Sensing Swelling: Towards Remote Monitoring of Craniectomy Patients.

Decompressive craniectomy (DC) is a surgical procedure where a portion of the skull is removed to relieve potentially fatal brain swelling. As the swelling can take months to subside, the patient is discharged from an acute care facility to recover prior to cranioplasty (reconstruction surgery). Cranioplasty is associated with complications due to infection, seizure, haematoma and death. The interval between these surgeries is potentially a modifiable risk factor to reduce the rate of complication. We aim to allow clinicians to remotely monitor patients to facilitate an optimal pre-operative review. We have developed a platform technology encompassing a 'smart' device fitted into a skullcap to measure physiological parameters, such as changes in brain swelling, and a clinician portal that allows remote viewing of the patients' physiological data. The use of patient generated data during the transition between craniectomy and cranioplasty has the potential to significantly improve neurorehabilitation outcomes for patients.

Choledocholithiasis: Long-term follow-up in patients without stone clearance at first endoscopic retrograde cholangiopancreatography.

OBJECTIVES: Complete clearance during endoscopic retrograde cholangiopancreatography (ERCP) for choledocholithiasis is not always successful and biliary stenting is commonplace. Strategies vary between temporary stent placement (TSP) with interval ERCP or permanent stent placement (PSP) and watchful waiting for recurrent biliary obstruction (RBO). This study aimed to describe outcomes in these two groups and stent patency rates in PSP. METHODS: Patients with incomplete clearance at first ERCP for choledocholithiasis between May 2015 and December 2018 were identified. Clinical outcomes were obtained by retrospective interrogation of the case notes. Median follow-up duration was 41 months (interquartile range 29-51 mo). RESULTS: Of 1263 index ERCP, 199 (15.8%) had no stone clearance, with 53.3% receiving PSP and 46.7% undergoing TSP. The TSP group had repeat ERCP after a median of 8 weeks; 75.3% had clearance on a repeat ERCP. The PSP group was elder than the TSP group (82 y vs 72 y, P < 0.001). The rates of RBO (32.1% vs 16.1%) and emergency readmissions (32.1% vs 19.4%) were higher in the PSP group (both P < 0.05). More patients died without further biliary disease in the PSP group (39.6% vs 12.9%, P = 0.001). PSP stent patency rates at 6, 12, 24, 36, and 61 months were 87.7%, 82.1%, 75.5%, 69.8% and 67.9%, respectively. CONCLUSIONS: Though PSP had higher RBO and emergency readmissions, two-thirds of patients either died or survived without recurrent biliary disease. Stent patency decreased fastest in the first 12 months. Criteria to guide decision-making for biliary stenting remain unclear.

Fifteen Years of the Australian Imaging, Biomarkers and Lifestyle (AIBL) Study: Progress and Observations from 2,359 Older Adults Spanning the Spectrum from Cognitive Normality to Alzheimer's Disease.

BACKGROUND: The Australian Imaging, Biomarkers and Lifestyle (AIBL) Study commenced in 2006 as a prospective study of 1,112 individuals (768 cognitively normal (CN), 133 with mild cognitive impairment (MCI), and 211 with Alzheimer's disease dementia (AD)) as an 'Inception cohort' who underwent detailed ssessments every 18 months. Over the past decade, an additional 1247 subjects have been added as an 'Enrichment cohort' (as of 10 April 2019). OBJECTIVE: Here we provide an overview of these Inception and Enrichment cohorts of more than 8,500 person-years of investigation. METHODS: Participants underwent reassessment every 18 months including comprehensive cognitive testing, neuroimaging (magnetic resonance imaging, MRI; positron emission tomography, PET), biofluid biomarkers and lifestyle evaluations. RESULTS: AIBL has made major contributions to the understanding of the natural history of AD, with cognitive and biological definitions of its three major stages: preclinical, prodromal and clinical. Early deployment of Aß-amyloid and tau molecular PET imaging and the development of more sensitive and specific blood tests have facilitated the assessment of genetic and environmental factors which affect age at onset and rates of progression. CONCLUSION: This fifteen-year study provides a large database of highly characterized individuals with longitudinal cognitive, imaging and lifestyle data and biofluid collections, to aid in the development of interventions to delay onset, prevent or treat AD. Harmonization with similar large longitudinal cohort studies is underway to further these aims.

Weight loss in adults following bariatric surgery, a systematic review of preoperative behavioural predictors.

Bariatric surgery is effective in treating obesity in many cases, yet as many as 50% of patients may not achieve the desired weight reduction. Preoperative modifiable behavioural factors could help patient selection and intervention design to improve outcomes. Medline, EMBASE, Cochrane Library and PsychINFO were searched to identify studies published between 1 January 2008 and 14 February 2019 reporting on preoperative modifiable behavioural factors associated with postoperative weight loss, with minimum 2 years follow-up. A total of 6888 articles were screened, 34 met the inclusion criteria. Maladaptive eating behaviours (MEB), preoperative weight loss (PWL), and tobacco use were reported 21, 18, and 3 times respectively. Physical activity and substance abuse were each reported once. Most articles on PWL (72.2%) and MEB (52.4%) reported no association. Positive associations were reported in 22.2% and 14.3% of articles for PWL and MEB respectively. Negative associations were reported in 5.6% and 33.3% of articles for PWL and MEB, respectively. Marked heterogeneity in outcome reporting hindered quantitative synthesis. The current paucity of evidence amenable to synthesis leads to ongoing uncertainty regarding the size and direction of association between PWL and MEB with outcomes following bariatric surgery. Long-term studies with common reporting of outcomes are needed.

A SMART on FHIR Prototype for Genomic Test Ordering.

Queensland Genomics recently undertook a number of Clinical Demonstration Projects (CDPs) to demonstrate the benefits of genomics in clinical practice. Integration of this testing requires the health system to provide the infrastructure for the appropriate ordering of these tests. Ordering of genomics tests will likely require greater exchange of information between the ordering clinician and the lab that is producing a clinical test report. The clinical demonstration projects were used to understand the information flow and the use of genomic, phenotypic and other information through the test ordering, analysis and reporting stages. This information was used to inform a set of requirements for a genomics test ordering and reporting system. A prototype of this system was developed as a SMART on FHIR application. This prototype will inform a future production system with FHIR Resources, software interfaces and interoperability requirements.

Health-e Minds: a Participatory Personalised and Gamified mHealth Platform to Support Healthy Living Behaviours for People with Mental Illness.

This paper presents the development of an innovative platform (Health-e Minds) to support persons with diagnosed serious mental illness (SMI) in their self-management, but also to enhance multidisciplinary care provision. It comprises of a smartphone app and an interactive internet-based clinician web portal. The smartphone app accompanies and guides persons with SMI through their recovery journey by monitoring health measures, delivering simple interactive questionnaires and providing educational and motivational multimedia content. The web-portal enables clinical care providers to view their client's progress and provide individualized feedback and/or early care intervention dependent on the advice of the clinical review. A unique feature of the platform is an inbuilt gaming component which encourages patients to adhere to the goals set in consultation with their clinicians. Rewards are attained by comparison of activities achieved, measured against individualized goals, set through the clinical portal. A feasibility study is underway among 40 patients with SMI at the Sunshine Coast University Hospital, in order to ascertain levels of program efficacy and successful health-related outcomes.

Does hiatal repair affect gastroesophageal reflux symptoms in patients undergoing laparoscopic sleeve gastrectomy?

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) has gained popularity as a treatment of choice for morbid obesity and associated comorbidities. There has been a concern about new onset or worsening of gastroesophageal reflux (GERD) following LSG. OBJECTIVE: The objective of the study was to evaluate the effect of surgically treating hiatal weakness on GERD symptoms in patients undergoing LSG. SETTING: Single tertiary referral institution, Sydney, Australia. METHODS: A prospective observational cohort study was conducted with consecutive patients undergoing LSG. Hiatal findings, patient demographics, medications and reflux score were recorded prospectively. Patients were followed up post-operatively for a minimum of 12 months and assessed using GERD-HRQL score to quantify reflux symptoms. RESULTS: Data from 100 patients with a minimum of 1-year follow-up were analysed. Mean follow-up was 18.9 months. Overall, GERD-HRQL improved from mean 4.5 ± 5.8 pre-operatively to 0.76 ± 1.5 after 18.9 months (p = 0.0001). For those with pre-operative reflux, GERD-HRQL improved from mean (SD) 8.43 ± 6.26 pre-operatively to 0.94 ± 1.55 (p = 0.0001). All the nine patients with troublesome daily reflux significantly improved. For those without pre-operative reflux, GERD-HRQL improved from 0.88 ± 1.37 to 0.47 ± 1.25 (p-ns) post-operatively. On multivariate analysis, higher pre-operative reflux and dysphagia/bloat scores, younger age and lower percentage excess weight loss after 18.9 months were associated with GERD-HRQL improvement. CONCLUSION: In the medium term, GERD-HRQL improves following sleeve gastrectomy with meticulous hiatal assessment and repair of hiatal laxity and herniation.

Predicting the occurrence of major adverse cardiac events within 30 days of a vascular surgery: an empirical comparison of the minimum p value method and ROC curve approach using individual patient data meta-analysis.

We aimed to compare the minimum p value method and the area under the receiver operating characteristics (ROC) curve approach to categorize continuous biomarkers for the prediction of postoperative 30-day major adverse cardiac events in noncardiac vascular surgery patients. Individual-patient data from six cohorts reporting B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NTproBNP) were obtained. These biomarkers were dichotomized using the minimum p value method and compared with previously reported ROC curve-derived thresholds using logistic regression analysis. A final prediction model was developed, internally validated, and assessed for its sensitivity to clustering effects. Finally, a preoperative risk score system was proposed. Thresholds identified by the minimum p value method and ROC curve approach were 115.57 pg/ml (p < 0.001) and 116 pg/ml for BNP, and 241.7 pg/ml (p = 0.001) and 277.5 pg/ml for NTproBNP, respectively. The minimum p value thresholds were slightly stronger predictors based on our logistic regression analysis. The final model included a composite predictor of the minimum p value method's BNP and NTproBNP thresholds [odds ratio (OR) = 8.5, p < 0.001], surgery type (OR = 2.5, p = 0.002), and diabetes (OR = 2.1, p = 0.015). Preoperative risks using the scoring system ranged from 2 to 49 %. The minimum p value method and ROC curve approach identify similar optimal thresholds. We propose to replace the revised cardiac risk index with our risk score system for individual-specific preoperative risk stratification after noncardiac nonvascular surgery.

Laparoscopic sleeve gastrectomy: review of 500 cases in single surgeon Australian practice.

INTRODUCTION: Reported results and techniques of laparoscopic sleeve gastrectomy (LSG) are variable. Our objective was to assess results of weight loss, complications and reflux in a large consecutive series of LSG, describing technical detail which contributed to outcomes. METHODS: Retrospective review of prospectively collected data of 500 consecutive patients undergoing LSG. Patient demographics, weight loss, complications and functional outcomes were analysed and operative technique described. RESULTS: Five hundred patients underwent LSG over 3 years (37 revisional). Mean (range) preoperative body mass index was 45 kg/m(2) (35-76 kg/m(2) ). Mean follow-up and length of hospital stay were 14 months (1-34) and 3.8 days (3-12), respectively. All-cause 30-day readmission rate 1.2%. Mean excess weight loss (interquartile range, available patient data) was 43% (22-65%, 423 patients), 58% (45-70%, 352 patients), 76% (52-84%, 258 patients), 71% (51-87%, 102 patients) and 73% (55-86%, 13 patients) at 3, 6, 12, 24, 36 months, respectively. There was no mortality. Intraoperative complications occurred in two (0.4%) - splenic bleeding; bougie related oesophageal injury. Early surgical complications in four (1.2%) patients (one staple line leak and three post-operative bleeds). Other early complications occurred in three (0.6%) patients (one pseudomembranous colitis; one central line sepsis; one portal venous thrombosis) and late in four (0.8%) patients (three port-site incisional hernias; mid-sleeve stricture requiring endoscopic dilatation). Gastro-oesophageal reflux symptoms decreased from 45 to 6%. CONCLUSION: With attention to detail, LSG can lead to good excess weight loss with minimal complications. Tenants to success include repair of hiatal laxity, generous width at angula incisura and complete resection of posterior fundus.

'Step-port' laparoscopic cystgastrostomy for the management of organized solid predominant post-acute fluid collections after severe acute pancreatitis.

BACKGROUND: Post-acute pancreatic collections (PAPCs) may require intervention when persistent, large or symptomatic. An open cystgastrostomy is an effective treatment option particularly for larger, solid predominant collections. A laparoscopic cystgastrostomy (LCG) as initially described, could be technically challenging. This report describes the evolution of the operative technique and the results from LCG in a tertiary referral centre. METHODS: Retrospective analysis of the unit's prospectively populated database was conducted. All patients who underwent a surgical cystgastrostomy (SCG) were identified. Patient demographics, outcome and complications were collected and analysed. RESULTS: Forty-four patients underwent SCG: 8 open and 36 laparoscopic. Of the 36 LCG, 6 required open conversion, although with evolution of the technique all of the last 17 cases were completed laparoscopically. The median interquartile range (IQR) length of stay in patients completed laparoscopically was 6 (2-10) compared with 15.5 days (8-19) in those patients who were converted (P = 0.0351). The only peri-operative complication after a LCG was a self-limiting upper gastrointestinal bleed. With a median (IQR) follow-up of 891 days (527-1495) one patient required re-intervention for a residual collection with no recurrent collections identified. CONCLUSION: LCG is a safe and effective procedure in patients with large, solid predominant PAPCs. With increased experience and technical expertise conversion rates can be lowered and outcome optimized.

A technological evaluation of the Microsoft Kinect for automated behavioural mapping at bed rest.

Behavioural mapping (BM) is a long established method of structured observational study used to understand where patients are and what they are doing within a hospital setting. BM is prominent in stroke rehabilitation research, where that research indicates patients spend most of their time at bed rest. We evaluate the technical feasibility of using the Microsoft Kinect to automate patient physical activity classification at bed rest.

Laparoscopic repair of giant hiatus hernia: prosthesis is not required for successful outcome.

BACKGROUND: Giant hiatus hernia (GHH) are difficult to manage effectively. This study reports a laparoscopic, prosthesis-free technique to repair of GHH. METHODS: Retrospective analysis of a prospectively populated database of a single surgeon's experience of GHH (>30 % intrathoracic stomach) repair using a novel, uniform technique was performed. Routine postoperative endoscopy, quality of life (QOL), and Visick scoring was conducted. RESULTS: Surgery was conducted in 100 patients (70F, 30 M). Mean (standard deviation [SD]) age was 69.1 (±11.4), median (interquartile range) ASA was 2 (range, 2-3), and mean (SD) body mass index (BMI) was 29.1 (±4.5). Mean follow-up was 574.1 (±240.5) days. One (1 %) patient was converted to an open procedure due to technical issues. Median stay was 2.5 days (range, 2-4). One postoperative death occurred secondary to respiratory sepsis. Eight (8 %) patients had perioperative complications: 4 major (PE, non-ST elevation MI, postoperative bleed managed conservatively, infected mediastinal fluid collection); and 4 minor (pneumothorax, asymptomatic troponin leak, subacute small bowel obstruction, and urinary retention). Ninety-nine (99 %) patients had objective screening for recurrence at 3-6 months. Two (2 %) patients have had symptomatic recurrence of their hiatus hernia; both involved a recurrent fundal herniation. Another seven (7 %) had small (<2 cm), asymptomatic recurrences diagnosed only on routine follow-up. Seven (7 %) patients have required reintervention for dysphagia with endoscopic dilatation conducted to good effect in all cases. Two (2 %) patients have required revisional surgery: one for a symptomatic recurrence at 3 months and a second for recurrent mediastinal collection. The Visick score fell from a mean (SD) of 3 (±1.1) to 1.7 (±0.8) postoperatively (p < 0.0001). The mean (SD) QOL preoperatively was 87.8 (±24) versus 109.1 (±22.3) postoperatively (p < 0.0001). CONCLUSIONS: GHH can be managed safely and effectively laparoscopically, without the use of a prosthesis.

B-type natriuretic peptide predicts postoperative cardiac events and mortality after elective open abdominal aortic aneurysm repair.

OBJECTIVE: The aim of this study was to determine if a single preoperative B-type natriuretic peptide (BNP) level correlated with perioperative cardiac events, cardiac death, and all-cause mortality in elective open abdominal aortic aneurysm (AAA) repair in the short term, intermediate term, and long term. METHODS: A prospective, 2-year multicenter observational cohort study in the three vascular units in Glasgow was performed. All patients who were admitted for elective open AAA repair were recruited. Preoperative BNP levels were performed and batch analyzed at the end of the study. Postoperative screening for cardiac events (nonfatal myocardial infarction and cardiac death) was performed at 2, 5, and 30 days. Follow-up for all-cause mortality was sustained to a minimum of 3 years, where possible. RESULTS: A total of 106 of 111 patients were recruited. Median BNP concentrations were higher in the 16 patients (15%) with immediate postoperative cardiac events (P = .001) and the five with cardiac death (P = .043). Area under the receiver-operating characteristic (AUC) curve analysis indicated BNP concentrations of 99.5 pg/mL best predicted cardiac events (AUC, 0.927), and 448 pg/mL predicted cardiac death (AUC, 0.963). BNP also predicted all-cause mortality in the short-term (P = .028), intermediate-term (P < .001), and long-term (P < .001) postoperative periods. CONCLUSIONS: Preoperative serum BNP concentration predicted postoperative cardiac events, cardiac death, and all-cause mortality in patients undergoing elective open AAA repair on short-term, intermediate-term, and long-term follow-up on an individual basis with greater accuracy than currently available risk prediction tools.

A method for the semantic enrichment of clinical trial data.

Clinical trial data have historically been implemented using relational databases. While this has expedited the dissemination of data among partners, it has hindered on the ability to swiftly query the data by relying on monolithic tables. This paper outlines a project that investigates the semantic enrichment of a large-scale longitudinal clinical trial, the AIBL study, by reusing entities from existing ontologies. The implication of the semantic enrichment of the AIBL study is that it is possible to query the data more effectively and efficiently. We are now able to implement our model and focus on an end-to-end data capture and analysis pipeline to query and visualise clinical trial data. The main contribution of this paper is a discussion of the methodology to semantically enrich clinical trial data using entities from existing ontologies.

Using Australian medicines terminology (AMT) and SNOMED CT-AU to better support clinical research.

A large scale, long term clinical study faced significant quality issues with its medications use data which had been collected from participants using paper forms and manually entered into a data capture system. A method was developed that automatically mapped 72.2% of the unique medication names collected for the study to the AMT and SNOMED CT-AU using Ontoserver, a terminology server for clinical ontologies. These initial results are promising and, with further improvements to the algorithms and evaluation, are expected to greatly improve the analysis of medication data gathered from the study.

Jejunal diverticulum with ectopic pancreatic mucosa: was it really a Meckel's diverticulum?

We report the case of a 72-year-old man who underwent surgery for a jejunal intussusception caused by an infarcted mass on the antimesenteric surface of the small bowel approximately 90 cm from the duodenojejunal flexure. The specimen was reported as an infarcted diverticulum containing heterotopic pancreatic mucosa in keeping with infarcted Meckel's diverticulum. We initially wished to establish when the term "Meckel's diverticulum" should be used. The anatomical site in the present case argues against this being a Meckel's diverticulum, a remnant from the mid-gut loop. Non-Meckelian diverticula are usually acquired and often multiple and generally occur on the mesenteric border of the bowel. It is rare for them to contain ectopic mucosa. The diverticulum in our patient thus has features which suggest it may have been congenital. We believe our patient had a rare occurrence of a congenital, but non-Meckelian, diverticulum with associated ectopic epithelium.

Is there still a role for preoperative 12-lead electrocardiography?

BACKGROUND: Twelve-lead electrocardiography is a standard preoperative investigation for patients undergoing major surgery. There is uncertainty and debate over the usefulness of this test for stratifying postoperative cardiac risk. The aim of this study was to investigate the correlation between an abnormal electrocardiogram (ECG) and the postoperative cardiac event rate. METHODS: A prospective single-center observational cohort study in patients undergoing major noncardiac surgery was performed. ECGs were analyzed at the end of the study by a cardiologist and a clinician blinded to the clinical outcomes. The primary endpoints were a major adverse cardiac event (MACE), defined as nonfatal myocardial infarction or cardiac death, and perioperative mortality. RESULTS: A total of 345 patients were included, who had undergone aortic surgery 25.8%, lower limb bypass 29.0%, amputation 25.2%, or laparotomy 20.0%. An abnormal ECG was present in 141 (40.9%) patients. MACE occurred in 46 (13.3%) cases. Patients with an abnormal ECG had a significantly higher incidence of MACE (21.6 vs. 8.3%, P < 0.001). Multivariate analysis showed that left ventricular strain and a prolonged QTc interval (>440 ms) were independent predictors of postoperative adverse events. Among patients with no prior history of ischemic heart disease, those with an abnormal ECG had a higher MACE rate (20.3%) than those patients with a normal ECG (8.6%) (P = 0.01). CONCLUSION: Preoperative electrocardiography is a useful screening test for predicting perioperative cardiac events. Patients with an abnormal ECG but without a prior history of heart disease are a high-risk group potentially amenable to intervention and risk reduction.

On selecting a clinical trial management system for large scale, multi-centre, multi-modal clinical research study.

Clinical research studies offer many challenges for their supporting information systems. AIBL assembled 1112 participants who volunteered crucial information for a comprehensive study on neurodegenerative diseases. This paper discusses the shortcomings of the clinical trial management system chosen to record the results of the study. A set of guidelines was devised and a critique of five systems ensued. OpenClinica was selected as the most appropriate option. The main contribution of this paper is: (i) proposing a set of guidelines to determine the appropriateness of Clinical Trial Management Systems (CTMS) solution; (ii) providing a brief critique of existing commercial and open-sourced CTMS; and (iii) alluding to some data migration issues and providing cues on how to address them. We conclude that open-source CTMS are viable alternatives to the more expensive commercial systems to conduct, record and manage clinical studies.

The predictive ability of pre-operative B-type natriuretic peptide in vascular patients for major adverse cardiac events: an individual patient data meta-analysis.

OBJECTIVES: The aims of this study were to perform an individual patient data meta-analysis of studies using B-type natriuretic peptides (BNPs) to predict the primary composite endpoint of cardiac death and nonfatal myocardial infarction (MI) within 30 days of vascular surgery and to determine: 1) the cut points for a natriuretic peptide (NP) diagnostic, optimal, and screening test; and 2) if pre-operative NPs improve the predictive accuracy of the revised cardiac risk index (RCRI). BACKGROUND: NPs are independent predictors of cardiovascular events in noncardiac and vascular surgery. Their addition to clinical risk indexes may improve pre-operative risk stratification. METHODS: Studies reporting the association of pre-operative NP concentrations and the primary study endpoint, post-operative major adverse cardiovascular events (defined as cardiovascular death and nonfatal MI) in vascular surgery, were identified by electronic database search. Secondary study endpoints included all-cause mortality, cardiac death, and nonfatal MI. RESULTS: Six data sets were obtained, 5 for BNP (n = 632) and 1 for N-terminal pro-BNP (n = 218). An NP level higher than the optimal cut point was an independent predictor for the primary composite endpoint (odds ratio: 7.9; 95% confidence interval: 4.7 to 13.3). BNP cut points were 30 pg/ml for screening (95% sensitivity, 44% specificity), 116 pg/ml for optimal (highest accuracy point; 66% sensitivity, 82% specificity), and 372 pg/ml for diagnostic (32% sensitivity, 95% specificity). Subsequent to revised cardiac risk index stratification, reclassification using the optimal cut point significantly improved risk prediction in all groups (net reclassification improvement 58%, p < 0.000001), particularly in the intermediate-risk group (net reclassification improvement 84%, p < 0.001). CONCLUSIONS: Pre-operative NP levels can be used to independently predict cardiovascular events in the first 30 days after vascular surgery and to significantly improve the predictive performance of the revised cardiac risk index.