Background: The Psoriasis Area and Severity Index (PASI) is the most frequently used clinical severity scale in clinical trials. Drug approval often depends on a 75%improvement in the baseline PASI score, also known a...Background: The Psoriasis Area and Severity Index (PASI) is the most frequently used clinical severity scale in clinical trials. Drug approval often depends on a 75%improvement in the baseline PASI score, also known as a PASI 75 or Delta PASI 75. This benchmark may be an overly stringent way to determine the success of psoriasis treatments as Delta PASIs appear to under-represent true clinical improvement. This discrepancy may relate to the way numerical values are assigned to the degree of body surface area (BSA) involvement. Objectives: To assesswhether altering the BSA component of the PASI formula so that it is weighted more heavily will result in a calculated change in psoriasis severity that more closely reflects patient assessment of improvement. Models developed included the Psoriasis Log-based Area and Severity Index (PLASI), which assigns values to the BSA score based on a linear scale using logarithms to define the intervals, and the Psoriasis Exact Area and Severity Index (PEASI), which uses the actual BSA as the multiplicative factor in the area score. Methods: Data were abstracted retrospectively fromtwo clinical trials involving psoriasis treatments that used the PASI. The same trained psoriasis graders were involved in both trials. In these trials, baseline and end-point PASI worksheets were completed that included the actual clinician-estimated BSA involvement (0-100%) for each of the four areas (head, upper extremities, trunk and lower extremities). In one of the trials, patients were asked to assess the percentage improvement in their psoriasis at the end of the treatment window. PASIs and Delta PASIs were recalculated based on the newmodels and all scoring systemswere validated by analysing their relationship to patients’self-assessments. Results: Clinical improvements under the new grading systems translated into greater percentage changes than calculated using the Delta PASI formula. Specifically, the Delta PASI 50 translated to a Delta PLASI 57.2 and Delta PEASI 61.1; Delta PASI 75 was eq展开更多
To test whether infants with bronchopulmonary dysplasia (BPD) express the same functional impairments at term as healthy, preterm infants, and whether clinical severity of BPD is qualitatively or quantitatively relate...To test whether infants with bronchopulmonary dysplasia (BPD) express the same functional impairments at term as healthy, preterm infants, and whether clinical severity of BPD is qualitatively or quantitatively related. Prospective measurements on a consecutive sample of 50 infants with BPD and 19 healthy preterm controls in a university hospital. BPD infants were classified as “severe, ”“moderate, ”or “mild, ”according to their need for oxygen. A multiple-breath nitrogen wash-out method was used to assess functional residual capacity (FRC)-and gas mixing efficiency. Mechanical variables were estimated by the occlusion test. Infants with severe BPD had lower FRC, less efficient gas mixing, and higher specific conductance than those with mild and moderate BPD, and the preterm controls. Mild and moderate BPD did not differ in any property from each other but differed from controls in the same variables. The elastic properties of the respiratory system appeared unaffected by BPD. The ventilatory impairments in BPD were of the same nature as in healthy preterm infants when compared with term infants, but their magnitude was related to the clinical severity of the BPD. Gas mixing efficiency together with FRC appears to be useful to assess lung development in BPD.展开更多
The adverse effects of acne on the psyche have been established in patients from ’first world’ countries. There has been no in depth study in predominantly black patients from Africa addressing this issue. This was ...The adverse effects of acne on the psyche have been established in patients from ’first world’ countries. There has been no in depth study in predominantly black patients from Africa addressing this issue. This was a prospective cross-sectional study of acnepatients attending a dermatology unit in K waZuluNatal, South Africa. A questionnaire was completed and acne graded by the Global Acne Grading scale. Psychological morbidity and quality of life (QOL) were assessed by the General Health Questionnaire and Dermatology Specific Quality of Life Questionnaires, respectively. We found that clinical severity was not associated with patient perception or psychological distress. The QOL measures such as feelings, social activities, performance at work or school, activities of daily living and overall mental health were found to be associated with distress with associated P- values of 0.0002, 0.0168, 0.0032, 0.033 and < 0.0001, respectively. The severity of acne was not associated with psychological distress. Painful and bleeding lesions were associated with distress levels: P=0.042 and P=0.019, respectively. In conclusion, South African patients with acne vulgaris suffer significant psychological distress, which affects the quality of their lives.展开更多
文摘Background: The Psoriasis Area and Severity Index (PASI) is the most frequently used clinical severity scale in clinical trials. Drug approval often depends on a 75%improvement in the baseline PASI score, also known as a PASI 75 or Delta PASI 75. This benchmark may be an overly stringent way to determine the success of psoriasis treatments as Delta PASIs appear to under-represent true clinical improvement. This discrepancy may relate to the way numerical values are assigned to the degree of body surface area (BSA) involvement. Objectives: To assesswhether altering the BSA component of the PASI formula so that it is weighted more heavily will result in a calculated change in psoriasis severity that more closely reflects patient assessment of improvement. Models developed included the Psoriasis Log-based Area and Severity Index (PLASI), which assigns values to the BSA score based on a linear scale using logarithms to define the intervals, and the Psoriasis Exact Area and Severity Index (PEASI), which uses the actual BSA as the multiplicative factor in the area score. Methods: Data were abstracted retrospectively fromtwo clinical trials involving psoriasis treatments that used the PASI. The same trained psoriasis graders were involved in both trials. In these trials, baseline and end-point PASI worksheets were completed that included the actual clinician-estimated BSA involvement (0-100%) for each of the four areas (head, upper extremities, trunk and lower extremities). In one of the trials, patients were asked to assess the percentage improvement in their psoriasis at the end of the treatment window. PASIs and Delta PASIs were recalculated based on the newmodels and all scoring systemswere validated by analysing their relationship to patients’self-assessments. Results: Clinical improvements under the new grading systems translated into greater percentage changes than calculated using the Delta PASI formula. Specifically, the Delta PASI 50 translated to a Delta PLASI 57.2 and Delta PEASI 61.1; Delta PASI 75 was eq
文摘To test whether infants with bronchopulmonary dysplasia (BPD) express the same functional impairments at term as healthy, preterm infants, and whether clinical severity of BPD is qualitatively or quantitatively related. Prospective measurements on a consecutive sample of 50 infants with BPD and 19 healthy preterm controls in a university hospital. BPD infants were classified as “severe, ”“moderate, ”or “mild, ”according to their need for oxygen. A multiple-breath nitrogen wash-out method was used to assess functional residual capacity (FRC)-and gas mixing efficiency. Mechanical variables were estimated by the occlusion test. Infants with severe BPD had lower FRC, less efficient gas mixing, and higher specific conductance than those with mild and moderate BPD, and the preterm controls. Mild and moderate BPD did not differ in any property from each other but differed from controls in the same variables. The elastic properties of the respiratory system appeared unaffected by BPD. The ventilatory impairments in BPD were of the same nature as in healthy preterm infants when compared with term infants, but their magnitude was related to the clinical severity of the BPD. Gas mixing efficiency together with FRC appears to be useful to assess lung development in BPD.
文摘The adverse effects of acne on the psyche have been established in patients from ’first world’ countries. There has been no in depth study in predominantly black patients from Africa addressing this issue. This was a prospective cross-sectional study of acnepatients attending a dermatology unit in K waZuluNatal, South Africa. A questionnaire was completed and acne graded by the Global Acne Grading scale. Psychological morbidity and quality of life (QOL) were assessed by the General Health Questionnaire and Dermatology Specific Quality of Life Questionnaires, respectively. We found that clinical severity was not associated with patient perception or psychological distress. The QOL measures such as feelings, social activities, performance at work or school, activities of daily living and overall mental health were found to be associated with distress with associated P- values of 0.0002, 0.0168, 0.0032, 0.033 and < 0.0001, respectively. The severity of acne was not associated with psychological distress. Painful and bleeding lesions were associated with distress levels: P=0.042 and P=0.019, respectively. In conclusion, South African patients with acne vulgaris suffer significant psychological distress, which affects the quality of their lives.
