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Background An important aspect of developing and maintaining a high-quality standardized patient (SP) program is incorporating quality assurance processes. Trainer and instructor feedbacks are considered critical in achieving these goals. The aim of this study is to determine programmatic and systematic issues in the scope of quality assurance and improvement through trainer and instructor feedback on SP performance. We also presented a logic model based on a synthesis of the current literature to ensure the development and maintenance of a quality management culture in the SP program. Methods A retrospective analysis of SP scoring was conducted, and written feedback forms completed by trainers and instructors in a large Canadian university's SP program were collected. The previous six years (2014-2020) of SP feedback forms in the scope of quality assurance were reviewed and analyzed. Descriptive statistics were utilized to analyze the ratings. Thematic analysis was conducted on the data gathered from the written feedback. Results A total of 138 feedback forms were reviewed and analyzed in the study. The mean ratings given by the trainers for feedback and professionalism were 4.27 ± 1.29 and 4.77 ± 0.8, respectively. The mean ratings given by the instructors for knowledge of case information, appropriate responses, and affect were 4.84 ± 0.64, 4.86 ± 0.35, and 4.71 ± 0.76, respectively (from a range of 1 to 5). Four key themes emerged from the written feedback: nonverbal behaviors in simulation activity or feedback sessions, providing feedback from the patient perspective, consistency between role portrayal and scenario, and adapting easily to changing situations. Conclusions Component scoring on SP performance did not discriminate individual issues, but the qualitative comments identified certain specific issues. Further research is needed to establish standards of continuous quality improvement (CQI) within an SP program.
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INTRODUCTIONThe pandemic readiness toolbox needs to be extended, providing diagnostic tools that target different biomolecules, using orthogonal experimental setups and fit-for-purpose specification of detection. Here we build on a previous Cov-MS effort that used liquid chromatography-mass spectrometry (LC-MS) and describe a method that allows accurate, high throughput measurement of SARS-CoV-2 nucleocapsid (N) protein. MATERIALS and METHODSWe used Stable Isotope Standards and Capture by Anti-Peptide Antibodies (SISCAPA) technology to enrich and quantify proteotypic peptides of the N protein from trypsin-digested samples from COVID-19 patients. RESULTSThe Cov2MS assay was shown to be compatible with a variety of sample matrices including nasopharyngeal swabs, saliva and blood plasma and increased the sensitivity into the attomole range, up to a 1000-fold increase compared to direct detection in matrix. In addition, a strong positive correlation was observed between the SISCAPA antigen assay and qPCR detection beyond a quantification cycle (Cq) of 30-31, the level where no live virus can be cultured from patients. The automatable "addition only" sample preparation, digestion protocol, peptide enrichment and subsequent reduced dependency upon LC allow analysis of up to 500 samples per day per MS instrument. Importantly, peptide enrichment allowed detection of N protein in a pooled sample containing a single PCR positive sample mixed with 31 PCR negative samples, without loss in sensitivity. MS can easily be multiplexed and we also propose target peptides for Influenza A and B virus detection. CONCLUSIONSThe Cov2MS assay described is agnostic with respect to the sample matrix or pooling strategy used for increasing throughput and can be easily multiplexed. Additionally, the assay eliminates interferences due to protein-protein interactions including those caused by anti-virus antibodies. The assay can be adapted to test for many different pathogens and could provide a tool enabling longitudinal epidemiological monitoring of large numbers of pathogens within a population, applied as an early warning system.
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Rising population density and global mobility are among the reasons why pathogens such as SARS-CoV-2, the virus that causes COVID-19, spread so rapidly across the globe. The policy response to such pandemics will always have to include accurate monitoring of the spread, as this provides one of the few alternatives to total lockdown. However, COVID-19 diagnosis is currently performed almost exclusively by Reverse Transcription Polymerase Chain Reaction (RT-PCR). Although this is efficient, automatable and acceptably cheap, reliance on one type of technology comes with serious caveats, as illustrated by recurring reagent and test shortages. We therefore developed an alternative diagnostic test that detects proteolytically digested SARS-CoV-2 proteins using Mass Spectrometry (MS). We established the Cov-MS consortium, consisting of fifteen academic labs and several industrial partners to increase applicability, accessibility, sensitivity and robustness of this kind of SARS-CoV-2 detection. This in turn gave rise to the Cov-MS Digital Incubator that allows other labs to join the effort, navigate and share their optimizations, and translate the assay into their clinic. As this test relies on viral proteins instead of RNA, it provides an orthogonal and complementary approach to RT-PCR, using other reagents that are relatively inexpensive and widely available, as well as orthogonally skilled personnel and different instruments. Data are available via ProteomeXchange with identifier PXD022550.
