Ontario health technology assessment series
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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)
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Ont Health Technol Assess Ser · Jan 2010
64-slice computed tomographic angiography for the diagnosis of intermediate risk coronary artery disease: an evidence-based analysis.
In July 2009, the Medical Advisory Secretariat (MAS) began work on Non-Invasive Cardiac Imaging Technologies for the Diagnosis of Coronary Artery Disease (CAD), an evidence-based review of the literature surrounding different cardiac imaging modalities to ensure that appropriate technologies are accessed by patients suspected of having CAD. This project came about when the Health Services Branch at the Ministry of Health and Long-Term Care asked MAS to provide an evidentiary platform on effectiveness and cost-effectiveness of non-invasive cardiac imaging modalities.After an initial review of the strategy and consultation with experts, MAS identified five key non-invasive cardiac imaging technologies for the diagnosis of CAD. Evidence-based analyses have been prepared for each of these five imaging modalities: cardiac magnetic resonance imaging, single photon emission computed tomography, 64-slice computed tomographic angiography, stress echocardiography, and stress echocardiography with contrast. For each technology, an economic analysis was also completed (where appropriate). A summary decision analytic model was then developed to encapsulate the data from each of these reports (available on the OHTAC and MAS website).The Non-Invasive Cardiac Imaging Technologies for the Diagnosis of Coronary Artery Disease series is made up of the following reports, which can be publicly accessed at the MAS website at: www.health.gov.on.ca/mas or at www.health.gov.on.ca/english/providers/program/mas/mas_about.html ⋯ Non-English studies.Pediatric populations.Studies of patients at low or high pre-test probability of CAD.Studies of unstable patients, e.g., emergency room visits, or a prior diagnosis of CAD.Studies in patients with non-ischemic heart disease.Studies in which outcomes were not specific to those of interest in this report.Studies in which CTA was not compared to CA in a stable population. OUTCOMES OF INTEREST): CAD defined as ≥50% stenosis. COMPARATOR: Coronary angiography. MEASURES OF INTEREST: Sensitivity, specificity;Negative predictive value (NPV), positive predictive value (PPV);Area under the curve (AUC) and diagnostic odds ratios (DOR). RESULTS OF LITERATURE SEARCH AND EVIDENCE-BASED ANALYSIS: The literature search yielded two HTAs, the first published by MAS in April 2005, the other from the Belgian Health Care Knowledge Centre published in 2008, as well as three recent non-randomized clinical studies. The three most significant studies concerning the accuracy of CTA versus CA are the CORE-64 study, the ACCURACY trial, and a prospective, multicenter, multivendor study conducted in the Netherlands. Five additional non-randomized studies were extracted from the Belgian Health Technology Assessment (2008). (ABSTRACT TRUNCATED)
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Ont Health Technol Assess Ser · Jan 2010
Stress echocardiography with contrast for the diagnosis of coronary artery disease: an evidence-based analysis.
In July 2009, the Medical Advisory Secretariat (MAS) began work on Non-Invasive Cardiac Imaging Technologies for the Diagnosis of Coronary Artery Disease (CAD), an evidence-based review of the literature surrounding different cardiac imaging modalities to ensure that appropriate technologies are accessed by patients suspected of having CAD. This project came about when the Health Services Branch at the Ministry of Health and Long-Term Care asked MAS to provide an evidentiary platform on effectiveness and cost-effectiveness of non-invasive cardiac imaging modalities.After an initial review of the strategy and consultation with experts, MAS identified five key non-invasive cardiac imaging technologies for the diagnosis of CAD. Evidence-based analyses have been prepared for each of these five imaging modalities: cardiac magnetic resonance imaging, single photon emission computed tomography, 64-slice computed tomographic angiography, stress echocardiography, and stress echocardiography with contrast. For each technology, an economic analysis was also completed (where appropriate). A summary decision analytic model was then developed to encapsulate the data from each of these reports (available on the OHTAC and MAS website).The Non-Invasive Cardiac Imaging Technologies for the Diagnosis of Coronary Artery Disease series is made up of the following reports, which can be publicly accessed at the MAS website at: www.health.gov.on.ca/mas or at www.health.gov.on.ca/english/providers/program/mas/mas_about.htmlSINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY FOR THE DIAGNOSIS OF CORONARY ARTERY DISEASE: An Evidence-Based AnalysisSTRESS ECHOCARDIOGRAPHY FOR THE DIAGNOSIS OF CORONARY ARTERY DISEASE: An Evidence-Based AnalysisSTRESS ECHOCARDIOGRAPHY WITH CONTRAST FOR THE DIAGNOSIS OF CORONARY ARTERY DISEASE: An Evidence-Based Analysis64-Slice Computed Tomographic Angiography for the Diagnosis of Coronary Artery Disease: An Evidence-Based AnalysisCARDIAC MAGNETIC RESONANCE IMAGING FOR THE DIAGNOSIS OF CORONARY ARTERY DISEASE: An Evidence-Based AnalysisPease note that two related evidence-based analyses of non-invasive cardiac imaging technologies for the assessment of myocardial viability are also available on the MAS website:POSITRON EMISSION TOMOGRAPHY FOR THE ASSESSMENT OF MYOCARDIAL VIABILITY: An Evidence-Based AnalysisMAGNETIC RESONANCE IMAGING FOR THE ASSESSMENT OF MYOCARDIAL VIABILITY: an Evidence-Based AnalysisThe Toronto Health Economics and Technology Assessment Collaborative has also produced an associated economic report entitled:The Relative Cost-effectiveness of Five Non-invasive Cardiac Imaging Technologies for Diagnosing Coronary Artery Disease in Ontario [Internet]. Available from: http://theta.utoronto.ca/reports/?id=7 OBJECTIVE: The objective of this report is to compare echocardiography (ECHO) performed with microsphere contrast agents (contrast echocardiography) to ECHO performed without contrast and to single photon emission computed tomography (SPECT). CONTRAST ECHO: Contrast agents for ECHO have been available since the technology was first introduced in the 1990s. Composed of tiny 'microbubbles' of an inert gas encapsulated within a lipid, protein, or polymer coat, these agents act to scatter incident ultrasound waves at the gas/liquid interface to increase the strength of a returning ECHO signal. When injected into a patient's arm, they are transported throughout even the smallest capillaries to greatly enhance the blood pool signal, which would otherwise appear black on conventional two dimensional ECHO. The enhanced signal then helps cardiologists to determine what parts of the patient's heart muscle are poorly perfused. The first commercially available microsphere contrast agent was Albunex, which received approval by the Food and Drug Administration in the United States in 1994. This original microsphere agent was limited by its rapid gas volume loss which caused a decline in the ultrasound signal. It worked well in the right chambers of the heart, but dissolved when passing through the pulmonary capillaries and so was unable to provide contrast in the left side. Second generation agents employed different gases that prolonged the life of the microbubbles within the circulation and increased the reproducibility of results. Today, the most common use for contrast ECHO is to enhance the definition of the left ventricular (LV) endocardial border for cases of LV opacification. The aim of contrast ECHO is to provide better quantification of LV volume and assessment of LV wall motion than ECHO alone. The newest area of development in the research of contrast ECHO is myocardial perfusion assessment, also known as myocardial contrast ECHO. Theoretically, since myocardial ischemia and infarction affect both perfusion and contractility (wall motion), contrast ECHO could be an ideal non-invasive imaging test as it could assess both perfusion and contractility, simultaneously and in real time. Notably, critically ill patients on ventilators and those with lung problems are more likely to generate poor or 'suboptimal' echocardiograms than other patients, as are obese patients and those who've undergone recent chest operations. Contrast agents can potentially be used in 10% to 15% of all studies and in approximately 33% of stress tests due to from such suboptimal echocardiograms. Stress can be induced either pharmaceutically (e.g., through dobutamine, dipyrimidamole, adenosine) or with exercise. Generally, contrast agents are used more in pharmaceutical stress echocardiograms than in exercise stress echocardiograms. EVIDENCE-BASED ANALYSIS: This MAS analysis sought to address the following research questions: Is contrast ECHO more effective than 99-technetium SPECT in terms its ability to detect CAD?What is the effectiveness of contrast ECHO in assessing patients with suboptimal echocardiograms?Is contrast ECHO safe compared to other cardiac imaging modalities?Is contrast ECHO cost-effective compared to other cardiac imaging modalities? ⋯ Twenty-three observational studies were identified that assessed the diagnostic accuracy of contrast ECHO for the diagnosis of CAD. All of these studies used stress ECHO with contrast. In addition, nine retrospective chart reviews were identified, which assessed the safety of contrast ECHO at rest or stress. Based on the results of these studies the following conclusions were made: Stress ECHO with contrast has a higher diagnostic accuracy in the diagnosis of CAD than stress ECHO (without contrast).Stress ECHO with contrast seems to have a similar diagnostic accuracy to 99 technetium SPECT.The addition of contrast to ECHO in patients with suboptimal ECHO results significantly improves interpretability of the results.There is not a statistically significantly higher mortality rate in patients who receive contrast compared to those who do not.
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Ont Health Technol Assess Ser · Jan 2010
Population-based smoking cessation strategies: a summary of a select group of evidence-based reviews.
The objective of this report was to provide the Ministry of Health Promotion (MHP) with a summary of existing evidence-based reviews of the clinical and economic outcomes of population-based smoking cessation strategies. ⋯ The evidence suggests that pharmacotherapy, physician advice to quit, nursing interventions, hospital-based interventions, and proactive telephone counselling are effective and cost-effective in the short-term.There is poor quality data around other population-based smoking cessation strategies including mass media campaigns, community interventions, quit and win contests, access to 'quitlines', and interventions for university and college campuses, making evaluation of their effectiveness and cost-effectiveness difficult.Based on pooled summary estimates of effect and safety data, the most effective strategies are varenicline, buproprion, and nicotine replacement therapies, followed by physician advice to quit and nursing interventions (in non-hospitalized smokers without cardiovascular disease).