Development of the Contact Lens User Experience: CLUE Scales.

PURPOSE: The field of optometry has become increasingly interested in patient-reported outcomes, reflecting a common trend occurring across the spectrum of healthcare. This article reviews the development of the Contact Lens User Experience: CLUE system designed to assess patient evaluations of contact lenses. CLUE was built using modern psychometric methods such as factor analysis and item response theory. METHODS: The qualitative process through which relevant domains were identified is outlined as well as the process of creating initial item banks. Psychometric analyses were conducted on the initial item banks and refinements were made to the domains and items. Following this data-driven refinement phase, a second round of data was collected to further refine the items and obtain final item response theory item parameters estimates. RESULTS: Extensive qualitative work identified three key areas patients consider important when describing their experience with contact lenses. Based on item content and psychometric dimensionality assessments, the developing CLUE instruments were ultimately focused around four domains: comfort, vision, handling, and packaging. Item response theory parameters were estimated for the CLUE item banks (377 items), and the resulting scales were found to provide precise and reliable assignment of scores detailing users' subjective experiences with contact lenses. CONCLUSIONS: The CLUE family of instruments, as it currently exists, exhibits excellent psychometric properties.

Changes in infant disposable diaper weights at selected intervals post-wetting.

Pediatric acute care nurses questioned the practice of weighing disposable infant diapers immediately after voiding. This study asked the research question, "Does volume of saline, diaper configuration, and/or size of diaper statistically effect changes in diaper weights over time?" The method was an experimental, laboratory model. Pre-set volumes of saline were added to disposable diapers that were then left folded or unfolded. Each diaper was weighed immediately post-wetting and re-weighed at hourly intervals for seven hours. Data were analyzed using a repeated measures analysis of variance (RMANOVA) with balanced data (F-test). Diaper weight changes over time were statistically significant for all time points and for all volumes regardless of diaper size; however, the changes in weight were small and without clinical significance. It is appropriate to weigh diapers at the end of eight hours without risk of altering subsequent fluid management of patients in open-air, non-humidified environments. This practice has led to more efficient use of nurses' time with fewer interruptions for patients and families.

Neuroleptic malignant syndrome in adolescents: four probable cases in the Western Cape.

BACKGROUND: Neuroleptic malignant syndrome (NMS) is a rare side-effect of neuroleptic medication. Most NMS reports have been on adults, and the incidence in children and adolescents is unknown. OBJECTIVE: This report reviews cases of NMS to highlight possible risk factors for the development of NMS in adolescents. METHOD: Four cases of probable NMS in adolescents diagnosed in the Western Cape between February 2009 and March 2010 are presented. RESULTS: Risk factors in the development of the syndrome in adolescents in the Western Cape may be male gender, polypharmacy, the use of zuclopenthixol acetate (clopixol acuphase), a previous history of extra-pyramidal side-effects or NMS, and a history of substance misuse - in particular methamphetamine. CONCLUSION: Caution must be applied in the apparent overuse of intramuscular antipsychotics, and especially zuclopenthixol acetate (clopixol acuphase), in neuroleptic-naïve and agitated psychotic adolescents where the short-term use of benzodiazepines is more appropriate.

Short-term corneal endothelial response to wear of silicone-hydrogel contact lenses in East Asian eyes.

OBJECTIVE: To evaluate corneal endothelial bleb response to wear of silicone-hydrogel contact lenses in eyes of East Asian subjects. METHODS: A total of 24 subjects of East Asian origin, attended 3 separate sessions for a prospective, single-centre, trial. The following contact lenses were used: ACUVUE ADVANCE with HYDRACLEAR (ADVANCE, -3 dioptres), ACUVUE OASYS with HYDRACLEAR Plus (OASYS, -3 dioptres), Focus NIGHT & DAY (NIGHT & DAY, -3 dioptres) and SofLens 38 (+3 dioptres). A modified Balaam's crossover design was used to randomize presentation of sessions and contact lenses within sessions. Session 1 was a comparison between OASYS and SofLens 38 under closed eye conditions, session 2 was a comparison between ADVANCE and NIGHT & DAY under open eye conditions, and session 3 was a comparison between OASYS and NIGHT & DAY worn under closed eye conditions. Corneal endothelial images were captured with the Topcon SP-3000P noncontact Specular Microscope before lens wear, after 20 mins of wear with lenses on and 5 and 10 mins later after lens removal. Blebs were manually identified on these digital images by a masked observer. The area of blebs and total area under consideration were derived using ImageNet software and used to calculate percentage area of blebs. A boundary of equivalence of 1% was used as a clinically significant bleb area difference, and two-sided 95% confidence intervals were utilized to evaluate differences between lenses within each session. RESULTS: In session 1, SofLens 38 produced a mean percentage area of blebs of 8.0% under closed eye conditions, which was significantly different to that produced by OASYS (1.6%). In session 2, both Advance and Night & Day produced a mean percentage bleb area of 0.4% under open eye conditions. In session 3, OASYS and NIGHT & DAY produced statistically similar mean percentage bleb areas of 1.7% and 2.0%, respectively. CONCLUSIONS: The similarity of bleb responses induced by the silicone-hydrogel lenses under the tested wearing conditions is consistent with the proposition that increases in Dk/t above a certain level will produce minimal change in corneal physiologic conditions compared with that when no lens is worn.

Multi-centre evaluation of two daily disposable contact lenses.

PURPOSE: To evaluate the clinical performance of two daily disposable contact lenses: 1-DAY ACUVUE (1DA) (etafilcon A, Johnson & Johnson Vision Care) and FOCUS DAILIES with AquaComfort (FD) (nelfilcon A, CIBA Vision, Inc.), which contains a quickly released moisture enhancing agent, polyvinyl alcohol (PVA). METHODS: This was a 1-week, daily wear, subject-masked, bilateral, parallel group study with subjects randomly assigned to one of two daily disposable soft contact lenses. Subjects were existing soft contact lens wearers in the age range 18-39 years with a spherical refraction between -0.50 and -6.00 D. Subjects were assessed at baseline and after 1 week. Assessments included both subjective (symptoms, wearing time, vision) and objective (lens fit and ocular health) outcomes. RESULTS: Twenty clinical sites enrolled 282 subjects (74% female) of whom 276 (98%) successfully completed the study. Significantly more 1DA wearers reported higher mean comfort scores than with FD (3.95 versus 3.41, respectively, P<0.0001). End-of-day comfort means were also significantly higher with the 1DA group compared to the FD group (3.3 versus 3.0, P=0.03). The 1DA group reported significantly longer mean overall wearing time (1DA was worn on average 0.66+/-0.30 h longer than FD, P=0.03) and longer mean comfortable wearing time (1DA was worn on average 1.73+/-0.35 h longer than FD, P<0.0001). The 1DA lens generally showed significantly better on-eye fitting in terms of movement in primary (P<0.0001) and upgaze (P<0.0001) and ease of removal from the eye (92% versus 63%, P<0.0001) compared to FD. There was significantly less corneal staining observed with the 1DA wearing eyes compared with the FD wearing eyes (23% versus 45%, respectively, P<0.0001). Finally, there was a weak correlation between corneal staining and comfort for FD (r=0.27, P=0.002, n=136), but not for 1DA (r=-0.11, P=0.18, n=140). CONCLUSION: Subjective and objective clinical performance differences between two commonly used daily disposable lenses highlight that, although both lenses may be considered as clinically acceptable, these lenses should not be regarded as interchangeable.