Development and Validation of the Eyelash Satisfaction Questionnaire.

BACKGROUND: Patient-reported outcome (PRO) measures have been used to assess treatment benefit in a variety of therapeutic areas and are now becoming increasingly important in aesthetic research. OBJECTIVES: The objective of the current study was to develop and validate a new PRO measure (Eyelash Satisfaction Questionnaire [ESQ]) to assess satisfaction with eyelash prominence. METHODS: The content of the questionnaire (including conceptual framework and questionnaire items) was generated by review of literature, participant interviews, and expert opinion. Cognitive interviews were conducted to pilot test the questionnaire. Psychometric properties of the questionnaire were examined in a combined sample of participants (n = 970) completing Internet- (n = 909) and paper-based (n = 61) versions. Item- and domain-level properties were examined using modern and classical psychometrics. RESULTS: Content-based analysis of qualitative data demonstrated the presence of 3 distinct domains (Length, Fullness, Overall Satisfaction; Confidence, Attractiveness, and Professionalism; and Daily Routine). Initial confirmatory factor analysis (CFA) results of 23 items revealed insufficient model-data fit (comparative fit index [CFI] of 0.86 and a non-normed fit index [NNFI] of 0.82). A revised model using 9 items (3 per domain) achieved appropriate fit (CFI of 0.99 and NNFI of 0.97). Analyses revealed measurement equivalence across the Internet- and paper-based versions. The 3 ESQ domains had strong internal consistency reliability (Cronbach's α [range] = 0.919-0.976) and adequate convergent and discriminant validity. CONCLUSIONS: The ESQ was found to be a reliable and valid PRO measure for assessing satisfaction with eyelash prominence. LEVEL OF EVIDENCE 3: Therapeutic.

Incorporating indirect costs into a cost-benefit analysis of laparoscopic adjustable gastric banding.

OBJECTIVES: The objective of this study was to estimate the time to breakeven and 5-year net costs of laparoscopic adjustable gastric banding (LAGB) taking both direct and indirect costs and cost savings into account. METHODS: Estimates of direct cost savings from LAGB were available from the literature. Although longitudinal data on indirect cost savings were not available, these estimates were generated by quantifying the relationship between medical expenditures and absenteeism and between medical expenditures and presenteeism (reduced on-the-job productivity) and combining these elasticity estimates with estimates of the direct cost savings to generate total savings. These savings were then combined with the direct and indirect costs of the procedure to quantify net savings. RESULTS: By including indirect costs, the time to breakeven was reduced by half a year, from 16 to 14 quarters. After 5 years, net savings in medical expenditures from a gastric banding procedure were estimated to be $4970 (±$3090). Including absenteeism increased savings to $6180 (±$3550). Savings were further increased to $10,960 (±$5864) when both absenteeism and presenteeism estimates were included. CONCLUSIONS: This study presented a novel approach for including absenteeism and presenteeism estimates in cost-benefit analyses. Application of the approach to gastric banding among surgery-eligible obese employees revealed that the inclusion of indirect costs and cost savings improves the business case for the procedure. This approach can easily be extended to other populations and treatments.

The impact of upper facial lines and psychological impact of crow's feet lines: content validation of the Facial Line Outcomes (FLO-11) Questionnaire.

BACKGROUND: Treatments for upper facial lines (UFL), the most visible sign of aging, are of interest to patients and clinicians alike. Patient-reported outcomes (PROs) are valuable in evaluating the impact of such treatments; however, regulatory recommendations have stipulated that the patient perspective be central in developing these assessments. OBJECTIVES: (1) To evaluate the content validity of the Facial Lines Outcomes Questionnaire, a PRO instrument developed to assess upper facial line impacts, according to the regulatory guidance of the United States Food and Drug Administration and (2) assess whether it adequately measures the psychological impacts associated with crow's feet lines (CFL) (lateral canthal lines) from the patient perspective. METHODS: Two patient groups participated in face-to-face qualitative interviews. One group included patients with UFL (Group 1, n = 25 interviews), and the other included patients specifically with CFL (Group 2, n = 41 interviews). Each interview consisted of a concept elicitation and cognitive debriefing phase. RESULTS: Interviews with both groups elicited all key concepts of the instrument, including "bothered by facial lines"; "looking older"; "looking less attractive"; and looking "tired," "stressed," or "angry." Most Group 2 patients (n = 35, 85%) agreed that the instrument adequately assessed the psychological impacts associated with CFL. During cognitive debriefing, the majority of patients in both groups agreed the instrument was understandable, comprehensive, and easy to complete. CONCLUSIONS: The Facial Line Outcomes Questionnaire is an appropriate and valid tool to assess the impact of UFL and the psychological impacts associated with CFL.

Direct and indirect costs and potential cost savings of laparoscopic adjustable gastric banding among obese patients with diabetes.

OBJECTIVE: To estimate the time to breakeven and 5-year net costs for laparoscopic adjustable gastric banding among obese patients with diabetes taking direct and indirect costs into account. METHODS: Indirect cost savings were generated by quantifying the cross-sectional relationship between medical expenditures and absenteeism and between medical expenditures and presenteeism (reduced on-the-job productivity) and simulating indirect cost savings based on these multipliers and reductions in direct medical costs available in the literature. RESULTS: Time to breakeven was estimated to be nine quarters with and without the inclusion of indirect costs. After 5 years, net savings increase from $26570 (±$9000) to $34160 (±$10 380) when indirect costs are included. CONCLUSION: This study presented a novel approach for incorporating indirect costs into cost-benefit analyses. Application to gastric banding revealed that inclusion of indirect costs improves the financial outlook for the procedure.

Financial implications of coverage for laparoscopic adjustable gastric banding.

BACKGROUND: Employers and insurers have become increasingly concerned about the cost implications of providing coverage for bariatric procedures. We sought to quantify the costs and potential cost savings resulting from coverage for laparoscopic adjustable gastric banding (LAGB) using a claims analysis. METHODS: U.S. healthcare claims data of >7000 LAGB patients and a propensity score-matched control group were used to quantify the costs and potential cost savings resulting from LAGB for the overall surgery-eligible population and for the subset of the surgery-eligible population with diabetes mellitus. The matched control group consisted of those with a morbid obesity diagnosis code and/or a body mass index >35 kg/m(2) as reported in the Health Risk Assessment data. RESULTS: Including the related medical payments in the 90 days before and after the procedure, the mean cost of LAGB was approximately $20,000. After placement, a modest reduction occurred in the health expenditures relative to the preoperative payments. In the postoperative period, these decreases were maintained for the LAGB sample. In contrast, the payments for the comparison sample continued to increase. As a result, the net cost of coverage for LAGB was reduced to 0 by approximately 4 years after band placement. For those with diabetes, the net costs resulting from LAGB were reduced to 0 in just >2 years. CONCLUSION: These results suggest that the LAGB procedure pays for itself within a relatively short period, especially for those with diabetes.

The costs of obesity in the workplace.

OBJECTIVE: To quantify per capita and aggregate medical expenditures and the value of lost productivity, including absenteeism and presenteeism, because of overweight, and grade I, II, and III obesity among U.S. employees. METHODS: Cross-sectional analysis of the 2006 Medical Expenditure Panel Survey and the 2008 National Health and Wellness Survey. RESULTS: Among men, estimates range from -$322 for overweight to $6087 for grade III obese men. For women, estimates range from $797 for overweight to $6694 for grade III. In aggregate, the annual cost attributable to obesity among full-time employees is $73.1 billion. Individuals with a body mass index >35 represent 37% of the obese population but are responsible for 61% of excess costs. CONCLUSIONS: Successful efforts to reduce the prevalence of obesity, especially among those with a body mass index >35, could result in significant savings to employers.