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Dr. Sarah Chen
Stanford · NLP & interpretability
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Randee Lawrence is an Adjunct Associate Professor at Teachers College, Columbia University. She is affiliated with the Organization & Leadership and Adult Learning and Leadership departments. Her office is located at 201 Zankel on the Teachers College campus in New York City. Contact information includes a phone number at 212-678-3760. The biography does not provide additional details about her research focus, background, or key contributions.
Background Clinical trials are criticized for excluding important clinical populations. Effectiveness trials propose to mitigate this, but whether they succeed has not been studied. We compared exclusion criteria in efficacy and effectiveness clinical trials and assessed their impact on eligibility in a clinical sample. Methods We used Qualitative Content Analysis to extract common exclusion criteria from recent trials, then assessed their frequencies among a one-month sample of adults in an emergency department with psychosis. Results Among 107 unique clinical trials, efficacy trials utilized 12.3 exclusion criteria categories on average, while effectiveness trials utilized 9.1. Efficacy trials were more likely to have exclusions for substance use, suicide risk, violence risk, and medical problems. In the clinical sample (N = 297), substance use, suicide risk, and violence risk had the greatest impact on eligibility, excluding 85.5% of patients. Other exclusion criteria also impact eligibility; trials that allow substance use, suicide risk, and violence risk would still likely exclude 81.8%. Conclusions Effectiveness trials do utilize fewer exclusion criteria than efficacy trials, but the difference is incremental and does not resolve generalizability problems. Even a few exclusion criteria can have a large impact on eligibility. Development of an evidence base for under-studied populations is needed.
Abstract In the course of its history, psychiatry has faced many challenges and controversies, including an ongoing search for biomarkers, a need for more effective treatments, difficulties in enabling access to care, questions surrounding the appropriateness of involuntary treatment, and ongoing stigma. These challenges are not unique to the present age. Each has historical precedent and exists in a historical context that has profoundly shaped how psychiatry has evolved over decades and sometimes over centuries. Understanding this historical context provides perspective on how these challenges developed into their current shape and offers hints of the future. This chapter provides a historical review of the field of psychiatry.
Archives of Suicide Research · 2024-02-28 · 6 citations
article1st authorCorresponding
OBJECTIVE: The use of exclusion criteria in clinical trials can cause research participants to differ markedly from clinical populations, which negatively impacts generalizability of results. This study identifies and quantifies common and recurring exclusion criteria in clinical trials studying suicide risk reduction, and estimates their impact on eligibility among a clinical sample of adults in an emergency department with high suicide risk. METHOD: Recent trials were identified by searching PubMed (terms suicide, efficacy, effectiveness, limited to clinical trials in prior 5 years). Common exclusion criteria were identified using Qualitative Content Analysis. A retrospective chart review examined a one-month sample of all adults receiving psychiatric evaluation in a large urban academic emergency department. RESULTS: = 232), psychosis exclusions would exclude 53.0% of patients and substance use exclusions would exclude 67.2% of patients. Overall, 5.6% of emergency psychiatry patients would be eligible for clinical trials that use common exclusion criteria. CONCLUSIONS: Recent clinical trials studying suicide risk reduction have low generalizability to emergency psychiatry patients with high suicide risk. Trials enrolling persons with psychosis and substance use in particular are needed to improve generalizability to this clinical population.
The American Journal of Bioethics · 2023-07-14 · 3 citations
letter1st authorCorresponding
Click to increase image sizeClick to decrease image sizeThis article refers to:Do Clinicians Have a Duty to Participate in Pragmatic Clinical Trials? Additional informationFundingThis work was funded by a gift from the Elizabeth Dollard Charitable Trust, to Columbia University.