Standardization of cerebrospinal fluid shunt valves in pediatric hydrocephalus: an analysis of cost, operative time, length of stay, and shunt failure.

OBJECTIVE: CSF shunts are the most common procedures performed in the pediatric neurosurgical population. Despite attempts in multiple studies, a superior shunt valve has never been shown. Because of this, the authors aim was to examine the impact of shunt valve standardization at their institution to determine if there is a difference in surgical cost, operative time, or short-term postoperative shunt failure. METHODS: A retrospective analysis at the authors' institution was performed for all new CSF diversion shunts, as well as shunt revisions requiring a new valve, or a new valve and at least a new proximal or distal catheter over a 1-year period (January 1, 2016, to December 31, 2016). After a period of transition, neurosurgeons were encouraged to use only one type of fixed-differential-pressure valve and one type of programmable valve when performing shunt surgeries. These patients who underwent "standardized" shunt surgery over a 1-year period (January 1, 2018, to December 31, 2018) were then compared to patients in the prestandardization epoch. All patients were followed for a 12-month period after surgery. Demographic information, surgical cost, operative time, and postoperative shunt failure data were collected in all patients in the study. RESULTS: The authors analyzed 87 shunt surgeries in patients prior to standardization and 94 shunt surgeries in patients after standardization. The rate of violation of the standardized shunt valve policy after implementation was 5.3% (5 of 94 procedures). When comparing the prestandardization group to those who received the standardized valve, operative costs were less ($1821.04 vs $1333.75, p = 0.0034). There was no difference in operative times between groups (78 minutes vs 81 minutes, p = 0.5501). There was no difference in total number of shunt failures between the two groups at 12 months after surgery (p = 0.0859). The rate of postoperative infection was consistent with the literature at 8%. CONCLUSIONS: In accordance with quality improvement principles, the reduction of unexplained clinical variance invariably leads to a decrease in cost and, more importantly, increased value. In this study, the implementation of a standardized shunt valve decreased operative cost. There were no differences in postoperative shunt failures at 12 months after surgery and no differences in length of surgery. Standardizing shunt valves in the treatment of pediatric hydrocephalus seems to be cost-effective and safe.

Implementation of an Anaesthesia Quality Improvement Programme to Reduce Fibreoptic Bronchoscope Repair Incidents.

BACKGROUND: This study was aimed at investigating the effectiveness of the implementation of a comprehensive quality improvement programme (QIP) for reducing the repair rate of the fibreoptic bronchoscope (FOB). METHODS: A three-stage improvement strategy was implemented between January 2013 and December 2016. Stage one is the acquisition of information on violations of practice guidelines, repair rate, cost of repair, and incidence of unavailability of FOB during anaesthesia induction of the previous year through auditing. Stage two is the implementation of a quality improvement campaign (QIC) based on the results of stage one. Stage three is the programme perpetuation through monitoring compliance with policy on FOB use by regular internal audits. The effectiveness was retrospectively analyzed on a yearly basis. RESULTS: The annual repair rate, repair cost, and incidence of FOB unavailability before the QIP implementation were 1%, 18,757 USD, and 1.4%, respectively. After QIC, the repair rate in 2013 dropped by 81% (from 1% in 2012 to 0.19% in 2013, p < 0.05). The annual repair cost fell by 32% from 18,758 USD (2012) to 12,820 USD (2013). Besides, the incidence of FOB unavailability plummeted by 71% from 1.4% to 0.4% during the same period. The annual repair rates and incidence of FOB unavailability remained lower in subsequent three years than those before QIP implementation. CONCLUSION: Implementation of a quality improvement programme was effective for reducing the rate and cost of FOB repair as well as unavailability rate, highlighting its beneficial impact on cost-effectiveness and patient safety in a tertiary referral center setting.

Fiberoptic versus Digital: A Comparison of Durability and Cost Effectiveness of the Two Flexible Ureteroscopes.

AIMS: We aimed to evaluate the durability and cost effectiveness of the latest digital flexible ureterescope by comparing it with the conventional fiberoptic one. MATERIALS AND METHODS: Data of patients who underwent retrograde intrarenal surgery between January 2013 and December 2014 were collected. Fiberoptic Flex-X2 or digital Cobra vision flexible ureteroscopes were used for the procedures. The comparison of both ureteroscopes was performed in terms of patient and stone characteristics, operative outcomes, durability, and cost effectiveness. RESULTS: A total of 105 patients were evaluated for the study. The patient and stone characteristics and operative outcomes were similar between the groups. Overall, 54 and 51 procedures were performed using Flex-X2 and Cobra vision, respectively, before they were sent for renovation. The purchase prices were USD 29,500 for Flex-X2 and USD 58,000 for Cobra vision. Costs of per case were determined as USD 549.29 for Flex-X2 and as USD 1,137.25 for Cobra vision. Per minute working time costs were USD 772.04 and 1,471.33 for Flex-X2 and Cobra vision respectively. CONCLUSIONS: The digital Cobra vision has high costs without any difference in durability as compared to Flex-X2. Moreover, it has no benefit over Flex-X2 in terms of surgical outcomes.

Analysis of cost of component replacement versus entire device replacement during artificial urinary sphincter revision surgery.

AIM: To identify the costs of replacing an entire malfunctioning AUS device versus an individual component at the time of device malfunction. METHODS: Decision analysis was performed by analyzing the costs associated with revising a malfunctioning artificial urinary sphincter using one of two techniques: either individual or entire device replacement. Costs were determined by including actual institutional costs. Model assumptions were based on a summary of published literature and were created based on a time horizon of 0-5 years since the original, primary AUS was placed, and models were created for malfunction of each individual component. Sensitivity analysis was done adjusting for costs of the device and failure rates. RESULTS: Total costs to replace an individual component were $8330 for the pump, $7611 for the cuff, and $5599 for the balloon, while entire device replacement cost $15 069. Over a 5-year time horizon the cost per patient for replacement of a balloon, pump, or cuff were $14 407, $17 491, and $15 212, respectively, versus $18 001 if the entire device was replaced. To be less costly to replace the entire device, balloon, pump, and cuff failure rates would need to be >55%, >25%, or >37.5% during the first 2 years after placement. CONCLUSION: In the event of failure of the artificial urinary sphincter, cost analysis demonstrates that removal and replacement of the entire device is more expensive than replacement of a malfunctioning component at any point up to 5 years after initial AUS placement.

Clinical outcomes and costs of reusable and single-use flexible ureterorenoscopes: a prospective cohort study.

The purpose of this study is to analyze clinical outcomes and costs of single-use flexible ureterorenoscopes in comparison with reusable flexible ureterorenoscopes in a tertiary referral center. Prospectively, 68 flexible ureterorenoscopies utilizing reusable (Flex-X2S, Flex-XC, Karl Storz) and 68 applying single-use flexible ureterorenoscopes (LithoVue, Boston Scientific) were collected. Clinical outcome parameters such as overall success rate, complication rates according to Clavien-Dindo, operation time and radiation exposure time were measured. Cost analysis was based on purchase costs and recurrent costs for repair and reprocessing divided by number of procedures. In each group 68 procedures were available for evaluation. In 91% of reusable and 88% of single-use ureterorenoscopies stone disease was treated with a mean stone burden of 101 ± 226 and 90 ± 244 mm2 and lower pole involvement in 47 and 41%, respectively (p > 0.05). Comparing clinical outcomes of reusable vs. single-use instruments revealed no significant difference for overall success rates (81 vs. 87%), stone-free rates (82 vs. 85%), operation time (76.2 ± 46.8 vs. 76.8 ± 40.2 min), radiation exposure time (3.83 ± 3.15 vs. 3.93 ± 4.43 min) and complication rates (7 vs. 17%) (p > 0.05). A wide range of repair and purchase costs resulted in total to $1212-$1743 per procedure for reusable ureterorenoscopy whereas price of single-use ureterorenoscopy was $1300-$3180 per procedure. The current work provided evidence for equal clinical effectiveness of reusable and single-use flexible ureterorenoscopes. Partially overlapping ranges of costs for single-use and reusable scopes stress the importance to precisely know the expenses and caseload when negotiating purchase prices, repair prices and warranty conditions.

Defining the Costs of Reusable Flexible Ureteroscope Reprocessing Using Time-Driven Activity-Based Costing.

PURPOSE: Careful decontamination and sterilization of reusable flexible ureteroscopes used in ureterorenoscopy cases prevent the spread of infectious pathogens to patients and technicians. However, inefficient reprocessing and unavailability of ureteroscopes sent out for repair can contribute to expensive operating room (OR) delays. Time-driven activity-based costing (TDABC) was applied to describe the time and costs involved in reprocessing. MATERIALS AND METHODS: Direct observation and timing were performed for all steps in reprocessing of reusable flexible ureteroscopes following operative procedures. Estimated times needed for each step by which damaged ureteroscopes identified during reprocessing are sent for repair were characterized through interviews with purchasing analyst staff. Process maps were created for reprocessing and repair detailing individual step times and their variances. Cost data for labor and disposables used were applied to calculate per minute and average step costs. RESULTS: Ten ureteroscopes were followed through reprocessing. Process mapping for ureteroscope reprocessing averaged 229.0 ± 74.4 minutes, whereas sending a ureteroscope for repair required an estimated 143 minutes per repair. Most steps demonstrated low variance between timed observations. Ureteroscope drying was the longest and highest variance step at 126.5 ± 55.7 minutes and was highly dependent on manual air flushing through the ureteroscope working channel and ureteroscope positioning in the drying cabinet. Total costs for reprocessing totaled $96.13 per episode, including the cost of labor and disposable items. CONCLUSIONS: Utilizing TDABC delineates the full spectrum of costs associated with ureteroscope reprocessing and identifies areas for process improvement to drive value-based care. At our institution, ureteroscope drying was one clearly identified target area. Implementing training in ureteroscope drying technique could save up to 2 hours per reprocessing event, potentially preventing expensive OR delays.

Substantial harm associated with failure of chronic paediatric central venous access devices.

Central venous access devices (CVADs) form an important component of modern paediatric healthcare, especially for children with chronic health conditions such as cancer or gastrointestinal disorders. However device failure and complications rates are high.Over 2½ years, a child requiring parenteral nutrition and associated vascular access dependency due to 'short gut syndrome' (intestinal failure secondary to gastroschisis and resultant significant bowel resection) had ten CVADs inserted, with ninesubsequently failing. This resulted in multiple anaesthetics, invasive procedures, injuries, vascular depletion, interrupted nutrition, delayed treatment and substantial healthcare costs. A conservative estimate of the institutional costs for each insertion, or rewiring, of her tunnelled CVAD was $A10 253 (2016 Australian dollars).These complications and device failures had significant negative impact on the child and her family. Considering the commonality of conditions requiring prolonged vascular access, these failures also have a significant impact on international health service costs.

Peripherally InSerted CEntral catheter dressing and securement in patients with cancer: the PISCES trial. Protocol for a 2x2 factorial, superiority randomised controlled trial.

INTRODUCTION: Around 30% of peripherally inserted central catheters (PICCs) fail from vascular, infectious or mechanical complications. Patients with cancer are at highest risk, and this increases morbidity, mortality and costs. Effective PICC dressing and securement may prevent PICC failure; however, no large randomised controlled trial (RCT) has compared alternative approaches. We designed this RCT to assess the clinical and cost-effectiveness of dressing and securements to prevent PICC failure. METHODS AND ANALYSIS: Pragmatic, multicentre, 2×2 factorial, superiority RCT of (1) dressings (chlorhexidine gluconate disc (CHG) vs no disc) and (2) securements (integrated securement dressing (ISD) vs securement device (SED)). A qualitative evaluation using a knowledge translation framework is included. Recruitment of 1240 patients will occur over 3 years with allocation concealment until randomisation by a centralised service. For the dressing hypothesis, we hypothesise CHG discs will reduce catheter-associated bloodstream infection (CABSI) compared with no CHG disc. For the securement hypothesis, we hypothesise that ISD will reduce composite PICC failure (infection (CABSI/local infection), occlusion, dislodgement or thrombosis), compared with SED. SECONDARY OUTCOMES: types of PICC failure; safety; costs; dressing/securement failure; dwell time; microbial colonisation; reversible PICC complications and consumer acceptability. Relative incidence rates of CABSI and PICC failure/100 devices and/1000 PICC days (with 95% CIs) will summarise treatment impact. Kaplan-Meier survival curves (and log rank Mantel-Haenszel test) will compare outcomes over time. Secondary end points will be compared between groups using parametric/non-parametric techniques; p values <0.05 will be considered to be statistically significant. ETHICS AND DISSEMINATION: Ethical approval from Queensland Health (HREC/15/QRCH/241) and Griffith University (Ref. No. 2016/063). Results will be published. TRIAL REGISTRATION: Trial registration number is: ACTRN12616000315415.

Healthcare Utilization and Expenditures Associated With Appropriate and Inappropriate Implantable Defibrillator Shocks.

BACKGROUND: In patients with implantable cardioverter-defibrillators, healthcare utilization (HCU) and expenditures related to shocks have not been quantified. METHODS AND RESULTS: We performed a retrospective cohort study of patients with implantable cardioverter-defibrillators identified from commercial and Medicare supplemental claims databases linked to adjudicated shock events from remote monitoring data. A shock event was defined as ≥1 spontaneous shocks delivered by an implanted device. Shock-related HCU was ascertained from inpatient and outpatient claims within 7 days following a shock event. Shock events were adjudicated and classified as inappropriate or appropriate, and HCU and expenditures, stratified by shock type, were quantified. Of 10 266 linked patients, 963 (9.4%) patients (61.3±13.6 years; 81% male) had 1885 shock events (56% appropriate, 38% inappropriate, and 6% indeterminate). Of these events, 867 (46%) had shock-related HCU (14% inpatient and 32% outpatient). After shocks, inpatient cardiovascular procedures were common, including echocardiography (59%), electrophysiology study or ablation (34%), stress testing (16%), and lead revision (11%). Cardiac catheterization was common (71% and 51%), but percutaneous coronary intervention was low (6.5% and 5.0%) after appropriate and inappropriate shocks. Expenditures related to appropriate and inappropriate shocks were not significantly different. CONCLUSIONS: After implantable cardioverter-defibrillator shock, related HCU was common, with 1 in 3 shock events followed by outpatient HCU and 1 in 7 followed by hospitalization. Use of invasive cardiovascular procedures was substantial, even after inappropriate shocks, which comprised 38% of all shocks. Implantable cardioverter-defibrillator shocks seem to trigger a cascade of health care. Strategies to reduce shocks could result in cost savings.

Cost Effectiveness of Childhood Cochlear Implantation and Deaf Education in Nicaragua: A Disability Adjusted Life Year Model.

INTRODUCTION: Cochlear implantation (CI) is a common intervention for severe-to-profound hearing loss in high-income countries, but is not commonly available to children in low resource environments. Owing in part to the device costs, CI has been assumed to be less economical than deaf education for low resource countries. The purpose of this study is to compare the cost effectiveness of the two interventions for children with severe-to-profound sensorineural hearing loss (SNHL) in a model using disability adjusted life years (DALYs). METHODS: Cost estimates were derived from published data, expert opinion, and known costs of services in Nicaragua. Individual costs and lifetime DALY estimates with a 3% discounting rate were applied to both two interventions. Sensitivity analysis was implemented to evaluate the effect on the discounted cost of five key components: implant cost, audiology salary, speech therapy salary, number of children implanted per year, and device failure probability. RESULTS: The costs per DALY averted are $5,898 and $5,529 for CI and deaf education, respectively. Using standards set by the WHO, both interventions are cost effective. Sensitivity analysis shows that when all costs set to maximum estimates, CI is still cost effective. CONCLUSION: Using a conservative DALY analysis, both CI and deaf education are cost-effective treatment alternatives for severe-to-profound SNHL. CI intervention costs are not only influenced by the initial surgery and device costs but also by rehabilitation costs and the lifetime maintenance, device replacement, and battery costs. The major CI cost differences in this low resource setting were increased initial training and infrastructure costs, but lower medical personnel and surgery costs.

A cost-effectiveness analysis of a proactive management strategy for the Sprint Fidelis recall: a probabilistic decision analysis model.

BACKGROUND: The management of the recall is complicated by the competing risks of lead failure and complications that can occur with lead revision. Many of these patients are currently undergoing an elective generator change--an ideal time to consider lead revision. OBJECTIVE: To determine the cost-effectiveness of a proactive management strategy for the Sprint Fidelis recall. METHODS: We obtained detailed clinical outcomes and costing data from a retrospective analysis of 341 patients who received the Sprint Fidelis lead in British Columbia, where patients younger than 60 years were offered lead extraction when undergoing generator replacement. These population-based data were used to construct and populate a probabilistic Markov model in which a proactive management strategy was compared to a conservative strategy to determine the incremental cost per lead failure avoided. RESULTS: In our population, elective lead revisions were half the cost of emergent revisions and had a lower complication rate. In the model, the incremental cost-effectiveness ratio of proactive lead revision versus a recommended monitoring strategy was $12,779 per lead failure avoided. The proactive strategy resulted in 21 fewer failures per 100 patients treated and reduced the chance of an additional complication from an unexpected surgery. CONCLUSIONS: Cost-effectiveness analysis suggests that prospective lead revision should be considered when patients with a Sprint Fidelis lead present for pulse generator change. Elective revision of the lead is justified even when 25% of the population is operated on per year, and in some scenarios, it is both less costly and provides a better outcome.

Tilt testing is more cost-effective than implantable loop recorder monitoring as a means of directing pacing therapy in people with recurrent episodes of suspected vasovagal syncope that affect their quality of life or present a high risk of injury.

OBJECTIVE: To assess the cost-effectiveness of implantable loop recorders (ILRs) and tilt testing (TT) to direct pacing therapy in people with recurrent episodes of transient loss of consciousness that are adversely affecting their quality of life or represent a high risk of injury and are suspected to be vasovagal. DESIGN: Decision analytical modelling was used to estimate the costs and benefits of diagnostic testing including the costs and benefits of treatment for several clinically important arrhythmias following diagnosis. SETTING: A UK National Health Service and personal social services perspective was taken. PATIENTS: People with recurrent episodes of transient loss of consciousness that are adversely affecting their quality of life or represent a high risk of injury and which are suspected to be vasovagal. INTERVENTIONS: The diagnostic test strategies compared were TT alone, TT followed by ILR (if TT 'negative'), ILR alone and no further testing. MAIN OUTCOME MEASURES: Benefits measured using quality-adjusted life years and incremental cost-effectiveness ratios (ICER) are reported. RESULTS: The ICERs for TT alone, ILR alone and TT followed by ILR were £5960, £24 620 and £19 110, respectively, compared with no testing. ILR alone was extendedly dominated by the other strategies, meaning that it is never the most cost-effective option. Sensitivity analysis found that the cost-effectiveness estimates were robust despite the areas of uncertainty identified in the evidence and assumptions used to inform the model. CONCLUSIONS: TT alone is likely to be the most cost-effective strategy in this population.

Analysis of deaths among children in the period 1996-2008 from closed claims registered by the Danish Patient Insurance Association.

AIM: We investigated the death circumstances among children in the Danish healthcare system by analysing closed claims. METHODS: This retrospective study investigated closed claims with regard to medically related deaths registered by the Danish Patient Insurance Association. RESULTS: From 1996 to 2008, 45 953 claims were made to the Danish Patient Insurance Association (DPIA) covering all medical specialties. Among these claims, a total of 3531 submitted claims were for children younger than 18 years old, and 74 of these children were registered as having died. Forty-one of the 74 deaths were caused by peripartum asphyxia or other birth-related reasons, and 33 children died of causes not related to their birth. Twenty-three of the 33 children died as a result of substandard treatment. This was the ruling of the DPIA or the courts of law on the claim. In these cases, the DPIA, the appeal board or the courts of law settled that an experienced specialist would have acted differently such that the injury could have been avoided. CONCLUSION: Twenty-three of the 33 deaths after the perinatal period could potentially have been avoided if experienced specialists had handled the cases.

Low cost polymer intramedullary nails for fracture fixation: a biomechanical study in a porcine femur model.

INTRODUCTION: Whilst intramedullary nailing is a commonly accepted technique for lower limb fracture fixation, the cost of nails can be prohibitive in hospitals in developing nations. In these institutions bone cement has found many off label applications, that whilst are effective do not meet manufacturers guidelines. The aim of this study was to examine the biomechanics of one such application, fracture fixation using a bone cement intramedullary nail. MATERIALS AND METHODS: Five porcine femurs underwent a mid-shaft osteotomy and were fixed using a nail made from antibiotic simplex bone cement. The torsional and flexural stiffness and shear modulus of these constructs were compared to five intact porcine femurs. RESULTS: The bone cement intramedullary nail was able to achieve relative stability in both torsion, with a mean shear modulus of 0.17 GPa and in flexion with a mean flexural stiffness of 358 N/mm. This corresponds to 47 and 22% of the respective measurements in the intact femurs. The mean ultimate flexural strength of fracture/nail constructs was 936 +/- 350 N, which is 20% of the ultimate flexural strength of an intact porcine femur (4,820 +/- 698 N). CONCLUSION: Intramedullary nails made from bone cement were able to provide sufficient promise in this situation to warrant further investigation for their applicability as a low cost alternative for use in developing countries.

Flexible bronchoscope damage and repair costs in a bronchoscopy teaching unit.

BACKGROUND: A significant part of the budget of our bronchoscopy unit represents repair costs for damaged bronchoscopes. OBJECTIVES: The purpose of this study was to determine the frequency, type and cause of damage to the bronchoscope as well as the repair costs. METHODS: Frequency, type and cause of bronchoscope damage and repair costs of 13 new bronchoscopes that were used between August 1, 2001, and December 31, 2006, were retrospectively studied. RESULTS: We recorded 47 instances of bronchoscope damage during the study, which is 1 instance of damage/141.6 procedures. Six instances of damage (12.7%) were potentially preventable. The most frequent wear and tear damage was to the rubber sheath on the distal bending portion of flexible bronchoscopes, and the most frequently preventable damage was that of the suction channel of the bronchoscope. The repair costs totaled 34,950.00 EUR or 5.25 EUR/procedure. 17,781.00 EUR (50.9%) can be attributed to preventable damage. The use of bronchoscopes for educational purposes was not associated with a higher rate of bronchoscope damage at our institution. CONCLUSIONS: Only a small number of occurrences of bronchoscope damage in our unit are potentially preventable, but they still represent an important expense. The relatively low occurrence of preventable damage is a result of the successful bronchoscopy training program.

An independent analysis of flexible cystoscope repairs and cost.

PURPOSE: To establish the repair patterns of flexible cystoscopes we performed a systematic review of repairs performed at an independent endoscope repair company. MATERIALS AND METHODS: Repair and cost data for 2000 to 2004 were obtained from an independent endoscope repair company. All cystoscopes underwent a detailed inspection using a preset protocol and the frequency of individual repair descriptions was extracted from a computer database. RESULTS: A total of 1,150 repairs were performed on the Olympus CYF (3%), CYF-2 (21%), CYF-3 (56%) and CYF-4 (20%) flexible cystoscopes. Repairs to the distal tip (28% of all repairs) most commonly involved the bending rubber or outer polymer sheath. Repairs to the hand control segment (14% of all repairs) most commonly involved the ocular. Repairs for image (14% of all repairs) and deflection (9%) were most commonly performed on the fiberoptic bundle and wires, respectively. Repairs to the deflection apparatus comprised a significantly greater proportion of total repairs in the early CYF models than in the CYF-4 model (10% to 12% vs 3%, p <0.01, chi-square 10.73). Less than 1% of all cystoscopes needed more than 2 repairs. CONCLUSIONS: Olympus cystoscopes require repair every 2 to 3 years and they appear to be durable. The distal deflection tip, specifically the outer bending rubber, is the most common site of flexible cystoscope damage. Although it appears that significant improvements have been made to the deflection apparatus, the number of repairs to other areas has not changed significantly with time. Improvements in form and function of the distal tip, the hand control segment and the fiberoptic bundles may enhance the durability of flexible cystoscopes.