Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: quantitative study findings.

OBJECTIVE: To quantitatively compare equivalence and compliance of patient-reported outcome (PRO) data collected via provisioned device (PD) versus bring your own device (BYOD). METHODS: Participants with stable chronic obstructive pulmonary disease (COPD) completed the EXAcerbations of Chronic Pulmonary Disease Tool (EXACT®) daily and COPD Assessment Test™ (CAT) and Patient Global Impression of Severity (PGIS) of COPD weekly on either PD or BYOD for 15 days, then switched device types for 15 days. EXACT was scored using the Evaluating Respiratory Symptoms in COPD (E-RS®: COPD) algorithm and equivalence assessed using intraclass correlation coefficients (ICCs) adjusting for cross-over sequence, period, and time. Two one-sided tests (TOSTs) used ICC adjusted means with 10%, 20%, and 40% of total score tested as equivalence margins. Compliance and comfort with technology were assessed. Equivalence across 3 device screen sizes was assessed following the second completion period. RESULTS: Participants (N = 64) reported high comfort with technology, with 79.7% reporting being "quite a bit" or "very" comfortable. Weekly compliance was high (BYOD = 89.7-100%; PD = 76.9-100%). CAT and E-RS: COPD scores correlated well with PGIS (r > 0.50) and demonstrated equivalence between PD and BYOD completion (ICC = 0.863-0.908). TOST equivalence was achieved within 10% of the total score (p > 0.05). PRO measure scores were equivalent across 3 different screen sizes (ICC = 0.972-0.989). CONCLUSIONS: Measure completion was high and scores equivalent between PD and BYOD, supporting use of BYOD in addition to PD for collecting PRO data in COPD studies and in demographically diverse patient populations.

Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: qualitative interview findings.

BACKGROUND: There is interest in participants using their own smartphones or tablets ("bring your own device"; BYOD) to complete patient-reported outcome (PRO) measures in clinical studies. Our study aimed to qualitatively evaluate participants' experience using a provisioned device (PD) versus their own smartphone (BYOD) for this purpose. METHODS: Participants with chronic obstructive pulmonary disease (COPD) were recruited for this observational, cross-over study and completed PRO measures daily on one device type for 15 days, then switched to the other device type to complete the same measures for another 15 days. After each 15-day period, semi-structured interviews were conducted about their experience with the device. RESULTS: Of 64 participants enrolled, the final qualitative analysis populations comprised those who participated in an interview without protocol violations. Thus, the qualitative longitudinal population (LP) included n = 57 (89%), while the qualitative cross-sectional population (CSP) included n = 60 (94%). CSP participants found both device types easy to use. Twenty CSP participants (33%) reported missing data entry on at least one day when using PD, and 24 (40%) reported missing at least one day when using BYOD. In the LP, preference for one of the device types was somewhat evenly split; 45.6% (n = 26) preferred PD and 50.9% (n = 29) preferred BYOD. The most common reason for preferring PD was that it was "dedicated" to the study; the "convenience" of carrying a single device was the main reason for preferring BYOD. CONCLUSION: The findings from the interviews demonstrated few differences in participants' experience completing PRO measures on a PD versus BYOD. Our study supports the use of BYOD as a potential addition to PD for collecting PRO data and contributes evidence that BYOD may be employed to collect PRO data in demographically diverse patient populations.

Recommendations for the Electronic Migration and Implementation of Clinician-Reported Outcome Assessments in Clinical Trials.

OBJECTIVES: Although best practices from electronic patient-reported outcome (PRO) measures are transferable, the migration of clinician-reported outcome (ClinRO) assessments to electronic modes requires recommendations that address their unique properties, such as the user (eg, clinician), and complexity associated with programming of clinical content. Faithful migration remains essential to ensuring that the content and psychometric properties of the original scale (ie, validated reference) are preserved, such that clinicians completing the ClinRO assessments interpret and respond to the items the same way regardless of data collection mode. The authors present a framework for how to "faithfully" migrate electronic ClinRO assessments for successful deployment in clinical trials. METHODS: Critical Path Institute's Electronic PRO Consortium and PRO Consortium convened a consensus panel of representatives from member firms to develop recommendations for electronic migration and implementation of ClinRO assessments in clinical trials based on industry standards, regulatory guidelines where available, and relevant literature. The recommendations were reviewed and approved by all member firms from both consortia. CONSENSUS RECOMMENDATIONS: Standard, minimal electronic modifications for ClinRO assessments are described. This article also outlines implementation steps, including planning, startup, electronic clinical outcome assessment system development, training, and deployment. The consensus panel proposes that functional clinical testing by a clinician or clinical outcome assessment expert, as well as copyright holder review of screenshots (if possible) are sufficient to support minimal modifications during migration. Additional evidence generation is proposed for modifications that deviate significantly from the validated reference.

Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically.

Implementing clinical outcome assessments electronically in clinical studies requires the sponsor and electronic clinical outcome assessment (eCOA) provider to work closely together to implement study-specific requirements and ensure consensus-defined best practices are followed. One of the most important steps is for sponsors to conduct user acceptance testing (UAT) using an eCOA system developed by the eCOA provider. UAT provides the clinical study team including sponsor or designee an opportunity to evaluate actual software performance and ensure that the sponsor's intended requirements were communicated clearly and accurately translated into the system design, and that the system conforms to a sponsor-approved requirements document based on the study protocol. The components of an eCOA system, such as the study-specific application, customization features, study portal, and custom data transfers should be tested during UAT. While the provider will perform their own system validation, the sponsor or designee should also perform their due diligence by conducting UAT. A clear UAT plan including the necessary documentation may be requested by regulatory authorities depending on the country. This paper provides the electronic patient-reported outcome (ePRO) Consortium's and patient-reported outcome (PRO) Consortium's best practice recommendations for clinical study sponsors or their designee for conducting UAT with support from eCOA providers to ensure data quality and enhance operational efficiency of the eCOA system. Following these best practice recommendations and completing UAT in its entirety will support a high quality eCOA system and ensure more reliable and complete data are collected, which are essential to the success of the study.

Validity and Reliability of the Student Refractive Error and Eyeglasses Questionnaire-Revised Version in Myopic Children.

SIGNIFICANCE: Multiple vision-related quality of life (VRQol) instruments exist, but questionnaires designed specifically for myopic children that are appropriate for assessing the impact of refractive error are rare. PURPOSE: This study aimed to assess the validity and reliability of the Student Refractive Error and Eyeglasses Questionnaire - Revised (SREEQ-R) in school-aged children with myopia in the United Kingdom. METHODS: Community optometrists in the United Kingdom invited children up to the age of 18 years presenting for an eye examination with current or previous reported use of eyeglasses for myopia to complete the SREEQ-R, which consists of 20 specific items divided into two sections each with three response categories. The "without glasses" section relates to perceptions of uncorrected vision/not wearing glasses, and the "with glasses" relates to corrected vision/wearing glasses. Rasch analysis was used to explore the psychometric performance (content, construct validity, and reliability) of the questionnaire items and scale using Winsteps software (Winsteps.com. Portland, OR). RESULTS: A total of 125 eligible children with a mean ± standard deviation age of 12.7 ± 2.9 years completed the SREEQ-R. All items fit the Rasch model and were retained, and the scale was found to be unidimensional. All children and item infit and outfit mean square statistics fell within the recommended fit criteria. As per the Rasch analysis, the person reliability coefficients were 0.84 and 0.91, whereas item reliabilities were 0.99 and 0.80 for the without glasses and with glasses sections, respectively. The internal consistency for the SREEQ-R was good; Cronbach α values were 0.84 for without glasses and 0.91 for with glasses. CONCLUSIONS: The SREEQ-R had satisfactory validity and reliability evidence. Construct validity of the scale was supported to measure the impact of uncorrected and corrected refractive error on vision-related quality of life in myopic school-aged children in the United Kingdom. The SREEQ-R could be used in future studies to evaluate vision-related quality of life in children with myopia.

HemPHL: A Personal Health Library and mHealth Recommender to Promote Self-Management of Hemophilia.

Hemophilia is a rare inherited bleeding disorder characterized by the blood's inability to clot and could result in potentially life-threatening spontaneous bleeding into joints, organs, and tissues. Moreover, long-term management of this chronic disease is complex and costly. Current scientific evidence demonstrates that personalized digital health technologies could promote and facilitate the self-management of chronic diseases. This study introduces HemPHL a Personal Health Library and mHealth Recommender platform to gather, manage, and exchange tailored health information and recommendations to facilitate self-management and home therapy among individuals with hemophilia. The proposed digital health solution will adopt novel data science, artificial intelligence tools and techniques to manage and use information, as well as promote best practices for health education to enable patients to make informed decisions about their health. To accomplish this, an array of complex health and non-health information will be obtained from multi-dimensional sources to develop a secure, single access point of information for patient use. Patient's access to personalized health information could harness their engagement and independence as well as empower them to remotely monitor their health progress and improve compliance with treatment plans. This hemophilia-focused, user-centered app can markedly improve patients' clinical outcomes and overall quality of life.

A Randomized Noninferiority Trial of Wearing Adjustable Glasses versus Standard and Ready-made Spectacles among Chinese Schoolchildren: Wearability and Evaluation of Adjustable Refraction III.

PURPOSE: To compare wear of standard, adjustable, and ready-made glasses among children. DESIGN: Randomized, controlled, open-label, noninferiority trial. PARTICIPANTS: Students aged 11 to 16 years with presenting visual acuity (VA) ≤6/12 in both eyes, correctable to ≥6/7.5, subjective spherical equivalent refractive error (SER) ≤-1.0 diopters (D), astigmatism and anisometropia both <2.00 D, and no other ocular abnormalities. METHODS: Participants were randomly allocated (1:1:1) to standard glasses, ready-made glasses, or adjustable glasses based on self-refraction. We recorded glasses wear on twice-weekly covert evaluation by head teachers (primary outcome), self-reported and investigator-observed wear, best-corrected visual acuity (BCVA) (not prespecified), children's satisfaction, and value attributed to glasses. MAIN OUTCOME MEASURE: Proportion of glasses wear on twice-weekly covert evaluation by head teachers over 2 months. RESULTS: Among 379 eligible participants, 127 were allocated to standard glasses (mean age, 13.7 years; standard deviation [SD], 1.0 years; 54.3% were male), 125 to ready-made (mean age, 13.6; SD, 0.83; 45.6%), and 127 to adjustable (mean age, 13.4 years; SD, 0.85; 54.3%). Mean wear proportion of adjustable glasses was significantly lower than for standard glasses (45% vs. 58%; P = 0.01), although the adjusted difference (90% confidence interval [CI], -19.0% to -3.0%) did not meet the prespecified inferiority threshold of 20%. Self-reported (90.2% vs. 84.8%, P = 0.64) and investigator-observed (44.1% vs. 33.9%, P = 0.89) wear did not differ between standard and adjustable glasses, nor did satisfaction with (P = 0.97) or value attributed to study glasses (P = 0.55) or increase in quality of life (5.53 [SD, 4.47] vs. 5.68 [SD, 4.34] on a 100-point scale, P > 0.30). Best-corrected visual acuity with adjustable glasses was better (P < 0.001) than with standard glasses. Change in power of study lenses at the end of the study (adjustable: 0.65 D, 95% CI, 0.52-0.79; standard, 0.01 D; 95% CI, -0.006 to 0.03, P < 0.001) was greater for adjustable glasses, although interobserver variation in power measurements may explain this. Lens scratches and frame damage were more common with adjustable glasses, whereas lens breakage was less common than for standard glasses. CONCLUSIONS: Proportion of wear was lower with adjustable glasses, although VA was better and measures of satisfaction and quality of life were not inferior to standard glasses.

Perceived Burden of Completion of Patient-Reported Outcome Measures in Clinical Trials:: Results of a Preliminary Study.

BACKGROUND: Understanding the perceived burden of clinical trial participation is an important element of patient-centric trial design and conduct. METHODS: We report the results of a study to gain preliminary insights into the perceived burden associated with patient-reported outcome (PRO) data collection among a sample (n = 61) of volunteers from the general population including people with various health conditions resulting in chronic pain. RESULTS: Participants identified morning completion as more burdensome than completion of PRO measures in the evening. Weekly completion was perceived as less burdensome than daily, and twice-a-day more burdensome than once-a-day. CONCLUSION: Our results, while not generalizable in isolation, provide a valuable starting point to understand the complex construct of subject burden. This preliminary work is intended to be a catalyst for more in-depth research to better understand and predict burden and acceptable burden thresholds in clinical trials. Understanding subject burden is a vital component of human subject research that will be valuable in helping to inform future clinical trial designs.

Best Practices for Avoiding Paper Backup When Implementing Electronic Approaches to Patient-Reported Outcome Data Collection in Clinical Trials.

Electronic data capture is fast becoming the preferred method of collecting patient-reported outcome (PRO) data in clinical trials. Data collection can be site-based (clinical study site), and typically collected on a tablet, or field-based (subject's typical environment such as home, school, or workplace), and most often accomplished with handheld devices, such as a smartphone. While site and study subject compliance with protocol-specific data collection procedures using these devices is critical to trial success, so is the robustness of the device hardware and the software these devices use to capture the trial data. Technology failures and/or site or subject resistance to the electronic data capture protocol may lead a subject to record data on paper, which can result in undesirable data challenges. As such, both site and subject compliance issues and technology-related factors must be anticipated to adhere to the ePRO data collection plan. The objective of this paper is to provide the technology industry's best practice recommendations for optimizing ePRO data collection in clinical trials by proposing the inclusion of a planned approach to data collection that includes viable electronic backup strategies so that defaulting to a paper-based backup becomes unnecessary.

Training on the Use of Technology to Collect Patient-Reported Outcome Data Electronically in Clinical Trials: Best Practice Recommendations from the ePRO Consortium.

Electronic capture of patient-reported outcome (PRO) data has many advantages over paper-based data collection. Regulatory agencies have consistently supported the use of electronic PRO (ePRO) data capture and recommended participant and site staff training on the correct use of electronic data capture systems. The objective of this paper is to outline best practice recommendations for training end users, including site staff and study participants, on the use of ePRO technology in clinical trials to enable consistent, accurate, and complete data collection. Site personnel should be trained on study-specific as well as technology-specific topics and be given instructions on whom to contact to obtain technical support. Optimal training takes place over time using multiple modalities, including hands-on, face-to-face training at an investigator meeting or directly in the clinical site; remote training via webinar or teleconference; interactive on-demand self-paced-training via e-learning modalities; and supplemented by proxy training performed by study clinical research associates. Like site personnel training, study participants should be provided with individual, hands-on training by site staff at the initiation of the trial and in conjunction with interactive electronic training modules that can be accessed on-demand throughout the duration of the trial. The recommendations put forth in this paper provide a structured framework for the training that site personnel and study participants need to optimize the advantages trials can gain from using ePRO data collection systems.

Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium.

BACKGROUND: Wearable devices offer huge potential to collect rich sources of data to provide insights into the effects of treatment interventions. Despite this, at the time of writing this report, limited regulatory guidance on the use of wearables in clinical trial programs has been published. OBJECTIVES: To present recommendations from the Critical Path Institute's Electronic Patient-Reported Outcome Consortium regarding the selection and evaluation of wearable devices and their measurements for use in regulatory trials and to support labeling claims. METHODS: The evaluation group was composed of Critical Path Institute's clinical outcome assessment (COA) scientists and COA specialists from pharmaceutical trial eCOA solution providers, including COA development and validation specialists. The resulting recommendations were drawn from a broad range of backgrounds, perspectives, and expertise that enriched the development of this report. Recommendations were developed through analysis of existing regulatory guidance relating to COA development and use in clinical trials, medical device certification/clearance regulations, literature-reported best practice, and practical experience of wearable technology application in clinical trials. RESULTS: We identify the essential properties of fit-for-purpose wearables and propose evidence needed to support their use. In addition, we overview the activities required to establish clinical endpoints derived from wearables data. CONCLUSIONS: Using this framework, we believe there is enough current understanding to promote the appropriate use of wearables in study protocols. We hope this will provide a basis for discussion among clinical trial stakeholders and catalyze the development of more robust regulatory guidance.

Literature review to characterize the empirical basis for response scale selection in pediatric populations.

BACKGROUND: Despite the importance of response option selection for patient-reported outcome measures, there seems to be little empirical evidence for the selected scale type. This article provides an overview of the published research on response scale types and empirical support within pediatric populations. METHODS: A comprehensive review of the scientific literature was conducted to identify response scale option types appropriate for use in pediatric populations and to review and summarize the available empirical evidence for each scale type. RESULTS: Eleven review/consensus guideline/expert opinion articles and 20 empirical articles that provided guidance or evidence regarding pediatric response scale selection were identified. There was general consensus that 5-point verbal rating scales, including Likert scales, were appropriate for children aged 7 or 8 and older, while graphical or faces scales are often used in pediatric studies with children of younger ages. CONCLUSION: In general, the verbal rating scale, numeric rating scale, visual analogue scale, and graphical scales have each demonstrated to be reliable and valid response option formats in specific contexts among pediatric populations; however, their appropriateness is dependent upon sample age. When selecting response scales, it is important to consider target population and context of use during the development of patient-reported outcome measures, especially with respect to tense, recall period, attribution, number of options, etc. In addition to age, cognitive development is an important aspect to consider for optimizing pediatric self-reported measures. More research is needed to determine clinically relevant changes and differences within pediatric research, which includes different response scale options.

Literature review to assemble the evidence for response scales used in patient-reported outcome measures.

BACKGROUND: In the development of patient-reported outcome (PRO) instruments, little documentation is provided on the justification of response scale selection. The selection of response scales is often based on the developers' preferences or therapeutic area conventions. The purpose of this literature review was to assemble evidence on the selection of response scale types, in PRO instruments. The literature search was conducted in EMBASE, MEDLINE, and PsycINFO databases. Secondary search was conducted on supplementary sources including reference lists of key articles, websites for major PRO-related working groups and consortia, and conference abstracts. Evidence on the selection of verbal rating scale (VRS), numeric rating scale (NRS), and visual analogue scale (VAS) was collated based on pre-determined categories pertinent to the development of PRO instruments: reliability, validity, and responsiveness of PRO instruments, select therapeutic areas, and optimal number of response scale options. RESULTS: A total of 6713 abstracts were reviewed; 186 full-text references included. There was a lack of consensus in the literature on the justification for response scale type based on the reliability, validity, and responsiveness of a PRO instrument. The type of response scale varied within the following therapeutic areas: asthma, cognition, depression, fatigue in rheumatoid arthritis, and oncology. The optimal number of response options depends on the construct, but quantitative evidence suggests that a 5-point or 6-point VRS was more informative and discriminative than fewer response options. CONCLUSIONS: The VRS, NRS, and VAS are acceptable response scale types in the development of PRO instruments. The empirical evidence on selection of response scales was inconsistent and, therefore, more empirical evidence needs to be generated. In the development of PRO instruments, it is important to consider the measurement properties and therapeutic area and provide justification for the selection of response scale type.

Accuracy of the Spot and Plusoptix photoscreeners for detection of astigmatism.

PURPOSE: To evaluate the accuracy of the Spot (V2.0.16) and Plusoptix S12 (ROC4, V6.1.4.0) photoscreeners in detecting astigmatism meeting AAPOS referral criteria in students from a population with high prevalence of astigmatism. METHODS: Students attending grades 3-8 on the Tohono O'odham reservation were examined. Screening was attempted with both the Spot and Plusoptix photoscreeners. Results were compared to cycloplegic refraction. Screening attempts providing no estimate of refractive error were considered fail/refer. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for detection of refractive errors were determined using AAPOS referral criteria and receiver operating characteristic area under the curve (ROC AUC) analysis was conducted for measures of astigmatism. Agreement between screening and cycloplegic refraction measurements of astigmatism, spherical equivalent, and anisometropia were assessed using t tests and correlation analyses. RESULTS: A total of 209 students were included. Of the total, 116 (55%) met examination-positive criteria based on cycloplegic refraction, with 105 of those (90%) meeting the criterion for astigmatism. Measurements success rates were 97% for Spot and 54% for Plusoptix. Comparing the Spot and the Plusoptix, sensitivity was 96% versus 100%, specificity was 87% versus 61%, PPV was 90% versus 76%, and NPV was 94% versus 100% for detection of refractive error. Both screeners overestimated astigmatism by 1/3 D to 2/3 D. AUC for astigmatism was 0.97 for Spot and 0.83 for Plusoptix. CONCLUSIONS: In this highly astigmatic population, the Spot and the Plusoptix had similar sensitivity, but the Spot had better specificity and measurement success rates. Compared with results from study samples with lower rates of astigmatism, our results highlight the need to assess the ability of screening instruments to detect individual types of refractive errors.

Accommodation in astigmatic children during visual task performance.

PURPOSE: To determine the accuracy and stability of accommodation in uncorrected children during visual task performance. METHODS: Subjects were second- to seventh-grade children from a highly astigmatic population. Measurements of noncycloplegic right eye spherical equivalent (Mnc) were obtained while uncorrected subjects performed three visual tasks at near (40 cm) and distance (2 m). Tasks included reading sentences with stimulus letter size near acuity threshold and an age-appropriate letter size (high task demands) and viewing a video (low task demand). Repeated measures ANOVA assessed the influence of astigmatism, task demand, and accommodative demand on accuracy (mean Mnc) and variability (mean SD of Mnc) of accommodation. RESULTS: For near and distance analyses, respectively, sample size was 321 and 247, mean age was 10.37 (SD 1.77) and 10.30 (SD 1.74) years, mean cycloplegic M was 0.48 (SD 1.10) and 0.79 diopters (D) (SD 1.00), and mean astigmatism was 0.99 (SD 1.15) and 0.75 D (SD 0.96). Poor accommodative accuracy was associated with high astigmatism, low task demand (video viewing), and high accommodative demand. The negative effect of accommodative demand on accuracy increased with increasing astigmatism, with the poorest accommodative accuracy observed in high astigmats (≥3.00 D) with high accommodative demand/high hyperopia (1.53 D and 2.05 D of underaccommodation for near and distant stimuli, respectively). Accommodative variability was greatest in high astigmats and was uniformly high across task condition. No/low and moderate astigmats showed higher variability for the video task than the reading tasks. CONCLUSIONS: Accuracy of accommodation is reduced in uncorrected children with high astigmatism and high accommodative demand/high hyperopia, but improves with increased visual task demand (reading). High astigmats showed the greatest variability in accommodation.

Rasch analysis of the Student Refractive Error and Eyeglass Questionnaire.

PURPOSE: To evaluate and refine a newly developed instrument, the Student Refractive Error and Eyeglasses Questionnaire (SREEQ), designed to measure the impact of uncorrected and corrected refractive error on vision-related quality of life (VRQoL) in school-aged children. METHODS: A 38-statement instrument consisting of two parts was developed: part A relates to perceptions regarding uncorrected vision and part B relates to perceptions regarding corrected vision and includes other statements regarding VRQoL with spectacle correction. The SREEQ was administered to 200 Native American 6th- through 12th-grade students known to have previously worn and who currently require eyeglasses. Rasch analysis was conducted to evaluate the functioning of the SREEQ. Statements on parts A and B were analyzed to examine the dimensionality and constructs of the questionnaire, how well the items functioned, and the appropriateness of the response scale used. RESULTS: Rasch analysis suggested two items be eliminated and the measurement scale for matching items be reduced from a four-point response scale to a three-point response scale. With these modifications, categorical data were converted to interval-level data to conduct an item and person analysis. A shortened version of the SREEQ was constructed with these modifications, the SREEQ-R, which included the statements that were able to capture changes in VRQoL associated with spectacle wear for those with significant refractive error in our study population. CONCLUSIONS: Although part B of the SREEQ appears to have a less-than-optimal reliability to assess the impact of spectacle correction on VRQoL in our student population, it is able to detect statistically significant differences from pretest to posttest on both the group and individual levels to show that the instrument can assess the impact that glasses have on VRQoL. Further modifications to the questionnaire, such as those included in the SREEQ-R, could enhance its functionality.

Predictors of adequate correction following vision screening failure.

PURPOSE: To determine whether compliance with referral 1 year after vision screening failure was associated with care model, demographic, or ocular factors. METHODS: Data were analyzed from 798 children in the Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error Study with habitual logMAR visual acuity (VA) ≥0.26 (20/40 + 2 or worse) in either eye due to uncorrected or undercorrected refractive error and who returned the following year. The parents of 492 children failing in TX and CA were sent letters indicating the need for a complete vision examination (screening model), while 306 children seen primarily in AZ and AL received a free complete examination and eyeglasses if needed (complete care model). Presenting to follow-up with adequate correction (logMAR <0.26) in each eye was considered compliant. Logistic regression models for compliance were fit to assess whether care model, ethnicity, sex, age, uncorrected logMAR in the better eye, or parental income, education, or myopia were predictors. RESULTS: Overall compliance was 28%. Age [p = 0.01, odds ratio (OR) = 1.12] and uncorrected logMAR (p < 0.001, OR = 1.13) were associated with compliance but care model, ethnicity, and sex were not. Among the 447 children for whom data on parental factors were available, 27% were compliant. In this model, age, ethnicity, sex, parental income, parental education, and parental myopia were not associated with compliance, but uncorrected logMAR (p = 0.005; OR = 1.13) was predictive. An interaction between unaided VA and care model predicted improved compliance with poorer unaided VA in the complete care model. CONCLUSIONS: Expensive complete care screening programs may not improve compliance over typical notification and referral screening protocols in school-aged children, unless unaided VA is worse than the common 20/40 referral criteria. Unaided VA had less impact on predicted compliance in the screening-only protocol.

Spectacle wear in children given spectacles through a school-based program.

PURPOSE: To investigate factors associated with spectacle wear in a group of primarily Native-American children provided spectacles free of charge through a school-based vision program. METHODS: Spectacle wear was studied in 247 participants provided two pairs of spectacles the previous year. Univariate and multivariate logistic regression models assessed whether gender, race, parental education levels, family income, uncorrected distance visual acuity, refractive error, or the children's attitudes and beliefs about their vision and spectacles were associated with spectacle wear. RESULTS: Two thirds of the participants (165/247) were not wearing their spectacles at their annual examination. The most common reasons given for non-wear were lost (44.9%) or broken (35.3%) spectacles. A 1 diopter increase in myopic spherical equivalent was associated with more than a twofold increase in the odds of wearing spectacles [odds ratio (OR) = 2.5, 95% confidence interval (CI) = 1.7 to 3.7]. Among non-myopic participants, increasing amounts of astigmatism in the better- and worse-seeing eye were associated with an increased likelihood of spectacle wear (p ≤ 0.02). In multivariate analysis, only poorer uncorrected acuity in the better-seeing eye (p < 0.001) and shorter acceptance time (p = 0.007) were found to be significantly associated with spectacle wear. For each line of poorer uncorrected acuity in the better-seeing eye, the likelihood that the participant was wearing spectacles increased by 60% (adjusted odds ratio = 1.6; 95% CI = 1.4 to 1.8). Not surprisingly, participants who reported never getting used to their spectacles were less likely to be wearing spectacles than those who reported getting used to wearing glasses in a few days (adjusted OR = 5.7, 95% CI = 1.9 to 17.5). CONCLUSIONS: Despite being provided with two pairs of spectacles, loss and breakage were the most commonly reported reasons for not wearing spectacles. The best predictive factor for determining whether participants were wearing spectacles was their uncorrected acuity.

Trends in health status and health care use among older men.

OBJECTIVES: This report examines trends in health status and risk factors, health care utilization, and health care expenditures among older men in the United States. METHODS: The estimates in this report are based on data from the National Vital Statistics System, National Health Interview Survey, National Health and Nutrition Examination Survey, National Health Care Surveys, Medicare Current Beneficiary Survey, and Current Population Survey. Trends in death rates, prevalence of chronic conditions, risk factors, vaccinations, health care utilization, and expenditures are summarized. Major differences in these indicators are described for older men and women and by age, race, and Hispanic origin. RESULTS: The difference in life expectancy between older men and women has narrowed since 1980, but a gap remains. Older men have lower hypertension and cholesterol levels and exercise regularly at higher rates than older women; however, the rates of obesity and cigarette smoking are similar in older men and women. Although health status has improved for all racial and ethnic groups, racial and ethnic disparities remain for many indicators. Older men and women have similar rates of hospital admissions and visits to emergency departments and physician offices.