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Sleep is rarely considered in drug development studies. Pre-existing sleep problems or changes in sleep parameters in response to therapeutics have the potential to diminish the true utility of the agent under development. Sleep is integral to human health and affects virtually every disease. We present evidence that indicates how sleep quality and quantity can be predictive of disease risk, progression, remission, and recurrence. Supporting the premise that we should conceptualize sleep as a 'vital sign' and measure sleep as an integral component in drug development. We highlight the emergence of digital health technologies that have enabled the capture of this 'vital sign' and ask the question: why is sleep still largely ignored in drug development studies?

While the importance of physician involvement in organizational quality and safety (QS) activities has been well established, a paucity of information exists on tangible supports needed to effectively execute this role. Interviews with 13 MD QS leads uncovered common enablers, including valuing QS work academically, hiring skilled collaborators, ensuring appropriate power and authority to advance QS initiatives, facilitating connections, emphasizing culture change and strong action by leadership. To operationalize these enablers and drive quality innovation, organizations should prioritize the identification and appointment of MD QS leads for each department/division and facilitate their assembly as a formal physician QS committee.

The COVID-19 pandemic has necessitated innovations in practice in almost all areas of healthcare, not least community nursing services. This article details how one organisation planned and executed a home vaccination programme for housebound members of the population in its remit. It discusses the challenges faced by the team, as well as the key learnings achieved from this programme, which will guide future home immunisation programmes. Implementation of this programme required excellent coordination between clinicians and administrative staff. Importantly, support from the procurement and IT teams and the medicines management committee went a long way in the ironing out of early hiccups and in ensuring smooth running of the programme.

Purpose: Although medicinal cannabis is prescribed for conditions such as pain, epilepsy, nausea and vomiting during cancer treatment, evidence about associated adverse side effects is still evolving. Because adverse events (AEs) might impact the performance of workers, it is important to consider their implications on workplace health and safety (WHS). This study aimed to map the types and prevalence of the AEs associated with medical cannabis and articulate how those events could impact WHS. Methods: A scoping review of systematic reviews and/or meta-analyses published between 2015 and March 2021 was performed to identify the AEs of medicinal cannabis in adults. Publications in English and full text available online were collected from Embase, MEDLINE, PsychINFO, PubMed, Scopus, and Web of Science. Results: Of 1,326 papers identified from the initial search, 31 met the inclusion criteria and were analyzed. The studies reported various AEs with the most predominant being sedation, nausea/vomiting, dizziness, and euphoria. Acute and chronic pain was the most prevalent disorder under review. Conclusions: Adverse events associated with the use of medicinal cannabis could increase workplace risks, including decreased alertness and reaction times, increased absenteeism, reduced ability to safely drive or operate machinery and an increased probability of falling. Focused research into the risk to workers and workplaces from the use of medical cannabis and related human performance impairment is urgently warranted.

Background Immense volumes of personal health information (PHI) are required to realize the anticipated benefits of artificial intelligence in clinical medicine. To maintain public trust in medical research, consent policies must evolve to reflect contemporary patient preferences. Methods Patients were invited to complete a 27-item survey focusing on: (a) broad versus specific consent; (b) opt-in versus opt-out approaches; (c) comfort level sharing with different recipients; (d) attitudes towards commercialization; and (e) options to track PHI use and study results. Results 222 participants were included in the analysis; 83% were comfortable sharing PHI with researchers at their own hospital, although younger patients (≤ 49 years) were more uncomfortable than older patients (50 + years; 13% versus 2% uncomfortable, p Conclusions While most patients were willing to share their PHI with researchers within their own institution, many preferred a transparent and reciprocal consent process. These data also suggest a generational shift, wherein younger patients preferred more specific consent options. Modernizing consent policies to reflect increased autonomy is crucial in fostering sustained public engagement with medical research.

Higher Education Institutions (HEIs) have the potential to impact positively on the health and wellbeing of their staff and students. Using and expanding on the 'health promoting university' (HPU) platform within HEIs, this article provides a description of 'Healthy Trinity', which is an initiative underway in Trinity College Dublin, the University of Dublin. First, Healthy Trinity is contextualized in background literature including international and national policy and practice. Second, an overview of Healthy Trinity is provided including its vision and goals. Third, the article describes the steps taken relating to the identification of stakeholders and use of a network and a co-lead model. Within this approach, the article describes a partnership approach whereby responsibilities regarding health and wellbeing are shared by individuals and the institution. Fourth, the design and implementation of Healthy Trinity is discussed by taking a 'settings approach', in which the emphasis for change is placed on individual behaviours, environment, policy and organizational culture. Consideration is given to the interplay between intervention, implementation strategy and context for successful systemic implementation. The fifth element presented is the early-stage challenges encountered during implementation, such as the need to secure recurrent funding and the importance of having a direct input to the governance of the University to enable systemic change. The sixth and final component of the article is an outline of Healthy Trinity's intention to utilize a process evaluation of the early implementation phases of this complex intervention within a settings approach. Potential deliverables and impacts of this HPU initiative are presented and discussed.Universities, such as Trinity College Dublin, the University of Dublin, can be looked at as a community of staff and students. The university community has needs in terms of health and wellbeing. ‘Healthy Trinity’ attempted to build strategies and practices to meet these needs for its community. The approach taken was from multiple angles and involved students and staff, focusing on both individual and organizational responsibility to promote and encourage healthy behaviours. Healthy Trinity achieved some successes as well as encountering some challenges. This article explores how the university might build upon the successes of Healthy Trinity in order to embed a culture which prioritizes health and wellbeing for the entire university community. The article also looks at the broader impact of achieving this goal, namely the University’s contribution to a healthier community beyond the university setting.

Background While racial/ethnic survival disparities have been described in pediatric oncology, the impact of income has not been extensively explored. We analyzed how public insurance influences 5‐year overall survival (OS) in young patients with sarcomas. Methods The University of California San Francisco Cancer Registry was used to identify patients aged 0‐39 diagnosed with bone or soft tissue sarcomas between 2000 and 2015. Low‐income patients were defined as those with no insurance or Medicaid, a means‐tested form of public insurance. Survival curves were computed using the Kaplan‐Meier method and compared using log‐rank tests and Cox models. Causal mediation was used to assess whether the association between public insurance and mortality is mediated by metastatic disease. Results Of 1106 patients, 39% patients were classified as low‐income. Low‐income patients were more likely to be racial/ethnic minorities and to present with metastatic disease (OR 1.96, 95% CI 1.35‐2.86). Low‐income patients had significantly worse OS (61% vs 71%). Age at diagnosis and extent of disease at diagnosis were also independent predictors of OS. When stratified by extent of disease, low‐income patients consistently had significantly worse OS (localized: 78% vs 84%, regional: 64% vs 73%, metastatic: 23% vs 30%, respectively). Mediation analysis indicated that metastatic disease at diagnosis mediated 15% of the effect of public insurance on OS. Conclusions Low‐income patients with bone and soft tissue sarcomas had decreased OS regardless of disease stage at presentation. The mechanism by which insurance status impacts survival requires additional investigation, but may be through reduced access to care., Low‐income patients with bone and soft tissue sarcomas had decreased overall survival compared to patients with private insurance regardless of disease stage at presentation. This survival disparity is partially mediated by presentation with advanced disease.

Pain is a common symptom associated with advanced cancer. An estimated 66.4% of people with advanced cancer experience pain from their disease or treatment. Pain management is an essential component of palliative care. Opioids and adjuvant therapies are the mainstay of cancer pain management. Nevertheless, a proportion of patients may experience complex pain that is not responsive to conventional analgesia. Interventional analgesia procedures may be appropriate and necessary to manage complex, cancer-related pain. This narrative review uses a theoretical case to highlight core principles of palliative care and interventional anesthesia, and the importance of collaborative, interdisciplinary care. An overview and discussion of pragmatic considerations of peripheral nervous system interventional analgesic procedures and neuraxial analgesia infusions are provided.

Malignant wounds as a result of cancer are under-recognized for the physical and emotional distress they cause patients and their families. Unfortunately, there is a lack of valid and reliable screening and assessment tools to aid in the management of malignant wounds. This study aims to validate a patient-reported outcome measurement tool, Malignant Wound Assessment Tool - Research (MWAT-R). Eight patients were recruited and interviewed using the cognitive interviewing methodology to validate this tool. Patients’ understanding and overall impression of the MWAT-R were explored. Our findings showed that the wording and response options posed challenges for patients in completing the tool. Overall, participants felt that questions captured the key issues related to dealing with a malignant wound and accounted for the patients’ perspective. Establishing the content and face validity of the MWAT-R from the patients’ perspectives using cognitive interviews has provided further evidence to the validity of this tool.

Study Objectives To assess potential effects of lemborexant on next-morning driving performance in adult and elderly healthy volunteers. Methods Randomized, double-blind, double-dummy, placebo and active-controlled, four period incomplete crossover study in 48 healthy volunteers (22 females), 23–78 years old. Participants were treated at bedtime for eight consecutive nights with two of three dose levels of lemborexant (2.5, 5, or 10 mg), zopiclone 7.5 mg (on the first and last night with placebo on intervening nights), or placebo. Driving performance was assessed in the morning on days 2 and 9 using a standardized highway driving test in normal traffic, measuring standard deviation of lateral position (SDLP). Drug–placebo differences in SDLP >2.4 cm were considered to reflect clinically meaningful driving impairment. Results Mean drug–placebo differences in SDLP following lemborexant 2.5, 5, and 10 mg on days 2 and 9 were 0.74 cm or less. The upper bound of the 95% confidence intervals (CIs) for lemborexant treatment groups were all below 2.4 cm and the 95% CIs included zero, indicating that the effects were neither clinically meaningful nor statistically significant. Symmetry analysis further supported the lack of clinically meaningful impairment with lemborexant. Conclusions When assessed starting ~9 h after lemborexant administration at bedtime the previous night, there was no statistically significant or clinically meaningful effect on driving performance in healthy adults and elderly, as assessed by either mean differences in SDLP relative to placebo or symmetry analysis. In this study, lemborexant at doses up to 10 mg was well-tolerated. Clinical Trial Registration clinicaltrials.gov, NCT02583451. https://clinicaltrials.gov/ct2/show/NCT02583451.

STUDY OBJECTIVES: Our aim was to evaluate the effect of lemborexant versus zolpidem tartrate extended release 6.25 mg (ZOL) or placebo (PBO) on postural stability, auditory awakening threshold (AAT), and cognitive performance (cognitive performance assessment battery [CPAB]). METHODS: Healthy women (≥ 55 years) and men (≥ 65 years) were randomized, double-blind, to 1 of 4-period, single-dose crossover sequences, starting with lemborexant 5 mg (LEM5), 10 mg (LEM10), ZOL, or PBO. A ≥ 14-day washout followed all 4 treatments. Assessments were middle-of-the-night (MOTN) change from baseline in postural stability (primary prespecified comparison: LEM vs ZOL), AAT, absolute AAT, and CPAB for LEM5 and LEM10 versus ZOL and PBO; and morning change from baseline in postural stability and CPAB for LEM5 and LEM10 versus ZOL and PBO. Change from baseline measures were time-matched to a baseline night/morning when no study drug was administered. RESULTS: MOTN: Mean MOTN change from baseline in body sway was significantly higher for ZOL versus both lemborexant doses. There were no differences among the treatments regarding decibels required to awaken a participant. LEM5 was not statistically different from PBO on any CPAB domain; LEM10 and ZOL showed poorer performance on some tests of attention and/or memory. Morning: Body sway and cognitive performance following LEM5 or LEM10 did not differ from PBO; body sway was significantly higher for ZOL than PBO. Rates of treatment-emergent adverse events were low; there were no serious adverse events. CONCLUSIONS: Lemborexant causes less postural instability than a commonly used sedative-hypnotic and does not impair the ability to awaken to auditory signals. CLINICAL TRIALS REGISTRATION: Registry: ClinicalTrials.gov; Name: Crossover Study to Evaluate the Effect of Lemborexant Versus Placebo and Zolpidem on Postural Stability, Auditory Awakening Threshold, and Cognitive Performance in Healthy Subjects 55 Years and Older; URL: https://clinicaltrials.gov/ct2/show/NCT03008447; Identifier: NCT03008447. CITATION: Murphy P, Kumar D, Zammit G, Rosenberg R, Moline M. Safety of lemborexant versus placebo and zolpidem: effects on auditory awakening threshold, postural stability, and cognitive performance in healthy older participants in the middle of the night and upon morning awakening. J Clin Sleep Med. 2020;16(5):765–773.