Patient-reported outcomes measures and patient preferences for minimally invasive glaucoma surgical devices.

BackgroundMany therapeutic options are available to glaucoma patients. One recent therapeutic option is minimally invasive glaucoma surgical (MIGS) devices. It is unclear how patients view different treatments and which patient-reported outcomes would be most relevant in patients with mild to moderate glaucoma. We developed a questionnaire for patients eligible for MIGS devices and a patient preference study to examine the value patients place on certain outcomes associated with glaucoma and its therapies.ObjectivesTo summarize the progress to date.MethodsQuestionnaire development: We drafted the questionnaire items based on input from one physician and four patient focus groups, and a review of the literature. We tested item clarity with six cognitive interviews. These items were further refined. Patient preference study: We identified important benefit and risk outcomes qualitatively using semi-structured, one-on-one interviews with patients who were eligible for MIGS devices. We then prioritized these outcomes quantitatively using best-worst scaling methods.ResultsQuestionnaire testing: Three concepts were deemed relevant for the questionnaire: functional limitations, symptoms, and psychosocial factors. We will evaluate the reliability and validity of the 52-item draft questionnaire in an upcoming field test. Patient preference study: We identified 13 outcomes that participants perceived as important. Outcomes with the largest relative importance weights were "adequate IOP control" and "drive a car during the day."ConclusionsPatients have the potential to steer clinical research towards outcomes that are important to them. Incorporating patients' perspectives into the MIGS device development and evaluation process may expedite innovation and availability of these devices

White paper on ophthalmic imaging for choroidal nevus identification and transformation into Melanoma

Purpose: To discuss the evolution of noninvasive diagnostic methods in the identification of choroidal nevus and determination of risk factors for malignant transformation as well as introduce the novel role that artificial intelligence (AI) can play in the diagnostic process. Methods: White paper. Results: Longstanding diagnostic methods to stratify benign choroidal nevus from choroidal melanoma and to further determine the risk for nevus transformation into melanoma have been dependent on recognition of key clinical features by ophthalmic examination. These risk factors have been derived from multiple large cohort research studies over the past several decades and have garnered widespread use throughout the world. More recent publications have applied ocular diagnostic testing (fundus photog-raphy, ultrasound examination, autofluorescence, and optical coherence tomography) to identify risk factors for the malignant transformation of choroidal nevus based on multimodal imaging features. The widespread usage of ophthalmic imaging systems to identify and follow choroidal nevus, in conjunction with the characterization of malignant transformation risk factors via diagnostic imaging, presents a novel path to apply AI. Conclusions: AI applied to existing ophthalmic imaging systems could be used for both identification of choroidal nevus and as a tool to aid in earlier detection of transformation to malignant melanoma. Translational Relevance: Advances in AI models applied to ophthalmic imaging systems have the potential to improve patient care, because earlier detection and treatment of melanoma has been proven to improve long-term clinical outcomes

Artificial Intelligence for Glaucoma: Creating and Implementing Artificial Intelligence for Disease Detection and Progression.

On September 3, 2020, the Collaborative Community on Ophthalmic Imaging conducted its first 2-day virtual workshop on the role of artificial intelligence (AI) and related machine learning techniques in the diagnosis and treatment of various ophthalmic conditions. In a session entitled Artificial Intelligence for Glaucoma, a panel of glaucoma specialists, researchers, industry experts, and patients convened to share current research on the application of AI to commonly used diagnostic modalities, including fundus photography, OCT imaging, standard automated perimetry, and gonioscopy. The conference participants focused on the use of AI as a tool for disease prediction, highlighted its ability to address inequalities, and presented the limitations of and challenges to its clinical application. The panelists discussion addressed AI and health equities from clinical, societal, and regulatory perspectives

Considerations for addressing bias in artificial intelligence for health equity.

Health equity is a primary goal of healthcare stakeholders: patients and their advocacy groups, clinicians, other providers and their professional societies, bioethicists, payors and value based care organizations, regulatory agencies, legislators, and creators of artificial intelligence/machine learning (AI/ML)-enabled medical devices. Lack of equitable access to diagnosis and treatment may be improved through new digital health technologies, especially AI/ML, but these may also exacerbate disparities, depending on how bias is addressed. We propose an expanded Total Product Lifecycle (TPLC) framework for healthcare AI/ML, describing the sources and impacts of undesirable bias in AI/ML systems in each phase, how these can be analyzed using appropriate metrics, and how they can be potentially mitigated. The goal of these Considerations is to educate stakeholders on how potential AI/ML bias may impact healthcare outcomes and how to identify and mitigate inequities; to initiate a discussion between stakeholders on these issues, in order to ensure health equity along the expanded AI/ML TPLC framework, and ultimately, better health outcomes for all

Symptoms and Satisfaction of Patients in the Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL) Studies.

ImportancePatient-reported outcomes should be collected using validated questionnaires prior to and following laser in situ keratomileusis (LASIK) surgery.ObjectiveTo report the frequency of patient-reported visual symptoms, dry eye symptoms, satisfaction with vision, and satisfaction with LASIK surgery in the Patient-Reported Outcomes With LASIK (PROWL) studies.Design, setting, and participantsThe PROWL-1 and PROWL-2 studies were prospective, observational studies conducted from September 13, 2011, to June 27, 2014. The PROWL-1 study was a single-military center study of 262 active-duty Navy personnel 21 to 52 years of age. The PROWL-2 study was a study of 312 civilians 21 to 57 years of age conducted at 5 private practice and academic centers. The LASIK surgery and the postoperative care were performed based on the usual practice and clinical judgment at the site. Participants completed a self-administered, web-based questionnaire, preoperatively and postoperatively at 1 and 3 months (the PROWL-1 and -2 studies) and at 6 months (the PROWL-2 study).ExposuresParticipants underwent LASIK surgery for myopia, hyperopia, and/or astigmatism.Main outcomes and measuresVisual symptoms (double images, glare, halos, and/or starbursts), dry eye symptoms, participant satisfaction (with vision and LASIK surgery), and clinical measures (visual acuity, refractive error, and slitlamp and posterior segment eye examination findings) were assessed preoperatively and at 1, 3, and 6 months postoperatively.ResultsA total of 262 participants were enrolled in the PROWL-1 study (mean [SD] age, 29.1 [6.1] years), and a total of 312 participants were enrolled in the PROWL-2 study (mean [SD] age, 31.5 [7.3] years). Visual symptoms and dissatisfaction with vision were common preoperatively. Overall, the prevalence of visual symptoms and dry eye symptoms decreased, although a substantial percentage of participants reported new visual symptoms after surgery (43% [95% CI, 31%-55%] from the PROWL-1 study and 46% [95% CI, 33%-58%] from the PROWL-2 study at 3 months). The percentages of participants in the PROWL-1 study with normal Ocular Surface Disease Index scores were 55% (95% CI, 48%-61%) at baseline, 66% (95% CI, 59%-72%) at 3 months, and 73% (95% CI, 67%-79%) at 6 months. The percentages of participants in the PROWL-2 study with normal Ocular Surface Disease Index scores were 44% (95% CI, 38%-50%) at baseline and 65% (95% CI, 59%-71%) at 3 months. Of those participants who had normal scores at baseline in both the PROWL-1 and -2 studies, about 28% (95% CI, 19%-37%) had mild, moderate, or severe dry eye symptoms at 3 months. While most participants were satisfied, the rates of dissatisfaction with vision ranged from 1% (95% CI, 0%-4%) to 4% (95% CI, 2%-7%), and the rates of dissatisfaction with surgery ranged from 1% (95% CI, 0%-4%) to 2% (95% CI, 1%-5%).Conclusions and relevanceThe systematic administration of a questionnaire to patients who have undergone LASIK surgery is a new approach to assess symptoms and satisfaction. Our findings support the need for adequate counseling about the possibility of developing new symptoms after LASIK surgery

Patient-reported outcomes measures and patient preferences for minimally invasive glaucoma surgical devices.

BackgroundMany therapeutic options are available to glaucoma patients. One recent therapeutic option is minimally invasive glaucoma surgical (MIGS) devices. It is unclear how patients view different treatments and which patient-reported outcomes would be most relevant in patients with mild to moderate glaucoma. We developed a questionnaire for patients eligible for MIGS devices and a patient preference study to examine the value patients place on certain outcomes associated with glaucoma and its therapies.ObjectivesTo summarize the progress to date.MethodsQuestionnaire development: We drafted the questionnaire items based on input from one physician and four patient focus groups, and a review of the literature. We tested item clarity with six cognitive interviews. These items were further refined. Patient preference study: We identified important benefit and risk outcomes qualitatively using semi-structured, one-on-one interviews with patients who were eligible for MIGS devices. We then prioritized these outcomes quantitatively using best-worst scaling methods.ResultsQuestionnaire testing: Three concepts were deemed relevant for the questionnaire: functional limitations, symptoms, and psychosocial factors. We will evaluate the reliability and validity of the 52-item draft questionnaire in an upcoming field test. Patient preference study: We identified 13 outcomes that participants perceived as important. Outcomes with the largest relative importance weights were "adequate IOP control" and "drive a car during the day."ConclusionsPatients have the potential to steer clinical research towards outcomes that are important to them. Incorporating patients' perspectives into the MIGS device development and evaluation process may expedite innovation and availability of these devices

Symptoms and Satisfaction of Patients in the Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL) Studies.

ImportancePatient-reported outcomes should be collected using validated questionnaires prior to and following laser in situ keratomileusis (LASIK) surgery.ObjectiveTo report the frequency of patient-reported visual symptoms, dry eye symptoms, satisfaction with vision, and satisfaction with LASIK surgery in the Patient-Reported Outcomes With LASIK (PROWL) studies.Design, setting, and participantsThe PROWL-1 and PROWL-2 studies were prospective, observational studies conducted from September 13, 2011, to June 27, 2014. The PROWL-1 study was a single-military center study of 262 active-duty Navy personnel 21 to 52 years of age. The PROWL-2 study was a study of 312 civilians 21 to 57 years of age conducted at 5 private practice and academic centers. The LASIK surgery and the postoperative care were performed based on the usual practice and clinical judgment at the site. Participants completed a self-administered, web-based questionnaire, preoperatively and postoperatively at 1 and 3 months (the PROWL-1 and -2 studies) and at 6 months (the PROWL-2 study).ExposuresParticipants underwent LASIK surgery for myopia, hyperopia, and/or astigmatism.Main outcomes and measuresVisual symptoms (double images, glare, halos, and/or starbursts), dry eye symptoms, participant satisfaction (with vision and LASIK surgery), and clinical measures (visual acuity, refractive error, and slitlamp and posterior segment eye examination findings) were assessed preoperatively and at 1, 3, and 6 months postoperatively.ResultsA total of 262 participants were enrolled in the PROWL-1 study (mean [SD] age, 29.1 [6.1] years), and a total of 312 participants were enrolled in the PROWL-2 study (mean [SD] age, 31.5 [7.3] years). Visual symptoms and dissatisfaction with vision were common preoperatively. Overall, the prevalence of visual symptoms and dry eye symptoms decreased, although a substantial percentage of participants reported new visual symptoms after surgery (43% [95% CI, 31%-55%] from the PROWL-1 study and 46% [95% CI, 33%-58%] from the PROWL-2 study at 3 months). The percentages of participants in the PROWL-1 study with normal Ocular Surface Disease Index scores were 55% (95% CI, 48%-61%) at baseline, 66% (95% CI, 59%-72%) at 3 months, and 73% (95% CI, 67%-79%) at 6 months. The percentages of participants in the PROWL-2 study with normal Ocular Surface Disease Index scores were 44% (95% CI, 38%-50%) at baseline and 65% (95% CI, 59%-71%) at 3 months. Of those participants who had normal scores at baseline in both the PROWL-1 and -2 studies, about 28% (95% CI, 19%-37%) had mild, moderate, or severe dry eye symptoms at 3 months. While most participants were satisfied, the rates of dissatisfaction with vision ranged from 1% (95% CI, 0%-4%) to 4% (95% CI, 2%-7%), and the rates of dissatisfaction with surgery ranged from 1% (95% CI, 0%-4%) to 2% (95% CI, 1%-5%).Conclusions and relevanceThe systematic administration of a questionnaire to patients who have undergone LASIK surgery is a new approach to assess symptoms and satisfaction. Our findings support the need for adequate counseling about the possibility of developing new symptoms after LASIK surgery

Assessment of the Psychometric Properties of a Questionnaire Assessing Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL).

ImportancePatient-reported outcome (PRO) measures for laser in situ keratomileusis (LASIK) are needed.ObjectiveTo develop PRO measures to assess satisfaction, eye-related symptoms, and their effect on functioning and well-being following LASIK based on patient and expert input.Design, setting, and participantsThe Patient-Reported Outcomes With LASIK (PROWL) studies were prospective observational studies of patients undergoing LASIK surgery for myopia, hyperopia, or astigmatism. PROWL-1 was a single-center study of active-duty US Navy personnel and PROWL-2 was a 5-center study of civilians. PROWL-1 enrolled 262 active-duty service personnel and PROWL-2 enrolled 312 civilians 21 years or older who spoke English; 241 individuals in PROWL-1 and 280 in PROWL-2 completed a baseline questionnaire before surgery. The analytic sample included those also completing 1 or more follow-up questionnaires: 240 (99.6%) of those in PROWL-1 and 271 (94.4%) of those in PROWL-2. Questionnaires were self-administered through the internet preoperatively and at 1 and 3 months postoperatively in both studies and at 6 months postoperatively in PROWL-1. PROWL-1 began in August 2011 and was completed May 30, 2014; PROWL-2 began in July 2012 and was completed June 27, 2014. Data were analyzed from June 28, 2014, to October 24, 2016.Main outcomes and measuresScales assessing visual symptoms (double images, glare, halos, and starbursts), dry eye symptoms, satisfaction with vision, and satisfaction with LASIK surgery. Items from the National Eye Institute (NEI) Refractive Error Quality of Life Instrument (NEI-RQL-42), NEI Visual Function Questionnaire (NEI-VFQ), and the Ocular Surface Disease Index (OSDI) were included. All scales are scored on a 0 to 100 possible range. Construct validity and responsiveness to change were evaluated (comparing scores before and after surgery).ResultsThe median age of the 240-person PROWL-1 analytic sample was 27 years (range, 21-52 years); 49 were women (20.4%). The median age of the 271-person PROWL-2 analytic sample was 30 years (range, 21-57 years); 147 were women (54.2%). Internal consistency reliabilities for the 4 visual symptom scales ranged from 0.96 to 0.98 in PROWL-1 and from 0.95 to 0.97 in PROWL-2. The median (interquartile range) test-retest intraclass correlation was 0.69 (0.57-0.79) and 0.76 (0.68-0.84) in PROWL-1 and PROWL-2, respectively. Product-moment correlations of satisfaction with surgery with visual symptom scales at follow-up evaluations ranged from r = 0.24 to r = 0.49. Measures improved from baseline to follow-up, with effect sizes of 0.14 to 1.98, but scores on the NEI-RQL-42 glare scale worsened at the 1-month follow-up. Hours of work did not change significantly from baseline to 1-month follow-up, with the mean number (mean [SD] difference) in PROWL-1 of 41.7 vs 40.9 hours (-0.8 [18.7]) and in PROWL-2 of 38.8 vs 38.2 hours (-0.6 [17.1]).Conclusions and relevanceThe results of these studies support the reliability and validity of visual symptom scales to evaluate the effects of LASIK surgery in future studies

Assessment of the Psychometric Properties of a Questionnaire Assessing Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL).

ImportancePatient-reported outcome (PRO) measures for laser in situ keratomileusis (LASIK) are needed.ObjectiveTo develop PRO measures to assess satisfaction, eye-related symptoms, and their effect on functioning and well-being following LASIK based on patient and expert input.Design, setting, and participantsThe Patient-Reported Outcomes With LASIK (PROWL) studies were prospective observational studies of patients undergoing LASIK surgery for myopia, hyperopia, or astigmatism. PROWL-1 was a single-center study of active-duty US Navy personnel and PROWL-2 was a 5-center study of civilians. PROWL-1 enrolled 262 active-duty service personnel and PROWL-2 enrolled 312 civilians 21 years or older who spoke English; 241 individuals in PROWL-1 and 280 in PROWL-2 completed a baseline questionnaire before surgery. The analytic sample included those also completing 1 or more follow-up questionnaires: 240 (99.6%) of those in PROWL-1 and 271 (94.4%) of those in PROWL-2. Questionnaires were self-administered through the internet preoperatively and at 1 and 3 months postoperatively in both studies and at 6 months postoperatively in PROWL-1. PROWL-1 began in August 2011 and was completed May 30, 2014; PROWL-2 began in July 2012 and was completed June 27, 2014. Data were analyzed from June 28, 2014, to October 24, 2016.Main outcomes and measuresScales assessing visual symptoms (double images, glare, halos, and starbursts), dry eye symptoms, satisfaction with vision, and satisfaction with LASIK surgery. Items from the National Eye Institute (NEI) Refractive Error Quality of Life Instrument (NEI-RQL-42), NEI Visual Function Questionnaire (NEI-VFQ), and the Ocular Surface Disease Index (OSDI) were included. All scales are scored on a 0 to 100 possible range. Construct validity and responsiveness to change were evaluated (comparing scores before and after surgery).ResultsThe median age of the 240-person PROWL-1 analytic sample was 27 years (range, 21-52 years); 49 were women (20.4%). The median age of the 271-person PROWL-2 analytic sample was 30 years (range, 21-57 years); 147 were women (54.2%). Internal consistency reliabilities for the 4 visual symptom scales ranged from 0.96 to 0.98 in PROWL-1 and from 0.95 to 0.97 in PROWL-2. The median (interquartile range) test-retest intraclass correlation was 0.69 (0.57-0.79) and 0.76 (0.68-0.84) in PROWL-1 and PROWL-2, respectively. Product-moment correlations of satisfaction with surgery with visual symptom scales at follow-up evaluations ranged from r = 0.24 to r = 0.49. Measures improved from baseline to follow-up, with effect sizes of 0.14 to 1.98, but scores on the NEI-RQL-42 glare scale worsened at the 1-month follow-up. Hours of work did not change significantly from baseline to 1-month follow-up, with the mean number (mean [SD] difference) in PROWL-1 of 41.7 vs 40.9 hours (-0.8 [18.7]) and in PROWL-2 of 38.8 vs 38.2 hours (-0.6 [17.1]).Conclusions and relevanceThe results of these studies support the reliability and validity of visual symptom scales to evaluate the effects of LASIK surgery in future studies