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PloS One 2015Economic evaluations are far less frequently reported for medical devices than for drugs. In addition, little is known about the quality of existing economic... (Review)
Review
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.
Topics: Cost-Benefit Analysis; Equipment and Supplies; Humans; Kyphoplasty; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic; Vertebroplasty
PubMed: 26661078
DOI: 10.1371/journal.pone.0144892 -
Orthopaedics & Traumatology, Surgery &... Sep 2015To assess the effectiveness and safety of stentoplasty in people with osteoporotic vertebral body fractures. A systematic search of databases including MEDLINE, EMBASE... (Review)
Review
UNLABELLED
To assess the effectiveness and safety of stentoplasty in people with osteoporotic vertebral body fractures. A systematic search of databases including MEDLINE, EMBASE and Cochrane library, between others, was conducted to June 9, 2014. Clinical trials and observational studies that included alive adults with osteoporotic vertebral body fractures and the comparators were the intervention himself, vertebroplasty or balloon kyphoplasty were selected. Quality of evidence was graded according to the GRADE approach. Two review authors independently selected studies, assessed risk of bias and extracted data. Forty-two citations were identified during the search. After removing duplicates, five studies were included: two clinical trials and three observational studies. Stentoplasty, showed higher rate of adverse events related to material (P=0.043) and cuff pressure (P=0.014) in comparison to kyphoplasty. There was no difference between two procedures in terms of reduction of kyphosis, time of exposure to radiation or postoperative loss of cement. Stentoplasty in comparison to vertebroplasty, showed an improvement of restoration of vertebral height (P=0.042), kyphosis correction and volume of bone cement. No differences were found between two procedures in terms of loss of vertebral body volume. Based on observational studies, stentoplasty improved vertebral height, pain and functional disability at 6 and 12months follow-up, and corrected the angle vertebral fractures in patients with osteoporotic vertebral body. Stentoplasty was presented as a safe procedure in short-medium term, with a low complication rate, a reduced loss of cement and new vertebral body fractures lower rates. Stentoplasty improves vertebral height, reduces the pain and functional disability and correct the vertebral angle in patients with osteoporotic vertebral body fracture with minimum adverse events. Stentoplasty is comparable to kyphoplasty in terms of correction of kyphosis, time of exposure to radiation and cement postoperative loss, and comparable to vertebroplasty in terms of restoration of vertebral height correction and bone cement volume.
LEVEL OF EVIDENCE
Level II systematic review.
Topics: Humans; Kyphoplasty; Osteoporotic Fractures; Pain; Spinal Fractures; Stents
PubMed: 26194207
DOI: 10.1016/j.otsr.2015.06.002 -
Journal of Orthopaedic Research :... Nov 2015The purpose of this research was to compare the efficacy and safety of unilateral versus bilateral PKP for osteoporotic vertebral compression fractures (OVCFs). Six... (Comparative Study)
Comparative Study Meta-Analysis Review
The purpose of this research was to compare the efficacy and safety of unilateral versus bilateral PKP for osteoporotic vertebral compression fractures (OVCFs). Six databases (Cochrane, PubMed, MEDLINE, EMBASE, SinoMed, and CNKI) were searched without language restrictions. Twelve randomized controlled trials involving a total of 1,030 patients were identified. The results indicate that unilateral PKP had a better degree of pain relief (visual analog scale) than bilateral PKP (p = 0.04; 95%CI = -0.36 to -0.00) with short-term follow-up (within 4 weeks) after operation. The radiological outcome assessment with short-term follow-up after operation indicates bilateral PKP had a better degree of anterior vertebral height restoration (p = 0.03; 95%CI = -2.58 to -0.14). Operation time and cement dosage were less for unilateral PKP (p < 0.05). There were no differences in complications such as cement leakage and adjacent vertebral fractures between two approaches (p = 0.06 and p = 0.97, respectively). Life quality assessment (SF-36) indicates unilateral PKP had a better result of bodily pain relief (p < 0.05; 95%CI = 3.93 to 7.48) and general health benefit (p < 0.05; 95%CI = 0.02 to 2.93) with short-term follow-up after operation. We suggest that a unilateral PKP is advantageous.
Topics: Fractures, Compression; Humans; Kyphoplasty; Osteoporotic Fractures; Quality of Life; Randomized Controlled Trials as Topic; Spinal Fractures
PubMed: 26123667
DOI: 10.1002/jor.22957 -
PloS One 2015Surgical and non-surgical interventions are the two categories for treatment of vertebral compression fractures (VCFs). However, there is clinical uncertainty over... (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
Surgical and non-surgical interventions are the two categories for treatment of vertebral compression fractures (VCFs). However, there is clinical uncertainty over optimal management. This study aimed to examine the safety and effectiveness of surgical management for treatment of VCFs with osteopenia compared with non-surgical treatment.
METHODS
We conducted a systematic search through electronic databases from inception to June 2014, with no limits on study data or language. Randomized controlled trials (RCTs) evaluating surgical versus non-surgical interventions for treatment of patients with VCFs due to osteopenia were considered. Primary outcomes were pain and adverse effects. A random-effects model was used to calculate the pooled mean difference (MD) or risk ratios with 95% confidence interval (CI).
RESULTS
Sixteen reports (11 studies) met the inclusion criteria, and provided data for the meta-analysis with a total of 1,401 participants. Compared with conservative treatment, surgical treatment was more effective in reducing pain (short-term: MD -2.05, 95% CI -3.55 to -0.56, P=0.007; mid-term: MD -1.70, 95% CI -2.78 to -0.62, P=0.002; long-term: MD -1.24, 95% CI -2.20 to -0.29, P=0.01) and disability on the Roland-Morris Disability score (short-term: MD -4.97, 95% CI -8.71 to -1.23, P=0.009), as well as improving quality of life on the Short-Form 36 Physical Component Summary score (short-term: MD 5.53, 95% CI 1.45 to 9.61, P=0.008) and the Quality of Life Questionnaire of the European Foundation for Osteoporosis score (short-term: MD -5.01, 95% CI -8.11 to -1.91, P=0.002). Indirect comparisons between vertebroplasty and kyphoplasty found no evidence that the treatment effect differed across the two interventions for any outcomes assessed. Compared with the sham procedure, surgical treatment showed no evidence of improvement in pain relief and physical function. Based on these two comparisons, no significant difference between groups was noted in the pooled results for adverse events.
CONCLUSION
Compared to conservative treatment, surgical treatment was more effective in decreasing pain in the short,mid and long terms. However, no significant mid- and long-term differences in physical function and quality of life was observed. Little good evidence is available for surgical treatment compared with that for sham procedure. PV and BK are currently used to treat VCFs with osteopenia, with little difference in treatment effects. Evidence of better quality and from a larger sample size is required before a recommendation can be made.
SYSTEMATIC REVIEW REGISTRATION
http://www.crd.york.ac.uk/PROSPERO PROSPERO registration number: CRD42013005142.
Topics: Bone Diseases, Metabolic; Female; Fractures, Compression; Humans; Male; Quality of Life; Randomized Controlled Trials as Topic; Spinal Fractures
PubMed: 26020950
DOI: 10.1371/journal.pone.0127145 -
PloS One 2015The question which kind of methods is most suitable for treating the old people for osteoporotic vertebral compression fracture is still discussed and pairwise... (Comparative Study)
Comparative Study Meta-Analysis Review
PURPOSE
The question which kind of methods is most suitable for treating the old people for osteoporotic vertebral compression fracture is still discussed and pairwise meta-analyses cannot get hierarchies of these treatments. Our aim is to integrate the evidence to provide hierarchies of the comparative efficacy measured by the change of VAS (Visual Analogue Scale) and tolerability measured by incidence of new fractures and risk of all-cause discontinuation on three treatments (percutaneous vertebroplasty (PVP)、balloon kyphoplasty (BK) and conservative treatment (CT)).
METHODS
We performed a Bayesian-framework network meta-analysis of randomized controlled trials (RCTs) to compare three treatments for the old people with osteoporotic vertebral compression fracture. The eligible RCTs were identified by searching Amed, British Nursing Index, Embase, Pubmed, the Cochrane Central Register of Controlled Trials (CENTRAL), Google scholar, SIGLE, the National Technical Information Service, the National Research Register (UK) and the Current Controlled Trials databases. Data from three outcomes (e.g. VAS, risk of all-cause discontinuation and incidence of new fractures) were independently extracted by two authors.
RESULTS
A total of five RCTs were finally included into this article. PVP and BK significantly decreased VAS when compared with CT. BK had a significantly lower risk of all-cause discontinuation contrast to CT. Three treatments (BK, PVP and CT) had no significant differences in the incidence of new fractures.
CONCLUSIONS
PVP may be the best way to relieve pain, CT might lead to the lowest incidence of new fractures and BK might had the lowest risk of all-cause discontinuation in old people with osteoporotic vertebral compression fracture. More large-scale and longer duration of follow-up studies are needed.
Topics: Aged; Bayes Theorem; Female; Fractures, Compression; Humans; Kyphoplasty; Male; Osteoporosis; Osteoporotic Fractures; Pain Measurement; Pain, Postoperative; Randomized Controlled Trials as Topic; Reproducibility of Results; Spinal Fractures; Treatment Outcome; Vertebroplasty; Visual Analog Scale
PubMed: 25874802
DOI: 10.1371/journal.pone.0123153