Sustained acoustic medicine as a non-surgical and non-opioid knee osteoarthritis treatment option: a health economic cost-effectiveness analysis for symptom management.

BACKGROUND: Patients diagnosed with osteoarthritis (OA) and presenting with symptoms are seeking conservative treatment options to reduce pain, improve function, and avoid surgery. Sustained acoustic medicine (SAM), a multi-hour treatment has demonstrated improved clinical outcomes for patients with knee OA. The purpose of this analysis was to compare the costs and effectiveness of multi-hour SAM treatment versus the standard of care (SOC) over a 6-month timeframe for OA symptom management. METHODS: A decision tree analysis was used to compare the costs and effectiveness of SAM treatment versus SOC in patients with OA. Probabilities of success for OA treatment and effectiveness were derived from the literature using systematic reviews and meta-analyses. Costs were derived from Medicare payment rates and manufacturer prices. Functional effectiveness was measured as the effect size of a therapy and treatment pathways compared to a SOC treatment pathway. A sensitivity analysis was performed to determine which cost variables had the greatest effect on deciding which option was the least costly. An incremental cost-effectiveness plot comparing SAM treatment vs. SOC was also generated using 1000 iterations of the model. Lastly, the incremental cost-effectiveness ratio (ICER) was calculated as the (cost of SAM minus cost of SOC) divided by (functional effectiveness of SAM minus functional effectiveness of SOC). RESULTS: Base case demonstrated that over 6 months, the cost and functional effectiveness of SAM was $8641 and 0.52 versus SOC at: $6281 and 0.39, respectively. Sensitivity analysis demonstrated that in order for SAM to be the less expensive option, the cost per 15-min session of PT would need to be greater than $88, or SAM would need to be priced at less than or equal to $2276. Incremental cost-effectiveness demonstrated that most of the time (84%) SAM treatment resulted in improved functional effectiveness but at a higher cost than SOC. CONCLUSION: In patients with osteoarthritis, SAM treatment demonstrated improved pain and functional gains compared to SOC but at an increased cost. Based on the SAM treatment ICER score being ≤ $50,000, it appears that SAM is a cost-effective treatment for knee OA.

From Anatomy to Functional and Molecular Biomarker Imaging and Therapy: Ultrasound Is Safe, Ultrafast, Portable, and Inexpensive.

Ultrasound is the most widely used medical imaging modality worldwide. It is abundant, extremely safe, portable, and inexpensive. In this review, we consider some of the current development trends for ultrasound imaging, which build upon its current strength and the popularity it experiences among medical imaging professional users.Ultrasound has rapidly expanded beyond traditional radiology departments and cardiology practices. Computing power and data processing capabilities of commonly available electronics put ultrasound systems in a lab coat pocket or on a user's mobile phone. Taking advantage of new contributions and discoveries in ultrasound physics, signal processing algorithms, and electronics, the performance of ultrasound systems and transducers have progressed in terms of them becoming smaller, with higher imaging performance, and having lower cost. Ultrasound operates in real time, now at ultrafast speeds; kilohertz frame rates are already achieved by many systems.Ultrasound has progressed beyond anatomical imaging and monitoring blood flow in large vessels. With clinical approval of ultrasound contrast agents (gas-filled microbubbles) that are administered in the bloodstream, tissue perfusion studies are now routine. Through the use of modern ultrasound pulse sequences, individual microbubbles, with subpicogram mass, can be detected and observed in real time, many centimeters deep in the body. Ultrasound imaging has broken the wavelength barrier; by tracking positions of microbubbles within the vasculature, superresolution imaging has been made possible. Ultrasound can now trace the smallest vessels and capillaries, and obtain blood velocity data in those vessels.Molecular ultrasound imaging has now moved closer to clinic; the use of microbubbles with a specific affinity to endothelial biomarkers allows selective accumulation and retention of ultrasound contrast in the areas of ischemic injury, inflammation, or neoangiogenesis. This will aid in noninvasive molecular imaging and may provide additional help with real-time guidance of biopsy, surgery, and ablation procedures.The ultrasound field can be tightly focused inside the body, many centimeters deep, with millimeter precision, and ablate lesions by energy deposition, with thermal or mechanical bioeffects. Some of such treatments are already in clinical use, with more indications progressing through the clinical trial stage. In conjunction with intravascular microbubbles, focused ultrasound can be used for tissue-specific drug delivery; localized triggered release of sequestered drugs from particles in the bloodstream may take time to get to clinic. A combination of intravascular microbubbles with circulating drug and low-power ultrasound allows transient opening of vascular endothelial barriers, including blood-brain barrier; this approach has reached clinical trial stage. Therefore, the drugs that normally would not be getting to the target tissue in the brain will now have an opportunity to produce therapeutic efficacy.Overall, medical ultrasound is developing at a brisk rate, even in an environment where other imaging modalities are also advancing rapidly and may be considered more lucrative. With all the current advances that we discuss, and many more to come, ultrasound may help solve many problems that modern medicine is facing.

Cost-minimisation model of magnetic resonance-guided focussed ultrasound therapy compared to unilateral deep brain stimulation for essential tremor treatment in Japan.

OBJECTIVE: To investigate the cost differences between magnetic resonance-guided focussed ultrasound (MRgFUS) and unilateral deep brain stimulation (DBS) for the treatment of medication-refractory essential tremor (ET) in Japan using a cost-minimisation model. METHODS: A cost-minimisation model estimated total costs for MRgFUS and unilateral DBS by summing the pre-procedure, procedure, and post-procedure costs over a 12-month time horizon, using data from published sources and expert clinical opinion. The model base case considered medical costs from fee-for-service tariffs. Scenario analyses investigated the use of Diagnosis Procedure Combination tariffs, a diagnosis-related group-based fixed-payment system, and the addition of healthcare professional labour costs healthcare professionals using tariffs from the Japanese Health Insurance Federation for Surgery. One-way sensitivity analyses altered costs associated with tremor recurrence after MRgFUS, the extraction rate following unilateral DBS, the length of hospitalisation for unilateral DBS and the procedure duration for MRgFUS. The impact of uncertainty in model parameters on the model results was further explored using probabilistic sensitivity analysis. RESULTS: Compared to unilateral DBS, MRgFUS was cost saving in the base case and Diagnosis Procedure Combination cost scenario, with total savings of JPY400,380 and JPY414,691, respectively. The majority of savings were accrued at the procedural stage. Including labour costs further increased the cost differences between MRgFUS and unilateral DBS. Cost savings were maintained in each sensitivity analysis and the probabilistic sensitivity analysis, demonstrating that the model results are highly robust. CONCLUSIONS: In the Japanese healthcare setting, MRgFUS could be a cost saving option versus unilateral DBS for treating medication-refractory ET. The model results may even be conservative, as the cost of multiple follow-ups for unilateral DBS and treatment costs for adverse events associated with each procedure were not included. This model is also consistent with the results of other economic analyses of MRgFUS versus DBS in various settings worldwide.

Magnetic Resonance-Guided Focused Ultrasound Neurosurgery for Essential Tremor: A Health Technology Assessment.

BACKGROUND: The standard treatment option for medication-refractory essential tremor is invasive neurosurgery. A new, noninvasive alternative is magnetic resonance-guided focused ultrasound (MRgFUS) neurosurgery. We aimed to determine the effectiveness, safety, and cost-effectiveness of MRgFUS neurosurgery for the treatment of moderate to severe, medication-refractory essential tremor in Ontario. We also spoke with people with essential tremor to gain an understanding of their experiences and thoughts regarding treatment options, including MRgFUS neurosurgery. METHODS: We performed a systematic review of the clinical literature published up to April 11, 2017, that examined MRgFUS neurosurgery alone or compared with other interventions for the treatment of moderate to severe, medication-refractory essential tremor. We assessed the risk of bias of each study and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic review of the economic literature and created Markov cohort models to assess the cost-effectiveness of MRgFUS neurosurgery compared with other treatment options, including no surgery. We also estimated the budget impact of publicly funding MRgFUS neurosurgery in Ontario for the next 5 years. To contextualize the potential value of MRgFUS neurosurgery as a treatment option for essential tremor, we spoke with people with essential tremor and their families. RESULTS: Nine studies met our inclusion criteria for the clinical evidence review. In noncomparative studies, MRgFUS neurosurgery was found to significantly improve tremor severity and quality of life and to significantly reduce functional disability (GRADE: very low). It was also found to be significantly more effective than a sham procedure (GRADE: high). We found no significant difference in improvements in tremor severity, functional disability, or quality of life between MRgFUS neurosurgery and deep brain stimulation (GRADE: very low). We found no significant difference in improvement in tremor severity compared with radiofrequency thalamotomy (GRADE: low). MRgFUS neurosurgery has a favourable safety profile.We estimated that MRgFUS neurosurgery has a mean cost of $23,507 and a mean quality-adjusted survival of 3.69 quality-adjusted life-years (QALYs). We also estimated that the mean costs and QALYs of radiofrequency thalamotomy and deep brain stimulation are $14,978 and 3.61 QALYs, and $57,535 and 3.94 QALYs, respectively. For people ineligible for invasive neurosurgery, we estimated the incremental cost-effectiveness ratio (ICER) of MRgFUS neurosurgery compared with no surgery as $43,075 per QALY gained. In people eligible for invasive neurosurgery, the ICER of MRgFUS neurosurgery compared with radiofrequency thalamotomy is $109,795 per QALY gained; when deep brain stimulation is compared with MRgFUS neurosurgery, the ICER is $134,259 per QALY gained. Of note however, radiofrequency thalamotomy is performed very infrequently in Ontario. We also estimated that the budget impact of publicly funding MRgFUS neurosurgery in Ontario at the current case load (i.e., 48 cases/year) would be about $1 million per year for the next 5 years.People with essential tremor who had undergone MRgFUS neurosurgery reported positive experiences with the procedure. The tremor reduction they experienced improved their ability to perform activities of daily living and improved their quality of life. CONCLUSIONS: MRgFUS neurosurgery is an effective and generally safe treatment option for moderate to severe, medication-refractory essential tremor. It provides a treatment option for people ineligible for invasive neurosurgery and offers a noninvasive option for all people considering neurosurgery.For people ineligible for invasive neurosurgery, MRgFUS neurosurgery is cost-effective compared with no surgery. In people eligible for invasive neurosurgery, MRgFUS neurosurgery may be one of several reasonable options. Publicly funding MRgFUS neurosurgery for the treatment of moderate to severe, medication-refractory essential tremor in Ontario at the current case load would have a net budget impact of about $1 million per year for the next 5 years.People with essential tremor who had undergone MRgFUS neurosurgery reported positive experiences. They liked that it was a noninvasive procedure and reported a substantial reduction in tremor that resulted in an improvement in their quality of life.

Low-intensity pulsed ultrasound for treatment of tibial fractures: an economic evaluation of the TRUST study.

AIMS: This 501-patient, multi-centre, randomised controlled trial sought to establish the effect of low-intensity, pulsed, ultrasound (LIPUS) on tibial shaft fractures managed with intramedullary nailing. We conducted an economic evaluation as part of this trial. PATIENTS AND METHODS: Data for patients' use of post-operative healthcare resources and time taken to return to work were collected and costed using publicly available sources. Health-related quality of life, assessed using the Health Utilities Index Mark-3 (HUI-3), was used to derive quality-adjusted life years (QALYs). Costs and QALYs were compared between LIPUS and control (a placebo device) from a payer and societal perspective using non-parametric bootstrapping. All costs are reported in 2015 Canadian dollars unless otherwise stated. RESULTS: With a cost per device of $3,995, the mean cost was significantly higher for patients treated with LIPUS versus placebo from a payer (mean increase = $3647, 95% confidence interval (CI) $3244 to $4070; p < 0.001) or a societal perspective (mean increase = $3425, 95% CI $1568 to $5283; p < 0.001). LIPUS did not provide a significant benefit in terms of QALYs gained (mean difference = 0.023 QALYs, 95% CI -0.035 to 0.069; p = 0.474). Incremental cost-effectiveness ratios of LIPUS compared with placebo were $155 433/QALY from a payer perspective and $146 006/QALY from a societal perspective. CONCLUSION: At the current price, LIPUS is not cost-effective for fresh tibial fractures managed with intramedullary nailing. Cite this article: Bone Joint J 2017;99-B:1526-32.

Therapeutic ultrasound for venous leg ulcers.

BACKGROUND: Venous leg ulcers are a type of chronic, recurring, complex wound that is more common in people aged over 65 years. Venous ulcers pose a significant burden to patients and healthcare systems. While compression therapy (such as bandages or stockings) is an effective first-line treatment, ultrasound may have a role to play in healing venous ulcers. OBJECTIVES: To determine whether venous leg ulcers treated with ultrasound heal more quickly than those not treated with ultrasound. SEARCH METHODS: We searched the Cochrane Wounds Specialised Register (searched 19 September 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library 2016, Issue 8); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations, MEDLINE Daily and Epub Ahead of Print) (1946 to 19 September 2016); Ovid Embase (1974 to 19 September 2016); and EBSCO CINAHL Plus (1937 to 19 September 2016). We also searched three clinical trials registries and the references of included studies and relevant systematic reviews. There were no restrictions based on language, date of publication or study setting. SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared ultrasound with no ultrasound. Eligible non-ultrasound comparator treatments included usual care, sham ultrasound and alternative leg ulcer treatments. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the search results and selected eligible studies. Details from included studies were summarised using a data extraction sheet, and double-checked. We attempted to contact trial authors for missing data. MAIN RESULTS: Eleven trials are included in this update; 10 of these we judged to be at an unclear or high risk of bias. The trials were clinically heterogeneous with differences in duration of follow-up, and ultrasound regimens. Nine trials evaluated high frequency ultrasound; seven studies provided data for ulcers healed and two provided data on change in ulcer size only. Two trials evaluated low frequency ultrasound and both reported ulcers healed data.It is uncertain whether high frequency ultrasound affects the proportion of ulcers healed compared with no ultrasound at any of the time points evaluated: at seven to eight weeks (RR 1.21, 95% CI 0.86 to 1.71; 6 trials, 678 participants; low quality evidence - downgraded once for risk of bias and once for imprecision); at 12 weeks (RR 1.26, 95% CI 0.92 to 1.73; 3 trials, 489 participants; moderate quality evidence - downgraded once for imprecision); and at 12 months (RR 0.93, 95% CI 0.73 to 1.18; 1 trial, 337 participants; low quality evidence - downgraded once for unclear risk of bias and once for imprecision).One trial (92 participants) reported that a greater percentage reduction in ulcer area was achieved at four weeks with high-frequency ultrasound, while another (73 participants) reported no clear difference in change in ulcer size at seven weeks. We downgraded the level of this evidence to very low, mainly for risk of bias (typically lack of blinded outcome assessment and attrition) and imprecision.Data from one trial (337 participants) suggest that high frequency ultrasound may increase the risk of non-serious adverse events (RR 1.29, 95% CI 1.02 to 1.64; moderate quality evidence - downgraded once for imprecision) and serious adverse events (RR 1.21, 95% CI 0.78 to 1.89; moderate quality evidence downgraded once for imprecision).It is uncertain whether low frequency ultrasound affects venous ulcer healing at eight and 12 weeks (RR 3.91, 95% CI 0.47 to 32.85; 2 trials, 61 participants; very low quality evidence (downgraded for risk of bias and imprecision)).High-frequency ultrasound probably makes little or no difference to quality of life (moderate quality evidence, downgraded for imprecision). The outcomes of adverse effects, quality of life and cost were not reported for low-frequency ultrasound treatment. AUTHORS' CONCLUSIONS: It is uncertain whether therapeutic ultrasound (either high or low frequency) improves the healing of venous leg ulcers. We rated most of the evidence as low or very low quality due to risk of bias and imprecision.

The Thunderbeat and Other Energy Devices in Laparoscopic Colorectal Resections: Analysis of Outcomes and Costs.

BACKGROUND: The THUNDERBEAT™ (TB) is a recently developed energy-based device. To date, there are no clinical studies comparing TB and other energy sources, such as standard electrosurgery (ES), ultrasonic coagulating shears (US) and electrothermal bipolar vessel sealers (EBVS) in patients undergoing laparoscopic colorectal resection (LCR). The aim of this study was to compare outcomes and costs in patients undergoing LCR with TB, US, EBVS, or ES for both benign and malignant colorectal diseases. METHODS: This study is a retrospective analysis of a prospective database of patients undergoing LCR. Unselected consecutive patients who had the laparoscopic dissection conducted by using TB were compared with consecutive patients undergoing LCR with US, EBVS, or ES. RESULTS: Mean operative time did not significantly differ between the groups (P = .947). Estimated blood loss was significantly higher in the ES group (P < .001). Device-related complications occurred in 2.5% of ES patients, in 2.5% of US patients, and in 5% of EBVS patients, while no complications occurred in TB patients (P = .768). No significant differences were observed in postoperative complication rates between the groups. Mean postoperative hospital stay was similar in the groups. Cost analysis showed no significant differences between US (1519.1 ± 303 €), EBVS (1474.4 ± 372.8 €), and TB (1474.3 ± 176.3 €) (P = .737). CONCLUSION: This is the first clinical study comparing TB and other energy-based devices in LCR. They all appear to be equally safe and effective. Costs of surgery are very similar. Further large randomized controlled trials are needed to confirm these data.

Low-intensity pulsed ultrasound (LIPUS) can decrease the economic burden of fracture non-union.

OBJECTIVES: Few studies have evaluated the economic burden of surgical and conservative treatment of fracture non-union. An analysis was undertaken of aggregated payer data to determine economic costs of non-unions treated with surgery only vs non-unions treated conservatively with low-intensity pulsed ultrasound (LIPUS) only. METHODS: This study used administrative claims from a health plan database including nearly 80 million people. Patients with a claim for non-union surgery or LIPUS for non-union were identified, from April 2007 until April 2010. A retrospective cohort was formed by pairwise demographic matching among patients who received 'Surgery Only' or 'LIPUS Only'. Date of the first non-union intervention (surgery or LIPUS) was defined as the index date. All medical costs were assessed over 12 months following the index date for the 'Surgery Only' and 'LIPUS Only' cohorts. RESULTS: A total of 1158 matched patients were identified. 'Surgery Only' patients used significantly more healthcare services. In the year following intervention, 'Surgery Only' patients had total medical costs $6289 higher than 'LIPUS Only' patients (Mean = $11,276 vs $4986; p < 0.0001). Outpatient costs accounted for >68% of overall costs in both cohorts, and outpatient costs were significantly higher among the 'Surgery Only' cohort (Mean = $7682 vs $4196; p < 0.0001). Total inpatient costs were also significantly higher among the 'Surgery Only' cohort (Mean = $3302 vs $381; p < 0.0001). LIMITATIONS: Limitations of this work are typical of all studies based on administrative claims data: errors in the database are assumed to distribute randomly between cohorts, and some patients may have been miscoded as to treatment received or costs billed. CONCLUSIONS: 'Surgery Only' patients used significantly and substantially more healthcare services in treatment of fracture non-union. Conservative treatment with 'LIPUS only' for fracture non-union could potentially result in cost savings projected to roughly $1 billion dollars [corrected].

What is the clinical effectiveness and cost-effectiveness of conservative interventions for tendinopathy? An overview of systematic reviews of clinical effectiveness and systematic review of economic evaluations.

BACKGROUND: Lateral elbow tendinopathy (LET) is a common complaint causing characteristic pain in the lateral elbow and upper forearm, and tenderness of the forearm extensor muscles. It is thought to be an overuse injury and can have a major impact on the patient's social and professional life. The condition is challenging to treat and prone to recurrent episodes. The average duration of a typical episode ranges from 6 to 24 months, with most (89%) reporting recovery by 1 year. OBJECTIVES: This systematic review aims to summarise the evidence concerning the clinical effectiveness and cost-effectiveness of conservative interventions for LET. DATA SOURCES: A comprehensive search was conducted from database inception to 2012 in a range of databases including MEDLINE, EMBASE and Cochrane Databases. METHODS AND OUTCOMES: We conducted an overview of systematic reviews to summarise the current evidence concerning the clinical effectiveness and a systematic review for the cost-effectiveness of conservative interventions for LET. We identified additional randomised controlled trials (RCTs) that could contribute further evidence to existing systematic reviews. We searched MEDLINE, EMBASE, Allied and Complementary Medicine Database, Cumulative Index to Nursing and Allied Health Literature, Web of Science, The Cochrane Library and other important databases from inception to January 2013. RESULTS: A total of 29 systematic reviews published since 2003 matched our inclusion criteria. These were quality appraised using the Assessment of Multiple Systematic Reviews (AMSTAR) checklist; five were considered high quality and evaluated using a Grading of Recommendations, Assessment, Development and Evaluation approach. A total of 36 RCTs were identified that were not included in a systematic review and 29 RCTs were identified that had only been evaluated in an included systematic review of intermediate/low quality. These were then mapped to existing systematic reviews where further evidence could provide updates. Two economic evaluations were identified. LIMITATIONS: The summary of findings from the review was based only on high-quality evidence (scoring of > 5 AMSTAR). Other limitations were that identified RCTs were not quality appraised and dichotomous outcomes were also not considered. Economic evaluations took effectiveness estimates from trials that had small sample sizes leading to uncertainty surrounding the effect sizes reported. This, in turn, led to uncertainty of the reported cost-effectiveness and, as such, no robust recommendations could be made in this respect. CONCLUSIONS: Clinical effectiveness evidence from the high-quality systematic reviews identified in this overview continues to suggest uncertainty as to the effectiveness of many conservative interventions for the treatment of LET. Although new RCT evidence has been identified with either placebo or active controls, there is uncertainty as to the size of effects reported within them because of the small sample size. Conclusions regarding cost-effectiveness are also unclear. We consider that, although updated or new systematic reviews may also be of value, the primary focus of future work should be on conducting large-scale, good-quality clinical trials using a core set of outcome measures (for defined time points) and appropriate follow-up. Subgroup analysis of existing RCT data may be beneficial to ascertain whether or not certain patient groups are more likely to respond to treatments. STUDY REGISTRATION: This study is registered as PROSPERO CRD42013003593. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing: a NICE medical technology guidance.

A routine part of the process for developing National Institute for Health and Care Excellence (NICE) medical technologies guidance is a submission of clinical and economic evidence by the technology manufacturer. The Birmingham and Brunel Consortium External Assessment Centre (EAC; a consortium of the University of Birmingham and Brunel University) independently appraised the submission on the EXOGEN bone healing system for long bone fractures with non-union or delayed healing. This article is an overview of the original evidence submitted, the EAC's findings, and the final NICE guidance issued.

MRI-guided focused ultrasound surgery for uterine fibroid treatment: a cost-effectiveness analysis.

OBJECTIVE. The purpose of this article is to evaluate the cost effectiveness of a treatment strategy for symptomatic uterine fibroids that uses MRI-guided focused ultrasound as a first-line therapy relative to uterine artery embolization (UAE) or hysterectomy. MATERIALS AND METHODS. We developed a decision-analytic model to compare the cost effectiveness of three first-line treatment strategies: MRI-guided focused ultrasound, UAE, and hysterectomy. Treatment-specific short- and long-term utilities, lifetime costs, and quality-adjusted life years (QALYs) were incorporated, allowing us to conduct an incremental cost-effectiveness analysis, using a societal willingness-to-pay (WTP) threshold of $50,000/QALY to designate a strategy as cost effective. Sensitivity analyses were subsequently performed on all key parameters. RESULTS. In the base-case analysis, UAE as a first-line treatment of symptomatic fibroids was the most effective and expensive strategy (22.75 QALYs; $22,968), followed by MRI-guided focused ultrasound (22.73 QALYs; $20,252) and hysterectomy (22.54 QALYs; $11,253). MRI-guided focused ultrasound was cost effective relative to hysterectomy, with an associated incremental cost-effectiveness ratio (ICER) of $47,891/QALY. The ICER of UAE relative to MRI-guided focused ultrasound was $234,565/QALY, exceeding the WTP threshold of $50,000/QALY, therefore rendering MRI-guided focused ultrasound also cost effective relative to UAE. In sensitivity analyses, results were robust to changes in most parameters but were sensitive to changes in probabilities of recurrence, symptom relief, and quality-of-life measures. CONCLUSION. First-line treatment of eligible women with MRI-guided focused ultra-sound is a cost-effective noninvasive strategy. For those not eligible for MRI-guided focused ultra-sound, UAE remains a cost-effective option. These recommendations integrate both the short- and long-term decrements in quality of life associated with the specific treatment modalities.

Managing chronic conditions: economic analysis can help mitigate costs of diabetic ulcers.

Hospital finance leaders should perform economic analyses of emerging treatments for chronic conditions that could provide cost-effective alternatives to generally accepted standards of care. One such treatment for diabetic foot ulcers (DFUs) is noncontact low-frequency ultrasound, which has been shown to reduce both costs and healing times associated with these conditions. By reviewing results of clinical trials to understand the costs and treatment considerations for DFUs and other chronic conditions, finance leaders can engage in informed conversations with physicians on how best to manage costs.

Cost analysis comparing ultrasonic fundus-first and conventional laparoscopic cholecystectomy using electrocautery.

BACKGROUND: Costs associated with laparoscopic fundus-first cholecystectomy using ultrasonic dissection versus a conventional laparoscopic cholecystectomy has not been compared. METHODS: Adult patients subjected to elective laparoscopic cholecystectomy between June 2002 and March 2004 were randomized to either an ultrasonic fundus-first dissection or dissection from the triangle of Calot with electrocautery. Differences in direct and indirect costs related to either technique were studied. RESULTS: The duration of the operation and hospitalization was longer when dissection was with the conventional technique. With the ultrasonic fundus-first technique, the direct cost was 1,190 SEK lower, and the total cost, taking also the cost for sick leave into account, was 5,370 SEK lower. CONCLUSIONS: Both direct and indirect costs are lower with a laparoscopic fundus-first cholecystectomy using ultrasonic dissection than conventional laparoscopic cholecystectomy using electrocautery.

Extracorporeal shock wave therapy (ESWT) for wound healing: technology, mechanisms, and clinical efficacy.

For almost 30 years, extracorporeal shock wave therapy has been clinically implemented as an effective treatment to disintegrate urinary stones. This technology has also emerged as an effective noninvasive treatment modality for several orthopedic and traumatic indications including problematic soft tissue wounds. Delayed/nonhealing or chronic wounds constitute a burden for each patient affected, significantly impairing quality of life. Intensive wound care is required, and this places an enormous burden on society in terms of lost productivity and healthcare costs. Therefore, cost-effective, noninvasive, and efficacious treatments are imperative to achieve both (accelerated and complete) healing of problematic wounds and reduce treatment-related costs. Several experimental and clinical studies show efficacy for extracorporeal shock wave therapy as means to accelerate tissue repair and regeneration in various wounds. However, the biomolecular mechanism by which this treatment modality exerts its therapeutic effects remains unclear. Potential mechanisms, which are discussed herein, include initial neovascularization with ensuing durable and functional angiogenesis. Furthermore, recruitment of mesenchymal stem cells, stimulated cell proliferation and differentiation, and anti-inflammatory and antimicrobial effects as well as suppression of nociception are considered important facets of the biological responses to therapeutic shock waves. This review aims to provide an overview of shock wave therapy, its history and development as well as its current place in clinical practice. Recent research advances are discussed emphasizing the role of extracorporeal shock wave therapy in soft tissue wound healing.

The efficacy, safety, effectiveness, and cost-effectiveness of ultrasound and shock wave therapies for low back pain: a systematic review.

BACKGROUND CONTEXT: Shock wave and especially ultrasound are commonly used to treat low back pain (LBP) in routine practice. PURPOSE: To assess the evidence on the efficacy, effectiveness, cost-effectiveness, and safety of ultrasound and shock wave to treat LBP. STUDY DESIGN: Systematic review. METHODS: An electronic search was performed in MEDLINE, EMBASE, and the Cochrane Library databases up to July 2009 to identify randomized controlled trials (RCTs) comparing vibrotherapy with placebo or with other treatments for LBP. No language restrictions were applied. Additional data were requested from the authors of the original studies. The risk of bias of each study was assessed following the criteria recommended by the Cochrane Back Review Group. RESULTS: Thirteen studies were identified. The four RCTs complying with the inclusion criteria included 252 patients. Two of the three RCTs on ultrasound had a high risk of bias. For acute patients with LBP and leg pain attributed to disc herniation, ultrasound, traction, and low-power laser obtained similar results. For chronic LBP patients without leg pain, ultrasound was less effective than spinal manipulation, whereas a shock wave device and transcutaneous electrical nerve stimulation led to similar results. Results from the only study comparing ultrasound versus a sham procedure are unreliable because of the inappropriateness of the sham procedure, low sample size, and lack of adjustment for potential confounders. No study assessed cost-effectiveness. No adverse events were reported. CONCLUSION: The available evidence does not support the effectiveness of ultrasound or shock wave for treating LBP. High-quality RCTs are needed to assess their efficacy versus appropriate sham procedures, and their effectiveness and cost-effectiveness versus other procedures shown to be effective for LBP. In the absence of such evidence, the clinical use of these forms of treatment is not justified and should be discouraged.

Economic evaluation of a randomized controlled trial of ultrasound therapy for hard-to-heal venous leg ulcers.

BACKGROUND: A pragmatic, multicentre randomized controlled trial (VenUS III) was conducted to determine whether low-dose ultrasound therapy increased the healing rate of hard-to-heal leg ulcers. This study was a cost-effectiveness analysis of the trial data. METHODS: Cost-effectiveness and cost-utility analyses were conducted alongside the VenUS III trial, in which patients were randomly allocated to either ultrasound treatment administered weekly for 12 weeks along with standard care, or standard care alone. The time horizon was 12 months and based on the UK National Health Service (NHS) perspective. RESULTS: The base-case analysis showed that ultrasound therapy added to standard care was likely to be more costly and provide no extra benefit over standard care alone. Individuals who received ultrasound treatment plus standard care took a mean of 14.7 (95 per cent confidence interval - 32.7 to 56.8) days longer to heal, had 0.009 (-0.042 to 0.024) fewer quality-adjusted life years and had higher treatment costs by £ 197.88 (-35.19 to 420.32). Based on these point estimates, ultrasound therapy plus standard care for leg ulcers was dominated by standard care alone. The analysis of uncertainty showed that this treatment strategy is unlikely to be cost-effective. CONCLUSION: Ultrasound treatment was not cost-effective for hard-to-heal leg ulcers and should not be recommended for adoption in the NHS.

Therapeutic ultrasound for venous leg ulcers.

BACKGROUND: Venous leg ulcers pose a significant burden for patients and healthcare systems. Ultrasound (US) may be a useful treatment for these ulcers. OBJECTIVES: To determine whether US increases the healing of venous leg ulcers. SEARCH STRATEGY: We searched the Cochrane Wounds Group Specialised Register (searched 24 February 2010); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2010); Ovid MEDLINE (1950 to February Week 2 2010); In-Process & Other Non-Indexed Citations (searched 24 February 2010); Ovid EMBASE 1980 to 2010 Week 07; EBSCO CINAHL 1982 to 24 February 2010. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing US with no US. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the search results and selected eligible studies. Details from included studies were summarised using a data extraction sheet, and double-checked. We tried to contact trial authors for missing data. MAIN RESULTS: Eight trials were included; all had unclear, or high, risks of bias, with differences in duration of follow-up, and US regimens. Six trials evaluated high frequency US and five of these reported healing at 7 - 8 weeks. Significantly more patients healed with US than without it at 7 - 8 weeks (pooled RR 1.4, 95% CI 1.0 to 1.96), but later assessments at 12 weeks showed the increased risk of healing with US was no longer statistically significant (pooled RR 1.47, 95% CI 0.99 to 2.20). One poor-quality study of high-frequency US found no evidence of an effect on healing after three weeks' treatment.Two trials evaluated low frequency US and reported healing at different time points. Both trials reported no evidence of a difference in the proportion of ulcers healed with US compared with no US: both were significantly underpowered. AUTHORS' CONCLUSIONS: The trials evaluating US for venous leg ulcers are small, poor-quality and heterogeneous. There is no reliable evidence that US hastens healing of venous ulcers. There is a small amount of weak evidence of increased healing with US, but this requires confirmation in larger, high-quality RCTs. There is no evidence of a benefit associated with low frequency US.