Wear Experiences with Two Soft Contact Lenses for Astigmatism of Different Modalities.

Introduction: Patients expect to have excellent vision and comfort when wearing soft contact lenses. The purpose of this study was to compare the wear experiences of participants with astigmatism when wearing a daily disposable soft toric lens to an established, commonly used reusable toric lens. Methods: In this crossover study, habitual soft toric lens wearers were fit with a daily replacement soft toric lens (delefilcon A) and a reusable, 1-month replacement soft toric lens (comfilcon A) in a randomized order. After 30 days of wear, Visual analog scale (VAS) surveys were used to assess wear experience, including vision and comfort, for overall wear and end-of-day wear. Scores were compared statistically with mixed-effects linear models. Participants also responded to questions about convenience, ease of use, and satisfaction with both lenses and preference questions based upon comfort, vision, and overall performance. Results: Fifty-nine participants completed the multi-site crossover study. VAS scores [mean(std dev)] for overall quality of vision for the delefilcon A [80.4(16.4)] and comfilcon A [66.8(27.7)] lenses were statistically significant (P=0.002). The difference in the mean overall comfort scores for the delefilcon A lenses [71.6(26.3)] and comfilcon A lenses [63.2(28.9)] was 8.4, which exceeds the establish criteria for clinical significance, although not statistically significant (P=0.08). Overall satisfaction scores were 68.8(26.9) for the delefilcon A and 59.7(30.3) for the comfilcon A lenses (P=0.08). Both lenses provided mean binocular visual acuities better than 20/20 Snellen equivalent. Over half of the participants preferred the delefilcon A lenses based upon comfort, vision, and overall performance. Convenience, ease of use, and satisfaction all scored higher with delefilcon A lenses. Conclusion: The results of this study show that wear experience with delefilcon A lenses for astigmatism can meet or exceed that of comfilcon A toric lenses while also providing healthy, daily disposable lens wear.

Systane iLux Thermal Pulsation System in the Treatment of Meibomian Gland Dysfunction: A Post-Hoc Analysis of a 12-Month, Randomized, Multicenter Study.

Purpose: This study aimed to demonstrate the effectiveness of Systane iLux, a thermal pulsation device, in patients with MGD, over 12 months post-single treatment. Methods: This is a post-hoc analysis of a previous prospective, assessor-masked, parallel-group, multicenter study (NCT03956225) that compared the effectiveness and safety of iLux with LipiFlow in subjects with MGD. The original study included subjects with meibomian gland score (MGS) ≤12 in lower eyelids, Impact of Dry Eye on Everyday Life-Symptom Bother (IDEEL-SB) module score >16, and non-invasive tear break-up time (NITBUT) <10 seconds. Subjects were randomized (1:1) to receive a single bilateral treatment of iLux or LipiFlow. In this post-hoc analysis, mean changes in MGS, NITBUT (first break-up; seconds), IDEEL-SB module score, and corneal staining, from baseline to 12 months were analyzed post-single treatment with iLux. Results: Data from 119 patients (n=238 eyes) treated with iLux were analyzed. The mean±SD age of the subjects was 58.4±13.4 years, with majority being female (79.0%). MGS (mean±SD) for both eyes improved significantly from baseline to 12 months (OD [baseline: 6.9±3.69; month 12: 22.8±11.31; change: 15.9±11.57, p<0.0001]; OS [baseline: 6.4±3.66; month 12: 23.0±11.33; change: 16.7±11.40, p<0.0001]). Similarly, significant improvements were observed in NITBUT (OD [baseline: 5.2±1.97; month 12: 7.0±3.68; change: 1.9±3.69, p<0.0001]; OS [baseline: 5.6±1.96; month 12: 7.9±4.58; change: 2.3±4.59, p<0.0001]) and IDEEL-SB score (p<0.0001). Corneal staining reduced significantly from baseline to 12 months (OD [baseline: 2.1±2.96; month 12: 0.7±1.56; change: -1.4±2.65, p<0.0001]; OS [baseline: 2.1±2.94; month 12: 0.7±1.44; change: -1.4±2.75, p<0.0001]). Improvements in MGS, NITBUT, IDEEL-SB module score, and corneal staining were seen as early as week 2, and at months 1, 3, 6, and 9 (all p<0.001). Conclusion: A single treatment with iLux significantly improved clinical parameters of MGS, NITBUT, and corneal staining, and patient-reported symptom assessment with IDEEL-SB in patients with MGD over 12 months.

Safety and Efficacy of a New Water Gradient Biomimetic Monthly Replacement Spherical Contact Lens Material (Lehfilcon A).

Purpose: The objective of this study was to evaluate the safety and performance of the investigational lens, lehfilcon A, when worn in a daily wear modality and replaced monthly as compared to the commercially available comfilcon A contact lens. Methods: This was a multicenter, prospective, controlled, double-masked, randomized, parallel-group clinical study with bilateral lens wear for 3 months. In all, 115 subjects completed the study (77 with test lehfilcon A and 38 with control comfilcon A contact lenses). Distance visual acuity (VA) was assessed using Snellen VA. Lens performance was assessed by examining lens fit/movement, centration, front surface wettability and front/back surface deposits using slit-lamp biomicroscopy. Results: At the 3-month follow-up visit, all eyes had a distance VA of 20/20 or better. Further, lens fit/movement was assessed as optimal in 92.9% of the eyes with lehfilcon A and 89.2% with comfilcon A. There were no ratings of unacceptably tight or loose fits for either contact lens material. Lens centration was assessed as optimal in 98.7% of eyes with lehfilcon A and 94.6% with comfilcon A. For front and back surface deposits, both materials showed minimal lens surface deposits. Front surface wettability was assessed as grade 0 or 1 for most of the study lenses in both lens groups across all attended study visits. There were no ocular adverse events related to the study lenses. Conclusion: Overall, lehfilcon A showed excellent VA, optimal lens fitting characteristics, a clean surface, high wettability, and low risk for adverse events after 3 months of lens wear.

Comparison of Two Thermal Pulsation Systems in the Treatment of Meibomian Gland Dysfunction: A Randomized, Multicenter Study.

SIGNIFICANCE: Given the significance of meibomian gland dysfunction subjects in evaporative dry eye, its chronic and progressive nature, limited promising treatment options, and novel treatment techniques are important. This randomized clinical study evaluated the noninferiority of SYSTANE iLux with LipiFlow in meibomian gland dysfunction treatment at 12 months. PURPOSE: This study aimed to demonstrate noninferiority of SYSTANE iLux compared with LipiFlow at 12 months after single treatment in meibomian gland dysfunction subjects with evaporative dry eye. METHODS: In this prospective, randomized, multicenter, assessor-masked, parallel-group trial, subjects (N = 236; aged ≥18 years) with meibomian gland score (MGS) of ≤12 in lower eyelids, noninvasive tear breakup time (NITBUT; first breakup) of <10 seconds, and Impact of Dry Eye on Everyday Life-Symptom Bother (IDEEL-SB) module score of >16 were randomized (1:1) to receive SYSTANE iLux (n = 119) or LipiFlow (n = 117). Subjects attended a total of eight visits, including screening, treatment, and follow-up visits at 2 weeks and at 1, 3, 6, 9, and 12 months/exit, to evaluate change from baseline in MGS, NITBUT, IDEEL-SB module score, and safety outcomes. RESULTS: A total of 227 subjects completed the study (mean ± standard deviation age, 57.3 ± 13.8 years). At 12 months, least squares mean change from baseline in MGS was similar between iLux and LipiFlow (17.4 ± 1.97 vs. 17.8 ± 1.98). Noninferiority of SYSTANE iLux compared with LipiFlow in change from baseline in MGS (95% lower confidence limit of least squares mean difference, >-5), NITBUT (>-2.5 seconds), and IDEEL-SB score (95% upper confidence limit, <12) was achieved at all post-treatment visits. No other serious ocular or device-related adverse events were reported. CONCLUSIONS: The treatment outcomes with SYSTANE iLux were noninferior to LipiFlow during the 12-month follow-up in subjects with dry eye-associated meibomian gland dysfunction.

Diversity and disparity of sparassodonts (Metatheria) reveal non-analogue nature of ancient South American mammalian carnivore guilds.

This study investigates whether terrestrial mammalian carnivore guilds of ancient South America, which developed in relative isolation, were similar to those of other continents. We do so through analyses of clade diversification, ecomorphology and guild structure in the Sparassodonta, metatherians that were the predominant mammalian carnivores of pre-Pleistocene South America. Body mass and 16 characters of the dentition are used to quantify morphological diversity (disparity) in sparassodonts and to compare them to extant marsupial and placental carnivores and extinct North American carnivoramorphans. We also compare trophic diversity of the Early Miocene terrestrial carnivore guild of Santa Cruz, Argentina to that of 14 modern and fossil guilds from other continents. We find that sparassodonts had comparatively low ecomorphological disparity throughout their history and that South American carnivore palaeoguilds, as represented by that of Santa Cruz, Argentina, were unlike modern or fossil carnivore guilds of other continents in their lack of mesocarnivores and hypocarnivores. Our results add to a growing body of evidence highlighting non-analogue aspects of extinct South American mammals and illustrate the dramatic effects that historical contingency can have on the evolution of mammalian palaeocommunities.

Use of standardized patients to examine physicians' communication strategies when addressing vaccine refusal: a pilot study.

Vaccine refusal is increasingly reported but few direct observations of the communication between physicians and parents skeptical about vaccines have been made. In a pilot study, a standardized patient posing as an expectant mother (standardized mother, SM) opposed to immunization met with blinded community physicians under the pretext of prenatal interviews. Persuasive communication strategies were scored using a standardized questionnaire. Recorded transcripts were evaluated for compliance with American Academy of Pediatrics recommendations for handling vaccine refusal. Nine encounters were conducted, representing 16% of pediatric and 3% of family practices in the area. Physicians scored high on listening, maintaining eye contact, spending time with the SM, using understandable terms, and avoiding a paternalistic posture. Lower scores were obtained on encouraging questions, checking for understanding, validating the importance of the SM's concerns, and assessing knowledge about vaccines. The median recorded encounter lasted 19 min. SMs represent a novel strategy for studying physician/parent communication about vaccines.

Tobacco cessation counseling training with standardized patients.

A pilot study was conducted to assess clinician receptivity to tobacco cessation counseling training methods using standardized patients. Additionally, the study assessed changes in clinician knowledge and behavioral intentions following the training. Medical and dental residents and dental hygiene students from the University of Louisville attended a one- to two-hour lecture addressing the counseling strategies (the Five As/the Five Rs) and pharmacotherapy recommended in the U.S. Public Health Service Clinical Practice Guideline: Treating Tobacco Use and Dependence. Participants subsequently had three training encounters with standardized patients representing various stages of change including a patient ready to quit, a patient contemplating quitting, and a patient resistant to quitting. Thirty-six participants completed a preprogram survey prior to the lecture and a postprogram evaluation that included questions about their attitudes and beliefs about tobacco, their comfort level with various aspects of tobacco intervention, and eight knowledge questions. Participants demonstrated a statistically significant increase in objective knowledge about the practices recommended in the Clinical Practice Guideline following intervention. Results also indicate a significant increase in subjective measures of participant receptivity, self-reported comfort, and perceived skill with various aspects of tobacco intervention. Overall, participants were found to be very receptive to training sessions on tobacco cessation counseling with standardized patients. In light of the educational gains and positive response from participants, the use of standardized patients is a promising strategy for training on tobacco cessation counseling.

Lecture versus standardized patient interaction in the surgical clerkship: a randomized prospective cross-over study.

BACKGROUND: Medical schools increasingly are incorporating the standardized patient (SP) interaction as a teaching and testing modality to prepare students for United States Medical Licensing Examination Step 2 Clinical Skills. Although SP interactions provide a safe environment in which to practice clinical skills, little is known about medical students' perceptions of the instructional SP interaction in comparison with the classic didactic lecture. We hypothesized that students would enjoy and value an instructional SP interaction more than a didactic lecture, and that this perception would be enhanced if the lecture immediately preceded the instructional SP interaction. METHODS: Students on the junior surgery clerkship from January to December 2004 were randomized into 2 groups. Group A (n = 71) received an hour-long didactic lecture about peripheral vascular disease followed by a 20-minute instructional SP interaction in which the SP portrayed a patient with lower-extremity claudication. Group B (n = 72) received the SP interaction first, followed by the lecture. All students received an identical quiz about peripheral vascular disease after the second educational encounter, whether the SP interaction or the lecture. Student perceptions were surveyed by written questionnaire before and after the session by using a 5-point Likert scale, with 5 being the most favorable rating. Data (perceptions, performances on the quiz and the SP interaction, clerkship grades) were compared using the Student t test or the Mann-Whitney rank sums test. RESULTS: Although all students on average enjoyed and valued the lecture more than the SP interaction (P <.001), group A students enjoyed the SP interaction more than group B (3.3 +/- .9 vs. 2.8 +/- 1.0, P = .008), and they perceived the SP interaction as having more value to their overall education (3.3 +/- 1.0 vs. 2.8 +/- 1.0, P = .004). Group A students performed statistically better on the physical examination (66% +/- 19% vs. 40% +/- 16%, P <.001) and communication portions (90% +/- 11% vs. 79% +/- 12%, P <.001) of the SP checklist than group B, but not on the history portion. Student confidence in their own history and physical examination skills increased similarly for both groups. CONCLUSIONS: The classic lecture format not only is enjoyed and valued as a learning tool more by our surgical clerkship students than the instructional SP interaction, but having a lecture just before an SP interaction increased perceived enjoyment and value of the SP interaction and enhanced performance on the SP checklist. These data suggest that educators can improve student perceptions and attitudes surrounding the instructional SP interaction by using strategically timed lectures.

Recognizing biothreat diseases: realistic training using standardized patients and patient simulators.

The UofL Center for the Deterrence of Biowarfare and Bioterrorism's (CDBB's) training involving standardized patients, who can make convincingly accurate representations of clinical signs and symptoms, and patient simulators has proven to be an effective means of enhancing bioterrorism preparedness. In addition to providing ready access to formative measures of preparedness, both of these teaching and learning tools also offer the option of summative evaluation of skills and knowledge acquired during training sessions. The use of moulage allows for very realistic representations of cutaneous anthrax and smallpox as well as other conditions such as recluse spider bites and chickenpox with which these biothreat infections can be confused. Exercises and drills expose deficiencies and permit essential reinforcement of skills developed in training. Unannounced exercises are especially useful in assessing public health preparedness.

Educating health professionals to respond to bioterrorism.

In September 2003, a consortium of bioterrorism and health education experts from the University of Louisville, the University of Kentucky, the Kentucky Department for Public Health, and the Louisville Metro Health Department received funding from the Health Resources and Services Administration (HRSA) to develop a broadly based bioterrorism education program for health professionals in the Commonwealth of Kentucky and the surrounding region. This grant will fund a series of presentations tailored to the needs of professionals in medicine, dentistry, public health, nursing, behavioral medicine, allied health, pharmacy, veterinary medicine, and agriculture, providing coordinated training both on site and through distance learning technology. This article outlines the major grant-funded activities envisioned for the grant years 2003 through 2005, focusing on the use of standardized patients and computerized biosimulators, the transdisciplinary partnerships of the universities involved, and the essential collaboration provided by the state and local health departments.

Didactic lecture versus instructional standardized patient interaction in the surgical clerkship.

BACKGROUND: Medical schools increasingly employ the standardized patient interaction (SPI) as a teaching and testing modality to prepare students for USMLE Step 2 Clinical Skills (Step 2 CS). However, little is known about the perceptions medical students have toward SPIs. We hypothesized that the SPI would increase the self-confidence of surgery students in their history and physical examination (H&P) skills as compared with the classic lecture format and that students would perceive the SPI as a valuable learning tool. METHODS: Students (n = 126) on the junior surgery clerkship were randomized into two groups. Group A (n = 61) received a didactic lecture on acute appendicitis. Group B (n = 65) participated in an SPI in which the portrayed patient had acute appendicitis. Student perceptions were surveyed by written questionnaire pre- and postencounter using a 5-point Likert scale, with 5 being the most favorable rating. Data (perceptions, performances on the SPI, clerkship grades) were compared using a Student t test followed by the Mann-Whitney rank sums test. RESULTS: Group A "enjoyed" the lecture format more than group B "enjoyed" the SPI format (3.4 +/- 0.1 versus 2.6 +/- 0.1, P <.001) and perceived the lecture as having more value to their overall education (3.5 +/- 0.1 versus 2.6 +/- 0.1, P <.001) than the SPI group. Surprisingly, student self-confidence in their H&P skills increased after the didactic lecture (from 3.6 +/- 0.1 to 4.1 +/- 0.1, P = .001) but not after the SPI (from 3.6 +/- 0.1 to 3.8 +/- 0.1, P = not significant). CONCLUSIONS: The didactic lecture format was not only enjoyed and valued more than the SPI, but our surgery students also perceived it as superior to the SPI in building confidence in history and physical examination skills. These findings suggest that surgical educators should develop ways to improve students' perceptions and attitudes surrounding the surgical SPI.

Development and Evaluation of a Nutrition and Physical Activity Counseling Module for First-Year Medical Students.

INTRODUCTION: Few Americans follow recommendations regarding nutrition or physical activity, and few physicians provide nutritional counseling (NC) or physical activity counseling (PAC) to patients. Clinical, systems-based, and institutional barriers to teaching and providing NC and PAC exist, but theoretical models of behavior change and principles of adult learning theory (ALT) can enable medical educators to overcome these barriers. METHODS: We developed an educational intervention consisting of interactive lectures and two standardized patient experiences to provide first-year medical students with practical experience in PAC and NC. Students completed pre and post educational assessments of attitudes, knowledge, and self-efficacy with the counseling techniques. RESULTS: Knowledge scores increased from 6.1 to 8.5 (p<.001) on a 13-item test. Self-confidence scores for NC increased from 45 to 78 (p<.001), and self-confidence scores for PAC increased from 51 to 82 (p<.001). While overall attitudes regarding the necessity and utility of counseling with specific disease states were not different pre/ post test (necessity pre/post 6.3 to 6.2 p= .71; utility pre/post 5.8 to 5.7 p=.88), necessity and utility scores for disease states treated primarily with counseling were different compared to disease states students perceive to be primarily pharmacologically treated (counseling vs. pharmacological necessity 5.9 vs. 6.6 p<.001; utility 5.4 vs. 6.1 p<.001). CONCLUSION: An educational intervention based on theoretical models of behavior change and ALT can increase knowledge and self confidence scores regarding counseling for NC and PAC.