Multiplatform web app (My Way Up) plus motivational interviewing for improving treatment retention in patients with onset of alcohol-related liver disease and alcohol use disorder - an example of participatory research.

Background: With the aim of improving treatment retention in patients with the onset of alcohol-related liver disease (ArLD), we designed a blended intervention (brief motivational intervention + 'serious game' (SG)). We present the participatory design methodology and outcomes and the usability assessment of the intervention. Methods: (1) The design of the SG was based on the outcomes of two 3-h co-creation sessions with 37 participants (healthcare and technology professionals, patients, and patients' relatives). The brief face-to-face motivational intervention was based on the 5 As Model and adapted to the ArLD population. (2) Usability pilot study: 20 participants (10 ArLD patients + 10 healthcare professionals) received the intervention. System Usability Scale (SUS) and Post-Study System Usability Questionnaire (PSSUQ) were applied to assess the SG usability and patients' satisfaction with it. Weekly semi-structured interviews on the phone were conducted to identify the preferred elements in the SG and those aspects that should be improved. Results: (1) Design: an SG in the form of a gamified web app, consisting of a daily activity for six weeks and adapted brief motivational interviewing. (2) Usability pilot study: usability results were excellent for both patients and healthcare professionals (SUS median score = 85). The general usability, the quality of the information provided by the SG and the quality of the interface were very positively rated in the PSSUQ (overall median score = 2, IQR = 1-2). The best-rated aspects were the provision of feedback, the use of metaphors and the application of audiovisual material. Changes in the design, response mechanics and content were applied after the study. Conclusions: The usability and acceptability of an intervention for increasing retention to treatment in patients with recent onset of ArLD and AUD were excellent for patients and healthcare professionals. A randomized-controlled trial is required to test the efficacy of this approach.

Optimizing Digital Tools for the Field of Substance Use and Substance Use Disorders: Backcasting Exercise.

BACKGROUND: Substance use trends are complex; they often rapidly evolve and necessitate an intersectional approach in research, service, and policy making. Current and emerging digital tools related to substance use are promising but also create a range of challenges and opportunities. OBJECTIVE: This paper reports on a backcasting exercise aimed at the development of a roadmap that identifies values, challenges, facilitators, and milestones to achieve optimal use of digital tools in the substance use field by 2030. METHODS: A backcasting exercise method was adopted, wherein the core elements are identifying key values, challenges, facilitators, milestones, cornerstones and a current, desired, and future scenario. A structured approach was used by means of (1) an Open Science Framework page as a web-based collaborative working space and (2) key stakeholders' collaborative engagement during the 2022 Lisbon Addiction Conference. RESULTS: The identified key values were digital rights, evidence-based tools, user-friendliness, accessibility and availability, and person-centeredness. The key challenges identified were ethical funding, regulations, commercialization, best practice models, digital literacy, and access or reach. The key facilitators identified were scientific research, interoperable infrastructure and a culture of innovation, expertise, ethical funding, user-friendly designs, and digital rights and regulations. A range of milestones were identified. The overarching identified cornerstones consisted of creating ethical frameworks, increasing access to digital tools, and continuous trend analysis. CONCLUSIONS: The use of digital tools in the field of substance use is linked to a range of risks and opportunities that need to be managed. The current trajectories of the use of such tools are heavily influenced by large multinational for-profit companies with relatively little involvement of key stakeholders such as people who use drugs, service providers, and researchers. The current funding models are problematic and lack the necessary flexibility associated with best practice business approaches such as lean and agile principles to design and execute customer discovery methods. Accessibility and availability, digital rights, user-friendly design, and person-focused approaches should be at the forefront in the further development of digital tools. Global legislative and technical infrastructures by means of a global action plan and strategy are necessary and should include ethical frameworks, accessibility of digital tools for substance use, and continuous trend analysis as cornerstones.

Vickybot, a Chatbot for Anxiety-Depressive Symptoms and Work-Related Burnout in Primary Care and Health Care Professionals: Development, Feasibility, and Potential Effectiveness Studies.

BACKGROUND: Many people attending primary care (PC) have anxiety-depressive symptoms and work-related burnout compounded by a lack of resources to meet their needs. The COVID-19 pandemic has exacerbated this problem, and digital tools have been proposed as a solution. OBJECTIVE: We aimed to present the development, feasibility, and potential effectiveness of Vickybot, a chatbot aimed at screening, monitoring, and reducing anxiety-depressive symptoms and work-related burnout, and detecting suicide risk in patients from PC and health care workers. METHODS: Healthy controls (HCs) tested Vickybot for reliability. For the simulation study, HCs used Vickybot for 2 weeks to simulate different clinical situations. For feasibility and effectiveness study, people consulting PC or health care workers with mental health problems used Vickybot for 1 month. Self-assessments for anxiety (Generalized Anxiety Disorder 7-item) and depression (Patient Health Questionnaire-9) symptoms and work-related burnout (based on the Maslach Burnout Inventory) were administered at baseline and every 2 weeks. Feasibility was determined from both subjective and objective user-engagement indicators (UEIs). Potential effectiveness was measured using paired 2-tailed t tests or Wilcoxon signed-rank test for changes in self-assessment scores. RESULTS: Overall, 40 HCs tested Vickybot simultaneously, and the data were reliably transmitted and registered. For simulation, 17 HCs (n=13, 76% female; mean age 36.5, SD 9.7 years) received 98.8% of the expected modules. Suicidal alerts were received correctly. For the feasibility and potential effectiveness study, 34 patients (15 from PC and 19 health care workers; 76% [26/34] female; mean age 35.3, SD 10.1 years) completed the first self-assessments, with 100% (34/34) presenting anxiety symptoms, 94% (32/34) depressive symptoms, and 65% (22/34) work-related burnout. In addition, 27% (9/34) of patients completed the second self-assessment after 2 weeks of use. No significant differences were found between the first and second self-assessments for anxiety (t8=1.000; P=.34) or depressive (t8=0.40; P=.70) symptoms. However, work-related burnout scores were moderately reduced (z=-2.07, P=.04, r=0.32). There was a nonsignificant trend toward a greater reduction in anxiety-depressive symptoms and work-related burnout with greater use of the chatbot. Furthermore, 9% (3/34) of patients activated the suicide alert, and the research team promptly intervened with successful outcomes. Vickybot showed high subjective UEI (acceptability, usability, and satisfaction), but low objective UEI (completion, adherence, compliance, and engagement). Vickybot was moderately feasible. CONCLUSIONS: The chatbot was useful in screening for the presence and severity of anxiety and depressive symptoms, and for detecting suicidal risk. Potential effectiveness was shown to reduce work-related burnout but not anxiety or depressive symptoms. Subjective perceptions of use contrasted with low objective-use metrics. Our results are promising but suggest the need to adapt and enhance the smartphone-based solution to improve engagement. A consensus on how to report UEIs and validate digital solutions, particularly for chatbots, is required.

"Doctor, Can I Drink an Alcohol-Free Beer?" Low-Alcohol and Alcohol-Free Drinks in People with Heavy Drinking or Alcohol Use Disorders: Systematic Review of the Literature.

No- and low-alcohol drinks (NoLo) have been proposed as a potential way forward for the reduction in the alcohol burden of disease. So far, there is scarce synthesized evidence on the effects of these products on people with alcohol use disorder (AUD), or with a heavy or high-risk drinking pattern. The aim of the present study is to systematically review the evidence of the use of NoLo drinks in these populations. A total of 4045 records were screened and 10 studies were included in the review. Craving and desire to drink have been found to increase after the consumption of NoLo drinks in patients with AUD. The increase in craving correlates with the severity of alcohol dependence. In addition, in this population, alcohol-related cues might trigger physiological responses similar to those experienced when using alcohol. Furthermore, as mentioned, in some of the studies, consumption was shown to increase as the %ABV or verbal descriptors indicate lower alcohol. Last, according to the epidemiological data, heavy drinkers tend to use NoLo drinks on top of their usual alcohol consumption rather than as part of regular drinking patterns. Further studies should be conducted in people with AUD or people with a high-risk drinking pattern to provide new insight to guide clinicians, patients, and other stakeholders to make evidence-based informed decisions.

Telemedicine in the treatment of addictions.

PURPOSE OF REVIEW: The purpose of this update is to provide an overview of recent research publications (January 2020-January 2022) on real-time telemedicine solutions for the management of addictions (alcohol, tobacco, opioids, and other drugs). RECENT FINDINGS: Motivational interviewing by real-time telemedicine showed effectiveness in youth and adults for risky alcohol use and alcohol use disorders, even when a concurrent mental health disorder exists. Live telemedicine is well accepted for managing tobacco use disorders. The range of interventions for treating opioid use disorder by real-time telemedicine is large and has been increased due to the coronavirus disease 2019 (COVID-19) pandemic (prescription of opioid agonists, peer-to-peer support, counseling, and group therapy). SUMMARY: The COVID-19 pandemic has accelerated the implementation of real-time telemedicine and, in parallel, research has been conducted to test its effectiveness. Videoconferencing and telephone interventions are supported by solid evidence for risky alcohol use and alcohol use disorder, tobacco use disorder and opioid use disorder. The Integration of other types of telemedicine (asynchronous telemedicine and remote monitoring) and with the entire health system is lacking. Many areas and vulnerable populations (e.g., homeless, elderly, and cannabis use disorders) need more attention.

Rehabilitation Gaming System for Alcohol-Related Cognitive Impairment: A Pilot Usability Study.

AIMS: Cognitive impairment in patients with alcohol use disorder (AUD) is highly prevalent, and it negatively impacts treatment outcome. However, this condition is neither systematically assessed nor treated. Thus, we aimed to explore the usability of a virtual reality-based protocol ('Rehabilitation Gaming System', RGS) for patients with AUD. METHODS: Twenty AUD patients (50% also cognitive impairment) underwent a single session of the RGS protocol (four cognitive training tasks, 10 minutes each). System Usability Scale (SUS) and Post-Study System Usability Questionnaire (PSSUQ) were applied to assess the RGS usability and patients' satisfaction with it. Also, the Perceived Competence Scale was administered to assess the patients' feelings of competence when using the training protocol. Comparisons of the responses to these questionnaires were performed between AUD patients with cognitive impairment and those without cognitive impairment. RESULTS: RGS usability was very positively rated (median SUS score = 80, Interquartile Range, IQR = 68.13-86-88). No significant differences were found in the median SUS scores for any of the sociodemographic or clinical variables, excepting for gender (women median score = 85; IQR = 80-94.38 vs. men median score = 71.25; IQR = 61.25-89.25; P-value = 0.035). The quality of the information provided by the RGS training scenarios and the usability were positively rated (PSSUQ), and patients experienced high feelings of competence. CONCLUSIONS: The RGS has been found to be usable in the short term and patients with AUD stated to be satisfied with it. Future larger, randomized trials are needed to explore the effectiveness of this tool to help overcome the cognitive deficits in AUD patients.

A randomized controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website (EFAR Spain).

BACKGROUND: Brief interventions (BI) for risky drinkers in primary healthcare have been demonstrated to be cost-effective but they are still poorly implemented. Digital BI seems to be a complementary strategy to overcome some barriers to implementation but there is a scarcity of studies in clinical environments. We present the results of a randomized controlled non-inferiority trial which tests the non-inferiority of facilitated access to a digital intervention (experimental condition) for risky drinkers against a face-to-face BI (control condition) provided by primary healthcare professionals. METHOD: In a non-inferiority randomized controlled trial, unselected primary healthcare patients (≥ 18 years old) were given a brief introduction and asked to log on to the study website to fill in the 3-item version of the Alcohol Use Disorders Identification Test. Positively screened patients (4+ for women and 5+ for men) received further online assessment (AUDIT, socio-demographic characteristics and EQ-5D-5L) and were automatically randomized to either face-to-face or digital BI (1:1). The primary outcome was the proportion of patients classified as risky drinkers by the digitally administered AUDIT at month 3. A multiple imputation approach for the missing data was performed. RESULTS: Of the 4499 patients approached by 115 healthcare professionals, 1521 completed the AUDIT-C. Of the 368 positively screened patients, 320 agreed to participate and were randomized to either intervention. At month 3, there were more risky drinkers in the experimental group (59.8%) than in the control group (52%), which was similar to the distribution at baseline and less than the pre-specified margin of 10%. The difference was not significant when accounting for possible confounders. CONCLUSION: Digital BI was not inferior to face-to-face BI, in line with previous findings and the a priori hypothesis. However, the low power of the final sample, due to the low recruitment and loss to follow-up, limits the interpretation of the findings. New approaches in this field are required to ensure the effective implementation of digital interventions in actual practice.

Mid and long-term effects of a SBIRT program for at-risk drinkers attending to an emergency department. Follow-up results from a randomized controlled trial.

BACKGROUND AND IMPORTANCE: SBIRT programs (Screening Brief Intervention and Referral to Treatment) for at-risk drinkers in emergency departments (ED) have shown to be effective, particularly at short term. In this article, we report mid and long-term follow-up results of a specialized SBIRT program. A short-term follow-up after 1.5 months showed encouraging results, with more than a 20% greater reduction of at-risk drinking in the intervention group and more than double of successful referrals to specialized treatment. OBJECTIVE: We aimed to evaluate the mid and long-term efficacy of an SBIRT program conducted by psychiatrist specialists in addictive disorders and motivational interviewing in the ED of a tertiary hospital. DESIGN, SETTINGS AND PARTICIPANTS: We conducted a secondary analysis of a previously published randomized controlled trial of an SBIRT program conducted by alcohol specialists for at-risk drinkers presenting to the ED, measured with the AUDIT-C scale. INTERVENTION OR EXPOSURE: Patients were randomized into two groups, with the control group receiving two leaflets: one regarding alcohol use and the other giving information about the study protocol. The intervention group received the same leaflets as well as a brief motivational intervention on alcohol use and, where appropriate, a referral to specialized treatment. OUTCOMES MEASURE AND ANALYSIS: Long-term assessment primary outcome was the proportion of at-risk alcohol use measured by AUDIT-C scale. The main effectiveness analysis at 18 weeks and 12 months' follow-up was conducted with multilevel logistic regression analyses. Missing values were imputed with the last observation carried forward. MAIN RESULTS: Of 200 patients included in the study, 133 (66.5%) and 131 (65.5%) completed 18 weeks and 1-year follow-up respectively. Although the proportion of risky drinkers was substantially lower in the intervention group (38.5 vs. 57.4% at 4.5 months and 58.5 vs 68.2% at 1 year), these results did not reach statistical significance (OR = 2.15; CI, 0.87-5.33). CONCLUSIONS: In this secondary analysis for mid- and long-term effects of a specialized SBIRT program, there was no significant difference in the reduction of risky drinkers at 18 weeks and 1 year. The small size of the studied sample and the low retention rate precluded any significant conclusion, although point estimates suggest a positive effect. Overall, SBIRT programs are an effective tool to reduce alcohol use at short time and to refer patients to specialized treatment; however, its effects seem to decay over time.

A systematic review of treatments for alcohol-related cognitive impairment: lessons from the past and gaps for future interventions.

Alcohol-related cognitive impairment (ARCI) is highly prevalent among patients with alcohol dependence. Although it negatively influences treatment outcome, this condition is underdiagnosed and undertreated. The aim of this systematic review is to investigate the existing evidence regarding both cognitive and pharmacological interventions for ARCI. We systematically reviewed PubMed, Scopus and Science direct databases up to May 2019 and followed the PRISMA guidelines. The quality of the studies was assessed using the Jadad Scale. Twenty-six studies were eligible for inclusion (14 referring to neuropsychological interventions and 12 to pharmacological treatments). Among neuropsychological interventions, computerised treatments, errorless learning and component method showed positive effects on working memory, memory measures and general cognitive function. On the other hand, thiamine, memantine and methylphenidate improved working memory, long-term memory and general cognitive function. Nevertheless, these studies have several limitations, such as small sample size, lack of replication of the results or low specificity of the interventions. Therefore, no gold-standard intervention can yet be recommended for clinical practice, and further research based on promising strategies (e.g. digital interventions, thiamine) is required.

Active Smoking Before Liver Transplantation in Patients with Alcohol Use Disorder: Risk Factors and Outcomes.

Tobacco use is more prevalent among alcohol liver disease (ALD) transplant patients and exerts harmful effects to the patient and to the graft. The aims of this study were to examine the impact of smoking status (nonsmoker, ex-smoker, active smoker) on patient survival and clinical outcomes, and to assess risk factors for active smoking before and after liver transplant (LT). An observational retrospective cohort study with 314 ALD patients undergoing LT from January 2004 to April 2016. Recipients were followed until April 2017 or death. Kaplan-Meier and Cox proportional hazards regression analyses were used to assess risk of mortality according to smoking status before LT. Smokers had a 79% higher risk of dying than those who had never smoked or quit smoking before LT. Ex-smokers had a greater survival probability (96.2%, 93.8%, 86.9%, and 83.1% at 1, 3, 5, and 10 years after LT) than active smokers until LT (96.0%, 85.6%, 80.0%, and 70.4%). Active smokers before LT with poor toxicity awareness had more than a twofold higher risk of mortality (Cox HR = 2.20, 95% CI: 1.05-4.58, p = 0.04) than ex-smokers. Younger age (OR = 94), higher Model for End-Stage Liver Disease (MELD) (OR = 1.06), and comorbid substance use disorder (OR = 2.35) were predictors of smoking until LT. Six months or less of alcohol abstinence (OR = 3.23), and comorbid substance use disorder (OR = 4.87) were predictors of active smoking after LT. Quitting smoking before transplantation improved survival. Evidence based smoking cessation interventions should be offered before and after LT.

Remote Monitoring Telemedicine (REMOTE) Platform for Patients With Anxiety Symptoms and Alcohol Use Disorder: Protocol for a Case-Control Study.

BACKGROUND: Monitoring mental health outcomes has traditionally been based on heuristic decisions, often based on scarce, subjective evidence, making the clinical decisions made by professionals, as well as the monitoring of these diseases, subject to flaws. However, the digital phenotype, which refers to the analysis of data collected by measuring human behavior with mobile sensors and smart bracelets, is a promising tool for filling this gap in current clinical practice. OBJECTIVE: The objectives of this study are to develop the digital phenotyping of patients with alcohol use disorder and anxiety symptoms using data collected from a mobile device (ie, smartphone) and a wearable sensor (ie, Fitbit) and to analyze usability and patient satisfaction with the data collection service provided by the app. METHODS: We propose to conduct a study among a group of 60 participants split into two subgroups-experimental and control-of 30 participants each. The experimental group will be recruited by physicians from the Hospital Clínic de Barcelona, and the control group will be recruited on a volunteer basis through fliers and social media. All participants will go through pretraining to ensure technological capability and understanding of tasks, then each participant will download the HumanITcare app and will be given a wearable sensor (ie, Fitbit). Throughout the 4-month period, participants will be monitored on a range of factors, including sleep cycle, heart rate, movement patterns, and sociability. All data from the wearable sensors and the mobile devices will be saved and sent to the HumanITcare server. Participants will be asked to complete weekly questionnaires about anxiety, depression, and alcohol use disorder symptoms. Research assistants will ensure timely responses. The data from both sensors will then be compared to the questionnaire responses to determine how accurately the devices can predict the same symptoms. RESULTS: The recruitment phase was completed in November 2019 and all the data were collected by the end of December 2019. Data are being processed; this process is expected to be completed by October 2020. CONCLUSIONS: This study was created and conducted as a pilot study with the Hospital Clínic de Barcelona, with the purpose of exploring the feasibility of our approach. The study is focused on patients diagnosed with anxiety and alcohol use disorder, but participants were also monitored for depressive symptoms throughout the trial, although these were not part of the initial inclusion criteria. A limitation to our study was the exclusive use of Android smartphones over iOS devices; this could result in a potential selection bias, due to the accessibility and affordability of Android phones as opposed to iOS-based phones. Another limitation might be that reviews of usability and satisfaction could be confounded by factors such as age and familiarity. An additional function that we might add in future studies is the ability for patients to manage their own data. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16964.

Digital brief interventions for risky drinkers are not the panacea: A pilot study exploring barriers for its implementation according to professionals' perceptions.

Digital brief interventions have emerged as an instrument to improve the implementation of Screening, Brief Intervention and Referral to Treatment programs for risky drinkers. However, trials in Catalonia have been unsuccessful. This study was aimed at researching professionals' perceptions regarding the usefulness of digital brief interventions in overcoming traditional barriers of face-to-face Screening, Brief Intervention and Referral to Treatment and new barriers posed by the use of digital brief interventions. Professionals who participated in the Effectiveness of primary care based Facilitated Access to alcohol Reduction website (EFAR)digital brief intervention clinical trial were surveyed on April 2017 on the following areas: (1) satisfaction, (2) usefulness, (3) perceived ability of digital interventions on overcoming traditional barriers and (4) perceived new barriers of digital interventions. Sixty-eight professionals completed the survey. Univariate and multivariate analyses were performed using the level of professional engagement with the project as the dependent variable, barriers as independent variables and socio-demographic characteristics as covariables. Of all professionals, 79.4 percent were satisfied with their participation in the project, but only 26.5 percent perceived the website as useful. Low engagement was associated with the perceived lack of feedback (0.22; 95% confidence interval: 0.05 -0.88), perception that it was difficult to use among the elderly(0.22; 95 confidence interval: 0.05 -0.091) and among low socioeconomic population (0.14; 95% confidence interval: 0.03 -0.64). The majority of the participants indicated that digital brief intervention for risky drinkers succeeded in overcoming most of the traditional barriers. However, new barriers emerged as difficulties for implementing digital brief interventions in the Catalan Primary Health Care System. Usefulness perception is a key factor, which must be addressed in any proposed intervention in primary care.

Safety of nalmefene for the treatment of alcohol use disorder: an update.

Introduction: Reduced drinking has been debated as a treatment goal for heavy drinking alcohol-dependent patients, in whom treatment based on abstinence is not always an option. Nalmefene was the first drug approved by the European Medicines Agency (2013) with the indication of reduced drinking in high drinking risk level alcohol-dependent patients. Six years after its introduction in Europe, data from clinical experience can be compared with those from preclinical studies and pivotal registration studies to evaluate what nalmefene has added to the treatment of AUD.Areas covered: Systematic review of efficacy and safety data of nalmefene use in humans from preclinical, phase III and phase IV studies, including systematic reviews, meta-analyses, cost-effectiveness analyses, and other secondary analyses.Expert opinion: Nalmefene introduces a paradigm change in the treatment of AUD that makes it appealing to patients that are reluctant to embrace abstinence, and facilitate patient-centered care in heavy users. However, information regarding safety data in special populations (e.g., patients with alcohol-related diseases, pregnancy, psychiatric disease), and direct comparisons with other potential drugs for alcohol reduction are further needed. Despite the promising role of nalmefene, there are still some factors that limit its wide prescription further than in specialized settings.