Cost-effectiveness analysis of the diagnosis of temporal arteritis.

Temporal arteritis (TA) is the most common form of systemic vasculitis. Its diagnosis is based on criteria proposed by the American College of Rheumatology (1990), and its treatment is high-dose corticosteroids. Our objective is to assess the cost of diagnosing TA, and secondarily, cost-effective analysis of different diagnostic strategies (clinical, biopsy, doppler ultrasound) and therapeutic strategies (corticosteroid suspension). MATERIAL AND METHOD: Observational, retrospective study has been carried out on patients with AT (2012-2021). Demographic data, comorbidities, signs and symptoms suggestive of AT were collected. AT was diagnosed with a score ≥ 3 according to American College of Rheumatoloy criteria (ACR-SCORE). The costs of diagnosis and treatment modification were analysed. RESULTS: Seventy-five patients have been included, median age 77 (46-87) years. Headache, temporal pain and jaw claudication were significant for the diagnosis of TA. Patients with a halo on Doppler ultrasound and a positive biopsy have significantly elevated ESR and CRP compared to patients who do not. The cost of the AT diagnosis was 414.7 euros/patient. If we use ACR-SCORE ≥ 3-echodoppler it is 167.2 є/patient (savings 59.6%) and ACR-SCORE ≥ 3-biopsy 339.75 є/patient (savings 18%). If the corticosteroid was removed and a biopsy was performed, 21.6 є/patient (94.7% savings), if the corticosteroid was removed and Doppler ultrasound was performed, 10.6 є/patient (97.4% savings). CONCLUSIONS: Headache, temporary pain and jaw claudication are predictors of AT. Elevated ESR and CRP are predictors of positive biopsy and presence of halo on ultrasound. The uses of ACR-SCORE ≥ 3 with Doppler ultrasound or biopsy, and with corticosteroid suspension, are cost-effective.

Cost Effectiveness of Assessing Ultrasound Plaque Characteristics to Risk Stratify Asymptomatic Patients With Carotid Stenosis.

Background Imaging may play an important role in identifying high-risk plaques in patients who have carotid disease and who could benefit from surgical revascularization. We sought to evaluate the cost effectiveness of a decision-making rule based on the ultrasound imaging assessment of plaque echolucency in patients with asymptomatic carotid stenosis. Methods and Results We used a decision-analytic model to project lifetime quality-adjusted life years and costs for 5 stroke prevention strategies: (1) medical therapy only; (2) revascularization if both plaque echolucency and stenosis progression to >90% are present; (3) revascularization only if plaque echolucency is present; (4) revascularization only if stenosis progression >90% is present; or (5) either plaque echolucency or stenosis progression is present. Risks of clinical events, costs, and quality-of-life values were estimated based on published sources and the analysis was conducted from a healthcare system perspective for asymptomatic patients with 70% to 89% carotid stenosis at presentation. Patients who did not undergo revascularization had the highest stroke events (17.6%) and lowest life-years (8.45), while those who underwent revascularization on the basis of either presence of plaque echolucency on ultrasound or progression of carotid stenosis had the lowest stroke events (12.0%) and longest life-years (14.41). The either plaque echolucency or progression-based revascularization group had an incremental cost-effectiveness ratio of $110 000/quality-adjusted life years compared with the plaque echolucency-based strategy, which had an incremental cost-effectiveness ratio of $29 000/quality-adjusted life years compared with the joint echolucency and progression-based strategy. Conclusions Plaque echolucency on ultrasound can be a cost-effective tool to identify patients with asymptomatic carotid artery stenosis most likely to benefit from carotid endarterectomy.

Detection of subclinical synovial hypertrophy by musculoskeletal gray-scale/ power Doppler ultrasonography in systemic lupus erythematosus patients: A cross-sectional study.

OBJECTIVE: Laboratory investigations are invasive methods. Magnetic resonance imaging (MRI) has a small field of view. Ultrasound can be performed at multiple parts of the body. The objective of the study was to find out subclinical synovial hypertrophy in systemic lupus erythematosus patients using gray-scale/power Doppler ultrasonography. METHODS: A total of 247 systemic lupus erythematosus (without musculoskeletal involvement) patients from 21 February 2017 to 28 October 2018 were included in the cross-sectional study. Patients were subjected to physical examinations, laboratory tests, and gray-scale/power Doppler ultrasonography examinations. Synovial hypertrophy was confirmed if it was present in at least 4 out of 100 of the examined location sites. MRI examinations were performed for confirmation purposes. Spearman correlation was performed between imaging and laboratory investigations at the 99% confidence level. RESULTS: No correlation was observed for results of synovial hypertrophy between physical examinations/laboratory tests and gray-scale/power Doppler ultrasonography examinations except erythrocyte sedimentation rate (r = 0.354). Cost of laboratory tests (315.47 ± 19.15 ¥/person) for subclinical synovial hypertrophy detection was higher than that of gray-scale/power Doppler ultrasonography examinations (135.47 ± 8.17 ¥/person, P <0.0001, q = 230.87). Results of gray-scale/power Doppler ultrasonography have a correlation with results of MRI (r = 0.34). CONCLUSION: Only perform gray-scale/power Doppler ultrasonography examinations for regular maintenance of rheumatologic disease in systemic lupus erythematosus patients.

Use of Doppler Probe in Nonvariceal Upper-Gastrointestinal Bleeding Is Less Costly and More Effective Than Standard of Care.

BACKGROUND & AIMS: Upper gastrointestinal bleeding is a common emergency and rebleeding is associated with an increased risk of death. Proper assessment of high-risk lesions and appropriate endoscopic hemostasis are required for the best outcomes. The endoscopic Doppler probe examination (DPE) allows for a more complete assessment of the stigmata of hemorrhage, providing better evaluation of the need for endoscopic hemostasis and determination of its completeness. We aimed to evaluate whether use of the DPE provides an additional advantage in cost and effectiveness compared with traditional endoscopic visual assessment (TEA) of high-risk stigmata in patients with nonvariceal upper gastrointestinal bleeding. METHODS: We drew a decision tree representing the choice between DPE and TEA approaches for patients undergoing an index endoscopy for active nonvariceal upper gastrointestinal bleeding. Clinical probabilities were retrieved from randomized controlled trial data. Costs were expressed in 2017 US dollars. A third-party payer perspective was adopted. We performed deterministic and probabilistic sensitivity analyses. The adopted time horizon was 30 days after the index endoscopy. RESULTS: We found that DPE is a dominant strategy over the TEA, in that DPE is more efficacious (92.6% of patients avoiding rebleeding vs 78.6% for TEA) and less expensive ($8502 vs $9104 for TEA). The economic dominance of DPE over TEA was robust to sensitivity analyses across all assumptions of the model when varied among ranges spanning 30% of their respective baseline values. CONCLUSIONS: In a cost-effectiveness analysis, we found DPE to be an economically dominant strategy to TEA (the traditional approach) in the management of high-risk lesions in patients with nonvariceal upper gastrointestinal bleeding. DPE was less costly and more effective.

Cost-Effectiveness Analysis of Routine Venous Doppler Ultrasound for Diagnosis of Deep Venous Thrombosis at Admission to Inpatient Rehabilitation.

OBJECTIVE: The aims of the study were to identify whether timing of venous thromboembolism diagnosis is associated with differences in patient outcomes and to perform a cost-effectiveness analysis of routine venous Doppler ultrasound at admission to inpatient rehabilitation, taking into account costs associated with prolonged inpatient rehabilitation length of stay, and development of pulmonary embolism. DESIGN: This was a retrospective cohort study of 2312 consecutive patient discharges from a single inpatient rehabilitation facility for an 18-mo period. Cost-effectiveness model was built using TreeAge Healthcare Pro. The base case was constructed using probabilities and inpatient rehabilitation length of stay identified from retrospective analysis. Cost of Doppler ultrasound was obtained through the literature, and daily inpatient rehabilitation cost was obtained from the study institution. RESULTS: Venous thromboembolism was diagnosed in 6.6% of patients. Asymptomatic patients diagnosed with venous thromboembolism on screening Doppler ultrasound had shorter inpatient rehabilitation length of stay (P = 0.045) and lower rate of pulmonary embolism (P < 0.001) and acute hospital transfer (P = 0.002) than those diagnosed after clinical symptoms developed. Use of routine Doppler ultrasound at inpatient rehabilitation admission was found to be cost-effective, with a total cost of US $20,265 per admission compared with $20,269 per admission without use of Doppler ultrasound at inpatient rehabilitation admission. CONCLUSIONS: Routine Doppler ultrasound screening for venous thromboembolism at inpatient rehabilitation admission is associated with improved patient outcomes without added cost per admission.

Adding access blood flow surveillance reduces thrombosis and improves arteriovenous fistula patency: a randomized controlled trial.

PURPOSE: Stenosis is the main cause of arteriovenous fistula (AVF) failure. It is still unclear whether surveillance based on vascular access blood flow (QA) enhances AVF function and longevity. METHODS: We conducted a three-year follow-up randomized, controlled, multicenter, open-label trial to compare QA-based surveillance and pre-emptive repair of subclinical stenosis with standard monitoring/surveillance techniques in prevalent mature AVFs. AVFs were randomized to either the control group (surveillance based on classic alarm criteria; n = 104) or to the QA group (QA measured quarterly using Doppler ultrasound [M-Turbo®] and ultrasound dilution [Transonic®] added to classic surveillance; n = 103).The criteria for intervention in the QA group were: 25% reduction in QA, QA<500 mL/min or significant stenosis with hemodynamic repercussion (peak systolic velocity [PSV] more than 400 cm/sc or PSV pre-stenosis/stenosis higher than 3). RESULTS: At the end of follow-up we observed a significant reduction in the thrombosis rate in the QA group (0.025 thrombosis/patient/year in the QA group vs. 0.086 thrombosis/patient/year in the control group [p = 0.007]). There was a significant improvement in the thrombosis-free patency rate (HR, 0.30; 95% CI, 0.11-0.82; p = 0.011) and in the secondary patency rate in the QA group (HR, 0.49; 95% CI, 0.26-0.93; p = 0.030), with no differences in the primary patency rate between the groups (HR, 0.98; 95% CI, 0.57-1.61; p = 0.935).There was greater need for a central venous catheter and more hospitalizations associated with vascular access in the control group (p = 0.034/p = 0.029).Total vascular access-related costs were higher in the control group (€227.194 vs. €133.807; p = 0.029). CONCLUSIONS: QA-based surveillance combining Doppler ultrasound and ultrasound dilution reduces the frequency of thrombosis, is cost effective, and improves thrombosis free and secondary patency in autologous AVF.

Cost-effectiveness of New Surgical Treatments for Hemorrhoidal Disease: A Multicentre Randomized Controlled Trial Comparing Transanal Doppler-guided Hemorrhoidal Artery Ligation With Mucopexy and Circular Stapled Hemorrhoidopexy.

OBJECTIVE: To compare Doppler-guided hemorrhoidal artery ligation (DGHAL) with circular stapled hemorrhoidopexy (SH) in the treatment of grade II/III hemorrhoidal disease (HD). BACKGROUND: DGHAL is a treatment option for symptomatic HD; existing studies report limited risk and satisfactory outcomes. DGHAL has never before been compared with SH in a large-scale multi-institutional randomized clinical trial. METHODS: Three hundred ninety-three grade II/III HD patients recruited in 22 centers from 2010 to 2013 were randomized to DGHAL (n = 197) or SH (n = 196). The primary endpoint was operative-related morbidity at 3 months (D.90) based on the Clavien-Dindo surgical complications grading. Total cost, cost-effectiveness, and clinical outcome were assessed at 1 year. RESULTS: At D.90, operative-related adverse events occurred after DGHAL and SH, respectively, in 47 (24%) and 50 (26%) patients (P = 0.70). DGHAL resulted in longer mean operating time (44±16 vs 30±14 min; P < 0.001), less pain (postoperative and at 2 wks visual analogic scale: 2.2 vs 2.8; 1.3 vs 1.9; P = 0.03; P = 0.013) and shorter sick leave (12.3 vs 14.8 d; P = 0.045). At 1 year, DGHAL led to more residual grade III HD (15% vs 5%) and a higher reoperation rate (8% vs 4%). Patient satisfaction was >90% for both procedures. Total cost at 1 year was greater for DGHAL [&OV0556;2806 (&OV0556;2670; 2967) vs &OV0556;2538 (&OV0556;2386; 2737)]. The D.90, incremental cost-effectiveness ratio (ICER) was &OV0556;7192 per averted complication. At 1 year DGHAL strategy was dominated. CONCLUSIONS: DGHAL and SH are viable options in grade II/III HD with no significant difference in operative-related risk. Although resulting in less postoperative pain and shorter sick leave, DGHAL was more expensive, took longer, and provided a possible inferior anatomical correction suggesting an increased risk of recurrence.

Value analysis of postoperative staging imaging for asymptomatic, early-stage breast cancer: implications of clinical variation on utility and cost.

BACKGROUND: Routine staging imaging for early-stage breast cancer is not recommended. Despite this, there is clinical practice variation with imaging studies obtained for asymptomatic patients with a positive sentinel node (SN+). We characterize the utility, cost, and clinical implications of imaging studies obtained in asymptomatic SN+ patients. METHODS: A retrospective review was performed of asymptomatic, clinically node-negative patients who were found to have a positive sentinel node after surgery. The type of imaging, subsequent tests/interventions, frequency of additional malignancy detected, and costs were recorded. RESULTS: From April 2009 to April 2013, a total of 50 of 113 (44%) asymptomatic patients underwent staging imaging for a positive sentinel node; 11 (22%) patients had at least 1 subsequent imaging study or diagnostic intervention. No instance of metastatic breast cancer was identified, with a total cost of imaging calculated at $116,905. CONCLUSIONS: Staging imaging for asymptomatic SN+ breast cancer demonstrates clinical variation. These tests were associated with low utility, increased costs, and frequent false positives leading to subsequent testing/intervention. Evidence-based standardization may help increase quality by decreasing unnecessary variation and cost.

Is radial artery Doppler scanning mandatory for use as coronary bypass conduit?

BACKGROUND: Screening of the radial artery prior to harvesting as a conduit for coronary bypass may be performed clinically by the Allen test or by Doppler ultrasound. In a developing country like ours, the use of resources for Doppler studies may be questioned when Allen tests lead to a low rate of clinical sequelae. However, the rare occurrence of hand ischemia may be devastating and could justify the routine use of Doppler screening. This study aimed to address this question. METHODS: One hundred patients undergoing elective coronary artery bypass grafting were screened by the modified Allen test and Doppler ultrasound for suitability of use of a radial artery conduit. After harvesting, proximal and distal segments of the radial artery were subjected to histopathological examination. RESULTS: Of the 95 patients deemed suitable for radial artery grafting, 6 had mild calcification on Doppler ultrasound and 9 had calcification on histopathological examination. While Doppler showed atherosclerosis in 9 patients, only 6 had histopathological evidence of this (false-positive rate 3%). Of the 6 patients with histopathologic evidence of atherosclerosis, 2 were negative on Doppler (false-negative rate 2%). CONCLUSION: Routine preoperative Doppler screening of the radial artery in the setting of limited resources is not justified. On the other hand, the time-tested Allen test which is easy to perform, interpret, and reproduce can be safely used as the sole screening test to harvest the radial artery.

Audible handheld Doppler ultrasound determines reliable and inexpensive exclusion of significant peripheral arterial disease.

OBJECTIVE: To determine the accuracy of audible arterial foot signals with an audible handheld Doppler ultrasound for identification of significant peripheral arterial disease as a simple, quick, and readily available bedside screening tool. METHODS: Two hundred consecutive patients referred to an interprofessional wound care clinic underwent audible handheld Doppler ultrasound of both legs. As a control and comparator, a formal bilateral lower leg vascular study including the calculation of Ankle Brachial Pressure Index and toe pressure (TP) was performed at the vascular lab. Diagnostic reliability of audible handheld Doppler ultrasound was calculated versus Ankle Brachial Pressure Index as the gold standard test. RESULTS: A sensitivity of 42.8%, a specificity of 97.5%, negative predictive value of 94.10%, positive predictive value of 65.22%, positive likelihood ratio of 17.52, and negative likelihood ratio of 0.59. The univariable logistic regression model had an area under the curve of 0.78. There was a statistically significant difference at the 5% level between univariable and multivariable area under the curves of the dorsalis pedis and posterior tibial models (p < 0.001). CONCLUSION: Audible handheld Doppler ultrasound proved to be a reliable, simple, rapid, and inexpensive bedside exclusion test of peripheral arterial disease in diabetic and nondiabetic patients.

A cost-utility analysis of the use of preoperative computed tomographic angiography in abdomen-based perforator flap breast reconstruction.

BACKGROUND: Computed tomographic angiography is a diagnostic tool increasingly used for preoperative vascular mapping in abdomen-based perforator flap breast reconstruction. This study compared the use of computed tomographic angiography and the conventional practice of Doppler ultrasonography only in postmastectomy reconstruction using a cost-utility model. METHODS: Following a comprehensive literature review, a decision analytic model was created using the three most clinically relevant health outcomes in free autologous breast reconstruction with computed tomographic angiography versus Doppler ultrasonography only. Cost and utility estimates for each health outcome were used to derive the quality-adjusted life-years and incremental cost-utility ratio. One-way sensitivity analysis was performed to scrutinize the robustness of the authors' results. RESULTS: Six studies and 782 patients were identified. Cost-utility analysis revealed a baseline cost savings of $3179, a gain in quality-adjusted life-years of 0.25. This yielded an incremental cost-utility ratio of -$12,716, implying a dominant choice favoring preoperative computed tomographic angiography. Sensitivity analysis revealed that computed tomographic angiography was costlier when the operative time difference between the two techniques was less than 21.3 minutes. However, the clinical advantage of computed tomographic angiography over Doppler ultrasonography only showed that computed tomographic angiography would still remain the cost-effective option even if it offered no additional operating time advantage. CONCLUSIONS: The authors' results show that computed tomographic angiography is a cost-effective technology for identifying lower abdominal perforators for autologous breast reconstruction. Although the perfect study would be a randomized controlled trial of the two approaches with true cost accrual, the authors' results represent the best available evidence.

Comparison of ultrasound and electrodiagnostic testing for diagnosis of carpal tunnel syndrome: study using a validated clinical tool as the reference standard.

BACKGROUND: Ultrasound examination is both accurate and cost-effective for the confirmation of a clinical diagnosis of carpal tunnel syndrome. Previous studies have shown electrodiagnostic testing and ultrasound to be similar with regard to sensitivity and specificity. The purpose of this study was to compare the sensitivity and specificity of ultrasound and electrodiagnostic testing by using a validated clinical diagnostic tool as the reference standard. METHODS: All consecutive patients referred to an upper-extremity practice for electrodiagnostic testing for any reason over a three-month period were recruited to participate in this study. All patients were evaluated with the use of the Carpal Tunnel Syndrome 6 (CTS-6) clinical diagnostic tool, and a score of ≥12 was considered positive for carpal tunnel syndrome. A positive finding on ultrasound was considered to be a cross-sectional area of the median nerve, measured just proximal to the level of the pisiform, of ≥10 mm(2). A positive finding on electrodiagnostic testing was a distal motor latency of ≥4.2 ms and/or a distal sensory latency of ≥3.2 ms. Sensitivity, specificity, and accuracy were calculated for ultrasound and electrodiagnostic testing with use of the CTS-6 as the reference standard. RESULTS: With use of the CTS-6 as the reference standard, ultrasound had a sensitivity of 89% and a specificity of 90% in our series of eighty-five patients. Electrodiagnostic testing had a sensitivity of 89% and a specificity of 80%. The positive predictive value of ultrasound was 94% compared with 89% for electrodiagnostic testing. The negative predictive value of ultrasound was 82% compared with 80% for electrodiagnostic testing. Ultrasound was accurate in seventy-six (89%) of the eighty-five cases whereas electrodiagnostic testing was accurate in seventy-three (86%) of the eighty-five cases (p = 0.5). CONCLUSIONS: While ultrasound will not replace electrodiagnostic testing in complicated or unclear cases, in a select group of patients with a positive CTS-6, ultrasound can be used to confirm the diagnosis of carpal tunnel syndrome with better specificity and equal sensitivity as compared with those of electrodiagnostic testing. LEVEL OF EVIDENCE: Diagnostic Level I. See Instructions for Authors for a complete description of levels of evidence.

Making the financial case for a surgeon-directed critical care ultrasound program.

BACKGROUND: We sought to demonstrate that a well-staffed, surgeon-directed, critical care ultrasound program (CCUP) is financially sustainable and provides administrative and educational support for point-of-care ultrasound. METHODS: The CCUP provides a clinical service and training as well as conducts research. Initial costs, annual costs (C), revenue (R), and savings (S) were prospectively recorded. Using data from the first 3 years, we calculated the projected C, R, and S at 5 years. We determined CCUP sustainability by C < R and C < R + S at 3 years and 5 years. RESULTS: During 36 months, the CCUP covered four surgical intensive care units (55 beds). Start-up costs included one basic and one cardiovascular device per 25 beds and a data storage system linking reports and images to the electronic medical record ($203,650). Billing increased threefold from Years 1 to 3, with a 21% increase between Years 2 to 3. Yearly costs included 0.5 full-time equivalent (FTE) sonographer and 0.2 FTE surgeon ($106,025); this was increased to 1 FTE and 0.25 FTE, respectively, for Years 4 and 5. The total 3-year cost was $521,725 and projected to be $863,325 by Year 5. The total 3-year revenue was $290,775 and projected to be $891,600 at 5 years. The total 3-year savings associated with the CCUP was $600,035 and is projected to be $1,194,220. With the use of the C < R, the CCUP meets operating expenses at Year 3 and covers overall cost at 5 years. If savings are included, then the CCUP is sustainable by its third year and is potentially profitable by Year 5. CONCLUSION: A surgeon-directed CCUP is financially sustainable, addresses administrative issues, and provides valuable training in point-of-care ultrasound.

Cost-effectiveness of prenatal screening strategies for congenital heart disease.

OBJECTIVE: The economic implications of strategies to improve prenatal screening for congenital heart disease (CHD) in low-risk mothers have not been explored. The aim was to perform a cost-effectiveness analysis of different screening methods. METHODS: We constructed a decision analytic model of CHD prenatal screening strategies (four-chamber screen (4C), 4C + outflow, nuchal translucency (NT) or fetal echocardiography) populated with probabilities from the literature. The model included whether initial screens were interpreted by a maternal-fetal medicine (MFM) specialist and different referral strategies if they were read by a non-MFM specialist. The primary outcome was the incremental cost per defect detected. Costs were obtained from Medicare National Fee estimates. A probabilistic sensitivity analysis was undertaken on model variables commensurate with their degree of uncertainty. RESULTS: In base-case analysis, 4C + outflow referred to an MFM specialist was the least costly strategy per defect detected. The 4C screen and the NT screen were dominated by other strategies (i.e. were more costly and less effective). Fetal echocardiography was the most effective, but most costly. On simulation of 10 000 low-risk pregnancies, 4C + outflow screen referred to an MFM specialist remained the least costly per defect detected. For an additional $580 per defect detected, referral to cardiology after a 4C + outflow was the most cost-effective for the majority of iterations, increasing CHD detection by 13 percentage points. CONCLUSIONS: The addition of examination of the outflow tracts to second-trimester ultrasound increases detection of CHD in the most cost-effective manner. Strategies to improve outflow-tract imaging and to refer with the most efficiency may be the best way to improve detection at a population level.

Cost-effectiveness of laser Doppler imaging in burn care in the Netherlands.

BACKGROUND: Early accurate assessment of burn depth is important to determine the optimal treatment of burns. The method most used to determine burn depth is clinical assessment, which is the least expensive, but not the most accurate.Laser Doppler imaging (LDI) is a technique with which a more accurate (>95%) estimate of burn depth can be made by measuring the dermal perfusion. The actual effect on therapeutic decisions, clinical outcomes and the costs of the introduction of this device, however, are unknown. Before we decide to implement LDI in Dutch burn care, a study on the effectiveness and cost-effectiveness of LDI is necessary. METHODS/DESIGN: A multicenter randomised controlled trial will be conducted in the Dutch burn centres: Beverwijk, Groningen and Rotterdam. All patients treated as outpatient or admitted to a burn centre within 5 days post burn, with burns of indeterminate depth (burns not obviously superficial or full thickness) and a total body surface area burned of ≤ 20% are eligible. A total of 200 patients will be included. Burn depth will be diagnosed by both clinical assessment and laser Doppler imaging between 2-5 days post burn in all patients. Subsequently, patients are randomly divided in two groups: 'new diagnostic strategy' versus 'current diagnostic strategy'. The results of the LDI-scan will only be provided to the treating clinician in the 'new diagnostic strategy' group. The main endpoint is the effect of LDI on wound healing time.In addition we measure: a) the effect of LDI on other patient outcomes (quality of life, scar quality), b) the effect of LDI on diagnostic and therapeutic decisions, and c) the effect of LDI on total (medical and non-medical) costs and cost-effectiveness. DISCUSSION: This trial will contribute to our current knowledge on the use of LDI in burn care and will provide evidence on its cost-effectiveness. TRIAL REGISTRATION: NCT01489540.

Implantable Doppler in monitoring free flaps: a cost-effectiveness analysis based on a systematic review of the literature.

OBJECTIVE: The purpose of this paper is to evaluate the efficacy and cost-effectiveness of the implantable Doppler system based on the analysis of the available scientific literature and clinical and cost data available in our hospital. The results of this system are compared to those of conventional free flap monitoring methods. MATERIALS AND METHODS: The literature published between 1991 and 2011 was systematically reviewed. All available cost data were collected and several simulations were performed. A retrospective assessment of the efficacy of conventional methods in our hospital was also conducted. RESULTS AND CONCLUSION: The implantable Doppler system is more effective than the conventional methods used to monitor free flap perfusion. The mean flap salvage rate with the implantable Doppler was 21 percentage points higher (81.4 vs. 60.4). The excess cost compared to conventional methods was about CAD 120 per patient (about EUR 94). However, this excess cost can be compensated or even reversed, depending on the initial flap salvage rate in the health facility and the type of free flap (buried vs. non-buried).

Implantable continuous Doppler monitoring device for detection of hepatic artery thrombosis after liver transplantation.

BACKGROUND: Early hepatic artery thrombosis (eHAT) after liver transplantation occurs in 3% of adults and 8% of children and often results in retransplantation. eHAT is initially asymptomatic and arterial patency is monitored with percutaneous Doppler ultrasound screening (pDUS). The aim of the study is to analyze the diagnostic accuracy of "continuous" Doppler registration (CONDOR) using an implantable miniature Doppler. METHODS: This prospective observational study was conducted in 102 liver transplant recipients. Hepatic arterial signal is checked by CONDOR at least six times per day for the first 10 days after transplantation with comparison of diagnostic accuracy of CONDOR versus pDUS. RESULTS: Extra investigations were performed after 48 (11%) regular pDUS where arterial patency was questioned: 32 extra pDUS, 14 computed tomography (CT) angiographies, and 2 reoperations. CT scan confirmed eHAT in 4 cases. In 10 cases of pDUS-suspected eHAT, where subsequent CT showed an open artery, the CONDOR signal was clearly pulsatile. In 2 of 4 patients with five eHATs, a weak arterial signal was inadvertently interpreted as an open artery (sensitivity of 60%). The accuracy for detection of eHAT increased from 93% (pDUS) to 99% (CONDOR). Using CONDOR, additional CT angiographies may be prevented in 10% of cases. CONCLUSION: CONDOR is a useful adjunct to pDUS because it reduces the false-positive rate of pDUS. Further development of the technique and analysis of the signal generated by CONDOR are needed to improve the sensitivity before CONDOR can replace pDUS as a reliable screening method for detection of eHAT.

Routine transplant Doppler ultrasonography following pediatric kidney transplant.

The utility and cost-effectiveness of routine transplant renal DU as a screening test in the immediate postoperative period following pediatric renal transplantation has not been systematically evaluated. Our center's transplant protocol includes a routine DU on postoperative day 3, unless an earlier DU was obtained for a specific indication. We retrospectively evaluated 113 consecutive pediatric renal transplant recipients. Indication for DU (routine vs. non-routine), timing, results, and graft outcome data were collected. We determined whether the DU result affected patient management. Eighty routine DU examinations were evaluated. Thirty (37.5%) of the 80 routine DUs had abnormalities. Most abnormalities were minor and did not require intervention. One patient with a dysfunctional bladder had mild hydronephrosis; this led to a decision to increase the frequency of bladder catheterization. This was the only intervention based upon the routine DUs. Twenty percent of routine DUs revealed abnormalities that led to a follow-up study, but none of these studies led to an intervention. The incremental cost of each DU exceeded $1080 and the incremental cost-effectiveness ratio for a documented change in management exceeded $86, 400. Our results suggest that routine post-transplant DU is not cost-effective in pediatric renal allograft recipients.

Non-invasive diagnostic assessment tools for the detection of liver fibrosis in patients with suspected alcohol-related liver disease: a systematic review and economic evaluation.

BACKGROUND: Excessive alcohol consumption may lead to the development of alcohol-related liver disease (ALD). Liver biopsy may be used in patients with suspected ALD to confirm the diagnosis, exclude other or additional liver pathologies, and provide accurate staging of the degree of liver injury in order to enable the prediction of prognosis and inform treatment decisions. However, as it is an invasive procedure that carries the risk of morbidity and mortality, current UK guidance recommends that biopsy is not required to confirm the diagnosis in patients with a high clinical suspicion of ALD in whom blood tests have excluded other causes of liver disease, unless it is necessary to confirm a diagnosis of acute alcoholic hepatitis in order to inform specific treatment decisions. OBJECTIVES: To evaluate the diagnostic accuracy, cost-effectiveness, and effect on patient outcomes of four non-invasive tests for liver fibrosis [the Enhanced Liver Fibrosis (ELF™) test (Siemens Healthcare Diagnostic Inc., Tarrytown, NY, USA), FibroTest (BioPredictive, Paris, France), FibroMAX (BioPredictive, Paris, France) and transient elastography (FibroScan(®); produced by EchoSens, Paris, France and distributed in the UK by Artemis Medical Ltd, Kent, UK)] in patients suspected of having ALD. DATA SOURCES: A systematic review was undertaken to identify studies reporting the diagnostic and prognostic accuracy of the ELF test, FibroTest, FibroMAX, and FibroScan for the identification of liver fibrosis and associated conditions in patients with suspected ALD. The following databases were searched in January 2010: MEDLINE (from 1950 to January 2010), MEDLINE In-Process & Other Non-Indexed Citations (from 1950 to January 2010), EMBASE (from 1980 to January 2010), Cochrane Database of Systematic Reviews (from 1996 to January 2010), Cochrane Central Register of Controlled Trials (from 1898 to January 2010), Cochrane Methodology Register (from 1904 to January 2010), Database of Abstracts of Reviews of Effects (from 1995 to January 2010), HTA Database (from 1995 to January 2010), NHS Economic Evaluation Database (from 1995 to January 2010), Cumulative Index to Nursing and Allied Health Literature (from 1982 to January 2010), Web of Knowledge and Science Citation Index (from 1969 to January 2010). REVIEW METHODS: Study quality was assessed using the QUADAS (Quality Assessment of Diagnostic Accuracy Studies) checklist. Owing to the heterogeneity of the studies, no formal meta-analysis was undertaken. A de novo mathematical model was constructed to estimate the incremental costs and incremental quality-adjusted life-years (QALYs) associated with alternative strategies compared with a biopsy-all strategy. The tests are assessed first as a replacement for liver biopsy, and secondly as an additional test prior to liver biopsy. Thirty-six scenarios were assessed for each non-invasive test strategy, which varied the sensitivity of biopsy, the anxiety associated with biopsy, sensitivity and specificity values and whether or not the biopsy was percutaneous or transjugular. For each scenario, threshold levels were reported where biopsying all patients was more cost-effective than the strategy for two parameters (the decreased level of abstinence associated with the strategy compared with biopsying all and the level of incidental QALY gain associated with biopsy). RESULTS: No studies were identified that specifically assessed the ELF test, although a study was identified that evaluated the diagnostic accuracy of the European Liver Fibrosis Test (essentially, the ELF test with the addition of age to the algorithm) compared with biopsy. Three studies of FibroTest, no relevant studies of FibroMax, and six studies of FibroScan assessing accuracy compared with biopsy in patients with known or suspected alcohol-related liver disease were identified. In all studies, the number of patients with suspected ALD was small, meaning that the estimated sensitivities and specificities were not robust. No conclusive estimate of the cost per QALY of each non-invasive test could be provided. Scenarios exist in which each of the strategies analysed is more cost-effective than biopsying all patients and, in contrast, scenarios exist in which each strategy is less cost-effective than biopsying all patients. LIMITATIONS: Study selection and data analysis were undertaken by one reviewer. CONCLUSIONS: No conclusive result can be provided on the most cost-effective strategy until further data are available. A large number of parameters require data; however, the following are selected as being of most importance: (1) the sensitivity and specificity of each non-invasive liver test (NILT) against biopsy at validated and pre-selected cut-off thresholds; (2) the influence of potential confounding variables such as current drinking behaviour and the degree of hepatic inflammation on the performance of NILTs; and (3) the likelihood, and magnitude, of decreases in abstinence rates associated with a diagnosis of significant ALD by diagnostic modality and the incidental gains in QALYs that may be associated with biopsy. FUNDING: The National Institute for Health Research Technology Assessment programme.