Returning Individual Research Results from Digital Phenotyping in Psychiatry.

Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants' locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant's real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by a National Institute of Mental Health grant. Building on established guidelines and the emerging norm of returning results in participant-centered research, we present a novel framework specific to the ethical, legal, and social implications of returning IRRs in digital phenotyping research. Our framework offers researchers, clinicians, and Institutional Review Boards (IRBs) urgently needed guidance, and the principles developed here in the context of psychiatry will be readily adaptable to other therapeutic areas.

An Ethics Checklist for Digital Health Research in Psychiatry: Viewpoint.

BACKGROUND: Psychiatry has long needed a better and more scalable way to capture the dynamics of behavior and its disturbances, quantitatively across multiple data channels, at high temporal resolution in real time. By combining 24/7 data-on location, movement, email and text communications, and social media-with brain scans, genetics, genomics, neuropsychological batteries, and clinical interviews, researchers will have an unprecedented amount of objective, individual-level data. Analyzing these data with ever-evolving artificial intelligence could one day include bringing interventions to patients where they are in the real world in a convenient, efficient, effective, and timely way. Yet, the road to this innovative future is fraught with ethical dilemmas as well as ethical, legal, and social implications (ELSI). OBJECTIVE: The goal of the Ethics Checklist is to promote careful design and execution of research. It is not meant to mandate particular research designs; indeed, at this early stage and without consensus guidance, there are a range of reasonable choices researchers may make. However, the checklist is meant to make those ethical choices explicit, and to require researchers to give reasons for their decisions related to ELSI issues. The Ethics Checklist is primarily focused on procedural safeguards, such as consulting with experts outside the research group and documenting standard operating procedures for clearly actionable data (eg, expressed suicidality) within written research protocols. METHODS: We explored the ELSI of digital health research in psychiatry, with a particular focus on what we label "deep phenotyping" psychiatric research, which combines the potential for virtually boundless data collection and increasingly sophisticated techniques to analyze those data. We convened an interdisciplinary expert stakeholder workshop in May 2020, and this checklist emerges out of that dialogue. RESULTS: Consistent with recent ELSI analyses, we find that existing ethical guidance and legal regulations are not sufficient for deep phenotyping research in psychiatry. At present, there are regulatory gaps, inconsistencies across research teams in ethics protocols, and a lack of consensus among institutional review boards on when and how deep phenotyping research should proceed. We thus developed a new instrument, an Ethics Checklist for Digital Health Research in Psychiatry ("the Ethics Checklist"). The Ethics Checklist is composed of 20 key questions, subdivided into 6 interrelated domains: (1) informed consent; (2) equity, diversity, and access; (3) privacy and partnerships; (4) regulation and law; (5) return of results; and (6) duty to warn and duty to report. CONCLUSIONS: Deep phenotyping research offers a vision for vastly more effective care for people with, or at risk for, psychiatric disease. The potential perils en route to realizing this vision are significant; however, and researchers must be willing to address the questions in the Ethics Checklist before embarking on each leg of the journey.

Lewd, crude, and rude behavior: the impact of manners and etiquette in the general hospital.

BACKGROUND: Lewd, crude, and rude behaviors of patients and staff members have the potential to complicate care; unfortunately, the medical literature on manners and etiquette is sparse. OBJECTIVE: We sought to understand the impact of lewd, crude, and rude behaviors in the general hospital and to provide a context in which to educate clinicians about the management of troublesome behaviors of patients and staff members. METHOD: We reviewed the history of etiquette in the general hospital, and discuss the ethical ramifications and clinical management of inappropriate behaviors. RESULTS: Lewd, crude, and rude language and behaviors are often heard and seen in the general hospital; such behaviors can be understood in a biopsychosocial context. CONCLUSIONS: Teaching trainees about manners and etiquette can help them identify and manage offensive behaviors and can facilitate the provision of effective and ethical care.

Portrayals of professionalism by the media: trends in etiquette and bedside manners as seen on television.

BACKGROUND: Critics of current healthcare argue that professionalism, as manifest by etiquette and bedside manners, has been eroding, in part as a consequence of portrayals on television (TV) and in the media. OBJECTIVE: We sought to identify changing patterns of physicians' behaviors as shown on TV (as these interactions have often served as models for physicians-in-training) over the last 30 years. METHOD: We selected popular TV shows that portrayed practicing physicians and analyzed doctor-family, doctor-doctor, and doctor-nurse interactions as well as methods of disclosing errors to identify changing behavioral trends. RESULTS: We found that difficult news was more commonly delivered while standing, and that handshakes were rarely offered to patients. Male physicians were seen raising their voices toward, disclosing errors to, as well as inappropriately touching, peers or subordinates. In comparison, female physicians were identified as raising their voices toward, disclosing errors to, as well as inappropriately touching, their supervisors. Over the past several decades, official salutations between physicians and nurses have become less common; physicians have started to address nurses solely by their first names. More recently, sexual banter and sexual activity have been portrayed as occurring predominantly between male physicians and female nurses. CONCLUSIONS: While shifts in behavioral patterns (in etiquette, bedside manners, and professionalism) of physicians as seen on television have not been radical, potentially concerning trends were identified. Media portrayals may change patients' perceptions of physicians, hospitals, and the health care profession as well as influence behaviors of medical trainees. Moreover, TV and the media can be used as teaching tools about professionalism in healthcare providers.

Psychiatric treatment of the VIP: some paradoxical risks.

One might expect that VIPs-individuals with wealth, fame, or power-would typically receive excellent care when treated for psychiatric disorders. Often, this is the case, but paradoxically, VIP status may compromise the quality of psychiatric treatment. In this article, we present four case examples, representing disguised amalgamations of actual cases from our experience, demonstrating how VIP patients may sometimes receive suboptimal psychiatric care. These cases show certain similarities; typically, there was no serious doubt about the general nature of the treatment that should be undertaken, but the treatment team was unable to deliver that treatment in the usual manner because of various outside pressures created by the VIP status of the patient and by the patient's entourage. One possible solution to this problem, when feasible, is to assign treatment to a team specifically experienced with VIP patients. A strong and united treatment team, accustomed to the unusual difficulties and pressures often encountered with VIP patients, can be prepared to act promptly, firmly, and unanimously to devise an appropriate treatment plan and then maintain this plan true to its course despite these pressures.

Excluding People With Disabilities From Clinical Research: Eligibility Criteria Lack Clarity And Justification.

The exclusion of people with disabilities from clinical research without appropriate justification is discriminatory, is counter to federal regulations and research guidelines, and limits study generalizability. This matter is understudied, and data on the disability status of trial participants are rarely collected or reported. We analyzed ninety-seven recent interventional protocols in four therapeutic areas registered on ClinicalTrials.gov. Eighty-five percent of protocols allowed broad investigator discretion to determine eligibility, whereas only 18 percent explicitly permitted people with disabilities to use forms of support (such as supported decision making or assistive devices) to facilitate study participation. Eligibility criteria affecting people with disabilities included exclusions for psychiatric (68 percent), substance use (62 percent), HIV or hepatitis (53 percent), cognitive or intellectual (42 percent), visual (34 percent), hearing (10 percent), mobility (9 percent), long-term care (6 percent), and speech and communication (3 percent) disability-related domains. Documented justification was provided for only 24 percent of these exclusions. We recommend greater scrutiny of study eligibility criteria, scientific or ethical justification of exclusions, and accessible study design.

Using Wearable Cameras to Investigate Health-Related Daily Life Experiences: A Literature Review of Precautions and Risks in Empirical Studies.

Automated, wearable cameras can benefit health-related research by capturing accurate and objective information about individuals' daily experiences. However, wearable cameras present unique privacy- and confidentiality-related risks due to the possibility of the images capturing identifying or sensitive information from participants and third parties. Although best practice guidelines for ethical research with wearable cameras have been published, limited information exists on the risks of studies using wearable cameras. The aim of this literature review was to survey risks related to using wearable cameras, and precautions taken to reduce those risks, as reported in empirical research. Forty-five publications, comprising 36 independent studies, were reviewed, and findings revealed that participants' primary concerns with using wearable cameras included physical inconvenience and discomfort in certain situations (e.g., public settings). None of the studies reviewed reported any serious adverse events. Although it is possible that reported findings do not include all risks experienced by participants in research with wearable cameras, our findings suggest a low level of risk to participants. However, it is important that investigators adopt recommended precautions, which can promote autonomy and reduce risks, including participant discomfort.

Interferon-induced psychosis as a "psychiatric contraindication" to hepatitis C treatment: a review and case-based discussion.

BACKGROUND: Hepatitis C (HCV) infection is a major cause of liver disease, cirrhosis, and hepatocellular carcinoma. Interferon-based treatments have the potential to decrease the burden of disease, but are complicated by side effects, including neuropsychiatric symptoms. OBJECTIVE: The authors described a case of interferon-induced psychosis as a framework to review the literature and discuss the decision to pursue antiviral treatment in psychiatrically ill patients with hepatitis C. METHOD: The authors followed a patient with chronic HCV who received interferon and ribavirin and who developed hallucinations ultimately requiring psychiatric hospitalization. RESULTS: Despite treatment with various neuroleptics, the psychosis resolved only when the interferon/ribavirin were discontinued. CONCLUSION: Psychiatric illness should not rule out the possibility of interferon-based therapy, but it calls for close integration of psychiatric and medical care and individualized decision-making based on the biological and psychosocial circumstances of each case.

Patient-targeted googling: the ethics of searching online for patient information.

With the growth of the Internet, psychiatrists can now search online for a wide range of information about patients. Psychiatrists face challenges of maintaining professional boundaries with patients in many circumstances, but little consideration has been given to the practice of searching online for information about patients, an act we refer to as patient-targeted Googling (PTG). Psychiatrists are not the only health care providers who can investigate their patients online, but they may be especially likely to engage in PTG because of the unique relationships involved in their clinical practice. Before searching online for a patient, psychiatrists should consider such factors as the intention of searching, the anticipated effect of gaining information online, and its potential value or risk for the treatment. The psychiatrist is obligated to act in a way that respects the patient's best interests and that adheres to professional ethics. In this article, we propose a pragmatic model for considering PTG that focuses on practical results of searches and that aims to minimize the risk of exploiting patients. We describe three cases of PTG, highlighting important ethical dilemmas in multiple practice settings. Each case is discussed from the standpoint of the pragmatic model.

Characterization of renal allograft rejection by urinary proteomic analysis.

OBJECTIVE: To develop a diagnostic method with no morbidity or mortality for the detection of acute renal transplant rejection. SUMMARY BACKGROUND DATA: Rejection constitutes the major impediment to the success of transplantation. Currently available methods, including clinical presentation and biochemical organ function parameters, often fail to detect rejection until late stages of progression. Renal biopsies have associated morbidity and mortality and provide only a limited sample of the organ. METHODS: Thirty-four urine samples were collected from 32 renal transplant patients at various stages posttransplantation. Samples were collected from 17 transplant recipients with acute rejection and 15 patients with no rejection. Samples from patients less than 4 days posttransplant were omitted from data analysis due to the presence of excessive inflammatory response proteins. Rejection status was confirmed by kidney biopsy. Specimens were analyzed in triplicate using SELDI mass spectrometry. The obtained spectra were subjected to bioinformatic analysis using ProPeak as well as CART (Classification and Regression Tree) algorithms to identify rejection biomarker candidates. These candidates were identified by their molecular weight and ranked by their ability to distinguish between nonrejection and rejection based on receiver operating characteristic (ROC) analysis. The candidates with the highest area under the ROC curve (AUC) exhibited the best diagnostic performance. RESULTS: The best candidate biomarkers demonstrated highly successful diagnostic performance: 6.5 kd (AUC = 0.839, P <.0001), 6.7 kd (AUC = 0.839, P <.0001), 6.6 kd (AUC = 0.807, P <.0001), 7.1 kd (AUC = 0.807, P <.0001), and 13.4 kd (AUC = 0.804, P <.0001). A separate analysis using the CART algorithm in the Ciphergen Biomarker Pattern Software correctly classified 91% of the 34 specimens in the training set, giving a sensitivity of 83% and specificity of 100% using two separate biomarker candidates at 10.0 kd and 3.4 kd. CONCLUSIONS: Biomarker candidates exist in urine that have the ability to distinguish between renal transplant patients with no rejection and those with acute rejection. These biomarker candidates are the basis for development of a noninvasive method of diagnosing acute rejection without the morbidity and mortality associated with needle biopsy. The combination of biomarkers into a panel for diagnosis leads to the possibility of enhanced diagnostic performance.