Standard Patient Evaluation Research Articles

Investigating Risk Factors for Meibomian Gland Dysfunction and Loss Among Young Medical Trainees.

To determine risk factors for meibomian gland disease and associated structural abnormalities in meibography among young medical trainees. This study included 84 medical students and residents younger than 45 years. All participants completed an ocular history and lifestyle questionnaire and the standardized patient evaluation of eye dryness (SPEED) II questionnaire. Meibomian gland (MG) dropout and structural changes were evaluated using meibography and scored by 2 graders using meiboscores. Statistical analysis aimed to identify MG loss risk factors. Eighty-four individuals participated, and 168 meibography images were reviewed. Previous contact lens (CL) use (n = 88) demonstrated increased MG loss (P = 0.007). Correlation analysis revealed positive associations between MG loss and both frequency (Spearman r = 0.212, P = 0.003) and duration (Spearman r = 0.271, P <0.001) of CL use. Eye makeup users (n = 112) showed greater MG loss than nonusers (n = 56, P = 0.030), particularly eyeliner (n = 102) and eyeshadow (n = 100) users showing increased meiboscores (P = 0.020 and P = 0.040, respectively). Self-reported screen time and SPEED II scores did not correlate with meiboscores (P >0.05). In a young trainee population, where age-related factors are reduced, previous CL use and eye makeup use are significant risk factors for MG loss. Frequency and length of CL wear affect MG dropout severity. Eye makeup usage also affected MG loss. Highlighting the incongruence of symptoms to signs, SPEED II scores showed no relationship with MG structural integrity.

Insular Infraorbital Neurovascular Pedicle Labial Salivary Gland Transplantation for Severe Dry Eye: Anatomy Study and Case Report.

Severe dry eyes often require surgical intervention. Submandibular salivary and minor salivary gland transplantation are options for refractory dry eyes but have limitations. We innovatively designed an insular infraorbital neurovascular pedicle labial salivary gland transplantation (IINPLSGT) and validated its feasibility and safety through anatomical studies. An anatomical study was conducted on 13 red-colored latex arterial-perfused cadavers (24 sides). Two specimens (4 sides) simulated IINPLSGT. We recorded the branching patterns and courses of the infraorbital artery, infraorbital nerve, and angular artery, as well as the distribution of nerves, vessels, and salivary glands in the upper lip. Infraorbital artery and angular artery were anatomically classified. The feasibility of the IINPLSGT was validated. Otolaryngologists and ophthalmologists performed IINPLSGT, transferring the labial mucosal flap to the lower eyelid conjunctival fornix to treat severe dry eye in 1 patient. Infraorbital artery exhibited 5 potential branches, classified into 5 types based on developmental patterns. Angular artery was classified into 3 types based on the courses. Patient symptoms significantly improved postoperatively, with Schirmer I increasing from 0 mm to 6 mm, noninvasive breakup time from 0 seconds to 6 seconds, and SPEED (Standard Patient Evaluation of Eye Dryness questionnaire) score decreasing from 10.5 to 3 in the OD 1 year after surgery. No severe complications were observed. IINPLSGT is a safe and feasible method for treating severe dry eyes. The procedure is simple, with a high postoperative gland survival rate, stable secretion, and minimal complications.

Efficacy and Safety of Useul for Dry Eye Disease: Protocol for a Randomized, Double-Blind, Placebo-Controlled, Parallel, Phase 2 Clinical Trial

Introduction: Dry eye disease (DED) is a very frequently encountered ocular disease, making it a growing public health burden. However, current treatments for DED present unmet medical needs owing to their side effects or ineffectiveness. Therefore, an effective and safe therapeutic agent to manage DED is needed. Method and Analysis: We planned a phase 2, dose-finding, double-blind, randomized placebo-controlled trial to evaluate the efficacy and safety of two different doses of USL (Useul), the extract of Achyranthis Radix, compared with placebo, for DED. USL has been found to protect against DED by inducing tear secretion and improving corneal irregularity via anti-inflammatory effects, which will provide new therapeutic options. One hundred and twenty participants will be enrolled, after assessing the inclusion/exclusion criteria, at Daejeon University Daejeon Korean Medicine Hospital. Enrolled participants will be allocated to standard-dose USL, high-dose USL, or placebo groups in a 1:1:1 ratio and will be required to administer the trial medication twice a day for 12 weeks and visit the clinic five times. For efficacy outcomes, objective endpoints of fluorescein corneal staining score, tear break-up time, Schirmer’s test, and meibomian test and subjective endpoints of Ocular Surface Disease Index, visual analog scale, Standard Patient Evaluation for Eye Dryness-II, and biomarkers will be assessed throughout the trial. Safety will be assessed based on adverse events, vital signs, laboratory tests, visual acuity, and intraocular pressure. Discussion: Our study results are expected to provide clinical evidence for the use of DED as an effective and safe agent for DED.

Efficacy of indirect intense pulsed light irradiation on meibomian gland dysfunction: a randomized controlled study.

To investigate the efficacy and mechanisms of indirect intense pulsed light (IPL) irradiation on meibomian gland dysfunction (MGD). A total of 60 MGD patients was included in this prospective randomized controlled trial. Patients were randomly assigned 1:1 into two groups (3-mm group and 10-mm group) in which IPL was applied at distances from the lower eyelid margin of 3 and 10 mm, respectively. Both groups received three times treatment with 3-week interval. Meibomian gland yield secretion score (MGYSS), standard patient evaluation of eye dryness (SPEED) questionnaire, tear break-up time (TBUT), corneal fluorescein staining (CFS), and in vivo confocal microscopy were performed at baseline and after every treatment. After three IPL treatments, both groups had significant improvement in MGYSS (both P<0.05). The non-inferiority test showed that improvement in 10-mm group was not inferior to that in 3-mm group (P<0.001). In both groups, temporal regions of both upper and lower eyelids showed significant improvement in MGYSS. Scores of SPEED questionnaire in both groups declined significantly (both P<0.001) and changes of SPEED had no difference between two groups (P=0.57). Density of central corneal subepithelial nerves and TBUTs showed no statistically significant changes. The 3-mm group had improvement on corneal fluorescein staining (P=0.048) and meibomian gland morphology (acini wall thickness P=0.003, hyperreflective points P=0.024) while the 10-mm group had not. The efficacy of IPL indirect irradiation in improving meibomian gland secretion and alleviating dry eye symptoms remains unchanged with increase in treatment distance. IPL may primarily act on the functional improvement of the meibomian glands and corneal nerves.

Standardized Patient Communication and Low-Value Spinal Imaging

Acute back pain is a common reason for primary care visits and often results in low-value spinal imaging. To evaluate the effect of a standardized patient-delivered intervention on rates of low-value spinal imaging among primary care patients with acute low back pain. In this randomized clinical trial, physicians or advanced practice clinicians were recruited from March 22 to August 5, 2021, from 10 adult primary care or urgent care clinics in Sacramento, California. The intervention period was from May 1, 2021, to March 30, 2022, with follow-up from October 28, 2021, to June 30, 2023. Analyses were performed from April 1 to June 25, 2024. Clinicians were randomized 1:1 to intervention or control. Intervention clinicians received 3 simulated office visits, each with a standardized patient instructor (SPI) portraying a patient with acute uncomplicated back pain. At each visit, SPIs provided clinician feedback guided by a 3-step model: (1) set the stage for deferred imaging by building trust, (2) convey empathy, and (3) communicate optimism while advocating watchful waiting without imaging. Control clinicians received no intervention. The primary outcome was lumbar spinal imaging completion within 90 days of acute low back pain visits, with study clinicians assessed up to 18 months of follow-up. Secondary outcomes were cervical spine imaging completion after acute neck pain visits, any imaging completion after an adult visit, patient experience ratings of clinicians (scale range, 0-100), and use of targeted communication skills during an audio-recorded standardized patient evaluation visit at median follow-up of 16.8 months (range, 14.1-18.0 months). The analysis included 53 clinicians; mean (SD) age was 46.7 (1.0) years, and 35 (66.0%) reported female gender. A total of 25 were in the intervention group and 28 in the control group. After adjustment for prerandomization rates, patients with acute low back pain who saw intervention and control clinicians during follow-up had similar rates of lumbar imaging (194 of 1234 clinic visits [15.7%] vs 226 of 1306 clinic visits [17.3%]; adjusted ratio of postintervention vs preintervention odds ratios [AORR], 1.00; 95% CI, 0.72-1.40). Adjusted follow-up rates of imaging for acute neck pain (AORR, 1.16; 95% CI, 0.83-1.63) and overall imaging (AORR, 1.07; 95% CI, 0.97-1.19) were not significantly different among patients of intervention and control clinicians. Intervention and control clinicians had similar mean (SD) patient experience ratings during follow-up (88.6 [28.7] vs 88.8 [28.3]; adjusted mean difference-in-differences, -1.0; 95% CI, -3.0 to 0.9). During audio-recorded standardized patient visits, intervention clinicians had significantly better ratings than controls on eliciting the patient's perspective (adjusted standardized difference [ASD], 0.62; 95% CI, 0.05-1.19) and conveying empathy (ASD, 1.16; 95% CI, 0.55-1.77). In this randomized clinical trial of an educational intervention using simulated office visits to encourage a watchful waiting approach for acute low back pain, the intervention had no significant effect on low-value spinal imaging rates or patient experience ratings. ClinicalTrials.gov Identifier: NCT04255199.

Echocardiographic evaluation of ventricular performance in VA-ECMO weaning: results from a observational monocentric prospective study

Abstract Background Although temporary mechanical circulatory support (MCS) devices are increasingly used in the management of cardiogenic shock (CS), several open question regarding the kind of support and timing of institution/weaning remains open. Echocardiography is widely applied to drive the weaning process and decision although there are no standardized protocols for the trial nor accordance on the parameters to apply. Purpose We sought to evaluate the overall accuracy of echocardiographic indices in predicting successful weaning from VA ECMO in patients with CS. Specifically, we tested total isovolumic time (tIVT), an index of ventricular performance, and longitudinal function (MAPSE) on top of the commonly used parameters (left ventricular ejection fraction, LVEF; left ventricular velocity time integral, LV VTI; TAPSE; right ventricular S’ at tissue Doppler imaging, RV S’). Methods Monocentric prospective study on adults receiving VA-ECMO due to refractory CS and/or cardiac arrest (CA) from 2012 to 2020. Echocardiography was performed at VA-ECMO placement and during the weaning trials. Weaning trials were performed daily, starting 48 hours after VA-ECMO institution, when patients were hemodynamically stable: mean arterial pressure &amp;gt;65 mmHg, no or minimum adrenergic support (vasoactive inotropic score &amp;lt;10), heart rate &amp;lt;110 bpm, lactate &amp;lt;2 mmol/L, and no signs of respiratory distress. Weaning trials were performed with a stepwise decrease of VA-ECMO blood flow until reaching 1 or 1.5 L/min under adequate anticoagulation. Successful weaning was defined as removal of VA-ECMO with no requirement for further MCS in the following 30 days. Results 76 patients were enrolled (23.8% female, 54.2±10.6 years-old), 52.6% due to CA. Median duration of VA-ECMO was 58 hours; 47 (61.8%) had intra-aortic balloon pump (IABP) inserted upfront. In-hospital mortality was 62.4% overall, 40% for CS without CA. 6 of the 32 weaned patients died for multiorgan failure due to septic shock. The baseline echocardiographic parameters associated with successful weaning were (table): stroke volume &amp;gt;13.9 mL (p 0.002), tIVT &amp;gt;23.6 min/sec (p 0.053), LV VTI &amp;gt;6.6 cm (p&amp;lt;0.001), MAPSE &amp;gt;6.15 mm (p 0.001), TAPSE &amp;gt;11 mm (p 0.023), RV S’ &amp;gt;10 cm/s (p 0.012). LVEF did not reach the statistical significance. Figure shows Kaplan-Meier analysis on echocardiographic indices collected at time of cannulation (panel A) and during the last weaning trial (panel B). Conclusions Echocardiography is pivotal in defining cardiac recovery and monitoring the weaning trial. Indices reflecting ventricular performance and delivered flow from LV were associated with weaning success both at VA-ECMO institution and throughout the weaning trials. Considering the known limitations of LVEF (heart rate, loading and left ventricular dyssynchrony dependence), tIVT and MAPSE should be introduced in the standard evaluation of patients in the acute setting.TableFigure

Tolerability of Diquas LX on tear film and meibomian glands findings in a real clinical scenario.

Long-acting diquafosol ophthalmic solution (DQS-LX) has significant advantages regarding patient adherence owing to the reduced frequency of required eye drops; however, some patients prefer conventional diquafosol ophthalmic solution (DQS) over DQS-LX. Herein, to clarify the characteristics of patients according to their preference for ophthalmic solutions, dry eye (DE) and meibomian gland (MG) findings were retrospectively investigated. This study enrolled 341 patients with DE (mean age, 62.1 ± 11.7 years) treated at the Itoh Clinic between November 8, 2022, and July 31, 2023, who switched from DQS to DQS-LX. Patients were divided into two groups: those who continued DQS-LX administration (DQS-LX group) and those who wished to revert to conventional DQS (DQS group). Data regarding subjective symptoms assessed using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, tear film breakup time (BUT), tear meniscus height (TMH), corneal and conjunctival fluorescein staining (CFS), conjunctival hyperemia/papilla, meiboscore, plugging, vascularity, meibum grade, and Schirmer's score at the time of DQS-LX switch were evaluated. Of the 341 patients, 31 (9.1%) wished to revert to conventional DQS. In total, 16 eyes of 16 patients in the DQS group and 32 eyes of 32 patients in the DQS-LX group-for whom complete data were available-were included in the analysis. The DQS-LX group had higher SPEED scores, lower TMHs (P < 0.001, respectively), shorter FBUTs, greater CFS findings, larger meibum grades, lower Schirmer scores, and more pluggings compared with the DQS group (P = 0.005, 0.001, 0.001, 0.046, 0.003, respectively). Meiboscores and vascularity did not differ significantly between the two groups (P = 0.73 and 0.39, respectively). In conclusion, patients with low tear film volume and DE complicated by moderate or severe meibomian gland dysfunction (MGD) preferred DQS-LX, while those with allergic findings preferred conventional DQS.

Psychometric properties and diagnostic performance of three dry eye questionnaires in Italian: OSDI, OSDI-6, and SPEED.

Psychometric questionnaires are highly valuable instruments in clinical practice as they make subjective symptoms easier to measure. Recently, a short version of the Ocular Surface Disease Index (OSDI) questionnaire was developed, named OSDI-6. This study aimed to assess the psychometric properties and compare the diagnostic criteria of three questionnaires, available in the Italian language, designed for assessing dry eye disease: Standard Patient Evaluation of Eye Dryness (SPEED), OSDI-12, and specifically the new shortened version, OSDI-6. Psychometric evaluations were conducted on 250 adult participants aged 20 to 83 years. Classic and Rasch psychometric analyses were performed on the three questionnaires. The repeatability of the questionnaires was assessed by retesting 120 participants. The exploratory factor analysis of OSDI-6 indicated saturation on two factors. Repeatability was optimal for all three questionnaires. Based on the reference OSDI-12, the cutoff for OSDI-6 was 5 points and 7 for SPEED. Rasch analysis showed that OSDI-6 and OSDI-12 present disordered response categories and thresholds. Conversely, the SPEED questionnaire shows the optimal item characteristic curve. The OSDI-12 is a reference questionnaire used in dry eye disease studies and clinics, but OSDI-6 does not represent a perfect shortened version, primarily for the absence of one factor measured and secondarily for the same problem of category response order and thresholds. Conversely, SPEED focusing only on symptoms showed better psychometric properties.

Patient screening and assessment for home dialysis therapies: A scoping review.

Home dialysis therapies have limited uptake in most regions despite recognized benefits such as increasing patients' independence, and several domains of quality of life with cost savings in some systems. To perform a scoping review of published literature to identify tools and guides used in systematically screening and assessing patient suitability for home dialysis. A secondary objective was to explore barriers and enablers associated with the home dialysis assessment process. It is important to identify gaps in current research to pose pertinent questions for future work in the field. Online databases Embase, Medline (Ovid), and CINAHL were used to identify articles published between January 2007 to May 2023. A total of 23 peer-reviewed primary and secondary studies that investigated screening or selection for patients > 18 years old with kidney failure for home dialysis met the study inclusion criteria. The studies consisted of secondary studies (n = 10), observational studies (n = 8), and survey-based studies (n = 5). The major themes identified that influence patient screening and assessment for home dialysis candidacy included: screening tools and guidelines (n = 8), relative contraindications (n = 4), patient or program education (n = 9), and socioeconomic factors (n = 2). Consistent with the scoping review methodology, the methodological quality of included studies was not assessed. The possible omission of evidence in languages other than English is a limitation. This scoping review identified tools and factors that potentially guide the assessment process for home dialysis candidacy. Patient screening and assessment for home dialysis requires a comprehensive evaluation of clinical, psychosocial, and logistical factors. Further research is required to validate and refine existing tools to establish standardized patient screening criteria and evaluation processes. Up-to-date training and education for healthcare providers and patients are needed to improve the utilization of home dialysis and ensure optimal outcomes.

Silicone hydrogel versus hydrogel soft contact lenses for differences in patient-reported eye comfort and safety: A Cochrane systematic review summary.

This work is significant because it is the first Cochrane systemic review that compares the comfort and safety of hydrogel and silicone hydrogel soft contact lenses (SCL). This study aimed to conduct a systemic review of randomized trials comparing the comfort and safety of silicone hydrogel and hydrogel SCLs. CENTRAL, MEDLINE Ovid, EMBASE.com , PubMed, LILACS, ClinicalTrials.gov , and World Health Organization International Clinical Trials Registry Platform were searched on or before June 24, 2022, to identify randomized clinical trials that compared silicone hydrogel and hydrogel SCLs. Seven trials were identified and evaluated. One trial reported Ocular Surface Disease Index results, with the evidence being very uncertain about the effects of SCL material on Ocular Surface Disease Index scores (mean difference, -1.20; 95% confidence interval, -10.49 to 8.09). Three trials reported visual analog scale comfort score results, with no clear difference in comfort between materials, although results were of low certainty; trial results could not be combined because the three trials reported results at different time points. None of the included trials reported Contact Lens Dry Eye Questionnaire 8 or Standard Patient Evaluation of Eye Dryness scores. There was no evidence of a clinically meaningful difference (>0.5 unit) between daily disposable silicone hydrogel and hydrogel SCLs in corneal staining, conjunctival staining, or conjunctival redness (very low certainty evidence). The overall evidence for a difference between all included silicone hydrogel and hydrogel SCL trials was of very low certainty, with most trials judged as having a high overall risk of bias. There was insufficient evidence to support recommending one SCL material over the other. Future well-designed trials are needed to generate high certainty evidence to further clarify differences in SCL material comfort and safety.

Efficacy assessment of liposome crosslinked hyaluronic acid and standard hyaluronic acid eye drops for dry eye disease management: a comparative study employing the ocular surface analyzer and subjective questionnaires.

Dry eye disease (DED) is a prevalent condition causing ocular discomfort and visual disturbances, often managed with artificial tears. This study aimed to assess and compare the efficacy of eye drops containing Crosslinked Hyaluronic Acid (CHA) with liposomes and crocin and standard Hyaluronic Acid (HA) for DED management. A single-blind, longitudinal study was conducted on 24 participants (48 eyes), randomized to receive one of the two treatments. Ocular health measures, including the ocular surface disease index (OSDI) and the standard patient evaluation of eye dryness (SPEED) scores, were assessed at baseline and 6 weeks post-treatment using the Ocular Surface Analyzer. CHA achieved a lipid layer thickness increase of 1.29 ± 1.08 Guillon pattern degree (p < 0.01), FNIBUT increase 0.64 ± 0.77 s (p < 0.01), MNIBUT increase1.28 ± 4.74 s (p = 0.19), OSDI decrease 11.72 ± 6.73 score points (p < 0.01) and SPEED decrease 1.16 ± 5.05 score points (p = 0.27). Significant reductions in the OSDI and SPEED scores post-treatment were observed with both treatments, indicating their effectiveness. CHA with liposomes exhibits superior efficacy compared to standard HA eye drops in the management of DED. These findings highlight the potential for personalized treatment strategies incorporating CHA, indicating a more effective approach to DED management. However, further research is required to validate these results and investigate the long-term effects, which may pave the way for a data-driven and optimized approach to managing DED.

Prevalence and Correlates of Dry Eye in a German Population Sample.

In this cross-sectional survey, we assessed the prevalence of dry eye disease (DED) in a representative German population sample. In addition, we examined the associations between DED, health-related quality of life (HRQoL), and level of fatigue. Finally, we further validated the German version of the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire and present norm data of the German population. A random sample of German residents aged 16 years and older was recruited between October and December 2021. All participants completed the SPEED, Short Form 36, and Multidimensional Fatigue Inventory 20 questionnaires. Of the 2495 participants who completed the survey, 450 (21.6%; 95% confidence intervals 20.0-23.1) reported a SPEED total score of ≥4, indicating a positive screening for DED. DED was significantly more common in women and older age. Participants who screened positive for DED reported significantly higher levels of fatigue and lower values in all domains of HRQoL. A receiver operating characteristic curve of the SPEED was generated using an ophthalmologist's diagnosis. The area under the curve was estimated to be 0.886 (95% confidence intervals 0.858-0.913). A cutoff score ≥4 seemed to be appropriate as an indicator of DED. Cronbach's α was excellent (0.95). DED is common in the German population. We confirmed associations with sex, age, HRQoL, and fatigue level, indicating a high burden of DED. The German version of the SPEED is a valid instrument for the assessment of DED symptoms.

Analysis of Factors Associated with Anterior Location of Marx’s Line

Purpose The study aimed to investigate the factors associated with anterior location of Marx’s line in ocular surface and living habits, especially in tear film. Materials and methods This cross-sectional study enlisted 483 participants with meibomian gland dysfunction, who were divided into two groups: 160 participants with mild anterior location of Marx’s line and 323 participants with moderate-to-severe anterior location. Participants completed a survey of demographic characteristics (sex, age, length of visual terminal use, sleep duration, skin property), and the Ocular Surface Disease Index and Standard Patient Evaluation of Eye Dryness questionnaires. They also underwent slit-lamp examinations of the lids, and measurements of non-invasive tear break up time, tear meniscus height, fluorescein tear break up time, lipid layer thickness, partial blink rate, lid wiper epitheliopathy, and meibomian gland dropout. Results The tear meniscus height (mild:0.21(0.18–0.25), moderate-to-severe:0.19(0.16–0.23), p = 0.004), fluorescein tear break up time(mild:3(2–4),moderate to severe:2(1–3), p = 0.000), max LLT(mild:87(62–100), moderate-to-severe:99(69–100), p = 0.04), average LLT(mild:64.5(47.5–96.75), moderate-to-severe:74(53–100), p = 0.012), min LLT(mild:52(38–75), moderate-to-severe:59(41–85), p = 0.029) differed significantly between mild and moderate-to-severe anterior location of Marx’s line, and associated to the anterior location of Marx’s line(r=-0.134, p = 0.03; r=-0.194, p = 0.000; r = 0.093, p = 0.041; r = 0.119, p = 0.009; r = 0.105, p = 0.022) However, no statistical significance was observed in the OSDI, SPEED, partial blink rate, non-invasive tear breakup time, lipid layer thickness, meibomian gland dropout and lid wiper epitheliopathy(p > 0.05). Meanwhile, in the demographic characteristics, statistically significant correlations were associated with skin property(r = 0.154, p = 0.001) and sleep duration(r=-0.124, p = 0.006), but not with age, sex, and the length of visual terminal use (p > 0.05). Conclusions Lower TMH and shorter TBUT positively correlated with anterior location of the Marx’s line, and were risk factors. Meanwhile, participants with oily skin and shorter sleep duration were more likely to exhibit anterior location of Marx’s line.

Validity and reliability of the Thai version of the ASCRS SPEED II preoperative OSD questionnaire in Thai cataract surgery candidates.

To develop a Thai version of the American Society of Cataract and Refractive Surgery (ASCRS)-modified Standard Patient Evaluation of Eye Dryness (SPEED) II© preoperative ocular surface disease (OSD) questionnaire (ASCRS SPEED II-Thai) and evaluate its validity and reliability in Thai cataract surgery candidates. The original English version of the questionnaire was translated and adapted cross-culturally to Thai language. The ASCRS SPEED II-Thai was evaluated for content validity, internal consistency, and test-retest reliability. Five experts in the ocular surface field critically reviewed the ASCRS SPEED II-Thai to measure the content validity indexes (CVI). A total of 105 cataract surgery candidates were recruited from an ophthalmology clinic to complete the questionnaire. Cronbach's alpha and intraclass correlation coefficient (ICC) were calculated to assess internal consistency and test-retest reliability, respectively. During the translation and cross-cultural adaptation processes, only two minor modifications were made to the original version for clarification without changing their meaning. All items in the ASCRS SPEED II-Thai had an item-level CVI of 1.00, representing complete agreement among content experts. The scale-level CVI was 1.00, indicating excellent content validity of the questionnaire. The participants found no difficulty in understanding each question in the pilot test. Cronbach's alpha for the ASCRS SPEED II-Thai was 0.82, indicating good internal consistency. The test-retest reliability was good to excellent, with ICC values ranging from 0.83 to 1.00 (P < 0.001). The ASCRS SPEED II-Thai is a valid clinical tool with adequate reliability for preoperative OSD screening among Thai cataract surgery candidates.

A novel multi-ingredient supplement significantly improves ocular symptom severity and tear production in patients with dry eye disease: results from a randomized, placebo-controlled clinical trial.

Dry eye disease (DED) is multifactorial and characterized by a loss of tear film homeostasis that causes a cycle of tear film instability, tear hyperosmolarity, and inflammation. While artificial tears are the traditional mainstay of treatment, addressing the underlying pathophysiology could relieve symptoms and prevent progression. Increasing evidence indicates a role for oral nutritional supplementation in multiple ophthalmic diseases, including DED. Lutein, zeaxanthin, curcumin, and vitamin D3 have demonstrated protective and anti-inflammatory properties in ocular models. This prospective, randomized, double-blind, parallel, placebo-controlled study evaluated the efficacy and safety of a proprietary blend of lutein, zeaxanthin isomers, curcumin, and vitamin D3 (LCD) as a daily supplement in adult participants with DED. Participants were randomized to receive one LCD supplement capsule (lutein 20 mg, zeaxanthin isomers 4 mg, curcumin 200 mg curcuminoids, and vitamin D3 600 IU) or placebo per day for 8 weeks (LCD, n=77; placebo, n=78). Primary outcomes were changes in tear volume (Schirmer's test) and ocular symptoms (Ocular Surface Disease Index [OSDI]). The study met its primary endpoints: the LCD group demonstrated significantly better Schirmer's test scores and improvement in overall OSDI score, versus placebo, at Day 56 (p<0.001 for both). Scores for total OSDI, and symptoms and vision domains, significantly improved by Day 14 for LCD versus placebo, (p<0.05 for all) and were maintained to Day 56 (p<0.001). In addition, the LCD group demonstrated significantly improved tear film break-up time (TBUT) and tear film osmolarity, versus placebo, by Day 56 (p<0.001), along with significant improvements in corneal and conjunctival staining (p<0.001 for both), and inflammation (matrix metalloproteinase-9; p<0.001 for each eye). Total Standard Patient Evaluation of Eye Dryness (SPEED) score, and scores for the frequency and severity domains, were significantly improved by Day 14 for LCD versus placebo (p<0.05 for all) and maintained to Day 56 (p<0.001). There was no difference between groups for artificial tear usage. The supplement was well-tolerated. Once-daily LCD supplementation significantly improved tear production, stability and quality, reduced ocular surface damage and inflammation, and improved participants' symptoms. LCD supplementation could offer a useful adjunct to artificial tears for patients with DED (NCT05481450).

Dry Eye Disease Symptoms Among Glaucoma Patients at a Portuguese Hospital.

Glaucoma-related dry eye disease (DED) is often underestimated, but it is an important comorbidity affecting 40% to 59% of glaucoma patients. It may be an exacerbation of a pre-existing condition or a novel disease starting after the initiation of topical medication. The cumulative effect of medication, preservatives and excipients leads to an alteration in tear film composition and ocular surface stability. The main purpose of this investigation was to study a group of Portuguese glaucoma patients regarding the presence of DED symptoms and correlate the severity of the symptoms with the usage of different types of glaucoma topical medications. This is a cross-sectional observational study of patients diagnosed with primary and secondary open-angle glaucoma. The questionnaire Standardized Patient Evaluation of Eye Dryness (SPEED) translated to Portuguese (SPEED-Vp) was taken by patients followed in the Glaucoma Department of Unidade Local de Saúde Entre Douro e Vouga, Santa Maria da Feira, Portugal. Data was collected regarding their age, gender, type of topical medication in use as well as frequency and duration of usage. A statistical analysis was performed. A total of 75 patients answered the SPEED-Vp questionnaire. The mean age was 72 ± 7 years old. Fifty-two percent (n=39) were male, and 48% (n=36) were female patients. About 49.33% (n=37) had been on intraocular pressure (IOP)-lowering eyedrops for more than five years. About 61.43% (n=43) of patients used IOP-lowering eyedrops with preservatives. Most of the patients used prostaglandin analogs (75.71%, n=53) and beta-blockers (72.86%, n=51). SPEED score average was 2.75. About 25.33% (n=19) had no DED symptoms, 58.67% (n=44) had mild symptoms, 8% (n=6) had moderate symptoms and 8% (n=6) had severe symptoms. No statistically significant correlation was found between SPEED score and age, gender, number of eyedrop containers, number of active principles, application frequency, presence of preservatives, number of eyedrop containers with preservatives, duration of eyedrops usage or any of the medication groups. Although a high percentage of patients were on eyedrops with preservatives, this low rate of symptoms might be because patients tended to devalue these symptoms;were already on treatment with artificial tears; or have an underestimation of the sensation of dry eye due to decreased neuronal corneal nerve responses and density. These results were surprisingly positive. This might also be the result of the healthcare provider's sensibilization to this issue (early diagnosis, early prescription of artificial tears and change from preservative to preservative-free medication).

Comparing meibomian gland visibility on optical coherence tomography and Keratograph 5M images using objective and subjective grading methods

PurposeTo investigate if there is a visible difference in meibomian gland (MG) length between images captured with the Visante optical coherence tomography (OCT; wavelength = 1,310 nm) and the OCULUS Keratograph 5M (K5M; wavelength = 880 nm). MethodsAdults between 18 and 40 years were recruited. Baseline dry eye disease was evaluated with the Standard Patient Evaluation of Eye Dryness (SPEED) and tear meniscus height and tear breakup time with the K5M. Right upper and lower eyelid MGs were imaged with the K5M and Visante OCT. Each image was graded with the 0 to 3 meiboscore scale. The central 5 MGs were evaluated with ImageJ for percent gland length visibility. ResultsThirty participants were analyzed with a median (interquartile range [IQR]) age of 23.0 (5.0) years (53.3 % female). Overall, participants were asymptomatic and had normal tear films. Meiboscores based on K5M and Visante OCT was significantly different for the lower eyelid (0[1] vs 1[2]; p = 0.007) but not the upper eyelid (0[1] vs 0[1]; p = 1.00). The mean percent gland visibility of the upper eyelid (82.7[9.6] vs 75.2[13.5]; p < 0.001) and the lower eyelid (81.2[12.7] vs 64.1[17.6]; p < 0.001) were significantly greater on the Visante OCT than the K5M images, respectively. ConclusionOCT images had significantly greater percent visible MG lengths than the K5M images. This suggests viable segments of the MGs may be missed with typical imaging, which may explain how it is possible that studies have found less post-treatment MG atrophy.

Psychometric Properties of Entrustable Professional Activity-Based Objective Structured Clinical Examinations During Transition From Undergraduate to Graduate Medical Education: A Generalizability Study.

The objective structured clinical examination (OSCE) assesses clinical competence in health sciences education. There is little research regarding the reliability and validity of using an OSCE during the transition from undergraduate to graduate medical education. The goal of this study was to measure the reliability of a unique 2-rater entrustable professional activity (EPA)-based OSCE format for transition to internship using generalizability theory for estimating reliability. During the 2018 to 2022 academic years, 5 cohorts of interns (n = 230) at the University of Iowa Hospital and Clinics participated in a 6-station OSCE assessment delivered during orientation. A univariate and multivariate generalizability study (G study) was conducted on the scores generated by the 3 cases in the orientation OSCE that shared the 2-rater format. This analysis was supplemented with an associated decision study (D study). The univariate G study for the cases that used a simulated patient and a faculty rater demonstrated that this OSCE generated a moderately reliable score with 3 cases. The D study showed that increasing the OCSE to 12 cases yielded a mean score reliable enough (G = 0.76) for making high-stakes normative decisions regarding remediation and readiness to practice. The universe score correlation between 2 types of raters was 0.398. The faculty ratings displayed a larger proportion of universe (true) score variance and yielded a more reliable (G = 0.433) score compared with the standardized patient ratings (G = 0.337). This study provides insight into the development of an EPA-based OSCE. The univariate G study demonstrated that when using the 2 rater types, this assessment could generate a moderately reliable score with 3 cases. The multivariate G study showed that the 2 types of raters assessed different aspects of clinical skills and faculty raters were more reliable.

Standardized clinical evaluation of dry anophthalmic socket syndrome in a real-world approach

PurposeTo assess which signs and eye prosthesis care habits are related to subjective discomfort in patients with dry anophthalmic socket syndrome (DASS), using standardized tools from daily practice. Methods62 anophthalmic sockets were compared with their healthy fellow eye using the Standard Patient Evaluation of Eye Dryness (SPEED) score. The correlations between SPEED questionnaire and the prosthesis care, discharge characteristics score, conjunctival inflammation score, meibomian gland dysfunction (MGD) scores and Schirmer I test were studied. ResultThe anophthalmic sockets group achieved a higher SPEED test score (p < 0.01), discharge score (p < 0.01), conjunctival inflammation score (p < 0.01), MGD scores (p < 0.01) and lower Schirmer I test (p < 0.01) compared with their fellow, healthy eye. Patients with a prosthesis replacement of one year or less, those with a current fit time of one year or less and those with a cleaning frequency above one month reported better SPEED, (p < 0.01), conjunctiva inflammation (p < 0.01) and MGD scores (p < 0.01). ConclusionMost anophthalmic patients suffer mild to severe DASS, which seems related to discharge, conjunctival inflammation and MGD. Moreover, certain practices related to the care of the prosthesis such as replacing with a frequency lower than yearly, current fitting time inferior to one year and a removing and cleaning regime above one month, were related to a lower discomfort sensation, conjunctival inflammation and MGD. Clinicians should consider the DASS when facing patients with anophthalmic socket and discomfort symptoms.

Racial Implicit Bias and Communication Among Physicians in a Simulated Environment

Racial implicit bias can contribute to health disparities through its negative influence on physician communication with Black patients. Interventions for physicians to address racial implicit bias in their clinical encounters are limited by a lack of high-fidelity (realistic) simulations to provide opportunities for skill development and practice. To describe the development and initial evaluation of a high-fidelity simulation of conditions under which physicians might be influenced by implicit racial bias. This cross-sectional study, performed on an online platform from March 1 to September 30, 2022, recruited a convenience sample of physician volunteers to pilot an educational simulation. In the simulation exercise, physicians saw a 52-year-old male standardized patient (SP) (presenting as Black or White) seeking urgent care for epigastric pain, nausea, and vomiting. The case included cognitive stressors common to clinical environments, including clinical ambiguity, stress, time constraints, and interruptions. Physicians explained their diagnosis and treatment plan to the SP, wrote an assessment and management plan, completed surveys, and took the Race Implicit Association Test (IAT) and Race Medical Cooperativeness IAT. The SPs, blinded to the purpose of the study, assessed each physician's communication using skills checklists and global rating scales. Association between physicians' IAT scores and SP race with SP ratings of communication skills. In 60 physicians (23 [38.3%] Asian, 4 [6.7%] Black, 23 [38.3%] White, and 10 [16.7%] other, including Latina/o/x, Middle Eastern, and multiracial; 31 [51.7%] female, 27 [45.0%] male, and 2 [3.3%] other), the interaction of physicians' Race IAT score and SP race was significant for overall communication (mean [SD] β = -1.29 [0.41]), all subdomains of communication (mean [SD] β = -1.17 [0.52] to -1.43 [0.59]), and overall global ratings (mean [SD] β = -1.09 [0.39]). Black SPs rated physicians lower on communication skills for a given pro-White Race IAT score than White SPs; White SP ratings increased as physicians' pro-White bias increased. In this cross-sectional study, a high-fidelity simulation calibrated with cognitive stressors common to clinical environments elicited the expected influence of racial implicit bias on physicians' communication skills. The outlined process and preliminary results can inform the development and evaluation of interventions that seek to address racial implicit bias in clinical encounters and improve physician communication with Black patients.