Adherence, health care utilization, and costs between long-acting injectable and oral antipsychotic medications in South Carolina Medicaid beneficiaries with schizophrenia.

BACKGROUND: Schizophrenia and schizoaffective disorder require long-term antipsychotic treatment with antipsychotic medications, but poor medication adherence can lead to increased health care utilization and costs. Long-acting injectable antipsychotics (LAIs) offer potential therapeutic advantages in that they require less frequent dosing and improved medication adherence. South Carolina has the highest adoption of LAIs among US states, making it an ideal population for comparing the effectiveness of LAIs vs oral antipsychotics (OAPs) in treating schizophrenia or schizoaffective disorder. OBJECTIVE: To evaluate the effect of LAIs compared with OAPs on medication adherence, health care resource utilization, and costs among South Carolina Medicaid beneficiaries with schizophrenia or schizoaffective disorder. METHODS: South Carolina Medicaid beneficiaries with at least 1 claim for an LAI or OAP between January 1, 2015, and December 31, 2018, aged 18 to 65, with at least 2 claims with diagnoses of schizophrenia or schizoaffective disorder were included. Propensity scores (PSs) were calculated using logistic regression adjusting for confounders and predictors of the outcome. We estimated the "average treatment effect on the treated" by employing PS-weighted t-tests and chi-square tests. RESULTS: A total of 3,531 patients met the inclusion criteria, with 1,537 (44.5%) treated with LAIs and 1,994 (56.5%) treated with OAPs. In PS-weighted analyses, the LAI cohort had a greater proportion of days covered than the OAP cohort with a 365-day fixed denominator (69% vs 64%; P < 0.0001), higher medication possession ratio with a variable denominator while on therapy (85% vs 80%; P < 0.0001), and higher persistence (82% vs 64%; P < 0.0001). The average number of inpatient visits and emergency department visits did not significantly differ between cohorts (0.28 hospitalizations, P = 0.90; 3.68 vs 2.96 emergency department visits, P = 0.19). The number of outpatient visits, including visits for medication administration, were greater in the LAI cohort (23.1 [SD 24.2]) vs OAP (16.9 [SD 21.2]; P < 0.0001); however, including the costs for medication administration visits, outpatient costs (per member) were approximately $2,500 lower in the LAI cohort (P < 0.0001). The number of pharmacy visits was greater in the OAP cohort (LAI 21.0 [SD 17.0] vs OAP 23.0 [SD 15.0]; P = 0.006). All-cause total costs were greater in the LAI cohort ($26,025 [SD $29,909]) vs the OAP cohort ($17,291 [SD $25,261]; P < 0.0001) and were driven by the difference in pharmaceutical costs (LAI $15,273 [SD $16,183] vs OAP $4,696 [SD $10,371]; P < 0.0001). CONCLUSIONS: Among South Carolina Medicaid beneficiaries, treatment with LAIs for schizophrenia or schizoaffective disorder was associated with greater medication adherence rates. Patients using LAIs had higher drug costs and total costs, but lower outpatient and total nondrug costs compared with those using OAPs.

Artificial intelligence is set to transform mental health services.

The current development in the field of artificial intelligence and its applications has advantages and disadvantages in the digital age that we now live in. The state of the use of AI for mental health has to be assessed by stakeholders, which includes all of us. We must comprehend the trends, gaps, opportunities, challenges, and shortcomings of this new technology. As the field evolves, rules, regulatory frameworks, guidelines, standards, and policies will develop and will progressively scale upwards. To advance the field, mental health professionals must be prepared to meet obstacles and seize possibilities presented by creative and disruptive technologies like AI. Therefore, a collaborative strategy must include multi-stakeholder participation in basic, translational, and clinical aspects of AI. Mental health practitioners need to be ready to face challenges and embrace and harness the power of innovative and disruptive technology such as AI that could offer to move the field forward.

Harbingers of Hope: Scientists and the Pursuit of World Peace.

The ongoing wars in many regions-such as the conflict between Israel and Hamas-as well as the effects of war on communities, social services, and mental health are covered in this special editorial. This article emphasizes the need for international efforts to promote peace, offer humanitarian aid, and address the mental health challenges faced by individuals and communities affected by war and violence.

Neuropsychiatric Consequences of COVID-19 Pandemic: A Synthetic Review from a Global Perspective.

Some research suggests that distress, secondary to isolation and fear following COVID-19 infection, can negatively affect the long-term more than the COVID-19 infection itself. This narrative review aims to provide a global view on the neuropsychiatric consequences of COVID-19 that can be ascribed to several factors, ranging from the direct effect of infection, to the body's responses against the infection, or to the psychological sequelae of social isolation, unemployment, and fear for one's health and livelihood. Current findings show that the more severe the respiratory infection, the more likely are central nervous system (CNS) complications regarding the infection itself. The immune reactions to the infection may result in symptoms similar to chronic fatigue as well as neurocognitive deficits, which last long after the infection is gone. An increase in symptoms of depression, anxiety, and trauma-related stress may also follow upon economic fears and isolation from friends and family. The consequences of the pandemic are not limited to adults; children learning remotely and away from classmates and routine activities may develop adjustment disorders, acute stress disorder, and a variety of manifestations of grief. A summary of case reports suggests that COVID-19-related stress, economic recession, and political unrest increase the risk of suicidal behaviors and acts of violence. However, it is unknown whether manifestations of mental disorders result from social causes or whether CNS complications may be responsible.

How Different Pre-existing Mental Disorders and Their Co-occurrence Affects COVID-19 Clinical Outcomes? A Real-World Data Study in the Southern United States.

Background: Although a psychiatric history might be an independent risk factor for COVID-19 infection and mortality, no studies have systematically investigated how different clusters of pre-existing mental disorders may affect COVID-19 clinical outcomes or showed how the coexistence of mental disorder clusters is related to COVID-19 clinical outcomes. Methods: Using a retrospective cohort study design, a total of 476,775 adult patients with lab-confirmed and probable COVID-19 between March 06, 2020 and April 14, 2021 in South Carolina, United States were included in the current study. The electronic health record data of COVID-19 patients were linked to all payer-based claims data through the SC Revenue and Fiscal Affairs Office. Pre-existing mental disorder diagnoses from Jan 2, 2019 to Jan 14, 2021 were extracted from the patients' healthcare utilization data via ICD-10 codes. Results: There is an elevated risk of COVID-19-related hospitalization and death among participants with pre-existing mental disorders adjusting for key socio-demographic and comorbidity covariates. Co-occurrence of any two clusters was positively associated with COVID-19-related hospitalization and death. The odds ratio of being hospitalized was 1.26 (95% CI: 1.151, 1.383) for patients with internalizing and externalizing disorders, 1.65 (95% CI: 1.298, 2.092) for internalizing and thought disorders, 1.76 (95% CI: 1.217, 2.542) for externalizing and thought disorders, and 1.64 (95% CI: 1.274, 2.118) for three clusters of mental disorders. Conclusions: Pre-existing internalizing disorders and thought disorders are positively related to COVID-19 hospitalization and death. Co-occurrence of any two clusters of mental disorders have elevated risk of COVID-19-related hospitalization and death compared to those with a single cluster.

Beam Me Out: Review of Emergency Department Telepsychiatry and Lessons Learned During COVID-19.

PURPOSE OF REVIEW: The aim of this review is to critically evaluate recent literature on the use of telepsychiatry in emergency departments (EDTP) and synthesize the evidence on telepsychiatry during public health emergencies. We also report on experiences and success stories from a state-wide EDTP program in South Carolina during the COVID-19 pandemic. RECENT FINDINGS: We identified 12 peer-reviewed articles published between January 2019 and February 2021 that evaluated EDTP interventions and their impact on patient outcomes. The recent evidence on EDTP shows a significant association between EDTP implementation or use and decreased patients' wait time in emergency department (ED), shorter length of stay in certain settings, reduced ED revisit rates, improved ED patient disposition (e.g., more discharge to home, less observational stays, and decreased inpatient admissions), and reduced follow-up encounters involving self-harm diagnosis. The EDTP virtual delivery model can help healthcare systems reduce burden of public health emergencies on providers, staff, and patients alike. While a disruption of magnitude seen by COVID-19 may be infrequent, strategies used during the pandemic may be implemented to enhance care in rural settings, and/or enhance preparedness of communities and healthcare systems during more commonly occurring natural disasters.

'Distant socializing,' not 'social distancing' as a public health strategy for COVID-19.

Social distancing, also referred to as physical distancing, means creating a safe distance of at least two meters (six feet) between yourself and others. This is a term popularized during the COVID-19 pandemic, as it is one of the most important measures to prevent the spread of this virus. However, the term 'social distancing' can be misleading, as it may imply that individuals should stop socializing. However, socializing in a safe context (i.e. over the phone, video-chat, etc.) is especially important during this time of crisis. Therefore, in this narrative review, we suggest the term 'distant socializing' as more apt expression, to promote physical distancing measures while also highlighting the importance of maintaining social bonds. Further, articles discussing the practice, implementation, measurement, and mental health effects of physical distancing are reviewed. Physical distancing is associated with psychiatric symptoms (such as anxiety and depression), suicidal ideation, and domestic violence. Further, unemployment and job insecurity have significantly increased during COVID-19, which may exacerbate these negative mental health effects. Governments, medical institutions, and public health bodies should therefore consider increasing mental health resources both during and after the pandemic, with a specific focus on frontline workers, COVID-19 survivors, and marginalized communities.

Knowledge-Infused Abstractive Summarization of Clinical Diagnostic Interviews: Framework Development Study.

BACKGROUND: In clinical diagnostic interviews, mental health professionals (MHPs) implement a care practice that involves asking open questions (eg, "What do you want from your life?" "What have you tried before to bring change in your life?") while listening empathetically to patients. During these interviews, MHPs attempted to build a trusting human-centered relationship while collecting data necessary for professional medical and psychiatric care. Often, because of the social stigma of mental health disorders, patient discomfort in discussing their presenting problem may add additional complexities and nuances to the language they use, that is, hidden signals among noisy content. Therefore, a focused, well-formed, and elaborative summary of clinical interviews is critical to MHPs in making informed decisions by enabling a more profound exploration of a patient's behavior, especially when it endangers life. OBJECTIVE: The aim of this study is to propose an unsupervised, knowledge-infused abstractive summarization (KiAS) approach that generates summaries to enable MHPs to perform a well-informed follow-up with patients to improve the existing summarization methods built on frequency heuristics by creating more informative summaries. METHODS: Our approach incorporated domain knowledge from the Patient Health Questionnaire-9 lexicon into an integer linear programming framework that optimizes linguistic quality and informativeness. We used 3 baseline approaches: extractive summarization using the SumBasic algorithm, abstractive summarization using integer linear programming without the infusion of knowledge, and abstraction over extractive summarization to evaluate the performance of KiAS. The capability of KiAS on the Distress Analysis Interview Corpus-Wizard of Oz data set was demonstrated through interpretable qualitative and quantitative evaluations. RESULTS: KiAS generates summaries (7 sentences on average) that capture informative questions and responses exchanged during long (58 sentences on average), ambiguous, and sparse clinical diagnostic interviews. The summaries generated using KiAS improved upon the 3 baselines by 23.3%, 4.4%, 2.5%, and 2.2% for thematic overlap, Flesch Reading Ease, contextual similarity, and Jensen Shannon divergence, respectively. On the Recall-Oriented Understudy for Gisting Evaluation-2 and Recall-Oriented Understudy for Gisting Evaluation-L metrics, KiAS showed an improvement of 61% and 49%, respectively. We validated the quality of the generated summaries through visual inspection and substantial interrater agreement from MHPs. CONCLUSIONS: Our collaborator MHPs observed the potential utility and significant impact of KiAS in leveraging valuable but voluminous communications that take place outside of normally scheduled clinical appointments. This study shows promise in generating semantically relevant summaries that will help MHPs make informed decisions about patient status.

Factors Contributing to Adolescents' and Young Adults' Participation in Web-Based Challenges: Survey Study.

BACKGROUND: Web-based challenges, phenomena that are familiar to adolescents and young adults who spend large amounts of time on social media, range from minimally harmful behaviors intended to support philanthropic endeavors to significantly harmful behaviors that may culminate in injury or death. OBJECTIVE: This study aims to investigate the beliefs that lead adolescents and young adults to participate in these activities by analyzing the amyotrophic lateral sclerosis (ALS) ice bucket challenge, representing nonharmful behaviors associated with web-based challenges, and the cinnamon challenge, representing web-based challenges that lead to harmful behaviors. METHODS: A retrospective quantitative study was conducted with a total of 471 participants aged between 13 and 35 years who either had participated in the ALS ice bucket challenge or the cinnamon challenge, or had never participated in any web-based challenge. Binomial logistic regression models were used to classify those who participated in the ALS ice bucket challenge or cinnamon challenge versus those who did not engage in either challenge using the integrated behavioral model's beliefs as predictors. RESULTS: The findings showed that participants of both the cinnamon challenge and the ALS ice bucket challenge had significantly greater expectations from the public to participate in the challenge they completed in comparison with individuals who never participated in any challenge (P=.01 for the cinnamon challenge and P=.003 for the ALS ice bucket challenge). Cinnamon challenge participants had greater value for the outcomes of the challenge (P<.001) and perceived positive public opinion about the challenge (P<.001), in comparison with individuals who never participated in any challenge. In contrast, ALS ice bucket challenge participants had significantly greater positive emotional responses than individuals who never participated in any challenge (P<.001). CONCLUSIONS: The constructs that contribute to the spread of web-based challenges vary based on the level of self-harm involved in the challenge and its purpose. Intervention efforts could be tailored to address the beliefs associated with different types of web-based challenges.

Factor structure of cognitive performance and functional capacity in schizophrenia: Evidence for differences across functional capacity measures.

BACKGROUND: Cognition and functional capacity predict functional outcomes in mental illness. Traditional approaches conceptualize cognition as comprised of domains, but many studies support a unifactorial structure. Some functional capacity measures may share a single-factor structure with cognition. In this study, we examined the factor structure of two measures of functional capacity, a conventional assessment and a newer computerized assessment, testing for a shared factor structure with cognition. METHODS: Patients with schizophrenia and healthy controls were examined with the MATRICS Consensus Cognitive Battery (MCCB), the UCSD Performance Based Skills Assessment (UPSA), and the Virtual Reality Functional Capacity Assessment Tool (VRFCAT). Models of the factor structures of the MCCB, UPSA, and VRFCAT were calculated, as were correlations between MCCB scores and individual VRFCAT objectives. RESULTS: The MCCB, VRFCAT, and UPSA all had unifactorial structures. The best fitting model of the correlations between MCCB and UPSA was a shared single factor, while the best fit for the relationship between MCCB and VRFCAT had two factors. Correlations between the MCCB domain and composite scores and the VRFCAT objectives suggested global rather than specific patterns of correlation. DISCUSSION: The relationship between cognitive performance and functional capacity was found to vary across functional capacity assessments. The UPSA and MCCB were not differentiated into separate factors, suggesting that the UPSA may overlap with neurocognitive performance. However, the VRFCAT appears to measure functional abilities that are separable from, yet correlated with, neurocognitive performance. It may provide a more distinctive assessment of the functional capacity construct.

Herding cats and other epic challenges: Creating meaningful stakeholder engagement in community mental health research.

Stakeholder-centered approaches, that restrict patient barriers to clinical community mental health research, affect outcomes. It is suggested that a restructuring of clinical research organizational behavior and attitudes may overcome this problem. It is further advocated that consultation with an engagement of study patient stakeholders encourages their interest in the study, and is essential for successful research. This editorial considers the concept of stakeholder participation and management in the clinical research environment. It further offers practical suggestions for fostering meaningful stakeholder engagement.

Validation of the tablet-administered Brief Assessment of Cognition (BAC App).

Computerized tests benefit from automated scoring procedures and standardized administration instructions. These methods can reduce the potential for rater error. However, especially in patients with severe mental illnesses, the equivalency of traditional and tablet-based tests cannot be assumed. The Brief Assessment of Cognition in Schizophrenia (BACS) is a pen-and-paper cognitive assessment tool that has been used in hundreds of research studies and clinical trials, and has normative data available for generating age- and gender-corrected standardized scores. A tablet-based version of the BACS called the BAC App has been developed. This study compared performance on the BACS and the BAC App in patients with schizophrenia and healthy controls. Test equivalency was assessed, and the applicability of paper-based normative data was evaluated. Results demonstrated the distributions of standardized composite scores for the tablet-based BAC App and the pen-and-paper BACS were indistinguishable, and the between-methods mean differences were not statistically significant. The discrimination between patients and controls was similarly robust. The between-methods correlations for individual measures in patients were r>0.70 for most subtests. When data from the Token Motor Test was omitted, the between-methods correlation of composite scores was r=0.88 (df=48; p<0.001) in healthy controls and r=0.89 (df=46; p<0.001) in patients, consistent with the test-retest reliability of each measure. Taken together, results indicate that the tablet-based BAC App generates results consistent with the traditional pen-and-paper BACS, and support the notion that the BAC App is appropriate for use in clinical trials and clinical practice.

Validation of a Computerized test of Functional Capacity.

Regulatory guidance for schizophrenia cognition clinical trials requires that the assessment of cognitive change is accompanied by a functionally meaningful endpoint. However, currently available measures are challenged by resistance to change, psychometric weaknesses, and for interview-based assessments, dependence upon the presence of an informant. The aims of the current study were to: 1) assess the validity, sensitivity, and reliability of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) as a measure of functional capacity; 2) determine the association between performance on the VRFCAT and performance on the MATRICS Consensus Cognitive Battery (MCCB); and 3) compare the metrics of the VRFCAT with the UCSD Performance-based Skills Assessment (UPSA). 167 patients with schizophrenia and 166 healthy controls completed the VRFCAT, UPSA, and the MCCB at baseline. The VRFCAT and UPSA were completed again at follow-up. The VRFCAT, MCCB, and UPSA were very sensitive to impairment in schizophrenia (d=1.16 to 1.22). High test-retest reliability was demonstrated for VRFCAT total completion time and the UPSA total score in patients (ICC=0.81 and 0.78, respectively). The UPSA demonstrated significant practice effects in patients (d=0.35), while the VRFCAT did not (d=-0.04). VRFCAT total completion time was correlated with both UPSA (r=-0.56, p<0.0001 for patients and -0.58, p<0.0001 for controls) and MCCB Composite (r=-0.57, p<0.0001 for patients and -0.68, p<0.0001 for controls). The VRFCAT is a highly reliable and sensitive measure of functional capacity with associations to the UPSA and MCCB. These results provide encouraging support for a computerized functional capacity assessment for use in schizophrenia.

Use of Pooled State Administrative Data for Mental Health Services Research.

State systems are a rich, albeit challenging, laboratory for policy-relevant services research studies. State mental health authorities routinely devote resources to collect data for state planning and reporting purposes. However, these data are rarely used in cross-state comparisons to inform state or federal policy development. In 2008, in response to key recommendations from the National Institute of Mental Health (NIMH) Advisory Council's "The Road Ahead: Research Partnership to Transform Services," (http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/road-ahead.pdf), NIMH issued a request for applications (RFA) to support studies on the impact of state policy changes on access, cost, quality and outcomes of care for individuals with mental disorders. The purpose of the RFA was to bridge the divide between research and policy by encouraging research that used state administrative data across states, and to address significant state-defined health policy initiatives. Five projects involving eight states were selected through peer review for funding. Projects began in 2009 and were funded for 3 years. This report provides a brief description of the five projects, followed by an analysis of the impact, challenges, and lessons learned from these policy-partnered studies. We conclude by offering suggestions on ways to use state administrative data for informing state health policies, which is especially timely given national and state changes in the structure and financing of healthcare.

Comorbid depression in obstructive sleep apnea: an under-recognized association.

BACKGROUND: Obstructive sleep apnea (OSA) and depression may coexist in the same patient. This article aims to review the link between OSA and comorbid depression and critically evaluate the results of studies that assessed the correlation between OSA and depression, the impact of OSA treatment on comorbid depression, and the impact of comorbid depression on continuous positive airway pressure (CPAP) adherence. METHODS: An integrative review was conducted on English language studies and reports that assessed the relationship between OSA and depression. Studies were identified by searching PubMed, Web of Science and Google Scholar databases, and reference lists of included studies. RESULTS: Generally, cross-sectional studies show a higher prevalence of depression among OSA patients with both community and sleep disorder clinic samples. Nevertheless, the relationship between OSA and depression is complicated by the fact that the disorders have overlapping symptoms. Longitudinal studies demonstrate an increased risk of developing depression among people with OSA, as well as an association between OSA severity and the likelihood of developing depression. On the other hand, studies assessing the impact of CPAP therapy on depression among OSA patients report conflicting results. Therefore, it is essential to consider how the disorders affect one another and to understand the clinical consequences of treating each disorder in isolation. CONCLUSION: Depression is prevalent among patients with OSA both in the community and in sleep disorder clinics. Clinicians in general should be aware of this significant association and should aim to treat both disorders.

Long-acting injectable vs oral risperidone for schizophrenia and co-occurring alcohol use disorder: a randomized trial.

OBJECTIVE: Alcohol use disorders worsen the course of schizophrenia. Although the atypical antipsychotic clozapine appears to decrease alcohol use in schizophrenia, risperidone does not. We have proposed that risperidone's relatively potent dopamine D2 receptor blockade may partly underlie its lack of effect on alcohol use. Since long-acting injectable (LAI) risperidone both results in lower average steady-state plasma concentrations than oral risperidone (with lower D2 receptor occupancy) and encourages adherence, it may be more likely to decrease heavy alcohol use (days per week of drinking 5 or more drinks per day) than oral risperidone. METHOD: Ninety-five patients with DSM-IV-TR diagnoses of schizophrenia and alcohol use disorder were randomized to 6 months of oral or LAI risperidone between 2005 and 2008. Explanatory (efficacy) analyses were carried out to evaluate the potential benefits of LAI under suitably controlled conditions (in contrast to real-world settings), with intent-to-treat analyses being secondary. RESULTS: Explanatory analyses showed that heavy drinking in the oral group worsened over time (P = .024) and that there was a statistical trend toward significance in the difference between the changes in heavy drinking days in the oral and LAI groups (P = .054). Furthermore, the 2 groups differed in the mean number of drinking days per week (P = .035). The intent-to-treat analyses showed no difference in heavy drinking but did show a difference in average drinking days per week similar to that obtained from the explanatory analyses (P = .018). Neither explanatory nor intent-to-treat analyses showed any between-group differences in alcohol use as measured by intensity or the Alcohol Use Scale. The plasma concentrations of the active metabolite 9-hydroxyrisperidone were significantly lower in patients taking LAI (P < .05), despite their significantly (overall) better treatment adherence (P < .005). CONCLUSION: For the population considered here, schizophrenia patients with alcohol use disorder appear to continue drinking some alcohol while taking either form of risperidone. Nonetheless, our data suggest that injectable risperidone may be a better choice than the oral form for these dual diagnosis patients. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00130923.

Impact of a Telepsychiatry Program at Emergency Departments Statewide on the Quality, Utilization, and Costs of Mental Health Services.

OBJECTIVE: This study estimated the impact of a statewide, centralized telepsychiatry service provided in nonpsychiatric emergency departments (EDs) on use of mental health services. METHODS: Individuals treated via telepsychiatry were compared with a matched control group of individuals with mental health diagnoses who were treated in nonparticipating hospitals. Bivariate and two-part and generalized linear regression models were used to assess differences between the two groups in outpatient follow-up, hospital admission following the ED visit, length of hospital stay if admitted, and inpatient and total costs. RESULTS: Between March 2009 and June 2013, there were 9,066 patients with at least one telepsychiatry visit. Of these, 7,261 had index telepsychiatry visits that the authors were able to successfully match. Compared with the matched control group, telepsychiatry recipients were more likely to receive 30-day outpatient follow-up (46% versus 16%, p<.001) and 90-day outpatient follow-up (54% versus 20%, p<.001). Telepsychiatry recipients were less likely than the control group to be admitted to the hospital during the index ED visit (11% versus 22%, p<.001). The combined effect of having a telepsychiatry consult during the index ED visit was a reduction of .86 days in inpatient length of stay. Thirty-day inpatient costs were $2,336 (p=.04) lower for the telepsychiatry versus the control group, but 30-day total health care costs were not statistically different. CONCLUSIONS: Telepsychiatry delivered in the ED through a centralized coordinated program has great promise for improving linkage with outpatient mental health services while reducing inpatient utilization and hospital costs.

Project Stakeholder Management in the Clinical Research Environment: How to Do it Right.

This review introduces a conceptual framework for understanding stakeholder management (ShM) in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve patients and other stakeholders in the center of the research process. Substantial evidence has now been provided that stakeholder involvement is essential for management effectiveness in clinical research. Feedback from stakeholders has critical value for research managers inasmuch as it alerts them to the social, environmental, and ethical implications of research activities. Additionally, those who are directly affected by program development and clinical research, the patients, their families, and others, almost universally have a strong motivation to be involved in the planning and execution of new program changes. The current overview introduces a conceptual framework for ShM in the clinical research environment and offers practical suggestions for fostering meaningful stakeholder engagement. The fifth edition of PMBOK(®) of the Project Management Institute, has served as basis for many of the suggested guidelines that are put forward in this article.

A 13-week, randomized double-blind, placebo-controlled, cross-over trial of ziprasidone in bipolar spectrum disorder.

OBJECTIVE: Features of bipolarity in a major depressive disorder sample were used to define a "bipolar spectrum disorder" population for treatment with a neuroleptic agent, ziprasidone. METHODS: Forty-nine acutely depressed patients were randomized to ziprasidone-washout-placebo or placebo-washout-ziprasidone in this double-blind, prospective, 13-week crossover trial. All patients met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for a major depressive episode and were positive for at least 3 predictors of bipolarity: family history of bipolar disorder, antidepressant-induced mania, highly recurrent depressive episodes (>5), atypical depression, early onset of depression (

Reliability, validity and treatment sensitivity of the Schizophrenia Cognition Rating Scale.

Cognitive functioning can be assessed with performance-based assessments such as neuropsychological tests and with interview-based assessments. Both assessment methods have the potential to assess whether treatments for schizophrenia improve clinically relevant aspects of cognitive impairment. However, little is known about the reliability, validity and treatment responsiveness of interview-based measures, especially in the context of clinical trials. Data from two studies were utilized to assess these features of the Schizophrenia Cognition Rating Scale (SCoRS). One of the studies was a validation study involving 79 patients with schizophrenia assessed at 3 academic research centers in the US. The other study was a 32-site clinical trial conducted in the US and Europe comparing the effects of encenicline, an alpha-7 nicotine agonist, to placebo in 319 patients with schizophrenia. The SCoRS interviewer ratings demonstrated excellent test-retest reliability in several different circumstances, including those that did not involve treatment (ICC> 0.90), and during treatment (ICC>0.80). SCoRS interviewer ratings were related to cognitive performance as measured by the MCCB (r=-0.35), and demonstrated significant sensitivity to treatment with encenicline compared to placebo (P<.001). These data suggest that the SCoRS has potential as a clinically relevant measure in clinical trials aiming to improve cognition in schizophrenia, and may be useful for clinical practice. The weaknesses of the SCoRS include its reliance on informant information, which is not available for some patients, and reduced validity when patient's self-report is the sole information source.