Diabetic Retinopathy and Macular Edema Quality-of-Life Item Banks: Development and Initial Evaluation Using Computerized Adaptive Testing

Fenwick, Eva; Khadka, Jyoti; Pesudovs, Konrad; Rees, Gwyn; Wong, Tien Yin; Lamoureux, Ecosse L.

doi:10.1167/iovs.16-20950

Cited by 32 publications

(52 citation statements)

References 46 publications

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“…Diabetic macular edema (DME) is one of the major causes of visual loss in patients with diabetes mellitus [4,5] and it has a huge impact on the life quality of patients [6]. e treatment of DME still remains controversial [4,7].…”

Section: Introductionmentioning

confidence: 99%

Combination of Intravitreal Bevacizumab and Topical Dorzolamide versus Intravitreal Bevacizumab Alone for Diabetic Macular Edema: A Randomized Contralateral Clinical Trial

Fazel

Nikpour

Pourazizi

2020

BioMed Research International

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Purpose. To evaluate the efficacy of three intravitreal bevacizumab (IVB) injections versus the same combined with 2% of topical dorzolamide in the treatment of diabetic macular edema (DME). Methods. In this randomized double-masked clinical trial, 32 eyes of 16 treatment-naive patients with bilateral DME were enrolled. The eyes were randomly assigned to receive three monthly injections of IVB (1.25 mg) plus topical dorzolamide 2% twice daily or IVB (1.25 mg) plus topical artificial tear twice daily. Best-corrected visual acuity (BCVA) was the primary outcome of the study followed by the central macular thickness (CMT) and central macular volume (CMV) as the secondary outcomes. Results. Mean BCVA changes were insignificant in both groups. It changed from 0.21 ± 0.08 logMAR at baseline to 0.23 ± 0.09 (P=0.24) in the combination group and from 0.18 ± 0.09 logMAR to 0.21 ± 0.09 (P=0.11) in the IVB alone group, at 3 months, respectively. Changes in mean CMT and CMV were significant in both groups. However, the difference between the groups was not significant at all the visits. In the study, no major ocular complication or systemic side effects were noted regarding IVB or topical dorzolamide. Conclusion. This randomized contralateral clinical trial demonstrated that adjuvant topical dorzolamide with IVB injection had no additional effects on IVB in the treatment of DME over a three-month course. This trial is registered with the Iranian Registry of Clinical Trials under the registration code IRCT20131229015975N5.

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Section: Introductionmentioning

confidence: 99%

Combination of Intravitreal Bevacizumab and Topical Dorzolamide versus Intravitreal Bevacizumab Alone for Diabetic Macular Edema: A Randomized Contralateral Clinical Trial

Fazel

Nikpour

Pourazizi

2020

BioMed Research International

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“…The CAT also creates on opportunity for electronic implementation via digital portals including smart phones for real time scoring and recording of data. Such systems have been widely developed across different health elds [20,48,51,53]. This study adds to the previous study reported upon by the PROMIS group conducted in adult populations by providing early evidence that item banking is feasible in the development of HRQoL instruments that may subsequently be applied in health economics context [14,22].…”

Section: Discussionmentioning

confidence: 77%

“…However, the removal of the four items reduced the precision of the item bank, which suggests that these items were adding more signal than noise, hence they were retained. Similar approaches were utilised to tackle item clustering and multi-dimensionality while developing item banks in other health elds [20,48]. It is found that when a range of items representing different HRQoL dimensions pooled together a valid unidimensional latent scale was identi ed.…”

Section: Discussionmentioning

confidence: 99%

Exploring the potential for item banking in assessing quality of life for evaluating adolescent health interventions

Khadka

Chen

Ratcliffe

2020

Preprint

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Background To develop and validate an item bank using existing items from both preference and non-preference-based health-related quality of life (HRQoL) instruments targeted for application with adolescent populations. Methods Australian adolescents completed the Child Health Utility 9D (CHU9D), demographic details, self-rated health status, disability and one other instrument (either preference-based: Health Utilities Index (HUI) or EuroQoL-5 Dimension-Youth (EQ-5D-Y) or Assessment of Quality of Life (AQoL)-6D Adolescent or non-preference-based: Pediatric Quality of Life Inventory (PedsQL) Short Form 15 or KIDSCREEN-10) using online survey portals. Data from all the instruments were pooled together to create an item bank, which was then subjected to Rasch analysis to tests its psychometric properties. Validity of the item bank was assessed by testing its ability to discriminate varying levels of self-reported health, disability and socio-economic status (as approximated by the Family Affluence Scale). Results A total of 4,352 Australian adolescents aged 11–17 years from the general population participated. The CHU9D (common instrument) items were used as anchor items to create the item bank. Rasch analysis demonstrated that 2 of the 75 items (2.7%) misfit and were removed from the item bank. The 73-item item bank had adequate precision, no misfitting items, no item bias and demonstrated sufficient unidimensionality. In general boys exhibited higher HRQoL scores than girls (p = 0.001). More severe health status/disability and lower socio-economic status being associated with lower HRQoL (p < 0.0001). Conclusions The item bank demonstrated adequate Rasch-based psychometric properties and validity demonstrating the feasibility of the construction of an item bank in this context. The addition of more targeted items for adolescents in the general population and the addition of participants with more health impairments may improve the general applicability of the item bank for both general population and patient cohorts.

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“…Moreover, with automated scoring and realtime feedback, CATs are ideal for use in clinical and research settings. 11 In previously published work, we developed and psychometrically tested item banks to measure the impact of DR across ten domains of QoL, [12][13][14] and based on these promising findings, we subsequently developed ten final CATs. The aim of the current study is to evaluate the performance of our ten DR-QoL CATs-"RetCAT"-in a clinical sample of patients across the severity spectrum of DR, following the approach outlined in previous similar studies in other health fields.…”

Section: Introductionmentioning

confidence: 99%

Computerized Adaptive Tests: Efficient and Precise Assessment of the Patient-Centered Impact of Diabetic Retinopathy

Fenwick

Barnard

Gan

et al. 2020

Trans. Vis. Sci. Tech.

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Evaluate efficiency, precision, and validity of RetCAT, which comprises ten diabetic retinopathy (DR) quality of life (QoL) computerized adaptive tests (CATs). Methods: In this cross-sectional clinical study, 183 English and/or Mandarin-speaking participants with DR (mean age ± standard deviation [SD] 56.4 ± 11.9 years; 38% proliferative DR [worse eye]) were recruited from retinal clinics in Singapore. Participants answered the RetCAT tests (Symptoms, Activity Limitation, Mobility, Emotional, Health Concerns, Social, Convenience, Economic, Driving, and Lighting), which were capped at seven items each, and other questionnaires, and underwent eye tests. Our primary evaluation focused on RetCAT efficiency (i.e. standard error of measurement [SEM] ± SD achieved and time needed to complete each CAT). Secondary evaluations included an assessment of RetCAT's test precision and validity. Results: Mean SEM across all RetCAT tests was 0.351, ranging from 0.272 ± 0.130 for Economic to 0.484 ± 0.130 for Emotional. Four tests (Mobility, Social, Convenience, and Driving) had a high level of measurement error. The median time to take each RetCAT test was 1.79 minutes, ranging from 1.12 (IQR [interquartile range] 1.63) for Driving to 3.28 (IQR 2.52) for Activity Limitation. Test precision was highest for participants at the most impaired end of the spectrum. Most RetCAT tests displayed expected correlations with other scales (convergent/divergent validity) and were sensitive to DR and/or vision impairment severity levels (criterion validity). Conclusions: RetCAT can provide efficient, precise, and valid measurement of DRrelated QoL impact. Future application of RetCAT will employ a stopping rule based on SE rather than number of items to ensure that all tests can detect meaningful differences in person abilities. Responsiveness of RetCAT to treatment interventions must also be determined. Translational Relevance: RetCAT may be useful for measuring the patient-centered impact of DR severity and disease progression and evaluating the effectiveness of new therapies.

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Diabetic Retinopathy and Macular Edema Quality-of-Life Item Banks: Development and Initial Evaluation Using Computerized Adaptive Testing

Abstract: Our eight psychometrically robust and efficient DR/DME item banks will enable researchers and clinicians to accurately assess the impact and effectiveness of treatment therapies for DR/DME in all areas of QoL.

Cited by 32 publications

References 46 publications

Combination of Intravitreal Bevacizumab and Topical Dorzolamide versus Intravitreal Bevacizumab Alone for Diabetic Macular Edema: A Randomized Contralateral Clinical Trial

Combination of Intravitreal Bevacizumab and Topical Dorzolamide versus Intravitreal Bevacizumab Alone for Diabetic Macular Edema: A Randomized Contralateral Clinical Trial

Exploring the potential for item banking in assessing quality of life for evaluating adolescent health interventions

Computerized Adaptive Tests: Efficient and Precise Assessment of the Patient-Centered Impact of Diabetic Retinopathy

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