The ethical case for placebo control in HIV-cure-related studies with ART interruption
Abstract: Many studies that seek to cure HIV must ask participants to interrupt their antiretroviral treatment. In such circumstances, is it permissible to include a placebo group in the study? We explain why doing so is a scientific and an ethical necessity, and more benign than imagined…
Trends in Prescribing Preferences for Antidiabetic Medications Among Patients With Type 2 Diabetes in the U.K. With and Without Chronic Kidney Disease, 2006–2020
OBJECTIVE: To evaluate trends in antidiabetic medication initiation patterns among patients with type 2 diabetes mellitus (T2DM) with and without chronic kidney disease (CKD)…
Improving the prospective prediction of a near-term suicide attempt in veterans at risk for suicide, using a go/no-go task
Background: Neurocognitive testing may advance the goal of predicting near-term suicide risk. The current study examined whether performance on a Go/No-go (GNG) task, and computational modeling to extract latent cognitive variables, could enhance prediction of suicide attempts within next 90 days, among individuals at high-risk for suicide…
A modified Delphi process to identify experts’ perceptions of the most beneficial and harmful laws to reduce opioid-related harm
Background: States have enacted multiple types of laws, with a variety of constituent provisions, in response to the opioid epidemic, often simultaneously. This temporal proximity and variation in state-to-state operationalization has resulted in significant challenges for empirical research on their effects. Thus, expert consensus can be helpful to classify laws and their provisions by their degree of helpfulness and impact…
Artificial Intelligence, Healthcare, Clinical Genomics, and Pharmacogenomics Approaches in Precision Medicine
Precision medicine has greatly aided in improving health outcomes using earlier diagnosis and better prognosis for chronic diseases. It makes use of clinical data associated with the patient as well as their multi-omics/genomic data to reach a conclusion regarding how a physician should proceed with a specific treatment. Compared to the symptom-driven approach in medicine, precision medicine considers the critical fact that all patients do not react to the same treatment or medication in the same way. When considering the intersection of traditionally distinct arenas of medicine, that is, artificial intelligence, healthcare, clinical genomics, and pharmacogenomics—what ties them together is their impact on the development of precision medicine as a field and how they each contribute to patient-specific, rather than symptom-specific patient outcomes. This study discusses the impact and integration of these different fields in the scope of precision medicine and how they can be used in preventing and predicting acute or chronic diseases. Additionally, this study also discusses the advantages as well as the current challenges associated with artificial intelligence, healthcare, clinical genomics, and pharmacogenomics…
Benzodiazepine and Stimulant Prescriptions Before Overdose in Youth
In 2019, 4777 youth died of a drug overdose in the United States. Seven-hundred and twenty-seven youth died of overdoses involving benzodiazepines (BZDs) and 902 from overdoses involving psychostimulants. Opioid-related overdose deaths frequently involve other substances, and in youth, stimulants and BZDs are the most commonly involved substances. Overdoses can involve prescription drugs accessed through medical prescriptions or through illicit means. Among persons aged 18 to 25 years, 5.8% report past-year prescription stimulant misuse and 3.8% prescription BZD misuse…
Culture: The missing link in health research
Abstract: Culture is essential for humans to exist. Yet surprisingly little attention has been paid to identifying how culture works or developing standards to guide the application of this concept in health research. This paper describes a multidisciplinary effort to find consensus on essential elements of a definition of culture to guide researchers in studying how cultural processes influence health and health behaviors…
One lesson of COVID-19: Conduct more health policy trials
The Global Health Security Index, published in October 2019 by public health experts (1), rated nations by their readiness to respond to infectious disease outbreaks. The United States ranked first, whereas New Zealand trailed in 35th place. Yet when the coronavirus disease 2019 (COVID-19) pandemic struck months later, these rankings turned out to be unreliable (2): The United States has to date reported the most deaths, whereas New Zealand fares considerably better. These results point to a fundamental challenge more than to the failings of a particular assessment approach. They may demonstrate that, for all our careful testing of pharmaceuticals, researchers lack a solid evidence base regarding the effectiveness of health policies—against pandemics, and more widely…
Racial and Ethnic Disparities in Buprenorphine and Extended-Release Naltrexone Filled Prescriptions During the COVID-19 Pandemic
Abstract: Importance COVID-19 disrupted delivery of buprenorphine and naltrexone treatment for opioid use disorder (OUD), and during the pandemic, members of racial and ethnic minority groups experienced increased COVID-19 and opioid overdose risks compared with White individuals. However, whether filled buprenorphine and naltrexone prescriptions varied across racial and ethnic groups during the COVID-19 pandemic remains unknown…
Coronavirus Disease 2019 (COVID-19) Vaccine Prioritization in Low- and Middle-Income Countries May Justifiably Depart From High-Income Countries’ Age Priorities
Abstract: In high-income countries that were first to roll out coronavirus disease 2019 (COVID-19) vaccines, older adults have thus far usually been prioritized for these vaccines over younger adults. Age-based priority primarily resulted from interpreting evidence available at the time, which indicated that vaccinating the elderly first would minimize COVID-19 deaths and hospitalizations…
Research ethics and public trust in vaccines: the case of COVID-19 challenge trials
Abstract: Despite their clearly demonstrated safety and effectiveness, approved vaccines against COVID-19 are commonly mistrusted. Nations should find and implement effective ways to boost vaccine confidence. But the implications for ethical vaccine development are less straightforward than some have assumed. Opponents of COVID-19 vaccine challenge trials, in particular, made speculative or empirically implausible warnings on this matter, some of which, if applied consistently, would have ruled out most COVID-19 vaccine trials and many non-pharmaceutical responses…
A new day for human challenge trials?
On 31 March 2022, Killingley et al. published the results from the world’s first COVID-19 human challenge trial, in which 36 healthy volunteers between the ages of 18 and 30 years were intranasally exposed to a low dose of wild type severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [1.]. Around half (53%) of the volunteers became infected with COVID-19, with researchers finding that the viral load peaked 5 days after inoculation. SARS-CoV-2 was first detectable in the throat, before rising higher in the respiratory tract, where its presence in the nose continued for 10 days. The team found that symptoms develop rapidly, starting on average just 2 days after infection. They also found that lateral flow tests were a reliable indicator of whether or not volunteers were infectious. Six volunteers were given remdesivir after testing positive. No volunteers reported any major negative health outcomes after 180 days, though some reported partial smell disturbance…
Frailty Risks of Prescription Analgesics and Sedatives across Frailty Models: the Health and Retirement Study
Introduction: Limited evidence for incident frailty risks associated with prescription analgesics and sedatives in older (≥ 65 years) community-living adults prompted a more comprehensive investigation…
Feeling anxious yet? Interpreting findings on drug safety from large healthcare databases
In this issue of Clinical and Translational Science, Yun-Han Wang and colleagues report on a potential link between treatment with proton pump inhibitors (PPIs) and incident depression and anxiety disorders in children. The proposed mechanism between PPI use and anxiety and depression is related to the “microbiota-gut-brain axis.”…
Potential sources of moral distress during COVID-19: Perspectives of hospice interdisciplinary teams
Objective: This study aimed to examine the impact of COVID-19 on hospice Interdisciplinary team (IDT) members’ self-reported stress and identify possible sources of moral distress…
Risks for Anaphylaxis With Intravenous Iron Formulations: A Retrospective Cohort Study
BACKGROUND: The risks for anaphylaxis among intravenous (IV) iron products currently in use have not been assessed. OBJECTIVE: To compare risks for anaphylaxis among 5 IV iron products that are used frequently. DESIGN: Retrospective cohort study using a target trial emulation framework. SETTING: Medicare fee-for-service data with Part D coverage between July 2013 and December 2018…
Commentary on Lo-Ciganic et al. The importance of evidence-based clinical and policy approaches to reduce opioid harms
The overdose epidemic remains an urgent public health concern, with recent estimates indicating that deaths in the United States have surged to over 100 000 per year, predominantly attributed to opioids. Responses to growth in opioid-involved mortality over time have emphasized opioid prescribing regulations or restrictions, including a proliferation of state laws aimed at reducing harm by limiting exposure to opioids…
Using Mindfulness-Based Cognitive Therapy to Prevent Suicide Among High Suicide–Risk Patients Who Also Misuse Opioids: a Preliminary Probe of Feasibility and Effectiveness
Abstract: Knowledge of how to effectively prevent suicide attempt (SA) in high suicide–risk patients who also misuse opioids is limited. In a subset of data from 36 participants with baseline opioid misuse in a randomized clinical trial testing adjunctive mindfulness-based cognitive therapy to prevent suicide among high suicide–risk veterans (n = 18 per treatment condition), MBCT-S reduced the likelihood of SA and acute psychiatric hospitalization over 12-month follow-up…
Comparative Risk of Alzheimer Disease and Related Dementia among Medicare Beneficiaries with Rheumatoid Arthritis Treated with Targeted Disease-Modifying Antirheumatic Agents
Importance: Cytokine signaling, including tumor necrosis factor (TNF) and interleukin (IL)-6, through the Janus-kinase (JAK)-signal transducer and activator of transcription pathway, was hypothesized to attenuate the risk of Alzheimer disease and related dementia (ADRD) in the Drug Repurposing for Effective Alzheimer Medicines (DREAM) initiative based on multiomics phenotyping. Objective: To evaluate the association between treatment with tofacitinib, tocilizumab, or TNF inhibitors compared with abatacept and risk of incident ADRD…
2021 American College of Rheumatology Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Oligoarthritis, Temporomandibular Joint Arthritis, and Systemic Juvenile Idiopathic Arthritis
Objective: To provide updated guidelines for pharmacologic management of juvenile idiopathic arthritis (JIA), focusing on treatment of oligoarthritis, temporomandibular joint (TMJ) arthritis, and systemic JIA with and without macrophage activation syndrome. Recommendations regarding tapering and discontinuing treatment in inactive systemic JIA are also provided…