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

An Internet-Based Guided Self-Help Intervention for Panic Symptoms: Randomized Controlled Trial.

Background: Internet-based guided self-help is efficacious for panic disorder, but it is not known whether such treatment is effective for milder panic symptoms as well. Objective: To evaluate the effectiveness of Don't Panic Online, an Internet-based self-help course for mild panic symptoms, which is based on cognitive behavioral principles and includes guidance by email. Methods: A pragmatic randomized controlled trial was conducted. Participants (N=126) were recruited from the general population and randomized to either the intervention group or to a waiting-list control group. Inclusion criteria were a Panic Disorder Severity Scale-Self Report (PDSS-SR) score between 5-15 and no suicide risk. Panic symptom severity was the primary outcome measure; secondary outcome measures were anxiety and depressive symptom severity. Measurements were conducted online and took place at baseline and 12 weeks after baseline (T1). At baseline, diagnoses were obtained by telephone interviews. Results: Analyses of covariance (intention-to-treat) showed no significant differences in panic symptom reduction between groups. Completers-only analyses revealed a moderate effect size in favor of the intervention group (Cohen's d=0.73, P=.01). Only 27% of the intervention group finished lesson 4 or more (out of 6). Nonresponse at T1 was high for the total sample (42.1%). Diagnostic interviews showed that many participants suffered from comorbid depression and anxiety disorders. Conclusions: The Internet-based guided self-help course appears to be ineffective for individuals with panic symptoms. However, intervention completers did derive clinical benefits from the intervention

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

The feasibility of using smartphone apps as treatment components for depressed suicidal outpatients

Mental health smartphone apps could increase the safety and self-management of patients at risk of suicide, but it is still unclear whether it is feasible to integrate such apps into routine mental healthcare. This study reports on the feasibility of using a safety planning app (BackUp) and a self-monitoring app (mEMA) as components of the routine treatment of depressed outpatients with suicidal ideation. Clinicians were trained in working with both of the apps, and they invited their eligible patients with suicidal ideation for study participation. Patients used the apps for 3 months and discussed these with their clinician during treatment. Patients completed assessments at baseline (T0), 4 weeks (T1) and post-test (T2, 12 weeks after baseline). Both patients and clinicians also participated in telephone interviews. Feasibility was assessed in terms of usability (score > 70 on System Usability Scale, SUS), acceptability (score > 20 on Client Satisfaction Questionnaire-8, CSQ-8), and uptake (sufficient rates of component completion and app usage in treatment). The sample included 17 adult outpatients (52.9% male, age range 20–50 years) diagnosed with a depressive disorder and suicidal ideation at baseline. BackUp was rated by patients at above the cut-off scores for usability (SUS mean score at T1 75.63 and at T2 77.71) and acceptability (CSQ-8 mean score at T1 23.42 and at T2 23.50). mEMA was similarly rated (SUS mean score at T1 75.83 and at T2 76.25; CSQ-8 mean score at T1 23.92 and at T2 22.75). Telephone interviews with patients and clinicians confirmed the usability and acceptability. The uptake criteria were not met. Our findings suggest that mobile safety planning and mobile self-monitoring can be considered acceptable and usable as treatment components for depressed suicidal outpatients, but the integration of apps into routine treatment needs to be further explored

Internet-based, culturally sensitive, problem-solving therapy for turkish migrants with depression: Randomized controlled trial

Background: Turkish migrants living in the Netherlands have a high prevalence of depressive disorders, but experience considerable obstacles to accessing professional help. Providing easily accessible Internet treatments may help to overcome these barriers. Objective: The aim of this study was to evaluate the effectiveness of a culturally sensitive, guided, self-help, problem-solving intervention through the Internet for reducing depressive symptoms in Turkish migrants. Methods: A two-armed randomized controlled trial was conducted. The primary outcome measure was the severity of depressive symptoms; secondary outcome measures were somatic symptoms, anxiety, quality of life, and satisfaction with the treatment. Participants were assessed online at baseline, posttest (6 weeks after baseline), and 4 months after baseline. Posttest results were analyzed on the intention-to-treat sample. Missing values were estimated by means of multiple imputation. Differences in clinical outcome between groups were analyzed with a t test. Cohen's d was used to determine the between-groups effect size at posttreatment and follow-up. Results: Turkish adults (N=96) with depressive symptoms were randomized to the experimental group (n=49) or to a waitlist control group (n=47). High attrition rates were found among the 96 participants of which 42% (40/96) did not complete the posttest (6 weeks) and 62% (59/96) participants did not complete the follow-up assessment at 4 months. No significant difference between the experimental group and the control group was found for depression at posttest. Recovery occurred significantly more often in the experimental group (33%, 16/49) than in the control group (9%, 4/47) at posttest (P=.02). Because of the high attrition rate, a completers-only analysis was conducted at follow-up. The experimental group showed significant improvement in depression compared to the control group both at posttest (P=.01) and follow-up (P=.01). Conclusions: The results of this study did not show a significant effect on the reduction of depressive symptoms. However, the effect size at posttest was high, which might be an indicator of the possible effectiveness of the intervention when assessed in a larger sample and robust trial. Future research should replicate our study with adequately powered samples. © Burçin Ünlü Ince, Pim Cuijpers, Edith van 't Hof, Wouter van Ballegooijen, Helen Christensen, Heleen Riper

The effects of an Internet based self-help course for reducing panic symptoms - Don't Panic Online: study protocol for a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Internet based self-help for panic disorder (PD) has proven to be effective. However, studies so far have focussed on treating a full-blown disorder. Panic symptoms that do not meet DSM-IV criteria are more prevalent than the full-blown disorder and patients with sub-clinical panic symptoms are at risk of developing PD. This study is a randomised controlled trial aimed to evaluate an Internet based self-help intervention for sub-clinical and mild PD compared to a waiting list control group.</p> <p>Methods</p> <p>Participants with mild or sub-clinical PD (N = 128) will be recruited in the general population. Severity of panic and anxiety symptoms are the primary outcome measures. Secondary outcomes include depressive symptoms, quality of life, loss of production and health care consumption. Assessments will take place on the Internet at baseline and three months after baseline.</p> <p>Discussion</p> <p>Results will indicate the effectiveness of Internet based self-help for sub-clinical and mild PD. Strengths of this design are the external validity and the fact that it is almost completely conducted online.</p> <p>Trial registration</p> <p>Netherlands Trial Register (NTR): <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1639">NTR1639</a> The Netherlands Trial Register is part of the Dutch Cochrane Centre.</p