Ontario health technology assessment series
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Ont Health Technol Assess Ser · Jan 2005
Intrathecal baclofen pump for spasticity: an evidence-based analysis.
To conduct an evidence-based analysis of the effectiveness and cost-effectiveness of intrathecal baclofen for spasticity. ⋯ Level 2 evidence supports the effectiveness of intrathecal baclofen infusion for the short-term reduction of severe spasticity in patients who are unresponsive or cannot tolerate oral baclofenLevel 3 evidence supports the effectiveness of intrathecal baclofen for the long-term reduction of severe spasticity in patients who are unresponsive or cannot tolerate oral baclofenLevel 4 qualitative evidence demonstrates functional improvement for patients who are unresponsive or cannot tolerate oral baclofenIntrathecal baclofen is cost-effective with costs which may or may not be avoided in the Ontario health systemTrue functional use remains to be determined.
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Ont Health Technol Assess Ser · Jan 2005
Osteogenic protein-1 for long bone nonunion: an evidence-based analysis.
To assess the efficacy of osteogenic protein-1 (OP-1) for long bone nonunion. ⋯ Friedlaender et al. conducted a prospective, randomized, partially blinded clinical trial on the treatment tibial nonunions with OP-1. Tibial nonunions were chosen for this study because of their high frequency, challenging treatment requirements, and substantial morbidity. All of the nonunions were at least 9 months old and had shown no progress toward healing over the previous 3 months. The patients were randomized to receive either treatment with autologous bone grafting or treatment with OP-1 in a type-1 collagen carrier. Both groups received reduction and fixation with an intramedullary rod. Table 1 summarizes the clinical outcomes of this study. Table 1:Outcomes in a Randomized Clinical Trial on Tibial Nonunions: Osteogenic Protein-1 versus Autologous Bone GraftingClinical Indicator at 9 monthsSuccess by ProcedureOP-1 % (range)Autograft % (range)PWeight-bearing*8685not significantPain on Weight-bearing*8990not significantBridging seen on radiograph (at least 1 view)7584not significantBridging seen on radiograph (at least 3 views)6274not significantRepeated surgery*510not significantPhysician satisfaction8690not significantMean operative time in minutes (range)169 (58 - 420)178 (58 - 420)not significantMean operative blood loss in ml (range)254 (10-1,150)345 (35 - 1,200).049Mean length of stay in days (range)3.7 (0 - 18)4.1 (1 - 24)not significantPain at the donor siteN/A80N/AAt 6 months postsurgery20At 12 months postsurgery13Osteomyelitis % (number)3 (2/61)21 (13/61). (ABSTRACT TRUNCATED)
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Ont Health Technol Assess Ser · Jan 2005
Endovascular repair of descending thoracic aortic aneurysm: an evidence-based analysis.
To conduct an assessment on endovascular repair of descending thoracic aortic aneurysm (TAA). ⋯ Mortality The results of a comparative study found that in-hospital mortality was not significantly different between ESG placement and surgery patients (2 [4.8%] for ESG vs. 6 [11.3%] for surgery).Pooled data from case series with a mean follow-up ranging from 12 to 38 months showed a 30-day mortality and late mortality rate of 3.9% and 5.5%, respectively. These rates are lower than are those reported in the literature for surgical repair of TAA.Case series showed that the most common cause of early death in patients undergoing endovascular repair is aortic rupture, and the most common causes of late death are cardiac events and aortoesophageal or aortobronchial fistula.Technical Success Rate Technical success rates reported by case series are 55% to 100% (100% and 94.4% in 2 studies with all elective cases, 89% in a study with 5% emergent cases, and 55% in a study with 42% emergent cases).Surgical Reintervention In the comparative study, 3 (7.1%) patients in the ESG group and 14 (26.5%) patients in the surgery group required surgical reintervention. In the ESG group, the reasons for surgical intervention were postoperative bleeding at the access site, paraplegia, and type 1 endoleak. In the surgical group, the reasons for surgery were duodenal perforation, persistent thoracic duct leakage, false aneurysm, and 11 cases of postoperative bleeding.Pooled data from case series show that 9 (2.6%) patients required surgical intervention. The reasons for surgical intervention were endoleak (3 cases), aneurysm enlargement and suspected infection (1 case), aortic dissection (1 case), pseudoaneurysm of common femoral artery (1 case), evacuation of hematoma (1 case), graft migration (1 case), and injury to the access site (1 case).Endovascular Revision In the comparative study, 3 (7.1%) patients required endovascular revision due to persistent endoleak.Pooled data from case series show that 19 (5.3%) patients required endovascular revision due to persistent endoleak.Graft Migration Two case series reported graft migration. In one study, 3 proximal and 4 component migrations were noted at 2-year follow-up (total of 5%). Another study reported 1 (3.7%) case of graft migration. Overall, the incidence of graft migration was 2.6%.Aortic Rupture In the comparative study, aortic rupture due to bare stent occurred in 1 case (2%). The pooled incidence of aortic rupture or dissection reported by case series was 1.4%.Postprocedural Complications In the comparative study, there were no statistically significant differences between the ESG and surgery groups in postprocedural complications, except for pneumonia. The rate of pneumonia was 9% for those who received an ESG and 28% for those who had surgery (P = .02). There were no cases of paraplegia in either group. The rate of other complications for ESG and surgery including stroke, cardiac, respiratory, and intestinal ischemia were all 5.1% for ESG placement and 10% for surgery. The rate for mild renal failure was 16% in the ESG group and 30% in the surgery group. The rate for severe renal failure was 11% for ESG placement and 10% for surgery.POOLED DATA FROM CASE SERIES SHOW THE FOLLOWING POSTPROCEDURAL COMPLICATION RATES IN THE ESG PLACEMENT GROUP: paraplegia (2.2%), stroke (3.9%), cardiac (2.9%), respiratory (8.7%), renal failure (2.8%), and intestinal ischemia (1%).Time-Related Outcomes The results of the comparative study show statistically significant differences between the ESG and surgery group for mean operative time (ESG, 2.7 hours; surgery, 5 hours), mean duration of intensive care unit stay (ESG, 11 days; surgery, 14 days), and mean length of hospital stay (ESG, 10 days; surgery, 30 days).The mean duration of intensive care unit stay and hospital stay derived from case series is 1.6 and 7.8 days, respectively. ONTARIO-BASED ECONOMIC ANALYSIS: In Ontario, the annual treatment figures for fiscal year 2004 include 17 cases of descending TAA repair procedures (source: Provincial Health Planning Database). Fourteen of these have been identified as "not ruptured" with a mean hospital length of stay of 9.23 days, and 3 cases have been identified as "ruptured," with a mean hospital length of stay of 28 days. However, because one Canadian Classification of Health Interventions code was used for both procedures, it is not possible to determine how many were repaired with an EVAR procedure or with an open surgical procedure. (ABSTRACT TRUNCATED)
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Ont Health Technol Assess Ser · Jan 2005
Spinal cord stimulation for neuropathic pain: an evidence-based analysis.
The objective of this health technology policy assessment was to determine the effectiveness of spinal cord stimulation (SCS) to manage chronic intractable neuropathic pain and to evaluate the adverse events and Ontario-specific economic profile of this technology. ⋯ SCS may be considered for patients with chronic, neuropathic pain for whom standard pain treatments have failed and when there is no indication for surgical intervention to treat the underlying condition.
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The aim of this review was to assess the effectiveness, in terms of pain reduction and functional improvement, and costing of total knee replacement (TKR) for people with osteoarthritis for whom less invasive treatments (such as physiotherapy, analgesics, anti-inflammatory drugs, intra-articular steroids, hyaluronic acids, and arthroscopic surgery) have failed. ⋯ There is substantial evidence to indicate that TKR effectively reduces pain and improves function.