Decentralized Clinical Trials as a New Paradigm of Trial Delivery to Improve Equity of Access.

Importance: The need to maintain clinical trial recruitment during the COVID-19 pandemic has precipitated the rapid uptake of digital health for the conduct of clinical trials. Different terms are used in different jurisdictions and clinical contexts, including digital trials, networked trials, teletrials (TT), and decentralized clinical trials (DCT) with a need to agree to terms. Observations: This clinical care review summarized publications and gray literature, including government policies for the safe conduct of clinical trials using digital health. It compares 2 frequently used methodologies, DCT and TT, first developed before the COVID-19 pandemic by trialists and stakeholders in Australia to improve access to cancer clinical trials for geographically dispersed populations. TT uses a networked approach to implement clinical trials to share care between facilities and uses an agreement between sites or a supervision plan to improve governance and safety. Government regulators have adapted existing regulations and invested in the rollout of the TT model. The term DCT emerged in the northern hemisphere and has been the subject of guidance from regulatory agencies. DCT uses digital health to deliver care in nontraditional sites, such as participants' homes, but does not mandate a networked approach between health facilities or require a supervision plan to be in place. Conclusions and Relevance: TT can be considered as a specific type of DCT with several potential advantages, including upskilling across a network. DCT is a new paradigm for the use of digital health in the safe conduct of clinical trials and is a transformative issue in cancer care, addressing disparities in access to clinical trials and improving clinical outcomes.

Six months in: COVID-19 and its impact on oncology social work practice.

The extent to which oncology social workers (OSWs) are available and adapting to disruptions in service delivery throughout the COVID-19 pandemic is unknown.Objectives: The purpose of this report is to outline the initial impact of COVID-19 on oncology social work practice during the first six months of the pandemic.Methods: As part of a nationwide investigation of workforce conditions for OSWs, three professional organizations surveyed their members to assess the effects of COVID-19 on changes to work hours, employment status, work setting, pay, and mode for patient contact (e.g., telephone or videoconference).Findings: Among 939 OSWs, 20% reported a reduction in work hours, and two-thirds indicated a temporary shift in work to home, with most patient contact occurring primarily via telephone or videoconference.Implications: Results speak to the essential nature of oncology social work and the need for evidence to inform OSW training and advocacy efforts for however long the pandemic continues.

Surgical intensive care unit mobility is increased after institution of a computerized mobility order set and intensive care unit mobility protocol: a prospective cohort analysis.

In some populations, intensive care unit (ICU) mobility has been shown to be safe and beneficial. We gathered data on 50 nonintubated surgical patients in a 10-bed surgical ICU (SICU) who met physiologic inclusion criteria beginning in May 2008 (A group). In January 2009, we began mandatory entry of computerized mobility orders as part of a standardized ICU order set. We also created a mobility protocol for nurses in this ICU. We then collected data on 50 patients in this postintervention cohort (B group). Both groups had similar baseline characteristics. A group patients had some form of mobility orders entered in 29 patients (58%) versus 47 patients (82%) in the B group, P < 0.05. In the A group, 11 patients (22%) were mobilized; in the B group, 40 patients (80%) were mobilized, P < 0.05. In our SICU patient population, mandatory entry of computerized mobility orders as part of a standard SICU order set and establishment of an ICU mobility nursing protocol was associated with an increase in number of mobility orders entered as well as an increase in SICU patient activity. Further studies should focus on measurement of the effect of mobility interventions on patient outcomes.