1,720,968 research outputs found
Assessing Companion Diagnostics (CDx) for Reimbursement Within Alberta: Pilot Study Using Health Technology Assessment of Programmed Death Ligand 1 (PD-L1) Testing in Non-Small Cell Lung Cancer (NSCLC)
Full text linkIntroduction: The number of investigational and licensed indications for companion diagnostic (CDx)-drug pairs is increasing. National assessments of the linked drug to support provincial funding decisions do not specifically address the CDx. The project objectives were to: (1) review a proposed process for Alberta to undertake health technology assessments (HTAs) of CDx and the rationale for a pilot, (2) provide background on the pilot HTA topic and identify the information elements for assessing CDx, (3) conduct the pilot HTA, (4) assess the proposed process for feasibility (timeliness, resources, and efficiencies), and compare the HTA findings with assessments in other jurisdictions/countries.
Methods: Documents were reviewed describing a previous jurisdictional scan, literature review, workshop with Australian, British and American representatives, and process for CDx assessments as proposed to a provincial cross-sectoral, multidisciplinary CDx working group. A pilot of the proposed process using programmed-death ligand-1 (PD-L1) testing for advanced non-small cell lung cancer (NSCLC) was initiated. Using available guidance and literature, information elements related to CDx―specific to clinical utility, clinical validity and analytical validity―were identified. Research questions for the pilot HTA were developed using input from a topic working group, on clinical use of, and the laboratory capacity for PD-L1 testing in Alberta. For research questions about the prognostic role, clinical utility, analytical validity, cost-effectiveness, and patient perspectives of PD-L1 testing for advanced NSLC, a systematic review using standard methodology was conducted. Other research questions (i.e., budget impact, social and ethical considerations) were answered based on literature from the systematic review and input/data from the topic working group. The HTA focused on use of the 22C3 PharmDx assay for PD-L1 testing to determine eligibility for pembrolizumab treatment in NSCLC. A process evaluation was conducted, based on: (i) data collection on timing, skill requirements and resources for all HTA steps, (ii) assessment (in retrospect) on how and when the information provided in reports by the national body providing recommendations on the linked drug(s) may be incorporated and/or impact the results, (iii) comparison of the findings with those of other countries.
Results: The proposed process was designed to coincide with the pan-Canadian review of the drug and focus on information elements specific to the CDx. Findings from the pilot revealed that very low quality evidence exists for clinical utility of PD-L1 testing at the thresholds currently used for eligibility in advanced NSCLC for treatment with pembolizumab. PD-L1 expression may not greatly impact cost-effectiveness of the drug, because the benefits and costs change in the same direction as PD-L1 expression changes. The analytical validity of the PharmDx assay is sub-optimal; important considerations are that quality assurance is essential for local laboratories to undertake, and that a single biopsy in patients with multifocal lung cancer, as well as tissue samples from early stage disease, may not accurately capture PD-L1 expression status as used for treatment decisions. The budget impact to Alberta in 2017 was estimated at $535,296 annually when using actual cases submitted for testing (approx. 1,600); this cost may not be required if only cases of newly diagnosed advanced NSCLC (approx.. 450-500 per year) are tested in the future. The pilot was completed using 5.4 full-time equivalent months of effort (across personnel having expertise in systematic reviews, information science, and statistics), and could be conducted over a 5- to 6-month period to align with the current national assessments of the linked drug. Information on the cost-effectiveness and patient experiences with the CDx from the initial and/or final reports from the national assessments will likely prove very valuable. Assessment for reimbursement of the CDx alone, without concurrent and similar considerations applied for decisions about funding the drug, may lead to differences in access to the drug and CDx. This could limit the available options for funding the CDx and may lend towards lack of credibility to both processes.
Conclusions: The proposed CDx review process appears feasible and generates the type and level of information required to support decision-making in Alberta. Rationale for decisions should be made transparent to assist with comparisons between provinces and other countries
Social values and their role in allocating resources for new health technologies
Full text linkEvery healthcare system faces unlimited demands and limited resources, creating a need to make decisions that may limit access to some new, potentially effective technologies. It has become increasingly clearer that such decisions are more than technical ones. They require social value judgements - statements of the public’s distributive preferences for healthcare across the population. However, these value judgements largely remain ill-defined. The purpose of this thesis was to explicate distributive preferences of the public to inform funding/coverage decisions on new health technologies. It contains six papers. The first comprises a systematic review of current coverage processes around the world, including value assumptions embedded within them. The second paper presents findings from an expert workshop and key-informant interviews with senior-level healthcare decision-makers in Canada. A technology funding decision-making framework, informed by the results of the first paper and the experiences of these decision-makers, was developed. Their input also highlighted the lack of and need for information on values that reflect those of the Canadian public. The third paper provides a systematic review of empirical studies attempting to explicate distributive preferences of the public. It also includes an analysis of social value arguments found in appeals to negative coverage decisions. From the results of both components, possible approaches to eliciting social values from the public and a list of factors around which distributive preferences may be sought were compiled. Such factors represented characteristics of unique, competing patient populations. Building on findings from the third paper, the fourth paper describes a citizens’ jury held to explicate distributive preferences for new health technologies in Alberta, Canada. The jury involved a broadly representative sample of the public, who participated in decision simulation exercises involving trade-offs between patient populations characterized by different combinations of factors. A list of preference statements, demonstrating interactions among such factors, emerged. The fifth and sixth papers address methodological issues related to citizens’ juries, including the comparability of findings from those carried out in the same way but with different samples of the public, and the extent to which they changed the views of individuals who participate in them
Going Beyond Counting First Authors in Author Co-citation Analysis
Full text linkThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Variations on the Author
Full text link“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Appropriate Similarity Measures for Author Cocitation Analysis
Full text linkWe provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis
The Clinical Adoption of anti-CD19 CAR T-cell Therapy in Alberta: A Historical Review and Retrospective Comparative Case Study
Full text linkThis thesis details the adoption of anti-CD19 CAR T-cell therapy in Alberta from 2018-2021, during which time a commercial (tisagenlecleucel) and investigative (ACT-C01) CAR T product were implemented as standard of care and under a clinical trial, respectively. Information was gathered through stakeholder interviews, primary source documents obtained from Alberta Health Services employees involved in the adoption process, and peer-reviewed and grey literature acquired by targeted database searches. Herein, we provide a timeline of the events and processes at both centres; a comprehensive list of the stakeholders and their relationships; and an analysis of the challenges of and enablers to adoption using the Consolidated Framework for Implementation Research. Potential approaches to assessing the outcomes of the adoption process across each site from a health system perspective are proposed, and lastly, limitations of the study are acknowledged and future research avenues proposed
Dispelling the Myths Behind First-author Citation Counts
Full text linkWe conducted a full-scale evaluative citation analysis study of scholars in the XML research field to explore just how different from each other author rankings resulting from different citation counting methods actually are, and to demonstrate the capability of emerging data and tools on the Web in supporting more realistic citation counting methods. Our results contest some common arguments for the continued
use of first-author citation counts in the evaluation of scholars, such as high correlations between author rankings by first-author citation counts and other citation
counting methods, and high costs of using more realistic citation counting methods that are not well-supported by the ISI databases. It is argued that increasingly available digital full text research papers make it possible for citation analysis studies to go beyond what the ISI databases have directly supported and to employ more
sophisticated methods
koamabayili/VECTRON-author-checklist: VECTRON author checklist
No full textWe have done our best to complete the author checklist relating to the use of animals in the hut study. Note that the objective for the hut study was to evaluate the IRS treatment applications for residual efficacy against Anopheles mosquitoes, including the local An. coluzzii mosquito population. Cows were only used to attract mosquitoes into the huts and no tests were carried out directly on the cows. The author checklist is intended for use with studies where experiments are carried out on animals, which is why we have had such difficulty in completing this for the hut study, as many of the questions do not relate to how the cows were used
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