Introduction: The Liebowitz Social Anxiety Scale (LSAS), used to assess the severity of social anxiety disorder (SAD), requires considerable effort and time to complete. The aims of this study were: 1) to investigate ...Introduction: The Liebowitz Social Anxiety Scale (LSAS), used to assess the severity of social anxiety disorder (SAD), requires considerable effort and time to complete. The aims of this study were: 1) to investigate whether a visual analogue scale (VAS) could be linear with the LSAS and substitute for the LSAS, 2) to relate such a VAS instrument to patient demographics. Methods: Fifty SAD patients were assessed using the LSAS and VAS instruments completed by both patients and doctors at the same session. We then drew distributions and calculated the Spearman’s ρ and κ coefficient values (divided at the median for each scale) between patient and doctor assessments. Next, each pair among the scores for the LSAS, the patient VAS and the doctor VAS was compared using Wilcoxon rank sum tests according to patient life profile data. Results: Scatter plots of pairs of scores were obtained. Spearman’s ρ was 0.661 between the LSAS and the patient VAS, 0.461 between the LSAS and the doctor VAS, and 0.494 between VAS scores of patients and doctors. The κ coefficients were 0.501 between the LSAS and patient VAS, 0.251 between the LSAS and doctor VAS, and 0.425 between patient VAS and doctor VAS (for all six, p < 0.001). The Wilcoxon rank sum tests indicated a significant difference between the groups with/ without “employment” (LSAS, patient/doctor VAS), with/without “graduation from junior college/university” (doctor VAS) (p < 0.05) and with/without marital history (the age of first consultation) (p < 0.01). Conclusions: A patient VAS may substitute for the LSAS and offer the versatility necessary to capture patient states and life profiles.展开更多
Caffeine is a commonly ingested psychoactive substance which affects alertness and cognition. A clinical study was conducted to determine the effect of orally ingested caffeine on visual analogue scale (VAS) responses...Caffeine is a commonly ingested psychoactive substance which affects alertness and cognition. A clinical study was conducted to determine the effect of orally ingested caffeine on visual analogue scale (VAS) responses in healthy, moderate caffeine-consuming volunteers through the use of population pharmacokinetic-pharmacodynamic (PK-PD) modeling. Twelve subjects were recruited for a three-period cross-over study which utilized caffeine containing beverages. Each visit included 8-hour blood plasma and VAS response collection for PK and PD assessment respectively. The VAS used in the study, also called the caffeine analog scale, has been previously validated for caffeine. Population PK-PD modeling was conducted with NONMEM 7.2. Simultaneous and sequential modeling of PK-PD was attempted. Final model selection was based on parameter estimate precision, diagnostic plots, and visual predictive check (VPC) plots. Results showed that a one-compartment open model with first-order absorption and elimination best described the pharmacokinetics of caffeine. Sequential PK-PD modeling was successful and an effect compartment model with linear slope and baseline parameter best described caffeine pharmacodynamics. Diagnostic plots showed no major bias and VPC plots showed agreement between observations and predictions. The model was able to link VAS responses to caffeine concentration in healthy volunteers and may be useful in clinical trial simulations and design.展开更多
Background and Aims:A visual analogue score (VAS),based on application of a visual analogue scale,has been widely used to assess pruritus in clinical studies of patients with cholestatic liver disease.A VAS is a numer...Background and Aims:A visual analogue score (VAS),based on application of a visual analogue scale,has been widely used to assess pruritus in clinical studies of patients with cholestatic liver disease.A VAS is a numerical score of the severity of the perception of pruritus,and,hence,is inherently subjective.The objective of this study was to assessthe reliability of a VAS as an index of pruritus in cholestatic patients.Methods:In 8 patients with chronic pruritus due to primary biliary cholangitis,values for a VAS of pruritus were compared with corresponding measurements of scratching activity,which were generated by a monitoring system specifically designed to quantitate this activity.The relationship between individual values for the VAS and corresponding values for scratching activity during a specific interval immediately preceding the recording of the VAS was examined by determining the Spearman's rank correlation coefficient.Results:The mean Spearman's rank correlation coefficient between individual values for the VAS and corresponding mean values for scratching activity was 0.072;the range of these coefficients was-0.04 to 0.26.A VAS of pruritus is an unreliable index of scratching activity,and,hence,of the pathophysiological process responsible for the pruritus of cholestasis.Conclusion:It is concluded that the use of a VAS as a primary quantitative endpoint in trials of the efficacy of potential therapies for the pruritus of cholestasis may be inappropriate.展开更多
Objectives: “Patient-reported outcome measures” has been used extensively, and it has shown the diseases’ impact on patient quality of life and has enabled the clinician to evaluate the clinical care efficacy. In t...Objectives: “Patient-reported outcome measures” has been used extensively, and it has shown the diseases’ impact on patient quality of life and has enabled the clinician to evaluate the clinical care efficacy. In the literature, there are more than 34 shoulder function assessment scoring instruments;the Modified Constant Murley Score (M-CMS) is one of the most popular scores. Although, the M-CMS had been translated and culturally adapted to Danish, Brazilian and Turkish versions, there is no Arabic version found in the literature. We aim to translate and culturally adapt M-CMS into the Arabic language. Method: The M-CMS was translated using previously published guidelines. The translation and cultural adaptation were done in five stages, initial translation by two bilingual translators then a synthesis of the translations after that, back translation by two native English speakers. Then an expert committee meeting approved the pre-final Arabic version. Finally, a pilot test was conducted on 41 patients to ensure its validity. Results: The M-CMS was successfully translated from the original English version to the Arabic version;no difficulties in the translation process were faced. Conclusion: A validated Arabic version of the M-CMS was produced and ready to be used for functional assessment of different shoulder pathologies in Arabic-speaking countries. Future study is needed for translation and cultural adaptation of the English standardized test protocol to assure the reproducibility of the Arabic version of the M-CMS.展开更多
文摘Introduction: The Liebowitz Social Anxiety Scale (LSAS), used to assess the severity of social anxiety disorder (SAD), requires considerable effort and time to complete. The aims of this study were: 1) to investigate whether a visual analogue scale (VAS) could be linear with the LSAS and substitute for the LSAS, 2) to relate such a VAS instrument to patient demographics. Methods: Fifty SAD patients were assessed using the LSAS and VAS instruments completed by both patients and doctors at the same session. We then drew distributions and calculated the Spearman’s ρ and κ coefficient values (divided at the median for each scale) between patient and doctor assessments. Next, each pair among the scores for the LSAS, the patient VAS and the doctor VAS was compared using Wilcoxon rank sum tests according to patient life profile data. Results: Scatter plots of pairs of scores were obtained. Spearman’s ρ was 0.661 between the LSAS and the patient VAS, 0.461 between the LSAS and the doctor VAS, and 0.494 between VAS scores of patients and doctors. The κ coefficients were 0.501 between the LSAS and patient VAS, 0.251 between the LSAS and doctor VAS, and 0.425 between patient VAS and doctor VAS (for all six, p < 0.001). The Wilcoxon rank sum tests indicated a significant difference between the groups with/ without “employment” (LSAS, patient/doctor VAS), with/without “graduation from junior college/university” (doctor VAS) (p < 0.05) and with/without marital history (the age of first consultation) (p < 0.01). Conclusions: A patient VAS may substitute for the LSAS and offer the versatility necessary to capture patient states and life profiles.
文摘Caffeine is a commonly ingested psychoactive substance which affects alertness and cognition. A clinical study was conducted to determine the effect of orally ingested caffeine on visual analogue scale (VAS) responses in healthy, moderate caffeine-consuming volunteers through the use of population pharmacokinetic-pharmacodynamic (PK-PD) modeling. Twelve subjects were recruited for a three-period cross-over study which utilized caffeine containing beverages. Each visit included 8-hour blood plasma and VAS response collection for PK and PD assessment respectively. The VAS used in the study, also called the caffeine analog scale, has been previously validated for caffeine. Population PK-PD modeling was conducted with NONMEM 7.2. Simultaneous and sequential modeling of PK-PD was attempted. Final model selection was based on parameter estimate precision, diagnostic plots, and visual predictive check (VPC) plots. Results showed that a one-compartment open model with first-order absorption and elimination best described the pharmacokinetics of caffeine. Sequential PK-PD modeling was successful and an effect compartment model with linear slope and baseline parameter best described caffeine pharmacodynamics. Diagnostic plots showed no major bias and VPC plots showed agreement between observations and predictions. The model was able to link VAS responses to caffeine concentration in healthy volunteers and may be useful in clinical trial simulations and design.
文摘Background and Aims:A visual analogue score (VAS),based on application of a visual analogue scale,has been widely used to assess pruritus in clinical studies of patients with cholestatic liver disease.A VAS is a numerical score of the severity of the perception of pruritus,and,hence,is inherently subjective.The objective of this study was to assessthe reliability of a VAS as an index of pruritus in cholestatic patients.Methods:In 8 patients with chronic pruritus due to primary biliary cholangitis,values for a VAS of pruritus were compared with corresponding measurements of scratching activity,which were generated by a monitoring system specifically designed to quantitate this activity.The relationship between individual values for the VAS and corresponding values for scratching activity during a specific interval immediately preceding the recording of the VAS was examined by determining the Spearman's rank correlation coefficient.Results:The mean Spearman's rank correlation coefficient between individual values for the VAS and corresponding mean values for scratching activity was 0.072;the range of these coefficients was-0.04 to 0.26.A VAS of pruritus is an unreliable index of scratching activity,and,hence,of the pathophysiological process responsible for the pruritus of cholestasis.Conclusion:It is concluded that the use of a VAS as a primary quantitative endpoint in trials of the efficacy of potential therapies for the pruritus of cholestasis may be inappropriate.
文摘Objectives: “Patient-reported outcome measures” has been used extensively, and it has shown the diseases’ impact on patient quality of life and has enabled the clinician to evaluate the clinical care efficacy. In the literature, there are more than 34 shoulder function assessment scoring instruments;the Modified Constant Murley Score (M-CMS) is one of the most popular scores. Although, the M-CMS had been translated and culturally adapted to Danish, Brazilian and Turkish versions, there is no Arabic version found in the literature. We aim to translate and culturally adapt M-CMS into the Arabic language. Method: The M-CMS was translated using previously published guidelines. The translation and cultural adaptation were done in five stages, initial translation by two bilingual translators then a synthesis of the translations after that, back translation by two native English speakers. Then an expert committee meeting approved the pre-final Arabic version. Finally, a pilot test was conducted on 41 patients to ensure its validity. Results: The M-CMS was successfully translated from the original English version to the Arabic version;no difficulties in the translation process were faced. Conclusion: A validated Arabic version of the M-CMS was produced and ready to be used for functional assessment of different shoulder pathologies in Arabic-speaking countries. Future study is needed for translation and cultural adaptation of the English standardized test protocol to assure the reproducibility of the Arabic version of the M-CMS.
