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Biomedical subjects

Eric Jacobson

Publications and source records attributed to Eric Jacobson.

7 recordsLinked to original sources
PubMed2006

A phase 1/2A trial of STA 5326, an oral interleukin-12/23 inhibitor, in patients with active moderate to severe Crohn's disease.

BACKGROUND: Intestinal inflammation associated with Crohn's disease is characterized by a type 1 helper T cell response and elevated levels of interleukin (IL)-12. We report our clinical experience with a novel oral IL-12/IL-23 inhibitor (STA 5326) for the treatment of active Crohn's disease. MATERIALS AND METHODS: We conducted an open-label, dose-escalating trial of the orally delivered small molecule immunomodulator STA 5326 in 73 patients with active Crohn's disease (Crohn's disease activity index [CDAI] 220-450, inclusive). Five cohorts of patients were treated for up to 4 weeks with 14 mg twice a day (bid), 35 mg daily (qd), 28 mg bid, 35 mg bid, or 70 mg qd. The endpoints of the study included safety and improvement in clinical activity measured by the CDAI and the Crohn's disease endoscopic index of severity. RESULTS: STA 5326 was well tolerated. Reported adverse events were similar across dose cohorts. The most common (>15%) drug-related adverse events observed were dizziness, nausea, headache, and fatigue. Clinical activity at day 28/29 was observed at qd doses of 28 mg and above for the clinical endpoints of response and remission: 70 points or greater decrease in CDAI (range 42%-82% of patients); 100 points or greater decrease in CDAI (range 38%-64% of patients), and CDAI <150 (range 15%-36%). CONCLUSIONS: Oral qd dosing of STA 5326 for 4 weeks was well tolerated in doses up to 70 mg qd in patients with active moderate to severe Crohn's disease. Clinical activity was observed at qd doses of 28 mg and above.

Administration, Oral↗
PubMed2005

Development of a Chinese medicine assessment measure: an interdisciplinary approach using the delphi method.

BACKGROUND: The diagnostic framework and clinical reasoning process in Chinese medicine emphasizes the contextual and qualitative nature of a patient's illness. Chinese medicine assessment data may help interpret clinical outcomes. OBJECTIVES: As part of a study aimed at assessing the validity and improving the inter-rater reliability of the Chinese diagnostic process, a structured assessment instrument was developed for use in clinical trials of acupuncture and other Chinese medical therapies. STUDY DESIGN: To foster collaboration and maximize resources and information, an interdisciplinary advisory team was assembled. Under the guidance of two group process facilitators, and in order to establish whether the assessment instrument was consistent with accepted Chinese medicine diagnostic categories (face validity) and included the full range of each concept's meaning (content validity), a panel of Traditional Chinese Medicine (TCM) expert clinicians was convened and their responses were organized using the Delphi process, an iterative, anonymous, idea-generating and consensus-building process. An aggregate rating measure was obtained by taking the mean of mean ratings for each question across all 10 experts. RESULTS: Over three rounds, the overall rating increased from 7.4 (SD = 1.3) in Round 1 to 9.1 (SD = 0.5) in Round 3. The level of agreement among clinicians was measured by a decrease in SD. CONCLUSIONS: The final instrument TEAMSI-TCM (Traditional East Asian Medicine Structured Interview, TCM version) uses the pattern differentiation model characteristic of TCM. This modular, dynamic version was specifically designed to assess women, with a focus on gynecologic conditions; with modifications it can be adapted for use with other populations and conditions. TEAMSI-TCM is a prescriptive instrument that guides clinicians to use the proper indicators, combine them in a systematic manner, and generate conclusions. In conjunction with treatment manualization and training it may serve to increase inter-rater reliability and inter-trial reproducibility in Chinese medicine clinical trials. Testing of the validity and reliability of this instrument currently is underway.

Data Interpretation, Statistical↗
PubMed2005

Patient expectations in placebo-controlled randomized clinical trials.

OBJECTIVE: To explore participants' experience in placebo-controlled randomized clinical trials (RCTs) specifically in relationship to their expectations. BACKGROUND: Aspects of being in RCTs, such as informed consent, perception of benefit and understanding of randomization, have been examined. In contrast, little is known concerning the formation of patient expectations before and during trials. METHODS: Qualitative methods using in-depth interviews with a semi-structured interview guide of nine patients from four different RCTs. Data analysis was conducted using a codebook format arranging participant responses under broad analytical headings. The interviewer used a semi-structured interview guide to direct the conversation from one broad topic to the next within the context of the ongoing conversation. A checklist of topics encouraged participants to describe their experiences in RCTs. Narratives concerning expectation, blinding and placebo were compared to identify common themes. RESULTS: Patient anticipatory processes were influenced and modified both before and during the trial from multiple inputs. Such factors as past experiences in RCTs, past experiences of ineffective treatment, stress of being off regular medications, fear of being a 'placebo responder', input of non-study doctors or other health professionals, the experience of other participants, measurements of health parameters made during the trial and the presence or absence of side-effects all affected patient expectation. CONCLUSION: Expectations in RCTs are not fixed and instead may be viewed as continuously shaped by multiple inputs that include experience and information received both before and during the trial. Variability in placebo response observed in previous studies may be related to the fluid nature of expectations. Trying to control and equalize expectations in RCTs may be more difficult than previously assumed.

Adult↗
PubMed2003

Development and implementation of an objective structured teaching exercise (OSTE) to evaluate improvement in feedback skills following a faculty development workshop.

BACKGROUND: Faculty development programs focusing on teaching have become widespread. PURPOSE: Despite the popularity of such programs, evidence as to their effectiveness is limited. This article reports on the development of an objective structured teaching exercise (OSTE) and its pilot implementation in an evaluation of a faculty development program module. A written test intended to measure feedback skills was also developed and pilot tested. METHODS: A separate-sample, pretest-posttest design was used to pilot test both instruments. RESULTS: The results showed some evidence of significant differences between groups tested preworkshop and postworkshop. Higher scores were observed for the posttest group compared to the pretest group only for OSTE items focusing on prioritizing and limiting the amount of feedback given at one time and on action planning. CONCLUSIONS: Results suggest that an OSTE may be sensitive to changes in preceptor skill level for skills that are relatively easy to incorporate immediately into practice. Lack of differences in other skill areas may be due to lack of sensitivity of the measure or to need for practice and reflection before changes in performance on other feedback skills are evident.

Education, Medical↗
PubMed2002

Medical students' perspectives on and responses to abuse during the internal medicine clerkship.

BACKGROUND: The abuse of medical students on clinical rotations is a recognized problem, but the effects on students and their responses warrant further study. PURPOSE: To determine the severity of student abuse and the effects of abuse on students during the internal medicine clerkship. METHODS: Internal medicine clerks at 11 medical schools (N = 1,072) completed an exit survey. Students were asked whether they had been abused. If they had, they were asked about the severity of the abuse, whether they reported it, and its effects on them. RESULTS: Of the responding students, 123 (11%) believed they had been abused. Only 31% of the students who felt abused reported the episodes to someone. The most common consequences of the events included poor learning environments, lack of confidence, and feelings of depression, anger, and humiliation. CONCLUSION: Students described a variety of personal and educational effects of abuse. They generally did not report abuse because of fear of retaliation and the belief that reporting is pointless.

Adult↗