Evaluating the Clinical Feasibility of an Artificial Intelligence-Powered, Web-Based Clinical Decision Support System for the Treatment of Depression in Adults: Longitudinal Feasibility Study.

BACKGROUND: Approximately two-thirds of patients with major depressive disorder do not achieve remission during their first treatment. There has been increasing interest in the use of digital, artificial intelligence-powered clinical decision support systems (CDSSs) to assist physicians in their treatment selection and management, improving the personalization and use of best practices such as measurement-based care. Previous literature shows that for digital mental health tools to be successful, the tool must be easy for patients and physicians to use and feasible within existing clinical workflows. OBJECTIVE: This study aims to examine the feasibility of an artificial intelligence-powered CDSS, which combines the operationalized 2016 Canadian Network for Mood and Anxiety Treatments guidelines with a neural network-based individualized treatment remission prediction. METHODS: Owing to the COVID-19 pandemic, the study was adapted to be completed entirely remotely. A total of 7 physicians recruited outpatients diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria. Patients completed a minimum of one visit without the CDSS (baseline) and 2 subsequent visits where the CDSS was used by the physician (visits 1 and 2). The primary outcome of interest was change in appointment length after the introduction of the CDSS as a proxy for feasibility. Feasibility and acceptability data were collected through self-report questionnaires and semistructured interviews. RESULTS: Data were collected between January and November 2020. A total of 17 patients were enrolled in the study; of the 17 patients, 14 (82%) completed the study. There was no significant difference in appointment length between visits (introduction of the tool did not increase appointment length; F2,24=0.805; mean squared error 58.08; P=.46). In total, 92% (12/13) of patients and 71% (5/7) of physicians felt that the tool was easy to use; 62% (8/13) of patients and 71% (5/7) of physicians rated that they trusted the CDSS. Of the 13 patients, 6 (46%) felt that the patient-clinician relationship significantly or somewhat improved, whereas 7 (54%) felt that it did not change. CONCLUSIONS: Our findings confirm that the integration of the tool does not significantly increase appointment length and suggest that the CDSS is easy to use and may have positive effects on the patient-physician relationship for some patients. The CDSS is feasible and ready for effectiveness studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT04061642; http://clinicaltrials.gov/ct2/show/NCT04061642

Bevacizumab Added to Neoadjuvant Chemotherapy for Breast Cancer

BACKGROUND Bevacizumab and the antimetabolites capecitabine and gemcitabine have been shown to improve outcomes when added to taxanes in patients with metastatic breast cancer. The primary aims of this trial were to determine whether the addition of capecitabine or gemcitabine to neoadjuvant chemotherapy with docetaxel, followed by doxorubicin plus cyclophosphamide, would increase the rates of pathological complete response in the breast in women with operable, human epidermal growth factor receptor 2 (HER2)–negative breast cancer and whether adding bevacizumab to these chemotherapy regimens would increase the rates of pathological complete response. METHODS We randomly assigned 1206 patients to receive neoadjuvant therapy consisting of docetaxel (100 mg per square meter of body-surface area on day 1), docetaxel (75 mg per square meter on day 1) plus capecitabine (825 mg per square meter twice a day on days 1 to 14), or docetaxel (75 mg per square meter on day 1) plus gemcitabine (1000 mg per square meter on days 1 and 8) for four cycles, with all regimens followed by treatment with doxorubicin–cyclophosphamide for four cycles. Patients were also randomly assigned to receive or not to receive bevacizumab (15 mg per kilogram of body weight) for the first six cycles of chemotherapy. RESULTS The addition of capecitabine or gemcitabine to docetaxel therapy, as compared with docetaxel therapy alone, did not significantly increase the rate of pathological complete response (29.7% and 31.8%, respectively, vs. 32.7%; P=0.69). Both capecitabine and gemcitabine were associated with increased toxic effects — specifically, the hand–foot syndrome, mucositis, and neutropenia. The addition of bevacizumab significantly increased the rate of pathological complete response (28.2% without bevacizumab vs. 34.5% with bevacizumab, P=0.02). The effect of bevacizumab on the rate of pathological complete response was not the same in the hormone-receptor–positive and hormone-receptor–negative subgroups. The addition of bevacizumab increased the rates of hypertension, left ventricular systolic dysfunction, the hand–foot syndrome, and mucositis. CONCLUSIONS The addition of bevacizumab to neoadjuvant chemotherapy significantly increased the rate of pathological complete response, which was the primary end point of this study. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00408408.

Drug and alcohol use among patients with schizophrenia and related psychoses : levels, consequences and changes in psychiatric symptoms and substance abuse at twelve-month follow-up

Patients with schizophrenia and related psychoses frequently use, abuse and become dependent on psychoactive substances. A cross-sectional survey was conducted to document substance abuse in 207 successive outpatients with schizophrenia and related psychoses presenting to a psychiatric continuing care facility in a large Canadian city. Nicotine, alcohol and cannabis were the most frequently abused substances. Excluding nicotine, 44.9% met criteria for lifetime and 14.0% for current abuse/dependence. Current dual diagnosis (DD) patients had significantly more positive psychotic and depressive symptoms, higher rates of medication non-compliance, as well as higher rates of tobacco smoking and significantly longer smoking histories compared to single diagnosis (SD) patients. The smoking behavior of the DD population is discussed in terms of enhanced risk for alcohol abuse, as well as effects on antipsychotic blood levels and metabolism.In the second phase of the study, the starting sample was reassessed at 4 month intervals out to 12-months of follow-up. The follow-up study was designed to test the hypothesis that current-DD patients would fare significantly worse than SD patients. This study found that during the course of standard psychiatric outpatient treatment there was little decrease in substance use or abuse over time among the DD group. However, DD subjects experienced a greater reduction in positive psychotic symptoms compared to SD patients. The follow up study demonstrated that DD patients in treatment for schizophrenia and related psychoses did reasonably well in terms of reduced psychosis; however they continued to use substances of abuse and remained more depressed than SD

Management of conventional antipsychotic-induced tardive dyskinesia

International audienc

The Best Predictor of the Future—the Metaverse, Mental Health, and Lessons Learned From Current Technologies

The metaverse—a virtual world accessed via virtual reality technology—has been heralded as the next key digital experience. It is meant to provide the next evolution of human interaction after social media and telework. However, in the context of the growing awareness of the risks to mental health posed by current social media technologies, there is a great deal of uncertainty as to the potential effects of this new technology on mental health. This uncertainty is compounded by a lack of clarity regarding what form the metaverse will ultimately take and how widespread its application will be. Despite this, given the nascent state of the metaverse, there is an opportunity to plan the research and regulatory approaches needed to understand it and promote its positive effects while protecting vulnerable groups. In this viewpoint, we examine the following three current technologies whose functions comprise a portion of what the metaverse seeks to accomplish: teleworking, virtual reality, and social media. We attempted to understand in what ways the metaverse may have similar benefits and pitfalls to these technologies but also how it may fundamentally differ from them. These differences suggest potential research questions to be addressed in future work. We found that current technologies have enabled tools such as virtual reality–assisted therapy, avatar therapy, and teletherapy, which have had positive effects on mental health care, and that the metaverse may provide meaningful improvements to these tools. However, given its similarities to social media and its expansion upon the social media experience, the metaverse raises some of the same concerns that we have with social media, such as the possible exacerbation of certain mental health problems. These concerns led us to consider questions such as how the users will be protected and what regulatory mechanisms will be put in place to ensure user safety. Although clear answers to these questions are challenging in this early phase of metaverse research, in this viewpoint, we use the context provided by comparator technologies to provide recommendations to maximize the potential benefits and limit the putative harms of the metaverse. We hope that this paper encourages discussions among researchers and policy makers

Patient-reported outcomes with anastrozole versus tamoxifen for postmenopausal patients with ductal carcinoma in situ treated with lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial

BACKGROUND: The NSABP B-35 trial compared 5 years of treatment with anastrozole versus tamoxifen for reducing subsequent occurrence of breast cancer in postmenopausal patients with ductal carcinoma in situ. This report assesses the effect of these drugs on quality of life and symptoms. METHODS: The study was done at 333 hospitals in North America. Postmenopausal women with hormone-positive ductal carcinoma in situ treated by lumpectomy with clear resection margins and whole breast irradiation were randomly assigned to receive either tamoxifen (20 mg/day) or anastrazole (1 mg/day) for 5 years, stratified by age (<60 years vs ≥60 years). Patients and investigators were masked to treatment allocation. Patients completed questionnaires at baseline and every 6 months thereafter for 6 years. The primary outcomes were SF-12 physical and mental health component scale scores, and vasomotor symptoms (as per the BCPT symptom scale). Secondary outcomes were vaginal symptoms and sexual functioning. Exploratory outcomes were musculoskeletal pain, bladder symptoms, gynaecological symptoms, cognitive symptoms, weight problems, vitality, and depression. We did the analyses by intention to treat, including patients who completed questionnaires at baseline and at least once during follow-up. This study is registered with ClinicalTrials.gov, NCT00053898. FINDINGS: Between Jan 6, 2003, and June 15, 2006, 3104 patients were enrolled in the study, of whom 1193 were included in the quality-of-life substudy: 601 assigned to tamoxifen and 592 assigned to anastrozole. We detected no significant difference between treatment groups for: physical health scores (mean severity score 46.72 for tamoxifen vs 45.85 for anastrozole; p=0.20), mental health scores (52.38 vs 51.48; p=0.38), energy and fatigue (58.34 vs 57.54; p=0.86), or symptoms of depression (6.19 vs 6.39; p=0.46) over 5 years. Vasomotor symptoms (1.33 vs 1·17; p=0.011), difficulty with bladder control (0.96 vs 0.80; p=0.0002), and gynaecological symptoms (0.29 vs 0.18; p<0.0001) were significantly more severe in the tamoxifen group than in the anastrozole group. Musculoskeletal pain (1.50 vs 1.72; p=0.0006) and vaginal symptoms (0.76 vs 0.86; p=0.035) were significantly worse in the anastrozole group than in the tamoxifen group. Sexual functioning did not differ significantly between the two treatments (43.65 vs 45.29; p=0.56). Younger age was significantly associated with more severe vasomotor symptoms (mean severity score 1.45 for age <60 years vs 0.65 for age ≥60 years; p=0.0006), vaginal symptoms (0.98 vs 0.65; p<0.0001), weight problems (1.32 vs 1·02; p<0.0001), and gynaecological symptoms (0.26 vs 0.22; p=0.014). INTERPRETATION: Given the similar efficacy of tamoxifen and anastrozole for women older than age 60 years, decisions about treatment should be informed by the risk for serious adverse health effects and the symptoms associated with each drug. For women younger than 60 years old, treatment decisions might be driven by efficacy (favouring anastrozole); however, if the side-effects of anastrozole are intolerable, then switching to tamoxifen is a good alternative. FUNDING: US National Cancer Institute, AstraZeneca Pharmaceuticals