Evidence-Based Decision Making 3: Health Technology Assessment.

This chapter begins with a brief introduction to health technology assessment (HTA). HTA is concerned with the systematic evaluation of the consequences of the adoption and use of new health technologies and to improve the evidence on existing technologies. The objective of mainstream HTA is to support evidence-based decision- and policy-making that encourage the uptake of efficient and effective health-care technologies.

Steps toward improving ethical evaluation in health technology assessment: a proposed framework.

Background: While evaluation of ethical aspects in health technology assessment (HTA) has gained much attention during the past years, the integration of ethics in HTA practice still presents many challenges. In response to the increasing demand for expansion of health technology assessment (HTA) methodology to include ethical issues more systematically, this article reports on a multi-stage study that aimed at construction of a framework for improving the integration of ethics in HTA.

Methods: The framework was developed through the following phases: 1) a systematic review and content analysis of guidance documents for ethics in HTA; 2) identification of factors influencing the integration of ethical considerations in HTA; 3) preparation of an action-oriented framework based on the key elements of the existing guidance documents and identified barriers to and facilitators of their implementation; and 4) expert consultation and revision of the framework.

Barriers and facilitators influencing ethical evaluation in health technology assessment.

Objectives: The objective of this study was to explore barriers and facilitators influencing the integration of ethical considerations in health technology assessment (HTA).

Methods: The study consisted of two complementary approaches: (a) a systematic review of the literature; and (b) an eighteen-item online survey that was distributed to fifty-six HTA agencies affiliated with the International Network of Agencies for Health Technology Assessment.

Results: The review identified twenty-six relevant articles.

Evidence-based decision-making 3: Health technology assessment.

This chapter begins with a brief introduction to health technology assessment (HTA). HTA is concerned with the systematic evaluation of the consequences of the adoption and use of new health technologies and improving the evidence on existing technologies. The objective of mainstream HTA is to support evidence-based decision- and policy-making that encourage the uptake of efficient and effective health care technologies.

Methodological guidance documents for evaluation of ethical considerations in health technology assessment: a systematic review.

Despite the advances made in the development of ethical frameworks for health technology assessment (HTA), there is no clear agreement on the scope and details of a practical approach to address ethical aspects in HTA. This systematic review aimed to identify existing guidance documents for incorporation of ethics in HTA to provide an overview of their methodological features. The review identified 43 conceptual frameworks or practical guidelines, varying in their philosophical approach, structure, and comprehensiveness.

Cost-effectiveness of catheter ablation for rhythm control of atrial fibrillation.

Objective. The objective of this study is to evaluate the cost-effectiveness of catheter ablation for rhythm control compared to antiarrhythmic drug (AAD) therapy in patients with atrial fibrillation (AF) who have previously failed on an AAD. Methods.

Hyperbaric oxygen therapy for diabetic ulcers: systematic review and meta-analysis.

Objectives: Approximately 10-15 percent of individuals with diabetes mellitus develop foot ulcers, which precede 85 percent of amputations. Increased oxygen, through the use of hyperbaric oxygen therapy (HBOT), has been suggested to encourage ulcer healing thus reducing the risk of amputation. The objective of this systematic review is to evaluate the efficacy of systemic HBOT for nonhealing ulcers of the lower limb in diabetes patients.

Comparative effectiveness of catheter ablation strategies for rhythm control in patients with atrial fibrillation: a meta-analysis.

Background: Pulmonary vein isolation (PVI) forms the basis of catheter ablation strategies for atrial fibrillation (AF). Ablation of additional sites has been used to increase the efficacy of ablation procedures in restoring and maintaining normal sinus rhythm.

Objective: The aim of this paper was to compare the effectiveness of PVI versus PVI plus adjuvant atrial ablations (PVI+) in patients with AF.

Economic evaluations conducted for assessment of genetic testing technologies: a systematic review.

Aims: To systematically review the methods used in economic evaluations (EEs) included in health technology assessments (HTAs) of genetic testing technologies (GTTs).

Methods: A systematic search using bibliographic databases and gray literature was undertaken to identify HTA reports on GTTs that included EEs in addition to clinical effectiveness results. Studies were reviewed in terms of methodology and reporting.

Canadian cost- utility analysis of intravenous immunoglobulin for acute childhood idiopathic thrombocytopenic purpura.

Background: Idiopathic thrombocytopenic purpura (ITP) is a hematological disorder and can be classified as acute or chronic. The main goal of treatment for acute childhood ITP is the prevention of potentially fatal bleeding complications, the most serious of which is intracranial hemorrhage (ICH). Treatment options for acute childhood ITP include splenectomy, corticosteroids, and blood products such as intravenous immunoglobulin.

Canadian cost-utility analysis of initiation and maintenance treatment with anti-TNF-α drugs for refractory Crohn's disease.

Objectives: Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract. Symptoms include but are not limited to abdominal pain, nausea, emesis, and diarrhea. Anti-TNF-α drugs are increasingly being used in patients with CD who have inadequate response to conventional therapy.

Triple therapy for the management of COPD: a review.

Triple therapy for COPD consists of a long-acting anti-cholinergic bronchodilator, a long-acting beta-agonist bronchodilator, and an inhaled corticosteroid. Guidelines from the Canadian Thoracic Society advocate triple therapy for some patients with moderate-to-severe COPD. The objective of this review was to evaluate the evidence based clinical efficacy of triple therapy compared to dual bronchodilator therapy (long-acting anti-cholinergic bronchodilator + beta-agonist bronchodilator) or long-acting anti-cholinergic bronchodilator monotherapy for managing COPD.

Cost-utility of Intravenous Immunoglobulin (IVIG) compared with corticosteroids for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Canada.

Objectives: Intravenous immunoglobulin (IVIG) has demonstrated improvement in chronic inflammatory demyelinating polyneuropathy (CIDP) patients in placebo controlled trials. However, IVIG is also much more expensive than alternative treatments such as corticosteroids. The objective of the paper is to evaluate, from a Canadian perspective, the cost-effectiveness of IVIG compared to corticosteroid treatment of CIDP.

Patient outcomes after anti TNF-alpha drugs for Crohn's disease.

Crohn's disease (CD) is a chronic inflammatory bowel disease with a relatively high prevalence rate in North America. More than 50% of CD patients require surgery at some stage of their disease. Anti-TNF-alpha drugs are increasingly being used in patients with CD who have had an inadequate response to conventional therapy.

Intravenous immunoglobulin for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy: a systematic review and meta-analysis.

Background: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an acquired immune-mediated inflammatory disorder that targets the myelin sheaths of the peripheral nervous system. Intravenous immunoglobulin (IVIg) is a blood product containing immunoglobulin G pooled from many human donors. In fall 2008, CIDP became an approved indication for IVIg in the United States and Canada.

Cost-utility analysis of infliximab and adalimumab for refractory ulcerative colitis.

Objective: To evaluate cost-utility of infliximab and adalimumab for the treatment of moderate-to-severe ulcerative colitis (UC) refractory to conventional therapies in Canada.

Methods: A Markov model was constructed to evaluate incremental cost-utility ratios (ICUR) of 5 mg/kg and 10 mg/kg infliximab and adalimumab therapies compared to 'usual care' in treating a hypothetical cohort of patients (aged 40 years and weighing 80 kg) over a five-year time horizon from the perspective of a publicly-funded health care system. Clinical parameters were derived from the Active Ulcerative Colitis Trials 1 and 2.

Results of a model analysis to estimate cost utility and value of information for intravenous immunoglobulin in Canadian adults with chronic immune thrombocytopenic purpura.

Objective: The aim of this work was to estimate the cost-effectiveness of intravenous immunoglobulin (IVIg) compared with oral prednisone as a treatment for Canadian adults with persistent chronic immune thrombocytopenic purpura (ITP).

Methods: The lifetime costs and effectiveness of IVIg and prednisone were estimated from the perspective of a publicly funded health care system in Canada, using a Markov model that was developed based on a systematic clinical and economic review and recommendations of clinical experts in Canada. Transition probabilities (ie, point estimates and 95% CIs) were estimated from the studies identified in a systematic literature review using a random-effect meta-analysis; point estimates were weighted-mean values from the meta-analysis.