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Brain metastasis as exclusion criteria in clinical trials involving extensive-stage small cell lung cancer.
No full textBACKGROUND: The American Society of Clinical Oncology and Friends of Cancer Research submitted recommendations to the FDA to reduce barriers in clinical trial participation. They proposed the removal of several specific exclusion criteria, including brain metastasis. Clinical trials involving small cell lung cancer (SCLC) have varying exclusion criteria regarding brain metastasis.
METHODS: We completed an online search of clinicaltrials.gov for the query SCLC, extensive stage. The trials were classified into a group of strict exclusion, allowed only if treated, allowed without treatment, or undefined. Relationships between status of brain metastasis in exclusion criteria and study characteristics (trial status, trial design, sponsor, location, and treatment groups) were investigated by Chi-squared test. The trends of exclusion status were investigated by a comparison against the variable time.
RESULTS: Of the 204 eligible trials, 32 strictly excluded any form or history of CNS metastases, 129 allowed patients that are undergoing or have undergone CNS-specific therapy, 9 allowed patients without any CNS-specific therapy, and 34 did not mention any criteria involving CNS metastases. Studies conducted outside the United States and with single systemic therapy were associated with strict exclusion of brain metastasis (p = 0.026 and 0.039, respectively). The proportion of clinical trials with strict exclusion has remained around 15% for the past few decades.
CONCLUSION: Non-US and single systemic therapy studies are more commonly associated with strict exclusion of brain metastasis in ES-SCLC trials. The strict exclusion of brain metastases in clinical trials has remained relatively constant for the past few decades
Data Integration and Interoperability for Patient-Centered Remote Monitoring of Cardiovascular Implantable Electronic Devices
Get PDFAbstract: The prevalence of cardiovascular implantable electronic devices with remote monitoring capabilities continues to grow, resulting in increased volume and complexity of biomedical data. These data can provide diagnostic information for timely intervention and maintenance of implanted devices, improving quality of care. Current remote monitoring procedures do not utilize device diagnostics to their potential, due to the lack of interoperability and data integration among proprietary systems and electronic medical record platforms. However, the development of a technical framework that standardizes the data and improves interoperability shows promise for improving remote monitoring. Along with encouraging the implementation of this framework, we challenge the current paradigm and propose leveraging the framework to provide patients with their remote monitoring data. Patient-centered remote monitoring may empower patients and improve collaboration and care with health care providers. In this paper, we describe the implementation of technology to deliver remote monitoring data to patients in two recent studies. Our body of work explains the potential for developing a patent-facing information display that affords the meaningful use of implantable device data and enhances interactions with providers. This paradigm shift in remote monitoring—empowering the patient with data—is critical to using the vast amount of complex and clinically relevant biomedical data captured and transmitted by implantable devices to full potential
Effects of body mass index on the safety and effectiveness of direct oral anticoagulants: a retrospective review.
No full textBACKGROUND: The International Society on Thrombosis and Haemostasis recommends avoiding the use of direct oral anticoagulants (DOACs) in patients with a body mass index (BMI) greater than 40 kg/m
HYPOTHESIS: Higher BMI is associated with altered pharmacokinetics which may affect the safety and effectiveness for DOACs.
METHODS: Data were collected on 3458 patients taking a DOAC prior to admission to a Midwestern health system between February 2013 and August 2016. Of these, 43 patients had a thrombotic event and 70 patients had an overt bleeding event. Patients were stratified among the following three BMI groups: BMI \u3c 30 kg/m
RESULTS: There was no statistically significant difference between BMI groups for thrombotic events (p = 0.598) or for overt bleeding events (p = 0.065). The BMI \u3c 30 kg/m
CONCLUSIONS: Among patients admitted to a single health system on DOAC therapy over a three-and-a-half-year period, obesity did not significantly correlate with thrombotic or overt bleeding complications. This study is limited as a single health system study with low overall event rates. A preliminary finding of this study showed a trend towards decreased bleeding frequency as BMI increased
In response to Hsia TC et al. Addition of chemotherapy improves overall survival in patients with T2N0M0 non-small cell lung cancer undergoing definitive radiation therapy: An analysis of the SEER database .
No full textNeuroticism and Facebook Addiction: How Social Media can Affect Mood?
No full textIndividuals high in neuroticism experience negative affect and social anxiety, therefore, they may prefer online communications where they are able to portray an idealized image of themselves to attract social support, seek validation, and enhance mood. These motivations may lead to greater social media use and addiction. In this study of Facebook users (N = 742; 474 females, 268 males) who mostly resided in the United States, we explored the association between neuroticism, Facebook addiction, and negative affect. Our mediation model showed a partial mediating effect of Facebook addiction in predicting negative affect in individuals who were high in neuroticism. In theory, individuals who use Facebook as a tool to improve their mood may actually experience more negative affect due to social overload, jealousy, and envy. Individuals high in neuroticism, who already maintain a higher negative affect than those low in neuroticism, might be particularly inclined towards increased Facebook use, which could deteriorate their mood further. Consequently, individuals and therapists should be aware of the personality traits that could lead to greater Facebook addiction and a higher negative mood. Therapists could encourage users to engage in activities, other than social media use, that can improve mood without leading to addiction
Exploring Indicators of Digital Self-Harm with Eating Disorder Patients: A Case Study
No full textProceedings of the ACM on Human-Computer Interaction
Digital self-harm encompasses a variety of activities, including the use of social media to facilitate or amplify mental illness-related behaviors. To understand the extent of these behaviors and their impacts, we conducted an in-depth case study with three patients who are in recovery from an eating disorder. We collected survey data, conducted interviews reflecting back to their technology use during their active disease state, and reviewed up to 18 months of their social media data leading up to the start of their initial point of recovery. Through the triangulation of this data, we explore the role of social media and social technologies in relation to their eating disorder. By utilizing this methodology, we were able to provide a contextually rich and nuanced lens for exploring the impacts of digital self-harm on this group of patients. We found that patients acknowledged that the eating disordered content on social media had a negative impact on their health, often contributing to a worsening of the physical manifestations of their disorder. Conversely, while they actively consumed this content, our participants did not produce online content related to eating disordered activities or behaviors. Finally, we discuss the patterns within their social media data and how platform designers and operators could use these findings in the future through design considerations for future platform-based interventions.
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Audience Response Systems and Missingness Trends: Using Interactive Polling Systems to Gather Sensitive Health Information From Youth.
Get PDFBACKGROUND: The widespread availability and cost-effectiveness of new-wave software-based audience response systems (ARSs) have expanded the possibilities of collecting health data from hard-to-reach populations, including youth. However, with all survey methods, biases in the data may exist because of participant nonresponse.
OBJECTIVE: The aims of this study were to (1) examine the extent to which an ARS could be used to gather health information from youths within a large-group school setting and (2) examine individual- and survey-level response biases stemming from this Web-based data collection method.
METHODS: We used an ARS to deliver a mental health survey to 3418 youths in 4 high schools in the Midwestern United States. The survey contained demographic questions, depression, anxiety, and suicidality screeners, and questions about their use of offline resources (eg, parents, peers, and counselors) and Web-based resources (ie, telemental health technologies) when they faced stressful life situations. We then examined the response rates for each survey item, focusing on the individual- and survey-level characteristics that related to nonresponse.
RESULTS: Overall, 25.39% (868/3418) of youths answered all 38 survey questions; however, missingness analyses showed that there were some survey structure factors that led to higher rates of nonresponse (eg, questions at the end of survey, sensitive questions, and questions for which precise answers were difficult to provide). There were also some personal characteristics that were associated with nonresponse (eg, not identifying as either male or female, nonwhite ethnicity, and higher levels of depression). Specifically, a multivariate model showed that male students and students who reported their gender as other had significantly higher numbers of missed items compared with female students (B=.30 and B=.47, respectively, P
CONCLUSIONS: Although our methodology-focused study showed that it is possible to gather sensitive mental health data from youths in large groups using ARSs, we also suggest that these nonresponse patterns need to be considered and controlled for when using ARSs for gathering population health data
Impact of a Primary Care Pharmacist Utilizing a Team-Based Model of Care
No full text2019 ASHP Midyear Clinical Meeting / Las Vegas, Nevada / Poster 11-134
Objective: To characterize the impact of a primary care pharmacist working in a team-based care model, by determining: • The acceptance rate for all recommendations • The total number of each recommendation type • The number of referrals to the primary care pharmacist, if the patient was an appropriate candidate for comprehensive medication managemen