Reporting ethics committee approval and patient consent by study design in five general medical journals.

BACKGROUND: Authors are required to describe in their manuscripts ethical approval from an appropriate committee and how consent was obtained from participants when research involves human participants. OBJECTIVE: To assess the reporting of these protections for several study designs in general medical journals. DESIGN: A consecutive series of research papers published in the Annals of Internal Medicine, BMJ, JAMA, Lancet and The New England Journal of Medicine between February and May 2003 were reviewed for the reporting of ethical approval and patient consent. Ethical approval, name of approving committee, type of consent, data source and whether the study used data collected as part of a study reported elsewhere were recorded. Differences in failure to report approval and consent by study design, journal and vulnerable study population were evaluated using multivariable logistic regression. RESULTS: Ethical approval and consent were not mentioned in 31% and 47% of manuscripts, respectively. 88 (27%) papers failed to report both approval and consent. Failure to mention ethical approval or consent was significantly more likely in all study designs (except case-control and qualitative studies) than in randomised controlled trials (RCTs). Failure to mention approval was most common in the BMJ and was significantly more likely than in The New England Journal of Medicine. Failure to mention consent was most common in the BMJ and was significantly more likely than in all other journals. No significant differences in approval or consent were found when comparing studies of vulnerable and non-vulnerable participants. CONCLUSION: The reporting of ethical approval and consent in RCTs has improved, but journals are less good at reporting this information for other study designs. Journals should publish this information for all research on human participants

Visualization Literacy and Decision-making in Healthcare

The ability of workers in the healthcare industry to analyze, interpret and communicate with health data is critical to decision-making and impacts both health and business outcomes. Optimal decision-making requires having real-time access to information that provides useful insights and that lends itself to collaborative decision-making. Data visualizations have the potential to facilitate decision-making in healthcare when presented as a dashboard. However, dashboards have shown varying results in both effectiveness and adoption. Data or graphical literacy challenges experienced by health team members could complicate strategic decision-making through an inability to correctly interpret or summarize the information presented in a dashboard. One assumption is that visualization literacy and its impact on how people process health data visualizations play a part in the effective interpretation of information to support decision-making. To determine the impact of visualization literacy on the process of decision-making in a healthcare setting, we first developed and deployed a dashboard designed to provide important information for decision-makers on a clinical trial management team. We engaged Project Managers and Medical Managers in the project as key decision-makers on the team. The dashboard was integrated into the normal workflow of a clinical trial management team and designated as the tool used in the workflow to report on the trial status within the organization. Next, we administered a series of assessments to the key decision-makers. The assessments were designed to evaluate numeracy, visualization literacy, and the impact of both on the decision-making ability of participants. Decision-making was assessed using a common workflow scenario supported by visualizations from the deployed dashboard. Additionally, we were interested in exploring indicators related to job satisfaction that was collected during the project period through a formal engagement survey. We performed a general linear model to assess the relationship between the assessments and decision-making. Results of our project show a significant and clear relationship between visualization literacy and decision-making ability and an insignificant relationship between numeracy and decision-making ability. Job satisfaction scores for the participant group obtained through the engagement survey suggest favorable results. However, areas of opportunity for improvement illuminated through the survey included better tools and additional resources to support the execution of tasks, a better workload balance, and improvements in collaboration across departments and functions. The results of this project contribute to the informatics discipline by demonstrating that information obtained from data visualizations produced through the aggregation of multiple sources of data can be effective decision-support tools if they are designed with user skills and abilities in mind. The results of the project suggest an opportunity to develop more useful and usable tools to improve job satisfaction as well as organizational business objectives related to workforce staffing, job competencies, and learning and development initiatives

Implementing clinical trial data sharing requires training a new generation of biomedical researchers

Data sharing enhances the value of medical research and builds trust in clinical trials, but more biomedical researchers need to be trained in these approaches, which include meta-research, data science and ethical, legal and social issues

Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs.

A number of important drugs used to treat cancer-many of which serve as the backbone of modern chemotherapy regimens-have outdated prescribing information in their drug labeling. The Food and Drug Administration is undertaking a pilot project to develop a process and criteria for updating prescribing information for longstanding oncology drugs, based on the breadth of knowledge the cancer community has accumulated with the use of these drugs over time. This article highlights a number of considerations for labeling updates, including selecting priorities for updating; data sources and evidentiary criteria; as well as the risks, challenges, and opportunities for iterative review to ensure prescribing information for oncology drugs remains relevant to current clinical practice

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