Growing Pains in the Administrative State: The Patent Office’s Troubled Quest for Managerial Control

In the last ten years, the workload of the Patent and Trademark Office ( PTO ) has increased dramatically. Complaints about the PTO\u27s ability to manage its workload have increased in tandem. Interestingly, although Congress has explicitly given the PTO rulemaking authority over the processing of patent applications, and withheld from it authority over substantive patent law, the PTO has arguably enjoyed more success in influencing substantive law than in executing direct efforts to manage its workload. This Article explores the multiple, mutually reinforcing reasons for this anomaly. It argues that although there are good reasons to be frustrated with the PTO\u27s past performance, the anomaly should not persist. To the contrary, incremental reform that gave the new PTO administration greater control over its procedures and its budgetary outlook would move us a long way toward a more efficient system of patent examination

Smartphone-based safety planning and self-monitoring for suicidal patients: Rationale and study protocol of the CASPAR (Continuous Assessment for Suicide Prevention And Research) study

Background: It remains difficult to predict and prevent suicidal behaviour, despite growing understanding of the aetiology of suicidality. Clinical guidelines recommend that health care professionals develop a safety plan in collaboration with their high-risk patients, to lower the imminent risk of suicidal behaviour. Mobile health applications provide new opportunities for safety planning, and enable daily self-monitoring of suicide-related symptoms that may enhance safety planning. This paper presents the rationale and protocol of the Continuous Assessment for Suicide Prevention And Research (CASPAR) study. The aim of the study is two-fold: to evaluate the feasibility of mobile safety planning and daily mobile self-monitoring in routine care treatment for suicidal patients, and to conduct fundamental research on suicidal processes. Methods: The study is an adaptive single cohort design among 80 adult outpatients or day-care patients, with the main diagnosis of major depressive disorder or dysthymia, who have an increased risk for suicidal behaviours. There are three measurement points, at baseline, at 1 and 3 months after baseline. Patients are instructed to use their mobile safety plan when necessary and monitor their suicidal symptoms daily. Both these apps will be used in treatment with their clinician. Conclusion: The results from this study will provide insight into the feasibility of mobile safety planning and self-monitoring in treatment of suicidal patients. Furthermore, knowledge of the suicidal process will be enhanced, especially regarding the transition from suicidal ideation to behaviour

Understanding and Promoting Effective Engagement With Digital Behavior Change Interventions.

This is the author accepted manuscript. The final version is available from Elsevier via https://doi.org/10.1016/j.amepre.2016.06.015This paper is one in a series developed through a process of expert consensus to provide an overview of questions of current importance in research into engagement with digital behavior change interventions, identifying guidance based on research to date and priority topics for future research. The first part of this paper critically reflects on current approaches to conceptualizing and measuring engagement. Next, issues relevant to promoting effective engagement are discussed, including how best to tailor to individual needs and combine digital and human support. A key conclusion with regard to conceptualizing engagement is that it is important to understand the relationship between engagement with the digital intervention and the desired behavior change. This paper argues that it may be more valuable to establish and promote "effective engagement," rather than simply more engagement, with "effective engagement" defined empirically as sufficient engagement with the intervention to achieve intended outcomes. Appraisal of the value and limitations of methods of assessing different aspects of engagement highlights the need to identify valid and efficient combinations of measures to develop and test multidimensional models of engagement. The final section of the paper reflects on how interventions can be designed to fit the user and their specific needs and context. Despite many unresolved questions posed by novel and rapidly changing technologies, there is widespread consensus that successful intervention design demands a user-centered and iterative approach to development, using mixed methods and in-depth qualitative research to progressively refine the intervention to meet user requirements.This paper is one of the outputs of two workshops, one supported by the Medical Research Council (MRC)/National Institute for Health Research (NIHR) Methodology Research Programme (PI Susan Michie) and the Robert Wood Johnson Foundation (PI Kevin Patrick), and the other by the National Science Foundation (PI Donna Spruitj-Metz, proposal # 1539846)

Experienced Burden of and Adherence to Smartphone-Based Ecological Momentary Assessment in Persons with Affective Disorders

(1) Background: The use of smartphone-based ecological momentary assessment (EMA) questionnaires in affective disorder research has rapidly increased. Though, a thorough understanding of experienced burden of and adherence to EMA is crucial in determining the usefulness of EMA. (2) Methods: Persons with current affective disorders (n = 100), remitted persons (n = 190), and healthy controls (n = 94) participated in a smartphone-based EMA two-week monitoring period. Our primary outcomes were (momentary) perceived burden of and adherence to EMA. (3) Results: In the whole sample, lower positive and higher negative affect were associated with slightly higher levels of perceived momentary burden (B = -0.23 [95%CI = -0.27-0.19], B = 0.30 [95%CI = 0.24-0.37], respectively). The persons with current affective disorders reported slightly higher levels of experienced momentary burden (Mdn = 1.98 [IQR = 1.28-2.57]), than the remitted persons (Mdn = 1.64 [IQR = 1.11-2.24]) and healthy controls (Mdn = 1.28 [IQR = 1.04-1.92]). Nevertheless, the persons with current affective disorders still showed very high adherence rates (Mdn = 94.3% [IQR = 87.9-97.1]), at rates on a par with the remitted persons (Mdn = 94.3% [IQR = 90.0-97.1]) and healthy controls (Mdn = 94.3% [IQR = 90.0-98.6]). (4) Discussion: Frequent momentary questionnaires of mental well-being are slightly more burdensome to the persons with current affective disorders, but this does not seem to have a negative impact on adherence. Their high rate of adherence to EMA-which was similar to that in remitted persons and healthy controls -suggests that it is feasible to apply (short-duration) EMA

e-INEBRIA special interest group roadmap to best practices for practice and research on brief digital interventions for problematic alcohol and illicit drug use

Background: There is huge potential for scaling up the delivery of brief interventions for alcohol and illicit drug use, given the increasing coverage and technologies of e-digital interventions, including applications for smartphones and tablets. However, while the quantity of digital interventions is increasing rapidly, the involvement of brief-intervention researchers and the development of good practices has just begun. Roadmap: In 2018, the Special Interest Group on digital interventions from the International Network on Brief Interventions for Alcohol & Other Drugs (e-INEBRIA SIG) initiated a conversation on possible avenues of future research, which subsequently turned into a roadmap for digital interventions during further discussions. This roadmap consists of points considered relevant for future research, ongoing technological developments, and their implementation across a continuum of prevention and care. Moreover, it outlines starting points for the diversification of brief digital interventions, as well as next steps for quality improvement and implementation in public health and clinical practice. Conclusions: The roadmap of the e-INEBRIA SIG on digital interventions is a starting point that indicates relevant next steps and provides orientation for researchers and interested practitioners in the ambiguous literature and complexity of current digital interventions

Effectiveness, Cost-effectiveness, and Cost-Utility of a Digital Alcohol Moderation Intervention for Cancer Survivors: Health Economic Evaluation and Outcomes of a Pragmatic Randomized Controlled Trial

Background: Alcohol moderation (AM) interventions may contribute to better treatment outcomes and the general well-being of cancer survivors.Objective: This study evaluates the effectiveness, cost-effectiveness, and cost-utility of MyCourse, a digital AM intervention, compared with a noninteractive digital information brochure for cancer survivors.Methods: A health economic evaluation alongside a pragmatic 2-arm parallel-group randomized controlled trial was conducted with follow-ups at 3, 6, and 12 months after randomization. The study was conducted on the web in the Netherlands from 2016 to 2019. Participants were adult 10-year cancer survivors drinking over the Dutch-recommended drinking guidelines (≤7 standard units [10 g of alcohol] per week) with the intention to moderate or quit drinking. Overall, 103 participants were randomized and analyzed: 53 (51.5%) in the MyCourse group and 50 (48.5%) in the control group. In the MyCourse group, participants had access to a newly developed, digital, minimally guided AM intervention, MyCourse–Moderate Drinking. The primary outcome was the self-reported number of standard drinks (10 g of ethanol) consumed in the past 7 days at the 6-month follow-up. The secondary outcome measures were alcohol-related problems as measured by the Alcohol Use Disorders Identification Test (AUDIT) and treatment satisfaction. For the health economic evaluation, health care costs, costs because of productivity losses, and intervention costs were assessed over a 12-month horizon.Results: Alcohol use at the 6-month follow-up decreased by 38% in the MyCourse group and by 33% in the control group. No difference in 7-day alcohol use was found between the groups (B=2.1, 95% CI −7.6 to 3.1; P=.22) at any of the follow-ups. AUDIT scores for alcohol-related problems decreased over time in both groups, showing no significant difference between the groups (Cohen d=0.3, 95% CI −0.1 to 0.6; P=.21). Intervention costs per participant were estimated at US $279 for the MyCourse group and US$74 for the control group. The mean societal costs were US $18,092 (SD 25,662) and US$23,496 (SD 34,327), respectively. The MyCourse group led to fewer gained quality-adjusted life years at lower societal costs in the cost-utility analysis. In the cost-effectiveness analysis, the MyCourse group led to a larger reduction in drinking units over time at lower societal costs (incremental cost-effectiveness ratio per reduced drink: US $ −1158, 95% CI −1609 to −781).Conclusions: At 6 months, alcohol use was reduced by approximately one-third in both groups, with no significant differences between the digital intervention MyCourse and a noninteractive web-based brochure. At 12 months, cost-effectiveness analyses showed that MyCourse led to a larger reduction in drinking units over time, at lower societal costs. The MyCourse group led to marginally fewer gained quality-adjusted life years, also at lower societal costs.Trial Registration: Netherlands Trial Register NTR6010; https://www.trialregister.nl/trial/5433International Registered Report Identifier (IRRID): RR2-10.1186/s12885-018-4206-z</p

Cost-effectiveness of blended vs. face-to-face cognitive behavioural therapy for severe anxiety disorders: study protocol of a randomized controlled trial

Background: Anxiety disorders are among the most prevalent psychiatric conditions, and are associated with poor quality of life and substantial economic burden. Cognitive behavioural therapy is an effective treatment to reduce anxiety symptoms, but is also costly and labour intensive. Cost-effectiveness could possibly be improved by delivering cognitive behavioural therapy in a blended format, where face-to-face sessions are partially replaced by online sessions. The aim of this trial is to determine the cost-effectiveness of blended cognitive behavioural therapy for adults with anxiety disorders, i.e. panic disorder, social phobia or generalized anxiety disorder, in specialized mental health care settings compared to face-to-face cognitive behavioural therapy. In this paper, we present the study protocol. It is hypothesized that blended cognitive behavioural therapy for anxiety disorders is clinically as effective as face-to-face cognitive behavioural therapy, but that intervention costs may be reduced. We thus hypothesize that blended cognitive behavioural therapy is more cost-effective than face-to-face cognitive behavioural therapy. Methods/design: In a randomised controlled equivalence trial 156 patients will be included (n = 78 in blended cognitive behavioural therapy, n = 78 in face-to-face cognitive behavioural therapy) based on a power of 0.80, calculated by using a formula to estimate the power of a cost-effectiveness analysis: $n = \frac{2(z_\alpha + z_\beta)^2(sd^2 + (W^2sd^2) - (2Wpsd_csd_q))}{(WE-C)^2}$ Measurements will take place at baseline, midway treatment (7 weeks), immediately after treatment (15 weeks) and 12-month follow-up. At baseline a diagnostic interview will be administered. Primary clinical outcomes are changes in anxiety symptom severity as measured with the Beck Anxiety Inventory. An incremental cost-effectiveness ratio will be calculated to obtain the costs per quality-adjusted life years (QALYs) measured by the EQ-5D (5-level version). Health-economic outcomes will be explored from a societal and health care perspective. Discussion: This trial will be one of the first to provide information on the cost-effectiveness of blended cognitive behavioural therapy for anxiety disorders in routine specialized mental health care settings, both from a societal and a health care perspective

Pragmatic Quasi-Experimental Controlled Trial Evaluating the Outcomes of Blended CBT Compared to Face-to-Face CBT and Treatment as Usual for Adolescents with Depressive Disorders

Depression is a major problem in youth mental health. Current treatment is on average effective, but adolescents are hesitant to seek help. Blended treatment could lower the barriers to seeking treatment. Evidence on effectiveness is, however, scarce. The present pragmatic quasi-experimental controlled trial aimed to compare the outcomes of blended cognitive behavioral therapy (CBT) to face-to-face CBT and treatment as usual. A total of 129 adolescents with clinical depression (82.2% female), aged 13–22 (M = 16.60, SD = 2.03) received blended CBT, face-to-face CBT or treatment as usual. Clinical diagnosis, depressive symptoms, and secondary outcomes were assessed at baseline, post-intervention, and six-months follow-up. Participants receiving blended CBT were, compared to participants receiving face-to-face CBT and treatment as usual, evenly likely to be in remission from their depressive disorder at post-intervention and at six-month follow-up. Depressive symptoms decreased significantly over time in all three conditions, and changes were not significantly different between conditions. Other secondary outcomes (suicide risk, internalizing and externalizing symptoms, severity of depression, and global functioning) did not differ between treatment conditions at post-intervention and six-month follow-up. Since there was no evidence for favorable outcomes for face-to-face therapies above blended CBT, blended CBT may also be an effective treatment format in clinical practice

A proof of concept study on individual trends in suicidal ideation: an ecological momentary assessment study of 5 patients over three months

Background: Suicidal ideation (SI) is a significant and long-lasting mental health problem, with a third of individuals still experiencing SI after two years. To date, most Ecological Momentary Assessment (EMA) studies of SI have assessed its day-to-day course over one to four consecutive weeks and found no consistent trends in average SI severity over time. Aim: The current proof of concept study assessed daily fluctuations of SI over a time span of 3 to 6 months to explore whether individual trends in SI severity could be detected, and if so, if the trajectory of changes were gradual or sudden. The secondary aim was to explore whether changes in SI severity could be detected at an early stage. Method: Five adult outpatients with depression and SI used an EMA app on their smartphone in addition to their regular treatment for 3 to 6 months, where SI was assessed 3 times a day. To detect trends in SI for each patient, three models were tested: a null model, a gradual change model and a sudden change model. To detect changes in SI before a new plateau was reached, Early Warning Signals and Exponentially Weighted Moving Average control charts were used. Results: In each patient, average SI severity had a unique trajectory of sudden and/or gradual changes. Additionally, in some patients, increases in both sudden and gradual SI could be detected at an early stage. Conclusions: The study presents a first indication of unique individual trends in SI severity over a 3 to 6 months period. Though replication in a larger sample is needed to test how well results generalize, a first proof-of-concept is provided that both sudden and gradual changes in SI severity may be detectable at an early stage using the dynamics of time-series data