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OBJECTIVES: To conduct a systematic review and meta-analysis assessing whether the use of antipsychotic medications in critically ill adult patients with delirium impacts patient-important outcomes. DATA SOURCES: A medical librarian searched Ovid MEDLINE, EMBASE, APA PsycInfo, and Wiley's Cochrane Library as well as clinicaltrials.gov and the World Health Organization International Clinical Trials Registry Platform up to November 2023. STUDY SELECTION: Independently and in duplicate, reviewers screened abstracts and titles for eligibility, then full text of qualifying studies. We included parallel-group randomized controlled trials (RCTs) that included critically ill adult patients with delirium. The intervention group was required to receive antipsychotic medications at any dose, whereas the control group received usual care or placebo. DATA EXTRACTION: Reviewers extracted data independently and in duplicate using a piloted abstraction form. Statistical analyses were conducted using RevMan software (version 5.4). DATA SYNTHESIS: Five RCTs ( n = 1750) met eligibility criteria. The use of antipsychotic medications compared with placebo did not increase the number of delirium- or coma-free days (mean difference 0.90 d; 95% CI, -0.32 to 2.12; moderate certainty), nor did it result in a difference in mortality, duration of mechanical ventilation, ICU, or hospital length of stay. The use of antipsychotics did not result in an increased risk of adverse events (risk ratio 1.27; 95% CI, 0.71-2.30; high certainty). Subgroup analysis of typical versus atypical antipsychotics did not identify any subgroup effect for any outcome. CONCLUSIONS: In conclusion, our systematic review and meta-analysis demonstrated with moderate certainty that there is no difference in delirium- or coma-free days when delirious critically ill adults are treated with antipsychotic medications. Further studies in the subset of patients with hyperactive delirium may be of benefit.
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Antipsicóticos , Estado Terminal , Delírio , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Delírio/tratamento farmacológico , Antipsicóticos/uso terapêutico , Antipsicóticos/efeitos adversos , Estado Terminal/terapiaRESUMO
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. METHODS: A systematic search, using controlled and keyword terms focusing on "HBOT" and "lower limb diabetic ulcers," was conducted. Databases searched included Medline, EMBASE, CINAHL, PubMed, Wiley's Cochrane Library, and Biosis. Randomized controlled trials (RCTs) and observational studies were included. Pooled estimates of outcomes were determined when appropriate. RESULTS: Of the 654 citations identified, 157 articles underwent full-text review. Data were abstracted from twelve publications (six RCTs and six comparative observational studies). Pooled analysis of the RCT and observational data showed that treatment with HBOT reduced the risk of major amputation by 60 percent (p = .29) and 61 percent (p = .003) compared with standard wound care, respectively. The RCT data revealed that the relative risk of having an unhealed wound following HBOT was 0.54 (p = .10) and 0.24 (p < .0001) based on observational data. CONCLUSIONS: Due to the limited RCT evidence, it is not possible to conclusively establish the benefits and harms of treating diabetic lower limb ulcers with HBOT. No significant effects on amputation rates were found in the RCT evidence and in the high quality studies, no difference was found.
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Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 2/complicações , Úlcera do Pé/terapia , Oxigenoterapia Hiperbárica , Humanos , Resultado do TratamentoRESUMO
OBJECTIVE: The objective of this review is to provide an overview of the existing literature on psychosocial interventions aimed at addressing suicidality among adults in the context of an inpatient psychiatric admission. INTRODUCTION: For individuals admitted to a psychiatric inpatient unit, their risk of suicide in the period following discharge is significantly higher compared with the prevalence of death by suicide in the general population. During an inpatient admission, there is opportunity for supportive interventions that may lead to reduced risks of suicide. Yet, interventions that directly address suicidality have primarily been studied in outpatient settings. A broader understanding of inpatient interventions will assist clinicians in understanding key considerations when implementing suicide-related interventions in this setting. INCLUSION CRITERIA: Studies involving adult patients (≥18 years) that describe psychosocial interventions aiming to address suicidality in the context of inpatient psychiatry will be considered. Studies that only describe pharmacological interventions will be excluded, as will studies that describe psychosocial interventions initiated in the context of an outpatient setting. METHODS: We will search MEDLINE (Ovid), CINAHL (EBSCO), APA PsycINFO (EBSCOhost), the Cochrane Central Register of Controlled Trials (CENTRAL), Embase, and Web of Science for studies in English and Spanish. Gray literature and materials will also be searched for using Google and websites relevant to the review topic. No date limit will be set. Two independent reviewers will screen titles and abstracts from studies that meet the inclusion criteria and review eligible studies at full text. Data will be extracted and synthesized and then presented in tabular and graphical formats accompanied by a narrative summary. DETAILS OF THE REVIEW AVAILABLE AT: Open Science Framework https://osf.io/5cwhx.
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Suicídio , Adulto , Humanos , Pacientes Internados , Intervenção Psicossocial , Hospitalização , Alta do Paciente , Literatura de Revisão como AssuntoRESUMO
BACKGROUND: Adults with cannabis hyperemesis syndrome (CHS) are increasingly presenting to the emergency department (ED), and this systematic review will evaluate the direct evidence on the effectiveness of capsaicin and dopamine antagonists in its clinical management. METHODS: A bibliographic search was conducted to address the following population-intervention-control-outcome (PICO) question: (P) adults >18 years old with a diagnosis of acute CHS presenting to the ED; (I) dopamine antagonists (e.g., haloperidol, droperidol) and topical capsaicin; (C) usual care or no active comparator; and (O) symptoms improvement/resolution in ED, ED length of stay, admission rate, ED recidivism, need for rescue medication, and adverse events. This systematic review was conducted in accordance with PRISMA reporting recommendations. RESULTS: From 53 potentially relevant articles, seven articles were included: five observational studies and two randomized controlled trials, including a total of 492 patients. Five of these studies evaluated the efficacy of capsaicin cream (n = 386), and two examined dopamine antagonists (haloperidol, droperidol; n = 106). There was mixed evidence for the efficacy of capsaicin for reducing nausea and emesis. Both studies evaluating dopamine antagonists detected clinical benefit to usual care or no active comparator. CONCLUSIONS: There is limited direct evidence on the efficacy of dopamine antagonists or capsaicin for treating CHS in the ED. Current evidence is mixed for capsaicin and potentially beneficial for dopamine antagonists. Because of the small number of studies, small number of participants, lack of standardization of treatment administration, and risk of bias of the included studies, methodologically rigorous trials on both types of intervention are needed to directly inform ED management of CHS.
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OBJECTIVES: Alcohol-related concerns commonly present to the emergency department (ED), with a subset of individuals experiencing the symptoms of an alcohol use disorder (AUD). As such, examining the efficacy of pharmacological anti-craving treatment for AUD in the ED is of increasing interest. The objective of this systematic review was to evaluate the direct evidence assessing the efficacy of providing anti-craving medications for AUD treatment in the ED. METHODS: A systematic search was conducted according to the patient-intervention-control-outcome question: (P) adults (≥18 years old) presenting to the ED with an AUD (including suspected AUD); (I) anti-craving medications (i.e., naltrexone, acamprosate, gabapentin); (C) no prescription or placebo; (O) reduction of repeat ED visits, engagement in addiction services, reductions in heavy drinking days, reductions in any drinking and amount consumed (or abstinence), and in relapse. Two reviewers independently assessed articles for inclusion and conducted risk of bias assessments for included studies. RESULTS: From 143 potentially relevant articles, 6 met inclusion criteria: 3 clinical trials, and 3 case studies. The clinical trials identified evaluated oral versus extended-release naltrexone, monthly extended-release naltrexone injections, and disulfiram. Both oral and extended-release naltrexone resulted in decreased alcohol consumption. Monthly extended-release naltrexone injections resulted in significant improvements in drinking and quality of life. Although out of scope, the disulfiram studies identified did not result in an improvement in drinking in comparison to no medication. CONCLUSIONS: Overall, there are few studies directly examining the efficacy of anti-craving medications for AUD in the ED, although the limited evidence that exists is supportive of naltrexone pharmacotherapy, particularly extended-release injection formulation. Additional randomized controlled trials are necessary for substantive direct evidence on anti-craving medication initiation in the ED.
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OBJECTIVES: Alcohol withdrawal syndrome (AWS) is a commonly presenting condition in the emergency department (ED) and can have severe complications, including mortality. Benzodiazepines are first-line medications for treating AWS but may be unavailable or insufficient. This systematic review evaluates the direct evidence assessing the utility of phenobarbital for treating AWS in the ED. METHODS: A systematic search was conducted and designed according to the patient-intervention-comparator-outcome (PICO) question: (P) adults (≥18 years old) presenting to the ED with alcohol withdrawal; (I) phenobarbital (including adjunctive); (C) benzodiazepines or no intervention; and (O) AWS complications, admission to a monitored setting, control of symptoms, adverse effects, and adjunctive medications. Two reviewers independently assessed articles for inclusion and conducted risk of bias assessments for included studies. RESULTS: From 70 potentially relevant articles, seven studies met inclusion criteria: three retrospective cohort studies, two retrospective chart reviews, and two randomized controlled trials (RCTs), one examining phenobarbital monotherapy and one examining adjunctive phenobarbital. Across the retrospective cohort studies, treatment of AWS with phenobarbital resulted in lower odds of a subsequent ED visit. The retrospective chart reviews indicated that phenobarbital was associated with higher discharge rate compared to benzodiazepine-only treatments. For the two RCTs, phenobarbital did not differ significantly from benzodiazepine for most outcomes, although concomitant treatment with phenobarbital was associated with lower benzodiazepine use and intensive care unit admission. The heterogeneous designs and small number of studies prevented quantitative synthesis. CONCLUSIONS: Relatively few studies provide direct evidence on the utility of phenobarbital for AWS in the ED, but the evidence that exists generally suggests that it is a reasonable and appropriate approach. Additional RCTs and other methodologically rigorous investigations are needed for more definitive direct evidence.
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This project aims to assess the utility of bibliographic databases beyond the three major ones (MEDLINE, EMBASE and Cochrane CENTRAL) for finding controlled trials of complementary and alternative medicine (CAM). Fifteen databases were searched to identify controlled clinical trials (CCTs) of CAM not also indexed in MEDLINE. Searches were conducted in May 2006 using the revised Cochrane highly sensitive search strategy (HSSS) and the PubMed CAM Subset. Yield of CAM trials per 100 records was determined, and databases were compared over a standardized period (2005). The Acudoc2 RCT, Acubriefs, Index to Chiropractic Literature (ICL) and Hom-Inform databases had the highest concentrations of non-MEDLINE records, with more than 100 non-MEDLINE records per 500. Other productive databases had ratios between 500 and 1500 records to 100 non-MEDLINE records-these were AMED, MANTIS, PsycINFO, CINAHL, Global Health and Alt HealthWatch. Five databases were found to be unproductive: AGRICOLA, CAIRSS, Datadiwan, Herb Research Foundation and IBIDS. Acudoc2 RCT yielded 100 CAM trials in the most recent 100 records screened. Acubriefs, AMED, Hom-Inform, MANTIS, PsycINFO and CINAHL had more than 25 CAM trials per 100 records screened. Global Health, ICL and Alt HealthWatch were below 25 in yield. There were 255 non-MEDLINE trials from eight databases in 2005, with only 10% indexed in more than one database. Yield varied greatly between databases; the most productive databases from both sampling methods were Acubriefs, Acudoc2 RCT, AMED and CINAHL. Low overlap between databases indicates comprehensive CAM literature searches will require multiple databases.
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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. This chapter provides a basic framework for conducting an HTA, as well as some fundamental concepts and challenges in assessing health technologies. Whether HTA is beneficial-supporting timely access to needed technologies-or detrimental depends on three critical issues: when the assessment is performed; how it is performed; and how the findings are used.
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Tomada de Decisão Clínica/métodos , Avaliação da Tecnologia Biomédica/métodos , Tecnologia Biomédica , Medicina Baseada em Evidências/métodos , Política de Saúde , HumanosRESUMO
INTRODUCTION: Gastrointestinal recovery after surgery is of worldwide significance. Postoperative gastrointestinal dysfunction is multifaceted and known to represent a major source of postoperative morbidity, however, its significance to postoperative care across all surgical procedures is unknown. The complexity of postoperative gastrointestinal recovery is poorly defined within gastrointestinal surgery, and even less so outside this field. To inform the clinical care of surgical patients worldwide, this systematic review and meta-analysis will aim to characterise the duration of postoperative gastrointestinal recovery that can be expected across all surgical procedures and determine the associations between factors that may affect this. METHODS AND ANALYSIS: MEDLINE, Embase, Cochrane Library and CINAHL will be searched for studies reporting the time to first postoperative passage of stool after any surgical procedure. We will screen records, extract data and assess risk of bias in duplicate. Forest plots will be constructed for time to postoperative gastrointestinal recovery, as assessed by various outcome measures. Because of potential heterogeneity, a random-effects model will be used throughout the meta-analysis. Funnel plots will be used to test for publication bias. Meta-regressions will be undertaken where the outcome is the mean time to first postoperative passage of stool, with potential predictors and confounders being patient characteristics, postoperative outcomes and surgical factors. ETHICS AND DISSEMINATION: This study will not involve human or animal subjects and, thus, does not require ethics approval. The outcomes will be disseminated via publication in peer-reviewed scientific journal(s) and presentations at scientific conferences. PROSPERO REGISTRATION NUMBER: CRD42021256210.
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Projetos de Pesquisa , Humanos , Metanálise como Assunto , Viés de Publicação , Revisões Sistemáticas como AssuntoRESUMO
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. METHODS: A markov model was used to evaluate the costs and QALYs for IVIG and corticosteroids over 5 years of treatment for CIDP. Patients initially responding to IVIG could remain a responder or relapse every 12 week model cycle. Non-responding IVIG patients were assumed to be switched to corticosteroids. Patients on corticosteroids were at risk of a number of adverse events (fracture, diabetes, glaucoma, cataract, serious infection) in each cycle. RESULTS: Over the 5 year time horizon, the model estimated the incremental costs and QALYs of IVIG treatment compared to corticosteroid treatment to be $124,065 and 0.177 respectively. The incremental cost per QALY gained of IVIG was estimated to be $687,287. The cost per QALY of IVIG was sensitive to the assumptions regarding frequency and dosing of maintenance IVIG. CONCLUSIONS: Based on common willingness to pay thresholds, IVIG would not be perceived as a cost effective treatment for CIDP.
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BACKGROUND: Cost-utility analyses are commonly used in economic evaluations of interventions or conditions that have an impact on health-related quality of life. However, evaluating utilities in children presents several challenges since young children may not have the cognitive ability to complete measurement tasks and thus utility values must be estimated by proxy assessors. Another solution is to use utilities derived from an adult population. To better inform the future conduct of cost-utility analyses in paediatric populations, we reviewed the published literature reporting utilities among children and adults across selected conditions common to paediatric and adult populations. METHODS: An electronic search of Ovid MEDLINE, EMBASE, and the Cochrane Library up to November 2008 was conducted to identify studies presenting utility values derived from the Health Utilities Index (HUI) or EuroQoL-5Dimensions (EQ-5D) questionnaires or using time trade off (TTO) or standard gamble (SG) techniques in children and/or adult populations from randomized controlled trials, comparative or non-comparative observational studies, or cross-sectional studies. The search was targeted to four chronic diseases/conditions common to both children and adults and known to have a negative impact on health-related quality of life (HRQoL). RESULTS: After screening 951 citations identified from the literature search, 77 unique studies included in our review evaluated utilities in patients with asthma (n = 25), cancer (n = 23), diabetes mellitus (n = 11), skin diseases (n = 19) or chronic diseases (n = 2), with some studies evaluating multiple conditions. Utility values were estimated using HUI (n = 33), EQ-5D (n = 26), TTO (n = 12), and SG (n = 14), with some studies applying more than one technique to estimate utility values. 21% of studies evaluated utilities in children, of those the majority being in the area of oncology. No utility values for children were reported in skin diseases. Although few studies provided comparative information on utility values between children and adults, results seem to indicate that utilities may be similar in adolescents and young adults with asthma and acne. Differences in results were observed depending on methods and proxies. CONCLUSIONS: This review highlights the need to conduct future research regarding measurement of utilities in children.
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Análise Custo-Benefício , Anos de Vida Ajustados por Qualidade de Vida , Adulto , Asma/terapia , Criança , Técnicas de Apoio para a Decisão , Diabetes Mellitus/terapia , Feminino , Pesquisa sobre Serviços de Saúde , Humanos , Masculino , Neoplasias/terapia , Pediatria/métodos , Dermatopatias/terapiaRESUMO
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. No published studies directly estimate the utility weight for patients with relapsed or refractory ITP; therefore, a value of 0.76 was used, based on the mean of the utilities for thrombocytopenia without major bleeding or hemorrhagic stroke. Costs and incremental cost-effectiveness ratios were reported as year-2007 Can $. RESULTS: The incremental costs and quality-adjusted life-years (QALYs) of IVIg versus prednisone were Can $8080 and 0.0071, respectively, resulting in an incremental cost-effectiveness ratio of Can $1.13 million/ QALY in the base-case analysis. The probability of IVIg being cost-effective was 0 if the maximum willingness-to-pay (WTP) value for an additional QALY was below Can $40,000. The probability that IVIg would be cost-effective was only 20%, even if the WTP increased to Can $100,000. The expected value of perfect information (EVPI) and expected value of partial perfect information (EVPPI) were 0 if the WTP was less than Can $30,000. If WTP increased to Can $100,000, the EVPI was Can $1700, and the EVPPI was Can $1010 for utility weights of relapse/refractory states, Can $136 for initial response rates of the treatments, and Can $6 for first-year relapse rates for the treatments. CONCLUSION: Based on the current available clinical evidence, this model analysis of hypothetical patients suggests that IVIg may not be a cost-effective option for adults with persistent chronic ITP in Canada.
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Imunoglobulinas Intravenosas/economia , Imunoglobulinas Intravenosas/uso terapêutico , Modelos Econômicos , Púrpura Trombocitopênica/tratamento farmacológico , Púrpura Trombocitopênica/economia , Administração Oral , Adulto , Idoso , Anti-Inflamatórios/administração & dosagem , Anti-Inflamatórios/economia , Anti-Inflamatórios/uso terapêutico , Canadá , Doença Crônica , Análise Custo-Benefício/métodos , Análise Custo-Benefício/estatística & dados numéricos , Técnicas de Apoio para a Decisão , Humanos , Imunoglobulinas Intravenosas/administração & dosagem , Pessoa de Meia-Idade , Prednisona/administração & dosagem , Prednisona/economia , Prednisona/uso terapêutico , Anos de Vida Ajustados por Qualidade de Vida , Sensibilidade e Especificidade , Resultado do TratamentoRESUMO
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. This chapter provides a basic framework for conducting an HTA, as well as some fundamental concepts and challenges in assessing health technologies. A case study of the assessment of drug-eluting stents in Ontario is presented to illustrate the HTA process. Whether HTA is beneficial (supporting timely access to needed technologies) or detrimental depends on three critical issues: when the assessment is performed, how it is performed, and how the findings are used.
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Tomada de Decisões , Avaliação da Tecnologia Biomédica/métodos , Humanos , Disseminação de Informação , Reprodutibilidade dos TestesRESUMO
BACKGROUND: Reducing wait times for cataract surgery is a priority in Ontario. However, no previous analysis has determined whether the extra treatment volumes required to reduce wait times are of good monetary value when compared with allocating those same financial resources to new programs, drugs, or technologies. The objective of the study was to use queuing models to determine the cost-effectiveness of reducing, to target levels, wait times for cataract surgery at the provincial level within 1 to 10 years by increasing treatment volumes. METHODS: A cost-effectiveness analysis was performed by estimating the extra treatment volume required to reduce wait times using queuing model methodology. The cost of these extra treatments was obtained from Ontario provincial data. The incremental benefits of surgery are improvements in quality-adjusted life years (QALYs), and these values were obtained from the clinical literature. Incremental costs were compared with incremental benefits to determine an incremental cost-effectiveness ratio. RESULTS: To reach the publicly stated target wait times, annual treatment volumes must increase by 4%. An extra increase in treatment volumes of 25,660 must also be provided for the transition period from the current wait time. The incremental cost-effectiveness ratio is $17,829 per QALY if the target wait time is achieved in 5 years, and this ratio is less than the common threshold for approval of new interventions, of $50,000 per QALY. INTERPRETATION: Increasing treatment volumes is a cost-effective way of reducing wait times.
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Extração de Catarata/economia , Catarata/economia , Efeitos Psicossociais da Doença , Listas de Espera , Análise Custo-Benefício , Prioridades em Saúde , Pesquisa sobre Serviços de Saúde , Humanos , Ontário , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de VidaRESUMO
PURPOSE: To investigate if study design factors such as randomization, multi-center versus single center evidence, institutional surgical volume, and patient selection affect the outcomes for endovascular repair (EVAR) versus open surgical repair (OSR). Finally, we investigate trends over time in EVAR versus OSR outcomes. METHODS: Search strategies for comparative studies were performed individually for: OVID's MEDLINE, EMBASE, CINAHL, HAPI, and Evidence Based Medicine (EBM) Reviews (including Cochrane DSR, ACP Journal Club, DARE and CCTR), limited to 1990 and November 2006. RESULTS: Identified literature: 84 comparative studies pertaining to 57,645 patients. These include 4 randomized controlled trials (RCTs), plus 2 RCTs with long-term follow-up. The other 78 comparative studies were nonrandomized with 75 reporting perioperative outcomes, of which 16 were multi-center, and 59 single-center studies. Of the single-center studies 31 were low-volume and 28 were high-volume centers. In addition, 5 studies had all patients anatomically eligible for EVAR, and 8 studies included high-risk patients only. Finally, 25 long term observational studies reported outcomes up to 3 years. OUTCOMES: Lower perioperative mortality and rates of complications for EVAR versus OSR varied across study designs and patient populations. EVAR adverse outcomes have decreased in recent times. CONCLUSION: EVAR highlights the problem of performing meta-analysis when the experience evolves over time.
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Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular , Ensaios Clínicos como Assunto/métodos , Projetos de Pesquisa , Aneurisma da Aorta Abdominal/mortalidade , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/mortalidade , Feminino , Humanos , Isquemia/etiologia , Masculino , Procedimentos Cirúrgicos Minimamente Invasivos , Razão de Chances , Desenho de Prótese , Falha de Prótese , Medição de Risco , Stents , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: The introduction of new oral anticoagulants for the prevention of stroke in atrial fibrillation (AF) has changed the clinical management of AF. To inform decision making around dabigatran by identifying factors influencing cost-effectiveness results, we undertook a systematic review of economic evaluations of dabigatran versus warfarin for the prevention of stroke in AF patients. METHODS: A systematic literature search of Ovid Medline and Embase, Wiley's Cochrane Library, HEED, PubMed databases and grey literature was carried out for primary economic evaluations comparing dabigatran versus warfarin in patients with AF. Data on study characteristics, model inputs and results, and sensitivity analyses were abstracted and synthesized qualitatively. RESULTS: Twenty-three economic evaluations were identified and RE-LY was cited in 52% of studies as the source of the efficacy data. Twenty evaluations used Markov modelling, 2 performed discrete event simulation, and 1 was a trial-based evaluation. Eighty-two percent reported base case incremental cost-effectiveness ratios (ICERs) of less than $50,000 USD/QALY. Key variables, including international normalized ratio (INR) control, the cost of monitoring, risk of stroke and bleeding, and age were found to alter the conclusions in only a few studies. Less commonly explored factors included time horizon and cost of long-term care follow-up. CONCLUSIONS: Several factors should be considered when interpreting the results of economic analyses which are based on randomized clinical trial evidence. Real-world data are needed to further assess the clinical and economic consequences of dabigatran relative to warfarin for the prevention of stroke in AF.
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Fibrilação Atrial/economia , Análise Custo-Benefício/métodos , Dabigatrana/economia , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/prevenção & controle , Varfarina/economia , Anticoagulantes/economia , Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Dabigatrana/uso terapêutico , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Varfarina/uso terapêuticoRESUMO
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. This chapter provides a basic framework for conducting an HTA as well as some fundamental concepts and challenges in assessing health technologies. A case study of the assessment of drug eluting stents in Ontario is presented to illustrate the HTA process. Whether HTA is beneficial-supporting timely access to needed technologies-or detrimental depends on three critical issues: when the assessment is performed; how it is performed; and how the findings are used.
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Tecnologia Biomédica/métodos , Avaliação da Tecnologia Biomédica/métodos , Tecnologia Biomédica/economia , Tecnologia Biomédica/ética , Análise Custo-Benefício , Tomada de Decisões , Stents Farmacológicos/economia , Humanos , Avaliação da Tecnologia Biomédica/economia , Avaliação da Tecnologia Biomédica/éticaRESUMO
BACKGROUND: Many systematic reviews have evaluated the effectiveness of interventions to prevent, delay, or decrease frailty symptoms, but no effort has been made to identify, map, and synthesize the findings from reviews across the full spectrum of interventions. Our objectives are to (1) synthesize findings from all existing systematic reviews evaluating interventions for preventing, delaying the onset, or decreasing the burden of frailty symptoms; (2) examine different conceptualizations of frailty that have been used in the development and implementation of interventions; and (3) inform policy by convening a stakeholder dialogue with Canadian health-system leaders. METHODS/DESIGN: We will conduct an overview of systematic reviews to identify and synthesize all of the systematic reviews addressing interventions to preventing, delaying the onset, or decreasing the burden of frailty symptoms. To identify relevant systematic reviews, we will conduct database searches for published and grey literature as well as contact key experts and search reference lists of included reviews. Two reviewers will independently review all search results for inclusion and then conceptually map, extract key findings (including the conceptualization/definition of frailty used) and assess the methodological quality of all included reviews. We will then synthesize the findings by producing a 'gap map' (i.e. mapping reviews in a matrix according to the interventions and outcomes assessed), and narratively synthesize the key messages across reviews related to type of interventions. DISCUSSION: Following the completion of the synthesis, we will use the findings to develop an evidence brief that mobilizes the best available evidence about the problem related to preventing, delaying the onset, or decreasing the burden of frailty symptoms in older adults, policy and programmatic options to address the problem and implementation considerations. The evidence brief will then be used as the input into a stakeholder dialogue, which will engage 18-22 Canadian health-system leaders (including policymakers, health providers, researchers, and other stakeholders) in 'off-the-record' deliberations to inform future actions and policymaking. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015022082.
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Envelhecimento , Pesquisa Biomédica , Efeitos Psicossociais da Doença , Idoso Fragilizado , Geriatria/métodos , Idoso , Humanos , Literatura de Revisão como Assunto , Pesquisa Translacional BiomédicaRESUMO
BACKGROUND: Pulmonary rehabilitation (PR) is a comprehensive intervention of exercise training, education, and behaviour change to improve the physical and psychological condition of people with chronic respiratory disorders, such as chronic obstructive pulmonary disease (COPD) and to promote long-term adherence to health-enhancing behaviours. Although PR is considered the standard of care for patients with COPD who remain symptomatic despite bronchodilator therapies, current evidence suggests that only 1.15% of COPD patients across Canada have access to PR facilities for care. OBJECTIVES: The objectives of this study were to identify the number of health care facilities across Ontario providing PR services for patients with COPD, describe the scope of those services, and determine the province's current capacity to provide PR services relative to need, for the province as a whole and by local health integration network (LHIN). METHODS: The Pulmonary Rehabilitation Programs in Ontario (PRO) Survey was a province-wide, descriptive, cross-sectional survey of health care facilities (hospitals, family health teams, and community health centres). It was distributed to 409 facilities to collect information on various aspects of PR services in the province. RESULTS: Between April 2013 and February 2014, 187 facilities responded to the survey (46% response rate). Most responding centres (144) did not offer PR services, and only 43 were full PR sites providing a comprehensive program. Hospital-based programs made up the majority of sites offering full PR services (67%), followed by programs based at family health teams (19%) and community health centres (14%). More than 90% of PR programs are outpatient-based. The average wait time for outpatient PR was 6.9 weeks, and 58% of programs provide services 5 days per week. More than 80% of patients attending PR complete the full program. Across all program types, the total estimated provincial capacity for PR outpatient care is 4,524 patients per year, or 0.66% to 1.78% of patients with COPD, depending on the estimated prevalence of disease. LIMITATIONS: These results are representative of 12 of the 14 LHINs in Ontario due to low response rates in facilities in 2 LHINs. CONCLUSIONS: Although some increase in capacity has occurred since a similar survey in 2005, PR resources in Ontario are insufficient to support the delivery of care to people with COPD in accordance with clinical practice guideline recommendations.
Assuntos
Acessibilidade aos Serviços de Saúde , Serviços de Saúde , Doença Pulmonar Obstrutiva Crônica/reabilitação , Assistência Ambulatorial , Estudos Transversais , Pesquisas sobre Atenção à Saúde , Humanos , OntárioRESUMO
BACKGROUND: The safety and effectiveness of CAM interventions are of great relevance to pediatric health care providers. The objective of this study is to identify sources of reported randomized controlled trials (RCTs) in the field of pediatric complementary and alternative medicine (CAM). METHODS: Reports of RCTs were identified by searching Medline and 12 additional bibliographic databases and by reviewing the reference lists of previously identified pediatric CAM systematic reviews. RESULTS: We identified 908 reports of RCTs that included children under 18 and investigated a CAM therapy. Since 1965, there has been a steady growth in the number of these trials that are being published. The four journals that published the most reported RCTs are The American Journal of Clinical Nutrition, Pediatrics, Journal of Pediatrics, and Lancet. Medline, CAB Health, and Embase were the best database sources for identifying these studies; they indexed 93.2%, 58.4% and 42.2 % respectively of the journals publishing reports of pediatric CAM RCTs. CONCLUSIONS: Those working or interested in the field of pediatric CAM should routinely search Medline, CAB Health and Embase for literature in the field. The four core journals identified above should be included in their collection.