Development and validation of a novel tool for identification and categorization of non-technical errors associated with surgical mortality.

BACKGROUND: Up to half of all surgical adverse events are due to non-technical errors, making non-technical skill assessment and improvement a priority. No specific tools are available to retrospectively identify non-technical errors that have occurred in surgical patient care. This original study aimed to develop and provide evidence of validity and inter-rater reliability for the System for Identification and Categorization of Non-technical Error in Surgical Settings (SICNESS). METHODS: A literature review, modified Delphi process, and two pilot phases were used to develop and test the SICNESS tool. For each pilot, 12 months of surgical mortality data from the Australian and New Zealand Audit of Surgical Mortality were assessed by two independent reviewers using the SICNESS tool. Main outcomes included tool validation through modified Delphi consensus, and inter-rater reliability for: non-technical error identification and non-technical error categorization using Cohen's κ coefficient, and overall agreement using Fleiss' κ coefficient. RESULTS: Version 1 of the SICNESS was used for pilot 1, including 412 mortality cases, and identified and categorized non-technical errors with strong-moderate inter-rater reliability. Non-technical error exemplars were created and validated through Delphi consensus, and a novel mental model was developed. Pilot 2 included an additional 432 mortality cases. Inter-rater reliability was near perfect for leadership (κ 0.92, 95% c.i. 0.82 to 1.00); strong for non-technical error identification (κ 0.89, 0.84 to 0.93), communication and teamwork (κ 0.89, 0.79 to 0.99), and decision-making (κ 0.85, 0.79 to 0.92); and moderate for situational awareness (κ 0.79, 0.71 to 0.87) and overall agreement (κ 0.69, 0.66 to 0.73). CONCLUSION: The SICNESS is a reliable and valid tool, enabling retrospective identification and categorization of non-technical errors associated with death, occurring in real surgical patient interactions.

Many errors in surgery occur because of poor non-technical skills. The aim of this study was to create a tool to identify this type of error using patient data so future errors may be prevented. The tool was designed through expert opinion and literature review. It was tested using surgical patient death data from Australia and New Zealand. The final tool was able to identify and group non-technical errors reliably. This tool makes it possible to identify non-technical errors so future errors may be reduced.

Chronic glycemic control influences the relationship between acute perioperative dysglycemia and perioperative outcome.

BACKGROUND: The objective of this study was to evaluate the impact of dysglycemia on perioperative outcomes, in patients with and without diabetes, and how prior glycemic control modifies these relationships. METHODS: Consecutive surgical patients admitted to six South Australian tertiary hospitals between 2017 and 2023 were included. Blood glucose levels within 48 h pre- and post-operatively were assessed in an adjusted analyses against a priori selected covariates. Dysglycemia metrics were hyperglycemia (>10.0 mmol/L), hypoglycemia (<4.0 mmol/L), glycemic variability (standard deviation of mean blood glucose >1.7 mmol/L), and stress hyperglycemic ratio (SHR). The primary outcome was hospital mortality. RESULTS: Of 52 145 patients, 7490 (14.4%) had recognized diabetes. Inpatient mortality was observed in 787 patients (1.5%), of which 150 (19.1%) had diabetes mellitus. Hyperglycemia was associated with increased mortality in patients with diabetes (odds ratio [OR] = 2.99, 95% CI: 1.63-5.67, p = 0.004) but not in non-diabetics, who instead had an increased odds of intensive care unit (ICU) admission if hyperglycemic (OR = 1.95, 95% CI: 1.40-2.72, p < 0.0001). Glycemic variability was associated with increased mortality in patients with diabetes (OR = 1.46, 95% CI: 1.05-2.01, p < 0.05) but not in non-diabetics. Preoperative glycemic control (HbA1c) attenuated both of these associations in a dose-dependent fashion. Hypoglycemia was associated with increased mortality in non-diabetics (OR = 2.14, 95% CI: 1.92-2.37, p < 0.001) but not in patients with diabetes. CONCLUSIONS,: In surgical patients with diabetes, prior exposure to hyperglycemia attenuates the impact of perioperative hyperglycemia and glycemic variability on inpatient mortality and ICU admission. In patients without diabetes mellitus, all absolute thresholds of dysglycemia are associated with ICU admission, unlike those with diabetes, suggesting the need to use more relative measures such as the SHR.

Health technology assessment and innovation: here to help or hinder?

Innovative health technologies offer much to patients, clinicians, and health systems. Policy makers can, however, be slow to embrace innovation for many reasons, including a less robust body of evidence, perceived high costs, and a fear that once technologies enter the health system, they will be difficult to remove. Health technology funding decisions are usually made after a rigorous health technology assessment (HTA) process, including a cost analysis. However, by focusing on therapeutic value and cost-savings, the traditional HTA framework often fails to capture innovation in the assessment process. How HTA defines, evaluates, and values innovation is currently inconsistent, and it is generally agreed that by explicitly defining innovation would recognize and reward and, in turn, stimulate, encourage, and incentivize future innovation in the system. To foster innovation in health technology, policy needs to be innovative and utilize other HTA tools to inform decision making including horizon scanning, multicriteria decision analysis, and funding mechanisms such as managed agreements and coverage with evidence development. When properly supported and incentivized, and by shifting the focus from cost to investment, innovation in health technology such as genomics, point-of-care testing, and digital health may deliver better patient outcomes. Industry and agency members of the Health Technology Assessment International Asia Policy Forum (APF) met in Taiwan in November 2023 to discuss the potential of HTA to foster innovation, especially in the Asia region. Discussions and presentations during the 2023 APF were informed by a background paper, which forms the basis of this paper.

An international consensus panel on the potential value of Digital Surgery.

OBJECTIVES: The use of digital technology in surgery is increasing rapidly, with a wide array of new applications from presurgical planning to postsurgical performance assessment. Understanding the clinical and economic value of these technologies is vital for making appropriate health policy and purchasing decisions. We explore the potential value of digital technologies in surgery and produce expert consensus on how to assess this value. DESIGN: A modified Delphi and consensus conference approach was adopted. Delphi rounds were used to generate priority topics and consensus statements for discussion. SETTING AND PARTICIPANTS: An international panel of 14 experts was assembled, representing relevant stakeholder groups: clinicians, health economists, health technology assessment experts, policy-makers and industry. PRIMARY AND SECONDARY OUTCOME MEASURES: A scoping questionnaire was used to generate research questions to be answered. A second questionnaire was used to rate the importance of these research questions. A final questionnaire was used to generate statements for discussion during three consensus conferences. After discussion, the panel voted on their level of agreement from 1 to 9; where 1=strongly disagree and 9=strongly agree. Consensus was defined as a mean level of agreement of >7. RESULTS: Four priority topics were identified: (1) how data are used in digital surgery, (2) the existing evidence base for digital surgical technologies, (3) how digital technologies may assist surgical training and education and (4) methods for the assessment of these technologies. Seven consensus statements were generated and refined, with the final level of consensus ranging from 7.1 to 8.6. CONCLUSION: Potential benefits of digital technologies in surgery include reducing unwarranted variation in surgical practice, increasing access to surgery and reducing health inequalities. Assessments to consider the value of the entire surgical ecosystem holistically are critical, especially as many digital technologies are likely to interact simultaneously in the operating theatre.

To be or not to be on: aspirin and coronary artery bypass graft surgery.

Aspirin's role in secondary prevention for patients with known coronary artery disease (CAD) is well established, validated by numerous landmark trials over the past several decades. However, its perioperative use in coronary artery bypass graft (CABG) surgery remains contentious due to the delicate balance between the risks of thrombosis and bleeding. While continuation of aspirin in patients undergoing CABG following acute coronary syndrome is widely supported due to the high risk of re-infarction, the evidence is less definitive for elective CABG procedures. The literature indicates a significant benefit of aspirin in reducing cardiovascular events in CAD patients, yet its impact on perioperative outcomes in CABG surgery is less clear. Some studies suggest increased bleeding risks without substantial improvement in cardiac outcomes. Specific to elective CABG, evidence is mixed, with some data indicating no significant difference in thrombotic or bleeding complications whether aspirin is continued or withheld preoperatively. Advancements in pharmacological therapies and perioperative care have evolved significantly since the initial aspirin trials, raising questions about the contemporary relevance of earlier findings. Individualized patient assessments and the development of risk stratification tools are needed to optimize perioperative aspirin use in CABG surgery. Further research is essential to establish clearer guidelines and improve patient outcomes. The objective of this review is to critically evaluate the existing evidence into the optimal management of perioperative aspirin in elective CABG patients.

Impact of surgical specialization on emergency upper gastrointestinal surgery outcomes: A systematic review and meta-analysis.

BACKGROUND: Emergency presentations make up a large proportion of a general surgeon's workload. Patients who have emergency surgery carry a higher rate of mortality and complications. We aim to review the impact of surgical subspecialization on patients following upper gastrointestinal (UGI) emergency surgery. METHODS: A systematic search of Ovid Embase, Ovid MEDLINE, and Cochrane databases using a predefined search strategy was completed reviewing studies published from 1st of January 1990 to August 27, 2023. The study was prospectively registered with PROSPERO (CRD42022359326). Studies were reviewed for the following outcomes: 30-day mortality, in-hospital mortality, conversion to open, length of stay, return to theater, and readmission. RESULTS: Of 5181 studies, 24 articles were selected for full text review. Of these, seven were eligible and included in this study. There was a statistically significant improvement in 30-day mortality favoring UGI specialists (OR 0.71 [95% CI 0.55-0.92 and p = 0.009]) and in-hospital mortality (OR 0.29 [95% CI 0.14-0.60 and p = 0009]). There was a high degree of study heterogeneity in 30-day mortality; however, a low degree of heterogeneity within in-hospital mortality. There was no statistical significance when considering conversion to open and insufficient data to allow meta-analysis for return to theater or readmission rates. CONCLUSION: In emergency UGI surgery, there was improved 30-day and in-hospital mortality for UGI specialists. Therefore, surgeons should consider early involvement of a subspecialist team to improve patient outcomes.

Effect of lixisenatide on liquid gastric emptying in type 2 diabetes - Implications for the use of GLP-1 receptor agonists before procedures.

Gastric emptying of a glucose drink was measured in people with type 2 diabetes given lixisenatide (20 µg/day or placebo) for 8 weeks. Intragastric retention at 240 min (2 (0-11)% vs 48 (3-97)%; P < 0.0001) was much greater with lixisenatide than placebo. Accordingly, lixisenatide may delay liquid gastric emptying markedly.

Evaluation of a culture change program to reduce unprofessional behaviours by hospital co-workers in Australian hospitals.

BACKGROUND: Unprofessional behaviours between healthcare workers are highly prevalent. Evaluations of large-scale culture change programs are rare resulting in limited evidence of intervention effectiveness. We conducted a multi-method evaluation of a professional accountability and culture change program "Ethos" implemented across eight Australian hospitals. The Ethos program incorporates training for staff in speaking-up; an online system for reporting co-worker behaviours; and a tiered accountability pathway, including peer-messengers who deliver feedback to staff for 'reflection' or 'recognition'. Here we report the final evaluation component which aimed to measure changes in the prevalence of unprofessional behaviours before and after Ethos. METHODS: A survey of staff (clinical and non-clinical) experiences of 26 unprofessional behaviours across five hospitals at baseline before (2018) and 2.5-3 years after (2021/2022) Ethos implementation. Five of the 26 behaviours were classified as 'extreme' (e.g., assault) and 21 as incivility/bullying (e.g., being spoken to rudely). Our analysis assessed changes in four dimensions: work-related bullying; person-related bullying; physical bullying and sexual harassment. Change in experience of incivility/bullying was compared using multivariable ordinal logistic regression. Change in extreme behaviours was assessed using multivariable binary logistic regression. All models were adjusted for respondent characteristics. RESULTS: In total, 3975 surveys were completed. Staff reporting frequent incivility/bullying significantly declined from 41.7% (n = 1064; 95% CI 39.7,43.9) at baseline to 35.5% (n = 505; 95% CI 32.8,38.3; χ2(1) = 14.3; P < 0.001) post-Ethos. The odds of experiencing incivility/bullying declined by 24% (adjusted odds ratio [aOR] 0.76; 95% CI 0.66,0.87; P < 0.001) and odds of experiencing extreme behaviours by 32% (aOR 0.68; 95% CI 0.54,0.85; P < 0.001) following Ethos. All four dimensions showed a reduction of 32-41% in prevalence post-Ethos. Non-clinical staff reported the greatest decrease in their experience of unprofessional behaviour (aOR 0.41; 95% CI 0.29, 0.61). Staff attitudes and reported skills to speak-up were significantly more positive at follow-up. Awareness of the program was high (82.1%; 95% CI 80.0, 84.0%); 33% of respondents had sent or received an Ethos message. CONCLUSION: The Ethos program was associated with significant reductions in the prevalence of reported unprofessional behaviours and improved capacity of hospital staff to speak-up. These results add to evidence that staff will actively engage with a system that supports informal feedback to co-workers about their behaviours and is facilitated by trained peer messengers.

Diagnostic and prognostic significance of circulating secreted frizzled-related protein 5 in colorectal cancer.

BACKGROUND: Secreted Frizzled-Related Protein 5 (SFRP5) modulates Wnt signalling pathways, affecting diverse biological processes. We assessed the diagnostic and prognostic value of circulating SFRP5 (cSFRP5) in colorectal cancer (CRC) METHODS: Plasma cSFRP5 concentrations were measured using enzyme-linked immunosorbent assay (ELISA) in healthy donors (n = 133), individuals diagnosed with CRC (n = 449), colorectal polyps (n = 85), and medical conditions in other organs including cancer, inflammation, and benign states (n = 64). RESULTS: Patients with CRC, polyps, and other conditions showed higher cSFRP5 levels than healthy individuals (p < 0.0001). Receiver operating characteristic curves comparing healthy donors with medical conditions, polyps and CRC were 0.814 (p < 0.0001), 0.763 (p < 0.0001) and 0.762 (p < 0.0001), respectively. In CRC, cSFRP5 correlated with patient age (p < 0.0001), tumour stage (p < 0.0001), and histological differentiation (p = 0.0273). Levels, adjusted for patient age, sex, plasma age and collection institution, peaked in stage II versus I (p < 0.0001), III (p = 0.0002) and IV (p < 0.0001), were lowest in stage I versus III (p = 0.0002) and IV (p = 0.0413), with no difference between stage III and IV. Elevated cSFRP5 levels predicted longer overall survival in stages II-III CRC (univariate: HR 1.82, 95% CI: 1.02-3.26, p = 0.024; multivariable: HR 2.34, 95% CI: 1.12-4.88, p = 0.015). CONCLUSION: This study confirms cSFRP5 levels are elevated in CRC compared to healthy control and reveals a correlation between elevated cSFRP5 and overall survival in stages II-III disease.

Use of tryptic peptide MALDI mass spectrometry imaging to identify the spatial proteomic landscape of colorectal cancer liver metastases.

Colorectal cancer (CRC) is the second leading cause of cancer-related deaths worldwide. CRC liver metastases (CRLM) are often resistant to conventional treatments, with high rates of recurrence. Therefore, it is crucial to identify biomarkers for CRLM patients that predict cancer progression. This study utilised matrix-assisted laser desorption/ionisation mass spectrometry imaging (MALDI-MSI) in combination with liquid chromatography-tandem mass spectrometry (LC-MS/MS) to spatially map the CRLM tumour proteome. CRLM tissue microarrays (TMAs) of 84 patients were analysed using tryptic peptide MALDI-MSI to spatially monitor peptide abundances across CRLM tissues. Abundance of peptides was compared between tumour vs stroma, male vs female and across three groups of patients based on overall survival (0-3 years, 4-6 years, and 7+ years). Peptides were then characterised and matched using LC-MS/MS. A total of 471 potential peptides were identified by MALDI-MSI. Our results show that two unidentified m/z values (1589.876 and 1092.727) had significantly higher intensities in tumours compared to stroma. Ten m/z values were identified to have correlation with biological sex. Survival analysis identified three peptides (Histone H4, Haemoglobin subunit alpha, and Inosine-5'-monophosphate dehydrogenase 2) and two unidentified m/z values (1305.840 and 1661.060) that were significantly higher in patients with shorter survival (0-3 years relative to 4-6 years and 7+ years). This is the first study using MALDI-MSI, combined with LC-MS/MS, on a large cohort of CRLM patients to identify the spatial proteome in this malignancy. Further, we identify several protein candidates that may be suitable for drug targeting or for future prognostic biomarker development.

Achieving equity: patient demographics and outcomes after surgical and non-surgical procedures in South Australia, 2022.

BACKGROUND: Although modern Australian healthcare systems provide patient-centred care, the ability to predict and prevent suboptimal post-procedural outcomes based on patient demographics at admission may improve health equity. This study aimed to identify patient demographic characteristics that might predict disparities in mortality, readmission, and discharge outcomes after either an operative or non-operative procedural hospital admission. METHODS: This retrospective cohort study included all surgical and non-surgical procedural admissions at three of the four major metropolitan public hospitals in South Australia in 2022. Multivariable logistic regression, with backwards selection, evaluated association between patient demographic characteristics and outcomes up to 90 days post-procedurally. RESULTS: 40 882 admissions were included. Increased likelihood of all-cause, post-procedure mortality in-hospital, at 30 days, and 90 days, were significantly associated with increased age (P < 0.001), increased comorbidity burden (P < 0.001), an emergency admission (P < 0.001), and male sex (P = 0.046, P = 0.03, P < 0.001, respectively). Identification as ATSI (P < 0.001) and being born in Australia (P = 0.03, P = 0.001, respectively) were associated with an increased likelihood of 30-day hospital readmission and decreased likelihood of discharge directly home, as was increased comorbidity burden (P < 0.001) and emergency admission (P < 0.001). Being married (P < 0.001) and male sex (P = 0.003) were predictive of an increased likelihood of discharging directly home; in contrast to increased age (P < 0.001) which was predictive of decreased likelihood of this occurring. CONCLUSIONS: This study characterized several associations between patient demographic factors present on admission and outcomes after surgical and non-surgical procedures, that can be integrated within patient flow pathways through the Australian healthcare system to improve healthcare equity.

Intraoperative complications of robotic-assisted extended totally extraperitoneal (eTEP) ventral hernia retromuscular repairs with mesh: a systematic literature review and narrative synthesis.

Minimally invasive extended totally extraperitoneal (eTEP) technique is revolutionising ventral hernia repairs. Robotic-assisted eTEP has been gaining popularity due to better visual clarity and greater dexterity provided by the robotic systems, compared to laparoscopy. Despite growing number of papers being published each year, so far, no study has explored intraoperative complications in robotic-assisted eTEP. The aim was to perform a systematic literature review on the incidence of intraoperative complications in robotic-assisted eTEP ventral hernia repairs. The study protocol was preregistered with PROSPERO, registration number CRD42023450072. Twelve categories of intraoperative complications were defined by the authors. A search of PubMed and Embase was conducted on 16/08/2023, for articles pertaining to robotic-assisted eTEP operations in ventral hernias in adults. Articles were critically appraised and data were extracted using predefined extraction templates. No data were suitable for statistical analysis and a narrative synthesis was performed instead. Ten studies fulfilled the inclusion criteria, of which four studies reported intraoperative complications. Of the 12 categories of intraoperative complications, only 5 were reported. Three studies encountered adherent bowel inside the hernia sac. One reported linea alba injury with subsequent anterior layer dehiscence. There was one case of unrecognised intraoperative retromuscular bleeding and one case of insufflation injury with subcutaneous emphysema. There is a paucity of literature on the incidence of intraoperative complications in robotic-assisted eTEP ventral hernia repairs. Available studies suggest complication rates are low. More robust studies using prospective data from hernia registries are required before further conclusions can be drawn.

Generation and assessment of cytokine-induced killer cells for the treatment of colorectal cancer liver metastases.

Colorectal cancer (CRC) is the second leading cause of cancer-related death worldwide. Cytokine-induced killer (CIK) cells are an adoptive immunotherapy reported to have strong anti-tumour activity across a range of cancers. They are a heterogeneous mix of lymphoid cells generated by culturing human peripheral blood mononuclear cells with cytokines and monoclonal antibodies in vitro. In this study, we investigated the yield and function of CIK cells generated from patients with CRC liver metastases. We first showed that CIK cells generated in serum free medium X-VIVO 15 were comparable to those from RPMI medium with 10% FBS in terms of the number and percentages of the main subsets of cells in the CIK culture, and the intracellular levels of granzyme B and perforin, and the pro-inflammatory cytokines IL-2, IFN-γ and TNF-α. The CIK cells were cytotoxic to CRC cell lines grown in 2D cultures or as spheroids, and against autologous patient-derived tumour organoids. Donor attributes such as age, sex, or prior chemotherapy exposure had no significant impact on CIK cell numbers or function. These results suggest that functional CIK cells can be generated from patients with CRC liver metastatic disease, and support further investigations into the therapeutic application of autologous CIK cells in the management of patients with CRC liver metastases.

Clinical application of cytokine-induced killer (CIK) cell therapy in colorectal cancer: Current strategies and future challenges.

Colorectal cancer (CRC) remains a significant global health burden and is the second leading cause of cancer-related death. Cytokine induced killer (CIK) cell therapy is an immunotherapy which has the potential to meet this need. Clinical trials of CIK cell therapy for the management of CRC have reported improved clinical outcomes. However, production and delivery protocols varied significantly, and many studies were reported only in Chinese language journals. Here we present the most comprehensive review of the clinical CIK cell therapy trials for CRC management to date. We accessed both English and Chinese language clinical studies, and summarise how CIK cell therapy has been implemented, from manufacturing to patient delivery. We discuss current challenges that impede wider adoption of CIK cell therapy in CRC management.