The Irish National Orthopaedic Register Under Cyberattack: What Happened, and What Were the Consequences?

BACKGROUND: On May 14, 2021, a criminal cyberattack was launched against the Irish public healthcare system, the Health Service Executive, resulting in a complete shutdown of all national healthcare computer systems, including the Irish National Orthopaedic Register (INOR). Cyberattacks of this kind occur sporadically, and postevent analyses can inform future preparedness efforts, but few such analyses have been published. QUESTION/PURPOSE: What was the impact of the cyberattack in terms of (1) registry downtime, (2) harms to patients, and (3) costs to the INOR for data contingency and reconciliation? METHODS: All nine hospitals using the INOR were included for data collection. Since establishment in 2014, the INOR has been rolled out to all eight public elective hospitals, capturing all hip and knee arthroplasty procedures. One private hospital was also captured, with plans to expand the private sector coverage. Individual institutional records and central INOR records were queried with respect to downtime, potential harms to patients (including intraoperative complications because of a lack of data on existing implanted components and complications directly attributed to delayed or canceled procedures), and costs related to additional person-hours addressing data reconciliation. Objective data directly related to the uncontrolled INOR downtime were collected, including duration of downtime, contingency methods employed, quality of contingency data collected, adverse patient events, methods of data salvage and reconciliation, and the cost of data contingency and reconciliation measures. Costs were estimated by the additional person-hours of work completed, multiplied by the hourly rate of that employee. Employees at each of the nine hospitals were asked to provide their additional person-hours of work performed because of the attack. These hours were corroborated by observing the time taken at each unit to reconcile data for single cases multiplied by the number of cases at that unit. Employees included nurses, clinical nurse specialists, and doctors of various grades. Person-hour rates were calculated using the Health Service Executive's published salary scales. RESULTS: The INOR suffered a median downtime of 134 days (range 119 to 272 days) across nine sites. No serious adverse patient events were identified. The immediate implementation of a paperwork fallback method for the INOR successfully resulted in 100% case capture during the downtime. However, 2850 additional person-hours were required for data reconciliation at an estimated cost of USD 181,000 to USD 216,000. More subjectively, as reported by interviews with INOR leads at each hospital, the cyberattack negatively impacted operating room efficiency with delays between procedures because of additional paperwork data collection, disrupted patient flow for paperwork data collection on the ward level and in the outpatient clinics, and disrupted resource allocations and staff capabilities because of additional paperwork requirements during the contingency period. CONCLUSION: Disruptions to data collection and data accessibility after this cyberattack were successfully countered by a contingency plan; however, substantial financial costs and additional resources were required for data conservation and reconciliation. CLINICAL RELEVANCE: In addition to robust preventative security measures, national registers and other healthcare systems should have secondary data backup facilities and reliable fallback procedures prepared for such events.

Differential pathologic variables and outcomes across the spectrum of adenocarcinoma of the esophagogastric junction.

BACKGROUND: Adenocarcinoma of the esophagogastric junction (AEG) as described by Siewert et al. is classified as one entity in the latest (7th Edition) American Joint Cancer Committee/International Union Against Cancer (AJCC/UICC) manual, compared with the previous mix of esophageal and gastric staging systems. The origin of AEG tumors, esophageal or gastric, and their biology remain controversial, particularly for AEG type II (cardia) tumors. METHODS: We adapted a large prospective database (n = 520: 180 type I, 182 type II, 158 type III) to compare AEG tumors under the new TNM system Pathological variables associated with prognosis were compared (pT, pN, stage, differentiation, R status, lymphovascular invasion, perineural involvement, number of positive nodes, percent of positive nodes, and tumor length), as well as overall survival. RESULTS: Compared with AEG type I tumors, type II and type III tumors had significantly (p < 0.05) more advanced pN stages, greater number and percentage of positive nodes, poorer differentiation, more radial margin involvement, and more perineural invasion. In AEG type I, 14/180 patients (8%) had >6 involved nodes (pN3), compared with 16 and 30% of patients classified type II and III, respectively. Median survival was significantly (p = 0.03) improved for type I patients (38 months) compared with those with tumors classified as type II (28 months) and type III (24 months). In multivariate analysis node positivity and pN staging but not AEG site had an impact on survival. CONCLUSIONS: In this series AEG type I is associated with more favorable pathologic features and improved outcomes compared with AEG type II and III. This may reflect earlier diagnosis, but an alternative possibility, that type I may be a unique paradigm with more favorable biology, requires further study.

Breast cancer outcomes following a national initiative in Ireland to restructure delivery of services for symptomatic disease.

BACKGROUND: A national initiative in Ireland in 2000 defined 13 designated Units to provide care for symptomatic breast cancer, and resources, including an ability to develop audit programmes, were provided. In the absence of a national audit of breast cancer outcomes, the aim of this study is to provide a detailed report of one Unit's subsequent experience, in particular comparing process and outcome data with international norms and benchmarks, and to infer on the likely impact of the national initiative. METHODS: A 5-year prospective audit of patients presenting to the Symptomatic Breast Clinic from 2001 to 2005 was conducted. All cancer diagnoses were discussed at the Breast Multidisciplinary Conference, and all clinicopathological treatment details and follow-up information were entered by a full-time data manager. Overall survival was calculated using the Kaplan-Meier method. RESULTS: Eight hundred and thirty-nine patients were diagnosed through the clinic, 18 (2%) Stage 0, 169 (20%) Stage I, 380 (45%) Stage II, 142 (17%) Stage III, and 123 (15%) Stage IV. At a median follow-up of 35 months the overall 5-year survival was 71%, with 100%, 91%, 83%, 72%, and 11% survival for Stages 0-IV, respectively, and disease-specific survival of 82%. CONCLUSIONS: The process and outcome data are consistent with international benchmarks. These data from one designated centre support the national initiatives in Ireland to restructure breast services.

Association of hypoalbuminemia on the first postoperative day and complications following esophagectomy.

OBJECTIVE: Changes in serum albumin may reflect systemic immunoinflammation and hypermetabolism in response to insults such as trauma and sepsis. Esophagectomy is associated with a major metabolic stress, and the aim of this study was to determine if the absolute albumin level on the first postoperative day was of value in predicting in-hospital complications. METHODS: A retrospective study of 200 patients undergoing esophagectomy for malignant disease at St. James Hospital between 1999 and 2005 was performed. Patients who had pre and postoperative (days 1, 3, and 7) serum albumin levels measured were included in the study. Patients were subdivided into three postoperative albumin categories <20 g/l, 20-25 g/l, >25 g/l. Logistic regression analysis was performed to calculate the odds of morbidity and mortality according to the day 1 albumin level. RESULTS: Patients with an albumin of less than 20 g/l on the first postoperative day were twice as likely to develop postoperative complications than those with an albumin of greater than 20 g/l (54 vs 28% respectively, p < 0.011). Correspondingly, these patients also had a significantly higher rate of Adult Respiratory Distress Syndrome (22 vs 5%, p < 0.001), respiratory failure (27 vs 8%, p < 0.01) and in-hospital mortality (27 vs 6% (p < 0.001). On multivariate logistic regression analysis, day 1 albumin level was independently related to postoperative complications (odds ratios, 0.89: 95%; confidence intervals, 0.83-0.96; p < 0.005). In addition, albumin <20 g/l on the first postoperative day was associated with the need for further surgery and a return to ICU. CONCLUSION: Serum albumin concentration on the first postoperative day is a better predictor of surgical outcome than many other preoperative risk factors. It is a low cost test that may be used as a prognostic tool to detect the risk of adverse surgical outcomes.

Impact of solitary involved lymph node on outcome in localized cancer of the esophagus and esophagogastric junction.

Node-positive esophageal cancer is associated with a dismal prognosis. The impact of a solitary involved node, however, is unclear, and this study examined the implications of a solitary node compared with greater nodal involvement and node-negative disease. The clinical and pathologic details of 604 patients were entered prospectively into a database from1993 and 2005. Four pathologic groups were analyzed: node-negative, one lymph node positive, two or three lymph nodes positive, and greater than three lymph nodes positive. Three hundred and fifteen patients (52%) were node-positive and 289 were node-negative. The median survival was 26 months in the node-negative group. Patients (n=84) who had one node positive had a median survival of 16 months (p=0.03 vs node-negative). Eighty-four patients who had two or three nodes positive had a median survival of 11 months compared with a median survival of 8 months in the 146 patients who had greater than three nodes positive (p=0.01). The survival of patients with one node positive [number of nodes (N)=1] was also significantly greater than the survival of patients with 2-3 nodes positive (N=2-3) (p=0.049) and greater than three nodes positive (p<0001). The presence of a solitary involved lymph node has a negative impact on survival compared with node-negative disease, but it is associated with significantly improved overall survival compared with all other nodal groups.

Adenocarcinoma of the oesophagus and gastric cardia: male preponderance in association with obesity.

Recent evidence links obesity with the rising incidence of oesophageal adenocarcinoma. In Ireland between 1995 and 2004 the incidence of oesophageal adenocarcinoma increased by 38%, and this coincided with a 67% increase in the prevalence of obesity. In this study, a prospective case-control study was undertaken in 760 patients presenting to a tertiary centre between 1994 and 2004 diagnosed with cancer of the oesophagus, gastric cardia or stomach. Data were compared with 893 healthy controls. Multivariate logistic regression models were used to calculate the odds ratio (OR) of developing either cancer type according to quartiles of body mass index (BMI). Based on pre-illness BMI, 82% of patients who developed adenocarcinoma of the oesophagus were either overweight or obese compared with 59% of the healthy control population (P<0.001). A dose-dependent relationship existed between BMI and oesophageal adenocarcinoma in males. The adjusted odds ratio was 4.3 (95% CI: 2.3-7.9) among males in the highest BMI quartile compared with males in the lowest quartile (P<0.001 for trend). Using common cut-off points for BMI, the OR of adenocarcinoma of the lower oesophagus was 11.3 times higher (95% CI: 3.5-36.4) for individuals with a BMI >30 kg/m2 versus individuals with a BMI <22 kg/m2 (P<0.001 for trend). For adenocarcinoma of the gastric cardia, males in the top quartile of BMI had an OR of 3.5 (95% CI: 1.3-9.4) compared with the lowest quartile (P=0.03 for trend). A significant (P<0.001) inverse relationship between BMI and oesophageal SCC was observed. The odds ratio for adenocarcinoma of the oesophagus, the oesophago-gastric junction and gastric cardia rose significantly with increasing BMI. For tumours of the lower oesophagus, obesity increased the risk 10.9-fold. The increased risk is significant in males only.

Post-oesophagectomy early enteral nutrition via a needle catheter jejunostomy: 8-year experience at a specialist unit.

BACKGROUND AND AIMS: The purpose of this study was to prospectively evaluate post-operative jejunostomy feeding in terms of nutritional, biochemical, gastrointestinal and mechanical complications in patients undergoing upper gastrointestinal surgery for oesophageal malignancy. METHODS: The study included 205 consecutive patients who underwent oesophagectomy for malignancy. All patients had a needle catheter jejunostomy (NCJ) inserted at the conclusion of laparotomy. Patients were followed prospectively to record nutritional intake, type of feed administered, rate progression, tolerance, weight changes and complications either mechanical, biochemical or gastrointestinal. RESULTS: Ninety-two per cent of patients were successfully fed exclusively by NCJ post-oesophagectomy, and 94% of patients were tolerating a maintenance regimen of 2000 ml feed over 20 h by day 2 post-operatively. Patients spent a median of 15 days on jejunostomy feeding post-surgery (range 2-112 days); however, 26% required prolonged jejunostomy feeding (>20 days). Minor gastrointestinal complications were effectively managed by slowing the rate of infusion, or administering medication. Three (1.4%) serious complications of jejunostomy feeding occurred, all requiring re-laparotomy, one resulting in death. NCJ feeding was extremely effective in preventing severe post-operative weight loss in the majority of oesophagectomy patients post-op. However, oral intake was generally poor at discharge with only 65% of requirements being met orally. Sixteen patients (8%) patients required home jejunostomy feeding. By the first post-operative month, a further 6% (12) patients were recommenced on jejunostomy feeding. CONCLUSION: NCJ feeding is an effective method of providing nutritional support post-oesophagectomy, and allows home support for the subset that fail to thrive. Serious complications, most usually intestinal ischaemia or intractable diarrhoea, are rare.

Acid normalization and improved esophageal motility after Nissen fundoplication: equivalent outcomes in patients with normal and ineffective esophageal motility.

BACKGROUND: Severe gastroesophageal reflux disease may result in acquired esophageal dysmotility. The correct surgical approach to associated gastroesophageal reflux disease and dysmotility is controversial, in particular whether the "gold-standard" total fundoplication of Nissen is appropriate compared with partial fundoplication. Our unit has performed total fundoplication for all patients, irrespective of esophageal motility, and this article describes that experience. METHODS: Ninety-eight patients undergoing antireflux surgery were divided into 2 groups. Group 1 (n=60) consisted of patients with normal esophageal motility, and group 2 (n=38) had dysmotility. All patients underwent preoperative and postoperative manometry, 24-hour pH testing, symptom scoring, and quality-of-life assessment. RESULTS: The median postoperative acid score was not significantly different between groups 1 and 2. Eighty-eight percent of patients with normal motility and 89% of patients with dysmotility had no symptoms or minor symptoms, with a significant improvement in quality of life 6 months after surgery. There was a significant increase in esophageal wave amplitude in both groups, and 20 patients (53%) in the dysmotility group reverted to normal motility after surgery. Recurrent symptoms were associated with postoperative abnormal pH profiles in 5 patients from group 1 and 3 from group 2. CONCLUSIONS: Preoperative dysmotility is not a contraindication for total fundoplication. Postoperative acid control is associated with improved esophageal clearance and symptoms.

Short-term and long-term outcome in low body mass index patients undergoing cardiac surgery.

OBJECTIVE: We sought to assess the effect of low body mass index (BMI) on short- and long-term outcomes following cardiac surgery. METHODS: This is a retrospective review of a prospectively collected departmental database over a 6-year period. Patients were eligible for the study if the BMI was <25 kg/m(2). All morbidities, length of hospital stay, and short- and long-term mortality were reviewed. RESULTS: There were 704 patients divided into low (n = 71) and normal (n = 633) BMI. Postoperative pulmonary complications were higher in the low BMI group compared to the normal BMI group (24% vs. 11%, P < 0.001) with a higher incidence of in-hospital mortality (10% vs. 5%). Using multiple logistic regression, low BMI was an independent risk factor for in-hospital mortality. The 1-, 3-, and 5-year survivals for the low group were 90%, 78%, and 70% compared to 94%, 86%, and 81% in the normal BMI group. CONCLUSION: Low BMI is associated with increased morbidity and mortality following cardiac surgery. Risk scoring systems should utilize the BMI in the preoperative risk assessment with special attention to low BMI.

Impact of obesity on outcomes in the management of localized adenocarcinoma of the esophagus and esophagogastric junction.

OBJECTIVE: Obesity trends in the Western world parallel the increased incidence of adenocarcinoma of the esophagus and esophagogastric junction. The implications of obesity on standard outcomes in the management of localized adenocarcinoma, particularly operative risks, have not been systematically addressed. METHODS: This retrospective analysis of prospectively collected data included 150 consecutive patients (36 [24%] obese [body mass index > 30] and 114 nonobese), of whom 43 were normal weight (body mass index 20-25) and 71 were overweight (body mass index 25-30). Eighty-one patients underwent multimodal therapy. The primary end points were in-hospital mortality and morbidity, and median and overall survivals. RESULTS: Thirty of 36 obese patients (84%) had a body mass index from 30 to 35. Compared with those of the nonobese cohort, obese patients had significantly increased respiratory complications (P = .037), perioperative blood transfusions (P = .021), anastomotic leaks (P = .009), and length of stay (P = .001), but no difference in mortality (P = .582) or major respiratory complications (P = .171). Median and overall survivals were equivalent (P = .348) in both groups. CONCLUSIONS: Obesity was associated with increased respiratory complications and anastomotic leak rates but not with major respiratory complications, mortality, or survival. These outcomes suggest that the added risks of obesity on standard outcomes in esophageal cancer surgery are modest and should not independently have a significant impact on risk assessment in esophageal cancer management.

Short-term nutritional implications of total gastrectomy for malignancy, and the impact of parenteral nutritional support.

AIMS: To report on peri-operative nutritional status in gastric cancer patients undergoing total gastrectomy, and to examine the role of post-operative parenteral nutrition. METHODS: Retrospective study of prospectively collected data on 90 consecutive patients who underwent total gastrectomy for malignancy. RESULTS: At diagnosis 46% of patients reported clinically severe weight loss, and dietary intake was inadequate in 72% of patients. Post-operatively 42% were given total parenteral nutrition (TPN) and 53% were given intravenous fluids (IVF) alone. TPN patients spent a mean of 13.6 days on nutrition support versus IVF patients who spent a mean of 9.2 days without any form of nutrition. IVF patients lost significantly more weight in hospital than TPN patients (5.2 kg versus 3.1 kg, p=0.008). 69% of IVF patients lost severe amount of weight versus 34% in the TPN group (p=0.01). Post-discharge, IVF patients continued to lose significantly more weight than those given TPN post-operatively (7.5 kg versus 2.9 kg, p=0.01) corresponding to 10.5% of their body weight from discharge to follow up versus 4.9% for TPN group (p=0.014). From pre-illness to follow up, patients lost an average of 15.5 kg--IVF patients lost 17.8 kg versus 9.6 kg in TPN (p<0.01). There was no difference in post-operative complications between the groups; however, patients with >10% weight loss had a significantly higher rate of complications and a significantly higher mortality rate than patients who lost <10% body weight (26.2% versus 51.9%, p=0.036 and 11.1% versus 0%, p=0.027, respectively). On multivariate logistic regression analysis >10% weight loss at diagnosis was the only predictive factor of post-operative complications OR 3.1 (95% CI 1.0-9.6), p=0.04). CONCLUSIONS: There is a high prevalence of malnutrition in gastric cancer patients undergoing surgery. Total gastrectomy is associated with dramatic weight loss, which continues beyond the surgeon's view post-discharge, with patients losing an average of 15.5 kg by 3-month follow up. Provision of nutrition support in the form of TPN post-operatively significantly reduces in-hospital weight loss and also helps to attenuate further weight loss post-discharge.

Long-term outcomes following neoadjuvant chemoradiotherapy for esophageal cancer.

OBJECTIVE: We present and analyze long-term outcomes following multimodal therapy for esophageal cancer, in particular the relative impact of histomorphologic tumor regression and nodal status. PATIENTS AND METHODS: A total of 243 patients [(adenocarcinoma (n = 170) and squamous cell carcinoma (n = 73)] treated with neoadjuvant chemoradiotherapy in the period 1990 to 2004 were followed prospectively with a median follow-up of 60 months. Pathologic stage and tumor regression grade (TRG) were documented, the site of first failure was recorded, and Kaplan-Meier survival curves were plotted. RESULTS: Thirty patients (12%) did not undergo surgery due to disease progression or deteriorated performance status. Forty-one patients (19%) had a complete pathologic response (pCR), and there were 31(15%) stage I, 69 (32%) stage II, and 72 (34%) stage III cases. The overall median survival was 18 months, and the 5-year survival was 27%. The 5-year survival of patients achieving a pCR was 50% compared with 37% in non-pCR patients who were node-negative (P = 0.86). Histomorphologic tumor regression was not associated with pre-CRT cTN stage but was significantly (P < 0.05) associated with ypN stage. By multivariate analysis, ypN status (P = 0.002) was more predictive of overall survival than TRG (P = 0.06) or ypT stage (P = 0.39). CONCLUSION: Achieving a node-negative status is the major determinant of outcome following neoadjuvant chemoradiotherapy. Histomorphologic tumor regression is less predictive of outcome than pathologic nodal status (ypN), and the need to include a primary site regression score in a new staging classification is unclear.

Neoadjuvant chemoradiation may increase the risk of respiratory complications and sepsis after transthoracic esophagectomy.

BACKGROUND: The role of neoadjuvant chemotherapy and radiation therapy before resection in esophageal cancer remains controversial. Operative risks may be increased, but this has not been systematically addressed in published trials or reports. METHODS: This was a prospective, nonrandomized, restricted cohort design of patients (n = 200) from 1997 to 2003 with resectable cancer of the esophagus or esophagogastric junction. A total of 102 patients underwent multimodal therapy with 5-fluorouracil, cisplatin, and radiation therapy before surgery, and 98 patients opted for surgery alone. In-hospital mortality and morbidity were the primary end points, and cancer survival was a secondary end point. RESULTS: In patient cohorts matched for operative risk factors, the odds ratio for postoperative sepsis (P = .007), respiratory failure (P = .009), and acute respiratory distress syndrome (P = .02) was increased in the multimodal group. There was no significant difference between groups comparing median and 1-, 2-, and 3-year survivals. CONCLUSIONS: Multimodal therapy was associated with increased respiratory and septic complications compared with a surgery-only cohort undergoing the equivalent surgery. Respiratory failure was in most cases idiopathic. The data suggest that efforts should be made to limit radiation lung exposure in multimodal regimens, and to understand and modulate the local and systemic effects of preoperative chemoradiation.