Jane P. Kim

All Publications

• Robust Tests in Online Decision-Making Kim, G., Kim, J. P., Yang, H., Assoc Advancement Artificial Intelligence ASSOC ADVANCEMENT ARTIFICIAL INTELLIGENCE. 2022: 10016-10024

  View details for Web of Science ID 000893639103004

• Engagement Patterns of Users and Providers: a Study of Messaging on App Usage in a Smartphone App for the Treatment of Eating Disorders J. technol. behav. sci. Kim, J. P., Hwang, J., Tregarthen, J. 2021; 6: 572–577

  View details for DOI 10.1007/s41347-021-00220-8

• Accelerated failure time model under general biased sampling scheme BIOSTATISTICS Kim, J. P., Sit, T., Ying, Z. 2016; 17 (3): 576-588

  Abstract

  Right-censored time-to-event data are sometimes observed from a (sub)cohort of patients whose survival times can be subject to outcome-dependent sampling schemes. In this paper, we propose a unified estimation method for semiparametric accelerated failure time models under general biased estimating schemes. The proposed estimator of the regression covariates is developed upon a bias-offsetting weighting scheme and is proved to be consistent and asymptotically normally distributed. Large sample properties for the estimator are also derived. Using rank-based monotone estimating functions for the regression parameters, we find that the estimating equations can be easily solved via convex optimization. The methods are confirmed through simulations and illustrated by application to real datasets on various sampling schemes including length-bias sampling, the case-cohort design and its variants.

  View details for DOI 10.1093/biostatistics/kxw008

  View details for Web of Science ID 000379762000012

  View details for PubMedID 26941240

  View details for PubMedCentralID PMC5006413

• A Unified Approach to Semiparametric Transformation Models Under General Biased Sampling Schemes JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION Kim, J. P., Lu, W., Sit, T., Ying, Z. 2013; 108 (501): 217-227

  Abstract

  We propose a unified estimation method for semiparametric linear transformation models under general biased sampling schemes. The new estimator is obtained from a set of counting process-based unbiased estimating equations, developed through introducing a general weighting scheme that offsets the sampling bias. The usual asymptotic properties, including consistency and asymptotic normality, are established under suitable regularity conditions. A closed-form formula is derived for the limiting variance and the plug-in estimator is shown to be consistent. We demonstrate the unified approach through the special cases of left truncation, length-bias, the case-cohort design and variants thereof. Simulation studies and applications to real data sets are presented.

  View details for DOI 10.1080/01621459.2012.746073

  View details for Web of Science ID 000316648200017

  View details for PubMedCentralID PMC3649773

• Rejoinder to "A Note on Using Regression Models to Analyze Randomized Trials: Asymptotically Valid Hypothesis Tests Despite Incorrectly Specified Models" BIOMETRICS Kim, J. P. 2013; 69 (1)

  View details for DOI 10.1111/j.1541-0420.2012.01799.x

  View details for Web of Science ID 000317303500031

• A composite likelihood approach for spatially correlated survival data Computational Statistics and Data Analysis Paik J, Ying Z 2012; 56 (1): 209-216
• Demonstrating Patterns in the Views Of Stakeholders Regarding Ethically-Salient Issues in Clinical Research: A Novel Use of Graphical Models in Empirical Ethics Inquiry. AJOB empirical bioethics Kim, J. P., Roberts, L. W. ; 6 (2): 33–42

  Abstract

  Empirical ethics inquiry works from the notion that stakeholder perspectives are necessary for gauging the ethical acceptability of human studies and assuring that research aligns with societal expectations. Although common, studies involving different populations often entail comparisons of trends that problematize the interpretation of results. Using graphical model selection - a technique aimed at transcending limitations of conventional methods - this report presents data on the ethics of clinical research with two objectives: (1) to display the patterns of views held by ill and healthy individuals in clinical research as a test of the study's original hypothesis and (2) to introduce graphical model selection as a key analytic tool for ethics research.In this IRB-approved, NIH-funded project, data were collected from 60 mentally ill and 43 physically ill clinical research protocol volunteers, 47 healthy protocol-consented participants, and 29 healthy individuals without research protocol experience. Respondents were queried on the ethical acceptability of research involving people with mental and physical illness (i.e., cancer, HIV, depression, schizophrenia, and post-traumatic stress disorder) and non-illness related sources of vulnerability (e.g., age, class, gender, ethnicity). Using a statistical algorithm, we selected graphical models to display interrelationships among responses to questions.Both mentally and physically ill protocol volunteers revealed a high degree of connectivity among ethically-salient perspectives. Healthy participants, irrespective of research protocol experience, revealed patterns of views that were not highly connected.Between ill and healthy protocol participants, the pattern of views is vastly different. Experience with illness was tied to dense connectivity, whereas healthy individuals expressed views with sparse connections. In offering a nuanced perspective on the interrelation of ethically relevant responses, graphical model selection has the potential to bring new insights to the field of ethics.

  View details for PubMedID 25961066

  View details for PubMedCentralID PMC4423405

• Understanding Physician's Perspectives on AI in Health Care: Protocol for a Sequential Multiple Assignment Randomized Vignette Study. JMIR research protocols Kim, J. P., Yang, H. J., Kim, B., Ryan, K., Roberts, L. W. 2024; 13: e54787

  Abstract

  As the availability and performance of artificial intelligence (AI)-based clinical decision support (CDS) systems improve, physicians and other care providers poised to be on the front lines will be increasingly tasked with using these tools in patient care and incorporating their outputs into clinical decision-making processes. Vignette studies provide a means to explore emerging hypotheses regarding how context-specific factors, such as clinical risk, the amount of information provided about the AI, and the AI result, may impact physician acceptance and use of AI-based CDS tools. To best anticipate how such factors influence the decision-making of frontline physicians in clinical scenarios involving AI decision-support tools, hypothesis-driven research is needed that enables scenario testing before the implementation and deployment of these tools.This study's objectives are to (1) design an original, web-based vignette-based survey that features hypothetical scenarios based on emerging or real-world applications of AI-based CDS systems that will vary systematically by features related to clinical risk, the amount of information provided about the AI, and the AI result; and (2) test and determine causal effects of specific factors on the judgments and perceptions salient to physicians' clinical decision-making.US-based physicians with specialties in family or internal medicine will be recruited through email and mail (target n=420). Through a web-based survey, participants will be randomized to a 3-part "sequential multiple assignment randomization trial (SMART) vignette" detailing a hypothetical clinical scenario involving an AI decision support tool. The SMART vignette design is similar to the SMART design but adapted to a survey design. Each respondent will be randomly assigned to 1 of the possible vignette variations of the factors we are testing at each stage, which include the level of clinical risk, the amount of information provided about the AI, and the certainty of the AI output. Respondents will be given questions regarding their hypothetical decision-making in response to the hypothetical scenarios.The study is currently in progress and data collection is anticipated to be completed in 2024.The web-based vignette study will provide information on how contextual factors such as clinical risk, the amount of information provided about an AI tool, and the AI result influence physicians' reactions to hypothetical scenarios that are based on emerging applications of AI in frontline health care settings. Our newly proposed "SMART vignette" design offers several benefits not afforded by the extensively used traditional vignette design, due to the 2 aforementioned features. These advantages are (1) increased validity of analyses targeted at understanding the impact of a factor on the decision outcome, given previous outcomes and other contextual factors; and (2) balanced sample sizes across groups. This study will generate a better understanding of physician decision-making within this context.DERR1-10.2196/54787.

  View details for DOI 10.2196/54787

  View details for PubMedID 38573756

• A novel experimental vignette methodology: SMART vignettes Methodological Innovations Kim, J. P., Yang, H. 2024

  View details for DOI 10.1177/20597991241240081

• Academic machine learning researchers' ethical perspectives on algorithm development for health care: a qualitative study. Journal of the American Medical Informatics Association : JAMIA Kasun, M., Ryan, K., Paik, J., Lane-McKinley, K., Dunn, L. B., Roberts, L. W., Kim, J. P. 2023

  Abstract

  We set out to describe academic machine learning (ML) researchers' ethical considerations regarding the development of ML tools intended for use in clinical care.We conducted in-depth, semistructured interviews with a sample of ML researchers in medicine (N = 10) as part of a larger study investigating stakeholders' ethical considerations in the translation of ML tools in medicine. We used a qualitative descriptive design, applying conventional qualitative content analysis in order to allow participant perspectives to emerge directly from the data.Every participant viewed their algorithm development work as holding ethical significance. While participants shared positive attitudes toward continued ML innovation, they described concerns related to data sampling and labeling (eg, limitations to mitigating bias; ensuring the validity and integrity of data), and algorithm training and testing (eg, selecting quantitative targets; assessing reproducibility). Participants perceived a need to increase interdisciplinary training across stakeholders and to envision more coordinated and embedded approaches to addressing ethics issues.Participants described key areas where increased support for ethics may be needed; technical challenges affecting clinical acceptability; and standards related to scientific integrity, beneficence, and justice that may be higher in medicine compared to other industries engaged in ML innovation. Our results help shed light on the perspectives of ML researchers in medicine regarding the range of ethical issues they encounter or anticipate in their work, including areas where more attention may be needed to support the successful development and integration of medical ML tools.

  View details for DOI 10.1093/jamia/ocad238

  View details for PubMedID 38069455

• A preliminary randomized controlled trial of repetitive transcranial magnetic stimulation applied to the left dorsolateral prefrontal cortex in treatment seeking participants with cannabis use disorder. Drug and alcohol dependence Sahlem, G. L., Kim, B., Baker, N. L., Wong, B. L., Caruso, M. A., Campbell, L. A., Kaloani, I., Sherman, B. J., Ford, T. J., Musleh, A. H., Kim, J. P., Williams, N. R., Manett, A. J., Kratter, I. H., Short, E. B., Killeen, T. K., George, M. S., McRae-Clark, A. L. 2023; 254: 111035

  Abstract

  Cannabis use disorder (CUD) is a common and consequential disorder. When applied to the dorsolateral prefrontal cortex (DLPFC), repetitive transcranial magnetic stimulation (rTMS) reduces craving across substance use disorders and may have therapeutic clinical effects when applied in serial-sessions. The present study sought to preliminarily determine whether serial-sessions of rTMS applied to the DLPFC had a therapeutic effect in CUD.This study was a two-site, phase-2, double-blind, randomized-controlled-trial. Seventy-two treatment-seeking participants (37.5% Women, mean age 30.2±9.9SD) with ≥moderate-CUD were randomized to active or sham rTMS (Beam-F3, 10Hz, 20-total-sessions, two-sessions-per-visit, two-visits-per-week, with cannabis cues) while undergoing a three-session motivational enhancement therapy intervention. The primary outcome was the change in craving between pre- and post- treatment (Marijuana Craving Questionnaire Short-Form-MCQ-SF). Secondary outcomes included the number of weeks of abstinence and the number of days-per-week of cannabis use during 4-weeks of follow-up.There were no significant differences in craving between conditions. Participants who received active-rTMS reported numerically, but not significantly, more weeks of abstinence in the follow-up period than those who received sham-rTMS (15.5%-Active; 9.3%-Sham; rate ratio = 1.66 [95% CI: 0.84, 3.28]; p=0.14). Participants who received active-rTMS reported fewer days-per-week of cannabis use over the final two-weeks of the follow-up period than those receiving sham-rTMS (Active vs. Sham: -0.72; Z=-2.33, p=0.02).This trial suggests rTMS is safe and feasible in individuals with CUD and may have a therapeutic effect on frequency of cannabis use, though further study is needed with additional rTMS-sessions and a longer follow-up period.

  View details for DOI 10.1016/j.drugalcdep.2023.111035

  View details for PubMedID 38043228

• Physicians' and Machine Learning Researchers' Perspectives on Ethical Issues in the Early Development of Clinical Machine Learning Tools: Qualitative Interview Study. JMIR AI Kim, J. P., Ryan, K., Kasun, M., Hogg, J., Dunn, L. B., Roberts, L. W. 2023; 2: e47449

  Abstract

  Innovative tools leveraging artificial intelligence (AI) and machine learning (ML) are rapidly being developed for medicine, with new applications emerging in prediction, diagnosis, and treatment across a range of illnesses, patient populations, and clinical procedures. One barrier for successful innovation is the scarcity of research in the current literature seeking and analyzing the views of AI or ML researchers and physicians to support ethical guidance.This study aims to describe, using a qualitative approach, the landscape of ethical issues that AI or ML researchers and physicians with professional exposure to AI or ML tools observe or anticipate in the development and use of AI and ML in medicine.Semistructured interviews were used to facilitate in-depth, open-ended discussion, and a purposeful sampling technique was used to identify and recruit participants. We conducted 21 semistructured interviews with a purposeful sample of AI and ML researchers (n=10) and physicians (n=11). We asked interviewees about their views regarding ethical considerations related to the adoption of AI and ML in medicine. Interviews were transcribed and deidentified by members of our research team. Data analysis was guided by the principles of qualitative content analysis. This approach, in which transcribed data is broken down into descriptive units that are named and sorted based on their content, allows for the inductive emergence of codes directly from the data set.Notably, both researchers and physicians articulated concerns regarding how AI and ML innovations are shaped in their early development (ie, the problem formulation stage). Considerations encompassed the assessment of research priorities and motivations, clarity and centeredness of clinical needs, professional and demographic diversity of research teams, and interdisciplinary knowledge generation and collaboration. Phase-1 ethical issues identified by interviewees were notably interdisciplinary in nature and invited questions regarding how to align priorities and values across disciplines and ensure clinical value throughout the development and implementation of medical AI and ML. Relatedly, interviewees suggested interdisciplinary solutions to these issues, for example, more resources to support knowledge generation and collaboration between developers and physicians, engagement with a broader range of stakeholders, and efforts to increase diversity in research broadly and within individual teams.These qualitative findings help elucidate several ethical challenges anticipated or encountered in AI and ML for health care. Our study is unique in that its use of open-ended questions allowed interviewees to explore their sentiments and perspectives without overreliance on implicit assumptions about what AI and ML currently are or are not. This analysis, however, does not include the perspectives of other relevant stakeholder groups, such as patients, ethicists, industry researchers or representatives, or other health care professionals beyond physicians. Additional qualitative and quantitative research is needed to reproduce and build on these findings.

  View details for DOI 10.2196/47449

  View details for PubMedID 38875536

  View details for PubMedCentralID PMC11041441

• Study protocol for a sequential multiple assignment randomized trial to reduce risky drinking among service members and their partners. Contemporary clinical trials Osilla, K. C., Gore, K. L., Pedersen, E. R., Hummer, J., Deyoreo, M., Manuel, J. K., McKay, J. R., Kim, J. P., Nameth, K. 2023: 107324

  Abstract

  Military spouses and partners in relationships with a heavy drinking service member report high levels of mental health concerns and consequences, which are compounded when both partners drink heavily. Military spouses and partners -termed "concerned partners" (CPs)-may be an important gateway for motivating service members (SMs) to seek care. However, CPs may first need to reduce their own drinking and improve their communication to effectively support and encourage changes for their service member partner. Partner's Connect is a web-based intervention aimed at improving communication and relationship quality and increasing SM help-seeking.The current study design is a two-stage Sequential Multiple Assignment Randomized Trial (SMART) to develop an adaptive CP intervention to decrease CP drinking and increase SM help-seeking. CPs aged 18 and older (n = 408) will be recruited via social media and followed for six months. In stage one, we will randomize CPs to either a 4-session web-based intervention (Partners Connect) or to receive communication resources from the Gottman Institute website. The goal is to have CPs invite their SM to complete an online personalized normative feedback (PNF) session. If their SM completes the PNF at stage one, CPs will be considered "responders," if the SM does not complete, CPs who are "non-responders" will be re-randomized during stage two to receive either (1) a CRAFT workbook or (2) phone-based CRAFT if in Partners Connect; or (1) Partners Connect or (2) a CRAFT workbook if in Gottman.By first intervening with the service member's CP, we aim to better equip them to engage their service member partner in treatment services. In doing so, we develop a model that increases treatment accessibility and appeal among a group that may not otherwise seek care.gov Identifier: NCT05619185.

  View details for DOI 10.1016/j.cct.2023.107324

  View details for PubMedID 37652360

• A Preliminary Investigation Of Repetitive Transcranial Magnetic Stimulation Applied To The Left Dorsolateral Prefrontal Cortex In Treatment Seeking Participants With Cannabis Use Disorder. medRxiv : the preprint server for health sciences Sahlem, G. L., Kim, B., Baker, N. L., Wong, B. L., Caruso, M. A., Campbell, L. A., Kaloani, I., Sherman, B. J., Ford, T. J., Musleh, A. H., Kim, J. P., Williams, N. R., Manett, A. J., Kratter, I. H., Short, E. B., Killeen, T. K., George, M. S., McRae-Clark, A. L. 2023

  Abstract

  Background: Cannabis use disorder (CUD) is a common and consequential disorder. When applied to the dorsolateral prefrontal cortex (DLPFC), repetitive transcranial magnetic stimulation (rTMS) reduces craving across substance use disorders and may have a therapeutic clinical effect when applied in serial sessions. The present study sought to preliminarily determine whether serial sessions of rTMS applied to the DLPFC had a therapeutic effect in CUD.Methods: This study was a two-site, phase-2, double-blind, randomized-controlled-trial. Seventy-two treatment-seeking participants (37.5% Women, mean age 30.2±9.9SD) with ≥moderate-CUD were randomized to active or sham rTMS (Beam-F3, 10Hz, 20-total-sessions, with cannabis cues) while undergoing a three-session motivational enhancement therapy intervention. The primary outcome was the change in craving between pre- and post- treatment (Marijuana Craving Questionnaire Short-Form-MCQ-SF). Secondary outcomes included the number of weeks of abstinence and the number of days-per-week of cannabis use during 4-weeks of follow-up.Results: There were no significant differences in craving between conditions. Participants who received active rTMS reported numerically, but not significantly, more weeks of abstinence in the follow-up period than those who received sham rTMS (15.5%-Active; 9.3%-Sham; rate ratio = 1.66 [95% CI: 0.84, 3.28]; p =0.14). Participants who received active rTMS reported fewer days-per-week of cannabis use over the final two-weeks of the follow-up period (Active vs. Sham: -0.72; Z=-2.33, p =0.02).Conclusions: This trial suggests rTMS is safe and feasible in individuals with CUD and may have a therapeutic effect on frequency of cannabis use, though further study is needed with additional rTMS-sessions and a longer follow-up period.Highlights: This phase-2 RCT tested the efficacy of prefrontal rTMS for cannabis use disorderThe study paradigm was safe and feasible, and participants tolerated rTMS wellThe active-group had numerically more weeks of abstinence during follow-upThe active-group had fewer days-per-week of cannabis use during follow-upMore rTMS and a longer follow-up may result in a larger effect in future studies.

  View details for DOI 10.1101/2023.07.10.23292461

  View details for PubMedID 37503294

• EARLY SLEEP INTERVENTION MITIGATES POOR SLEEP AND IMPROVES MOOD IN THE COVID-19 PANDEMIC Osorno, R., Solomon, N., Ahmadi, M., O'hora, K., Lopez, M., Morehouse, A., Kim, J., Manber, R., Goldstein-Piekarski, A. OXFORD UNIV PRESS INC. 2023: A141

  View details for Web of Science ID 001008232900318

• Beliefs about prescription sleep medications and interest in reducing hypnotic use: an examination of middle-aged and older adults with insomnia disorder. Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine Tully, I. A., Kim, J. P., Simpson, N., Palaniappan, L., Tutek, J., Gumport, N. B., Dietch, J. R., Manber, R. 2023

  Abstract

  STUDY OBJECTIVES: To examine beliefs about prescription sleep medications (hypnotics) among individuals with insomnia disorder seeking cognitive behavioral therapy for insomnia (CBTI) and predictors of wishing to reduce use.METHODS: Baseline data was collected from 245 adults 50 years and older enrolled in the "RCT of the effectiveness of stepped-care sleep therapy in general practice (RESTING)" study. T-tests compared characteristics of prescription sleep medication users with those of non-users. Linear regression assessed predictors of patients' beliefs about sleep medication necessity and hypnotic-related concerns. Among users, we examined predictors of wishing to reduce sleep medications, including perceived hypnotic dependence, beliefs about medications, and demographic characteristics.RESULTS: Users endorsed stronger beliefs about the necessity of sleep medications and less concern about potential harms than non-users (p < .01). Stronger dysfunctional sleep-related cognitions predicted greater beliefs about necessity and concern about use (p < .01). Patients wishing to reduce sleep medications reported greater perceived hypnotic dependence than those disinterested in reduction (p < .001). Self-reported dependence severity was the strongest predictor of wishing to reduce use (p = .002).CONCLUSIONS: Despite expressing strong beliefs about necessity, and comparatively less concern about taking sleep medications, three-quarters of users wished to reduce prescription hypnotics. Results may not generalize to individuals with insomnia not seeking non-pharmacological treatments. Upon completion, the RESTING study will provide information about the extent to which therapist-led and digital CBTI contribute to prescription hypnotic reduction.CLINICAL TRIAL REGISTRY: Registry: ClinicalTrials.gov; Name: The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy (RESTING); URL: https://clinicaltrials.gov/ct2/show/NCT03532282; Identifier: NCT03532282.

  View details for DOI 10.5664/jcsm.10552

  View details for PubMedID 36883379

• Just Do Something: Comparing Self-proposed and Machine-recommended Stress Interventions among Online Workers with Home Sweet Ofice Tong, X., Mauriello, M., Mora-Mendoza, M., Prabhu, N., Kim, J., Paredes, P. E., ACM ASSOC COMPUTING MACHINERY. 2023

  View details for DOI 10.1145/3544548.3581319

  View details for Web of Science ID 001048393803023

• Factors Influencing Perceived Helpfulness and Participation in Innovative Research: A Pilot Study of Individuals with and without Mood Symptoms. Ethics & behavior Kim, J. P., Tsungmey, T., Rostami, M., Mondal, S., Kasun, M., Roberts, L. W. 2022; 32 (7): 601-617

  Abstract

  Little is known about how individuals with and without mood disorders perceive the inherent risks and helpfulness of participating in innovative psychiatric research, or about the factors that influence their willingness to participate. We conducted an online survey with 80 individuals (self-reported mood disorder [n = 25], self-reported good health [n = 55]) recruited via MTurk. We assessed respondents' perceptions of risk and helpfulness in study vignettes associated with two innovative research projects (intravenous ketamine therapy and wearable devices), as well as their willingness to participate in these projects. Respondents with and without mood disorders perceived risk similarly across projects. Respondents with no mood disorders viewed both projects as more helpful to society than to research volunteers, while respondents with mood disorders viewed the projects as equally helpful to volunteers and society. Individuals with mood disorders perceived ketamine research, and the two projects on average, as more helpful to research volunteers than did individuals without mood disorders. Our findings add to a limited empirical literature on the perspectives of volunteers in innovative psychiatric research.

  View details for DOI 10.1080/10508422.2021.1957678

  View details for PubMedID 36200069

  View details for PubMedCentralID PMC9528999

• Self-reported influences on willingness to receive COVID-19 vaccines among physically ill, mentally ill, and healthy individuals. Journal of psychiatric research Roberts, L. W., Kim, J. P., Rostami, M., Kasun, M., Kim, B. 2022; 155: 501-510

  Abstract

  OBJECTIVE: Individuals with mental and physical disorders have been disproportionately affected by adverse health outcomes due to the COVID-19 pandemic, and yet vaccine hesitancy persists despite clear evidence of health benefits. Therefore, our study explored factors influencing willingness to receive a COVID-19 vaccine.METHODS: Individuals with mental illness (n=332), physical illness (n=331), and no health issues (n=328) were recruited via Amazon Mechanical Turk. Participants rated willingness to obtain a fully approved COVID-19 vaccine or a vaccine approved only for experimental/emergency use and influences in six domains upon their views. We examined differences by health status.RESULTS: Participants across groups were moderately willing to receive a COVID-19 vaccine. Perceived risk was negatively associated with willingness. Participants differentiated between vaccine risk by approval stage and were less willing to receive an experimental vaccine. Individuals with mental illness rated risk of both vaccines similarly to healthy individuals. Individuals with physical illness expressed less willingness to receive an experimental vaccine. Domain influences differently affected willingness by health status as well as by vaccine approval status.CONCLUSIONS: Our findings are reassuring regarding the ability of people with mental disorders to appreciate risk in medical decision-making and the ability of people of varied health backgrounds to distinguish between the benefits and risks of clinical care and research, refuting the prevailing notions of psychiatric exceptionalism and therapeutic misconception. Our findings shine a light on potential paths forward to support vaccine acceptance.

  View details for DOI 10.1016/j.jpsychires.2022.09.017

  View details for PubMedID 36191518

• THE FIRST STEP OF A TRIAGED STEPPED-CARE DELIVERY OF CBTI: A PRELIMINARY REPORT FROM THE RESTING STUDY Manber, R., Kim, J., Simpson, N., Tully, I., Tutek, J., Dietch, J., Gumport, N., Rosas, L., Zulmann, D., Palaniappan, L. OXFORD UNIV PRESS INC. 2022: A203

  View details for Web of Science ID 000838094800455

• PRESCRIBING PATTERNS FOR HYPNOTIC MEDICATION AMONG ADULTS SEEKING CBTI TREATMENT: A PRELIMINARY REPORT FROM THE RESTING STUDY Simpson, N., Kim, J., Tully, I., Dietch, J., Tutek, J., Gumport, N., Palaniappan, L., Rosas, L., Zulman, D., Manber, R. OXFORD UNIV PRESS INC. 2022: A212

  View details for Web of Science ID 000838094800475

• Influence of Dispositional Optimism on Ethically Salient Research Perspectives: A Pilot Study. Ethics & human research Kim, J. P., Mondal, S., Tsungmey, T., Ryan, K., Dunn, L. B., Roberts, L. W. 2022; 44 (3): 12-23

  Abstract

  Research participants should be drawn as fairly as possible from the potential volunteer population. Underlying personality traits are underexplored as factors influencing research decision-making. Dispositional optimism, known to affect coping, physical health, and psychological well-being, has been minimally studied with respect to research-related attitudes. We conducted an exploratory, online survey with 151 individuals (with self-reported mental illness [n = 50], physical illness [n = 51], or neither [n = 50]) recruited via MTurk. We evaluated associations between dispositional optimism (assessed with the Life Orientation Test-Revised) and general research attitudes, perceived protectiveness of five research safeguards, and willingness to participate in research using safeguards. Strongly optimistic respondents expressed more positive research attitudes and perceived four safeguards as more positively influencing willingness to participate. Optimism was positively associated with expressed willingness to participate in clinical research. Our findings add to a limited literature on the influence of individual traits on ethically salient research perspectives.

  View details for DOI 10.1002/eahr.500126

  View details for PubMedID 35543260

• RCT of the effectiveness of stepped-care sleep therapy in general practice: The RESTING study protocol. Contemporary clinical trials Manber, R., Tully, I. A., Palaniappan, L., Kim, J. P., Simpson, N., Zulman, D. M., Goldhaber-Fiebert, J. D., Rangel, E., Dietch, J. R., Rosas, L. G. 2022: 106749

  Abstract

  Cognitive behavioral therapy for insomnia (CBT-I) is an effective, non-pharmacological intervention, designated by the American College of Physicians as the first-line treatment of insomnia disorder. The current randomized controlled study uses a Hybrid-Type-1 design to compare the effectiveness and implementation potential of two approaches to delivering CBT-I in primary care. One approach offers therapy to all patients through an automated, digital CBT-I program (ONLINE-ONLY). The other is a triaged STEPPED-CARE approach that uses a simple Decision Checklist to start patients in either digital or therapist-led treatment; patients making insufficient progress with digital treatment at 2 months are switched to therapist-led treatment. We will randomize 240 individuals (age 50 or older) with insomnia disorder to ONLINE-ONLY or STEPPED-CARE arms. The primary outcomes are insomnia severity and hypnotic medication use, assessed at baseline and at months 2, 4, 6, 9, and 12 after randomization. We hypothesize that STEPPED-CARE will be superior to ONLINE-ONLY in reducing insomnia severity and hypnotic use. We also aim to validate the Decision Checklist and explore moderators of outcome. Additionally, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, we will use mixed methods to obtain data on the potential for future dissemination and implementation of each approach. This triaged stepped-care approach has the potential to improve sleep, reduce use of hypnotic medications, promote safety, offer convenient access to treatment, and support dissemination of CBT-I to a large number of patients currently facing barriers to accessing treatment. Clinical trial registration:NCT03532282.

  View details for DOI 10.1016/j.cct.2022.106749

  View details for PubMedID 35367385

• Eating disorders early app use mediates treatment effect on clinical improvement. The International journal of eating disorders Kim, J. P., Sadeh-Sharvit, S., Welch, H. A., Neri, E., Tregarthen, J., Lock, J. 1800

  Abstract

  OBJECTIVE: Eating disorders (EDs) contribute considerably to the global burden of disease. However, most affected individuals do not receive treatment. Mobile apps present an enormous opportunity to increase access to mental healthcare services. This study examined whether the degree of usage of a self-help app for EDs mediated the app's effects on the clinical response by individuals with EDs.METHOD: App usage measures included the total number of cognitive-behavioral meal logs, total number of days spent using the app, and the last day the app was used during the study period. Mediation analysis was performed using the MacArthur framework.RESULTS: All usage variables met the analytic requirements for testing mediation (group means (sd) for app and standard app, respectively: logs=74 (108) vs. 51.4 (88.1), days spent=14.3 (17.5) vs. 10.6 (15.0), p-values from Wilcox rank sum tests p<.01). Regression coefficients indicated mediation effects. The mediation effects demonstrated support that increased engagement (as measured by logs and time spent on the app) was related to an increased likelihood of achieving a significant clinical change by the end of the trial.DISCUSSION: Greater and longer engagement in an ED app mediates its efficacy in terms of ED remission.

  View details for DOI 10.1002/eat.23652

  View details for PubMedID 34904745

• Stakeholders' Perspectives regarding Participation in Neuromodulation-Based Dementia Intervention Research. Journal of empirical research on human research ethics : JERHRE Dunn, L. B., Kim, J. P., Rostami, M., Mondal, S., Ryan, K., Waraich, A., Roberts, L. W., Palmer, B. W. 2021: 15562646211060997

  Abstract

  This study evaluated stakeholders' perspectives regarding participation in two hypothetical neuromodulation trials focused on individuals with Alzheimer's disease and related disorders (ADRDs). Stakeholders (i.e., individuals at risk for ADRDs [n=56], individuals with experience as a caregiver for someone with a cognitive disorder [n=60], and comparison respondents [n=124]) were recruited via MTurk. Primary outcomes were willingness to enroll (or enroll one's loved one), feeling lucky to have the opportunity to enroll, and feeling obligated to enroll in two protocols (transcranial magnetic stimulation, TMS; deep brain stimulation, DBS). Relative to the Comparison group, the At Risk group endorsed higher levels of "feeling lucky" regarding both research protocols, and higher willingness to participate in the TMS protocol. These findings provide tentative reassurance regarding the nature of decision making regarding neurotechnology-based research on ADRDs. Further work is needed to evaluate the full range of potential influences on research participation.

  View details for DOI 10.1177/15562646211060997

  View details for PubMedID 34870511

• Factors Influencing Perceived Helpfulness and Participation in Innovative Research:A Pilot Study of Individuals with and without Mood Symptoms ETHICS & BEHAVIOR Kim, J., Tsungmey, T., Rostami, M., Mondal, S., Kasun, M., Roberts, L. 2021

  View details for DOI 10.1080/10508422.2021.1957678

  View details for Web of Science ID 000698691500001

• Maternal Perceptions of Safeguards for Research Involving Children JOURNAL OF CHILD AND FAMILY STUDIES Rostami, M., Kim, J., Turner-Essel, L., Roberts, L. 2021

  View details for DOI 10.1007/s10826-021-02037-8

  View details for Web of Science ID 000682656300001

• Perceived protectiveness of research safeguards and influences on willingness to participate in research: A novel MTurk pilot study. Journal of psychiatric research Kim, J. P., Ryan, K., Tsungmey, T., Kasun, M., Roberts, W. A., Dunn, L. B., Roberts, L. W. 2021; 138: 200–206

  Abstract

  Little is known about how individuals with mood disorders view the protectiveness of research safeguards, and whether their views affect their willingness to participate in psychiatric research. We conducted an online survey with 80 individuals (self-reported mood disorder [n=25], self-reported good health [n=55]) recruited via MTurk. We assessed respondents' perceptions of the protectiveness of five common research safeguards, as well as their willingness to participate in research that incorporates each safeguard. Perceived protectiveness was strongly related to willingness to participate in research for four of the safeguards. Our findings add to a limited literature on the motivations and perspectives of key stakeholders in psychiatric research.

  View details for DOI 10.1016/j.jpsychires.2021.04.005

  View details for PubMedID 33865169

• Letter to the editor: Machine learning and artificial intelligence in psychiatry: Balancing promise and reality. Journal of psychiatric research Kim, J. P. 2021; 136: 244–45

  View details for DOI 10.1016/j.jpsychires.2021.02.021

  View details for PubMedID 33621909

• Viability of an Early Sleep Intervention to Mitigate Poor Sleep and Improve Well-being in the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial. JMIR research protocols O'Hora, K. P., Osorno, R. A., Sadeghi-Bahmani, D., Lopez, M., Morehouse, A., Kim, J. P., Manber, R., Goldstein-Piekarski, A. N. 2021

  Abstract

  The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown.Here, we present the framework and protocol for a novel feasibility, pilot study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life.The protocol details a two-arm randomized controlled feasibility trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56.The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol.To our knowledge, this protocol would represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this feasibility study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being.Nct04409743.

  View details for DOI 10.2196/34409

  View details for PubMedID 34995204

• Artificial Intelligence and Suicide Prevention: A Systematic Review of Machine Learning Investigations. International journal of environmental research and public health Bernert, R. A., Hilberg, A. M., Melia, R., Kim, J. P., Shah, N. H., Abnousi, F. 2020; 17 (16)

  Abstract

  Suicide is a leading cause of death that defies prediction and challenges prevention efforts worldwide. Artificial intelligence (AI) and machine learning (ML) have emerged as a means of investigating large datasets to enhance risk detection. A systematic review of ML investigations evaluating suicidal behaviors was conducted using PubMed/MEDLINE, PsychInfo, Web-of-Science, and EMBASE, employing search strings and MeSH terms relevant to suicide and AI. Databases were supplemented by hand-search techniques and Google Scholar. Inclusion criteria: (1) journal article, available in English, (2) original investigation, (3) employment of AI/ML, (4) evaluation of a suicide risk outcome. N = 594 records were identified based on abstract search, and 25 hand-searched reports. N = 461 reports remained after duplicates were removed, n = 316 were excluded after abstract screening. Of n = 149 full-text articles assessed for eligibility, n = 87 were included for quantitative synthesis, grouped according to suicide behavior outcome. Reports varied widely in methodology and outcomes. Results suggest high levels of risk classification accuracy (>90%) and Area Under the Curve (AUC) in the prediction of suicidal behaviors. We report key findings and central limitations in the use of AI/ML frameworks to guide additional research, which hold the potential to impact suicide on broad scale.

  View details for DOI 10.3390/ijerph17165929

  View details for PubMedID 32824149

• Attitudes of Mothers Regarding Willingness to Enroll Their Children in Research. Journal of empirical research on human research ethics : JERHRE Kim, J. P., Rostami, M. n., Roberts, L. W. 2020: 1556264620927583

  Abstract

  This study assessed mothers' perspectives regarding research involvement by their children, factors that might affect perceptions of research risks, and attitudes regarding willingness to enroll children in research. Participants completed a survey on Amazon Mechanical Turk. Mothers were less inclined to enroll children in research involving procedures posing higher risk (regression coefficient = -0.51). Mothers without mental health issues with children without health issues were more sensitive to risk than mothers without mental health issues with children with health issues (estimated difference = 0.49). Mothers with mental health issues were more willing than mothers without mental health issues to enroll children in research (regression coefficient = -0.90). Among mothers with mental health issues, having a child with a health issue was associated with increased willingness to enroll in research, compared with having children without health issues (estimated difference = 0.65).

  View details for DOI 10.1177/1556264620927583

  View details for PubMedID 32552481

• Comparing a Tailored Self-Help Mobile App With a Standard Self-Monitoring App for the Treatment of Eating Disorder Symptoms: Randomized Controlled Trial. JMIR mental health Tregarthen, J., Paik Kim, J., Sadeh-Sharvit, S., Neri, E., Welch, H., Lock, J. 2019; 6 (11): e14972

  Abstract

  BACKGROUND: Eating disorders severely impact psychological, physical, and social functioning, and yet, the majority of individuals with eating disorders do not receive treatment. Mobile health apps have the potential to decrease access barriers to care and reach individuals who have been underserved by traditional treatment modalities.OBJECTIVE: The objective of this study was to evaluate the effectiveness of a tailored, fully automated self-help version of Recovery Record, an app developed for eating disorders management. We examined differences in eastin disorder symptom change in app users that were randomized to receive either a standard, cognitive behavioral therapy-based version of the app or a tailored version that included algorithmically determined clinical content aligned with baseline and evolving user eating disorder symptom profiles.METHODS: Participants were people with eating disorder symptoms who did not have access to traditional treatment options and were recruited via the open-access Recovery Record app to participate in this randomized controlled trial. We examined both continuous and categorical clinical improvement outcomes (measured with the self-report Eating Disorder Examination Questionnaire [EDE-Q]) in both intervention groups.RESULTS: Between December 2016 and August 2018, 3294 Recovery Record app users were recruited into the study, out of which 959 were considered engaged, completed follow-up assessments, and were included in the analyses. Both study groups achieved significant overall outcome improvement, with 61.6% (180/292) of the tailored group and 55.4% (158/285) of the standard group achieving a clinically meaningful change in the EDE-Q, on average. There were no statistically significant differences between randomized groups for continuous outcomes, but a pattern of improvement being greater in the tailored group was evident. The rate of remission on the EDE-Q at 8 weeks was significantly greater in the group receiving the tailored version (d=0.22; P≤.001).CONCLUSIONS: This is the first report to compare the relative efficacy of two versions of a mobile app for eating disorders. The data suggest that underserved individuals with eating disorder symptoms may benefit clinically from a self-help app and that personalizing app content to specific clinical presentations may be more effective in promoting symptomatic remission on the EDE-Q than content that offers a generic approach.TRIAL REGISTRATION: ClinicalTrials.gov NCT02503098; https://clinicaltrials.gov/ct2/show/NCT02503098.

  View details for DOI 10.2196/14972

  View details for PubMedID 31750837

• Attitudes Regarding Enrollment in a Genetic Research Project: An Informed Consent Simulation Study Comparing Views of People With Depression, Diabetes, and Neither Condition. Journal of empirical research on human research ethics : JERHRE Kim, J. P., Ryan, K., Roberts, L. W. 2019: 1556264619862467

  Abstract

  In this study, participants with a self-reported history of depression, diabetes, or no illness underwent a simulated informed consent process for a hypothetical genetic study related to depression or diabetes. Participants completed a survey assessing their perceived understanding of the research process, perceptions of its risks and benefits, their satisfaction with the informed consent process, and their readiness to make a hypothetical enrollment decision. All participants indicated strong readiness to make an enrollment decision regarding the research characterized in the simulation. Participants reported understanding the consent process relatively well and being generally satisfied with it. Greater concerns were expressed regarding psychosocial risks than biological risks for genetic studies on mental disorders. Our study documented positive attitudes toward volunteering for research that involved the collection of genetic data.

  View details for DOI 10.1177/1556264619862467

  View details for PubMedID 31328612

• Do human subject safeguards matter to potential participants in psychiatric genetic research? Journal of psychiatric research Roberts, L. W., Kim, J. P., Tsungmey, T. n., Dunn, L. B. 2019; 116: 95–103

  Abstract

  Despite longstanding concerns about the adequacy of human research protections in mental illness investigations, minimal work has focused on the perspectives of key stakeholders regarding these safeguards. This investigation examined the perspectives of potential research participants regarding safeguards for psychiatric genetic research. Individuals with mental illness (n = 71), first-degree family members of individuals with mental illness (n = 54), and individuals with no personal or close family history of mental illness (n = 57) provided responses to items regarding perceptions of: 1) protectiveness of a range of research safeguards in genetic research on mental illness; 2) influence of these safeguards on research participation decision-making; and 3) importance of these safeguards depending on the nature of the research (i.e., genetic vs. non-genetic mental illness research; and genetic research on mental illness vs. physical illness). Potential research participants perceived existing safeguard procedures as generally protective. The three groups did not differ in their ratings of protectiveness, with the exception of the safeguard domain of "Informed Consent or Alternative Decision-Making Procedures," which was viewed as more protective by family members of people with mental illness than by individuals with mental illness or comparison participants. Safeguard procedures were perceived as strongly influential with respect to willingness to enroll in psychiatric genetic research. These findings suggest that the presence of safeguards positively influences enrollment decision-making by research volunteers and indicate that potential psychiatric genetic research participants find safeguards to be protective, underscoring the responsibility to implement safeguard practices conscientiously.

  View details for DOI 10.1016/j.jpsychires.2019.06.004

  View details for PubMedID 31226581

• Negative association of perceived risk and willingness to participate in innovative psychiatric research protocols. Journal of psychiatric research Tsungmey, T. n., Kim, J. P., Dunn, L. B., Ryan, K. n., Lane-McKinley, K. n., Roberts, L. W. 2019; 122: 9–16

  Abstract

  Psychiatric researchers grapple with concerns that individuals with mental illness may be less likely to appreciate risks of research participation, particularly compared to people not suffering from mental illness. Therefore, empirical studies that directly compare the perspectives of such individuals are needed. In addition, it is important to evaluate perspectives regarding varied types of research protocols, particularly as innovative psychiatric research protocols emerge. In this pilot study, respondents with a mood disorder (n = 25) as well as respondents without a mood disorder (n = 55) were recruited using Amazon's Mechanical Turk (MTurk) platform. These respondents were surveyed regarding four psychiatric research projects (i.e., experimental medication [pill form]; non-invasive magnetic brain stimulation; experimental medication [intravenous infusion]; and implantation of a device in the brain). Regardless of health status, respondents rated the four research protocols as somewhat to highly risky. The brain-device implant protocol was seen as the most risky, while the magnetic brain stimulation project was viewed as "somewhat risky". Respondents, on average and regardless of health status, rated their willingness at or below "somewhat willing." Respondents were least willing to participate in the brain-device implant protocol, whereas they were "somewhat willing" to participate in the magnetic brain stimulation protocol. Trust in medical research was negatively associated with perceived risk of research protocols. Perceived risk was negatively associated with willingness to participate, even when adjusting for potential confounders, suggesting that attunement to risk crosses diagnostic, gender, and ethnic categories, and is more salient to research decision-making than trust in medical research and dispositional optimism. The findings of this study may offer reassurance about the underlying decision-making processes of individuals considering participation in innovative neuroscience studies.

  View details for DOI 10.1016/j.jpsychires.2019.12.010

  View details for PubMedID 31891880

• Safeguarding Participants in Psychiatric Genetic Research: Perspectives of Key Stakeholder Groups. Ethics & human research Rostami, M. n., Dunn, L. B., Kim, J. P., Roberts, L. W. 2019; 41 (6): 12–22

  Abstract

  Public trust in research depends on implementation of research protections. Genetic and psychiatric research may elicit "exceptionalism," the belief that these types of research deserve special protections. Genetic information has been viewed as different from other health information. Psychiatric research has been scrutinized based on concerns about the impact of psychiatric illness on individuals' abilities to make decisions. This study compared four stakeholder groups' attitudes toward research safeguards. Psychiatric genetic researchers and institutional review board chairs received structured surveys. Individuals with mental illness and family members participated in semistructured interviews. Paired sample t-tests were used to compare mean ratings of importance of safeguard procedures for genetic versus nongenetic research on physical versus mental illnesses. All groups provided higher ratings for the importance of safeguards for genetic research and for mental illness. Individuals with mental illness and family members rated the importance of safeguards more highly than researchers and chairs did. Results of generalized linear models showed significant effects of gender and ethnicity.

  View details for DOI 10.1002/eahr.500034

  View details for PubMedID 31743628

• Views of the importance of psychiatric genetic research by potential volunteers from stakeholder groups. Journal of psychiatric research Roberts, L. W., Tsungmey, T., Kim, J. P., Hantke, M. 2018; 106: 69–73

  Abstract

  Few studies have explored potential volunteers' attitudes toward genetic research. To address this gap in the literature, we developed an empirical project to document views held by individuals who may wish to enroll in genetic studies involving mental disorders. People living with mental illness, family members of people with mental illness, and community comparison volunteers were queried regarding their views on the importance of genetic research generally, in comparison with medical research, and in relation to 12 health conditions categorized in four types. T-tests and univariate and multivariate analysis of variance were used as appropriate. Participants expressed support for the importance of genetic research (mean = 9.43, scale = 1-10) and endorsed genetic research more highly compared with non-genetic medical research (mean = 9.43 vs. 8.69, P value = <0.001). The most highly endorsed genetic research was for cognitive disorders, followed by mental illness disorders, physical illness disorders, and addiction disorders (means = 8.88, 8.26, 8.16 and 7.55, respectively, P value = <0.001). Overall, this study provides evidence of strong endorsement of genetic research over non-genetic research by potential volunteers.

  View details for PubMedID 30292779

• Perspectives of psychiatric investigators and IRB chairs regarding benefits of psychiatric genetics research. Journal of psychiatric research Roberts, L. W., Dunn, L. B., Kim, J. P., Rostami, M. 2018; 106: 54–60

  Abstract

  There is hope that psychiatric genetics inquiry will provide important insights into the origins and treatment of mental illness given the burden of these conditions. We sought to examine perspectives of psychiatric genetic investigators regarding the potential benefits of genetic research in general and the potential benefits of genetic research for the diagnosis and treatment of mental illnesses specifically. We compared investigator attitudes with those of chairs of Institutional Review Boards (IRBs) entrusted with evaluating the benefits and risks of human research studies. Two groups directly engaged with the conduct and oversight of psychiatric genetic research were examined (psychiatric investigators, n = 203; IRB Chairs, n = 183). Participants rated 15 survey items regarding current and future benefits of general genetic research, possible benefits of psychiatric genetic research, and the importance to society of genetic vs. non-genetic research examining causes and treatments of illnesses. Investigators and IRB Chairs strongly endorsed the future benefits of general genetic research for society and for the health of individuals; compared to IRB Chairs, investigators were more positive about these benefits. Even after adjusting for demographic variables, psychiatric genetic investigators were significantly more optimistic about genetic research compared with IRB Chairs. Both groups were moderately optimistic about the possible benefits of genetic research related to mental illness. Greater optimism was seen regarding new or personalized medications for mental illnesses, as well as genetic predictive testing of mental illnesses. Greater precision and circumspection about the potential benefits of psychiatric genetic research are needed.

  View details for PubMedID 30273801

• The Utility and Acceptability of a Self-Help Smartphone Application for Eating Disorder Behaviors. Journal of technology in behavioral science Kim, J. P., Sadeh-Sharvit, S., Darcy, A. M., Neri, E., Vierhile, M., Robinson, A., Tregarthen, J., Lock, J. D. 2018; 3 (3): 161–64

  Abstract

  Objective: Smartphone applications (apps) for eating disorders are a promising approach to assist individuals who do not receive traditional treatment. This study examines usage characteristics, perceptions regarding the acceptability of a new self-help intervention developed for users with eating disorders, and associations between attitudes and use patterns.Methods: 189 individuals pilot-tested a personalized app-based program, and 133 completed the required components of the pilot-test over an 8-day period. Of these, 64 individuals (49%) completed an exit survey pertaining to acceptability.Results: Seventy percent of those who pilot-tested the app-based program completed the required components, i.e. a baseline review and then a 1-week assessment. Body mass index was associated with the total number of recorded meal logs. Study participants rated the app as highly suitable and acceptable, providing evidence of the feasibility and appropriateness of the program.Conclusion: The app-based program demonstrated feasibility of deploying the app across user groups and high acceptability.

  View details for PubMedID 30374444

• Does informed consent given by healthy individuals when enrolling in clinical research feel less voluntary than for ill individuals? Journal of psychiatric research Roberts, L., Kim, J. P. 2018; 103: 33–37

  Abstract

  Clinical research is predicated ethically on the authentic voluntarism of individuals who choose to enroll in human studies. Existing literature has focused on aspects of informed consent for clinical research other than voluntarism. The objective of this study was to compare the perspectives of clinical research participants who are in good health and who are ill regarding voluntarism-related aspects of informed consent and to assess situational influences that enable voluntarism in the process of obtaining clinical research consent. A 23-item written survey, the Informed Consent Questionnaire (ICQ), was administered in a "piggyback" semi-structured interview study of ill and healthy volunteers enrolled in IRB-approved clinical research studies. A total of 150 (60 mentally ill, 43 physically ill, and 47 healthy) clinical research participants participated. Respondents expressed positive views of their experiences with the informed consent processes for their respective clinical research protocols and respondents strongly endorsed items related to voluntarism irrespective of their illness type (range of means = [3.9, 4.8]). Ill participants more highly endorsed items relating to informed consent conditions (mentally ill vs healthy: 0.54 on a 5-point scale, P value = 0.01) (physically ill vs. healthy: 0.47 on a 5-point scale, P value = 0.01). The favorable views of clinical research participants regarding their experience of giving informed consent to enroll in a study were not surprising. Contrary to our a priori hypothesis, healthy individuals did not feel as positively as their ill counterparts.

  View details for PubMedID 29772484

• Subgrouping the users of a specialized app for eating disorders. Eating disorders Sadeh-Sharvit, S., Kim, J. P., Darcy, A. M., Neri, E., Vierhile, M., Robinson, A., Tregarthen, J., Lock, J. D. 2018: 1–12

  Abstract

  Although mobile technologies for eating disorders (EDs) are burgeoning, there is limited data about the clinical characteristics of individuals using specialized smartphone applications (apps) without accompanying traditional forms of treatment. This study evaluated whether the users of an ED app cluster in clinically meaningful groups. Participants were 1,280 app users (91.3% female; mean age 27) who reported not being in a weekly treatment for their ED. A hierarchical cluster analysis distinguished five groups of participants, all approximating DSM-5 ED categories. One cluster comprised of non-female, ethnically diverse users with Bulimia Nervosa features. Findings suggest that app users resemble known patient classifications.

  View details for PubMedID 29452025

• The Transition to Precision Psychiatry and Pragmatic Inquiry Methods in Academic Psychiatry: The Example of Point-of-Care Clinical Trials. Academic psychiatry : the journal of the American Association of Directors of Psychiatric Residency Training and the Association for Academic Psychiatry Kim, J. P., Roberts, L. W. 2017

  View details for PubMedID 29134550

• Receptiveness to participation in genetic research: A pilot study comparing views of people with depression, diabetes, or no illness JOURNAL OF PSYCHIATRIC RESEARCH Roberts, L., Kim, J. 2017; 94: 156–62

  Abstract

  Genetic research in human health relies on the participation of individuals with or at-risk for different types of diseases, including health conditions that may be stigmatized, such as mental illnesses. This preliminary study examines the differences in attitudes toward participation in genetic research among individuals with a psychiatric disorder, individuals with a physical disorder, and individuals with no known illness.Seventy-nine individuals with a history of diabetes or depression, or no known illness, underwent a simulated consent process for a hypothetical genetic research study. They were then surveyed about their willingness to participate in the hypothetical study and their attitudes about future and family participation in genetic research.Participants with and without a history of depression ranked participating in genetic and medical research as very important and indicated that they were likely to participate in the hypothetical genetics study. Expressed willingness to participate was generally stable and consistent with future willingness. Individuals less strongly endorsed willingness to ask family members to participate in genetic research.Individuals with and without a history of mental illness viewed genetic and medical research favorably and expressed willingness to participate in real-time and in the future. Informed consent processes ideally include an exploration of influences upon volunteers' enrollment decisions. Additional empirical study of influences upon genetic research participation is important to ensure that volunteers' rights are respected and that conditions that greatly affect the health of the public are not neglected scientifically.

  View details for PubMedID 28719815

  View details for PubMedCentralID PMC5621512

• Lifetime anxiety disorder and current anxiety symptoms associated with hastened depressive recurrence in bipolar disorder. Journal of affective disorders Shah, S., Kim, J. P., Park, D. Y., Kim, H., Yuen, L. D., Do, D., Dell'Osso, B., Hooshmand, F., Miller, S., Wang, P. W., Ketter, T. A. 2017; 219: 165-171

  Abstract

  To assess differential relationships between lifetime anxiety disorder/current anxiety symptoms and longitudinal depressive severity in bipolar disorder (BD).Stanford BD Clinic outpatients enrolled during 2000-2011 were assessed with the Systematic Treatment Enhancement Program for BD (STEP-BD) Affective Disorders Evaluation and followed with the STEP-BD Clinical Monitoring Form while receiving naturalistic treatment for up to two years. Baseline unfavorable illness characteristics/current mood symptoms and times to depressive recurrence/recovery were compared in patients with versus without lifetime anxiety disorder/current anxiety symptoms.Among 105 currently recovered patients, lifetime anxiety disorder was significantly associated with 10/27 (37.0%) demographic/other unfavorable illness characteristics/current mood symptoms/current psychotropics, hastened depressive recurrence (driven by earlier onset age), and a significantly (> two-fold) higher Kaplan-Meier estimated depressive recurrence rate, whereas current anxiety symptoms were significantly associated with 10/27 (37.0%) demographic/other unfavorable illness characteristics/current mood symptoms/current psychotropics and hastened depressive recurrence (driven by lifetime anxiety disorder), but only a numerically higher Kaplan-Meier estimated depressive recurrence rate. In contrast, among 153 currently depressed patients, lifetime anxiety disorder/current anxiety symptoms were not significantly associated with time to depressive recovery or depressive recovery rate.American tertiary BD clinic referral sample, open naturalistic treatment.Research is needed regarding differential relationships between lifetime anxiety disorder and current anxiety symptoms and hastened/delayed depressive recurrence/recovery - specifically whether lifetime anxiety disorder versus current anxiety symptoms has marginally more robust association with hastened depressive recurrence, and whether both have marginally more robust associations with hastened depressive recurrence versus delayed depressive recovery, and related clinical implications.

  View details for DOI 10.1016/j.jad.2017.05.007

  View details for PubMedID 28558363

• Healthy individuals' perspectives on clinical research protocols and influences on enrollment decisions AJOB Empirical Bioethics Roberts, L. W., Kim, J. P. 2017; 8 (2): 89-98

  View details for DOI 10.1080/23294515.2016.1271062

• Perceptions of the Professional Development Value of Honorary Fellowship Award Experiences. Academic psychiatry Roberts, L. W., Kim, J. P., Samuels, C., Winstead, D. 2016; 40 (5): 761-767

  Abstract

  Professional societies engage in activities with the aim of nurturing highly talented early career members of their field. Little is known about the value of honorary fellowship awards given annually by professional societies. Following up on the only known prior study of this topic, authors queried fellowship awardees in one psychiatric society to better understand the perceived value of honorary fellowships and other outcomes, such as subsequent involvement in professional societies.The authors queried former participants in the Laughlin and Psychiatry Resident-In-Training Examination® (PRITE®) Programs regarding their fellowship experiences and their subsequent involvement in The American College of Psychiatrists and other psychiatry membership organizations. The authors obtained frequency data and analyzed responses using t-tests and chi-squared tests. Associations between the outcomes and demographic characteristics such as age, gender, and fellowship type was tested.Responses were gathered from 143 individuals who had participated in the Laughlin Fellowship and 22 in the PRITE Fellowship. Respondents felt that that the fellowship experience had been helpful professionally. Laughlin fellows were older and more likely to have assumed a leadership role in professional organizations (60 % vs 36 %, p = 0.04). Laughlin fellows also more strongly endorsed professional recognition as a benefit at the time of receiving their award. Survey respondents reported increased participation in professional organizations and assumed leadership roles in The College and other professional organizations subsequent to the fellowship experience.On the whole, fellows were generally positive about their experiences. Many respondents became involved with The College subsequent to their fellowship, but a larger proportion became involved with other organizations, including in leadership roles. Professional societies with early career programs such as the Laughlin Fellowship and the PRITE Fellowship appear to identify and support future leaders as intended, but these leaders may engage more with other professional societies.

  View details for DOI 10.1007/s40596-015-0482-y

  View details for PubMedID 26911491

• Are individuals living with mental illness and their preferred alternative decision-makers attuned and aligned in-their attitudes regarding treatment decisions? JOURNAL OF PSYCHIATRIC RESEARCH Roberts, L. W., Kim, J. P. 2016; 78: 42-47

  Abstract

  Mental disorders account for considerable suffering and societal burden. Prospective alternative decision-makers may be engaged in helping make treatment decisions for those who live with serious mental disorders. Little is known about the ways in which alternative decision makers arrive at treatment recommendations and whether the perspectives of alternative decision makers and ill individuals are aligned.The authors queried community-dwelling individuals diagnosed with schizophrenia, anxiety, or mood disorders and their preferred alternative decision-makers on issues regarding treatment decisions and underlying ethically-salient perspectives using a written survey instrument. Complete data were obtained on 26 pairs (n = 52, total). Outcomes included perspectives on clinical decision-making and underlying values that may shape their life choices. Two-sided paired t-tests and graphical representations were used.We found that preferred alternative decision-makers overall accurately predicted the views of ill individuals with respect to the role of the individual and of family in treatment decision making. Preferred alternative decision-makers slightly overestimated autonomy-related perspectives. The personal views of ill individuals and preferred alternative decision-makers were aligned with respect to different physical and mental disorders, except in relation to alcohol and substance use where alternative decision-makers placed greater emphasis on autonomy. Alignment was also discovered on underlying life values, except the role of spirituality which was greater among alternative decision-makers.Preferred alternative decision-makers are an ethical safeguard to ensure the wellbeing and rights of seriously ill individuals. In this pilot study, preferred alternative decision makers were aligned with their ill family members concerning treatment-related decisions and underlying life values. Future research should continue to explore and clarify the views of ill individuals and alternative decision makers to determine the quality of this safeguard used in clinical settings.

  View details for DOI 10.1016/j.jpsychires.2016.03.004

  View details for PubMedID 27058644

• Attunement and alignment of people with schizophrenia and their preferred alternative decision-makers: An exploratory pilot study comparing treatment and research decisions JOURNAL OF PSYCHIATRIC RESEARCH Roberts, L. W., Kim, J. P. 2015; 71: 70-77

  Abstract

  Schizophrenia is a serious mental disorder that may affect the decisional capacity, and as a consequence, preferred alternative decision-makers may be engaged to help with clinical care and research-related choices. Ideally, alternative decision-makers will seek to make decisions that fit with the views and preferences of the ill individual. Few data exist, however, comparing the views of alternative decision-makers to those of individuals with schizophrenia.We conducted a written survey with individuals with schizophrenia living in a community setting, and a parallel survey with the person whom the ill individual identified as being a preferred alternative decision-maker. Complete data were obtained on 20 pairs (n = 40, total). Domains queried included (a) burden, happiness, and safety of the ill individual and of his or her family in treatment and research decisions and (b) importance of ethical principles in every day life. Two-sided paired t-tests and graphical summaries were used to compare responses.Individuals with schizophrenia and their linked preferred alternative decision-makers were attuned on four of six aspects of treatment decision-making and on all six aspects of research decision-making that we queried.The preferred alternative decision-makers overall demonstrated attunement to the views of the ill individuals in this small study. Ill individuals and their preferred alternative decision-makers were aligned in their views of ethically-salient aspects of every day life. These novel findings suggest that alternative decision-makers identified by ill individuals may be able to guide choices based on an accurate understanding of the ill individuals' views and values.

  View details for DOI 10.1016/j.jpsychires.2015.09.014

  View details for Web of Science ID 000365053900009

  View details for PubMedID 26453915

• Informal Health Care Practices of Residents: "Curbside" Consultation and Self-Diagnosis and Treatment ACADEMIC PSYCHIATRY Roberts, L. W., Kim, J. P. 2015; 39 (1): 22-30

  Abstract

  The authors explore the experiences of residents with respect to informal care related to personal health, including "curbside consultation," self-diagnosis, and self-prescription-self-care practices that run counter to ethical guidelines in medicine.Residents at one medical school completed a written survey regarding their personal health care practices, including their experiences in seeking or providing informal consultation, self-diagnosis, and self-prescribing. The authors obtained frequency data and analyzed responses via cross-tabulation. They used logistic regression models to assess the association of reported informal care practices and potential confounders, such as age, gender, and training program.One hundred and fifty-five residents volunteered (71 % response rate). Most respondents had sought health care formally (70 %), and more had sought informal care in the previous 12 months (80 %). Of those who had pursued informal care, 90 % endorsed having requested a physical exam, a laboratory test, or a medication prescription from an attending, resident, or medical student. Respondents (28 %) commonly endorsed prescribing medication for themselves. Most respondents (90 %) reported being approached for informal care at least once in the previous year, including 84 % who were approached for prescriptions and 22 % who were approached by attending physicians. Main reasons endorsed for informal care seeking related to busy schedules and to cost and confidentiality advantages. Psychiatry residents reported using both formal and informal channels for personal health care, and 31 % acknowledged prescribing medications for themselves.Informal care was a common practice among the residents in this study. Residents reported time constraints as the greatest influence on informal care seeking, rather than reasons found in previous studies related to cost and quality of care, protection of confidentiality, or prevention of embarrassment. The effects of informal care practices involving resident physicians warrant additional study.

  View details for DOI 10.1007/s40596-014-0170-3

  View details for Web of Science ID 000349304800005

  View details for PubMedID 24923781

• Caring for patients takes time: dr. Peabody says so! Academic psychiatry Beresin, E. V., Balon, R., Coverdale, J. H., Louie, A. K., Kim, J. P., Roberts, L. W. 2015; 39 (1): 1-5

  View details for DOI 10.1007/s40596-014-0250-4

  View details for PubMedID 25416611

• Moving Beyond Community Mental Health: Public Mental Health as an Emerging Focus for Psychiatry Residency Training. Academic psychiatry : the journal of the American Association of Directors of Psychiatric Residency Training and the Association for Academic Psychiatry Roberts, L. W., Beresin, E. V., Coverdale, J. H., Balon, R., Louie, A. K., Kim, J. P., Ohayon, M. M. 2014

  View details for DOI 10.1007/s40596-014-0230-8

  View details for PubMedID 25339288

• Giving voice to study volunteers: Comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research JOURNAL OF PSYCHIATRIC RESEARCH Roberts, L. W., Kim, J. P. 2014; 56: 90-97

  Abstract

  Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable.Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation.Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives regarding the ethical acceptability of clinical research participation by potentially vulnerable subpopulations (difference in acceptability perceived by mentally ill - healthy = -0.04, CI [-0.46, 0.39]; physically ill - healthy = -0.13, CI [-0.62, -.36]).Clinical research volunteers and healthy clinical research-"naïve" individuals view studies involving ill people as ethically acceptable, and their responses reflect concern regarding research that poses considerable burdens and risks and research involving vulnerable subpopulations. Physically ill research volunteers may be more willing to see burdensome and risky research as acceptable. Mentally ill research volunteers and healthy individuals expressed similar perspectives in this study, helping to dispel a misconception that those with mental illness should be presumed to hold disparate views.

  View details for DOI 10.1016/j.jpsychires.2014.05.007

  View details for Web of Science ID 000340318600012

  View details for PubMedID 24931849

  View details for PubMedCentralID PMC4109648

• Do investigators understand ethically-important perspectives of clinical research participants?: A 'piggy-back' study of attunement and alignment in serious illness research. Journal of psychiatric research Roberts, L. W., Kim, J. P. 2014; 52: 36-43

  Abstract

  The authors sought to compare investigators' predictions of clinical research participants' attitudes regarding ethically-important considerations in serious illness research with attitudes expressed by participants ("attunement"), to compare the personal attitudes of investigators and clinical research participants ("alignment"), and to explore the association between views expressed and covariates.The authors queried clinical research participants with either physical or mental illness (n=100) and faculty investigators conducting the clinical research protocols in which these participants were enrolled (n=77). Outcomes included attitudes regarding importance of medical research, attributes of seriously ill people in the research situation, and influences on enrollment decisions by seriously ill people. Generalized estimating equations and linear regression models were used.Investigators underestimated the importance of research about physical illness, mental illness, and healthy people to participants (βPI=0.59, 95% CI [0.36, 0.83]; βMI=0.60, 95% CI [0.27, 0.92]; βH=0.93, 95% CI [0.57, 1.29]). Investigators incorrectly predicted that participants would assess seriously ill people as more vulnerable in the research situation than participants did (β=-0.68, 95% CI [-1.11, -0.25]). Investigators and participants were aligned on the importance of illness research. Participants expressed greater agreement than investigators regarding the influences of ill individuals indicative of will and cognition in their enrollment decisions (β=0.69, 95% CI [0.25, 1.13]).Investigators are attuned to and aligned with research participants in many, but not all, respects. Investigators may bring a protective bias in their predictions of the vulnerabilities of ill volunteers.

  View details for DOI 10.1016/j.jpsychires.2014.01.012

  View details for PubMedID 24507883

• Randomized Clinical Trial to Evaluate the Efficacy and Safety of Valganciclovir in a Subset of Patients With Chronic Fatigue Syndrome JOURNAL OF MEDICAL VIROLOGY Montoya, J. G., Kogelnik, A. M., Bhangoo, M., Lunn, M. R., Flamand, L., Merrihew, L. E., Watt, T., Kubo, J. T., Paik, J., Desai, M. 2013; 85 (12): 2101-2109

  Abstract

  There is no known treatment for chronic fatigue syndrome (CFS). Little is known about its pathogenesis. Human herpesvirus 6 (HHV-6) and Epstein-Barr virus (EBV) have been proposed as infectious triggers. Thirty CFS patients with elevated IgG antibody titers against HHV-6 and EBV were randomized 2:1 to receive valganciclovir (VGCV) or placebo for 6 months in a double-blind, placebo-controlled trial. Clinical endpoints aimed at measuring physical and mental fatigue included the Multidimensional Fatigue Inventory (MFI-20) and Fatigue Severity Scale (FSS) scores, self-reported cognitive function, and physician-determined responder status. Biological endpoints included monocyte and neutrophil counts and cytokine levels. VGCV patients experienced a greater improvement by MFI-20 at 9 months from baseline compared to placebo patients but this difference was not statistically significant. However, statistically significant differences in trajectories between groups were observed in MFI-20 mental fatigue subscore (P = 0.039), FSS score (P = 0.006), and cognitive function (P = 0.025). VGCV patients experienced these improvements within the first 3 months and maintained that benefit over the remaining 9 months. Patients in the VGCV arm were 7.4 times more likely to be classified as responders (P = 0.029). In the VGCV arm, monocyte counts decreased (P < 0.001), neutrophil counts increased (P = 0.037) and cytokines were more likely to evolve towards a Th1-profile (P < 0.001). Viral IgG antibody titers did not differ between arms. VGCV may have clinical benefit in a subset of CFS patients independent of placebo effect, possibly mediated by immunomodulation and/or antiviral effect. Further investigation with longer treatment duration and a larger sample size is warranted.

  View details for DOI 10.1002/jmv.23713

  View details for PubMedID 23959519

• Real-Time Optical Biopsy of Colon Polyps With Narrow Band Imaging in Community Practice Does Not Yet Meet Key Thresholds for Clinical Decisions GASTROENTEROLOGY Ladabaum, U., Fioritto, A., Mitani, A., Desai, M., Kim, J. P., Rex, D. K., Imperiale, T., Gunaratnam, N. 2013; 144 (1): 81-91

  Abstract

  Accurate optical analysis of colorectal polyps (optical biopsy) could prevent unnecessary polypectomies or allow a "resect and discard" strategy with surveillance intervals determined based on the results of the optical biopsy; this could be less expensive than histopathologic analysis of polyps. We prospectively evaluated real-time optical biopsy analysis of polyps with narrow band imaging (NBI) by community-based gastroenterologists.We first analyzed a computerized module to train gastroenterologists (N = 13) in optical biopsy skills using photographs of polyps. Then we evaluated a practice-based learning program for these gastroenterologists (n = 12) that included real-time optical analysis of polyps in vivo, comparison of optical biopsy predictions to histopathologic analysis, and ongoing feedback on performance.Twelve of 13 subjects identified adenomas with >90% accuracy at the end of the computer study, and 3 of 12 subjects did so with accuracy ≥90% in the in vivo study. Learning curves showed considerable variation among batches of polyps. For diminutive rectosigmoid polyps assessed with high confidence at the end of the study, adenomas were identified with mean (95% confidence interval [CI]) accuracy, sensitivity, specificity, and negative predictive values of 81% (73%-89%), 85% (74%-96%), 78% (66%-92%), and 91% (86%-97%), respectively. The adjusted odds ratio for high confidence as a predictor of accuracy was 1.8 (95% CI, 1.3-2.5). The agreement between surveillance recommendations informed by high-confidence NBI analysis of diminutive polyps and results from histopathologic analysis of all polyps was 80% (95% CI, 77%-82%).In an evaluation of real-time optical biopsy analysis of polyps with NBI, only 25% of gastroenterologists assessed polyps with ≥90% accuracy. The negative predictive value for identification of adenomas, but not the surveillance interval agreement, met the American Society for Gastrointestinal Endoscopy-recommended thresholds for optical biopsy. Better results in community practice must be achieved before NBI-based optical biopsy methods can be used routinely to evaluate polyps; ClinicalTrials.gov number, NCT01638091.

  View details for DOI 10.1053/j.gastro.2012.09.054

  View details for Web of Science ID 000312965100029

  View details for PubMedID 23041328

• A Unified Approach to Semiparametric Transformation Models under General Biased Sampling Schemes. Journal of the American Statistical Association Kim, J. P., Lu, W., Sit, T., Ying, Z. 2013; 108 (501): 217-227

  Abstract

  We propose a unified estimation method for semiparametric linear transformation models under general biased sampling schemes. The new estimator is obtained from a set of counting process-based unbiased estimating equations, developed through introducing a general weighting scheme that offsets the sampling bias. The usual asymptotic properties, including consistency and asymptotic normality, are established under suitable regularity conditions. A closed-form formula is derived for the limiting variance and the plug-in estimator is shown to be consistent. We demonstrate the unified approach through the special cases of left truncation, length-bias, the case-cohort design and variants thereof. Simulation studies and applications to real data sets are presented.

  View details for DOI 10.1080/01621459.2012.746073

  View details for PubMedID 23667280

  View details for PubMedCentralID PMC3649773

• Donor Recipient Sex Mismatch in Kidney Transplantation GENDER MEDICINE Tan, J. C., Kim, J. P., Chertow, G. M., Grumet, F. C., Desai, M. 2012; 9 (5): 335-347

  Abstract

  The lack of reliable human proxies for minor (ie, non-HLA) histocompatibility loci hampers the ability to leverage these factors toward improving transplant outcomes. Despite conflicting reports of the effect of donor-recipient sex mismatch on renal allografts, the association between acute rejection of renal allografts and the development of human alloantibodies to the male H-Y antigen suggested to us that donor-recipient sex mismatch deserved re-evaluation.To evaluate whether the relationships between donor sex and allograft failure differed by recipient sex.We studied recipients of deceased-donor (n = 125,369) and living-donor (n = 63,139) transplants in the United States Renal Data System. Using Cox proportional hazards models stratified by donor type, we estimated the association between donor-recipient sex mismatch and death-censored allograft failure with adjustment for known risk factors, with and without the use of multiple imputation methods to account for potential bias and/or loss of efficiency due to missing data.The advantage afforded by male donor kidneys was more pronounced among male than among female recipients (8% vs 2% relative risk reduction; interaction P < 0.01). This difference is of the order of magnitude of several other risk factors affecting donor selection decisions.Donor-recipient sex mismatch affects renal allograft survival in a direction consistent with immune responses to sexually determined minor histocompatibility antigens. Our study provides a paradigm for clinical detection of markers for minor histocompatibility loci.

  View details for DOI 10.1016/j.genm.2012.07.004

  View details for PubMedID 22906727

• The diagnostic yield of CT-guided percutaneous lung biopsy in solid organ transplant recipients CLINICAL TRANSPLANTATION Hsu, J. L., Kuschner, W. G., Paik, J., Bower, N., Guillamet, M. C., Kothary, N. 2012; 26 (4): 615-621

  Abstract

  Despite the widespread use of computed tomography(CT)-guided percutaneous lung biopsy (PLB) in immunocompetent patients, the diagnostic yield and safety in solid organ transplant (SOT)recipients is unknown. The purpose of this investigation was to determine the test performance of CT-PLB in SOT recipients.We performed a 10-yr single-center, retrospective analysis among heart, lung, kidney, and liver transplant recipients. We included all adult patients who underwent a PLB of a parenchymal lung nodule following their transplantation.Within the study period, 1754 SOTs were performed, of which 45 biopsies met study criteria. Overall, the incidence of PLB in SOT was 3%.PLB established a diagnosis in 24 of 45 cases. The yield of PLB was better for combined biopsy technique (fine-needle aspiration biopsy [FNAB]) and core biopsy than for FNAB alone (odds ratio [OR]: 4.2, 95% confidence interval [CI]: 1.2, 15.6), and for lesions that were malignant (OR: 10.0, 95%CI: 1.8, 75.4) or caused by an invasive fungal infection (OR: 5.0, 95% CI:1.1, 27.9). Complications occurred in 13% (6/45) of patients.CT-guided PLB is a safe modality that provides a moderate yield for diagnosing pulmonary nodules of malignant or fungal etiology in SOT recipients.

  View details for DOI 10.1111/j.1399-0012.2011.01582.x

  View details for Web of Science ID 000307344400032

  View details for PubMedID 23050274

  View details for PubMedCentralID PMC3473075

• Validation of Reported Predialysis Nephrology Care of Older Patients Initiating Dialysis JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY Kim, J. P., Desai, M., Chertow, G. M., Winkelmayer, W. C. 2012; 23 (6): 1078-1085

  Abstract

  The Centers for Medicare and Medicaid Services (CMS) Medical Evidence Report (form CMS-2728) queries providers about the timing of the patient's first nephrologist consultation before initiation of dialysis. The monitoring of disease-specific goals in the Healthy People 2020 initiative will use information from this question, but the accuracy of the reported information is unknown. We defined a cohort of 80,509 patients aged ≥67 years who initiated dialysis between July 2005 and December 2008 with ≥2 years of uninterrupted Medicare coverage as their primary payer. The primary referent, determined from claims data, was the first observed outpatient nephrologist consultation; secondary analyses used the earliest nephrology consultation, whether inpatient or outpatient. We used linear regression models to assess the associations among the magnitude of discrepant reporting and patient characteristics and we tested for any temporal trends. When using the earliest recorded outpatient nephrology encounter, agreement between the two sources of ascertainment was 48.2%, and the κ statistic was 0.29 when we categorized the timing of the visit into four periods (never, <6, 6-12, and >12 months). When we dichotomized the timing of first predialysis nephrology care at >12 or ≤12 months, accuracy was 70% (κ=0.36), but it differed by patient characteristics and declined over time. In conclusion, we found substantial disagreement between information from the CMS Medical Evidence Report and Medicare physician claims on the timing of first predialysis nephrologist care. More-specific instructions may improve reporting and increase the utility of form CMS-2728 for research and public health surveillance.

  View details for DOI 10.1681/ASN.2011080871

  View details for PubMedID 22518002

• Trends in Acute Nonvariceal Upper Gastrointestinal Bleeding in Dialysis Patients JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY Yang, J., Lee, T., Montez-Rath, M. E., Paik, J., Chertow, G. M., Desai, M., Winkelmayer, W. C. 2012; 23 (3): 495-506

  Abstract

  Impaired kidney function is a risk factor for upper gastrointestinal (GI) bleeding, an event associated with poor outcomes. The burden of upper GI bleeding and its effect on patients with ESRD are not well described. Using data from the US Renal Data System, we quantified the rates of occurrence of and associated 30-day mortality from acute, nonvariceal upper GI bleeding in patients undergoing dialysis; we used medical claims and previously validated algorithms where available. Overall, 948,345 patients contributed 2,296,323 patient-years for study. The occurrence rates for upper GI bleeding were 57 and 328 episodes per 1000 person-years according to stringent and lenient definitions of acute, nonvariceal upper GI bleeding, respectively. Unadjusted occurrence rates remained flat (stringent) or increased (lenient) from 1997 to 2008; after adjustment for sociodemographic characteristics and comorbid conditions, however, we found a significant decline for both definitions (linear approximation, 2.7% and 1.5% per year, respectively; P<0.001). In more recent years, patients had higher hematocrit levels before upper GI bleeding episodes and were more likely to receive blood transfusions during an episode. Overall 30-day mortality was 11.8%, which declined significantly over time (relative declines of 2.3% or 2.8% per year for the stringent and lenient definitions, respectively). In summary, despite declining trends worldwide, crude rates of acute, nonvariceal upper GI bleeding among patients undergoing dialysis have not decreased in the past 10 years. Although 30-day mortality related to upper GI bleeding declined, perhaps reflecting improvements in medical care, the burden on the ESRD population remains substantial.

  View details for DOI 10.1681/ASN.2011070658

  View details for PubMedID 22266666

• Validity of Surrogate Measures for Functional Nephron Mass TRANSPLANTATION Tan, J. C., Paik, J., Chertow, G. M., Grumet, F. C., Busque, S., Lapasia, J., Desai, M. 2011; 92 (12): 1335-1341

  Abstract

  Transplanted nephron mass is an important determinant of long-term allograft survival, but accurate assessment before organ retrieval is challenging. Newer radiologic imaging techniques allow for better determination of total kidney and cortical volumes.Using volume measurements reconstructed from magnetic resonance or computed tomography imaging from living donor candidates, we characterized total kidney (n=312) and cortical volumes (n=236) according to sex, age, weight, height, body mass index (BMI), and body surface area (BSA).The mean cortical volume was 204 mL (range 105-355 mL) with no significant differences between left and right cortical volumes. The degree to which existing anthropomorphic surrogates predict nephron mass was quantified, and a diligent attempt was made to derive a better surrogate model for nephron mass. Cortical volumes were strongly associated with sex and BSA, but not with weight, height, or BMI. Four prediction models for cortical volume constructed using combinations of age, sex, race, weight, and height were compared with models including either BSA or BMI.Among existing surrogate measures, BSA was superior to BMI in predicting renal cortical volume. We were able to construct a statistically superior proxy for cortical volume, but whether relevant improvements in predictive accuracy could be gained needs further evaluation in a larger population.

  View details for DOI 10.1097/TP.0b013e31823705ef

  View details for PubMedID 22011765

• Intradialytic Hypotension and Vascular Access Thrombosis JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY Chang, T. I., Paik, J., Greene, T., Desai, M., Bech, F., Cheung, A. K., Chertow, G. M. 2011; 22 (8): 1526-1533

  Abstract

  Identifying potential modifiable risk factors to reduce the incidence of vascular access thrombosis in hemodialysis could reduce considerable morbidity and health care costs. We analyzed data from a subset of 1426 HEMO study subjects to determine whether more frequent intradialytic hypotension and/or lower predialysis systolic BP were associated with higher rates of vascular access thrombosis. Our primary outcome measure was episodes of vascular access thrombosis occurring within a given 6-month period during HEMO study follow-up. There were 2005 total episodes of vascular access thrombosis during a median 3.1 years of follow-up. The relative rate of thrombosis of native arteriovenous fistulas for the highest quartile of intradialytic hypotension was approximately twice that of the lowest quartile, independent of predialysis systolic BP and other covariates. There was no significant association of intradialytic hypotension with prosthetic arteriovenous graft thrombosis after multivariable adjustment. Higher predialysis systolic BP was associated with a lower rate of fistula and graft thrombosis, independent of intradialytic hypotension and other covariates. In conclusion, more frequent episodes of intradialytic hypotension and lower predialysis systolic BP associate with increased rates of vascular access thrombosis. These results underscore the importance of including vascular access patency in future studies of BP management in hemodialysis.

  View details for DOI 10.1681/ASN.2010101119

  View details for PubMedID 21803971

• Epidemiologic trends in penile anomalies and hypospadias in the state of California, 1985-2006 JOURNAL OF PEDIATRIC UROLOGY Elliott, C. S., Halpern, M. S., Paik, J., Maldonado, Y., Shortliffe, L. D. 2011; 7 (3): 294-298

  Abstract

  Using statewide data, we evaluated whether the changing incidence of penile anomalies and hypospadias is reflected in the diverse California population of newborn males over the past 20 years.Discharge data from all California hospitals, prepared by the OSHPD (Sacramento, CA) was reviewed for the years 1985-2006 for male infant births with an ICD-9 code (752.6) for hypospadias, epispadias or other penile anomalies. Trends were examined by Generalized Estimation Equations for Poisson regression.From 1985 to 2006, the birth incidence of newborn penile anomalies increased in California from 47 to 57 cases per 10,000 newborn discharges, yet the trend for hypospadias alone appears stable from 1997. The rates for penile anomalies in newborns increased 1.4% annually (p < 0.001). All racial/ethnic groups analyzed showed this increase (p < 0.001 for each). During the study period there was a 2% increase per year in plural births (p < 0.001). Interestingly, the rate of change in penile anomaly incidence was greater in males of plural births compared to their singleton cohorts (2% vs 1% annually) (p < 0.001). The birth incidence of cleft palate, another congenital anomaly known to be stable over time, remained unchanged over this period.From 1985 to 2006 in California the incidence of penile anomalies increased in a statistically significant manner, but the incidence of hypospadias appears stable for the last decade. Our data support the notion that different racial/ethnic groups have distinct incidences of penile anomaly formation and that an association with plural births appears to be present.

  View details for DOI 10.1016/j.jpurol.2011.03.006

  View details for PubMedID 21527236

• Updated comorbidity assessments and outcomes in prevalent hemodialysis patients HEMODIALYSIS INTERNATIONAL Chang, T. I., Paik, J., Greene, T., Miskulin, D. C., Chertow, G. M. 2010; 14 (4): 478-485

  Abstract

  When evaluating clinical characteristics and outcomes in patients on hemodialysis, the prevalence and severity of comorbidity may change over time. Knowing whether updated assessments of comorbidity enhance predictive power will assist the design of future studies. We conducted a secondary data analysis of 1846 prevalent hemodialysis patients from 15 US clinical centers enrolled in the HEMO study. Our primary explanatory variable was the Index of Coexistent Diseases score, which aggregates comorbidities, as a time-constant and time-varying covariate. Our outcomes of interest were all-cause mortality, time to first hospitalization, and total hospitalizations. We used Cox proportional hazards regression. Accounting for an updated comorbidity assessment over time yielded a more robust association with mortality than accounting for baseline comorbidity alone. The variation explained by time-varying comorbidity assessments on time to death was greater than age, baseline serum albumin, diabetes, or any other covariates. There was a less pronounced advantage of updated comorbidity assessments on determining time to hospitalization. Updated assessments of comorbidity significantly strengthen the ability to predict death in patients on hemodialysis. Future studies in dialysis should invest the necessary resources to include repeated assessments of comorbidity.

  View details for DOI 10.1111/j.1542-4758.2010.00468.x

  View details for PubMedID 20955281