SIBAT-A Computerized Assessment Tool for Suicide Ideation and Behavior: Development and Psychometric Properties.

Objective: Most assessments of suicidal ideation and behavior (SIB) are limited by reliance on a single assessor, typically a clinician or patient, with scant detail on patient-related drivers of SIB and inability to detect rapid change in SIB. Furthermore, many techniques do not include a semistructured interview, increasing rater variability. The Suicide Ideation and Behavior Assessment Tool (SIBAT) addresses these limitations. Design: More than 30 experts in scale development, statistics, and clinical management of suicidal patients collaborated over a greater than four-year period to develop the SIBAT. Input for content and validity was received from patients, clinicians, and regulatory authorities in the United States (US) and Europe. Psychometric properties of the SIBAT were evaluated in validation studies. Results: The SIBAT is organized into eight independent patient- or clinician-rated modules with branching logic and scoring algorithms, which necessitates computerization. Patient-reported information is first captured in Modules 1 to 5. Thereafter, an experienced clinician reviews the patient's report, conducts a semistructured interview (Module 6), and assesses the patient's suicide risk (Module 7) and optimal antisuicide management (Module 8). Input from cognitive interviews of diverse adult, adolescent, and clinician participants was incorporated into the final version of the SIBAT. Psychometric testing demonstrated good inter-rater reliability (intraclass coefficient range: 0.68-0.82), intra-rater reliability (weighted-kappa range: 0.64-0.76), and concurrent validity with other instruments for assessing SIB. Conclusion: Patient- and clinician-based assessments and the psychometric studies summarized in this report support the validity and reliability of the SIBAT for capturing critical information related to assessment of SIB in adolescents and adults at risk for suicide.

THE DEPRESSION INVENTORY DEVELOPMENT SCALE: Assessment of Psychometric Properties Using Classical and Modern Measurement Theory in a CAN-BIND Trial.

Objective: The goal of the Depression Inventory Development (DID) project is to develop a comprehensive and psychometrically sound rating scale for major depressive disorder (MDD) that reflects current diagnostic criteria and conceptualizations of depression. We report here the evaluation of the current DID item bank using Classical Test Theory (CTT), Item Response Theory (IRT) and Rasch Measurement Theory (RMT). Methods: The present study was part of a larger multisite, open-label study conducted by the Canadian Biomarker Integration Network in Depression (ClinicalTrials.gov: NCT01655706). Trained raters administered the 32 DID items at each of two visits (MDD: baseline, n=211 and Week 8, n=177; healthy participants: baseline, n=112 and Week 8, n=104). The DID's "grid" structure operationalizes intensity and frequency of each item, with clear symptom definitions and a structured interview guide, with the current iteration assessing symptoms related to anhedonia, cognition, fatigue, general malaise, motivation, anxiety, negative thinking, pain, and appetite. Participants were also administered the Montgomery- Åsberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) that allowed DID items to be evaluated against existing "benchmark" items. CTT was used to assess data quality/reliability (i.e., missing data, skewness, scoring frequency, internal consistency), IRT to assess individual item performance by modelling an item's ability to discriminate levels of depressive severity (as assessed by the MADRS), and RMT to assess how the items perform together as a scale to capture a range of depressive severity (item targeting). These analyses together provided empirical evidence to base decisions on which DID items to remove, modify, or advance. Results: Of the 32 DID items evaluated, eight items were identified by CTT as problematic, displaying low variability in the range of responses, floor effects, and/or skewness; and four items were identified by IRT to show poor discriminative properties that would limit their clinical utility. Five additional items were deemed to be redundant. The remaining 15 DID items all fit the Rasch model, with person and item difficulty estimates indicating satisfactory item targeting, with lower precision in participants with mild levels of depression. These 15 DID items also showed good internal consistency (alpha=0.95 and inter-item correlations ranging from r=0.49 to r=0.84) and all items were sensitive to change following antidepressant treatment (baseline vs. Week 8). RMT revealed problematic item targeting for the MADRS and QIDSSR, including an absence of MADRS items targeting participants with mild/moderate depression and an absence of QIDS-SR items targeting participants with mild or severe depression. Conclusion: The present study applied CTT, IRT, and RMT to assess the measurement properties of the DID items and identify those that should be advanced, modified, or removed. Of the 32 items evaluated, 15 items showed good measurement properties. These items (along with previously evaluated items) will provide the basis for validation of a penultimate DID scale assessing anhedonia, cognitive slowing, concentration, executive function, recent memory, drive, emotional fatigue, guilt, self-esteem, hopelessness, tension, rumination, irritability, reduced appetite, insomnia, sadness, worry, suicidality, and depressed mood. The strategies adopted by the DID process provide a framework for rating scale development and validation.

Exploring Perceptions of a Computerized Cognitive Behavior Therapy Program in a U.S. Rural Western State.

Computerized mental health interventions have the potential to address existing mental health care disparities in rural communities. The aim of this study was to conduct an exploratory examination on the acceptability of an interactive computerized cognitive behavior therapy program to reduce depressive symptoms for adults in a rural Western state. Partnering with the land-grant university Extension system and a state non-profit organization, we identified and interviewed 18 key informants and conducted 19 focus groups in 15 rural communities to ascertain attitudes and perspectives about the program. Key informants were provided access to the Thrive program prior to the interviews. Focus group participants were provided a brief demonstration of the program and asked to provide feedback. Content analyses of interview and focus group transcripts yielded four general themes of program acceptability: privacy, accessibility, user-friendliness, and cultural inappropriateness. Overall, participants indicated that the Thrive program would be useful for many in their communities. They also reported that the program could be improved by making videos that better represent rural community members' lifestyles and experiences. The study team members acted on these findings to improve the Thrive program for rural Western populations.

The Depression Inventory Development Workgroup: A Collaborative, Empirically Driven Initiative to Develop a New Assessment Tool for Major Depressive Disorder.

The Depression Inventory Development project is an initiative of the International Society for CNS Drug Development whose goal is to develop a comprehensive and psychometrically sound measurement tool to be utilized as a primary endpoint in clinical trials for major depressive disorder. Using an iterative process between field testing and psychometric analysis and drawing upon expertise of international researchers in depression, the Depression Inventory Development team has established an empirically driven and collaborative protocol for the creation of items to assess symptoms in major depressive disorder. Depression-relevant symptom clusters were identified based on expert clinical and patient input. In addition, as an aid for symptom identification and item construction, the psychometric properties of existing clinical scales (assessing depression and related indications) were evaluated using blinded datasets from pharmaceutical antidepressant drug trials. A series of field tests in patients with major depressive disorder provided the team with data to inform the iterative process of scale development. We report here an overview of the Depression Inventory Development initiative, including results of the third iteration of items assessing symptoms related to anhedonia, cognition, fatigue, general malaise, motivation, anxiety, negative thinking, pain and appetite. The strategies adopted from the Depression Inventory Development program, as an empirically driven and collaborative process for scale development, have provided the foundation to develop and validate measurement tools in other therapeutic areas as well.

Prospective assessment of suicidal ideation and behavior: an internet survey of pharmaceutical sponsor practices.

OBJECTIVE: To survey the current approaches of clinical trial sponsors in prospective suicidal ideation and behavior assessments and challenges encountered. DESIGN: An internet-based survey. SETTING: Inclusion of prospective assessments of suicidal ideation and behavior in industry-sponsored clinical studies were required following the release of the September 2010 United States Federal Drug Administration draft guidance. The International Society for CNS Clinical Trials and Methodology Suicidal Ideation and Behavior Assessment Workgroup conducted an online survey to understand industry practices and experiences in implementing suicidal ideation and behavior assessments in clinical trials. PARTICIPANTS: The survey was sent to 1,447 industry employees at 178 pharmaceutical companies. A total of 89 evaluable responses, representing 39 companies, were obtained. MEASUREMENTS: A 30-item internet survey was developed asking about potential challenges and issues in implementing prospective suicidal ideation and behavior assessments. RESULTS: Common factors in deciding whether to include suicidal ideation and behavior assessments in a clinical trial were psychiatric or neurologic drug product (95%); central nervous system activity (78%); disease (74%) and patient population (71%); and regulatory announcements and policies (74%). The most common challenges in implementing suicidal ideation and behavior assessments included cross-cultural differences in acceptance of SIB assessments (40%); obtaining adequate baseline history (36.8%); obtaining translations (35%); investigator/rater discomfort with asking about suicidal ideation and behavior (32%); and inadequate training of raters to administer suicidal ideation and behavior ratings (30%). CONCLUSION: Among sponsors surveyed, the implementation rate of suicidal ideation and behavior assessment in central nervous systems studies is very high. Most have used the Columbia-Suicide Severity Rating Scale. Challenges regarding standardization of retrospective assessment timeframes and differing approaches to summarizing and analyzing suicidal ideation and behavior-related study data were frequently reported. These results suggest that inconsistent reports of suicidal ideation and behavior within study datasets may occur and that integration of data across studies remains a concern.

Voice response system to measure healthcare costs: a STAR*D report.

OBJECTIVE: To evaluate a telephone-operated, interactive voice response (IVR) system designed to collect use-of-care data from patients with major depression (UAC-IVR). STUDY DESIGN: Patient self-reports from repeated IVR surveys were compared with provider records for 3789 patients with major depression at 41 clinical sites participating in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial. METHODS: UAC-IVR responses were examined for consistency and compared with provider records to compute reporting biases and intraclass correlation coefficients. Predictors of inconsistent responses and reporting biases were based on mixed logistic and regression models adjusted for need and predisposing and enabling covariates, and corrected for nesting and repeated measures. RESULTS: Inconsistent responses were found for 10% of calls and 21% of patients. Underreporting biases (-20%) and moderate agreement (intraclass correlation of 68%) were found when UAC-IVR responses were compared with medical records. IVR reporting biases were less for patients after 3 calls or more (experience), for patients with severe baseline symptoms (motivation), and for patients who gave consistent IVR responses (reliability). Bias was unrelated to treatment outcomes or demographic factors. CONCLUSION: Clinical managers should use IVR systems to collect service histories only after patients are properly trained and responses monitored for consistency and reporting biases.

Using daily interactive voice response assessments: to measure onset of symptom improvement with duloxetine.

Most clinical trials measure patient responses weekly, requiring patients to accurately recall and report their symptoms from the previous six days. More frequent assessments would be less susceptible to recall errors and recency effects as weekly assessments, but increased office visits burden clinicians and patients and can lead to higher attrition or non compliance. Interactive voice response (IVR) technology permits data collection at greater frequencies with minimal reporting burdens. An ancillary study within a randomized clinical trial evaluated the use of IVR to gather measures of patients' ratings of emotional and painful symptoms of depression on a daily basis. Unmedicated patients randomized to a starting dose of duloxetine of 30 mg QD (n=67) or 60 mg QD (n=70) called an IVR system daily to complete Verbal Numeric Scales for pain and Patient Global Impression of Improvement for both physical and emotional changes. Patients' compliance with daily IVR assessments was examined, and the IVR data obtained showed that patients started at 60 mg reported less pain and greater physical and emotional improvements than patients started at 30 mg. Dose related differences were evident as early as one day after the start treatment. This study provides new data about the usefulness of daily IVR assessments in clinical research and supports other studies regarding early symptom improvement with duloxetine.

Prevalence and burden of illness of migraine in managed care patients.

OBJECTIVE: To determine the 3-month prevalence rate of migraine in a health maintenance organization (HMO) population, using a 2-stage screening process and neurologist exam, and to examine the burden of illness associated with both previously diagnosed and previously undiagnosed migraine in this population METHODS: A migraine assessment was sent to a random sample of 1,000 HMO patients between April 1999 and January 2000. Those screening positive and a random sample of those screening negative for migraine were evaluated by neurologists using a structured diagnostic assessment. Then, those diagnosed to have migraines by the study's neurologists completed a battery of 3 questionnaires, evaluating severity, distress, and impairment RESULTS: Of 1,000 questionnaires sent, 753 (75.3%) were returned. The estimate of prevalence of migraine in this population ranged from 21.4% (adjusted for response bias) to 27.8% (unadjusted for selection bias). Only 48% of respondents had been previously diagnosed with migraine. The typical migraine caused moderate-to-severe distress in 69%, and 66% had definite or extreme interference in their social or occupational functioning. The average migraineur missed 7.6 hours of work due to migraine in the past 3 months. Previously undiagnosed migraine was associated with substantial impairment, with 58% of responders reporting interference with daily activities and 54% reporting moderate or greater distress. There was no significant difference between previously diagnosed and undiagnosed migraineurs on 3 outcome measures: pain, interference, or days of missed work. A higher proportion of previously diagnosed migraineurs (84%) reported moderate or greater distress compared with undiagnosed migraineurs (54%, P=0.002). CONCLUSIONS: Using a neurologist exam, the researchers found that the prevalence of migraine headaches was higher than previously reported. About one half of migraineurs had been previously undiagnosed. Undiagnosed migraine is associated with significant pain, distress, and dysfunction and is similar in these respects to diagnosed migraine. Increased public education and physician education on migraine are warranted.

Suicide risk management for the sequenced treatment alternatives to relieve depression study: applied NIMH guidelines.

NIMH guidelines to manage subjects who are suicidal during their participation in clinical trials include a full range of procedures to minimize suicidal risk, yet no reports to date have shown how researchers should best implement these guidelines. The architects of the sequenced treatment alternatives to relieve depression (STAR*D) study operationalized and implemented the NIMH guidelines by developing a comprehensive set of procedures to detect, monitor, and manage suicidal subjects during a large, complex, multisite clinical trial. Because of the large size of the study (anticipated n = 4000), the wide geographic distribution, the large number of treating STAR*D clinicians, the broad array of subjects with psychiatric and medical comorbidities, and the focus on treatment-resistant depression, along with the complexity of multiple treatment steps and randomization points in STAR*D, the risk of suicide, safety monitoring of suicidal subjects presented a unique challenge. This paper describes methods derived from the NIMH guidelines used to manage suicidal risk in STAR*D including the use of an interactive voice response system to alert clinicians, regional center directors, and safety officers.

WCA recommendations for the long-term treatment of obsessive-compulsive disorder in adults.

What are the latest psychotherapeutic and pharmacotherapeutic treatment recommendations for obsessive-compulsive disorder (OCD)? OCD is a relatively common disorder with a lifetime prevalence of approximately 2% in the general population. It often has an early onset, usually in childhood or adolescence, and frequently becomes chronic and disabling if left untreated. High associated healthcare utilization and costs, and reduced productivity resulting in loss of earning, pose a huge economic burden to OCD patients and their families, employers, and society. OCD is characterized by the presence of obsessions and compulsions that are time-consuming, cause marked distress, or significantly interfere with a person's functioning. Most patients with OCD experience symptoms throughout their lives and benefit from long-term treatment. Both psychotherapy and pharmacotherapy are recommended, either alone or in combination, for the treatment of OCD. Cognitive-behavioral therapy is the psychotherapy of choice. Pharmacologic treatment options include the tricyclic antidepressant clomipramine and the selective serotonin reuptake inhibitors (SSRIs) citalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline. These have all shown benefit in acute treatment trials; clomipramine, fluvoxamine, fluoxetine, and sertraline have also demonstrated benefit in long-term treatment trials (at least 24 weeks), and clomipramine, sertraline, and fluvoxamine have United States Food and Drug Administration approvals for use in children and adolescents. Available treatment guidelines recommend first-line use of an SSRI (ie, fluoxetine, fluvoxamine, paroxetine, sertraline, or citalopram) in preference to clomipramine, due to the latter's less favorable adverse-event profile. Further, pharmacotherapy for a minimum of 1-2 years is recommended before very gradual withdrawal may be considered.