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Biomedical subjects

Joshua D Lipsitz

Publications and source records attributed to Joshua D Lipsitz.

14 recordsLinked to original sources
PubMed2006

Rating the raters: assessing the quality of Hamilton rating scale for depression clinical interviews in two industry-sponsored clinical drug trials.

OBJECTIVE: The quality of clinical interviews conducted in industry-sponsored clinical drug trials is an important but frequently overlooked variable that may influence the outcome of a study. We evaluated the quality of Hamilton Rating Scale for Depression (HAM-D) clinical interviews performed at baseline in 2 similar multicenter, randomized, placebo-controlled depression trials sponsored by 2 pharmaceutical companies. METHODS: A total of 104 audiotaped HAM-D clinical interviews were evaluated by a blinded expert reviewer for interview quality using the Rater Applied Performance Scale (RAPS). The RAPS assesses adherence to a structured interview guide, clarification of and follow-up to patient responses, neutrality, rapport, and adequacy of information obtained. RESULTS: HAM-D interviews were brief and cursory and the quality of interviews was below what would be expected in a clinical drug trial. Thirty-nine percent of the interviews were conducted in 10 minutes or less, and most interviews were rated fair or unsatisfactory on most RAPS dimensions. CONCLUSIONS: Results from our small sample illustrate that the clinical interview skills of raters who administered the HAM-D were below what many would consider acceptable. Evaluation and training of clinical interview skills should be considered as part of a rater training program.

Antidepressive Agents↗
PubMed2006

An open pilot study of interpersonal psychotherapy for panic disorder (IPT-PD).

Interpersonal psychotherapy (IPT) is a time-limited psychotherapy initially developed to treat depression. It has yet to be studied systematically for treatment of panic disorder. We modified IPT for the treatment of panic disorder and tested this treatment in an open clinical trial with 12 patients seeking treatment of DSM-IV panic disorder. Patients were assessed before during and after treatment. At completion of treatment, nine patients (75%) were independently categorized as responders (i.e., rated as much improved or very much improved on the Clinical Global Impression-Change Scale). Substantial improvement was found for panic symptoms, associated anxiety and depressive symptoms, and physical and emotional well-being. Degree of change in this sample approximated that obtained in studies using established treatments such as cognitive behavioral therapy. Results, though preliminary, suggest that IPT may have efficacy as a primary treatment of panic disorder. Further study is warranted.

Adolescent↗
PubMed2005

Enriched rater training using Internet based technologies: a comparison to traditional rater training in a multi-site depression trial.

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.

Clinical Competence↗
PubMed2005

Noncardiac chest pain and psychopathology in children and adolescents.

OBJECTIVE: We sought to examine the prevalence of DSM-IV psychiatric disorders in children and adolescents with complaints of noncardiac chest pain (NCCP). METHOD: We assessed 27 youngsters (ages 8-17 years) referred to a pediatric cardiology practice with complaints of NCCP. Each child and a parent were interviewed using the Anxiety Disorders Interview Schedule for Children. RESULTS: Sixteen youngsters (59%) were diagnosed with a current DSM-IV disorder. Fifteen (56%) had a current anxiety disorder, nine of whom were diagnosed with panic disorder. One participant was diagnosed with a depressive disorder. CONCLUSION: Results of this preliminary study suggest that DSM-IV anxiety disorders may be common in youngsters with NCCP. No evidence was found for high prevalence of depression in this sample. Larger controlled studies are needed to determine the prevalence and impact of psychopathology in youngsters with NCCP.

Adolescent↗
PubMed2005

A direct interview family study of obsessive-compulsive disorder. II. Contribution of proband informant information.

BACKGROUND: Overall findings of our first direct interview family study of obsessive-compulsive disorder (OCD) indicated that OCD is familial. In this replication study, we carefully examined the role of informant data in ascertaining OCD in relatives. METHOD: We interviewed 112 relatives of 57 OCD patients and 115 relatives of 41 not ill controls predominantly by telephone. Additional analyses included a combined sample of relatives about whom any diagnostic information was available (228 OCD and 239 controls). To examine the contribution of proband information about relatives, we considered two sets of best-estimate diagnoses. First, we ascertained best-estimate diagnoses for relatives using information from direct interviews and from all informants except the proband. Then, we re-diagnosed relatives based on all available information, including reports from the proband about their relatives. RESULTS: When relative diagnoses were derived without the benefit of proband informant reports, no evidence of familial OCD transmission was found. When diagnoses were made including information from the proband about the relative, evidence of familial OCD was found, but only when the diagnostic threshold was lowered to include cases with probable OCD or OCD symptoms. Other diagnoses (generalized anxiety disorder, social phobia, drug use disorder) were also higher among OCD relatives. CONCLUSIONS: This second study provides less robust support for familial transmission of OCD. Evidence for familial transmission of OCD was found only when diagnoses were made using information from the affected proband about their relatives. Taken in context of past findings, our own inconsistent results suggest that OCD may be heterogeneous with regard to familial transmission. Also, more careful attention should be paid to the contribution of informant reports, especially from relatives affected by the same disorder.

Adult↗
PubMed2005

A direct interview family study of obsessive-compulsive disorder. I.

BACKGROUND: This and the companion paper present two sequential family studies of obsessive-compulsive disorder (OCD) conducted by the same research group, but with different sampling and best-estimate procedures. In addition to providing further data on familial transmission of OCD, we used comparison of disparate findings (moderate, specific familial aggregation in this first study versus a stronger effect for other anxiety disorders than for OCD alone in the second) to examine possible effects of proband characteristics and informant data on outcome. METHOD: In this initial study we interviewed 179 first-degree relatives of 72 OCD probands and 112 relatives of 32 never mentally ill (NMI) controls. Informant data were obtained on an additional 126 relatives (total "combined" samples of 263 and 154 respectively). Analyses used best-estimate diagnoses made by consensus of two "blinded" senior clinicians who reviewed all diagnostic materials including proband informant data about relatives. RESULTS: Significantly higher risk for OCD but not other anxiety disorders was found in relatives of OCD probands compared to relatives of controls in both the directly interviewed and combined samples. There was no relationship between proband age at onset of OCD and strength of familial aggregation. CONCLUSIONS: These data indicate moderate familial aggregation of OCD, but do not support increased transmission by early onset probands, or a familial relationship between OCD and other anxiety disorders with the possible exception of generalized anxiety disorder.

Adult↗
PubMed2005

A new approach to rater training and certification in a multicenter clinical trial.

Recent evidence demonstrates that the quality of raters' applied clinical skills is directly related to study outcome. As such, the training and evaluation of raters' clinical skill in administering symptom-rating scales is essential before being certified to rate patients in clinical trials. This study examined a novel approach to rater training and certification that focused on both conceptual knowledge and applied skills. Forty-six raters (MDs = 14; PhDs = 7; MA = 5; BA/LPN/RN = 20) in a large multicenter depression study went through a 2-step Hamilton Rating Scale for Depression (HAMD) certification process: didactic training, administered online via an interactive Web tutorial, and live, applied training, where raters interviewed depressed patients while being remotely observed via 3-way teleconference. Raters' applied skills were evaluated using the Rater Applied Performance Scale (RAPS), designed specifically to evaluate critical rater behaviors associated with good clinical interviews. Raters received feedback immediately following the interviews; those receiving a failing score were given 2 more opportunities to pass. Each subsequent session was accompanied by feedback, and was conducted by a different trainer, who was blind to the results of the previous session as well as to which session number it was, to avoid bias. Raters who failed on the third attempt were excluded from rating patients in the trial. All training and testing occurred prior to the startup meeting. Results found a significant improvement pre-to-post Web training in raters knowledge of scoring conventions, P < 0.001. On the applied component, raters' RAPS scores improved significantly on the second attempt following feedback, from 9.05 to 11.58, P < 0.001, and from their second to their third session (from 9.00 to 11.00, P = 0.033. Three raters failed all 3 attempts and were excluded from the study. Results support the efficacy of the approach in improving both conceptual knowledge and applied interviewing skill.

Adult↗
PubMed2004

Anxiety and depressive symptoms and anxiety sensitivity in youngsters with noncardiac chest pain and benign heart murmurs.

OBJECTIVE: Chest pain in children and adolescents is rarely associated with cardiac disease. We sought to examine psychological symptoms in youngsters with medically unexplained chest pain. We hypothesized that children and adolescents with medically unexplained chest pain would have high rates of anxiety and depressive symptoms. METHODS: We assessed 65 youngsters with noncardiac chest pain (NCCP) and 45 comparison youngsters with benign heart murmurs using self-report measures of anxiety and depressive symptoms and anxiety sensitivity. RESULTS: Compared with the asymptomatic benign-murmur group, youngsters with NCCP had higher levels of some anxiety symptoms and anxiety sensitivity. Differences on depressive symptoms were not significant. CONCLUSIONS: Though preliminary, results suggest that youngsters with chest pain may experience increased levels of some psychological symptoms. Future studies of noncardiac chest pain in youngsters should include larger samples and comprehensive diagnostic assessments as well as long-term follow-up evaluations.

Adolescent↗
PubMed2002

Clinical features of four DSM-IV-specific phobia subtypes.

Seventy-three patients (ages 18 to 66) with specific phobias from one of four DSM-IV subtypes (animal, situational, blood-injection-injury, and natural environment) were assessed by experienced clinicians using a semistructured diagnostic interview. All patients were free of lifetime anxiety comorbidity. Subtype groups were compared on age of onset, mode of onset, presence of unexpected panic attacks, and focus of fear. Consistent with earlier findings, participants with situational phobia had a later age of onset and more unexpected panic attacks. No differences were found across subtypes in mode of onset. Contrary to previous findings, natural environment and situational phobias were most frequently associated with a focus on danger or harm rather than other foci such as internal sensations associated with panic attacks. Implications for the usefulness of current subtype categories are discussed.

Adolescent↗
PubMedDate not supplied

Alcohol use disorders in relatives of patients with panic disorder.

OBJECTIVE: The aim of this study was to use data from a family study of anxiety disorders to examine the familial association between alcohol use disorders and panic disorder (PD), controlling for alcohol use disorders in the proband. METHOD: Data from a family study of anxiety disorders were used to compare rates of alcohol use disorders in the relatives of 3 proband groups (PD with lifetime alcohol use disorders, PD without lifetime alcohol use disorders, and not-ill controls). RESULTS: There was a significantly higher rate (12%) of alcohol use disorders among the relatives of PD probands compared with relatives of controls (5%), even in the absence of alcohol use disorders in the proband and after adjusting for differences in sociodemographic characteristics and lifetime drug use disorders (chi2 = 5.4; df = 1; P = .02). Anxiety symptoms were more frequent among the male relatives of panic probands who received an alcohol diagnosis, compared with those who did not have alcohol use disorders (10/25 vs 22/111; chi2 = 4.6; df = 1; P = .03). A similar pattern was found in women (8/11 vs 63/156; chi2 = 4.4; df = 1; P = .036). CONCLUSIONS: These findings suggest a familial association between PD and alcohol use disorders. Future studies with more refined alcohol diagnoses are needed to replicate and investigate the mechanism of this association.

Alcoholism↗
PubMedDate not supplied

Development of a standardized training program for the Hamilton Depression Scale using internet-based technologies: results from a pilot study.

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.

Depression↗