Faculty Bibliography

There is a growing literature exploring the placebo response within specific mental disorders, but no overarching quantitative synthesis of this research has analyzed evidence across mental disorders. We carried out an umbrella review of meta-analyses of randomized controlled trials (RCTs) of biological treatments (pharmacotherapy or neurostimulation) for mental disorders. We explored whether placebo effect size differs across distinct disorders, and the correlates of increased placebo effects. Based on a pre-registered protocol, we searched Medline, PsycInfo, EMBASE, and Web of Knowledge up to 23.10.2022 for systematic reviews and/or meta-analyses reporting placebo effect sizes in psychopharmacological or neurostimulation RCTs. Twenty meta-analyses, summarising 1,691 RCTs involving 261,730 patients, were included. Placebo effect size varied, and was large in alcohol use disorder (g = 0.90, 95% CI [0.70, 1.09]), depression (g = 1.10, 95% CI [1.06, 1.15]), restless legs syndrome (g = 1.41, 95% CI [1.25, 1.56]), and generalized anxiety disorder (d = 1.85, 95% CI [1.61, 2.09]). Placebo effect size was small-to-medium in obsessive-compulsive disorder (d = 0.32, 95% CI [0.22, 0.41]), primary insomnia (g = 0.35, 95% CI [0.28, 0.42]), and schizophrenia spectrum disorders (standardized mean change = 0.33, 95% CI [0.22, 0.44]). Correlates of larger placebo response in multiple mental disorders included later publication year (opposite finding for ADHD), younger age, more trial sites, larger sample size, increased baseline severity, and larger active treatment effect size. Most (18 of 20) meta-analyses were judged 'low' quality as per AMSTAR-2. Placebo effect sizes varied substantially across mental disorders. Future research should explore the sources of this variation. We identified important gaps in the literature, with no eligible systematic reviews/meta-analyses of placebo response in stress-related disorders, eating disorders, behavioural addictions, or bipolar mania.

BACKGROUND:Lung cancer remains a critical public health issue, presenting multifaceted challenges in prevention, diagnosis, and treatment. This article aims to review the current landscape of lung cancer research and management, delineate the persistent challenges, and outline pragmatic solutions. MATERIALS AND METHODS/METHODS:Global experts from academia, regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the National Cancer Institute (NCI), professional societies, the pharmaceutical and biotech industries, and patient advocacy groups were gathered by the New York Lung Cancer Foundation to review the state of the art in lung cancer and to formulate calls to action. RESULTS:Improving lung cancer management and research involves promoting tobacco cessation, identifying individuals at risk who could benefit from early detection programs, and addressing treatment-related toxicities. Efforts should focus on conducting well-designed trials to determine the optimal treatment sequence. Research into innovative biomarkers and therapies is crucial for more personalized treatment. Ensuring access to appropriate care for all patients, whether enrolled in clinical trials or not, must remain a priority. CONCLUSIONS:Lung cancer is a major health burden worldwide, and its treatment has become increasingly complex over the past two decades. Improvement in lung cancer management and research requires unified messaging and global collaboration, expanded education, and greater access to screening, biomarker testing, treatment, as well as increased representativeness, participation, and diversity in clinical trials.

BACKGROUND:Opioid addiction is a worldwide public health crisis. In the United States, for example, opioids cause more drug overdose deaths than any other substance. However, opioid addiction treatments have limited efficacy, meaning that additional treatments are needed. METHODS:To help address this problem, we used network-based machine learning techniques to integrate results from genome-wide association studies of opioid use disorder and problematic prescription opioid misuse with transcriptomic, proteomic, and epigenetic data from the dorsolateral prefrontal cortex of people who died of opioid overdose and control individuals. RESULTS:We identified 211 highly interrelated genes identified by genome-wide association studies or dysregulation in the dorsolateral prefrontal cortex of people who died of opioid overdose that implicated the Akt, BDNF (brain-derived neurotrophic factor), and ERK (extracellular signal-regulated kinase) pathways, identifying 414 drugs targeting 48 of these opioid addiction-associated genes. Some of the identified drugs are approved to treat other substance use disorders or depression. CONCLUSIONS:Our synthesis of multiomics using a systems biology approach revealed key gene targets that could contribute to drug repurposing, genetics-informed addiction treatment, and future discovery.

Frailty is a syndrome that can inform clinical treatments and interventions for older adults. Although implementation of frailty across medical subspecialties has the potential to improve care for the aging population, its uptake has been heterogenous. While frailty assessment is highly integrated into certain medical subspecialties, other subspecialties have only recently begun to consider frailty in the context of patient care. In order to advance the field of frailty-informed care, we aim to detail what is known about frailty within the subspecialties of internal medicine. In doing so, we highlight cross-disciplinary approaches that can enhance our understanding of frailty, focusing on ways to improve the implementation of frailty measures, as well as develop potential interventional strategies to mitigate frailty within these subspecialties. This has important implications for the clinical care of the aging population and can help guide future research.

BACKGROUND:Placebo and nocebo effects are widely reported across psychiatric conditions, yet have seldom been examined in the context of gambling disorder. Through meta-analysis, we examined placebo effects, their moderating factors, and nocebo effects, from available randomised, controlled pharmacological clinical trials in gambling disorder. METHODS:We searched, up to 19 February 2024, a broad range of databases, for double-blind randomised controlled trials (RCTs) of medications for gambling disorder. Outcomes were gambling symptom severity and quality of life (for efficacy), and drop outs due to medication side effects in the placebo arms. RESULTS:= 833) in the meta-analysis. The overall effect size for gambling severity reduction in the placebo arms was 1.18 (95%CI 0.91-1.46) and for quality of life improvement was 0.63 (0.42-0.83). Medication class, study sponsorship, trial duration, baseline severity of gambling and publication year significantly moderated effect sizes for at least some of these outcome measures. Author conflict of interest, placebo run-in, gender split, severity scale choice, age of participants or unbalanced randomisation did not moderate effect sizes. Nocebo effects leading to drop out from the trial were observed in 6% of participants in trials involving antipsychotics, while this was less for other medication types. CONCLUSION/CONCLUSIONS:Placebo effects in trials of pharmacological treatment of gambling disorder are large, and there are several moderators of this effect. Nocebo effects were measureable and may be influenced by medication class being studied. Practical implications of these new findings for the field are discussed, along with recommendations for future clinical trials.

BACKGROUND:Adolescent voices are frequently excluded from sexual and reproductive health (SRH) research. Despite progressive policies and access to SRH care, adolescents in New York City who live in neighborhoods with high poverty and those who identify as Black or Hispanic experience poor SRH outcomes, including high rates of unplanned pregnancies and sexually transmitted infections. OBJECTIVE:This qualitative study aims to guide Black and Hispanic adolescent mothers in identifying problem areas in SRH care and cocreate health service recommendations with input from health care stakeholders to address those problems and improve SRH experiences. METHODS:Through ethnographic interview methods, adolescent mothers in New York City shared their experiences from before pregnancy through parenting and identified problem areas in adolescent SRH services and education. Data were analyzed inductively and using situational analysis. Adolescent participants attended 2 cocreation workshops. In the first workshop, they confirmed interview findings, set priorities, and created rough prototypes. Following the first workshop, health care providers were interviewed to inform refinement of the rough prototypes. Adolescents further developed prototypes in the second cocreation workshop and named the resulting toolkit. RESULTS:A total of 16 adolescent mothers participated in 47 interviews, and 10 (63%) participants attended at least 1 cocreation workshop. They highlighted deficiencies in sexual health education and emphasized the roles of health care providers and parents, rather than schools, in improving it. Adolescent participants designed recommendations for adolescents and health care providers to support quality conversations between adolescents, parents, and health care providers and created a preappointment checklist to help young patients initiate conversations with health care providers. Young participants stressed that sex education should address topics beyond sexually transmitted infections and pregnancy, such as emotional health and relationships. They created guidelines for health care providers outlining communication strategies to provide respectful, unbiased care and contraceptive counseling that encourages adolescent autonomy. Participants shared specific suggestions for how to support young parents respectfully. Health care stakeholders recommended adding information on confidential care; supporting lesbian, gay, bisexual, transgender, and queer youth; and focusing on improving communication between health care providers and patients rather than creating educational materials. In the second workshop, adolescent participants revised the prototypes based on feedback from health care stakeholders and named the toolkit of recommendations First Steps. CONCLUSIONS:This study highlighted the important roles that parents and health care workers play in adolescent sexual health education. Cocreated toolkits offer a practical approach for health care providers to engage adolescents and their parents in meaningful, adolescent-centered conversations that can promote health, safety, and well-being.

BACKGROUND:Type 2 diabetes (T2D) contributes to significant morbidity and mortality for Chinese immigrants in the United States, exacerbated by social determinants of health (SDOH) barriers such as language barriers, limited access to healthy foods, and low health literacy. OBJECTIVE:The goal of the Integrating Cultural Aspects into Diabetes Education (INCLUDE) study is to test a social media-based intervention adapting the Diabetes Prevention Program (DPP) for Chinese immigrants alongside a culturally adapted, community-supported agriculture program. Here, we report the protocol for the INCLUDE study. METHODS:INCLUDE is a 3-year randomized controlled trial (n=150). Participants with prediabetes or at risk for T2D are enrolled and randomized into either the control or intervention group (n=75 each). Participants from the intervention group receive 2-3 culturally tailored, in-language DPP videos weekly for 12 weeks, as well as biweekly phone calls from bilingual study staff to review video content, support goal setting, and assess and address SDOH-related barriers such as food insecurity. Intervention participants will also be given produce for 10 weeks as part of the community-supported agriculture program. Weight (primary outcome), self-efficacy, diet, physical activity, and food insecurity (secondary outcomes) are measured at baseline, 3-month, and 6-month intervals. Splined linear mixed models will be used to examine group differences in longitudinal weight and other secondary outcomes. The INCLUDE study was approved by the Institutional Review Board at the NYU Grossman School of Medicine. RESULTS:Recruitment started in May 2023, with the first cohort of 75 participants enrolled and randomized into 2 groups in July 2023. The 3-month and 6-month assessment of the first-year cohort has been completed. We have recruited 75 participants for the second cohort as of July 2024. CONCLUSIONS:The INCLUDE study will serve as an innovative model for culturally adapted, multilevel interventions for underserved communities previously unable to access evidence-based diabetes prevention initiatives. Aligning with several national calls for multilevel interventions, the INCLUDE intervention will provide critical data that will inform how researchers and public health professionals address SDOH barriers faced by underserved populations and prevent diabetes. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT05492916; https://clinicaltrials.gov/study/NCT05492916. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:DERR1-10.2196/65455.

OBJECTIVES/OBJECTIVE:This study aims to explore the impact of telehealth on buprenorphine prescribing and retention in care for patients with opioid use disorder (OUD) seen at a large federally qualified health center (FQHC) the year prior to and following the start of the COVID-19 pandemic. METHODS:We conducted a retrospective study of patients with OUD and at least one medical visit to the FQHC between March 1, 2019, and February 28, 2021. This study utilized March 1, 2020, to delineate the beginning of COVID as the FQHC widely instituted telehealth during the month in response to the pandemic. We examined buprenorphine prescribing before and during year 1 of the pandemic; we applied logistic regression to estimate the association between telehealth and buprenorphine prescribing and we assessed buprenorphine retention through survival analysis. RESULTS:In the year before COVID, 24% of patients (502/2090) received buprenorphine compared with 31% (656/2110) during the first year of COVID ( P < 0.01). Patients with at least one telehealth visit were three times more likely to receive buprenorphine compared to those without telehealth (odds ratio: 3.2, confidence interval: 2.1-5.0). Among those who received buprenorphine, those with at least one telehealth visit were retained in buprenorphine care longer (hazard ratio: 2.7, confidence interval: 1.8-3.9). CONCLUSIONS:During the first year of COVID, telehealth was associated with increased likelihood that patients received buprenorphine; those who had telehealth remained in buprenorphine care longer compared to those who only had office-based visits. Increasing buprenorphine access through telehealth can play a significant role in retention in care for OUD.