Ontario health technology assessment series
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Ont Health Technol Assess Ser · Jan 2009
Community-based care for chronic wound management: an evidence-based analysis.
In August 2008, the Medical Advisory Secretariat (MAS) presented a vignette to the Ontario Health Technology Advisory Committee (OHTAC) on a proposed targeted health care delivery model for chronic care. The proposed model was defined as multidisciplinary, ambulatory, community-based care that bridged the gap between primary and tertiary care, and was intended for individuals with a chronic disease who were at risk of a hospital admission or emergency department visit. The goals of this care model were thought to include: the prevention of emergency department visits, a reduction in hospital admissions and re-admissions, facilitation of earlier hospital discharge, a reduction or delay in long-term care admissions, and an improvement in mortality and other disease-specific patient outcomes.OHTAC approved the development of an evidence-based assessment to determine the effectiveness of specialized community based care for the management of heart failure, Type 2 diabetes and chronic wounds.PLEASE VISIT THE MEDICAL ADVISORY SECRETARIAT WEB SITE AT: www.health.gov.on.ca/ohtas to review the following reports associated with the Specialized Multidisciplinary Community-Based care series.Specialized multidisciplinary community-based care series: a summary of evidence-based analysesCommunity-based care for the specialized management of heart failure: an evidence-based analysisCommunity-based care for chronic wound management: an evidence-based analysisPlease note that the evidence-based analysis of specialized community-based care for the management of diabetes titled: "Community-based care for the management of type 2 diabetes: an evidence-based analysis" has been published as part of the Diabetes Strategy Evidence Platform at this URL: http://www.health.gov.on.ca/english/providers/program/mas/tech/ohtas/tech_diabetes_20091020.htmlPLEASE VISIT THE TORONTO HEALTH ECONOMICS AND TECHNOLOGY ASSESSMENT COLLABORATIVE WEB SITE AT: http://theta.utoronto.ca/papers/MAS_CHF_Clinics_Report.pdf to review the following economic project associated with this series:Community-based Care for the specialized management of heart failure: a cost-effectiveness and budget impact analysis. ⋯ The evidence supports that managing chronic wounds with a multidisciplinary wound care team significantly increases wound healing and reduces the severity of wound-associated pain and the required daily wound treatments compared to persons not managed by a wound care team. The quality of evidence supporting these outcomes is low to very low meaning that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
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Ont Health Technol Assess Ser · Jan 2009
Behavioural interventions for type 2 diabetes: an evidence-based analysis.
In June 2008, the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project, an evidence-based review of the literature surrounding strategies for successful management and treatment of diabetes. This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry's newly released Diabetes Strategy.After an initial review of the strategy and consultation with experts, the secretariat identified five key areas in which evidence was needed. Evidence-based analyses have been prepared for each of these five areas: insulin pumps, behavioural interventions, bariatric surgery, home telemonitoring, and community based care. For each area, an economic analysis was completed where appropriate and is described in a separate report.To review these titles within the Diabetes Strategy Evidence series, please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html,DIABETES STRATEGY EVIDENCE PLATFORM: Summary of Evidence-Based AnalysesContinuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics: An Evidence-Based Analysis Behavioural Interventions for Type 2 Diabetes: An Evidence-Based Analysis BARIATRIC SURGERY FOR PEOPLE WITH DIABETES AND MORBID OBESITY: An Evidence-Based Summary Community-Based Care for the Management of Type 2 Diabetes: An Evidence-Based Analysis Home Telemonitoring for Type 2 Diabetes: An Evidence-Based Analysis Application of the Ontario Diabetes Economic Model (ODEM) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario ⋯ The search identified 638 citations published between 1996 and August 2008, of which 12 met the inclusion criteria and one was a meta-analysis (Gary et al. 2003). The remaining 11 studies were RCTs (9 were used in the meta-analysis) and only one was defined as small (total sample size N=47). SUMMARY OF PARTICIPANT DEMOGRAPHICS ACROSS STUDIES: A total of 2,549 participants were included in the 11 identified studies. The mean age of participants reported was approximately 58 years and the mean duration of diabetes was approximately 6 years. Most studies reported gender with a mean percentage of females of approximately 67%. Of the eleven studies, two focused only on women and four included only Hispanic individuals. All studies evaluated type 2 diabetes patients exclusively. STUDY CHARACTERISTICS: The studies were conducted between 2002 and 2008. Approximately six of 11 studies were carried out within the USA, with the remaining studies conducted in the UK, Sweden, and Israel (sample size ranged from 47 to 824 participants). The quality of the studies ranged from moderate to low with four of the studies being of moderate quality and the remaining seven of low quality (based on the Consort Checklist). Differences in quality were mainly due to methodological issues such as inadequate description of randomization, sample size calculation allocation concealment, blinding and uncertainty of the use of intention-to-treat (ITT) analysis. Patients were recruited from several settings: six studies from primary or general medical practices, three studies from the community (e.g. via advertisements), and two from outpatient diabetes clinics. A usual care control group was reported in nine of 11 of the studies and two studies reported some type of minimal diabetes care in addition to usual care for the control group. INTERVENTION CHARACTERISTICS: All of the interventions examined in the studies were mapped to the 2007 Self-management Mapping Guide. The interventions most often focused on problem solving, goal setting and encouraging participants to engage in activities that protect and promote health (e.g. modifying behaviour, change in diet, and increase physical activity). All of the studies examined comprehensive interventions targeted at least two self-care topics (e.g. diet, physical activity, blood glucose monitoring, foot care, etc.). Despite the homogeneity in the aims of the interventions, there was substantial clinical heterogeneity in other intervention characteristics such as duration, intensity, setting, mode of delivery (group vs. individual), interventionist, and outcomes of interest (discussed below). DURATION, INTENSITY AND MODE OF DELIVERY: Intervention durations ranged from 2 days to 1 year, with many falling into the range of 6 to 10 weeks. The rest of the interventions fell into categories of ≤ 2 weeks (2 studies), 6 months (2 studies), or 1 year (3 studies). Intensity of the interventions varied widely from 6 hours over 2 days, to 52 hours over 1 year; however, the majority consisted of interventions of 6 to 15 hours. Both individual and group sessions were used to deliver interventions. Group counselling was used in five studies as a mode of instruction, three studies used both individual and group sessions, and one study used individual sessions as its sole mode of instruction. (ABSTRACT TRUNCATED)
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Ont Health Technol Assess Ser · Jan 2009
Intrastromal corneal ring implants for corneal thinning disorders: an evidence-based analysis.
The purpose of this project was to determine the role of corneal implants in the management of corneal thinning disease conditions. An evidence-based review was conducted to determine the safety, effectiveness and durability of corneal implants for the management of corneal thinning disorders. The evolving directions of research in this area were also reviewed. SUBJECT OF THE EVIDENCE-BASED ANALYSIS: The primary treatment objectives for corneal implants are to normalize corneal surface topography, improve contact lens tolerability, and restore visual acuity in order to delay or defer the need for corneal transplant. Implant placement is a minimally invasive procedure that is purported to be safe and effective. The procedure is also claimed to be adjustable, reversible, and both eyes can be treated at the same time. Further, implants do not limit the performance of subsequent surgical approaches or interfere with corneal transplant. The evidence for these claims is the focus of this review. The specific research questions for the evidence review were as follows: SafetyCorneal Surface Topographic Effects:Effects on corneal surface remodellingImpact of these changes on subsequent interventions, particularly corneal transplantation (penetrating keratoplasty [PKP])Visual AcuityRefractive OutcomesVISUAL QUALITY (SYMPTOMS): such as contrast vision or decreased visual symptoms (halos, fluctuating vision)Contact lens toleranceFunctional visual rehabilitation and quality of lifePatient satisfaction:Disease Process:Impact on corneal thinning processEffect on delaying or deferring the need for corneal transplantation ⋯ In the MAS evidence review on intrastromal corneal ring implants, 66 reports were identified on the use of implants for management of corneal thinning disorders. Reports varied according to their primary clinical indication, type of corneal implant, and whether or not secondary procedures were used in conjunction with the implants. Implants were reported to manage post LASIK thinning and/or uncorrected refractive error and were also reported as an adjunctive intervention both during and after corneal transplant to manage recurrent thinning and/or uncorrected refractive error. (ABSTRACT TRUNCATED)
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Ont Health Technol Assess Ser · Jan 2009
Fenestrated endovascular grafts for the repair of juxtarenal aortic aneurysms: an evidence-based analysis.
Endovascular repair of abdominal aortic aneurysm (AAA) allows the exclusion of the dilated aneurismal segment of the aorta from the systematic circulation. The procedure requires, however, that the endograft extends to the healthy parts of the aorta above and below the aneurysm, yet the neck of a juxtarenal aortic aneurysm (JRA) is too short for a standard endovascular repair. Fenestrated endovascular aortic repair (f-EVAR) provides a solution to overcome this problem by enabling the continuation of blood flow to the renal and visceral arteries through holes or 'fenestrations' in the graft. These fenestrations are designed to match the ostial diameter of the renal and visceral arteries.There are three varieties fenestration, small, large, and scallop, and their location needs to be customized to fit the anatomy of the patient. If the device is not properly designed, if the alignment is inaccurate, or if the catheterization of the visceral arteries is not possible, the procedure may fail. In such cases, conversion to open surgery may become the only option as fenestrated endografts are not retrievable.It is recommended that a stent be placed within each small fenestration to the target artery to prevent shuttering of the artery or occlusion. Many authors have noted an increased risk of vessel occlusion in unstented fenestrations and scallops.Once placed in a patient, life-long follow-up at regular intervals is necessary to ensure the graft remains in its intended location, and that the components have adequate overlap. Should the need arise, routine follow-up allows the performance of timely and appropriate intervention through detection of events that could impact the long-term outcomes. ⋯ f-EVAR Studies versus OSR StudiesTechniqueNumber ofPatientsMean Age(Range), YearsAneurysm Diameter(Range),mmMean Duration ofFollow-up, Yearsf-EVAR(5 studies)27474 (72-75)63 (59-68)9.4-25.8OSR(7 studies)856:JRA: 675SRA: 136TAA: 4572 (67-78)62 (50-70)1-48JRA, Juxtarenal aortic aneurysm; SRA, Suprarenal aortic aneurysm; TAA, Thoracic aortic aneurysm MORTALITY OUTCOMES: The pooled estimate for 30-day mortality was 1.8% among the f-EVAR studies and 3.1% among the OSR studies that reported data for the repair of JRA separately. The pooled estimate for late mortality was 12.8% among the f-EVAR studies and 23.7% among the OSR studies that reported data for JRA separately. VISCERAL ARTERY EVENTS REPORTED IN F#ENTITYSTARTX02014;EVAR STUDIES: RENAL EVENTS DURING F-EVAR: A total of three main renal arteries and two accessory renal arteries became occluded during the procedure. These were all due to technical issues, except one accessory renal artery in which the artery was intentionally covered. One patient required open surgery following the procedure. RENAL EVENTS DURING THE FOLLOW-UP: A total of 12 renal arteries (12 patients) were found to be occluded during follow-up. In two patients, the same side accessory renal artery was also occluded. Four (1.5%) patients lost one kidney and five (2.3%) patients underwent dialysis, three (1.4%) of which became permanent. A total of 16 cases of renal artery stenosis (16 patients) occurred during follow-up. Eight of these were treated and eight were observed. Segmental renal infarcts were found in six patients but renal function was not impaired. MESENTERIC EVENTS DURING F-EVAR: Three mesenteric events occurred during the f-EVAR procedures resulting in two deaths. One patient developed bowel ischemia due to embolization of the superior mesenteric artery (SMA); this patient died 13 days after the procedure from multiorgan failure. One patient died eights days after the procedure from mesenteric ischemia and bowel perforation. The third SMA event occurred during surgery with subsequent occlusion in early follow-up. MESENTERIC EVENTS DURING FOLLOW-UP: During follow-up, five (1.8%) SMA occlusions/partial occlusions and one SMA stenosis were noted. Three of the five patients with SMA occlusion/partial occlusion remained asymptomatic and no further intervention was necessary. One patient underwent SMA bypass surgery and in two patients, the problem solved by SMA stenting. A summary of the outcomes reported in the f-EVAR and OSR studies is shown in Table ES-2. ES-2.Summary of Outcomes: Fenestrated Endovascular Graft Versus Open Surgical Repair for Treatment of Juxtarenal Aortic AneurysmOutcomef-EVAROSRPooled Estimate (Rate)30-day mortality1.83.1Late mortality12.823.7Permanent dialysis0-2.50-3.5Loss of kidney1.5No report of kidney loss Incidence of post-op renal insufficiency: 14.4%Mesentric ischemia3.32.9Aortic rupture00Post-op cardiac complications1.510.7Post-op pulmonary complications0.713.4Post-op GI complications0.75.9Aneurysm expansion1.40Secondary intervention (Non-endoleak)8.87.8EndoleakType I: 4Type 2: 16.8Type III: 1.8N/AEndoleak required treatmentType I: 2.9Type 2: 3.3Type III: 1.1Graft migration1.5N/AGraft separation0.7Duration (Mean)Operation time (min)240287Hospital stay (days)613 SUMMARY: Short- and medium-term results (up to 2 years) of f-EVAR for the repair of JRA showed that outcomes in f-EVAR series compare favourably with the figures for the OSR series; however, uncertainty remains regarding the long-term results. The following observations are based on low quality evidence. F-EVAR has lower 30-day mortality than OSR (1.8% vs. 3.1%) and a lower late-mortality over the period of time that patients have been followed (12.8% vs. 23.7%).There is a potential for the loss of target vessels during or after f-EVAR procedures. Loss of a target vessel may lead to loss of its respective end organ. The risk associated with this technique is mainly due to branch vessel ischemia or occlusion (primarily among the renal arteries and SMA). Ischemia or occlusion of these arteries can occur during surgery due to technical failure and/or embolization or it may occur during follow-up due to graft complications such as graft migration, component separation, or arterial thrombosis. The risk of kidney loss in this series of f-EVAR studies was 1.5% and the risk of mesenteric ischemia was 3.3%. In the OSR studies, the risk of developing renal insufficiency was 14.4% and the risk of mesenteric ischemia was 2.9%.F-EVAR has a lower rate of postoperative cardiac and pulmonary complications.Endoleak occurs in 22.5% of patients undergoing f-EVAR (all types) and about 8% of these require treatment. Most of the interventions performed to treat such endoleaks conducted using a minimally invasive approach.Due to the complexity of the technique, patients must be appropriately selected for f-EVAR, the procedure performed by highly experienced operators, and in centers with advanced, high-resolution imaging systems to minimize the risk of complications.Graft fenestrations have to be custom designed for each patient to fit and match the anatomy of their visceral arteries. Planning and sizing thus requires scrutiny of the target vessels with a high degree precision. This is important not only to prevent end organ ischemia and infarction, but to avoid prolonging procedures and subsequent adverse outcomes.Assuming the average cost range of FEVAR procedure is $24,395-$30,070 as per hospital data and assuming the maximum number of annual cases in Ontario is 116, the average estimated cost impact range to the province for FEVAR procedures is $2.83M-$3.49M annually.
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Ont Health Technol Assess Ser · Jan 2009
Oral appliances for obstructive sleep apnea: an evidence-based analysis.
The objective of this review was to determine the clinical effectiveness of oral appliances compared to 'no treatment', continuous positive airway pressure (CPAP), or surgery for the management of obstructive sleep apnea (OSA). ⋯ Obstructive sleep apnea, oral appliances, mandibular advancement splints, tongue repositioning devices.