Dataset Information

A Systematic Review of the Level of Evidence in Economic Evaluations of Medical Devices: The Example of Vertebroplasty and Kyphoplasty.

ABSTRACT:

Context

Economic evaluations are far less frequently reported for medical devices than for drugs. In addition, little is known about the quality of existing economic evaluations, particularly for innovative devices, such as those used in vertebroplasty and kyphoplasty.

Objective

To assess the level of evidence provided by the available economic evaluations for vertebroplasty and kyphoplasty.

Data sources

A systematic review of articles in English or French listed in the MEDLINE, PASCAL, COCHRANE and National Health Service Economic Evaluation databases, with limits on publication date (up to the date of the review, March 2014).

Study selection

We included only economic evaluations of vertebroplasty or kyphoplasty. Editorial and methodological articles were excluded.

Data extraction

Data were extracted from articles by two authors working independently and using two analysis grids to measure the quality of economic evaluations.

Data synthesis

Twenty-one studies met our inclusion criteria. All were published between 2008 and 2014. Eighteen (86%) were full economic evaluations. Cost-effectiveness analysis (CEA) was the most frequent type of economic evaluation, and was present in 11 (52%) studies. Only three CEAs complied fully with the British Medical Journal checklist. The quality of the data sources used in the 21 studies was high, but the CEAs conforming to methodological guidelines did not use high-quality data sources for all components of the analysis.

Conclusions

This systematic review shows that the level of evidence in economic evaluations of vertebroplasty and kyphoplasty is low, despite the recent publication of a large number of studies. This finding highlights the challenges to be faced to improve the quality of economic evaluations of medical devices.

SUBMITTER: Martelli N

PROVIDER: S-EPMC4675526 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Systematic Review of the Level of Evidence in Economic Evaluations of Medical Devices: The Example of Vertebroplasty and Kyphoplasty.

Martelli Nicolas N Devaux Capucine C van den Brink Hélène H Pineau Judith J Prognon Patrice P Borget Isabelle I

PloS one 20151210 12

<h4>Context</h4>Economic evaluations are far less frequently reported for medical devices than for drugs. In addition, little is known about the quality of existing economic evaluations, particularly for innovative devices, such as those used in vertebroplasty and kyphoplasty.<h4>Objective</h4>To assess the level of evidence provided by the available economic evaluations for vertebroplasty and kyphoplasty.<h4>Data sources</h4>A systematic review of articles in English or French listed in the MED ...[more]

PMID: 26661078

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Project description:The cost-effectiveness of surgical versus conservative medical management of vertebral compression fractures in the US was analyzed in the context of inpatient versus outpatient treatment. Surgical intervention (balloon kyphoplasty and vertebroplasty) was found to be cost-effective relative to conservative medical management at a US willingness-to-pay threshold.IntroductionTo date, only one published study has evaluated the cost-effectiveness (C/E) of balloon kyphoplasty (BKP) or vertebroplasty (VP) in US Medicare patients with osteoporotic vertebral compression fractures. This study further evaluates the C/E of surgical treatment vs. conservative medical management (CMM), expanding on prior modeling by accounting for quality-adjusted life-years gained.MethodsA Markov microsimulation model of 1000 patients was constructed. Cost data were based on an analysis of Medicare claims payments, with propensity-score matching performed for BKP and VP vs. controls (CMM). Mortality inputs were based on US life tables, modified to account for age at initial fracture, presence of subsequent fracture(s), and relative risk of mortality by treatment. Separate incremental cost-effectiveness ratios (ICERs) were calculated for BKP and VP in inpatient and outpatient surgical treatment locations to account for individual clinical profiles presenting to each.ResultsThe discounted ICER for inpatient BKP vs. CMM was $43,455 per QALY gained; for outpatient BKP vs. CMM, $10,922; for inpatient VP vs. CMM, $39,774; and for outpatient VP vs. CMM, $12,293. Probabilistic sensitivity analysis confirmed that both BKP and VP would be considered C/E vs. CMM at a US willingness-to-pay (WTP) threshold of $50,000/QALY in 80% and 100% of 500 model simulations, respectively. The most sensitive parameters included quality of life estimates and hazard ratios for mortality.ConclusionWhile VP and BKP are more expensive treatment options than CMM in the short term, model results suggest interventional treatment is cost-effective, among patients eligible for surgery, at a US WTP threshold. This conclusion supports those from economic analyses conducted in EU-member countries.

Project description:STUDY DESIGN: Comparative effectiveness review. STUDY RATIONALE: The spine is among the most common location for bony metastases. In many cases these metastases cause fractures leading to increased morbidity. Percutaneous cement augmentation techniques have been developed over the past decades for the treatment of these fractures; however, there are little data comparing these interventions. CLINICAL QUESTION: Do comparative studies of vertebral cement augmentation for fractures caused by spinal tumors provide evidence of improved patient outcomes? METHODS: A systematic search and review of the literature was undertaken to identify studies published through June 8, 2011. Two individuals independently reviewed articles based on inclusion and exclusion criteria which were set a priori. Each article was evaluated using a predefined quality-rating system and an overall strength of evidence determined. RESULTS: The literature consists primarily of case series. Only two studies comparing vertebroplasty with kyphoplasty were found. Pain scores in both treatment groups were significantly decreased relative to preoperative scores and appear to have been sustained at follow-up times to 1 year. It is unclear whether one treatment provided superior pain relief than the other. Both studies reported decreased analgesic use after both treatments but neither study compared use between treatment groups. Balloon rupture occurred in one kyphoplasty patient in one study and extravasation of polymethylmethacrylate (PMMA) cement into the anterior perivertebral soft tissue was seen in another patient in the vertebroplasty group and no patients in the kyphoplasty group in the other study. No other intraoperative or postoperative complications occurred. CONCLUSIONS: There is only limited evidence from comparative studies (two small retrospective cohort studies) regarding the benefits of vertebroplasty versus kyphoplasty in patients with spinal fractures caused by tumors. Both appear to be effective in reducing pain with relatively few complications. Whether one method provides superior results over the other cannot be determined from the available evidence. Study limitations preclude making definitive conclusions. The overall strength of evidenced is very low.

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Project description:BackgroundOsteoporotic vertebral compression fractures (OVCF) is a common and often debilitating complication of osteoporosis, leading to significant morbidity and increased mortality. Percutaneous vertebroplasty (PVP) and Percutaneous kyphoplasty (PKP) are recommendable surgical treatments for OVCF.ObjectiveTo evaluate PVP/PKP utilisation and their related direct medical costs for OVCF treatment in China from the payer perspective.MethodsA population-based medical claims database of a metropolitan city in China was analysed from the payer perspective, which included all inpatient claims from 01/01/2015 to 31/12/2017. All vertebral fractures patients that met the eligibility criteria (aged ≥50 years old, having vertebral fracture diagnosis, without unrelated diseases diagnoses such as tumour and scoliosis, received PVP/PKP) were deemed as OVCF patients. Baseline characteristics, surgery rate, length of stay in hospital, time to re-surgery, and costs (including costs per hospitalisation and annual costs) were described. Survival analysis function was used to estimate the re-surgery rate.ResultsOf the 50,686 patients with OVCF identified, 14,527 (28.66%) received a total number of 15,599 records of PVP/PKP surgeries from 2015 to 2017. Mean age was 75 at the first surgery captured in the database analysis period; females accounted for 79.54% of all cases. The median length of surgery stay was 9 days. Cumulative re-surgery rates were 1.22% in 30 days, 2.58% in 90 days, 3.61% in 183 days, 5.42% in 1 year, and 7.95% in 2 years. There was no significant difference in re-surgery rate between PVP and PKP (p = 0.3897). The median time to the re-surgery was 139 days. Mean costs per PVP/PKP-related hospitalisation were 35,906 CNY/5122 USD (34,195 CNY/4878USD for PVP, 44,414 CNY/6336 USD for PKP, p < 0.01). The overall costs of hospitalisation averaged 186.61 million CNY (26.62 million USD) per year in this metropolitan city.ConclusionFrom 2015 to 2017, nearly one-third of OVCF inpatients received PVP/PKP and the re-surgery rate was 7.95%. PVP/PKP procedures for OVCF place a high economic burden for both the healthcare system and patients. Early detection and treatment of patients with osteoporosis are critical in China.

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Dataset Information

A Systematic Review of the Level of Evidence in Economic Evaluations of Medical Devices: The Example of Vertebroplasty and Kyphoplasty.

Context

Objective

Data sources

Study selection

Data extraction

Data synthesis

Conclusions

Publications

A Systematic Review of the Level of Evidence in Economic Evaluations of Medical Devices: The Example of Vertebroplasty and Kyphoplasty.

Similar Datasets

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