Search

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. [ABSTRACT FROM AUTHOR]

Although the use of telemedicine in psychiatry has a long history in providing clinical care to patients, its use in clinical trials research has not yet been commonly employed. Telemedicine allows for the remote assessment of study patients, which could be done by a centralized, highly calibrated, and impartial cohort of raters independent of the study site. This study examined the comparability of remote administration of the Montgomery–Asberg Depression Rating Scale (MADRS) by videoconference and by telephone to traditional face-to-face administration. Two parallel studies were conducted: one compared face-to-face with videoconference administration (N=35), and the other compared face-to-face with telephone administration (N=35). In each study, depressed patients were interviewed independently twice: once in the traditional face-to-face manner, and the second time by either videoconference or teleconference. A counterbalanced order was used. The mean MADRS score for interviews conducted remotely by videoconference was not significantly different from the mean MADRS scores conducted by face-to-face administration (mean difference=0.51 points), P=.388, intraclass correlation (ICC)=.94, P<0001. Similarly, the mean MADRS score for interviews conducted by telephone was not significantly different from the mean MADRS score conducted by face-to-face administration (mean difference=0.74 points), P=.270, ICC=.93, P<0001. Results of the study support the comparability of remote administration of the MADRS, by both telephone and videoconference, to face-to-face administration. Comparability of the administration mode allows for remote assessment of patients in both research and clinical applications. Depression and Anxiety, 2008. © 2007 Wiley-Liss, Inc. [ABSTRACT FROM AUTHOR]

Abstract: Poor inter-rater reliability (IRR) is an important methodological factor that may contribute to failed trials. The sheer number of raters at diverse sites in multicenter trials presents a formidable challenge in calibration. Videoconferencing allows for the evaluation of IRR of raters at diverse sites by enabling raters at different sites to each independently interview a common patient. This is a more rigorous test of IRR than passive rating of videotapes. To evaluate the potential impact of videoconferencing on IRR, we compared IRR obtained via videoconference to IRR obtained using face-to-face interviews. Four raters at three different locations were paired using all pair-wise combinations of raters. Using videoconferencing, each paired rater independently conducted an interview with the same patient, who was at a third, central location. Raters were blind to each others'' scores. ICC from this cohort (n =22) was not significantly different from the ICC obtained by a cohort using two face-to-face interviews (n =21) (0.90 vs. 0.93, respectively) nor from a cohort using one face-to-face interview and one remote interview (n =21) (0.88). The mean Hamilton Depression Rating Scale (HAMD) scores obtained were not significantly different. There appears to be no loss of signal using remote methods of calibration compared with traditional face-to-face methods. [Copyright &y& Elsevier]

Abstract: Problems associated with the clinician-administered rating scales have led to new approaches to improve rater training. These include interactive, on-line didactic tutorials and live, remote evaluation of raters'' clinical skills through the use of videoconferencing. The purpose of this study was to evaluate this approach in training novice raters on the administration of the Positive and Negative Symptom Scale (PANSS). Twelve trainees with no prior PANSS experience completed didactic training via CD-ROM and two remote training sessions where they interviewed a standardized patient-actor while being remotely observed in real time and given feedback. Results found a significant improvement in trainees'' conceptual knowledge and an improvement in trainees'' clinical skills. The use of these technologies allows for training to be more effectively delivered to diverse sites in multi-center trials, and for evaluation of raters'' applied clinical skills, an area that has previously been overlooked. [Copyright &y& Elsevier]

Background: While primary care physicians play a pivotal role in the treatment of depression, collaboration between primary care and psychiatry in clinical research has been limited. Primary care settings provide unique opportunities to improve the methodology of psychiatric clinical trials, by providing more generalizable and less treatment-resistant patients. We examined the feasibility of identifying, recruiting, screening and assessing primary care patients for psychiatric clinical trials using high-quality videoconferencing in a mock clinical trial. Methods: 1329 patients at two primary care clinics completed a self-report questionnaire. Those screening positive for major depression, panic, or generalized anxiety were given a diagnostic interview via videoconference. Those eligible were provided treatment as usual by their primary care physician, and had 6 weekly assessments by the off-site clinician via videoconferencing. Results: 45 patients were enrolled over 22 weeks, with 36 (80%) completing the six-week study with no more than two missed appointments. All diagnostic groups improved significantly; 94% reported they would participate again, 87% would recommend participation to others, 96% felt comfortable communicating via videoconference, and 94% were able to satisfactorily communicate their feelings via video. Conclusion: Results showed that primary care patients will enroll, participate in and complete psychiatric research protocols using remote interviews conducted via videoconference. [ABSTRACT FROM AUTHOR]

Abstract: Objective: The evaluation and training of raters who conduct efficacy evaluations in clinical trials is an important methodological variable that is often overlooked. Few rater training programs focus on teaching and assessing applied clinical skills, and even fewer have been empirically examined for efficacy. The goal of this study was to develop a comprehensive, standardized, interactive rater training program using new technologies, and to compare the relative effectiveness of this approach to “traditional” rater training in a multi-center clinical trial. Method: 12 sites from a 22 site multi-center study were randomly selected to participate (6=traditional, 6=enriched). Traditional training consisted of an overview of scoring conventions, watching and scoring videotapes with discussion, and observation of interviews in small groups with feedback. Enriched training consisted of an interactive web tutorial, and live, remote observation of trainees conducting interviews with real or standardized patients, via video- or teleconference. Outcome measures included a didactic exam on conceptual knowledge and blinded ratings of trainee’s audiotaped interviews. Results: A significant difference was found between enriched and traditional training on pre-to-post training improvement on didactic knowledge, t(27)=4.2, p <0.0001. Enriched trainees clinical skills also improved significantly more than traditional trainees, t(56)=2.1, p =0.035. All trainees found the applied training helpful, and wanted similar web tutorials with other scales. Conclusions: Results support the efficacy of enriched rater training in improving both conceptual knowledge and applied skills. Remote technologies enhance training efforts, and make training accessible and cost-effective. Future rater training efforts should be subject to empirical evaluation, and include training on applied skills. [Copyright &y& Elsevier]

Poor inter-rater reliability is a major concern, contributing to error variance, which decreases power and increases the risk for failed trials. This is particularly problematic with the Hamilton Depression Scale (HAMD), due to lack of standardized questions or explicit scoring procedures. Establishing standardized procedures for administering and scoring the HAMD is typically done at study initiation meetings. However, the format and time allotted is usually insufficient, and evaluation of the trainee''s ability to actually conduct a clinical interview is limited. To address this problem, we developed a web-based, interactive rater education program for standardized training to diverse sites in multi-center trials. The program includes both didactic training on scoring conventions and live, remote observation of trainees applied skills. The program was pilot tested with nine raters from a single site. Results found a significant increase in didactic knowledge pre-to-post testing, with the mean number of incorrect answers decreasing from 6.5 (S.D.=1.64) to 1.3 (S.D.=1.03), t(5)=7.35, P=0.001 (20 item exam). Seventy-five percent of the trainees'' interviews were within two points of the trainer''s score. Inter-rater reliability (intraclass correlation) (based on trainees actual interviews) was 0.97, P<0.0001. Results support the feasibility of this methodology for improving rater training. An NIMH funded study is currently underway examining this methodology in a multi-site trial. [Copyright &y& Elsevier]

Computer-administered versions of two clinician-administered symptom rating scales for social anxiety (the Liebowitz Social Anxiety Scale [LSAS] and the Brief Social Phobia Scale [BSPS]) and one paper-and-pencil scale (the Fear Questionnaire) were developed and utilized in a clinical trial for social phobia. The reliability and validity of the computer versions were examined, as were their equivalence to the traditional versions. Correlations between the computer and original versions were high at baseline, and remained high throughout the study. The internal consistency reliability of the computer scales was also high, and almost identical to the original versions. Mean score differences between computer and original versions were not significant at baseline, and no significant differences were found between computer and traditional versions on the amount of change detected from baseline to endpoint. Seventy-seven percent of subjects felt that the computer did not interfere with their visit at baseline and a plurality (36%) preferred the computer, with 30% preferring the clinician and 34% having no preference. By the end of the study, the plurality (41%) had no preference, with 27% preferring the computer and 32% preferring the clinician. Results support the use of these computer-administered symptom rating scales of social anxiety as a viable alternative to the clinician-administered versions with this subset of patients, which should offer researchers and clinicians a reliable and cost-effective method for evaluating social phobia. [ABSTRACT FROM AUTHOR]