BackgroundThe programmed death receptor 1 (PD-1) protein is a cell-surface receptor on certain lymphocytes that, with its ligand programmed death ligand 1 (PD-L1), helps to down-regulate immune responses. Many cancer types express PD-L1 and evade immune recognition via the PD-1/PD-L1 interaction. Precision therapies targeting the PD-1/PD-L1 pathway have the potential to improve response and thereby offer a novel treatment avenue to some patients with cancer. However, this new therapeutic approach requires reliable methods for identifying patients whose cancers are particularly likely to respond. Therefore, we conducted a systematic literature review assessing evidence on test validation and scoring algorithms for PD-L1 immunohistochemistry (IHC) tests that might be used to select potentially responsive patients with bladder/urothelial cell, lung, gastric, or ovarian cancers for immunotherapy treatment.Methods and resultsTo identify evidence on commercially available PD-L1 IHC assays, we systematically searched MEDLINE and Embase for relevant studies published between January 2010 and September 2016 and appraised abstracts from recent oncology conferences (January 2013 to November 2016). Publications that met the predefined inclusion criteria were extracted and key trends summarized.In total, 26 eligible primary studies were identified, all of which reported on the test validation metrics associated with PD-L1 IHC tests in lung cancer, most using immunohistochemistry testing. There was significant heterogeneity among the available tests for PD-L1. Specifically, no definitive cutoff for PD-L1 positivity was identifiable, with more than one threshold being reported for most antibodies. Studies also differed as to whether they evaluated tumor cells only or tumor cells and tumor-infiltrating immune cells. However, all of the tests developed and validated to support a therapeutic drug in the context of phase 2–3 clinical trials reported more than 90% inter-reader concordance. In contrast, other PD-L1 antibodies identified in the literature reported poorer concordance.ConclusionsPublished validation metric data for PD-L1 tests are mainly focused on immunohistochemistry tests from studies in lung cancer. The variability in test cutoffs and standards for PD-L1 testing suggests that there is presently no standardized approach. This current variability may have implications for the uptake of precision treatments.
To reduce harm to the environment resulting from the production, use, and disposal of health technologies, there are different options for how health technology assessment (HTA) agencies can consider environmental information. We identified four approaches that HTA agencies can use to take environmental information into account in healthcare decision making and the challenges associated with each approach. Republishing data that is in the public domain or has been submitted to an HTA agency we term the “information conduit” approach. Analyzing and presenting environmental data separately from established health economic analyses is described as “parallel evaluation.” Integrating environmental impact into HTAs by identifying or creating new methods that allow clinical, financial, and environmental information to be combined in a single quantitative analysis is “integrated evaluation.” Finally, evidence synthesis and analysis of health technologies that are not expected to improve health-related outcomes but claim to have relative environmental benefits are termed “environment-focused evaluation.”
PRIMARY TRACK: Guideline implementation SECONDARY TRACK: Guideline implementation methods BACKGROUND (INTRODUCTION): The BiliWheel was conceived of by the Neonatal Jaundice Guideline Development Group (GDG) as an aid for clinical staff. The GDG accepted that while visual inspection was useful in recognizing jaundice, it was unreliable in estimating its severity, and the GDG recommended that bilirubin levels be measured and managed according to age-appropriate management thresholds. An added problem is that it is generally accepted that calculating age in hours quickly and accurately is difficult. The GDG saw a need to create a tool that would make calculating the age in hours easier and would also inform on the age-appropriate management strategy recommended in the guidance. An evaluation study was carried out in a sample of third-year midwifery students and practicing midwives from two teaching hospitals.
LEARNING OBJECTIVES (TRAINING GOALS):1. Evaluate need for guideline-specific implementation tools to assist health care professionals in clinical practice. 2. Identify positive and negative outcomes of using a guideline-based implementation tool in clinical practice. 3. Evaluate health care professional training needs and other resources needed when implementing a guidelinebased implementation tool. 4. Identify barriers to the implementation of guideline-specific implementation tools in clinical practice. METHODS: Study participants were presented with case vignettes of six babies with jaundice and asked to complete a questionnaire covering management decisions, feedback on design and layout issues, and a Likert scale for determining the usefulness of the BiliWheel. Study results will be expressed as percentage correct from the total sample. Common themes regarding design, layout, and utility will be collated. RESULTS: To be presented and discussed at the conference.
DISCUSSION (CONCLUSION):To be presented and discussed at the conference.
TARGET AUDIENCE(S):1. Guideline implementer 2. Developer of guideline-based products 3. Medical educator 4. Allied health professionals 5. Consumers and patients representatives 6. Nurses
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