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Efficacy Criteria (efficacy + criterion)
Selected AbstractsA Liquid Adhesive Bandage for the Treatment of Minor Cuts and AbrasionsDERMATOLOGIC SURGERY, Issue 3 2002William H. Eaglstein MD Background. Octyl-2-cyanoacrylate is U.S. Food and Drug Administration (FDA) approved for the closure of incisions and lacerations. In animal studies, a more flexible formulation of octyl-2-cyanoacrylate suitable for cuts and abrasions produced faster healing of partial thickness wounds than traditional bandages. Objective. To evaluate the effectiveness of a more flexible octyl-2-cyanoacrylate liquid adhesive bandage for the treatment of minor cuts and abrasions. Methods. One hundred sixty-two volunteers with recent minor cuts or abrasions were recruited and randomized to treatment with either liquid adhesive bandage (LAB) or a control device (Band-Aid brand adhesive bandage, sheer, 2.5 cm). The primary efficacy criterion was complete healing at day 12. Secondary efficacy criteria were the ability of patients to properly apply LAB, and the ability of LAB to stop bleeding, to reduce pain, and to remain on the wound. Results. At day 12 there was no statistical difference between the number of completely healed wounds in the LAB and the bandage-treated patients (P = .493). The ability of patients, as rated by investigators, to effectively apply the LAB device and the bandage was not significantly different (P = .165). Only the LAB provided significant hemostasis (P = .0001) and pain relief (P = .002). conclusion. In this randomized, controlled trial, the LAB was as effective as the control at promoting healing as measured by complete healing at day 12. The LAB was easy to use and gave rapid control of bleeding and pain, forming a film that stayed on wounds well. [source] Comparison of efficacy criteria across onychomycosis trials: need for standardizationINTERNATIONAL JOURNAL OF DERMATOLOGY, Issue 4 2003Aditya K. Gupta MD, FRCP(C) Background The last 10 years have seen a substantial increase in the number of studies reporting the efficacy of the various antifungal agents used to treat onychomycosis. Aim To examine the definitions of efficacy parameters reported in clinical studies on the treatment of onychomycosis and discuss the importance of standardized reporting. Methods We searched MEDLINE (1966,2001) for studies in which oral treatments, griseofulvin, ketoconazole, terbinafine (continuous and pulse), itraconazole (continuous and pulse), and fluconazole, were used to treat dermatophyte onychomycosis. Results Mycologic cure was predominantly defined as negative microscopy and culture. Unlike mycologic cure, clinical parameters (e.g. clinical response, clinical cure) were variably defined. Subjective terms, such as "cure" or "markedly improved," were used; although these terms appear to be explicit, what is considered to be "cured" or "markedly improved" by one evaluator may not be by another. Also, infected nails were clinically evaluated to determine the response to treatment. Studies measured the distance between the proximal nail fold and a notch in the nail plate, at the junction between the diseased and normal-appearing nail, or in some cases estimated the diseased nail plate involvement. Conclusions This review of the literature on systemic agents used to treat onychomycosis shows that standard and explicit definitions are required for the accurate comparison of the effectiveness of the various therapies. [source] Agreement of efficacy assessments for five-grass pollen sublingual tablet immunotherapyALLERGY, Issue 1 2009A. Didier Background:, The optimal dose of five-grass pollen sublingual tablet immunotherapy (SLIT) was established recently by the primary criteria Rhinoconjunctivitis Total Symptom Score (RTSS) from the first treatment season. Secondary and exploratory criteria, such as RTSS at peak pollen season, exploratory combined symptom and rescue medication use score, quality of life and immunological markers are calculated and described in this analysis. Methods:, Six hundred and twenty-eight patients with grass pollen rhinoconjunctivitis (,2 years duration) were randomized in a double-blind, placebo-controlled trial conducted in Europe. Patients received once-daily SLIT (Stallergenes, Antony, France) of 100IR, 300IR, 500IR or placebo, starting 4 months before grass pollen season and throughout the 2005 season. Patients were instructed to take rescue medication only if symptoms were severe and record symptom severity on using the RTSS. Results:, Both 300IR and 500IR doses significantly reduced mean RTSS at pollen peak (P = 0.0005 and P = 0.0014, respectively) and the exploratory combined score (P = 0.0001 and P = 0.0026, respectively) compared with placebo. Compared with patients in the placebo group, those who were taking the 300IR and 500IR doses reported significantly improved quality of life using the mean Rhinoconjunctivitis Quality of Life Questionnaire scores during the peak of the pollen season (P < 0.0001) and at the end of the pollen season (P = 0.0031 and P , 0.0001, respectively). Specific immunoglobulin G4 increased significantly depending on the SLIT dose (P < 0.0001). Conclusions:, All secondary efficacy criteria, including efficacy at pollen peak, combined score, quality of life and immunological changes, indicate that 300IR tablets represent the optimal dose and suggest it is appropriate for use in clinical practice. [source] Phase 2 trial of pemetrexed disodium and carboplatin in previously untreated extensive-stage small cell lung cancer, N0423,CANCER, Issue 10 2010Cheng E. Chee MD Abstract BACKGROUND: In extensive-stage small cell lung cancer (SCLC), the combination of pemetrexed plus carboplatin has shown activity and appeared to be well-tolerated. We conducted a trial to confirm the efficacy and to assess the tolerability of this chemotherapy combination. METHODS: Patients with untreated extensive-stage SCLC were enrolled in this phase 2 open-labeled study. They receive pemetrexed 500 mg/m2 and carboplatin (area under the curve of 5) every 21 days for a maximum 6 cycles. The primary endpoint for this trial was the confirmed response rate and the accrual goal was 70 patients. RESULTS: Forty-six eligible patients (29 aged <70 years, 17 aged ,70 years) were accrued to this study. The efficacy outcomes were similar between the 2 age groups. Overall, the confirmed response rate was 35% (16 of 46; 95% confidence interval [CI], 21%-50%), where all 16 were partial responses. On the basis of these results, we had strong evidence that the study would not meet the preset efficacy criteria and was, therefore, closed before full accrual. The median duration of response was 4.4 months (95% CI, 2.9-5.2). Median overall survival for patients aged <70 years and aged ,70 years was 9.2 months (95% CI, 5.4-11.6) and 10.8 months (95% CI, 2.2-14.3), respectively. Grade 3 or higher toxicity rates were similar between the younger and older patients. Grade 3/4 and grade 4 hematological toxicities were observed in 46% and 26% of patients, respectively. CONCLUSIONS: Although well-tolerated, the combination of pemetrexed and carboplatin is not as effective as standard therapy in patients with untreated extensive-stage SCLC. Cancer 2010. © 2010 American Cancer Society. [source] | ||||||||||