Genomics-based non-invasive prenatal testing for detection of fetal chromosomal aneuploidy in pregnant women.

BACKGROUND: Common fetal aneuploidies include Down syndrome (trisomy 21 or T21), Edward syndrome (trisomy 18 or T18), Patau syndrome (trisomy 13 or T13), Turner syndrome (45,X), Klinefelter syndrome (47,XXY), Triple X syndrome (47,XXX) and 47,XYY syndrome (47,XYY). Prenatal screening for fetal aneuploidies is standard care in many countries, but current biochemical and ultrasound tests have high false negative and false positive rates. The discovery of fetal circulating cell-free DNA (ccfDNA) in maternal blood offers the potential for genomics-based non-invasive prenatal testing (gNIPT) as a more accurate screening method. Two approaches used for gNIPT are massively parallel shotgun sequencing (MPSS) and targeted massively parallel sequencing (TMPS). OBJECTIVES: To evaluate and compare the diagnostic accuracy of MPSS and TMPS for gNIPT as a first-tier test in unselected populations of pregnant women undergoing aneuploidy screening or as a second-tier test in pregnant women considered to be high risk after first-tier screening for common fetal aneuploidies. The gNIPT results were confirmed by a reference standard such as fetal karyotype or neonatal clinical examination. SEARCH METHODS: We searched 13 databases (including MEDLINE, Embase and Web of Science) from 1 January 2007 to 12 July 2016 without any language, search filter or publication type restrictions. We also screened reference lists of relevant full-text articles, websites of private prenatal diagnosis companies and conference abstracts. SELECTION CRITERIA: Studies could include pregnant women of any age, ethnicity and gestational age with singleton or multifetal pregnancy. The women must have had a screening test for fetal aneuploidy by MPSS or TMPS and a reference standard such as fetal karyotype or medical records from birth. DATA COLLECTION AND ANALYSIS: Two review authors independently carried out study selection, data extraction and quality assessment (using the QUADAS-2 tool). Where possible, hierarchical models or simpler alternatives were used for meta-analysis. MAIN RESULTS: Sixty-five studies of 86,139 pregnant women (3141 aneuploids and 82,998 euploids) were included. No study was judged to be at low risk of bias across the four domains of the QUADAS-2 tool but applicability concerns were generally low. Of the 65 studies, 42 enrolled pregnant women at high risk, five recruited an unselected population and 18 recruited cohorts with a mix of prior risk of fetal aneuploidy. Among the 65 studies, 44 evaluated MPSS and 21 evaluated TMPS; of these, five studies also compared gNIPT with a traditional screening test (biochemical, ultrasound or both). Forty-six out of 65 studies (71%) reported gNIPT assay failure rate, which ranged between 0% and 25% for MPSS, and between 0.8% and 7.5% for TMPS.In the population of unselected pregnant women, MPSS was evaluated by only one study; the study assessed T21, T18 and T13. TMPS was assessed for T21 in four studies involving unselected cohorts; three of the studies also assessed T18 and 13. In pooled analyses (88 T21 cases, 22 T18 cases, eight T13 cases and 20,649 unaffected pregnancies (non T21, T18 and T13)), the clinical sensitivity (95% confidence interval (CI)) of TMPS was 99.2% (78.2% to 100%), 90.9% (70.0% to 97.7%) and 65.1% (9.16% to 97.2%) for T21, T18 and T13, respectively. The corresponding clinical specificity was above 99.9% for T21, T18 and T13.In high-risk populations, MPSS was assessed for T21, T18, T13 and 45,X in 30, 28, 20 and 12 studies, respectively. In pooled analyses (1048 T21 cases, 332 T18 cases, 128 T13 cases and 15,797 unaffected pregnancies), the clinical sensitivity (95% confidence interval (CI)) of MPSS was 99.7% (98.0% to 100%), 97.8% (92.5% to 99.4%), 95.8% (86.1% to 98.9%) and 91.7% (78.3% to 97.1%) for T21, T18, T13 and 45,X, respectively. The corresponding clinical specificities (95% CI) were 99.9% (99.8% to 100%), 99.9% (99.8% to 100%), 99.8% (99.8% to 99.9%) and 99.6% (98.9% to 99.8%). In this risk group, TMPS was assessed for T21, T18, T13 and 45,X in six, five, two and four studies. In pooled analyses (246 T21 cases, 112 T18 cases, 20 T13 cases and 4282 unaffected pregnancies), the clinical sensitivity (95% CI) of TMPS was 99.2% (96.8% to 99.8%), 98.2% (93.1% to 99.6%), 100% (83.9% to 100%) and 92.4% (84.1% to 96.5%) for T21, T18, T13 and 45,X respectively. The clinical specificities were above 100% for T21, T18 and T13 and 99.8% (98.3% to 100%) for 45,X. Indirect comparisons of MPSS and TMPS for T21, T18 and 45,X showed no statistical difference in clinical sensitivity, clinical specificity or both. Due to limited data, comparative meta-analysis of MPSS and TMPS was not possible for T13.We were unable to perform meta-analyses of gNIPT for 47,XXX, 47,XXY and 47,XYY because there were very few or no studies in one or more risk groups. AUTHORS' CONCLUSIONS: These results show that MPSS and TMPS perform similarly in terms of clinical sensitivity and specificity for the detection of fetal T31, T18, T13 and sex chromosome aneuploidy (SCA). However, no study compared the two approaches head-to-head in the same cohort of patients. The accuracy of gNIPT as a prenatal screening test has been mainly evaluated as a second-tier screening test to identify pregnancies at very low risk of fetal aneuploidies (T21, T18 and T13), thus avoiding invasive procedures. Genomics-based non-invasive prenatal testing methods appear to be sensitive and highly specific for detection of fetal trisomies 21, 18 and 13 in high-risk populations. There is paucity of data on the accuracy of gNIPT as a first-tier aneuploidy screening test in a population of unselected pregnant women. With respect to the replacement of invasive tests, the performance of gNIPT observed in this review is not sufficient to replace current invasive diagnostic tests.We conclude that given the current data on the performance of gNIPT, invasive fetal karyotyping is still the required diagnostic approach to confirm the presence of a chromosomal abnormality prior to making irreversible decisions relative to the pregnancy outcome. However, most of the gNIPT studies were prone to bias, especially in terms of the selection of participants.

Collaborative writing applications in healthcare: effects on professional practice and healthcare outcomes.

BACKGROUND: Collaborative writing applications (CWAs), such as wikis and Google Documents, hold the potential to improve the use of evidence in both public health and healthcare. Although a growing body of literature indicates that CWAs could have positive effects on healthcare, such as improved collaboration, behavioural change, learning, knowledge management, and adaptation of knowledge to local context, this has never been assessed systematically. Moreover, several questions regarding safety, reliability, and legal aspects exist. OBJECTIVES: The objectives of this review were to (1) assess the effects of the use of CWAs on process (including the behaviour of healthcare professionals) and patient outcomes, (2) critically appraise and summarise current evidence on the use of resources, costs, and cost-effectiveness associated with CWAs to improve professional practices and patient outcomes, and (3) explore the effects of different CWA features (e.g. open versus closed) and different implementation factors (e.g. the presence of a moderator) on process and patient outcomes. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and 11 other electronic databases. We searched the grey literature, two trial registries, CWA websites, individual journals, and conference proceedings. We also contacted authors and experts in the field. We did not apply date or language limits. We searched for published literature to August 2016, and grey literature to September 2015. SELECTION CRITERIA: We included randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-and-after (CBA) studies, interrupted time series (ITS) studies, and repeated measures studies (RMS), in which CWAs were used as an intervention to improve the process of care, patient outcomes, or healthcare costs. DATA COLLECTION AND ANALYSIS: Teams of two review authors independently assessed the eligibility of studies. Disagreements were resolved by discussion, and when consensus was not reached, a third review author was consulted. MAIN RESULTS: We screened 11,993 studies identified from the electronic database searches and 346 studies from grey literature sources. We analysed the full text of 99 studies. None of the studies met the eligibility criteria; two potentially relevant studies are ongoing. AUTHORS' CONCLUSIONS: While there is a high number of published studies about CWAs, indicating that this is an active field of research, additional studies using rigorous experimental designs are needed to assess their impact and cost-effectiveness on process and patient outcomes.

Canadian Guidelines for Controlled Pediatric Donation After Circulatory Determination of Death-Summary Report.

OBJECTIVES: Create trustworthy, rigorous, national clinical practice guidelines for the practice of pediatric donation after circulatory determination of death in Canada. METHODS: We followed a process of clinical practice guideline development based on World Health Organization and Canadian Medical Association methods. This included application of Grading of Recommendations Assessment, Development, and Evaluation methodology. Questions requiring recommendations were generated based on 1) 2006 Canadian donation after circulatory determination of death guidelines (not pediatric specific), 2) a multidisciplinary symposium of national and international pediatric donation after circulatory determination of death leaders, and 3) a scoping review of the pediatric donation after circulatory determination of death literature. Input from these sources drove drafting of actionable questions and Good Practice Statements, as defined by the Grading of Recommendations Assessment, Development, and Evaluation group. We performed additional literature reviews for all actionable questions. Evidence was assessed for quality using Grading of Recommendations Assessment, Development, and Evaluation and then formulated into evidence profiles that informed recommendations through the evidence-to-decision framework. Recommendations were revised through consensus among members of seven topic-specific working groups and finalized during meetings of working group leads and the planning committee. External review was provided by pediatric, critical care, and critical care nursing professional societies and patient partners. RESULTS: We generated 63 Good Practice Statements and seven Grading of Recommendations Assessment, Development, and Evaluation recommendations covering 1) ethics, consent, and withdrawal of life-sustaining therapy, 2) eligibility, 3) withdrawal of life-sustaining therapy practices, 4) ante and postmortem interventions, 5) death determination, 6) neonatal pediatric donation after circulatory determination of death, 7) cardiac and innovative pediatric donation after circulatory determination of death, and 8) implementation. For brevity, 48 Good Practice Statement and truncated justification are included in this summary report. The remaining recommendations, detailed methodology, full Grading of Recommendations Assessment, Development, and Evaluation tables, and expanded justifications are available in the full text report. CONCLUSIONS: This process showed that rigorous, transparent clinical practice guideline development is possible in the domain of pediatric deceased donation. Application of these recommendations will increase access to pediatric donation after circulatory determination of death across Canada and may serve as a model for future clinical practice guideline development in deceased donation.

Pediatric Donation After Circulatory Determination of Death: A Scoping Review.

OBJECTIVE: Although pediatric donation after circulatory determination of death is increasing in frequency, there are no national or international donation after circulatory determination of death guidelines specific to pediatrics. This scoping review was performed to map the pediatric donation after circulatory determination of death literature, identify pediatric donation after circulatory determination of death knowledge gaps, and inform the development of national or regional pediatric donation after circulatory determination of death guidelines. DATA SOURCES: Terms related to pediatric donation after circulatory determination of death were searched in Embase and MEDLINE, as well as the non-MEDLINE sources in PubMed from 1980 to May 2014. STUDY SELECTION: Seven thousand five hundred ninety-seven references were discovered and 85 retained for analysis. All references addressing pediatric donation after circulatory determination of death were considered. Exclusion criteria were articles that did not address pediatric patients, animal or laboratory studies, surgical techniques, and local pediatric donation after circulatory determination of death protocols. Narrative reviews and opinion articles were the most frequently discovered reference (25/85) and the few discovered studies were observational or qualitative and almost exclusively retrospective. DATA EXTRACTION: Retained references were divided into themes and analyzed using qualitative methodology. DATA SYNTHESIS: The main discovered themes were 1) studies estimating the number of potential pediatric donation after circulatory determination of death donors and their impact on donation; 2) ethical issues in pediatric donation after circulatory determination of death; 3) physiology of the dying process after withdrawal of life-sustaining therapy; 4) cardiac pediatric donation after circulatory determination of death; and 5) neonatal pediatric donation after circulatory determination of death. Donor estimates suggest that pediatric donation after circulatory determination of death will remain an event less common than brain death, albeit with the potential to substantially expand the existing organ donation pool. Limited data suggest outcomes comparable with organs donated after neurologic determination of death. Although there is continued debate around ethical aspects of pediatric donation after circulatory determination of death, all pediatric donation after circulatory determination of death publications from professional societies contend that pediatric donation after circulatory determination of death can be practiced ethically. CONCLUSIONS: This review provides a comprehensive overview of the published literature related to pediatric donation after circulatory determination of death. In addition to informing the development of pediatric-specific guidelines, this review serves to highlight several important knowledge gaps in this topic.

The economic impact of Clostridium difficile infection: a systematic review.

OBJECTIVES: With Clostridium difficile infection (CDI) on the rise, knowledge of the current economic burden of CDI can inform decisions on interventions related to CDI. We systematically reviewed CDI cost-of-illness (COI) studies. METHODS: We performed literature searches in six databases: MEDLINE, Embase, the Health Technology Assessment Database, the National Health Service Economic Evaluation Database, the Cost-Effectiveness Analysis Registry, and EconLit. We also searched gray literature and conducted reference list searches. Two reviewers screened articles independently. One reviewer abstracted data and assessed quality using a modified guideline for economic evaluations. The second reviewer validated the abstraction and assessment. RESULTS: We identified 45 COI studies between 1988 and June 2014. Most (84%) of the studies were from the United States, calculating costs of hospital stays (87%), and focusing on direct costs (100%). Attributable mean CDI costs ranged from $8,911 to $30,049 for hospitalized patients. Few studies stated resource quantification methods (0%), an epidemiological approach (0%), or a justified study perspective (16%) in their cost analyses. In addition, few studies conducted sensitivity analyses (7%). CONCLUSIONS: Forty-five COI studies quantified and confirmed the economic impact of CDI. Costing methods across studies were heterogeneous. Future studies should follow standard COI methodology, expand study perspectives (e.g., patient), and explore populations least studied (e.g., community-acquired CDI).

CODA: an open-source platform for federated analysis and machine learning on distributed healthcare data.

OBJECTIVES: Distributed computations facilitate multi-institutional data analysis while avoiding the costs and complexity of data pooling. Existing approaches lack crucial features, such as built-in medical standards and terminologies, no-code data visualizations, explicit disclosure control mechanisms, and support for basic statistical computations, in addition to gradient-based optimization capabilities. MATERIALS AND METHODS: We describe the development of the Collaborative Data Analysis (CODA) platform, and the design choices undertaken to address the key needs identified during our survey of stakeholders. We use a public dataset (MIMIC-IV) to demonstrate end-to-end multi-modal FL using CODA. We assessed the technical feasibility of deploying the CODA platform at 9 hospitals in Canada, describe implementation challenges, and evaluate its scalability on large patient populations. RESULTS: The CODA platform was designed, developed, and deployed between January 2020 and January 2023. Software code, documentation, and technical documents were released under an open-source license. Multi-modal federated averaging is illustrated using the MIMIC-IV and MIMIC-CXR datasets. To date, 8 out of the 9 participating sites have successfully deployed the platform, with a total enrolment of >1M patients. Mapping data from legacy systems to FHIR was the biggest barrier to implementation. DISCUSSION AND CONCLUSION: The CODA platform was developed and successfully deployed in a public healthcare setting in Canada, with heterogeneous information technology systems and capabilities. Ongoing efforts will use the platform to develop and prospectively validate models for risk assessment, proactive monitoring, and resource usage. Further work will also make tools available to facilitate migration from legacy formats to FHIR and DICOM.

Quantitative patient preference evidence for health technology assessment: a case study.

OBJECTIVES: We conducted a systematic review of quantitative research regarding patients' preferences, perspectives and values for ventilation among chronic obstructive pulmonary disease (COPD) patients. Our objective was to explore the feasibility and desirability of incorporating patient preferences within the health technology assessment (HTA) process by working through a case study. METHODS: Medical and economic databases were searched for studies published in English from 1990 through March 4, 2011. Studies were selected based on title and abstract. Due to the heterogeneity of the studies, data were analyzed using a narrative synthesis approach. RESULTS: Among 1833 identified citations, twelve studies met our inclusion criteria. Ten of these studies pertained to COPD patient preferences for ventilation. Results indicate that a significant proportion of COPD patients are willing to forgo ventilation, particularly when it is expressed as "indefinite life support" (60-78 percent) rather than as temporary modality. Results indicate that patient preferences for mechanical or noninvasive ventilation cannot be predicted by covariates (e.g., age, quality of life) or by others who are frequently called upon to make decisions are their behalf. CONCLUSIONS: We found that it is indeed feasible to conduct a systematic review of quantitative preference-related evidence for an HTA topic. However, the process of conducting this preference-related case study also revealed several challenges because there is a high degree of variation in taxonomy, instrumentation, and study design. Therefore, we do not recommend it as a routine part of the HTA process, but we suggest that it is a promising area to pursue for preference-sensitive technological decisions.

Specialized multi-disciplinary heart failure clinics in Ontario, Canada: an environmental scan.

BACKGROUND: Multi-disciplinary heart failure (HF) clinics have been shown to improve outcomes for HF patients in randomized clinical trials. However, it is unclear how widely available specialized HF clinics are in Ontario. Also, the service models of current clinics have not been described. It is therefore uncertain whether the efficacy of HF clinics in trials is generalizable to the HF clinics currently operating in the province. METHODS: As part of a comprehensive evaluation of HF clinics in Ontario, we performed an environmental scan to identify all HF clinics operating in 2010. A semi-structured interview was conducted to understand the scope of practice. The intensity and complexity of care offered were quantified through the use of a validated instrument, and clinics were categorized as high, medium or low intensity clinics. RESULTS: We identified 34 clinics with 143 HF physicians. We found substantial regional disparity in access to care across the province. The majority of HF physicians were cardiologists (81%), with 81% of the clinics physically based in hospitals, of which 26% were academic centers. There was a substantial range in the complexity of services offered, most notably in the intensity of education and medication management services offered. All the clinics focused on ambulatory care, with only one having an in-patient focus. None of the HF clinics had a home-based component to care. CONCLUSIONS: Multiple HF clinics are currently operating in Ontario with a wide spectrum of care models. Further work is necessary to understand which components lead to improved patient outcomes.

Cost-effectiveness of specialized multidisciplinary heart failure clinics in Ontario, Canada.

BACKGROUND: Specialized multidisciplinary clinics have been shown to reduce mortality in heart failure (HF). Our objective was to evaluate the cost-effectiveness of this model of care delivery. METHODS: We performed a cost-effectiveness analysis, with a 12-year time horizon, from the perspective of the Ontario Ministry of Health and Long-term Care, comparing a standard care cohort, consisting of all patients admitted to hospital with HF in 2005, to a hypothetical cohort treated in HF clinics. Survival curves describing the natural history of HF were constructed using mortality estimates from the Enhanced Feedback for Effective Cardiac Treatment (EFFECT) study. Survival benefits and resource uptake associated with HF clinics were estimated from a meta-analysis of published trials. HF clinics costs were obtained by costing a representative clinic in Ontario. Health-related costs were determined through linkage to administrative databases. Outcome measures included life expectancy (years), costs (in 2008 Canadian dollars) and the incremental cost-effectiveness ratio (ICER). RESULTS: HF clinics were associated with a 29% reduction in all-cause mortality (risk ratio [RR] 0.71; 95% confidence interval [CI] 0.56-0.91) but a 12% increase in hospitalizations (RR 1.12; 95% CI 0.92-1.135). The cost of care in HF clinics was $52 per 30 patient-days. Projected life-expectancy of HF clinic patients was 3.91 years, compared to 3.21 years for standard care. The 12-year cumulative cost per patient in the HF clinic group was $66,532 versus $53,638 in the standard care group. The ICER was $18,259/life-year gained. CONCLUSIONS: HF clinics appear to be a cost effective way of delivering ambulatory care to HF patients.

Association of temporal trends in risk factors and treatment uptake with coronary heart disease mortality, 1994-2005.

CONTEXT: Coronary heart disease (CHD) mortality has declined substantially in Canada since 1994. OBJECTIVE: To determine what proportion of this decline was associated with temporal trends in CHD risk factors and advancements in medical treatments. DESIGN, SETTING, AND PATIENTS: Prospective analytic study of the Ontario, Canada, population aged 25 to 84 years between 1994 and 2005, using an updated version of the validated IMPACT model, which integrates data on population size, CHD mortality, risk factors, and treatment uptake changes. Relative risks and regression coefficients from the published literature quantified the relationship between CHD mortality and (1) evidence-based therapies in 8 distinct CHD subpopulations (acute myocardial infarction [AMI], acute coronary syndromes, secondary prevention post-AMI, chronic coronary artery disease, heart failure in the hospital vs in the community, and primary prevention for hyperlipidemia or hypertension) and (2) population trends in 6 risk factors (smoking, diabetes mellitus, systolic blood pressure, plasma cholesterol level, exercise, and obesity). MAIN OUTCOME MEASURES: The number of deaths prevented or delayed in 2005; secondary outcome measures were improvements in medical treatments and trends in risk factors. RESULTS: Between 1994 and 2005, the age-adjusted CHD mortality rate in Ontario decreased by 35% from 191 to 125 deaths per 100,000 inhabitants, translating to an estimated 7585 fewer CHD deaths in 2005. Improvements in medical and surgical treatments were associated with 43% (range, 11% to 124%) of the total mortality decrease, most notably in AMI (8%; range, -5% to 40%), chronic stable coronary artery disease (17%; range, 7% to 35%), and heart failure occurring while in the community (10%; range, 6% to 31%). Trends in risk factors accounted for 3660 fewer CHD deaths prevented or delayed (48% of total; range, 28% to 64%), specifically, reductions in total cholesterol (23%; range, 10% to 33%) and systolic blood pressure (20%; range, 13% to 26%). Increasing diabetes prevalence and body mass index had an inverse relationship associated with higher CHD mortality of 6% (range, 4% to 8%) and 2% (range, 1% to 4%), respectively. CONCLUSION: Between 1994 and 2005, there was a decrease in CHD mortality rates in Ontario that was associated primarily with trends in risk factors and improvements in medical treatments, each explaining about half of the decrease.

User-centered design and the development of patient decision aids: protocol for a systematic review.

BACKGROUND: Providing patient-centered care requires that patients partner in their personal health-care decisions to the full extent desired. Patient decision aids facilitate processes of shared decision-making between patients and their clinicians by presenting relevant scientific information in balanced, understandable ways, helping clarify patients' goals, and guiding decision-making processes. Although international standards stipulate that patients and clinicians should be involved in decision aid development, little is known about how such involvement currently occurs, let alone best practices. This systematic review consisting of three interlinked subreviews seeks to describe current practices of user involvement in the development of patient decision aids, compare these to practices of user-centered design, and identify promising strategies. METHODS/DESIGN: A research team that includes patient and clinician representatives, decision aid developers, and systematic review method experts will guide this review according to the Cochrane Handbook and PRISMA reporting guidelines. A medical librarian will hand search key references and use a peer-reviewed search strategy to search MEDLINE, EMBASE, PubMed, Web of Science, the Cochrane Library, the ACM library, IEEE Xplore, and Google Scholar. We will identify articles across all languages and years describing the development or evaluation of a patient decision aid, or the application of user-centered design or human-centered design to tools intended for patient use. Two independent reviewers will assess article eligibility and extract data into a matrix using a structured pilot-tested form based on a conceptual framework of user-centered design. We will synthesize evidence to describe how research teams have included users in their development process and compare these practices to user-centered design methods. If data permit, we will develop a measure of the user-centeredness of development processes and identify practices that are likely to be optimal. DISCUSSION: This systematic review will provide evidence of current practices to inform approaches for involving patients and other stakeholders in the development of patient decision aids. We anticipate that the results will help move towards the establishment of best practices for the development of patient-centered tools and, in turn, help improve the experiences of people who face difficult health decisions. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014013241.

Effects and repercussions of local/hospital-based health technology assessment (HTA): a systematic review.

BACKGROUND: Health technology assessment (HTA) is increasingly performed at the local or hospital level where the costs, impacts, and benefits of health technologies can be directly assessed. Although local/hospital-based HTA has been implemented for more than two decades in some jurisdictions, little is known about its effects and impact on hospital budget, clinical practices, and patient outcomes. We conducted a mixed-methods systematic review that aimed to synthesize current evidence regarding the effects and impact of local/hospital-based HTA. METHODS: We identified articles through PubMed and Embase and by citation tracking of included studies. We selected qualitative, quantitative, or mixed-methods studies with empirical data about the effects or impact of local/hospital-based HTA on decision-making, budget, or perceptions of stakeholders. We extracted the following information from included studies: country, methodological approach, and use of conceptual framework; local/hospital HTA approach and activities described; reported effects and impacts of local/hospital-based HTA; factors facilitating/hampering the use of hospital-based HTA recommendations; and perceptions of stakeholders concerning local/hospital HTA. Due to the great heterogeneity among studies, we conducted a narrative synthesis of their results. RESULTS: A total of 18 studies met the inclusion criteria. We reported the results according to the four approaches for performing HTA proposed by the Hospital Based HTA Interest Sub-Group: ambassador model, mini-HTA, internal committee, and HTA unit. Results showed that each of these approaches for performing HTA corresponds to specific needs and structures and has its strengths and limitations. Overall, studies showed positive impacts related to local/hospital-based HTA on hospital decisions and budgets, as well as positive perceptions from managers and clinicians. CONCLUSIONS: Local/hospital-based HTA could influence decision-making on several aspects. It is difficult to evaluate the real impacts of local HTA at the different levels of health care given the relatively small number of evaluations with quantitative data and the lack of clear comparators. Further research is necessary to explore the conditions under which local/hospital-based HTA results and recommendations can impact hospital policies, clinical decisions, and quality of care and optimize the use of scarce resources.

Conversion of the Seattle Angina Questionnaire into EQ-5D utilities for ischemic heart disease: a systematic review and catalog of the literature.

BACKGROUND: There is a paucity of preference-based (utility) measures of health-related quality of life for patients with ischemic heart disease (IHD); in contrast, the Seattle Angina Questionnaire (SAQ) is a widely used descriptive measure. Our objective was to perform a systematic review of the literature to identify IHD studies reporting SAQ scores in order to apply a mapping algorithm to convert these to preference-based scores for secondary use in economic evaluations. METHODS: Relevant articles were identified in MEDLINE (Ovid), EMBASE (Ovid), Cochrane Library (Wiley), HealthStar (Ovid), and PubMed from inception to 2012. We previously developed and validated a mapping algorithm that converts SAQ descriptive scores to European Quality of Life-5 Dimensions (EQ-5D) utility scores. In the current study, this mapping algorithm was used to estimate EQ-5D utility scores from SAQ scores. RESULTS: Thirty-six studies met the inclusion criteria. The studies were categorized into three groups, ie, general IHD (n=13), acute coronary syndromes (n=4), and revascularization (n=19). EQ-5D scores for patients with general IHD were in the range of 0.605-0.843 at baseline, and increased to 0.649-0.877 post follow-up. EQ-5D scores for studies of patients with recent acute coronary syndromes increased from 0.706-0.796 at baseline to 0.795-0.942 post follow-up. The revascularization studies had EQ-5D scores in the range of 0.616-0.790 at baseline, and increased to 0.653-0.928 after treatment; studies that focused only on coronary artery bypass grafting increased from 0.643-0.788 at baseline to 0.653-0.928 after grafting, and studies that focused only on percutaneous coronary intervention increased in score from 0.616-0.790 at baseline to 0.668-0.897 after treatment. CONCLUSION: In this review, we provide a catalog of estimated health utility scores across a wide range of disease severity and following various interventions in patients with IHD. Our catalog of EQ-5D scores can be used in IHD-related economic evaluations.

Insights into the contemporary management of heart failure in specialized multidisciplinary ambulatory clinics.

BACKGROUND: Heart failure (HF) clinics are associated with improved outcomes in randomized trials, however, there is substantial heterogeneity in the service models of HF clinics in practice. Our objective was to evaluate the effect of this clinic level heterogeneity on HF patient management in Ontario, Canada. METHODS: Charts were abstracted from 9 HF clinics, chosen at random from the 34 HF clinics in operation in Ontario in 2011. From each clinic, approximately 100 patient charts were randomly selected for detailed abstraction on patient demographic characteristics, comorbidities, diagnostic tests, medication use, and referrals, over a 1-year period from the first clinic visit. RESULTS: Significant heterogeneity was observed in patient baseline profiles, pharmacological therapies, diagnostic testing, clinic personnel, and referrals across 9 clinics. The mean age of patients was 66.1 ± 15.7 years and was significantly different between the clinics. Most patients were male (65%), and mean left ventricular ejection fraction was 33%. There was significant variation in the utilization of echocardiography (42%-94%) and coronary angiography (19%-62%). Overall, approximately 88% of patients were prescribed angiotensin converting enzyme inhibitors and/or angiotensin receptor blockers, and 85% were prescribe ß-blockers. The rates of referral to cardiac rehabilitation programs were overall low at 10.4% of patients, with substantial variation (1%-28%). CONCLUSIONS: Specialized HF clinics have wide variation in the health personnel involved and the care provided; in addition, patients treated at these HF clinics have important differences in clinical characteristics. Strategies should be considered at the appropriate level (eg, province-wide in Ontario) to standardize HF management and provide best evidence-based care to patients.

Achieving quality indicator benchmarks and potential impact on coronary heart disease mortality.

BACKGROUND: Quality indicators in coronary heart disease (CHD) measure the practice gap between optimal care and current clinical practice. However, the potential impact of achieving quality indicator benchmarks remains unknown. METHODS: Using a validated, epidemiologic model of CHD in Ontario, Canada, we estimated the potential impact on mortality of improved utilization on CHD quality indicators from 2005 levels to recommend benchmark utilization of 90%. Eight CHD disease subgroups were evaluated, including inpatients with acute myocardial infarction (AMI), acute coronary syndromes, and heart failure, in addition to ambulatory patients who were post-acute myocardial infarction survivors, or had heart failure, chronic stable angina, hypertension, or hyperlipidemia. The primary outcome was the predicted mortality reduction associated with meeting quality indicator targets for each CHD subgroup-treatment combination. RESULTS: In 2005, there were 10,060 CHD deaths in Ontario, representing an age-adjusted CHD mortality of 191 per 100,000 people. By meeting quality indicator utilization benchmarks, mortality could be potentially reduced by approximately 20% (95% confidence interval 17.8-21.1), representing approximately 1960 avoidable deaths. The bulk of this potential benefit was in ambulatory patients with chronic stable angina (36% of reduction) and heart failure (31% of reduction). The biggest drivers were optimizing angiotensin-converting enzyme inhibitor use in chronic stable angina patients (approximately 440 avoidable deaths) and ß-blocker use in heart failure (approximately 400 avoidable deaths). CONCLUSIONS: These findings reinforce the importance of quality indicators and could aid policy makers in prioritizing strategies to meet the goals outlined in the Canadian Heart Health Strategy and Action Plan for reducing cardiovascular mortality.