Clinical performance of a new silicone hydrogel contact lens over 6 months of extended wear

Purpose: Silicone hydrogel contact lenses (CLs) are becoming increasingly popular for daily wear (DW), extended wear (EW) and continuous wear (CW), due to their higher oxygen transmissibility compared to hydrogel CLs. The aim of this study was to investigate the clinical and subjective performance of asmofilcon A (Menicon Co., Ltd), a new surface treated silicone hydrogel CL, during 6-night EW over 6 months (M). Methods: A prospective, randomised, single-masked, monadic study was conducted. N=60 experienced DW soft CL wearers were randomly assigned to wear either asmofilcon A (test: Dk=129, water content (WC)=40%, Nanogloss surface treatment) or senofilcon A (control: Dk=103, WC=38%, PVP internal wetting agent, Vistakon, Johnson & Johnson Vision Care) CLs bilaterally for 6 M on an EW basis. A PHMB-preserved solution (Menicon Co., Ltd) was dispensed for CL care. Evaluations were conducted at CL delivery and after 1 week (W), 4 W, 3 M and 6 M of EW. At each visit, a range of objective and subjective clinical performance measures were assessed. Results: N=50 subjects (83%) successfully completed the study, with the majority of discontinuations due to loss to follow-up (n=3) or moving away/travel (n=5). N=2 subjects experienced adverse events; n=1 unilateral red eye with asmofilcon A and n=1 asymptomatic infiltrate with senofilcon A. There were no significant differences in high or low contrast distance visual acuity (HCDVA or LCDVA) between asmofilcon A and senofilcon A; however, LCDVA decreased significantly over time with both CL types (p<0.05). The two CL types did not vary significantly with respect to any of the objective and subjective measures assessed (p>0.05); CL fitting characteristics and CL surface measurements were very similar and mean bulbar and limbal redness measures were always less than grade 1.0. Superior palpebral conjunctival injection showed a statistically, but not clinically, significant increase over time with both CL types (p<0.05). Corneal staining did not vary significantly between asmofilcon A and senofilcon A (p>0.05), with low median gradings of less than 0.5 observed for all areas assessed. There were no solution-related staining reactions observed with either CL type. The asmofilcon A and senofilcon A CLs were both rated highly with respect to overall comfort, with medians of 14 or 15 hours of comfortable lens wearing time per day reported at each of the study visits (p>0.05). Conclusions: Over 6 months of EW, the asmofilcon A and senofilcon A CLs performed in a similar manner with respect to visual acuity, ocular health and CL performance measures. Some changes over time were observed with both CL types, including reduced LCDVA and increased superior palpebral injection, which warrant further investigation in longer-term EW studies. Asmofilcon A appeared to be equivalent in performance to senofilcon A.

The mini clinical evaluation exercise (mini-CEX) for assessing clinical performance of international medical graduates

Objective: To evaluate the feasibility, reliability and acceptability of the mini clinical evaluation exercise (mini-CEX) for performance assessment among international medical graduates (IMGs). Design, setting and participants: Observational study of 209 patient encounters involving 28 IMGs and 35 examiners at three metropolitan teaching hospitals in New South Wales, Victoria and Queensland, September-December 2006. Main outcome measures: The reliability of the mini-CEX was estimated using generatisability (G) analysis, and its acceptability was evaluated by a written survey of the examiners and IMGs. Results: The G coefficient for eight encounters was 0.88, suggesting that the reliability of the mini-CEX was 0.90 for 10 encounters. Almost half of the IMGs (7/16) and most examiners (14/18) were satisfied with the mini-CEX as a learning tool. Most of the IMGs and examiners enjoyed the immediate feedback, which is a strong component of the tool. Conclusion: The mini-CEX is a reliable tool for performance assessment of IMGs, and is acceptable to and well received by both learners and supervisors.

The use of scoring rubrics to determine clinical performance in the operating suite

Summary : This research evolved out of the need to examine the validity and inter-rater reliability of a set of performance-based scoring rubrics designed to measure competencies within the operating suite.

Method : Both holistic and analytical rubrics were developed aligned to the ACORN Standard [Australian College of Operating Room Nurses Standard NR4, 2004. ACORN Competency Standards for Perioperative Nurses: Standard NR4: The Instrument Nurse in the Perioperative Environment. Australian College of Operating Room Nurses Ltd, Adelaide] and underpinned by the Dreyfus model (1981). Three video clips that captured varying performance of nurses performing as instrument nurses in the operating suite were recorded and used as prompts by expert raters, who judged the performance using the rubrics.

Results : The study found that the holistic rubrics led to more consistent judgments than the analytical rubrics, yet the latter provided more diagnostic information for intervention purposes. Despite less consistency, the Analytical Observation Form had sufficient construct validity to satisfy the requirements of criterion referencing as determined by the Item Separation Index (Rasch, 1960), including high internal consistency and greater inter-rater reliability when average ratings were used.

Conclusion : The study was an empirical investigation of the use of concomitant Analytical and Holistic Rubrics to determine various levels of performance in the operating suite including inter-rater reliability. The methodology chosen was theoretically sound and sufficiently flexible to be used to develop other competencies within the operating suite.

Clinical performance of an innovative back surface multifocal contact lens in correcting presbyopia

Purpose: This prospective study was designed to subjectively and objectively evaluate the performance of an aspheric multifocal back surface rigid gas permeable (RGP) contact lens. The multifocal element of this lens design consisted of an aspheric optical zone that varied according to the patient's ametropia, corneal topography, and required reading addition.

Methods: We fit 28 presbyopic subjects with an aspheric multifocal back surface RGP contact lens (age range: 45 to 68 years). Reading additions ranged from +0.75 D to +2.50 D. Subjects were assessed initially and at 2, 6, and 12 weeks for ocular changes, visual performance, and subjective responses.

Results: We required 116 RGP lenses to achieve an acceptable fit and visual acuity in 28 subjects (55 eyes). At the final visit, the distance logMAR acuity with the multifocal contact lens (+0.12 +/-0.10) was not statistically different (t=-0.623, P= 0.5388) from spectacle acuity at the initial visit (+0.10 +/-0.12). The near logMAR acuity with the multifocal contact lens at the final visit (0.36 +/- 0.12) was not statistically different from that for near acuity with spectacles at the initial visit (0.33 +/- 0.13). No slit lamp signs worsened during the study. A reduction in myopia of 0.67 D was noted by the final visit. Spectacle blur was noted if the acuity at the initial refraction was compared to the acuity with the same refraction at the final visit (t= -3.287, P= 0.0028) but not when the refractive changes were incorporated (t= 1.058, P= 0.3127). All subjects rated the performance of the lenses very highly: comfort, 86%; distance acuity, 83%; near acuity, 73%; and stability of vision, 74%. Twenty-four subjects (86%) chose the multifocal contact lens as their preference.

Conclusion: We demonstrated that a multifocal design is able to provide acceptable distance and near correction for presbyopic patients. The aspheric geometry required can be optimized for a given patient by considering his/her degree of ametropia, as well as the corneal topography.

Assessing individual clinical performance: a primer for physicians

The assessment of individual physician performance has attracted interest from several quarters, including statutory licensing agencies and credentialing bodies of healthcare institutions. Performance measures and assessment methods have been developed, although their validity, reliability and feasibility in regards to physician specialty practice are open to challenge. Despite this, professional colleges and societies will be increasingly obliged to ensure their members are demonstrating high-quality performance on the basis of assessment methods viewed as being transparent, impartial and reproducible. This article provides an overview of the current state of the art which hopefully will serve to inform future debate both within and outside professional circles.