recovery after surgery (ERAS) programme in Hepato-pancreato-biliary (HPB) surgery

BACKGROUND : The Enhanced Recovery After Surgery (ERAS) programme is an evidence-based, multimodal and patient-centred approach to optimise patient care and experience. Multiple studies have demonstrated that the implementation of ERAS programme in Hepato-Pancreato-Biliary (HPB) surgery improves clinical outcomes such as reduction in length of stay and complications, while reducing hospital costs. However, there is only limited understanding of how the implementation process of ERAS programme and the contextual conditions contribute to success or failure. For many healthcare practitioners, implementation of ERAS protocols represents a significant departure from traditional care. For example, some of the clinical changes applied in ERAS programme are radical in nature and involve abandoning traditional practice such as preoperative fasting in favour of practices such as the consumption of preoperative carbohydrate drinks up to 2 hours prior to surgery. AIM: The aim was to develop an understanding of how particular contextual factors within an ERAS programme trigger mechanisms to produce outcomes in HPB surgery and examine how ERAS works, why, for whom and in what circumstances, from both the healthcare professionals’ and patients’ perspectives. METHODS: This realist evaluation adopted a mixed methods design to provide a detailed explanation of what works, why, how and under what circumstances when an ERAS programme is implemented in HPB surgery. The quantitative element was used to evaluate the impact of the ERAS programme on the clinical outcomes and to confirm whether the programme achieved its aim. This quantitative element was based on clinical outcomes data from a 12-month pre and post ERAS implementation period. A total of 227 adult patients who underwent liver and pancreatic surgery were included in the quantitative data analysis. The qualitative element enabled the study to explore how the contexts within the programme combined with mechanisms to influence the programme outcomes. Semi-structured interviews (25 participants) were used to explore the stakeholders and patients’ experiences and perspectives of the programme and to further probe issues as they emerged. Focus group (4 participants) allowed the study to re-test and refine some of the programme theories tested in the semi-structured interviews. FINDINGS: The outcomes show that the ERAS programme was successfully implemented in HPB surgery. The quantitative data analysis demonstrated that implementation of the ERAS programme resulted in a significantly shorter length of stay following pancreatic surgery and a reduction in major complications. However, implementation of the ERAS programme had no impact on clinical outcomes following liver surgery. Complications, BMI and type of surgery were independently associated with length of stay, whilst complications and high BMI are risk factors for prolonged hospital stay following pancreatic surgery. The analysis also found that longer operation times increased the risk of experiencing major complications following pancreatic surgery. The study identified several contextual factors required for the ERAS programme to be successful; it works when the implementation is supported by adequate resources, staff and patients have knowledge of the programme and patients take ownership of their care and take a collaborative approach. The qualitative data analysis demonstrated that when staff received training prior to involvement in the programme, their knowledge and understanding of the principles of the programme were further improved, which triggered their motivation and determination to empower patients to take responsibility for their care. The evaluation also found that adequately preparing patients for surgery, helps set clear expectations and triggers a sense of ownership in them, which increases their motivation and commitment to the recovery process. The findings of this evaluation also suggest that lack of resources, poor leadership and communication failures during handover hindered the delivery of ERAS programme, which often meant that programme interventions were not implemented. Conclusion This mixed methods study demonstrated that ERAS programmes can produce improved clinical outcomes when implemented in HPB surgery, findings that are consistent with existing literature on this topic. The study identified several contextual conditions that are needed for successful implementation of the ERAS programme in HPB surgery. The refined programme theories have been presented as a useful tool that could support successful future implementation and sustainability of ERAS programmes in HPB surgery

Enhanced recovery after surgery (ERAS) reduces hospital costs and improve clinical outcomes in liver surgery:A systematic review and meta-analysis

BackgroundEnhanced recovery after surgery (ERAS) protocols are evidence-based, multimodal and patient-centred approach to optimize patient care and experience during their perioperative pathway. It has been shown to be effective in reducing length of hospital stay and improving clinical outcomes. However, evidence on its effective in liver surgery remains weak. The aim of this review is to investigate clinical benefits, cost-effectiveness and compliance to ERAS protocols in liver surgery.MethodsA systematic literature search was conducted using CINAHL Plus, EMBASE, MEDLINE, PubMed and Cochrane for randomized control trials (RCTs) and cohort studies published between 2008 and 2019, comparing effect of ERAS protocols and standard care on hospital cost, LOS, complications, readmission, mortality and compliance.ResultsThe search resulted in 6 RCTs and 21 cohort studies of 3739 patients (1777 in ERAS and 1962 in standard care group). LOS was reduced by 2.22 days in ERAS group (MD = −2.22; CI, −2.77 to −1.68; p < 0.00001) compared to the standard care group. Fewer patients in ERAS group experienced complications (RR, 0.71; 95% CI, 0.65–0.77; p = < 0.00001). Hospital cost was significantly lower in the ERAS group (SMD = −0.98; CI, −1.37 to – 0.58; p < 0.0001).ConclusionOur review concluded that the introduction of ERAS protocols is safe and feasible in hepatectomies, without increasing mortality and readmission rates, whilst reducing LOS and risk of complications, and with a significant hospital cost savings. Laparoscopic approach may be necessary to reduce complication rates in liver surgery. However, further studies are needed to investigate overall compliance to ERAS protocols and its impact on clinical outcomes

Effect of Amoxicillin dose and treatment duration on the need for antibiotic re-treatment in children with Community-Acquired Pneumonia: The CAP-IT randomized clinical trial

Importance: The optimal dose and duration of oral amoxicillin for children with community-acquired pneumonia (CAP) are unclear. Objective: To determine whether lower-dose amoxicillin is noninferior to higher dose and whether 3-day treatment is noninferior to 7 days. Design, Setting, and Participants: Multicenter, randomized, 2 × 2 factorial noninferiority trial enrolling 824 children, aged 6 months and older, with clinically diagnosed CAP, treated with amoxicillin on discharge from emergency departments and inpatient wards of 28 hospitals in the UK and 1 in Ireland between February 2017 and April 2019, with last trial visit on May 21, 2019. Interventions: Children were randomized 1:1 to receive oral amoxicillin at a lower dose (35-50 mg/kg/d; n = 410) or higher dose (70-90 mg/kg/d; n = 404), for a shorter duration (3 days; n = 413) or a longer duration (7 days; n = 401). Main Outcomes and Measures: The primary outcome was clinically indicated antibiotic re-treatment for respiratory infection within 28 days after randomization. The noninferiority margin was 8%. Secondary outcomes included severity/duration of 9 parent-reported CAP symptoms, 3 antibiotic-related adverse events, and phenotypic resistance in colonizing Streptococcus pneumoniae isolates. Results: Of 824 participants randomized into 1 of the 4 groups, 814 received at least 1 dose of trial medication (median [IQR] age, 2.5 years [1.6-2.7]; 421 [52%] males and 393 [48%] females), and the primary outcome was available for 789 (97%). For lower vs higher dose, the primary outcome occurred in 12.6% with lower dose vs 12.4% with higher dose (difference, 0.2% [1-sided 95% CI -∞ to 4.0%]), and in 12.5% with 3-day treatment vs 12.5% with 7-day treatment (difference, 0.1% [1-sided 95% CI -∞ to 3.9]). Both groups demonstrated noninferiority with no significant interaction between dose and duration (P =.63). Of the 14 prespecified secondary end points, the only significant differences were 3-day vs 7-day treatment for cough duration (median 12 days vs 10 days; hazard ratio [HR], 1.2 [95% CI, 1.0 to 1.4]; P =.04) and sleep disturbed by cough (median, 4 days vs 4 days; HR, 1.2 [95% CI, 1.0 to 1.4]; P =.03). Among the subgroup of children with severe CAP, the primary end point occurred in 17.3% of lower-dose recipients vs 13.5% of higher-dose recipients (difference, 3.8% [1-sided 95% CI, -∞ to10%]; P value for interaction =.18) and in 16.0% with 3-day treatment vs 14.8% with 7-day treatment (difference, 1.2% [1-sided 95% CI, -∞ to 7.4%]; P value for interaction =.73). Conclusions and Relevance: Among children with CAP discharged from an emergency department or hospital ward (within 48 hours), lower-dose outpatient oral amoxicillin was noninferior to higher dose, and 3-day duration was noninferior to 7 days, with regard to need for antibiotic re-treatment. However, disease severity, treatment setting, prior antibiotics received, and acceptability of the noninferiority margin require consideration when interpreting the findings. Trial Registration: ISRCTN Identifier: ISRCTN76888927