Randomized, double-blind, placebo-controlled evaluation of the efficacy of oral psoralen plus ultraviolet A for the treatment of plaque-type psoriasis using the Psoriasis Area Severity Index score (improvement of 75% or greater) at 12 weeks.

BACKGROUND: Psoralen plus ultraviolet A (PUVA) for the treatment of psoriasis has never been evaluated using the Psoriasis Area Severity Index (PASI) in a randomized, double-blind, placebo-controlled trial. The lack of such data limits our capacity to estimate PUVA's efficacy relative to other treatment options that are available today. OBJECTIVES: The purpose of this study was to evaluate the efficacy of PUVA therapy for patients with plaque-type psoriasis. METHODS: This study involved 40 patients with psoriasis; 30 received PUVA and 10 received UVA with placebo. PASI scores were assessed at baseline and every 4 weeks thereafter for 12 weeks. RESULTS: By nonresponder imputation, 60% (18 of 30) in the PUVA group achieved 75% or more improvement in PASI score after 12 weeks of treatment compared with 0% (0 of 10) in the UVA plus placebo group (P < .0001). Using intent to treat with last observation carried forward analysis, 63% (19 of 30) in the PUVA group achieved 75% or more improvement in PASI score compared with 0% (0 of 10) in the UVA plus placebo group (P < .0001). By per protocol analysis, 86% (18 of 21) in the PUVA group as compared with 0% (0 of 7) in the UVA plus placebo group reached 75% or more improvement in PASI score after 12 weeks (P < .0001). LIMITATIONS: The study was relatively small with only 40 patients enrolled and 28 patients who completed the protocol. Further studies that involve head-to-head comparison of PUVA with other treatment modalities are needed. Nonresponder imputation, last observation carried forward with intent to treat, and per protocol analyses each have separate advantages and limitations when determining clinical significance. CONCLUSIONS: This study supports the observation that PUVA is a highly efficacious treatment for chronic plaque psoriasis.

The use of high definition video modules for delivery of informed consent and wound care education in the Mohs Surgery Unit.

The use of video in the informed consent process has been well documented in the literature to improve patient satisfaction, understanding, comprehension, and to decrease anxiety. At the MD Anderson Mohs Surgery Unit, we use high-definition (HD) audiovisual (AV) modules to assist with the delivery of informed consent and to educate patients on the subject of postoperative wound care. The purpose of this work was to develop HD-AV media to inform patients of the risks, benefits, and alternatives of Mohs surgery before they are asked to sign the consent form and to educate patients on basic wound care after Mohs Surgery. The use of a HD virtual surgeon and nurse in the videos educates the patient, allowing the surgeon and nursing staff to attend to other patients within the Mohs Surgery Unit. Using HD digital recording equipment, we captured real-time HD-AV media to explain the risks, alternatives, and benefits of Mohs surgery (surgeon explanation) and to give detailed instructions for postoperative wound care (nurse explanation). Once captured, HD modules were created and stored on a central University of Texas-MD Anderson Cancer Center server in the Texas Medical Center approximately 1 mile from the Mohs Surgery Unit. The full-screen HD modules are accessed on demand at the point of need with the use of standard institutional computers within any of the Mohs's center's examination/surgical suites. An early evaluation of this quality improvement initiative was performed to measure patient satisfaction, efficiency, and efficacy of the videos followed by physician/nurse discussion compared with physician/nurse discussion alone. Early evaluation of HD-AV modules used for the delivery of informed consent and postoperative wound care in the MD Anderson Mohs surgery Unit revealed that patient satisfaction was maintained and that this medium was preferred by patients in the video group over physician/nurse discussion alone. The HD modules allowed increased efficiency and patient comprehension, which improved patient education in the Mohs Surgery Unit.