Ontario health technology assessment series
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Ont Health Technol Assess Ser · Jan 2011
Constraint-induced movement therapy for rehabilitation of arm dysfunction after stroke in adults: an evidence-based analysis.
The purpose of this evidence-based analysis is to determine the effectiveness and cost of CIMT for persons with arm dysfunction after a stroke. ⋯ Stroke Impact Scale (SIS) SUMMARY OF FINDINGS: A significant difference was found in our primary outcome of arm motor function measured with the Action Research Arm Test in favour of CIMT compared with usual care delivered with the same intensity and duration. Significant differences were also found in three of the five secondary outcome measures including Arm Motor Impairment and Perceived Motor Function Amount of Use and Quality of Use. There was a nonsignificant effect found with the FIM score and the quality of life Stroke Impact Scale outcome measure. The nonsignificant effect found with the scale score and the quality of life score may be a factor of a nonresponsive outcome measure (FIM scale) and/or a type II statistical error from an inadequate sample size. The quality of evidence was moderate for arm motor function and low for all other outcome measures except quality of life, which was very low. Table 1:Summary of Results(*)OutcomeOutcome MeasureNumber of Studies (n)Mean Difference in Change scores CIMT vs. Usual Care [95% C.I.]ResultsGRADE Quality of EvidenceArm motor functionAction Research Arm Test4(43)13.6[8.7, 18.6]SignificantModerateArm motor impairmentFugl-Meyer Motor Assessment8(169)6.5[2.3, 10.7]SignificantLowActivities of daily livingFunctional Independence Measure4(128)3.6[-0.22, 7.4]NonsignificantLowSelf-reported amount of arm usePerceived Arm Motor Function (Amount of Use) Scale8(241)1.1[0.60, 1.7]SignificantLowSelf-reported quality of arm usePerceived Arm Motor Function (Quality of Use) Scale8(241)0.97[0.7, 1.3]SignificantLowQuality of lifeStroke Impact Scale2(66)3.9[-5.6, 13.5]NonsignificantVery Low*CI, Confidence Intervals; n, Sample Size.
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Ont Health Technol Assess Ser · Jan 2011
Collagen cross-linking using riboflavin and ultraviolet-a for corneal thinning disorders: an evidence-based analysis.
The main objectives for this evidence-based analysis were to determine the safety and effectiveness of photochemical corneal collagen cross-linking with riboflavin (vitamin B(2)) and ultraviolet-A radiation, referred to as CXL, for the management of corneal thinning disease conditions. The comparative safety and effectiveness of corneal cross-linking with other minimally invasive treatments such as intrastromal corneal rings was also reviewed. The Medical Advisory Secretariat (MAS) evidence-based analysis was performed to support public financing decisions. SUBJECT OF THE EVIDENCE-BASED ANALYSIS: The primary treatment objective for corneal cross-linking is to increase the strength of the corneal stroma, thereby stabilizing the underlying disease process. At the present time, it is the only procedure that treats the underlying disease condition. The proposed advantages for corneal cross-linking are that the procedure is minimally invasive, safe and effective, and it can potentially delay or defer the need for a corneal transplant. In addition, corneal cross-linking does not adversely affect subsequent surgical approaches, if they are necessary, or interfere with corneal transplants. The evidence for these claims for corneal cross-linking in the management of corneal thinning disorders such as keratoconus will be the focus of this review. The specific research questions for the evidence review were as follows: TECHNICAL: How technically demanding is corneal cross-linking and what are the operative risks? ⋯ A literature search was conducted on photochemical corneal collagen cross-linking with riboflavin (vitamin B(2)) and ultraviolet-A for the management of corneal thinning disorders using a search strategy with appropriate keywords and subject headings for CXL for literature published up until April 17, 2011. The literature search for this Health Technology Assessment (HTA) review was performed using the Cochrane Library, the Emergency Care Research Institute (ECRI) and the Centre for Reviews and Dissemination. The websites of several other health technology agencies were also reviewed, including the Canadian Agency for Drugs and Technologies in Health (CADTH) and the United Kingdom's National Institute for Clinical Excellence (NICE). The databases searched included OVID MEDLINE, MEDLINE IN-Process and other Non-Indexed Citations such as EMBASE. As the evidence review included an intervention for a rare condition, case series and case reports, particularly for complications and adverse events, were reviewed. A total of 316 citations were identified and all abstracts were reviewed by a single reviewer for eligibility. For those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. (ABSTRACT TRUNCATED)
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Ont Health Technol Assess Ser · Jan 2011
Endovascular radiofrequency ablation for varicose veins: an evidence-based analysis.
The objective of the MAS evidence review was to conduct a systematic review of the available evidence on the safety, effectiveness, durability and cost-effectiveness of endovascular radiofrequency ablation (RFA) for the treatment of primary symptomatic varicose veins. ⋯ THE MAS EVIDENCE SEARCH ON THE SAFETY AND EFFECTIVENESS OF ENDOVASCULAR RFA ABLATION OF VV IDENTIFIED THE FOLLOWING EVIDENCE: three HTAs, nine systematic reviews, eight randomized controlled trials (five comparing RFA to surgery and three comparing RFA to ELT), five controlled clinical trials and fourteen cohort case series (four were multicenter registry studies). The majority (12⁄14) of the cohort studies (3,664) evaluating RFA for VV involved treatment with first generation RFA catheters and the great saphenous vein (GSV) was the target vessel in all studies. Major adverse events were uncommonly reported and the overall pooled major adverse event rate extracted from the cohort studies was 2.9% (105⁄3,664). Imaging defined treatment effectiveness of vein closure rates were variable ranging from 68% to 96% at post-operative follow-up. Vein ablation rate at 6-month follow-up was reported in four studies with rates close to 90%. Only one study reported vein closure rates at 2 years but only for a minority of the eligible cases. The two studies reporting on RFA ablation with the more efficient second generation catheters involved better follow-up and reported higher ablation rates close to 100% at 6-month follow-up with no major adverse events. A large prospective registry trial that recruited over 1,000 patients at thirty-four largely European centers reported on treatment success in six overlapping reports on selected patient subgroups at various follow-up points up to 5 year. However, the follow-up for eligible recruited patients at all time points was low resulting in inadequate estimates of longer term treatment efficacy. The overall level of evidence of randomized trials comparing RFA with surgical ligation and vein stripping (n = 5) was graded as low to moderate. In all trials RFA ablation was performed with first generation catheters in the setting of the operating theatre under general anaesthesia, usually without tumescent anaesthesia. Procedure times were significantly longer after RFA than surgery. Recovery after treatment was significantly quicker after RFA both with return to usual activity and return to work with on average a one week less of work loss. Major adverse events occurring after surgery were higher [(1.8% (n=4) vs. 0.4% (n = 1) than after RFA but not significantly. Treatment effectiveness measured by imaging defined vein absence or vein closure was comparable in the two treatment groups. Significant improvements in vein symptoms and quality of life over baseline were reported for both treatment groups. (ABSTRACT TRUNCATED)
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Ont Health Technol Assess Ser · Jan 2011
Continuous glucose monitoring for patients with diabetes: an evidence-based analysis.
To determine the effectiveness and cost-effectiveness of continuous glucose monitoring combined with self-monitoring of blood glucose compared with self-monitoring of blood glucose alone in the management of diabetes. ⋯ Moderate quality evidence that CGM + SMBG: is not more effective than self monitoring of blood glucose (SMBG) alone in the reduction of HbA1c using insulin infusion pumps for Type 1 diabetes.is not more effective than SMBG alone in the reduction of hypoglycemic or severe hypoglycemic events using insulin infusion pumps for Type 1 diabetes.
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Ont Health Technol Assess Ser · Jan 2011
Clinical utility of serologic testing for celiac disease in asymptomatic patients: an evidence-based analysis.
The objective of this evidence-based analysis was to evaluate the clinical utility of serologic testing for celiac disease in asymptomatic individuals presenting with one of the non-gastrointestinal conditions evaluated in this report. The clinical utility was based on the effects of a gluten-free diet (GFD) on outcomes specific to each of these conditions. The prevalence of celiac disease in asymptomatic individuals and one of these non-gastrointestinal conditions was also evaluated. ⋯ The effects of a GFD on disease-specific outcomes for each condition evaluated in patients with asymptomatic celiac disease was assessed. The prevalence of asymptomatic celiac disease in patients presenting with one of the conditions evaluated was also assessed. RESULTS OF EVIDENCE-BASED ANALYSIS: Three eligible observational studies evaluated the effects of GFD on growth parameters in subjects with asymptomatic celiac disease and idiopathic short stature. Four eligible observational studies evaluated the effects of GFD on metabolic control in subjects with asymptomatic celiac disease and type 1 diabetes. Five eligible observational studies evaluated the risk of all-cause mortality and five eligible observational studies evaluated the risk of lymphoma in subjects with asymptomatic celiac disease. No eligible studies on the effects of the GFD for the other conditions evaluated were identified. Twenty-three eligible studies measured the prevalence of asymptomatic celiac disease in subjects presenting with one of the conditions evaluated. PREVALENCE OF CELIAC DISEASE IN ASYMPTOMATIC PATIENTS: The prevalence of celiac disease in asymptomatic patients presenting with one of the conditions evaluated was analysed. Most studies also included a control group that generally consisted of individuals randomly selected from the general population. Although there was a trend to a higher prevalence of asymptomatic celiac disease in individuals with the conditions evaluated compared to the controls, it only reached statistical significance in type 1 diabetes. No eligible prevalence studies were identified in patients with amenorrhea, delayed puberty, alopecia, and depression. THE EFFECTS OF A GLUTEN-FREE DIET ON DISEASE-SPECIFIC OUTCOMES IN PATIENTS WITH ASYMPTOMATIC CELIAC DISEASE: THE EFFECTS OF GFD ON METABOLIC CONTROL IN PATIENTS WITH ASYMPTOMATIC CELIAC DISEASE AND TYPE 1 DIABETES: The effects of a GFD on metabolic control (HbA1c, number of hypoglycemic episodes, and changes in insulin dosage) in subjects with asymptomatic celiac disease and type 1 diabetes were evaluated. One prospective case-control study reported an increase in HbA1c levels in cases with type 1 diabetes and asymptomatic celiac disease after the introduction of a GFD, however, the clinical significance of this change is unclear. Only one eligible retrospective case-control study evaluated the effects of a GFD on hypoglycemia episodes and since there were inadequate details in the study about both the ascertainment and severity of hypoglycemia episodes in both cases and controls, it is not possible to draw conclusions regarding the effects of a GFD on hypoglycemia episodes based on this study. One prospective case-control study did not show a statistically significant change in insulin dosage between cases with type 1 diabetes and asymptomatic celiac disease and controls with type 1 diabetes either before or after the introduction of a GFD. No eligible studies that evaluated the effects of a GFD on the long-term outcomes of type 1 diabetes such as cardiovascular or renal events in patients with asymptomatic celiac disease were identified. THE EFFECTS OF A GLUTEN-FREE DIET IN PATIENTS WITH IDIOPATHIC SHORT STATURE AND ASYMPTOMATIC CELIAC DISEASE: A total of 3 eligible studies were identified. All studies consisted of case series that compared growth parameters in subjects with asymptomatic celiac disease and idiopathic short stature before and after the celiac disease was diagnosed and the GFD was instituted. Most subjects included in the studies demonstrated an improvement in growth parameters. Compliance with the GFD was not reported in the studies. The results of the studies suggest an increase in growth velocity in pediatric patients with asymptomatic celiac disease and idiopathic short stature once a GFD is introduced. RISK OF LYMPHOMA IN PATIENTS WITH ASYMPTOMATIC CELIAC DISEASE: One retrospective cohort study evaluated the risk of lymphoma in patients with asymptomatic celiac disease. The authors concluded that the number of events identified was low during the long follow-up period and that the risk of overall malignancies was not increased among patients with asymptomatic celiac disease. RISK OF ASYMPTOMATIC CELIAC DISEASE IN PATIENTS WITH LYMPHOMA: Four case-control studies, one of which retrospective, evaluated the risk of asymptomatic celiac disease in patients newly diagnosed with lymphoma. One retrospective cohort study did not show an increase in the risk of lymphoma among subjects with asymptomatic celiac disease. Three prospective case-control studies did not find a statistically significant risk of asymptomatic celiac disease in patients with newly diagnosed lymphoma. (ABSTRACT TRUNCATED)