Botulinum Toxin Type A: Evaluation of Onset and Satisfaction.

With the increasing interest in nonsurgical cosmetic procedures, this research study sought to evaluate the onset of Botulinum toxin Type A (BoNTA) between naive and non-naive consumers and its effect on satisfaction. This single-blinded research study consisted of 15 adults with scheduled appointments for neurotoxin treatment of undesired glabellar lines. Participants completed pretreatment FACE-Q scales. Both the participant and the researcher rated pretreated glabellar lines with the Merz 5-point scale. Daily photographs of the treated area were taken by the participant and submitted to the researcher over a secure electronic system. Photographs were started on the treatment day and continued until both participant- and researcher-reported onset. The day of onset was determined with at least 1-point improvement when observed by both the participant and the researcher on the Merz 5-point scale. Once onset was determined, participants completed posttreatment FACE-Q scales. The average onset of treatment was 2.3 days. The average day of onset was 1.8 days in the naive group and 2.65 days in the non-naive group. Posttreatment, patients reported an average of 47.65% reduction in the appearance of glabellar lines; a 35.65% reduction was reported in the non-naive group, and a 59.67% reduction was reported in the naive group. The average participants perceived themselves 2.07 years younger prior to treatment and 6.47 years younger than their actual age posttreatment. On average, participants perceived themselves 4.4 years younger than at baseline. Both groups reported a high level of satisfaction with decision at an average of 85.73% and an average of 86.20% on satisfaction with outcome. The posttreatment FACE-Q expectation scores on average exceeded the pretreatment expectation scores by 8.25%; in the naive group, the scores were exceeded by 25.54%. The onset of BoNTA treatment in naive and non-naive participants demonstrated differences. The naive group experienced onset, on average, 1 day sooner than the non-naive group. The amount of time for a participant to see a noticeable difference influences patient satisfaction. Improvements in appearance and a reduction in the appraisal of age in relation to actual age enhanced satisfaction with treatment. Findings indicate that satisfaction is not solely based on onset, improvements in appearance, and reports of looking younger. The patient perception is also a key factor affecting satisfaction, which can be improved by setting clear expectations, improving patient communication, and encouraging follow-up assessments. The need for additional research on naive and non-naive patients demonstrating the influence of onset on satisfaction scores is crucial to confirm the evidence of this study.

Botulinum Toxin Type A: Evaluation of Onset and Satisfaction.

With the increasing interest in nonsurgical cosmetic procedures, this research study sought to evaluate the onset of Botulinum toxin Type A (BoNTA) between naive and non-naive consumers and its effect on satisfaction. This single-blinded research study consisted of 15 adults with scheduled appointments for neurotoxin treatment of undesired glabellar lines. Participants completed pretreatment FACE-Q scales. Both the participant and the researcher rated pretreated glabellar lines with the Merz 5-point scale. Daily photographs of the treated area were taken by the participant and submitted to the researcher over a secure electronic system. Photographs were started on the treatment day and continued until both participant- and researcher-reported onset. The day of onset was determined with at least 1-point improvement when observed by both the participant and the researcher on the Merz 5-point scale. Once onset was determined, participants completed posttreatment FACE-Q scales. The average onset of treatment was 2.3 days. The average day of onset was 1.8 days in the naive group and 2.65 days in the non-naive group. Posttreatment, patients reported an average of 47.65% reduction in the appearance of glabellar lines; a 35.65% reduction was reported in the non-naive group, and a 59.67% reduction was reported in the naive group. The average participants perceived themselves 2.07 years younger prior to treatment and 6.47 years younger than their actual age posttreatment. On average, participants perceived themselves 4.4 years younger than at baseline. Both groups reported a high level of satisfaction with decision at an average of 85.73% and an average of 86.20% on satisfaction with outcome. The posttreatment FACE-Q expectation scores on average exceeded the pretreatment expectation scores by 8.25%; in the naive group, the scores were exceeded by 25.54%. The onset of BoNTA treatment in naive and non-naive participants demonstrated differences. The naive group experienced onset, on average, 1 day sooner than the non-naive group. The amount of time for a participant to see a noticeable difference influences patient satisfaction. Improvements in appearance and a reduction in the appraisal of age in relation to actual age enhanced satisfaction with treatment. Findings indicate that satisfaction is not solely based on onset, improvements in appearance, and reports of looking younger. The patient perception is also a key factor affecting satisfaction, which can be improved by setting clear expectations, improving patient communication, and encouraging follow-up assessments. The need for additional research on naive and non-naive patients demonstrating the influence of onset on satisfaction scores is crucial to confirm the evidence of this study.

A Quantitative Retrospective Exposure Assessment for Former Chrysotile Asbestos Miners and Millers from Baie Verte, NL, Canada.

Despite numerous studies of asbestos workers in the epidemiologic literature, there are very few cohort studies of chrysotile asbestos miners/millers that include high-quality retrospective exposure assessments. As part of the creation of the Baie Verte Miners' Registry in 2008, a two-dimensional job exposure matrix (JEM) was developed for estimating asbestos exposures for former chrysotile asbestos miners/millers. Industrial hygiene data collected between 1963 and 1994 were analysed to assess validity for use in a retrospective exposure assessment and epidemiologic study. Registered former employees were divided into 52 exposure groups (EGs) based on job title and department and mean asbestos concentrations were calculated for each EG. The resulting exposure estimates were linked to individual registrants' work histories allowing for the calculation of cumulative asbestos exposure for each registrant. The distribution of exposure for most EGs (82.6%) could be described as fitting a log-normal distribution, although variability within some EGs (55%) exceeded a geometric standard deviation (GSD) of 2.5. Overall, the data used to create EGs in the development of the JEM were deemed to be of adequate quality for estimating cumulative asbestos exposures for the former employees of the Baie Verte asbestos mine/mill. The variability between workers in the same job was often high and is an important factor to be considered when using estimates of cumulative asbestos exposure to adjudicate compensation claims. The exposures experienced in this cohort were comparable to those of other chrysotile asbestos miners/millers cohorts, specifically Italian and Québec cohorts.

Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations.

The development of novel digital endpoints (NDEs) using digital health technologies (DHTs) may provide opportunities to transform drug development. It requires a multidisciplinary, multi-study approach with strategic planning and a regulatory-guided pathway to achieve regulatory and clinical acceptance. Many NDEs have been explored; however, success has been limited. To advance industry use of NDEs to support drug development, we outline a theoretical, methodological study as a use-case proposal to describe the process and considerations when developing and obtaining regulatory acceptance for an NDE to assess sleep in patients with rheumatoid arthritis (RA). RA patients often suffer joint pain, fatigue, and sleep disturbances (SDs). Although many researchers have investigated the mobility of joint functions using wearable technologies, the research of SD in RA has been limited due to the availability of suitable technologies. We proposed measuring the improvement of sleep as the novel endpoint for an anti-TNF therapy and described the meaningfulness of the measure, considerations of tool selection, and the design of clinical validation. The recommendations from the FDA patient-focused drug development guidance, the Clinical Trials Transformation Initiative (CTTI) pathway for developing novel endpoints from DHTs, and the V3 framework developed by the Digital Medicine Society (DiMe) have been incorporated in the proposal. Regulatory strategy and engagement pathways are also discussed.