18 results
530 Understanding Strengths and Weaknesses of Clinical Research Operations in Regional Settings
- Part of
- Allison Lambert, Laurie Hassell, James Probus, Kiet Pham, Monica Zigman-Suchsland, Jamie M. Besel, Dillon Van Rensburg
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- Journal:
- Journal of Clinical and Translational Science / Volume 8 / Issue s1 / April 2024
- Published online by Cambridge University Press:
- 03 April 2024, pp. 157-158
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OBJECTIVES/GOALS: An environmental scansoughtto understand research processes, areas for improvement, and opportunities for collaborative quality improvement (QI)across the Northwest Participant and Clinical Interactions Network (NW PCI). METHODS/STUDY POPULATION: NW PCI site champions were invited for semi-structured single and group Zoom-based interviews. Interviewers asked participants about local research processes, strengths and weaknesses, existing infrastructure to support QI, and interest in collaborative QI across the Network. Audio transcripts were coded using Dedoose and analyzed with deductive and inductive coding. RESULTS/ANTICIPATED RESULTS: Between February and April 2023, 10 interviews collected data from 7 research decision makers and 7 staff members across 7 sites. Most participants (n=13, 92%) agreed the diagram shown during the interview was representative of the local process. Organizations consistently identified strengths and weaknesses within the domains of study start-up, recruitment, budgets, and compliance. QI infrastructure was inconsistent (n=5, 36%) and all (n=14, 100%) saw potential for success in multisite QI initiatives to enhance efficiency. DISCUSSION/SIGNIFICANCE: NW PCI sites use similar processes, share common strengths and weaknesses, and universally reported interest in collaborating on QI. Study startup was reported as both a strength and weakness within the same organization, requiring unpacking of key elements before pursuing QI initiatives.
151 A Pragmatic Randomized Trial of Home-based testing for COVID-19 in Rural Native American and Latino Communities: Primary results of the Protecting Our Communities Study
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- Eliza Webber, Charlie Gregor, Laurie Hassell, Matthew Thompson, Paul Drain, Linda Ko, Virgil Dupuis, Lorenzo Garza, Allison Lambert, Sonia Bishop, Teresa Warne, Alexandra Adams
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- Journal:
- Journal of Clinical and Translational Science / Volume 7 / Issue s1 / April 2023
- Published online by Cambridge University Press:
- 24 April 2023, p. 46
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OBJECTIVES/GOALS: To test the effect of a trusted Community Health Worker (CHW) support model to increase accessibility, feasibility and completion of COVID-19 home-testing in Native American and Latino communities. METHODS/STUDY POPULATION: We conducted a multi-site pragmatic randomized controlled trial among adult Native Americans and Latinos from the Flathead reservation in Montana and Yakima Valley in Washington. Participants were block randomized by site location and age to either an active or passive study arm. Participants in the active arm received assistance with online COVID-19 test kit registration and virtual swabbing support from CHWs, while the passive study arm received the standard-of-care support from the COVID-19 home testing kit vendor. Simple and multivariate logistic regression modeled the association between home-testing distribution mechanism and test completion. Multivariate models included community and sex as covariates. Descriptive feedback was collected in a post-test survey. RESULTS/ANTICIPATED RESULTS: Overall, 63% of the 268 enrolled participants completed COVID-19 tests, and 50% completed tests yielding a valid result. Active arm participants had significantly higher odds of test completion (OR 1.66, 95% CI: [1.01, 2.75], p-value=0.04). Differences were most pronounced among adults ≥60 years, with 84% completing testing kits in the active arm, compared to 58% in the passive arm (p=0.07). Ease of use and not having to leave home were top positive aspects of the home-based test while transporting and mailing samples to lab and long/overwhelming instructions were cited as negative aspects. Most test completers (93%) were satisfied with their experience and 95% found CHW assistance useful. Sample expiration and insufficient identifiers were top causes of non-valid test results. DISCUSSION/SIGNIFICANCE: While test completion rates were low in both study arms, the CHW support led to a higher COVID-19 test completion rate, particularly among older adults. Still, CHW support alone does not fully eliminate testing barriers. Socio-economic differences must be accounted for in future product development for home-based testing to improve health equity.
PP09 Use Of Real-World Evidence For Managing Health Technologies Throughout The Life Cycle Of Transcatheter Aortic Valve Interventions
- Danielle de Verteuil, Leila Azzi, Laurie Lambert, Lucy Boothroyd, Marie-France Duranceau, Élisabeth Pagé, Catherine Truchon
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- International Journal of Technology Assessment in Health Care / Volume 38 / Issue S1 / December 2022
- Published online by Cambridge University Press:
- 23 December 2022, p. S42
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Introduction
A Cardiology Evaluation Unit was established in 2004 within Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) with a novel mandate to collect real-world evidence (RWE) to complement literature-based health technology assessment. In 2010 following publication of the seminal PARTNER trial, INESSS was mandated by the health ministry to review the evidence on transcatheter aortic valve intervention (TAVI) for patients with aortic stenosis. Herein we show how RWE was used to evaluate health system performance throughout the technology’s life cycle and inform organizational and clinical decisions.
MethodsVarious products were diffused by INESSS over the years: a guidance (2012), an updated literature review (2017) and provincial standards (2017), in parallel with RWE reports covering TAVI use from 2013-2015, from 2013-2018, and a 2021 RWE report combined with administrative data covering transcatheter and surgical treatment of aortic stenosis from 2013-2019.
ResultsBased on the guidance’s review of evidence, TAVI was initially recommended for patients considered at too high risk for the surgical approach, under the condition of continued evidence generation to address uncertainty. The subsequent literature review update highlighted that the indication for TAVI had been extended to patients at moderate surgical risk. INESSS produced standards in collaboration with clinical experts to optimize and harmonize the use of TAVI in designated centers. Evaluation of structures, processes and outcomes by INESSS continued until 2019, showing a continuous increase in the use of TAVI, improved short-term survival, and careful patient selection via a multidisciplinary process. RWE also highlighted the impact of TAVI on the overall organization of care for patients with aortic stenosis, as selection criteria further expanded to patients at lower surgical risk, raising important issues regarding patient selection processes, wait times, and longer-term outcomes.
ConclusionsTAVI clinical practice is constantly evolving and leads to changes in the management of aortic stenosis. RWE provided essential organizational and clinical input to inform clinical guidance and decision-making by Québec policy-makers, clinicians and patients.
Can we use existing guidance to support the development of robust real-world evidence for health technology assessment/payer decision-making?
- Gorana Capkun, Sorcha Corry, Oonagh Dowling, Fatemeh Asad Zadeh Vosta Kolaei, Shweta Takyar, Cláudia Furtado, Páll Jónsson, Diane Kleinermans, Laurie Lambert, Anja Schiel, Karen Facey
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 38 / Issue 1 / 2022
- Published online by Cambridge University Press:
- 02 November 2022, e79
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Advances in the digitization of health systems and expedited regulatory approvals of innovative treatments have led to increased potential for the use of real-world data (RWD) to generate real-world evidence (RWE) to complement evidence from clinical trials. However, health technology assessment (HTA) bodies and payers have concerns about the ability to generate RWE of sufficient quality to be pivotal evidence of relative treatment effectiveness. Consequently, there is a growing need for HTA bodies and payers to develop guidance for the industry and other stakeholders about the use of RWD/RWE to support access, reimbursement, and pricing. We therefore sought to (i) understand barriers to the use of RWD/RWE by HTA bodies and payers; (ii) review potential solutions in the form of published guidance; and (iii) review findings with selected HTA/payer bodies. Four themes considered key to shaping the generation of robust RWE for HTA bodies and payers were identified as: (i) data (availability, governance, and quality); (ii) methodology (design and analytics); (iii) trust (transparency and reproducibility); and (iv) policy and partnerships. A range of guidance documents were found from trusted sources that could address these themes. These were discussed with HTA experts. This commentary summarizes the potential guidance solutions available to help resolve issues faced by HTA decision-makers in the adoption of RWD/RWE. It shows that there is alignment among stakeholders about the areas that need improvement in the development of RWE and that the key priority to move forward is better collaboration to make data usable for multiple purposes.
141 Challenges to home-based COVID testing in rural Latino and Native American communities
- Charlie Gregor, Eliza Webber, Laurie Hassell, Matthew Thompson, Paul Drain, Linda Ko, Virgil Dupuis, Lorenzo Garza, Allison Lambert, Sonia Bishop, Teresa Warne
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- Journal:
- Journal of Clinical and Translational Science / Volume 6 / Issue s1 / April 2022
- Published online by Cambridge University Press:
- 19 April 2022, p. 12
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OBJECTIVES/GOALS: Test the effects of a community health worker supported model to deliver home-based COVID-19 testing in the Yakima Valley (Washington) and Flathead Reservation (Montana) METHODS/STUDY POPULATION: A pragmatic, randomized controlled clinical trial evaluating the effects of a community health worker supported model to deliver home-based COVID-19 testing in the Yakima Valley (Washington) and Flathead Reservation (Montana) vs. a modified direct-to-consumer. 400 participants will be enrolled, 200 from each community. Outcomes include comparing the number of completed testing kits as well as the number of testing kits with successful (detected vs not-detected) results. RESULTS/ANTICIPATED RESULTS: The poster presents preliminary results from 191 participants, blinded to study assignment. To date, 53% of enrolled participants returned a sample for testing and 39% received a usable (detected or not-detected) result. Our populations experienced a high-rate (16%) of sample errors, required 28 replacement kits and had 20 participants randomized to the control arm receive the intervention to ensure participants received testing during the pandemic. DISCUSSION/SIGNIFICANCE: Home-based testing models are build for those who are proficient in verbal and written English, have high tech. literacy and continuous access to internet. For home-based testing to have similar success rates as white Americans, cultural and demographic differences and disparities will need to be accounted for in development and implementation.
Chapter 11 - Postcolonial Stirrings
- from Part II - Cultural and Political Transitions
- Edited by Raphael Dalleo, Bucknell University, Pennsylvania, Curdella Forbes, Howard University, Washington DC
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- Caribbean Literature in Transition, 1920–1970
- Published online:
- 16 December 2020
- Print publication:
- 14 January 2021, pp 176-190
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Summary
The rise of Rastafari in popular consciousness and the 1968 Rodney disturbance in Jamaica, the 1970 Black Power revolution in Trinidad, and a range of leftist political parties emerged to challenge the post-independence status quo. The 1979 overthrow of Eric Gairy’s government in Grenada, by the New Jewel Movement (NJM) – a party of young, black radical intellectuals and activists – was yet another example of how the earlier independence models were being challenged, and in some cases completely dismantled. This chapter examines literary works by Merle Hodge, Earl Lovelace, and V. S. Naipaul, to analyse how anglophone Caribbean writers addressed questions around the unfinished business of independence. I also discuss work by Walter Rodney, Derek Walcott, and Sylvia Wynter. Their work represents many of the key formal, thematic, and philosophical experiments that define the literature of this period. I call the unfinished business these authors describe ‘postcolonial stirrings’, where stirrings means disorder and ferment. Concentrating on four themes that surface across the field – nation language, Black Power, history and literature debates, and radicalism in crisis – I mark the end of the radical 1970s in the Caribbean as 1983 with the end of the Grenada Revolution and the collapse of the NJM.
Demonstrating the influence of HTA: INAHTA member stories of HTA impact
- Sophie Söderholm Werkö, Tracy Merlin, Laurie Jean Lambert, Paul Fennessy, Ana Pérez Galán, Tara Schuller
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- International Journal of Technology Assessment in Health Care / Volume 37 / Issue 1 / 2021
- Published online by Cambridge University Press:
- 05 November 2020, e8
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A central function of health technology assessment (HTA) agencies is the production of HTA reports to support evidence-informed policy and decision making. HTA agencies are interested in understanding the mechanisms of HTA impact, which can be understood as the influence or impact of HTA report findings on decision making at various levels of the health system. The members of the International Network of Agencies for HTA (INAHTA) meet at their annual Congress where impact story sharing is one important activity. This paper summarizes four stories of HTA impact that were finalists for the David Hailey Award for Best Impact Story.
The methods to measure impact include: document review; claims analysis and review of reimbursement status; citation analysis; qualitative evaluation of stakeholders’ views; and review of media response. HTA agency staff also observed changes in government activities and priorities based on the HTA. Impact assessment can provide information to improve the HTA process, for example, the value of patient and clinician engagement in the HTA process to better define the assessment question and literature reviews in a more holistic and balanced way.
HTA reports produced by publicly funded HTA agencies are valued by health systems around the globe as they support decision making regarding the appropriate use, pricing, reimbursement, and disinvestment of health technologies. HTAs can also have a positive impact on information sharing between different levels of government and across stakeholder groups. These stories show how HTA can have a significant impact, irrespective of the health system and health technology being assessed.
Glycemic profile is improved by High Slowly Digestible Starch diet in type 2 diabetic patients
- Aurelie Goux, Anne-Esther Breyton, Alexandra Meynier, Stephanie Lambert-Porcheron, Monique Sothier, Laurie Van Den Berghe, Sylvie Normand, Emmanuel Disse, Martine Laville, Julie-Anne Nazare, Sophie Vinoy
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- Proceedings of the Nutrition Society / Volume 79 / Issue OCE2 / 2020
- Published online by Cambridge University Press:
- 10 June 2020, E165
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Introduction
Considering the dramatically increasing incidence of type 2 diabetes (T2D), decreasing glycemic variability in T2D patients is a key challenge to limit the occurrence of diabetic complications. Diet appears as one potential lever that can be set up above medications. Particularly, the ingestion of foods with a high content in slowly digestible starch (SDS) demonstrated both lower postprandial glycemic and insulin responses in healthy and insulin resistant subjects. This study aimed at designing a full high-SDS diet by selecting high-SDS starchy food products and at studying its impact on glycemic response and variability in T2D.
Materials and methodsThis pilot randomized controlled cross-over study included eight T2D patients (HbA1c = 7.0 ± 0.2%, BMI = 31.7 ± 2.1 kg/m2, treated by Metformin & Sitagliptin) who consumed twice, for one week a controlled diet containing starchy food products screened and selected to be either High (High-SDS) or Low (Low-SDS) in SDS, as determined by the SDS in-vitro method developed by Englyst et al. During each diet period, the glycemic profile was monitored for 6 days using a Continuous Glucose Monitoring System (CGMS). Multiple metrics related to variability and glycemic responses were calculated.
Results222 SDS analyses were realized on commercial food products as consumed. 23 High-SDS and 20 Low-SDS food items with associated specific cooking instructions were selected to design two diets consistent with local T2D recommendations. The High-SDS diet demonstrated a significantly higher SDS content compared to the Low-SDS diet (61.6 vs 11.6 g/day; p < 0.0001), mainly driven by selected pasta, rice and high-SDS biscuits (75.6% of the consumed SDS content). The % of total daily energy intake (TDEI) for all macronutrients remained similar between diets (p > 0.05) and the carbohydrate content specifically represented 49 ± 1 % and 47 ± 2 % of the TDEI for High-SDS and Low-SDS diets, respectively. With the high-SDS diet, the Mean Amplitude of Glycemic Excursion, a key parameter of glycemic variability, was significantly decreased (79.6 for Low-SDS vs 61.6 mg/dL for High-SDS; p = 0.0067). The significant correlation between the meals SDS contents and various glycemic parameters such as postprandial iAUC, tAUC (up to 180 min) or peak value strengthen this finding (p < 0.05 for all).
DiscussionIt was the first demonstration that a diet including selected starchy food items and cooking recommendations designed to favor products’ high SDS content beneficially impacts glycemic profile in T2D subjects. Carefully selecting starchy food may be a simple and valuable tool to improve glycemic control in T2D.
Two-month consumption of bread enriched with a fiber mix: impact on gut microbiota and cardiometabolic profile in at cardiometabolic-risk subjects.
- Harimalala Ranaivo, Susie Guilly, Monique Sothier, Laurie Van Den Berghe, Stéphanie Lambert-Porcheron, Isabelle Dussous, Loïc Roger, Christel Béra-Maillet, Hugo Roume, Nathalie Galleron, Nicolas Pons, Emmanuelle Le Chatelier, Dusko Ehrlich, Martine Laville, Joël Doré, Julie-Anne Nazare
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- Proceedings of the Nutrition Society / Volume 79 / Issue OCE2 / 2020
- Published online by Cambridge University Press:
- 10 June 2020, E135
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Introduction
Increased adiposity, dyslipidemia and insulin resistance are associated with increased risk of developing cardiometabolic diseases (CM). Such deleterious phenotypes have been shown to be associated with a low gene-richness microbiota that can partly be restored by a short-term dietary intervention (energy-restricted high-protein diet, low glycemic index, enrichment with fibers) in parallel to an improvement of CM profile. In this study, we aimed at increasing fiber intake in quantity and diversity through a two-month consumption of bread enriched with a mix of selected fibers and evaluated the impact of this dietary intervention on gut microbiota gene richness and CM risk profile in subjects at risk of developing CM.
Materials and methodsIn a randomized double blind cross-over design, thirty-nine subjects with CM risk profile (18–70 years old, BMI: 25–35 kg/m2, waist circumference > 80 cm for women and > 96 cm for men, fiber intake < 20g/day, low fiber diversity) consumed daily for 8 weeks 150 g of standard bread vs. 150 g of bread enriched with a 7-selected fibers mix (5.55 g vs. 16.35 g of fiber respectively; 4-week washout). Gut microbiota and CM risk factors’ analyzes were conducted before and after intervention. Stool samples were analyzed by shotgun metagenomics; microbial genes and metagenomics species (MSP) profiles were generated by mapping reads on a reference genes catalog (1529 MSP).
ResultsThe included dyslipidemic subjects with CM risk profile presented a lower microbiota gene richness compared to reference healthy cohorts. The two-month consumption of fiber-rich bread did not alter microbiota gene richness but modified microbiota composition with a significant decrease of Bacteroides vulgatus (q = 1.7e-4) and a significant increase of Parabacteroides distasonis (q = 2.8e-6), Fusicatenibacter saccharivorans (q = 5e-5) and Clostridiales (q = 3.8e-2). We observed in parallel a significant decrease in total cholesterol (- 0.26 mmol/L; - 5%; p = 0.021), LDL-cholesterol (- 0.2 mmol/L; - 6%, p = 0.0061) and an improvement of insulin sensibility estimated by HOMA index (3.23–2.54 mUI/L; - 21%; p = 0.0079).These effects were even significantly more pronounced for subjects presenting the higher waist circumference. Anthropometric parameters were not altered.
DiscussionThe enrichment of the diet with a mix of selected fibers for 2 months altered microbiota composition by modifying the relative abundance of specific gut bacterial species, in parallel to a significant improvement of cholesterol and insulin sensitivity parameters. Increasing the quantity and diversity of dietary fiber intake could be used as an efficient tool to favorably impact CM profile.
Metabolic breath signature of 13C-enriched wheat bran consumption related to gut fermentation in humans: a Fiber-TAG study
- Anne-Esther Breyton, Valérie Sauvinet, Laure Meiller, Stéphanie Lambert-Porcheron, Christelle Machon, Anne Mialon, Laurie Vandenberghe, Monique Sothier, Sylvie Normand, Alexandra Meynier, Maud Alligier, Audrey Neyrinck, Martine Laville, Nathalie Delzenne, Sophie Vinoy, Julie-Anne Nazare
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- Proceedings of the Nutrition Society / Volume 79 / Issue OCE2 / 2020
- Published online by Cambridge University Press:
- 10 June 2020, E132
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AbstractIntroduction
Dietary fibers (DF) have been classified mainly according to their physico-chemical and fermentability properties but it remains unclear whether such classification is relevant when addressing their health effects. Indeed, the nature of physiological effects induced by DF, particularly through their interaction with gut microbiota, remains poorly known due to their diversity, to gut microbiota inter-subjects variability and to the lack of validated non-invasive biomarkers to characterize DF-gut microbiota interaction. The aim of this pilot study was 1) to follow the metabolic fate of 13C-labeled DF through the assessment of 13C-labelled gut-derived metabolites in excreted breath and 2) to evaluate novel non-invasive breath-derived biomarkers of DF-gut microbiota interactions.
Materials and methodsSix healthy women (29.7 ± 1.7 years old, BMI: 23.2 ± 0.9kg/m2, fiber intake: 23 ± 1g/d) consumed in research settings a controlled breakfast containing eight 13C-labelled wheat bran biscuits (50 g of labelled wheat bran, 3.0At%13C). 13C-labelled wheat bran was obtained from wheat cultivated under 13CO2 enriched atmosphere. Samples of expired gases were collected during 24 h after ingestion in order to measure H2 and CH4 by gas chromatography (GC) with piezoelectric detection and 13CO2 and 13CH4 by gas chromatography coupled with an isotope ratio mass spectrometer (GC-IRMS). Apart test breakfast, subjects only consumed standardized meals without fibers.
ResultsThe analysis of H2 and CH4 24h-kinetic measurements distinguished 2 groups in terms of fermentation related gas excretion: the high-CH4 producers with high baseline CH4 concentrations (42.1 ± 13.7ppm) and low baseline H2 concentrations (7.3 ± 5.8ppm) and the low-CH4 producers with low baseline CH4 concentrations (6.5 ± 3.6ppm) and high baseline H2 concentrations (20.8 ± 16.0ppm). Following the 13C-wheat bran biscuits’ ingestion, postprandial H2 and CH4 concentrations increased more significantly in the high-CH4 producer subjects. 13C enrichment was detectable in expired gases in all subjects. 13CO2 kinetics were similar for all subjects and correspond to the oxidation of the digestible part of the bran. The appearance of 13CH4 was significantly enhanced and prolonged after 180 min in high-CH4 producers compared to low-CH4 producers, suggesting distinct fiber fermentation profile.
DiscussionThis pilot study allowed to consider novel procedures for development of non-invasive breath biomarkers of fiber-gut microbiota interactions. Assessment of expired gas excretion following 13C-labelled fiber ingestion allowed deciphering distinct fermentation profiles: high-CH4 producers vs low-CH4 producers and accordingly provide a related non-invasive breath metabolic signature of the fiber fermentation for each profile. Further gut microbiota and 13C-metabolites analysis will permit to relate the gut bacteria composition with breath gas excretion kinetics according to fiber fermentation profile.
OP47 Need For New Thrombectomy Centers? A Practical Decision Framework
- Maria Vutcovici Nicolae, Lucy Boothroyd, Leila Azzi, Laurie Lambert, Michèle de Guise
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- International Journal of Technology Assessment in Health Care / Volume 35 / Issue S1 / 2019
- Published online by Cambridge University Press:
- 31 December 2019, p. 11
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Introduction
Stroke is a major contributor to mortality, disability and long-term use of healthcare services. As for all chrono-dependant conditions, clinical results are associated with timely access to appropriate care. Thrombectomy (EVT) is an effective treatment for large vessel occlusions, but can only be provided in highly-specialized centers by experienced personnel. We sought to develop a framework to aid decision-making on the appropriateness of opening new EVT centers in Québec, Canada.
MethodsData sources included provincial administrative healthcare databases, population density statistics, field evaluation of Québec's four existing EVT care networks, and literature review concerning structural and performance criteria for EVT centers. We consulted EVT clinical teams, interdisciplinary stroke experts, patients, professional association representatives, healthcare managers and decision-makers.
ResultsAccess to EVT is suboptimal in all 17 regions of Québec, with virtually no access in remote areas. Results of key performance indicators indicated favorable treatment delays after arrival at the EVT center. However, door-to-needle and door-in-door-out times were long for patients transferred from non-EVT centers. High use of ambulances indicated the potential to transport patients to the most appropriate center. In light of ‘real world’ results and other sources of information, the need for a new EVT center should consider the following criteria: sub-optimal EVT access within the region; transport time to an existing EVT center >1 hour; expected patient volume within 2 hours of transport; impact on volume of existing programs; availability of long-term financial support; availability of a critical mass of neurointerventionists, vascular neurologists, and neurosurgeons; demonstrated quality of stroke care; and, presence of a stroke unit.
ConclusionsThe triangulation of literature, clinician experience and the Québec context enriched the evaluation process. Furthermore, this facilitated the development of a framework that was broadly applicable across regions to the real-world setting of decision-making in a complex system of care.
OP33 Treatment Of Mitral Insufficiency And Multicriteria Decision-Making
- François Désy, Mireille Goetghebeur, Maria Vutcovici Nicolae, Laurie Lambert, Michèle de Guise
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- International Journal of Technology Assessment in Health Care / Volume 35 / Issue S1 / 2019
- Published online by Cambridge University Press:
- 31 December 2019, p. 8
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Introduction
Controversy regarding the efficacy of transcatheter mitral valve repair with a clip (TMVRc) in reducing the mitral regurgitation is related to the lack of solid scientific evidence. Worldwide, refusal or conditional acceptance for implementation of TMVRc, reflect ongoing uncertainty. We sought to apply a systematic multicriteria framework to ensure a fair and reasonable decision regarding the use of TMVRc in Quebec.
MethodsThe framework included the following domains: context, quality of evidence concerning safety, efficacy and effectiveness, unmet patient needs, expected volume of patients, and impact on the health system including costs. Each domain within the framework was examined by a review of the literature and through consultations with a scientific advisory committee, a TMVRc clinical expert committee, TMVRc clinical teams, industry representatives and the Institut national d'excellence en santé et en services sociaux (INESSS) clinical excellence committee.
ResultsThe literature review indicated that uncertainty about the efficacy and effectiveness of TMVRc persists, particularly in the real world context, and this view was supported by scientific experts. The TMVRc clinical teams provided insight into the burden of mitral insufficiency on patients and the health system and their belief in the promise of TMVRc. They also highlighted the challenges of patient selection and organizational issues related to the introduction of TMVRc within their institutions. The advisory committee stressed the need for further evaluation prior to wide diffusion.
ConclusionsUsing a multicriteria framework facilitated a more standardized and transparent approach to our literature review and consultations as well as to the development of the proposed recommendations. This was especially important in the context of an evaluation of a promising new approach to treat mitral valve disease with many important uncertainties. This multi-criteria approach will facilitate a more standardized process for deliberation on how new health technologies should be implemented into the Quebec health system.
PP04 Co-Constructing Recommendations With Patients And Health Professionals
- Laurie Lambert, Lucy Boothroyd, Leila Azzi, Caroline Collette, Philippe Brouillard, Marie-Pascale Pomey, Monique Fournier, Alexandre Grégoire, Isabelle Ganache, Anabèle Brière, Peter Bogaty, Michèle de Guise
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- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, p. 67
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Introduction:
Decision-making about replacement or modification of an implantable cardioverter defibrillator (ICD) must be patient-centered and clinically appropriate. We engaged both patients and health care professionals in a multi-method approach in order to recommend structures and processes that facilitate informed and shared decision-making.
Methods:A systematic literature review (2000 to 2017) was performed focusing on the patient's perspective and the optimal organization of structures and processes for decision-making. A province-wide field evaluation based on medical chart review was carried out to provide ‘real world’ evidence in Québec's six ICD implanting centers (1 July to 31 December, 2016; N = 418). Patients and health care professionals reviewed the findings of the review and field evaluation, and deliberated recommendations in an anonymous manner by electronic mail. A joint meeting focused on proposed recommendations concerning shared decision-making.
Results:The patients provided feedback on the literature review based on their ICD experience, and highlighted the need for better and more interactive decision aids, clinical information and time, and a private space for sensitive discussions. The field evaluation underlined the variability of treatment choices at the time of replacement and that more than one in ten patients had undergone ICD deactivation. Proposed recommendations focus on multi-disciplinary, integrated follow-up of patients and outline best practice for incorporating patient wishes and life objectives when discussing treatment options. The multi-round consultation process allowed both patients and professionals to co-construct recommendations with our evaluation team.
Conclusions:This multi-method approach enriched our interpretation of literature and ‘real world’ data and facilitated identification and prioritization of important themes. Partnership with both patients and clinicians added a new and energizing dynamic to our evaluation and recommendation processes. We acknowledge the contribution of the members of the patient committee and the clinical experts committee.
PP65 Coordinated Implementation And Evaluation Of Promising Stroke Therapy
- Laurie Lambert, Leila Azzi, François Désy, Anabèle Brière, Lucy Boothroyd, Maria Vutcovici, Michèle de Guise
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- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, pp. 91-92
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Introduction:
One important objective at the Institut d'excellence en santé et en services sociaux (INESSS) is to guide the implementation of promising new technologies into Québec's healthcare system. A comprehensive evaluation framework was recently developed that takes into account the dynamic and iterative nature of the life cycle of such technologies. This framework is presently being used to inform the decision-making process concerning use of thrombectomy for ischemic stroke.
Methods:A field evaluation has been undertaken since April 2016 in all four of Québec's specialized tertiary stroke centers. This real-world evidence is communicated regularly to the clinical teams as well as decision-makers. A systematic literature surveillance is also ongoing, with results being shared amongst clinical experts on our interdisciplinary advisory committee. On the basis of the generated evidence from these sources, recommendations to optimize structures, processes of care and clinical outcomes will be developed, in collaboration with the interdisciplinary committee.
Results:Thrombectomy has been shown to be safe and effective for treating ischemic stroke in the randomized trial setting in high-volume, expert centers. Real-world evidence from Québec indicates increasing use of this new technology but with wide variation across health regions. Observed times to treatment appear favorable for patients admitted directly to tertiary centers, but inter-hospital transfer is associated with important increases in delays from first door to thrombectomy. The documentation of 90-day outcomes is problematic, especially for patients transferred out of tertiary stroke centers prior to discharge. Uncertainties raised in the literature include patient selection criteria and optimal processes of care during prehospital and inter-hospital phases of the patient's trajectory.
Conclusions:The ongoing comprehensive evaluation of thrombectomy for ischemic stroke in Québec is a concrete example of how the use of an innovative, disruptive technology can be optimized. We acknowledge the contribution of the members of the clinical expert committee.
PP17 Comprehensive Evaluation Of A Technology With Expanding Indications
- Laurie Lambert, François Désy, Leila Azzi, Maria Vutcovici, Anabèle Brière, Lucy Boothroyd, Peter Bogaty, Normand Racine, Michèle de Guise
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- International Journal of Technology Assessment in Health Care / Volume 34 / Issue S1 / 2018
- Published online by Cambridge University Press:
- 03 January 2019, p. 72
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Introduction:
The use of transcatheter aortic valve implantation (TAVI) is evolving. Our Cardiovascular Evaluation Unit is implementing a comprehensive approach to inform decision-makers on optimal use of TAVI, including the development of quality standards. We are implementing a multifaceted evaluation framework in collaboration with clinical stakeholders.
Methods:Our unit has carried out a continuous field evaluation in collaboration with the clinical teams at all six TAVI centers in Québec for the past four years (1 April 2013–31 March 2017), with regular feedback to the teams and sharing of results with each individual center. Hospital documentation was reviewed according to established national quality indicator definitions. Field evaluation data were combined with the results of systematic literature review to establish provincial standards for practice, through a deliberation process by an interdisciplinary committee of clinical experts from each center. Systematic surveillance of the literature is ongoing.
Results:In the period 2013–2017, use of TAVI in Québec was limited to very elderly patients with significant comorbidities at high risk of operative mortality. We observed improvements in both processes of care (e.g. documentation of risk scores) and clinical outcomes (e.g. 30-day and 1-year mortality) over time. Our consensus standards recognize the potential value of TAVI for patients at moderate operative risk, identify uncertainties and recommend best practices for patient evaluation and clinical decision-making about choice of treatment.
Conclusions:A comprehensive, long-term evaluation process of TAVI with feedback to centers is associated with improvements in processes of care and outcomes. In the present context of expanding clinical indications, we will continue to evaluate patient selection, processes and outcomes according to the newly-established provincial quality standards. This iterative approach facilitates continued evidence generation and decision-making for optimal use of an evolving intervention. We acknowledge the contribution of the members of the expert clinical committee.
VP05 Comprehensive Evaluation Of An Evolving Transcatheter Technology
- Laurie Lambert, Leila Azzi, François Désy, Maria Vutcovici, Lucy Boothroyd, Anabèle Brière, Peter Bogaty, Michèle de Guise
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- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, pp. 148-149
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INTRODUCTION:
Our cardiovascular evaluation unit is mandated to evaluate transcatheter aortic valve implantation (TAVI) in the province of Québec. In 2012, it was recommended that only patients at too high risk for surgery receive TAVI. In partnership with our six hospital TAVI programs, we have measured indicators of structure, process and outcomes since 2013. We are collaborating with multidisciplinary clinical experts to update recommendations for optimal use. Herein, we present the evolving portrait of TAVI in Québec and identify priority issues.
METHODS:Clinical data were collected and analyzed for all TAVI performed from 1 April 2013 to 31 March 2016. Regular site feedback was provided. A systematic review of recent guidelines and randomized trials facilitated the interpretation of “real world” results and formulation of provincial quality standards.
RESULTS:Provincial TAVI volume increased from 294 in 2013–14 to 340 in 2014–15, and to 360 in 2015–16. Patient age and sex distribution remained relatively constant over time (median age 83 years; 47 percent female). However, the median predicted risk of operative mortality (STS score) decreased in the latest period [6 percent (Interquartile Range, IQR: 4–9) versus 7 percent (IQR: 4–9) versus 4 percent (IQR: 3–7)], suggesting TAVI is increasingly being performed in lower-risk patients. Clinical documentation and processes of care generally improved. Thirty-day mortality decreased (6.1 percent versus 4.1 percent versus 2.8 percent). The literature review identified two central issues: TAVI futility in patients who are too sick and apparent non-inferiority of TAVI compared with surgical valve replacement in medium-risk patients.
CONCLUSIONS:Our province-wide TAVI evaluation indicates improving processes and outcomes. Patient selection remains the key in our universal healthcare system, with the need to minimize futile and costly therapy and offer TAVI to those most likely to benefit. Continued monitoring of clinical practice and newly-established quality standards, in close collaboration with clinical teams, remains essential to promote optimal use of this evolving technology.
OP24 A Framework For Improved Systems Of Care In Myocardial Infarction
- Laurie Lambert, Leila Azzi, Lucy Boothroyd, Anabèle Brière, François Désy, Maria Vutcovici, Peter Bogaty, Michèle de Guise
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 33 / Issue S1 / 2017
- Published online by Cambridge University Press:
- 12 January 2018, p. 11
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INTRODUCTION:
In the past decade numerous efforts have been made to enhance quality of care in the province of Québec for patients with ST-elevation myocardial infarction (STEMI). Despite two prior field evaluations and diffusion of a systematic review as well as recommendations, a third audit revealed persistent gaps in care, specifically excessive treatment delays. Our cardiovascular evaluation unit thus aimed to develop a more comprehensive quality improvement framework that further engaged healthcare professionals.
METHODS:A literature update identified best practices and ways to reduce treatment delays and improve outcomes. This review, combined with the latest evaluation results, was used to establish structural and process quality standards adapted to the Québec context, via a consensus process with a panel of clinical experts. The standards identified quality-of-care targets and key elements of a governance structure to guide the improvement process. Quality indicators to monitor change were also developed. An implementation plan was then created, likewise based on literature and evaluation results.
RESULTS:For the first time, the unit publicly disseminated the results of the third evaluation according to region, in addition to standard individual hospital “report cards”. A summit conference was held during which the standards and indicators were presented to clinicians and other stakeholders, in collaboration with the health ministry and a panel of cardiovascular experts. Site visits are planned to facilitate change and establishment of local improvement plans and committees. A “tool kit” was developed containing a treatment algorithm, a drug protocol, five quality indicators each for processes and care networks, and measurement tools for indicators. A 75 percent minimal achievement target was set for treatment times.
CONCLUSIONS:A comprehensive framework aimed at improving quality of care for STEMI patients and monitoring change was created by combining evidence from the literature and “real world” data and mobilizing key stakeholders.
Contributors
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- By Rose Teteki Abbey, K. C. Abraham, David Tuesday Adamo, LeRoy H. Aden, Efrain Agosto, Victor Aguilan, Gillian T. W. Ahlgren, Charanjit Kaur AjitSingh, Dorothy B E A Akoto, Giuseppe Alberigo, Daniel E. Albrecht, Ruth Albrecht, Daniel O. Aleshire, Urs Altermatt, Anand Amaladass, Michael Amaladoss, James N. Amanze, Lesley G. Anderson, Thomas C. Anderson, Victor Anderson, Hope S. Antone, María Pilar Aquino, Paula Arai, Victorio Araya Guillén, S. Wesley Ariarajah, Ellen T. Armour, Brett Gregory Armstrong, Atsuhiro Asano, Naim Stifan Ateek, Mahmoud Ayoub, John Alembillah Azumah, Mercedes L. García Bachmann, Irena Backus, J. Wayne Baker, Mieke Bal, Lewis V. Baldwin, William Barbieri, António Barbosa da Silva, David Basinger, Bolaji Olukemi Bateye, Oswald Bayer, Daniel H. Bays, Rosalie Beck, Nancy Elizabeth Bedford, Guy-Thomas Bedouelle, Chorbishop Seely Beggiani, Wolfgang Behringer, Christopher M. Bellitto, Byard Bennett, Harold V. Bennett, Teresa Berger, Miguel A. Bernad, Henley Bernard, Alan E. Bernstein, Jon L. Berquist, Johannes Beutler, Ana María Bidegain, Matthew P. Binkewicz, Jennifer Bird, Joseph Blenkinsopp, Dmytro Bondarenko, Paulo Bonfatti, Riet en Pim Bons-Storm, Jessica A. Boon, Marcus J. Borg, Mark Bosco, Peter C. Bouteneff, François Bovon, William D. Bowman, Paul S. Boyer, David Brakke, Richard E. Brantley, Marcus Braybrooke, Ian Breward, Ênio José da Costa Brito, Jewel Spears Brooker, Johannes Brosseder, Nicholas Canfield Read Brown, Robert F. Brown, Pamela K. Brubaker, Walter Brueggemann, Bishop Colin O. Buchanan, Stanley M. Burgess, Amy Nelson Burnett, J. Patout Burns, David B. Burrell, David Buttrick, James P. Byrd, Lavinia Byrne, Gerado Caetano, Marcos Caldas, Alkiviadis Calivas, William J. Callahan, Salvatore Calomino, Euan K. Cameron, William S. Campbell, Marcelo Ayres Camurça, Daniel F. Caner, Paul E. Capetz, Carlos F. Cardoza-Orlandi, Patrick W. Carey, Barbara Carvill, Hal Cauthron, Subhadra Mitra Channa, Mark D. Chapman, James H. Charlesworth, Kenneth R. Chase, Chen Zemin, Luciano Chianeque, Philip Chia Phin Yin, Francisca H. Chimhanda, Daniel Chiquete, John T. Chirban, Soobin Choi, Robert Choquette, Mita Choudhury, Gerald Christianson, John Chryssavgis, Sejong Chun, Esther Chung-Kim, Charles M. A. Clark, Elizabeth A. Clark, Sathianathan Clarke, Fred Cloud, John B. Cobb, W. Owen Cole, John A Coleman, John J. Collins, Sylvia Collins-Mayo, Paul K. Conkin, Beth A. Conklin, Sean Connolly, Demetrios J. Constantelos, Michael A. Conway, Paula M. Cooey, Austin Cooper, Michael L. Cooper-White, Pamela Cooper-White, L. William Countryman, Sérgio Coutinho, Pamela Couture, Shannon Craigo-Snell, James L. Crenshaw, David Crowner, Humberto Horacio Cucchetti, Lawrence S. Cunningham, Elizabeth Mason Currier, Emmanuel Cutrone, Mary L. Daniel, David D. Daniels, Robert Darden, Rolf Darge, Isaiah Dau, Jeffry C. Davis, Jane Dawson, Valentin Dedji, John W. de Gruchy, Paul DeHart, Wendy J. Deichmann Edwards, Miguel A. De La Torre, George E. Demacopoulos, Thomas de Mayo, Leah DeVun, Beatriz de Vasconcellos Dias, Dennis C. Dickerson, John M. Dillon, Luis Miguel Donatello, Igor Dorfmann-Lazarev, Susanna Drake, Jonathan A. Draper, N. Dreher Martin, Otto Dreydoppel, Angelyn Dries, A. J. Droge, Francis X. D'Sa, Marilyn Dunn, Nicole Wilkinson Duran, Rifaat Ebied, Mark J. Edwards, William H. Edwards, Leonard H. Ehrlich, Nancy L. Eiesland, Martin Elbel, J. Harold Ellens, Stephen Ellingson, Marvin M. Ellison, Robert Ellsberg, Jean Bethke Elshtain, Eldon Jay Epp, Peter C. Erb, Tassilo Erhardt, Maria Erling, Noel Leo Erskine, Gillian R. Evans, Virginia Fabella, Michael A. Fahey, Edward Farley, Margaret A. Farley, Wendy Farley, Robert Fastiggi, Seena Fazel, Duncan S. Ferguson, Helwar Figueroa, Paul Corby Finney, Kyriaki Karidoyanes FitzGerald, Thomas E. FitzGerald, John R. Fitzmier, Marie Therese Flanagan, Sabina Flanagan, Claude Flipo, Ronald B. Flowers, Carole Fontaine, David Ford, Mary Ford, Stephanie A. Ford, Jim Forest, William Franke, Robert M. Franklin, Ruth Franzén, Edward H. Friedman, Samuel Frouisou, Lorelei F. Fuchs, Jojo M. Fung, Inger Furseth, Richard R. Gaillardetz, Brandon Gallaher, China Galland, Mark Galli, Ismael García, Tharscisse Gatwa, Jean-Marie Gaudeul, Luis María Gavilanes del Castillo, Pavel L. Gavrilyuk, Volney P. Gay, Metropolitan Athanasios Geevargis, Kondothra M. George, Mary Gerhart, Simon Gikandi, Maurice Gilbert, Michael J. Gillgannon, Verónica Giménez Beliveau, Terryl Givens, Beth Glazier-McDonald, Philip Gleason, Menghun Goh, Brian Golding, Bishop Hilario M. Gomez, Michelle A. Gonzalez, Donald K. Gorrell, Roy Gottfried, Tamara Grdzelidze, Joel B. Green, Niels Henrik Gregersen, Cristina Grenholm, Herbert Griffiths, Eric W. Gritsch, Erich S. Gruen, Christoffer H. Grundmann, Paul H. Gundani, Jon P. Gunnemann, Petre Guran, Vidar L. Haanes, Jeremiah M. 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