Improving Small Business Viability Through the Strategic Longevity and Health Maintenance Evaluation

Most adults are urged to go through an annual health checkup. We recommend that most mature small businesses perform an annual strategic longevity and health maintenance evaluation as well to ensure their viability. To this end, we provide strategic areas of critical importance to a small business viability and longevity and offer guidelines for small business owners, managers, consultants, and small business/entrepreneurship educators use to help improve performance. We add to the body of literature on small business success and failure factors by emphasizing the need for a closer look at the open systems nature of these businesses and the impact of interaction with the larger external environmental system for viability. We urge small business owners to be more proactive in evaluating the health and viability of their businesses by using systems approach before the emergence of signs of trouble through the use of the Annual Health Maintenance and Viability Evaluation checklist. We recommend the use of the checkup for use by consultants including SBI student consulting projects

Motives For Employee Profit Sharing Schemes In The U.S., U.K. And Canada

This paper discusses different motives for profit sharing adoption in the U.S., Canada and the U.K., and analyzes employment-based factors that could contribute to these differences. Motives for profit sharing are classified into two groups: motivational and non-motivational. A theoretical model is presented that suggests a firm’s ability to use profit sharing for non-motivational purposes is limited by the status of domestic employment-related factors. The analytical review indicates that the non-motivational use of profit sharing is limited by the status of employment-related factors in each of the studied countries. However, the non-motivational use of profit sharing is probable if higher labor productivity is expected through other means. Implication of the results is discussed for future studies in this area

Motives For Employee Profit Sharing Schemes In The U.S., U.K. And Canada

This paper discusses different motives for profit sharing adoption in the U.S., Canada and the U.K., and analyzes employment-based factors that could contribute to these differences. Motives for profit sharing are classified into two groups: motivational and non-motivational. A theoretical model is presented that suggests a firm’s ability to use profit sharing for non-motivational purposes is limited by the status of domestic employment-related factors. The analytical review indicates that the non-motivational use of profit sharing is limited by the status of employment-related factors in each of the studied countries. However, the non-motivational use of profit sharing is probable if higher labor productivity is expected through other means. Implication of the results is discussed for future studies in this area

Application Of The Domestic Production Activities Tax Deduction (Relating To A Wide Range Of Industries)

Internal Revenue Code Section 199 is the domestic production activities deduction, which was enacted under the American Jobs Creation Act of 2004. This new deduction was to help compensate the repeal of the exterritorial income exclusion. Section 199 was intended to lower the tax burden on domestic manufacturers as well as to attract new investments in domestic manufacturing facilities.  The deduction would yield tax breaks for certain types of businesses ranging large to small that predominately manufacture, produce, grow, or extract tangible personal property entirely or partially within the United States.  The types of businesses, specifically, that will have an impact from Section 199 would be those in the film and sound recordings industries, companies in the construction business, and those in the field of architectural and engineering.  In addition, those that qualified as doing business in any of the specific industries falling under Section 199 must be located and providing services in the United States. The Section 199 tax break will also benefit those in the business of producing electricity, natural gas, and water in the United States. The deduction is allowed to be taken for taxable years beginning after 2004, which creates many challenges. First, Section 199 establishes detailed tax concepts conditions, de minimis rules, exceptions, and safe harbors. Second, the deduction forces many businesses to implement new accounting systems to classify between qualifying and non-qualifying activities.  All in all, this report explains how Section 199 works as well as benefits specific industries. However, important production eligibility issues remain in determining the production deduction for tangible property, which are the central items focused throughout this article. Furthermore, the research contain within, covers the guidance in Notice 2005-14, along with the proposed and final regulations to the rules under Section 199.   An understanding of these rules will provide additional opportunities to qualify property and take advantage of tax breaks, yielding a better financial result to the taxpayer

Budesonide Foam Has a Favorable Safety Profile for Inducing Remission in Mild-to-Moderate Ulcerative Proctitis or Proctosigmoiditis.

BackgroundBudesonide foam, a rectally administered, second-generation corticosteroid with extensive hepatic first-pass metabolism, is efficacious for the treatment of mild-to-moderate ulcerative proctitis and ulcerative proctosigmoiditis.AimThe aim of this study was to comprehensively assess the safety and pharmacokinetic profile of budesonide foam.MethodsData from five phase III studies were pooled to further evaluate safety, including an open-label study (once-daily treatment for 8 weeks), an active-comparator study (once-daily treatment for 4 weeks), and two placebo-controlled studies and an open-label extension study (twice-daily treatment for 2 weeks, then once daily for 4 weeks). Data from the placebo-controlled studies and two phase I studies (i.e., patients with mild-to-moderate ulcerative colitis and healthy volunteers) were pooled to evaluate the pharmacokinetics of budesonide foam.ResultsA similar percentage of patients reported adverse events in the budesonide foam and placebo groups, with the majority of adverse events being mild or moderate in intensity (93.3 vs 96.0%, respectively). Adverse events occurred in 41.4 and 36.3% of patients receiving budesonide foam and placebo, respectively. Mean morning cortisol concentrations remained within the normal range for up to 8 weeks of treatment; there were no clinically relevant effects of budesonide foam on the hypothalamic-pituitary-adrenal axis. Population pharmacokinetic analysis demonstrated low systemic exposure after budesonide foam administration.ConclusionsThis integrated analysis demonstrated that budesonide foam for the induction of remission of distal ulcerative colitis is safe overall, with no clinically relevant effects on the hypothalamic-pituitary-adrenal axis

Budesonide Foam Induces Remission in Patients With Mild to Moderate Ulcerative Proctitis and Ulcerative Proctosigmoiditis

BACKGROUND & AIMS: Budesonide is a high-potency, second-generation corticosteroid designed to minimize systemic adverse consequences of conventional corticosteroids. We performed 2 randomized, phase 3 trials to evaluate the ability of budesonide rectal foam, formulated to optimize retention and provide uniform delivery of budesonide to the rectum and distal colon, to induce remission in patients with ulcerative proctitis or ulcerative proctosigmoiditis. METHODS: Two identically designed, randomized, double-blind, placebo-controlled trials evaluated the efficacy of budesonide foam for induction of remission in 546 patients with mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis who received budesonide foam 2 mg/25 mL twice daily for 2 weeks, then once daily for 4 weeks, or placebo. RESULTS: Remission at week 6 occurred significantly more frequently among patients receiving budesonide foam than placebo (Study 1: 38.3% vs 25.8%; P = .0324; Study 2: 44.0% vs 22.4%; P < .0001). A significantly greater percentage of patients receiving budesonide foam vs placebo achieved rectal bleeding resolution (Study 1: 46.6% vs 28.0%; P = .0022; Study 2: 50.0% vs 28.6%; P = .0002) and endoscopic improvement (Study 1: 55.6% vs 43.2%; P = .0486; Study 2: 56.0% vs 36.7%; P = .0013) at week 6. Most adverse events occurred at similar frequencies between groups, although events related to changes in cortisol values were reported more frequently with budesonide foam. There were no cases of clinically symptomatic adrenal insufficiency. CONCLUSIONS: Budesonide rectal foam was well tolerated and more efficacious than placebo in inducing remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. ClinicalTrials.gov ID: NCT01008410 and NCT01008423

Electronic patient-reported outcomes in hidradenitis suppurativa: content validity and usability of the electronic hidradenitis suppurativa symptom daily diary, hidradenitis suppurativa symptom questionnaire and hidradenitis suppurativa quality of life questionnaire

Background: Hidradenitis suppurativa (HS), a chronic skin condition that causes pain and physical dysfunction, can impact significantly on quality of life. Disease‑specific tools have been designed to assess the patient impact of HS, including the HS Symptom Daily Diary (HSSDD), the HS Symptom Questionnaire (HSSQ) and the HS Quality of Life (HiSQOL©) questionnaire, which have been developed into electronic instruments (eHSSDD, eHSSQ and eHiSQOL©). Objectives: To establish the content validity of the electronic version of the HSSDD and HSSQ, and the acceptability and usability of the HSSDD, HSSQ and HiSQOL© using concept elicitation and cognitive debriefing interviews. Methods: This was a non‑interventional qualitative video interview study involving participants aged ≥18 years with moderate to severe HS recruited from a single clinical site in the USA. Interviews gathered feedback on participants’ symptom experience, followed by training and completion of the eHSSDD, eHSSQ, and eHiSQOL© questionnaires on electronic hand-held devices. Participants were then interviewed on the content of the eHSSDD and eHSSQ, and the acceptability and usability of all three instruments. Interviews were transcribed and qualitatively analysed. Results: Twenty participants with moderate to severe HS (median age: 41.5 [range: 20.0–64.0]; n=16/20 female) were included. All participants found the eHSSDD, eHSSQ and eHiSQOL© instructions clear, and described the instruments as ‘easy’, ’simple’ and ’self-explanatory’. Overall understanding of individual items within the eHSSDD and eHSSQ was high; however, 6/20 participants had difficulty in understanding the ‘average skin pain’ item in the eHSSDD. All participants were able to accurately recall their symptoms within the recall periods of the eHSSDD and eHSSQ, although 4/20 participants found the 24-hour recall period of the eHSSDD limiting. Completion time was quick across all instruments and usability was high, with the majority of participants reporting no difficulty in completing questionnaires on electronic devices. Conclusion: The concepts covered in the eHSSDD and eHSSQ are relevant and important to patients, supporting their content validity. The findings also provide evidence of acceptability and usability of the eHSSDD, eHSSQ, and eHiSQOL©. A limitation was that all participants were recruited from a single site, which may have introduced selection bias and thus limit the generalisability of results

Certolizumab Pegol for the treatment of chronic plaque psoriasis: results through 48 weeks of a phase 3, multicenter, andomized, double-blinded, etanercept- and placebo-controlled study (CIMPACT)

Background Phase 2 psoriasis studies with the Fc-free, PEGylated, anti-tumor necrosis factor biologic certolizumab pegol demonstrated meaningful clinical activity. Objective Assess safety and efficacy of certolizumab in adults with moderate-to-severe chronic plaque psoriasis. Methods Patients were randomized 3:3:1:3 to certolizumab 400 mg, 200 mg, or placebo every 2 weeks for 16 weeks or etanercept 50 mg twice-weekly for 12 weeks. Certolizumab-treated patients achieving ≥75% reduction in psoriasis area and severity index at Week 16 were re-randomized to certolizumab or placebo for 32 weeks. The primary endpoint was responder rate (≥75% reduction in psoriasis area and severity index) versus placebo (primary analysis) and etanercept (secondary analysis) at Week 12; secondary endpoints included responder rates on various measures versus placebo at Weeks 12, 16, and 48. Safety was assessed by treatment-emergent adverse events. Results All endpoints were significantly greater for certolizumab versus placebo with the greatest response seen with 400 mg. Certolizumab 400 mg was superior to and 200 mg was noninferior to etanercept. Adverse events were consistent with the anti-tumor necrosis factor class. Limitations Single-blind etanercept. Conclusion Both certolizumab regimens improved psoriasis symptoms with greater response at the higher dose. No new safety signals were observed

Validation of the Hidradenitis Suppurativa Investigator Global Assessment

Importance Few simplified instruments exist for use in hidradenitis suppurativa (HS) trials. Objective To assess psychometric properties of the Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA) score using a clinical trial data set. Design, Setting, and Participants This retrospective analysis of a phase 2 randomized double-blind, placebo-controlled, active-reference arm trial (UCB HS0001) included adults with moderate-to-severe HS. Exposures Trial participants were randomized at baseline to receive bimekizumab, adalimumab, or placebo. Main Outcomes and Measures The HS-IGA score at prespecified time points up to 12 weeks after randomization. Results The HS-IGA score showed strong convergent validity with IHS4 and HS-PhGA scores at baseline (Spearman correlation, 0.86 [P < .001] and 0.74 [P < .001], respectively) and at week 12 (Spearman correlation, 0.73 [P < .001] and 0.64 [P < .001], respectively). The HS-IGA scores assessed during predosing visits at screening and baseline showed good test-retest reliability (intraclass correlation coefficient [ICC] = 0.92). At week 12, HS-IGA responders were significantly associated with HiSCR-(50/75/90) responders (χ2 = 18.45; P < .001; χ2 = 18.11; P < .001; and χ2 = 20.83; P < .001, respectively). The HS-IGA score was predictive of HiSCR-50/75/90 and HS-PhGA response at week 12 (AUC, 0.69, 0.73, 0.85, and 0.71, respectively). However, the HS-IGA as a measure of disease activity showed low predictive validity with patient-reported outcomes at week 12. Conclusions and Relevance The HS-IGA score demonstrated good psychometric properties compared with existing measures and may be considered for use as an end point in clinical trials for HS