BackgroundConversational assistants, such as Siri, Alexa, and Google Assistant, are ubiquitous and are beginning to be used as portals for medical services. However, the potential safety issues of using conversational assistants for medical information by patients and consumers are not understood.ObjectiveTo determine the prevalence and nature of the harm that could result from patients or consumers using conversational assistants for medical information.MethodsParticipants were given medical problems to pose to Siri, Alexa, or Google Assistant, and asked to determine an action to take based on information from the system. Assignment of tasks and systems were randomized across participants, and participants queried the conversational assistants in their own words, making as many attempts as needed until they either reported an action to take or gave up. Participant-reported actions for each medical task were rated for patient harm using an Agency for Healthcare Research and Quality harm scale.ResultsFifty-four subjects completed the study with a mean age of 42 years (SD 18). Twenty-nine (54%) were female, 31 (57%) Caucasian, and 26 (50%) were college educated. Only 8 (15%) reported using a conversational assistant regularly, while 22 (41%) had never used one, and 24 (44%) had tried one “a few times.“ Forty-four (82%) used computers regularly. Subjects were only able to complete 168 (43%) of their 394 tasks. Of these, 49 (29%) reported actions that could have resulted in some degree of patient harm, including 27 (16%) that could have resulted in death.ConclusionsReliance on conversational assistants for actionable medical information represents a safety risk for patients and consumers. Patients should be cautioned to not use these technologies for answers to medical questions they intend to act on without further consultation from a health care provider.

Background: Several single-site alcohol treatment clinical trials have demonstrated efficacy for immediate-release (IR) gabapentin in reducing drinking outcomes among individuals with alcohol dependence. The purpose of this study was to conduct a large, multisite clinical trial of gabapentin enacarbil extended-release (GE-XR) (HORIZANT®), a gabapentin prodrug formulation, to determine its safety and efficacy in treating alcohol use disorder (AUD). Methods: Men and women (n= 346) who met DSM–5 criteria for at least moderate AUD were recruited across 10 US clinical sites. Participants received double-blind GE-XR (600 mg twice a day [BID]) or placebo and a computerized behavioral intervention (Take Control) for 6 months. Efficacy analyses were pre-specified for the last 4 weeks of the treatment period. Results: The GE-XR and placebo groups did not differ significantly on the primary outcome measure, percentage of subjects with no heavy drinking days (28.3 vs 21.5, respectively, p=0.157). Similarly, no clinical benefit was found for other drinking measures (percent subjects abstinent, percent days abstinent, percent heavy drinking days, drinks per week, drinks per drinking day), alcohol craving, alcohol-related consequences, sleep problems, smoking, and depression/anxiety symptoms. Common side-effects were fatigue, dizziness, and somnolence. A population pharmacokinetics analysis revealed that patients had lower gabapentin exposure levels compared with those in other studies using a similar dose but for other indications. Conclusion: Overall, GE-XR at 600 mg BID did not reduce alcohol consumption or craving in individuals with AUD. It is possible that, unlike the IR formulation of gabapentin, which showed efficacy in smaller Phase 2 trials at a higher dose, GE-XR is not effective in treating AUD, at least not at doses approved by the FDA for treating other medical conditions.

In June 2011, a cluster of suspected cases of Guillain-Barré syndrome (GBS), which can follow Campylobacter jejuni infection, was identified in San Luis Río Colorado (SLRC), Sonora, Mexico and Yuma County, Arizona, USA. An outbreak investigation identified 26 patients (18 from Sonora, eight from Arizona) with onset of GBS 4 May-21 July 2011, exceeding the expected number of cases (n = 1-2). Twenty-one (81%) patients reported antecedent diarrhoea, and 61% of 18 patients tested were seropositive for C. jejuni IgM antibodies. In a case-control study matched on age group, sex, ethnicity, and neighbourhood of residence, all Arizona GBS patients travelled to SLRC during the exposure period vs. 45% of matched controls (matched odds ratio 8·1, 95% confidence interval 1·5-∞). Exposure information and an environmental assessment suggested that GBS cases resulted from a large outbreak of C. jejuni infection from inadequately disinfected tap water in SLRC. Binational collaboration was essential in investigating this cross-border GBS outbreak, the first in mainland North America since 1976.

Opioid use disorder (OUD) is increasingly recognized as a chronic, relapsing brain disease whose treatment should be integrated into primary care settings alongside other chronic conditions. However, abstinence from all non-prescribed substance use continues to be prioritized as the only desired goal in many outpatient, primary care–based treatment programs. This presents a barrier to engagement for patients who continue to use substances and who may be at high risk for complications of ongoing substance use such as human immunodeficiency virus (HIV), hepatitis C virus (HCV), superficial and deep tissue infections, and overdose. Harm reduction aims to reduce the negative consequences of substance use and offers an alternative to abstinence as a singular goal. Incorporating harm reduction principles into primary care treatment settings can support programs in engaging patients with ongoing substance use and facilitate the delivery of evidence-based screening and prevention services. The objective of this narrative review is to describe strategies for the integration of evidence-based harm reduction principles and interventions into outpatient, primary care–based OUD treatment settings. We will offer specific tools for providers and programs including strategies to support safer injection practices, assess the risks and benefits of continuing medications for opioid use disorder in the setting of ongoing substance use, promote a non-stigmatizing program culture, and address the needs of special populations with ongoing substance use including adolescents, parents, and families. Supplementary Information The online version contains supplementary material available at 10.1007/s11606-021-06904-4.

No abstract

Background The coronavirus disease 2019 (COVID-19) pandemic has challenged researchers performing clinical trials to develop innovative approaches to mitigate infectious risk while maintaining rigorous safety monitoring. Methods In this report we describe the implementation of a novel exclusively remote randomized clinical trial (ClinicalTrials.gov NCT04354428) of hydroxychloroquine and azithromycin for the treatment of the SARS-CoV-2–mediated COVID-19 disease which included cardiovascular safety monitoring. All study activities were conducted remotely. Self-collected vital signs (temperature, respiratory rate, heart rate, and oxygen saturation) and electrocardiographic (ECG) measurements were transmitted digitally to investigators while mid-nasal swabs for SARS-CoV-2 testing were shipped. ECG collection relied on a consumer device (KardiaMobile 6L, AliveCor Inc.) that recorded and transmitted six-lead ECGs via participants’ internet-enabled devices to a central core laboratory, which measured and reported QTc intervals that were then used to monitor safety. Results Two hundred and thirty-one participants uploaded 3245 ECGs. Mean daily adherence to the ECG protocol was 85.2% and was similar to the survey and mid-nasal swab elements of the study. Adherence rates did not differ by age or sex assigned at birth and were high across all reported race and ethnicities. QTc prolongation meeting criteria for an adverse event occurred in 28 (12.1%) participants, with 2 occurring in the placebo group, 19 in the hydroxychloroquine group, and 7 in the hydroxychloroquine + azithromycin group. Conclusions Our report demonstrates that digital health technologies can be leveraged to conduct rigorous, safe, and entirely remote clinical trials.

BACKGROUND: Urine drug testing (UDT) is a recommended risk mitigation strategy for patients prescribed opioids for chronic pain, but evidence that UDT supports identification of substance misuse is limited. OBJECTIVE: Identify the prevalence of UDT results that may identify substance misuse, including diversion, among patients prescribed opioids for chronic pain. DESIGN: Retrospective cohort study. SUBJECTS: Patients (n=638) receiving opioids for chronic pain who had one or more UDTs, examining up to eight substances per sample, during a one 1-year period. MAIN MEASURES: Experts adjudicated the clinical concern that UDT results suggest substance misuse or diversion as not concerning, uncertain, or concerning. KEY RESULTS: Of 638 patients, 48% were female and 49% were over age 55 years. Patients had a median of three UDTs during the intervention year. We identified 37% of patients (235/638) with ≥1 concerning UDT and a further 35% (222/638) having ≥1 uncertain UDT. We found concerning UDTs due to non-detection of a prescribed substance in 24% (156/638) of patients and detection of a non-prescribed substance in 23% (147/638). Compared to patients over 65 years, those aged 18-34 years were more likely to have concerning UDT results with an adjusted odds ratio (AOR) of 4.8 (95% confidence interval [CI] 1.9-12.5). Patients with mental health diagnoses (AOR 1.6 [95% CI 1.1-2.3]) and substance use diagnoses (AOR 2.3 [95% CI 1.5-3.7]) were more likely to have a concerning UDT result. CONCLUSIONS: Expert adjudication of UDT results identified clinical concern for substance misuse in 37% of patients receiving opioids for chronic pain. Further research is needed to determine if UDTs impact clinical practice or patient-related outcomes.

BACKGROUND Conversational assistants, such as Siri, Alexa, and Google Assistant, are ubiquitous and are beginning to be used as portals for medical services. However, the potential safety issues of using conversational assistants for medical information by patients and consumers are not understood. OBJECTIVE To determine the prevalence and nature of the harm that could result from patients or consumers using conversational assistants for medical information. METHODS Participants were given medical problems to pose to Siri, Alexa, or Google Assistant, and asked to determine an action to take based on information from the system. Assignment of tasks and systems were randomized across participants, and participants queried the conversational assistants in their own words, making as many attempts as needed until they either reported an action to take or gave up. Participant-reported actions for each medical task were rated for patient harm using an Agency for Healthcare Research and Quality harm scale. RESULTS Fifty-four subjects completed the study with a mean age of 42 years (SD 18). Twenty-nine (54%) were female, 31 (57%) Caucasian, and 26 (50%) were college educated. Only 8 (15%) reported using a conversational assistant regularly, while 22 (41%) had never used one, and 24 (44%) had tried one “a few times.“ Forty-four (82%) used computers regularly. Subjects were only able to complete 168 (43%) of their 394 tasks. Of these, 49 (29%) reported actions that could have resulted in some degree of patient harm, including 27 (16%) that could have resulted in death. CONCLUSIONS Reliance on conversational assistants for actionable medical information represents a safety risk for patients and consumers. Patients should be cautioned to not use these technologies for answers to medical questions they intend to act on without further consultation from a health care provider.