PubMed Health⌕ Search

Biomedical subjects

Kenneth A Kobak

Publications and source records attributed to Kenneth A Kobak.

At least 19 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↗
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

St John's wort versus placebo in obsessive-compulsive disorder: results from a double-blind study.

Although St John's wort (Hypericum perforatum) is one of the most widely used and studied herbal medicines for depression, less is known about its efficacy in anxiety disorders, in spite of the fact that patients with anxiety disorders are among the most likely to self-medicate using alternative treatments. Pharmacokinetic evidence for the serotonergic, domaminergic and GABAminergic activity of hypericum, and a recent successful open-label study, suggests that it may be effective for obsessive-compulsive disorder (OCD). Sixty subjects were randomized to 12 weeks of treatment with St John's wort (LI 160) or matching placebo. Subjects with Hamilton Depression Scale scores of 16 or above were excluded. A flexible-dose schedule was utilized (600-1800 mg/day). The mean change on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) with St John's wort (3.43) was not significantly different than the mean change found with placebo (3.60) (P=899). No significant differences were found on any of the Y-BOCS subscales. The percentage of patients rated as 'much' or 'very much' improved at endpoint was not significantly different between St John's wort (17.9%) and placebo (16.7%) (P=0.905). Only one patient from each group discontinued due to adverse events [sinus infection (St John's wort); confusion (placebo)]. The results fail to support the efficacy of St John's wort for OCD.

Administration, Oral↗
PubMed2005

St. John's wort versus placebo in social phobia: results from a placebo-controlled pilot study.

Recognition of social anxiety disorder (social phobia) as a common and disabling condition has led to new advances in its pharmacotherapy. Limitations with selective seroton reuptake inhibitors (side effects) and behavior therapy (scarcity of trained therapists), coupled with the tendency for patients with the disorder to self-medicate with alternative treatments, have led to the interest in Saint John's wort (SJW) (Hypericum perforatum) for this disorder. Although the literature is mixed, SJW has demonstrated efficacy in several double-blind depression trials, and some open-label studies with anxiety disorders. There is pharmacokinetic evidence for the serotonergic, domaminergic, and GABAminergic activity of hypericum, all of which are implicated in social anxiety disorder. This study was designed to generate pilot data to examine the potential efficacy of SJW in generalized social anxiety disorder. Forty subjects were randomized to 12 weeks of treatment with a flexible dose (600-1800 mg) of SJW (n = 20) or placebo (n = 20). Subjects with comorbid depression (clinician HAMD > 16) were excluded. Results found no significant difference between mean change on the Liebowitz Social Anxiety Scale with SJW (11.4) and placebo (13.2), P = 0.27, effect size = -0.09. Post-hoc analyses found larger effects sizes associated with increased baseline severity, omitting patients with variable scores (+/-30%) during the first week, and use of self-report HAMD scores for exclusion. Results of the study fail to provide evidence for the efficacy of SJW in social phobia. The impact of methodologic improvements on signal detection, while suggestive of improvement, remains to be established.

Adolescent↗
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↗
PubMed2005

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.

Adult↗
PubMed2004

A comparison of face-to-face and videoconference administration of the Hamilton Depression Rating Scale.

To determine whether the mode of administration affected the psychometric properties of the Hamilton Depression Rating Scale (HAMD), 21 subjects with an affective disorder were administered two HAMD interviews on the same day, once via videoconference (at 384 kbit/s) and once face-to-face, by two independent interviewers. The interviewers were blind to the results of the other interview. The mean HAMD scores were almost identical (18.4 for videoconferencing and 18.2 for face to face). The intra-class correlation between the two sets of scores was 0.88. When another group of 21 subjects had the HAMD administered in two face-to-face interviews on the same day, the inter-rater reliability was not significantly different from that for the videoconference cohort. Most patients (91%) thought videoconferencing was a useful way to receive a psychological evaluation when other means were unavailable or limited. The study shows the psychometric equivalence of remote and face-to-face HAMD administration.

Adolescent↗
PubMed2002

Fluoxetine in social phobia: a double-blind, placebo-controlled pilot study.

The objective of the study was to examine the efficacy of fluoxetine in social phobia. Sixty subjects were randomly assigned to 14 weeks of double-blind therapy with either fluoxetine or placebo. Dose was fixed at 20 mg for fluoxetine during the first 8 weeks of double-blind treatment; during the final 6 weeks, the dose could be increased every two weeks by 20 mg to a maximum of 60 mg/day. An intentto-treat analysis was used. A significant change from baseline to endpoint was found for both fluoxetine and placebo on the Liebowitz Social Anxiety Scale. However, no significant difference was found between fluoxetine and placebo. The change for fluoxetine was somewhat lower than that found with other selective serotonin reuptake inhibitors, whereas the placebo response was greater. Fluoxetine failed to separate from placebo in this trial. It is unknown whether a larger dose for longer duration would have yielded separation from placebo. A higher than usual placebo response rate was found.

Adolescent↗
PubMed2002

Behavior therapy for obsessive-compulsive disorder guided by a computer or by a clinician compared with relaxation as a control.

BACKGROUND: The demand for effective behavior therapy for obsessive-compulsive disorder (OCD) by exposure and ritual prevention exceeds its supply by trained therapists. A computer-guided behavior therapy self-help system (BT STEPS) was created that patients access by telephone from home via interactive voice response technology. This study compared the value of computer-guided behavior therapy value with that of clinician-guided behavior therapy and systematic relaxation as a control treatment. METHOD: After screening by a clinician, 218 patients with DSM-IV OCD at 8 North American sites were randomly assigned to 10 weeks of behavior therapy treatment guided by (1) a computer accessed by telephone and a user workbook (N = 74) or (2) a behavior therapist (N = 69) or (3) systematic relaxation guided by an audiotape and manual (N = 75). RESULTS: By week 10, in an intent-to-treat analysis, mean change in score on the Yale-Brown Obsessive Compulsive Scale was significantly greater in clinician-guided behavior therapy (8.0) than in computer-guided (5.6), and changes in scores with both clinician-guided and computer-guided behavior therapy were significantly greater than with relaxation (1.7), which was ineffective. Similarly, the percentage of responders on the Clinical Global Impressions scale was significantly (p < .05) greater with clinician-guided (60%) than computer-guided behavior therapy (38%), and both were significantly greater than with relaxation (14%). Clinician-guided was superior to computer-guided behavior therapy overall, but not when patients completed at least 1 self-exposure session (N = 36 [65%]). At endpoint, patients were more satisfied with either behavior therapy group than with relaxation. Patients assigned to computer-guided behavior therapy improved more the longer they spent telephoning the computer (mostly outside usual office hours) and doing self-exposure. They improved slightly further by week 26 follow-up, unlike the other 2 groups. CONCLUSION: For OCD, computer-guided behavior therapy was effective, although clinician-guided behavior therapy was even more effective. Systematic relaxation was ineffective. Computer-guided behavior therapy can be a helpful first step in treating patients with OCD when clinician-guided behavior therapy is unavailable.

Adolescent↗
PubMed2002

Antidepressant medication management and Health Plan Employer Data Information Set (HEDIS) criteria: reasons for nonadherence.

BACKGROUND: While nationwide data have found that many patients do not meet the National Committee for Quality Assurance uniform standards for successful antidepressant treatment, reasons for this failure are not well understood. We examined the reasons for this failure through a systematic chart review. METHOD: A chart review was conducted on a random sample of 249 health maintenance organization patients who failed 1 or more of the 3 Health Plan Employer Data Information Set criteria (i.e., 3 follow-up visits or adequate duration of acute or continuation phase treatment). RESULTS: The most common reason for visits failure (N = 192) was that the patient restarted a previously prescribed successful antidepressant (N = 30, 16%). In 23 patients (12%), the patient had a visit with the prescribing provider, but mental health was not coded or documented in the case notes. Twenty-one percent (N = 40) were misclassified as not having 3 visits. The most common reasons for misclassification were mental health was discussed but not coded (N = 16, 8%) and wrong start dates due to use of medication samples (N = 10, 5%). Patient nonadherence was the most common reason for failure to meet adequate acute (N = 109) and continuation (N = 99) phase duration of treatment (13% and 24%, respectively); only 9% stopped taking medication in the acute phase due to side effects. Twenty-five percent of patients had told their doctor they were taking their medication while the pharmacy database found they were not. CONCLUSION: A large discrepancy between patients' actual and reported compliance was found and may in part account for physicians' inability to detect and thus address this issue. Patients' restarting a previous medication is common and warrants discussion regarding differential need for visit frequency.

Adolescent↗
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↗
PubMedDate not supplied

Obsessive-compulsive symptom dimensions as predictors of compliance with and response to behaviour therapy: results from a controlled trial.

BACKGROUND: Recent factor-analytic studies in obsessive-compulsive disorder (OCD) identified consistent symptom dimensions. Support for the validity of these dimensions comes from studies of psychiatric comorbidity, functional brain imaging, genetic transmission, and treatment response to medications. This study examined whether previously identified OCD symptom dimensions are associated with treatment compliance and response to behaviour therapy (BT) for OCD. METHODS: One hundred and fifty-three OCD outpatients who participated in a multi-centre randomised controlled trial of computer- versus clinician-guided BT for OCD were included in the study. Logistic and multiple regression models tested for significant predictors of compliance with and response to BT and relaxation. RESULTS: The patients studied were phenomenologically comparable (including the presence of 'pure' obsessions and mental rituals) to those in previous serotonin reuptake inhibitor (SRI) trials and those in clinical epidemiology studies. High scorers on the 'hoarding' dimension were more likely to drop out prematurely from the study and tended to improve less. For those completing treatment, the strongest predictor of outcome was pre-treatment severity. Initial depression scores were unrelated to outcome. After controlling for symptom severity, higher scores on the 'sexual/religious obsessions' factor predicted poorer outcome with BT, especially when computer-guided. CONCLUSIONS: BT is especially indicated for OCD patients with aggressive/checking, contamination/cleaning and symmetry/ordering symptoms. Previous accounts of unsuccessful BT in patients with hoarding symptoms may be due in part to their propensity to drop out earlier from treatment. Patients with sexual/religious obsessions, but not those with mental rituals, might respond less well to traditional BT techniques. Existing treatments need to be refined and/or new treatments developed to improve these patients' adherence and response to treatment.

Adult↗
PubMedDate not supplied

Pharmacist telemonitoring of antidepressant use: effects on pharmacist-patient collaboration.

OBJECTIVE: To explore the impact of telephone-based education and monitoring by community pharmacists on multiple outcomes of pharmacist-patient collaboration. DESIGN: A randomized, controlled, unblinded, mixed experimental design. SETTING: Eight Wisconsin community pharmacies within a large managed care organization. PATIENTS: A total of 63 patients presenting new antidepressant prescriptions to their community pharmacies. INTERVENTIONS: Patients were randomized to receive either three monthly telephone calls from pharmacists providing pharmacist-guided education and monitoring (PGEM) or usual pharmacist's care. Usual care is defined as that education and monitoring which pharmacists may typically provide patients at the study pharmacies. MAIN OUTCOME MEASURES: Patient's frequency of feedback with the pharmacist, antidepressant knowledge, antidepressant beliefs, antidepressant adherence at 3 and 6 months, improvement in depression symptoms, and orientation toward treatment progress. RESULTS: Of the 60 patients who completed the study, 28 received PGEM and 32 received usual pharmacist's care. Results showed that PGEM had a significant and positive effect on patient feedback, knowledge, medication beliefs, and perceptions of progress. There were no significant group differences in patient adherence or symptoms at 3 months; however, PGEM patients who completed the protocol missed fewer doses than did the usual care group at 6 months (P < or = .05). CONCLUSION: Antidepressant telemonitoring by community pharmacists can significantly and positively affect patient feedback and collaboration with pharmacists. Longer-term studies with larger samples are needed to assess the generalizability of findings. Future research also needs to explore additional ways to improve clinical outcomes.

Adult↗