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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.