Ontario health technology assessment series
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Ont Health Technol Assess Ser · Jan 2005
Use of automated external defibrillators in cardiac arrest: an evidence-based analysis.
The objectives were to identify the components of a program to deliver early defibrillation that optimizes the effectiveness of automated external defibrillators (AEDs) in out-of-hospital and hospital settings, to determine whether AEDs are cost-effective, and if cost-effectiveness was determined, to advise on how they should be distributed in Ontario. ⋯ The OPALS study model appears cost-effective, and effectiveness can be further enhanced by training community volunteers to improve the bystander-initiated CPR rates. Deployment of AEDs in all public access areas and in houses and apartments is not cost-effective. Further research is needed to examine the benefit of in-home use of AEDs in patients at high risk of cardiac arrest.
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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
Hyperbaric oxygen therapy for non-healing ulcers in diabetes mellitus: an evidence-based analysis.
To examine the effectiveness and cost-effectiveness of hyperbaric oxygen therapy (HBOT) to treat people with diabetes mellitus (DM) and non-healing ulcers. This policy appraisal systematically reviews the published literature in the above patient population, and applies the results and conclusions of the review to current health care practices in Ontario, Canada. Although HBOT is an insured service in Ontario, the costs for the technical provision of this technology are not covered publicly outside the hospital setting. Moreover, access to this treatment is limited, because many hospitals do not offer it, or are not expanding capacity to meet the demand. ⋯ In 2003, the Ontario Health Technology Advisory Committee recommended a more coordinated strategy for wound care in Ontario to the Ministry of Health and Long-term Care. This strategy has begun at the community care and long-term care institution levels, but is pending in other areas of the health care system. There are about 700,000 people in Ontario with diabetes; of these, 10% to 15% may have a foot ulcer sometime in their lifetimes. Foot ulcers are treatable, however, when they are identified, diagnosed and treated early according to best practice guidelines. Routine follow-up for people with diabetes who may be at risk for neuropathy and/or peripheral vascular disease may prevent subsequent foot ulcers. There are 4 chambers that provide HBOT in Ontario. Fewer than 20 people with DM received HBOT in 2003. The quality of the evidence assessing the effectiveness of HBOT as an adjunct to standard therapy for people with non-healing diabetic foot ulcers is low, and the results are inconsistent. The results of a recent meta-analysis that found benefit of HBOT to prevent amputation are therefore uncertain. Future well-conducted studies may change the currently published estimates of effectiveness for wound healing and prevention of amputation using HBOT in the treatment of non-healing diabetic foot ulcers. Although HBOT is an insured service in Ontario, a well conducted, randomized controlled trial that has wound healing and amputation as the primary end-points is needed before this technology is used widely among patients with foot wounds due to diabetes.
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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.