The Continuing Problem of Expert Evidence in Medical Litigation - A Surgical Perspective with Reference to Daubert.

The tension that exists between the medical and legal professions regarding expert evidence is longstanding. In this article, we will examine some of the issues regarding expert evidence particularly as it relates to matters involving surgeons. Many of the current aspects of the Australian uniform evidence law in relation to expert testimony were based on the Federal Rules of Evidence promulgated in the United States in 1975. We will discuss some of the problems of expert evidence in surgical matters, particularly in New South Wales, and offer some thoughts on how the so-called Daubert trilogy could form a basis on which to re-examine the concept of an "expert". Our analysis offers suggestions for further improvements to the process of adducing expert evidence in claims involving surgical matters.

Bile Duct Injuries as a Result of Cholecystectomy: An Australian Perspective.

Cholecystectomy remains the mainstay treatment for symptomatic gallstones. Despite the evolution of surgical techniques and approaches, bile duct injury represents a significant complication, even in experienced hands. It is associated with significant postoperative morbidity, resource utilisation and costs. Compared to the international data, there is a paucity of data on malpractice cases involving bile duct injuries (BDIs) proceeding to definitive judgment and defence. This article examines the surgical literature and the case law in Australia as it relates to BDIs following cholecystectomy. This article aims to discuss the issues surrounding major bile duct injury litigation and compares the Australian perspective with international experience.

Improving psychosocial outcomes for caregivers of people with poor prognosis gastrointestinal cancers: a randomized controlled trial (Family Connect).

PURPOSE: This study investigated the effectiveness of a structured telephone intervention for caregivers of people diagnosed with poor prognosis gastrointestinal cancer to improve psychosocial outcomes for both caregivers and patients. METHODS: Caregivers of patients starting treatment for upper gastrointestinal or Dukes D colorectal cancer were randomly assigned (1:1) to the Family Connect telephone intervention or usual care. Caregivers in the intervention group received four standardized telephone calls in the 10 weeks following patient hospital discharge. Caregivers' quality of life (QOL), caregiver burden, unmet supportive care needs and distress were assessed at 3 and 6 months. Patients' QOL, unmet supportive care needs, distress and health service utilization were also assessed at these time points. RESULTS: Caregivers (128) were randomized to intervention or usual care groups. At 3 months, caregiver QOL scores and other caregiver-reported outcomes were similar in both groups. Intervention group participants experienced a greater sense of social support (p = .049) and reduced worry about finances (p = .014). Patients whose caregiver was randomized to the intervention also had fewer emergency department presentations and unplanned hospital readmissions at 3 months post-discharge (total 17 vs. 5, p = .01). CONCLUSIONS: This standardized intervention did not demonstrate any significant improvements in caregiver well-being but did result in a decrease in patient emergency department presentations and unplanned hospital readmissions in the immediate post-discharge period. The trend towards improvements in a number of caregiver outcomes and the improvement in health service utilization support further development of telephone-based caregiver-focused supportive care interventions.

Percutaneous vs. endoscopic pre-operative biliary drainage in hilar cholangiocarcinoma - a systematic review and meta-analysis.

BACKGROUND: The strategy for preoperative management of biliary obstruction in hilar cholangiocarcinoma (HCCA) patients with regards to drainage by endoscopic (EBD) or percutaneous (PTBD) methods is not clearly defined. The aim of this study was to investigate the utility, complications and therapeutic efficacy of these methods in HCCA patients, with a secondary aim to assess the use of portal vein embolization (PVE) in patients undergoing drainage. METHODS: Studies incorporating HCCA patients undergoing biliary drainage prior to curative resection were included (EMBASE and Medline databases). Analyses included baseline drainage data, procedure-related complications and efficacy, post-operative parameters, and meta-analyses where applicable. RESULTS: Fifteen studies were included, with EBD performed in 536 patients (52%). Unilateral drainage of the future liver remnant was undertaken in 94% of patients. There was a trend towards higher procedure conversion (RR 7.36, p = 0.07) and cholangitis (RR 3.36, p = 0.15) rates in the EBD group. Where specified, 134 (30%) drained patients had PVE, in association with a major hepatectomy in 131 patients (98%). Post-operative hepatic failure occurred in 22 (11%) of EBD patients compared to 56 (13%) of PTBD patients, whilst median 1-year survival in these groups was 91% and 73%, respectively. DISCUSSION: The accepted practice is for most jaundiced HCCA patients to have preoperative drainage of the future liver remnant. EBD may be associated with more immediate procedure-related complications, although it is certainly not inferior compared to PTBD in the long term.

World Health Assembly Resolution WHA68.15: "Strengthening Emergency and Essential Surgical Care and Anesthesia as a Component of Universal Health Coverage"­Addressing the Public Health Gaps Arising from Lack of Safe, Affordable and Accessible Surgical and Anesthetic Services.

On May 22 2015, the 68th World Health Assembly (WHA) adopted resolution WHA68.15, "Strengthening emergency and essential surgical care and anesthesia as a component of universal health coverage (UHC)." For the first time, governments worldwide acknowledged and recognized surgery and anesthesia as key components of UHC and health systems strengthening. The resolution details and outlines the highest level of political commitments to address the public health gaps arising from lack of safe, affordable, and accessible surgical and anesthetic services in an integrated approach. This article reviews the background of resolution WHA68.15 and discusses how it can be of use to surgeons, anesthetists, advanced practice clinicians, nurses, and others caring for the surgical patients, especially in low- and middle-income countries.

Patient Selection for Oesophagectomy: Impact of Age and Comorbidities on Outcome.

INTRODUCTION: Surgical resection of oesophageal cancer is a major procedure with potential for significant morbidity and mortality. Patient selection can be challenging, as operative benefit must be balanced against risk and impact on quality of life. This study defines modern trends in patient selection, and evaluates the impact of age, stage, and comorbidities on complications and survival following oesophagectomy, in a tertiary Australian experience. METHODS: Data were compiled across two 15-year operative eras ('Era 1': 1981-1995; and 'Era 2': 1996-2010), with patients followed minimum 3 years. A total of 180 unselected records were analysed (powered for a relative hazard ratio of 0.5). Analyses defined patient selection trends, and for Era 2, the impact of age, comorbidities (Charlson score), and disease (T/N stage) on complications (Clavien-Dindo grade) and survival (Kaplan-Meier). A further sub-analysis was conducted with data divided into three 10-year periods. RESULTS: The age of operated patients increased from Era 1 to 2 (mean+5 years; P<0.001), but survival and complication rates were unchanged, including in patients≥75 years (P>0.5). In Era 2, reflecting recent practice, survival duration matched T/N stage (P<0.001) but was independent of age at surgery (P=0.56) and comorbidity score (P=0.78). However, grade of worst post-operative complication, including death (rate: 3.8%), was correlated with both age (P<0.01) and comorbidity score (P<0.01). DISCUSSION: Older patients are now undergoing oesophagectomy. However, if they are selected appropriately, then older patients and those with comorbidities can expect similar stage-matched survival outcomes to younger fitter patients, despite their higher operative risk. Poor outcomes persist in patients with locally advanced disease, and selection in this group should prioritise quality of life.

Perioperative mortality rate (POMR): a global indicator of access to safe surgery and anaesthesia.

INTRODUCTION: The unmet global burden of surgical disease is substantial. Currently, two billion people do not have access to emergency and essential surgical care. This results in unnecessary deaths from injury, infection, complications of pregnancy, and abdominal emergencies. Inadequately treated surgical disease results in disability, and many children suffer deformity without corrective surgery. METHODS: A consensus meeting was held between representatives of Surgical and Anaesthetic Colleges and Societies to obtain agreement about which indicators were the most appropriate and credible. The literature and state of national reporting of perioperative mortality rates was reviewed by the authors. RESULTS: There is a need for a credible national and/or regional indicator that is relevant to emergency and essential surgical care. We recommend introducing the perioperative mortality rate (POMR) as an indicator of access to and safety of surgery and anaesthesia. POMR should be measured at two time periods: death on the day of surgery and death before discharge from hospital or within 30 days of the procedure, whichever is sooner. The rate should be expressed as the number of deaths (numerator) over the number of procedures (denominator). The option of before-discharge or 30 days is practical for those low- to middle-income countries where postdischarge follow-up is likely to be incomplete, but it allows those that currently can report 30-day mortality rates to continue to do so. Clinical interpretation of POMR at a hospital or health service level will be facilitated by risk stratification using age, urgency (elective and emergency), procedure/procedure group, and the American Society of Anesthesiologists grade. CONCLUSIONS: POMR should be reported as a health indicator by all countries and regions of the world. POMR reporting is feasible, credible, achieves a consensus of acceptance for reporting at national level. Hospital and Service level POMR requires interpretation using simple measures of risk adjustment such as urgency, age, the condition being treated or the procedure being performed and ASA status.

A systematic review of a liver-first approach in patients with colorectal cancer and synchronous colorectal liver metastases.

BACKGROUND: Since the liver metastases rather than the colorectal cancer itself is the main determinant of patient's survival, the 'Liver-First Approach (LFA)' with upfront chemotherapy followed by a hepatic resection of colorectal liver metastases (CLM) and finally a colorectal cancer resection was proposed. The aim of this review was to analyse the evidence for LFA in patients with colorectal cancer and synchronous CLM. METHODS: A literature search of databases (MEDLINE and EMBASE) to identify published studies of LFA in patients with colorectal cancer and synchronous CLM was undertaken focussing on the peri-operative regimens of LFA and survival outcomes. RESULTS: Three observational studies and one retrospective cohort study were included for review. A total of 121 patients with colorectal cancer and synchronous CLM were selected for LFA. Pre-operative chemotherapy was used in 99% of patients. One hundred and twelve of the initial 121 patients (93%) underwent a hepatic resection of CLM. In total, 60% had a major liver resection and the R0 resection rate was 93%. Post-operative morbidity and mortality after the hepatic resection were 20% and 1%, respectively. Ultimately, 89 of the initial 121 (74%) patients underwent a colorectal cancer resection. Post-operative morbidity and mortality after a colorectal resection were 50% and 6%, respectively. The median overall survival was 40 months (range 19-50) with a recurrence rate of 52%. CONCLUSIONS: Current evidence suggests that LFA is safe and feasible in selected patients with colorectal cancer and synchronous CLM. Future studies are required to further define patient selection criteria for LFA and the exact role of LFA in the management of synchronous CLM.

Failure to rescue following oesophagectomy in Australia: a multi-site retrospective study using American College of Surgeons National Surgical Quality Improvement Program.

BACKGROUND: Failure to rescue (FTR), defined as death after a major complication, is increasingly being used as a surrogate for assessing quality of care following major cancer resection. The aim of this paper is to determine the failure to rescue (FTR) rate after oesophagectomy and explore factors that may contribute to FTR within Australia. METHODS: A retrospective review of the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database from 2015 to 2023 at five Australian hospitals was conducted to identify patients who underwent an oesophagectomy. The primary outcome was FTR rate. Perioperative parameters were examined to evaluate predictive factors for FTR. Secondary outcomes include major complications, overall morbidity, mortality, length of stay and 30-day readmissions. RESULTS: A total of 155 patients were included with a median age of 65.2 years, 74.8% being male. The FTR rate was 6.3%. In total, 50.3% of patients (n = 78) developed at least one postoperative complication with the most common complication being pneumonia (20.6%) followed by prolonged intubation (12.9%) and organ space SSI/anastomotic leak (11.0%). Multivariate logistic regression analysis was performed to determine any factors that were predictive for FTR however none reached statistical significance. CONCLUSION: This study is the first to evaluate the FTR rates following oesophagectomy within Australia, with FTR rates and complication profile comparable to international benchmarks. Integration of multi-institutional national databases such as ACS NSQIP into units is essential to monitor and compare patient outcomes following major cancer surgery, especially in low to moderate volume centres.

A systematic review of two-stage hepatectomy in patients with initially unresectable colorectal liver metastases.

OBJECTIVES: Selected patients with unresectable colorectal liver metastases (CLM) may be rendered resectable using the two-stage hepatectomy (TSH) approach. This review was conducted with the aim of collating and evaluating published evidence for TSH in patients with initially unresectable CLM. METHODS: Searches of the MEDLINE and EMBASE databases were undertaken to identify studies of TSH in patients with initially unresectable CLM. Studies were required to focus on the perioperative treatment regimen, operative strategy, morbidity, technical success and survival outcomes. RESULTS: Ten observational studies were reviewed. A total of 459 patients with initially unresectable CLM were selected for the first stage of TSH. Preoperative chemotherapy was used in 88% of patients and achieved partial and stable response rates of 59% and 39%, respectively. Postoperative morbidity and mortality after the first stage of TSH were 17% and 0.5%, respectively. Portal vein embolization (PVE) was used in 76% of patients. Ultimately, 352 of the initial 459 (77%) patients underwent the second stage of TSH. Major liver resection was undertaken in 84% of patients; the negative margin (R0) resection rate was 75%. Postoperative morbidity and mortality after the second stage of TSH were 40% and 3%, respectively. Median overall survival was 37 months (range: 24-44 months) in patients who completed both stages of TSH. In patients who did not complete both stages of TSH, median survival was 16 months (range: 10-29 months). The 3-year disease-free survival rate was 20% (range: 6-27%). CONCLUSIONS: Two-stage hepatectomy is safe and effective in selected patients with initially unresectable CLM. Further studies are required to better define patient selection criteria for TSH and the exact roles of PVE and preoperative and interval chemotherapy.

Gastric diverticulum: a contemporary review and update in management.

BACKGROUND: Gastric diverticula (GD) are the rarest form of gastrointestinal tract diverticulum, with an estimated incidence of 0.013-2.6%. GD are poorly understood and there are no established management guidelines. Only sparse updates have been published since the mid-20th century. This paper reviews the current literature and provides some suggested guidelines for the management of GD. METHODS: A search of Medline via OvidSP and Google Scholar for 'gastric diverticulum' and associated synonyms from the year 1950 onwards was performed. We included randomized controlled trials (RCTs), cohort and case-control studies, and case series. Full text, English language manuscripts on adult populations were included. RESULTS: A total of 103 manuscripts were included in the final selection - 77 individual case studies, 23 case series and three reviews. No RCTs, cohort or case-control studies were found. The case studies represent 305 patients, 50.8% female with average age 49.2 years (range 18-80). The most common symptom was abdominal pain (48.2%). The average maximum diameter was 3.97 cm (range 0.5-9). One hundred and four patients were managed operatively. Despite persistent recommendations in the literature that GD > 4 cm should be considered for resection, there are no data supporting this approach. CONCLUSION: The evidence pertaining to the management of GD is sparse. The decision for operative management should be individualized and based primarily on the presence of symptoms or complications which may be directly attributable to the GD. Where surgery is indicated, a laparoscopic approach, potentially with intra-operative gastroscopy, is appropriate.

Reducing unplanned general surgical readmissions: a review of the Australian and New Zealand National Surgical Quality Improvement Program Database.

BACKGROUND: Unplanned surgical readmissions are an important indicator of quality care and are a key focus of improvement programs. The aims of this study were to evaluate the factors that lead to unplanned hospital readmissions in patients undergoing general surgical procedures and to identify preventable readmissions. METHODS: A retrospective review of the American College of Surgeons National Surgical Quality Improvement Program database from 2016 to 2020 at a tertiary hospital was conducted to identify patients undergoing a general surgical procedure. Various perioperative parameters were studied to identify risk factors and reasons for unplanned readmission. Preventable readmissions were identified. RESULTS: A total of 3069 patients underwent a general surgical procedure. Of these, the overall unplanned readmission rate was 8.8% (n = 247). The most common reason for readmission was associated with surgical site infections (n = 112, 44.3%) followed by pain (n = 50, 20.2%), with over 45% deemed as preventable readmissions. Factors associated with increased risk of readmission included older age, longer index length of stay, prolonged operative time, elective procedures, higher ASA score and contaminated procedures. CONCLUSION: Unplanned readmissions are more likely to occur in patients who develop postoperative complications. Understanding factors associated with readmissions may facilitate targeted quality improvement projects that reduce hospital readmission after surgery.

Evolution of laparoscopic pancreaticoduodenectomy at Westmead Hospital.

BACKGROUND: Despite its proposed benefits, laparoscopic pancreaticoduodenectomy (LPD) has not been widely adopted due to its technical complexity and steep learning curve. The aim of this study was to report a single surgeon's experience in the stepwise implementation of LPD and evolution of technique over a nine-year period in a moderate-high volume unit. METHODS: Carefully selected patients underwent LPD initially by hybrid approach (laparoscopic resection and open reconstruction), which evolved into a total LPD (laparoscopic resection and reconstruction). Data was prospectively collected to include patient characteristics, intraoperative data, evolution of technique and postoperative outcomes. RESULTS: A total of 25 patients underwent hybrid LPD (HLPD) and 20 patients underwent total LPD (TLPD). There was no 90-day mortality. Three patients developed a postoperative pancreatic fistula (POPF), all of which occurred in patients undergoing HLPD. There was no POPF in 20 consecutive TLPD. There was no evidence of anastomotic strictures in the hepaticojejunostomy in patients undergoing TLPD at long term follow up. CONCLUSION: A gradual and cautious progression from HLPD to TLPD is essential to ensure safe implementation into a unit. LPD should only be considered in carefully selected patients, with outcomes subjected to regular and rigorous independent audit.

A systematic review of clinical response and survival outcomes of downsizing systemic chemotherapy and rescue liver surgery in patients with initially unresectable colorectal liver metastases.

BACKGROUND: Selected patients with unresectable colorectal liver metastases (CLM) may be rendered resectable after systemic chemotherapy. We reviewed the evidence of downsizing systemic chemotherapy followed by rescue liver surgery in patients with initially unresectable CLM. METHODS: Literature search of databases (Medline and PubMed) to identify published studies of neoadjuvant chemotherapy followed by liver resection in patients with initially unresectable CLM was undertaken and focused on response rate of chemotherapy and survival outcomes. RESULTS: Ten observational studies were reviewed. A total of 1,886 patients with initially unresectable CLM underwent systemic chemotherapy. An objective response was observed in 64% (range, 43-79%) of patients after systemic chemotherapy. Of these, 22.5% underwent macroscopically curative liver resection. Median overall survival was 45 (range, 36-60) months with 19% of patients alive and recurrence-free. CONCLUSIONS: Current evidence suggests that downsizing systematic chemotherapy followed by rescue liver resection is safe and effective for selected patients with initially unresectable CLM. Further studies are required to examine response rates and secondary resectability using new targeted molecular therapy-based regimens.

Systematic review of actual 10-year survival following resection for hepatocellular carcinoma.

BACKGROUND: Hepatic resection is a potentially curative therapy for hepatocellular carcinoma (HCC), but recurrence of disease is very common. Few studies have reported 10-year actual survival rates following hepatic resection; instead, most have used actuarial measures based on the Kaplan-Meier method. This systematic review aims to document 10-year actual survival rates and to identify factors significant in determining prognosis. METHODS: A comprehensive search was undertaken of MEDLINE and EMBASE. Only studies reporting the absolute number of patients alive at 10 years after first resection for HCC were included; these figures were used to calculate the actual 10-year survival rate. A qualitative review and analysis of the prognostic factors identified in the included studies were performed. RESULTS: Fourteen studies, all of which were retrospective case series, including data on 4197 patients with HCC were analysed. Ten years following resection, 303 of these patients were alive. The 10-year actual survival rate was 7.2%, whereas the actuarial survival quoted from the same studies was 26.8%. Positive prognostic factors included better hepatic function, a wider surgical margin and the absence of satellite lesions. CONCLUSIONS: The actual long-term survival rate after resection of HCC is significantly inferior to reported actuarial survival rates. The Kaplan-Meier method of actuarial survival analysis tends to overestimate survival outcomes as a result of censorship of data and subgroup analysis.

Endoscopic necrosectomy of pancreatic necrosis: a systematic review.

AIM: To review the current status of the novel technique of endoscopic necrosectomy in the management of pancreatic necrosis after acute pancreatitis. METHODS: Studies were identified by searching Medline, PubMed and Embase databases for articles from January 1990 to December 2009 using the keywords "acute pancreatitis", "pancreatic necrosis" and "endoscopy". Additional papers were identified by a manual search of the references from the key articles. Case series of fewer than five patients and case reports were excluded. RESULTS: Indications, techniques and outcomes of endoscopic necrosectomy were analysed. There were no randomised controlled trials identified. Ten case series were included in this analysis. There were a total of more than 1,100 endoscopic necrosectomy procedures in 260 patients with pancreatic necrosis. One hundred fifty-five were proven to be infected necrosis on culture. The overall mortality rate was 5%. The mean procedure-related morbidity rate was 27%. The rate of complete resolution of pancreatic necrosis with the endoscopic method alone was 76%. CONCLUSIONS: Endoscopic necrosectomy is a safe and effective treatment option in selected patients with pancreatic necrosis after acute pancreatitis. Future studies will be required to further define the selection criteria and the techniques for the endoscopic procedure.

RACS and its Fellows: a contribution to sustainable healthcare improvement in South East Asia.

The question of whether small non-government organizations with comparatively small budgets can make a substantial contribution to sustainable improvement in health care in low- and middle-income countries is crucial to funding global surgical projects. The Royal Australasian College of Surgeons and its Fellows have partnered with local organizations and clinicians to deliver a wide range of projects in South East Asia. These projects have proved sustainable and have increased healthcare capacity in these nations. This provides strong evidence that small non-government organizations such as the Royal Australasian College of Surgeons can make a major contribution to global surgeryI.

Management of Boerhaave syndrome in Australasia: a retrospective case series and systematic review of the Australasian literature.

BACKGROUND: Boerhaave syndrome is a rare and life-threatening condition characterized by a spontaneous transmural tear of the oesophagus. There remains wide variation in the condition's management with non-operative management (NOM) and surgery being the two main treatment strategies. The aim was to review the presentation, management and outcomes for patients treated for Boerhaave syndrome at our institution and to compare these data with that previously reported within the Australasian literature. METHODS: A retrospective case series was performed for consecutive patients diagnosed with Boerhaave syndrome at our institution between January 2000 and January 2020. A systematic review of the Australasian literature was also performed. RESULTS: In case series, 15 patients were included (n = 2 NOM, n = 13 operative). The most common operative technique was primary repair with intercostal drainage via thoracotomy. Major complications occurred in 11 (73%) patients. Median Comprehensive Complication Index was 53.4 (interquartile range: 50). There was a significantly lower Comprehensive Complication Index associated with primary repair when compared to oesophageal resection (P = 0.01). There was one death, in the operative management group. Median length of hospital stay was 33 days (interquartile range: 58). In systematic review, 11 articles were included; four case series and seven case reports. From these, 23 patients met inclusion criteria. The majority of patients (83%) were managed operatively, with only four undergoing NOM. Seven patients died, representing an overall mortality rate of 30%. CONCLUSIONS: We provide an updated overview of the management of Boerhaave syndrome within Australasia. Aggressive operative management is associated with reasonable outcomes.

Day-only elective cholecystectomy: early experience and barriers to implementation in Australia.

BACKGROUND: Day-only laparoscopic cholecystectomy (DOLC) has been shown to be safe and feasible yet has not been widely implemented in Australia. This study explores the introduction of routine DOLC to Westmead Hospital, and highlights the barriers to its implementation. METHODS: Routine day-only cholecystectomy protocol was introduced at Westmead Hospital in 2014. A retrospective review of patients who underwent elective laparoscopic cholecystectomy during a 12-month period in 2014 was compared to a 12-month period in 2018, to examine the changes in practice after implementation of a unit protocol. Data were collected on patient demographics, admission category, outcomes and re-presentations. RESULTS: A total of 282 patients were included in the study, of these 169 were booked as day procedures, with 124 (73%) successfully discharged on the same day. There was a significant increase in the proportion of patients booked as day-only from 2014 to 2018 (48% versus 73%, P < 0.001). Day-only failure rates (unplanned overnight admissions), readmissions and complication rates were comparable between the two periods. The most common reason for unplanned overnight admissions were due to intraoperative findings (n = 28/45). CONCLUSION: Routine DOLC can be adopted in Australian hospitals without compromise to patient safety. Unplanned overnight admission is predominantly due to unexpected surgical pathology and can be reduced by protocols for the use of drains and planned outpatient endoscopic retrograde cholangiopancreatography. Unplanned outpatient review can be minimized by optimizing both intra- and post-operative pain management. Individual surgeon and anaesthetist preferences remain an obstacle to a standardized protocol in the Australian setting.