Listening to the patient voice adds value to cancer clinical trials.

Randomized clinical trials are critical for evaluating the safety and efficacy of interventions in oncology and informing regulatory decisions, practice guidelines, and health policy. Patient-reported outcomes (PROs) are increasingly used in randomized trials to reflect the impact of receiving cancer therapies from the patient perspective and can inform evaluations of interventions by providing evidence that cannot be obtained or deduced from clinicians' reports or from other biomedical measures. This commentary focuses on how PROs add value to clinical trials by representing the patient voice. We employed two previously published descriptive frameworks (addressing how PROs are used in clinical trials and how PROs have an impact, respectively) and selected nine clinical trial publications that illustrate the value of PROs according to the framework categories. These include three trials where PROs were a primary trial endpoint, three trials where PROs as secondary endpoints supported the primary endpoint, and three trials where PROs as secondary endpoints contrast the primary endpoint findings in clinically important ways. The nine examples illustrate that PROs add valuable data to the care and treatment context by informing future patients about how they may feel and function on different treatments and by providing clinicians with evidence to support changes to clinical practice and shared decision-making. Beyond the patient and clinician, PROs can enable administrators to consider the cost-effectiveness of implementing new interventions, and contribute vital information to policy-makers, health technology assessors, and regulators. These examples provide a strong case for the wider implementation of PROs in cancer trials. [Abstract copyright: © The Author(s) (2022). Published by Oxford University Press.

Performance and Operation of the CMS Electromagnetic Calorimeter

The operation and general performance of the CMS electromagnetic calorimeter using cosmic-ray muons are described. These muons were recorded after the closure of the CMS detector in late 2008. The calorimeter is made of lead tungstate crystals and the overall status of the 75848 channels corresponding to the barrel and endcap detectors is reported. The stability of crucial operational parameters, such as high voltage, temperature and electronic noise, is summarised and the performance of the light monitoring system is presented

Performance of the CMS Cathode Strip Chambers with Cosmic Rays

The Cathode Strip Chambers (CSCs) constitute the primary muon tracking device in the CMS endcaps. Their performance has been evaluated using data taken during a cosmic ray run in fall 2008. Measured noise levels are low, with the number of noisy channels well below 1%. Coordinate resolution was measured for all types of chambers, and fall in the range 47 microns to 243 microns. The efficiencies for local charged track triggers, for hit and for segments reconstruction were measured, and are above 99%. The timing resolution per layer is approximately 5 ns

Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension

The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human–AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret, and critically appraise the design and risk of bias for a planned clinical trial

Coping with poachers in European stalked barnacle fisheries: Insights from a stakeholder workshop.

In January 2020, a stakeholder workshop was organized as a knowledge sharing strategy among European stalked barnacle fisheries. Management of this fishery differs greatly among regions and ranges from less organized and governed at large scales (>100 km, coasts of SW Portugal and Brittany in France) to highly participatory systems which are co-managed at small spatial scales (10′s km and less, Galicia and Asturias). Discussions revealed that poaching is ubiquitous, hard to eradicate, and adapts to all types of management. The stakeholders identified some key management initiatives in the fight against poaching: granting professional harvesters with exclusive access to the resource, increasing social capital among harvesters through tenure systems (e.g. Territorial Use Rights in Fisheries) that empower them as stewards of their resource and intensi- fication of surveillance with the active participation of the harvesters. Furthermore, increased cooperation be- tween fishers associations and regional fisheries authorities, improved legal frameworks, adoption of new technologies and the implementation of market-based solutions can also help coping with this systemic problem