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Sensor-based digital health technologies (sDHTs) are increasingly used to support scientific and clinical decision-making. The digital clinical measures they generate offer enormous benefits, including providing more patient-relevant data, improving patient access, reducing costs, and driving inclusion across health care ecosystems. Scientific best practices and regulatory guidance now provide clear direction to investigators seeking to evaluate sDHTs for use in different contexts. However, the quality of the evidence reported for analytical validation of sDHTs—evaluation of algorithms converting sample-level sensor data into a measure that is clinically interpretable—is inconsistent and too often insufficient to support a particular digital measure as fit-for-purpose. We propose a hierarchical framework to address challenges related to selecting the most appropriate reference measure for conducting analytical validation and codify best practices and an approach that will help capture the greatest value of sDHTs for public health, patient care, and medical product development.

The assessment of physical activity in healthy populations and in those with chronic diseases is challenging. The aim of this systematic review was to identify whether available activity monitors (AM) have been appropriately validated for use in assessing physical activity in these groups. Following a systematic literature search we found 134 papers meeting the inclusion criteria; 40 conducted in a field setting (validation against doubly labelled water), 86 in a laboratory setting (validation against a metabolic cart, metabolic chamber) and 8 in a field and laboratory setting. Correlation coefficients between AM outcomes and energy expenditure (EE) by the criterion method (doubly labelled water and metabolic cart/chamber) and percentage mean differences between EE estimation from the monitor and EE measurement by the criterion method were extracted. Random-effects meta-analyses were performed to pool the results across studies where possible. Types of devices were compared using meta-regression analyses. Most validation studies had been performed in healthy adults (n = 118), with few carried out in patients with chronic diseases (n = 16). For total EE, correlation coefficients were statistically significantly lower in uniaxial compared to multisensor devices. For active EE, correlations were slightly but not significantly lower in uniaxial compared to triaxial and multisensor devices. Uniaxial devices tended to underestimate TEE (−12.07 (95%CI; -18.28 to −5.85) %) compared to triaxial (−6.85 (95%CI; -18.20 to 4.49) %, p = 0.37) and were statistically significantly less accurate than multisensor devices (−3.64 (95%CI; -8.97 to 1.70) %, p<0.001). TEE was underestimated during slow walking speeds in 69% of the lab validation studies compared to 37%, 30% and 37% of the studies during intermediate, fast walking speed and running, respectively. The high level of heterogeneity in the validation studies is only partly explained by the type of activity monitor and the activity monitor outcome. Triaxial and multisensor devices tend to be more valid monitors. Since activity monitors are less accurate at slow walking speeds and information about validated activity monitors in chronic disease populations is lacking, proper validation studies in these populations are needed prior to their inclusion in clinical trials.

The International Pharmaco-EEG Society (IPEG) presents guidelines summarising the requirements for the recording and computerised evaluation of pharmaco-sleep data in man. Over the past years, technical and data-processing methods have advanced steadily, thus enhancing data quality and expanding the palette of sleep assessment tools that can be used to investigate the activity of drugs on the central nervous system (CNS), determine the time course of effects and pharmacodynamic properties of novel therapeutics, hence enabling the study of the pharmacokinetic/pharmacodynamic relationship, and evaluate the CNS penetration or toxicity of compounds. However, despite the presence of robust guidelines on the scoring of polysomnography -recordings, a review of the literature reveals inconsistent -aspects in the operating procedures from one study to another. While this fact does not invalidate results, the lack of standardisation constitutes a regrettable shortcoming, especially in the context of drug development programmes. The present guidelines are intended to assist investigators, who are using pharmaco-sleep measures in clinical research, in an effort to provide clear and concise recommendations and thereby to standardise methodology and facilitate comparability of data across laboratories.

The development and validation of biomarkers can often follow well-established principles of scientific investigation, but implementation of biomarkers into drug development requires careful consideration of many other practical issues. During the study planning process, careful consideration must be given to the suitability of the biomarker for the specific needs and objectives of the drug development team, performance of the biomarker at the specific sites, standardization and data transmittal, potential use of the biomarker at other stages in the life cycle of the compound, and a clear understanding of how the results will be used to make decisions about the compound. A close collaboration between the biomarker expert and the drug development team is needed maximize the likelihood that the full value of the biomarker will be realized.

Science and innovation benefit from diversity. However, as the global community fights COVID-19, the productivity and scientific output of female academics are disproportionately affected, leading to loss of women's scientific expertise from the public realm.Women comprise 70% of the global health workforce and more than 50% of medical graduates in many countries. Despite this, women and gender minorities remain underrepresented in medical leadership. Only 22% of full professors in American medical schools1 and 23% in Europe2 are women. Women of colour are particularly underrepresented; only 0·5% of full professors in American medical schools are Black women.1 Academic publishing is essential to career advancement. Women's first authorship in major medical journals has increased from 27% to 37% (1994–2014).3 Yet, COVID-19 is threatening progress by amplifying existing gender disparities.

Natural killer (NK) cells and dendritic cells (DCs) are crucial mediators of productive immune responses to infection and disease. NK cells and a subtype of DCs, the type 1 conventional DCs (cDC1s), are individually important for regulating immune responses to cancer in mice and humans. Recent work has found that NK cells and cDC1s engage in intercellular cross-talk integral to initiating and coordinating adaptive immunity to cancer. This NK cell–cDC1 axis has been linked to increased overall survival and responses to anti-PD-1 immunotherapy in metastatic melanoma patients. Here, we review recent findings on the role of NK cells and cDC1s in protective immune responses to cancer and immunotherapy, as well as current therapies targeting this NK cell–cDC1 axis. Further, we explore the concept that intercellular cross-talk between NK cells and cDC1s may be key for many of the positive prognostic associations seen with NK cells and DCs individually. It is clear that increasing our understanding of the NK cell–cDC1 innate immune cell axis will be critical for the generation of novel therapies that can modulate anti-cancer immunity and increase patient responses to common immunotherapies.

Understanding how extremes are changing globally, regionally, and locally is an important first step for planning appropriate adaptation measures, as changes in extremes have major impacts. The Intergovernmental Panel on Climate Change's synthesis of global extremes was not able to say anything about western central Africa, as no analysis of the region was available nor was there an adequate internationally exchanged long‐term daily data set available to use for analysis of extremes. This paper presents the first analysis of extremes in this climatically important region along with analysis of Guinea Conakry and Zimbabwe. As per many other parts of the world, the analysis shows a decrease in cold extremes and an increase in warm extremes. However, while the majority of the analyzed world has shown an increase in heavy precipitation over the last half century, central Africa showed a decrease. Furthermore, the companion analysis of Guinea Conakry and Zimbabwe showed no significant increases.