Laura Kauffman

Bio: Laura Kauffman is an academic researcher from Covance. The author has contributed to research in topics: Medical prescription & Medicine. The author has an hindex of 2, co-authored 4 publications receiving 18 citations.

A Large Cross-Sectional Survey Study of the Prevalence of Alopecia Areata in the United States.

Abstract: Purpose Alopecia areata (AA) is an autoimmune disease characterized by the development of non-scarring alopecia. The prevalence is not well known, and estimates vary considerably with no recent estimates in the United States (US). The objective of this study was to define the current AA point prevalence estimate among the general population in the US overall and by severity. Patients and methods We administered an online, cross-sectional survey to a representative sample of the US population. Participants self-screening as positive for AA using the Alopecia Assessment Tool (ALTO) also completed the Severity of Alopecia Tool (SALT) to measure the severity of disease as a percent of scalp hair loss. Self-reported AA participants were invited to upload photographs for adjudication of AA by 3 clinicians. Results The average age of participants was 43 years. Approximately half of the participants (49.2%) were male, and the majority were white (77.1%) and not of Hispanic origin (93.2%). Among the 511 self-reported AA participants, 104 (20.4%) uploaded photographs for clinician evaluation. Clinician-adjudicated point prevalence of AA was 0.21% (95% CI: 0.17%, 0.25%) overall, 0.12% (95% CI: 0.09%, 0.15%) for "mild" disease (≤50% SALT score), and 0.09% (95% CI: 0.06%, 0.11%) for "moderate to severe" disease (>50% SALT score) with 0.04% (95% CI: 0.02%, 0.06%) for the alopecia totalis/alopecia universalis (100% SALT score) "moderate to severe" subgroup. The average SALT score was 44.4% overall, 8.8% for "mild", and 93.4% for "moderate to severe". Conclusion This study suggests that the current AA prevalence in the US is similar to the upper estimates from the 1970s at approximately 0.21% (700,000 persons) with the current prevalence of "moderate to severe" disease at approximately 0.09% (300,000 persons). Given this prevalence and the substantial impact of AA on quality of life, the burden of AA within the US is considerable.

Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic.

Abstract: Buprenorphine medication assisted treatment (B-MAT) adherence for opioid use disorder (OUD) is suboptimal. reSET-O, an FDA-cleared prescription digital therapeutic, delivers neurobehavioral therapy...

Comparison of Healthcare Resource Utilization Between Patients Who Engaged or Did Not Engage With a Prescription Digital Therapeutic for Opioid Use Disorder.

Abstract: Background A prescription digital therapeutic (PDT) (reSET-O®) may expand access to behavioral treatment for patients with opioid use disorder (OUD) treated with buprenorphine, but long-term data on effectiveness are lacking. Objective To compare real-world healthcare resource utilization (HCRU) among patients who engaged with reSET-O and buprenorphine compared to similar patients in recovery treated with buprenorphine who did not fill their reSET-O script or engage with the PDT beyond week one. Methods A retrospective analysis of facility and clinical service claims data was conducted in adults with PDT initiation and between 12 weeks and 9 months of continuous enrollment in a health plan after initiation. Patients who filled their prescription and engaged with the therapeutic were compared to patients who filled the prescription but did not engage beyond week one (NE), and patients who did not fill the prescription (NR) (the latter two groups combined into one group hereafter referred to as "non-engagers"). Comparisons were analyzed using a repeated-measures negative binomial model of encounters/procedures, adjusted for number of days in each period. Associated cost trends assessed using current Medicare reimbursement rates. Results A total of 444 patients redeemed a prescription and engaged with the PDT (mean age 37.5 years, 63.1% female, 84% Medicaid), and 64 patients did not engage with the PDT (mean age 39.5 years, 32.8% female, 73.4% Medicaid). Total cost of hospital facility encounters was $2693 for engaged patients vs $6130 for non-engaged patients. Engaged patients had somewhat higher rates of certain clinician services. Total facility and clinician services costs for engaged vs non-engaged patients were $8733 vs $11,441, for a net cost savings over 9 months of $2708 per patient who engaged with reSET-O. Conclusion Patients who engaged with an OUD-specific PDT had a net cost reduction for inpatient and outpatient services of $2708 per patient over 9 months compared to patients who did not engage with the PDT, despite similar levels of buprenorphine adherence.

Real-world changes in US health system hospital-based services following treatment with a prescription digital therapeutic for opioid use disorder.

Abstract: Outcomes associated with buprenorphine therapy for the treatment of opioid use disorder (OUD) are suboptimal. reSET-O is an FDA-authorized prescription digital therapeutic (PDT) delivering neurobeh...

Reduced Healthcare Resource Utilization in Patients with Opioid Use Disorder in the 12 Months After Initiation of a Prescription Digital Therapeutic

Abstract: reSET-O, an FDA-authorized prescription digital therapeutic (PDT) delivering cognitive behavioral therapy and contingency management to patients with opioid u®se disorder (OUD), may help improve clinical outcomes. One-year differences in healthcare resource utilization (HCRU) and costs post-PDT initiation were evaluated.Retrospective analysis of healthcare claims data compared all-cause HCRU (across hospital facility encounters [sum of inpatient stays, treat-and-release emergency department [ED] visits, partial hospitalizations, and hospital outpatient department visits] and clinician services [procedure categories]) after PDT initiation (index) between reSET-O patients and controls. Overall and Medicaid-specific differences in HCRU, costs, and buprenorphine adherence were evaluated.Cohorts included 901 reSET-O patients (median age 36 years, 62.4% female, 73.9% Medicaid) and 978 controls (median age 38 years, 51.1% female, 65.4% Medicaid). Compared to the control group, the reSET-O group experienced 12% fewer total unique hospital encounters (non-significant), driven by 28% fewer inpatient stays (IRR 0.72; 95% CI 0.55-0.96; P = 0.02), 56% fewer hospital readmissions [IRR 0.44; 95% CI 0.20-0.93; P = 0.033]), and 7% fewer ED visits (IRR 0.93; 95% CI 0.79-1.09; P = 0.386). Total clinician services increased by 1391 events versus controls. Differences were greater among the Medicaid patients. Adjustment for concomitant baseline substance use and mental health disorders resulted in similar HCRU incidence rate ratios. Changes in all-cause HCRU drove per-patient per-year cost differences of - $2791 versus controls (- $3832 versus Medicaid controls). Adjusted mean medication possession ratio was 0.848 (SE 0.0118) at 12 months for reSET-O patients, which was significantly higher than controls (0.761 [SE 0.0108]; P < 0.001).Use of reSET-O is associated with significant and durable real-world reductions in ED and inpatient (including readmissions) utilization, reduced net costs, and increased clinician services and buprenorphine adherence. Differences in costs versus controls were greatest among Medicaid patients. INFOGRAPHIC.

Enhancing Digital Innovation for the Sustainable Transformation of Manufacturing Industry: A Pressure-State-Response System Framework to Perceptions of Digital Green Innovation and Its Performance for Green and Intelligent Manufacturing

Abstract: Low carbon and digitalization are the general trends of manufacturing upgrading and transformation. Digital technology enables the whole process of green manufacturing and breaks down the spatial barrier. To achieve the dual carbon goals, the pressure-state-response (PSR) model, in which digital technology enables the green innovation of the manufacturing industry, was theoretically analyzed in this study. The measurement system of the digital green innovation (DGI) in the manufacturing industry was constructed according to the PSR framework. An evaluation model based on the analytic hierarchy process and the deviation maximization technique for order preference by similarity to an ideal solution method was constructed to measure the level of DGI. The results of this study from Chinese manufacturing are as follows. (i) The measurement system of the level of DGI in manufacturing industry includes a pressure system, state system and response system. (ii) In the past five years, the comprehensive index of the DGI in manufacturing industry has generally shown a trend of fluctuating rise. There are overall low and unbalanced phenomena in all regions. The gap decreased from 0.1320 to 0.1187, showing a gradually narrowing trend. (iii) Compared with other regions, the composite index of DGI is generally higher in the regions with a better ecological environment in the east and a more developed economy in the north. State parameters are higher than pressure and response parameters in most areas. (iv) Compared with other regions, the composite index of DGI in western and southern regions is lower, and the parameters of pressure, status and response are basically coordinated. (v) The application degree of digital technology, the emission intensity of waste water/exhaust gas of output value of one hundred million yuan and the expenditure intensity of digital technology adopted by enterprises are the key influencing factors of DGI in the manufacturing industry. This study not only proposed an evaluation index system of the digital green innovation level, but also puts forward policy guidance and practical guidance of digital technology to accelerate the green and intelligent manufacturing industry.

"'You lose your hair, what's the big deal?' I was so embarrassed, I was so self-conscious, I was so depressed:" a qualitative interview study to understand the psychosocial burden of alopecia areata.

Abstract: Alopecia areata (AA) is characterized by hair loss that can affect the scalp and body. This study describes the psychosocial burden of AA. Participants diagnosed with AA who had experienced ≥50% scalp hair loss according to the Severity of Alopecia Tool (SALT) were identified by clinicians. A semi-structured interview guide, developed with expert clinician input, included open-ended questions to explore patients’ experiences of living with AA. Data were thematically analyzed to identify concepts and relationships. Participants (n = 45, 58% female, mean age 33.3 years [range 15–72], mean SALT 67.2 [range 0–100]) described the AA diagnosis as “devastating”. Both males and females reported emotional and psychological impacts of AA including feeling sad/depressed (n = 21), embarrassed/ashamed (n = 10) and angry/frustrated (n = 3). Patients felt helpless (n = 5) due to the unpredictability of disease recurrence, and anxious (n = 19) about judgement from others. Many patients avoided social situations (n = 18), which impaired relationships and increased isolation. Coping strategies included concealment of hair loss through wigs or make-up, although fear of the displacement of these coverings also caused anxiety and the avoidance of activities that could result in scalp exposure (n = 22). Some patients became more accepting of AA over time, which lessened the emotional impact, though efficacious treatment was still desired. A conceptual framework was developed, and a conceptual model was created to depict the relationship between the physical signs/symptoms and the associated psychosocial effects of AA. AA impairs patients’ emotional and psychological wellbeing, relationships and lifestyles. Greater disease awareness and effective treatments are needed.

Autoimmune Diseases Are Linked to Type IIb Autoimmune Chronic Spontaneous Urticaria

Abstract: PURPOSE Patients with chronic spontaneous urticaria (CSU) have an increased risk for comorbid autoimmune diseases. In this retrospective multicenter study of CSU patients, we evaluated clinical and laboratory features of CSU associated with a higher risk of comorbid autoimmune diseases. METHODS We analyzed records of CSU patients (n = 1,199) for a history or presence of autoimmune diseases. Patients were diagnosed with type IIb autoimmune CSU (aiCSU) if all 3 tests were positive: autologous serum skin test (ASST), basophil histamine release assay (BHRA) and/or basophil activation test (BAT), and IgG autoantibodies against FceRIα/IgE detected by immunoassay. RESULTS Twenty-eight percent of CSU patients had at least 1 autoimmune disease. The most prevalent autoimmune diseases were Hashimoto's thyroiditis (HT) (≥ 21%) and vitiligo (2%). Two percent of CSU patients had ≥ 2 autoimmune diseases, most frequently HT plus vitiligo. Comorbid autoimmune diseases, in patients with CSU, were associated with female sex, a family history of autoimmune diseases, and higher rates of hypothyroidism and hyperthyroidism (P < 0.001). Presence of autoimmune diseases was linked to aiCSU (P = 0.02). The risks of having autoimmune diseases were 1.7, 2.9 and 3.3 times higher for CSU patients with a positive ASST, BHRA and BAT, respectively. In CSU patients, markers for autoimmune diseases, antinuclear antibodies and/or IgG anti-thyroid antibodies were associated with non-response to omalizumab treatment (P = 0.013). CONCLUSIONS In CSU, autoimmune diseases are common and linked to type IIb autoimmune CSU. Our results suggest that physicians assess and monitor all adult patients with CSU for signs and symptoms of common autoimmune diseases, especially HT and vitiligo.

Phase 2 Randomized, Dose-Ranging Trial of CTP-543, a Selective Janus Kinase Inhibitor, in Moderate to Severe Alopecia Areata.

Abstract: Janus kinase (JAK) activation is suggested to have a pathological role in alopecia areata (AA). CTP-543, a deuterated compound that selectively inhibits JAK1 and JAK2, is being developed as an oral treatment for AA.To assess the safety and efficacy of a 24-week regimen of CTP-543 in patients with chronic, moderate-to-severe AA.In this phase 2, randomized, double-blind, placebo-controlled, sequential-design trial, patients were randomized to receive CTP-543 (4 mg, 8 mg, or 12 mg) or placebo every 12 hours for 24 weeks.A dose-related increase was observed in the percentage of patients with ≥50% relative reduction in Severity of Alopecia Tool scores from baseline at week 24 (9% placebo, 21% 4 mg twice daily, 47% 8 mg twice daily, and 58% 12 mg twice daily), with statistical significance versus placebo (P < .001) observed for the 8-mg twice daily and 12-mg twice daily groups, with differences from placebo noted as early as 12 weeks after the initiation of treatment. Safety results were consistent with the known safety profiles of JAK inhibitors.These initial findings are from a relatively small controlled trial, and additional studies are needed to fully characterize the safety and efficacy of CTP-543 in adult patients with AA.Patients treated with CTP-543 (8 or 12 mg, twice daily) had a significant reduction in the severity of AA.

Comparison of GIS-based AHP and fuzzy AHP methods for hospital site selection: a case study for Prayagraj City, India.

Abstract: Identification of hospital sites and their ranking is important for the planning and development of any country's health infrastructure. The site selection problem is a typical multi-criteria decision making problem involving multiple stakeholders and their interests. Multi-Criteria Decision Analysis (MCDA) is a promising approach to solve a location-based problem due to the constitution of various criteria involved in decision making. In this research, eleven criterion are chosen which are classified under three main criteria; socio-economic, geographical and environmental. This research aims to identify the appropriate MCDA method for the selection of a new hospital sites. Here, two MCDA methods named Analytical Hierarchy Process (AHP) and Fuzzy AHP (FAHP) are used. Further, Geographical Information System (GIS) based MCDA methodology is proposed in this paper. The results obtained with both AHP and FAHP methods are compared. This comparison is based on criterion rankings, proposed hospital locations and sensitivity analysis. The main difference in results is shown in the result of sensitivity analysis in which constant variation in site ranking is obtained when weight change analysis is performed using AHP. The FAHP result shows only one variation in site ranking after a change in weight from +10 to +20%. The result suggests that FAHP may be a better approach to the hospital site selection problem.