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High-throughput ‘omics’ technologies that generate molecular profiles for biospecimens have been extensively used in preclinical studies to reveal molecular subtypes and elucidate the biological mechanisms of disease, and in retrospective studies on clinical specimens to develop mathematical models to predict clinical endpoints. Nevertheless, the translation of these technologies into clinical tests that are useful for guiding management decisions for patients has been relatively slow. It can be difficult to determine when the body of evidence for an omics-based test is sufficiently comprehensive and reliable to support claims that it is ready for clinical use, or even that it is ready for definitive evaluation in a clinical trial in which it may be used to direct patient therapy. Reasons for this difficulty include the exploratory and retrospective nature of many of these studies, the complexity of these assays and their application to clinical specimens, and the many potential pitfalls inherent in the development of mathematical predictor models from the very high-dimensional data generated by these omics technologies. Here we present a checklist of criteria to consider when evaluating the body of evidence supporting the clinical use of a predictor to guide patient therapy. Included are issues pertaining to specimen and assay requirements, the soundness of the process for developing predictor models, expectations regarding clinical study design and conduct, and attention to regulatory, ethical, and legal issues. The proposed checklist should serve as a useful guide to investigators preparing proposals for studies involving the use of omics-based tests. The US National Cancer Institute plans to refer to these guidelines for review of proposals for studies involving omics tests, and it is hoped that other sponsors will adopt the checklist as well.

A checklist of criteria to determine the readiness of high-throughput ‘omics’-based tests for guiding patient therapy in clinical trials is discussed; the checklist, developed by the US National Cancer Institute in collaboration with additional scientists with relevant expertise, provides a framework to evaluate the strength of evidence for a test and outlines practical issues to consider before using the test in a clinical setting, with an aim to avoid premature advancement of omics-based tests in clinical trials. Guidelines for clinical use of omics data The potential of high-throughput 'omics' in clinical medicine is immense, with oncology leading the way in adopting these technologies. Working with researchers and clinicians from across the spectrum of these disciplines, the US National Cancer Institute (NCI) has developed a checklist of criteria that can be used to determine the readiness of omics-based tests for guiding patient care in clinical trials. Published in this Perspective feature, the checklist focuses on best practice in specimen preparation, assays, mathematical modelling, clinical trial design, ethics and more. It will be used to evaluate proposals for NCI-sponsored clinical trials in which omics tests guide therapy. The US National Cancer Institute (NCI), in collaboration with scientists representing multiple areas of expertise relevant to ‘omics’-based test development, has developed a checklist of criteria that can be used to determine the readiness of omics-based tests for guiding patient care in clinical trials. The checklist criteria cover issues relating to specimens, assays, mathematical modelling, clinical trial design, and ethical, legal and regulatory aspects. Funding bodies and journals are encouraged to consider the checklist, which they may find useful for assessing study quality and evidence strength. The checklist will be used to evaluate proposals for NCI-sponsored clinical trials in which omics tests will be used to guide therapy.

Purpose Some variability in recovery and outcomes after cardiac surgery may be influenced by psychosocial aspects not routinely captured. Preliminary evidence suggests patient expectations impact health status, but there is no specific measure of expectations for cardiac surgery. The purpose of this study was to adapt an expectations scale to cardiac surgery and assess the psychometric properties of the scale. Methods Before surgery, 93 patients awaiting non-emergent cardiac surgery completed questionnaires, including the adapted Cardiac Surgery Patient Expectations Questionnaire (C-SPEQ). At 1 year after surgery, 68 patients completed questionnaires. Results Mean C-SPEQ score was 39.4 ± 9.02, and scores were normally distributed (Cronbach's alpha = 0.86). Higher score indicated negative expectations. Higher presurgery C-SPEQ score was correlated with greater depression (r = 0.32, p = 0.01) and perceived stress (r = 0.36, p = 0.003), but not state anxiety (r = 0.18, p = 0.14), at one-year post-surgery. Higher C-SPEQ was associated with longer recovery time (B = 0.14, p = 0.006) and lower physical HRQL after surgery (B = -0.31, p = 0.005). Higher C-SPEQ was not related to greater odds for perioperative complications (OR 1.01, p = 0.68) or readmissions >30 days (OR 1.05, p = 0.31). C-SPEQ score was not related to survival. Conclusions Adaptation of an expectations questionnaire to cardiac surgery patients was successful with acceptable reliability and validity. Negative expectations had a detrimental impact on recovery and HRQL following cardiac surgery but were not related to clinical outcomes. Although focus is mainly on improving clinical outcomes, there are opportunities to improve non-clinical aspects of the patient experience. Presurgical education might better prepare patients, reduce negative expectations, and improve psychosocial outcomes after cardiac surgery.

My loud hurrahs and heartfelt appreciation go to Henry Mitchell for the way he has addressed the question of the treatment of laboratory animals [\"Savagery and Science and Civilization's Stake,\" Style, Sept. 21).

Perinatal nurses are increasingly encountering patients who have engaged in perinatal substance use (PSU). Despite growing evidence demonstrating the need to reduce nurses' stigmatizing attitudes toward PSU, limited interventions are available to target these attitudes and support behavior change, especially those reflecting the overwhelming evidence that education alone is insufficient to change practice behavior. Arts-based interventions are associated with increasing nursing empathy, changing patient attitudes, improving reflective practice, and decreasing stigma. We adapted ArtSpective for PSU-a previously evaluated, in-person, arts-based intervention to reduce stigma toward PSU among perinatal nurses-into an interactive, digital, and responsive platform that facilitates intervention delivery asynchronously. This study aimed to evaluate the usability, acceptability, and feasibility of the interactive, responsive platform version of ArtSpective for PSU. Our goal was to elicit the strengths and weaknesses of the responsive platform by evaluating the user experience to identify strategies to overcome them. This study used a mixed methods approach to explore the platform's usability, user experience, and acceptability as an intervention to address stigma and implicit bias related to PSU. Theatre testing was used to qualitatively assess usability and acceptability perspectives with nurses and experts; a modified version of the previously validated 8-item Abbreviated Acceptability Rating Profile was used for quantitative assessment. Quantitative data for acceptability and satisfaction were analyzed using descriptive statistics. All qualitative data were analyzed iteratively using an inductive framework analysis approach. Overall, 21 nurses and 4 experts in stigma, implicit bias, and instructional design completed theatre-testing sessions. The mean duration of interviews was 31.92 (SD 11.32) minutes for nurses and 40.73 (SD 8.57) minutes for experts. All participants indicated that they found the digital adaptation of the intervention to be highly acceptable, with mean acceptability items ranging from 5.0 (SD 1.0) to 5.5 (SD 0.6) on a 1-6 agreement scale. Nurses reported high satisfaction with the platform, with mean satisfaction items ranging from 5.14 (SD 0.56) to 5.29 (SD 0.63) on a 1-6 agreement scale. In total, 1797 interview segments were coded from the theatre-testing sessions with 4 major themes: appearance, navigation, characterization, and overall platform, and 16 subthemes were identified. Consistent with the quantitative findings, the results were positive overall, with participants expressing high satisfaction related to the platform's appearance, the ease with which they could navigate the various modules, engagement, clarity of the presentation, and feasibility of being completed asynchronously. Developing and evaluating the usability of a digital adaptation of ArtSpective for PSU resulted in strong support for the usability, acceptability, and satisfaction of the program. It also provided insight into key aspects related to acceptability and usability that should be considered when designing a digital adaptation of an arts-based intervention for health care providers.

BackgroundThe Canadian Open Genetics Repository is a collaborative effort for the collection, storage, sharing and robust analysis of variants reported by medical diagnostics laboratories across Canada. As clinical laboratories adopt modern genomics technologies, the need for this type of collaborative framework is increasingly important.MethodsA survey to assess existing protocols for variant classification and reporting was delivered to clinical genetics laboratories across Canada. Based on feedback from this survey, a variant assessment tool was made available to all laboratories. Each participating laboratory was provided with an instance of GeneInsight, a software featuring versioning and approval processes for variant assessments and interpretations and allowing for variant data to be shared between instances. Guidelines were established for sharing data among clinical laboratories and in the final outreach phase, data will be made readily available to patient advocacy groups for general use.ResultsThe survey demonstrated the need for improved standardisation and data sharing across the country. A variant assessment template was made available to the community to aid with standardisation. Instances of the GeneInsight tool were provided to clinical diagnostic laboratories across Canada for the purpose of uploading, transferring, accessing and sharing variant data.ConclusionsAs an ongoing endeavour and a permanent resource, the Canadian Open Genetics Repository aims to serve as a focal point for the collaboration of Canadian laboratories with other countries in the development of tools that take full advantage of laboratory data in diagnosing, managing and treating genetic diseases.