RESUMO
BACKGROUND/PURPOSE: NGX-4010 (QUTENZA(™); NeurogesX Inc, San Mateo, CA), a capsaicin 8% dermal patch, is licensed in the European Union for the treatment of peripheral neuropathic pain (PNP) in nondiabetic adults and in the United States for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN). While NGX-4010 treatment is associated with a low risk of systemic adverse events, patch application-related pain is common and may be managed with local cooling and/or oral analgesics. This article characterizes the tolerability of NGX-4010 and will help to guide any pain management. METHODS: This integrated analysis of tolerability data collected from the NGX-4010 clinical study program included 1696 patients with PNP. Patch application-related pain on the treatment day was captured as Numeric Pain Rating Scale (NPRS) "pain now" scores while "average pain for the past 24 hours" NPRS scores were analyzed for 7 days following treatment. Other tolerability assessments included the percentage of patients completing ≥90% of the intended treatment duration and patients using medication for patch application-related pain. RESULTS: The mean maximum change in "pain now" NPRS scores from pretreatment levels during and after patch application was 2.6 for all patients. This pain was transient and resolved following patch removal. Mean "average pain for the past 24 hours" NPRS scores returned to baseline by the evening of the treatment day for patients with PHN, and the evening of day 2 for patients with human immunodeficiency virus-associated distal sensory polyneuropathy or painful diabetic neuropathy. Repeated NGX-4010 applications did not affect the intensity of patch application-related pain. Almost all patients (≥98%) completed ≥90% of the full treatment duration, regardless of the number of treatments received. CONCLUSION: Transient patch application-related pain with NGX-4010 can be managed with local cooling and/or oral analgesics in nearly all cases. Patient adherence to the full intended treatment duration indicated that patch application-related pain was not a barrier to NGX-4010 use.
RESUMO
PURPOSE: The purpose of this pilot study was to determine the effectiveness of using feedback from a standardized patient (SP) to teach a surgical resident (SR) informed consent (IC) protocol. METHODS: Four general case types of increasing difficulty were tested in a longitudinal experimental design format. The four types of cases were appendectomy, cholecystectomy, colorectal cancer, and breast cancer. Eight SRs of varying years of completion in medical school served as subjects-four in the experimental group (received performance feedback from an SP) and four in the control group (received no SP feedback). Both the control and experimental groups participated in two patient encounters per case type. The first patient encounter served as the pretest, and the second patient encounter was the posttest. In each encounter, an SP rated the resident on 14 measures using an open-ended seven-point rating scale adopted and modified from the Brown University Interpersonal Skill Evaluation (BUISE). Each resident also reviewed a videotape of an expert giving IC between pretest and the posttest for basic instructional protocol. Random stratified sampling was used to equally distribute the residents by postgraduate years. A total of 16 SPs were used in this study. All patient/SR encounters were videotaped. RESULTS: There was a statistically significant overall change--pretest to posttest and across cases (p = 0.001). The group effect was statistically significant (p = 0.000), with the experimental group averaging about 10 points greater than the control group. CONCLUSIONS: Standardized patient feedback is an effective modality in teaching surgical residents informed consent protocol. This conclusion is tentative, due to the limitations of sample size. The results of this study support continued research on the effects of standardized patient feedback to teach informed consent to surgical residents.
