Clinical outcome measures in vision and eye care.

Traditionally, clinical outcome assessments have focused on the patient's perspective through patient-reported outcome assessments; however, given the complexity, integration, and interactions of various participants within the clinical ophthalmology setting, we propose that additional diverse clinical perspectives should be explored in order to appreciate fully the value of care provided to patients. In this review we introduce a framework by which clinical outcome assessments (COAs) can be organized. Our COA framework is composed of five outcome measurements that encompass the perspectives of each player in a patient's care: clinical data-reported outcomes, patient-reported outcomes, clinician-reported outcomes, observer-reported outcomes, and reviewer-reported outcomes. By establishing a standard for evaluating patient care, we hope to address gaps in expectations of patient care and encourage more thoughtful patient-clinician relationships.

Public engagement with genomics.

As detailed in its flagship report, Genome UK, the UK government recognises the vital role that broad public engagement across whole populations plays in the field of genomics. However, there is limited evidence about how to do this at scale. Most public audiences do not feel actively connected to science, are oftenunsure of the relevance to their lives and rarely talk to their family and friends about; we term this dis-connection a 'disengaged public audience'. We use a narrative review to explore: (i) UK attitudes towards genetics and genomics and what may influence reluctance to engage with these topics; (ii) innovative public engagement approaches that have been used to bring diverse public audiences into conversations about the technology. Whilst we have found some novel engagement methods that have used participatory arts, film, social media and deliberative methods, there is no clear agreement on best practice. We did not find a consistently used, evidence-based strategy for delivering public engagement about genomics across diverse and broad populations, nor a specific method that is known to encourage engagement from groups that have historically felt (in terms of perception) and been (in reality) excluded from genomic research. We argue there is a need for well-defined, tailor-made engagement strategies that clearly articulate the audience, the purpose and the proposed impact of the engagement intervention. This needs to be coupled with robust evaluation frameworks to build the evidence-base for population-level engagement strategies.

Prediction of MIGS outcomes on second eyes using first eyes' response.

To evaluate how well outcomes following cataract extraction and microinvasive glaucoma surgery in one eye predict outcomes in sequential second eye. Retrospective study of 78 patients who underwent cataract extraction and microinvasive glaucoma surgery in both eyes. Linear regressions using Pearson correlation coefficients were used to evaluate correlations in intraocular pressure and glaucoma medication change between eyes. Multivariable logistic regression models were used to evaluate the associations between first-eye variables and the likelihood of second-eye surgical success at 6 months. Surgical success was defined as meeting target intraocular pressure without additional medications compared to baseline or secondary surgical interventions. Baseline ocular characteristics were comparable between fellow eyes, with the majority having mild glaucoma. Intraocular pressure changes between fellow eyes at 6 months were modestly correlated between eyes (R = 0.48; P < .001). Changes in glaucoma medications were strongly correlated between eyes at all time points, and month 6 demonstrated the most significant correlation (R = 0.80; P < .001). First and second eye cohorts achieved 82% and 83% surgical success. Multivariate analysis for predictive factors of successful second eye surgery showed patients with successful first eye surgery at 6 months were significantly more likely to have successful second eye surgery (odds ratio, 20.67; P < .001). Reductions in intraocular pressure and glaucoma medications at 6 months following surgery in first eyes are correlated to second eye reductions. Successful surgical outcomes at 6 months following first eye surgeries are strongly associated with successful sequential second eye outcomes.

Short-Term Outcomes of Hydrus Microstent With and Without Additional Canaloplasty During Cataract Surgery.

PRCIS: Compared with phacoemulsification and microstent alone, we observed that phacoemulsification with combined microstent and canaloplasty resulted in a significantly greater reduction in glaucoma medications while maintaining similar rates of intraocular pressure reduction and low complications. PURPOSE: The purpose of this study was to compare the outcomes of phacoemulsification combined with Hydrus Microstent (Alcon Inc.) implantation alone or in combination with canaloplasty (OMNI Surgical System, Sight Sciences Inc.). MATERIALS AND METHODS: Retrospective study of mild-to-moderate primary open angle glaucoma patients who underwent phacoemulsification with microstent alone (42 eyes of 42 patients) or in combination with canaloplasty (canaloplasty-microstent, 32 eyes of 32 patients). The mean number of ocular hypotensive medications and intraocular pressure were assessed preoperatively and postoperatively at 1 week and at 1, 3, and 6 months. Complications and secondary surgical interventions were recorded. Outcomes measures included the percentage of unmedicated eyes and surgical success at 6 months. Surgical success was defined as reaching the target intraocular pressure without medications or secondary surgical interventions. RESULTS: Mean intraocular pressure at 6 months was 14.1±3.5 mm Hg (13% reduction) after microstent alone and 13.6±3.1 mm Hg (17% reduction) after canaloplasty-microstent. Mean medications at 6 months were 0.57±0.9 (67% reduction) after microstent alone and 0.16±0.4 (88% reduction) after canaloplasty-microstent ( P< 0.05). At 6 months, 64.3% of microstent alone and 87.3% of canaloplasty-microstent were off all medications ( P =0.02). Success probabilities at 6 months were 44.5% for microstent alone and 70.0% for canaloplasty-microstent ( P =0.04). No secondary surgical interventions occurred in either group. CONCLUSIONS: Microstent combined with canaloplasty resulted in a significantly higher rate of medication-free status compared with microstent alone through 6 months.

Trial to evaluate the immunogenicity and safety of a melanoma helper peptide vaccine plus incomplete Freund's adjuvant, cyclophosphamide, and polyICLC (Mel63).

BACKGROUND: Peptide vaccines designed to stimulate melanoma-reactive CD4+ T cells can induce T cell and antibody (Ab) responses, associated with enhanced overall survival. We hypothesized that adding toll-like receptor 3 agonist polyICLC to an incomplete Freund's adjuvant (IFA) would be safe and would support strong, durable CD4+ T cell and Ab responses. We also hypothesized that oral low-dose metronomic cyclophosphamide (mCy) would be safe, would reduce circulating regulatory T cells (T-regs) and would further enhance immunogenicity. PARTICIPANTS AND METHODS: An adaptive design based on toxicity and durable CD4+ T cell immune response (dRsp) was used to assign participants with resected stage IIA-IV melanoma to one of four study regimens. The regimens included a vaccine comprising six melanoma peptides restricted by Class II MHC (6MHP) in an emulsion with IFA alone (Arm A), with IFA plus systemic mCy (Arm B), with IFA+ local polyICLC (Arm C), or with IFA+ polyICLC+ mCy (Arm D). Toxicities were recorded (CTCAE V.4.03). T cell responses were measured by interferon γ ELIspot assay ex vivo. Serum Ab responses to 6MHP were measured by ELISA. Circulating T-regs were assessed by flow cytometry. RESULTS: Forty-eight eligible participants were enrolled and treated. Early data on safety and dRsp favored enrollment on arm D. Total enrollment on Arms A-D were 3, 7, 6, and 32, respectively. Treatment-related dose-limiting toxicities (DLTs) were observed in 1/7 (14%) participants on arm B and 2/32 (6%) on arm D. None exceeded the 25% DLT threshold for early closure to enrollment for any arm. Strong durable T cell responses to 6MHP were detected ex vivo in 0%, 29%, 67%, and 47% of participants on arms A-D, respectively. IgG Ab responses were greatest for arms C and D. Circulating T-regs frequencies were not altered by mCy. CONCLUSIONS: 6MHP vaccines administered with IFA, polyICLC, and mCy were well tolerated. The dRsp rate for arm D of 47% (90% CI 32 to 63) exceeded the 18% (90% CI 11 to 26) rate previously observed with 6MHP in IFA alone. Vaccination with IFA+ polyICLC (arm C) also showed promise for enhancing T cell and Ab responses.