Original Article
The Michigan Vision-Related Anxiety Questionnaire: A Psychosocial Outcomes Measure for Inherited Retinal Degenerations

https://doi.org/10.1016/j.ajo.2020.12.001Get rights and content

Highlights

  • The present article describes the development of the Michigan Vision-related Anxiety Questionnaire (MVAQ).

  • MVAQ is a patient-reported outcomes measure specific to inherited retinal degenerations.

  • The novel MVAQ measures is available for screening and monitoring psychosocial health in the context of visual function.

Objective

We sought to construct and validate a patient-reported outcome measure for screening and monitoring vision-related anxiety in patients with inherited retinal degenerations.

Design

Item-response theory and graded response modeling to quantitatively validate questionnaire items generated from qualitative interviews and patient feedback.

Methods

Patients at the Kellogg Eye Center (University of Michigan, Ann Arbor, Michigan, USA) with a clinical diagnosis of an inherited retinal degeneration (n = 128) participated in an interviewer-administered questionnaire. The questionnaire consisted of 166 items, 26 of which pertained to concepts of “worry” and “anxiety.” The subset of vision-related anxiety questions was analyzed by a graded response model using the Cai Metropolis–Hastings Robbins–Monro algorithm in the R software mirt package. Item reduction was performed based on item fit, item information, and item discriminability. To assess test–retest variability, 25 participants completed the questionnaire a second time 4 to 16 days later.

Results

The final questionnaire consisted of 14 items divided into 2 unidimensional domains: rod function anxiety and cone function anxiety. The questionnaire exhibited convergent validity with the Patient Health Questionnaire for symptoms of depression and anxiety. This vision-related anxiety questionnaire has high marginal reliability (0.81 for rod-function anxiety, 0.83 for cone-function anxiety) and exhibits minimal test–retest variability (ρ = 0.81 [0.64-0.91] for rod-function anxiety and ρ = 0.83 [0.68-0.92] for cone-function anxiety).

Conclusions

The Michigan Vision-Related Anxiety Questionnaire is a psychometrically validated 14-item patient-reported outcome measure to be used as a psychosocial screening and monitoring tool for patients with inherited retinal degenerations. It can be used in therapeutic clinical trials for measuring the benefit of an investigational therapy on a patient's vision-related anxiety.

Section snippets

Methods

Approval from the University of Michigan Institutional Review Board (HUM00115127) was obtained before the study and the research was performed in accordance with the Declaration of Helsinki. Participants were English speakers, ≥18 years of age, and were able to provide informed consent. Participants were recruited during routine clinical visits from December 2016 to March 2020 at the Kellogg Eye Center (University of Michigan, Ann Arbor, Michigan, USA) Retinal Dystrophy Clinic, and had a

Phase 1: Item Generation

Fifty-five adult patients with IRDs were interviewed to generate content items targeting 4 conceptual domains pertaining to visual function.11 Repeated patient feedback in the early interviews revealed a need to address themes of worry and anxiety, which prompted the generation of items targeting vision-related anxiety.

Phase 2: Administration

One hundred twenty-eight patients with IRDs were asked items pertaining to vision-related anxiety in functional daily tasks. Participant characteristics are shown in Table 1.

Discussion

In the era of emerging IRD therapeutics, the development of standardized, validated, and reliable outcome measures is critically important.21 Previously, patients with IRDs had minimal treatment options, but recent scientific progress has led to numerous therapeutics under development, including novel gene therapies.21, 22, 23 Furthermore, as critical evaluation of potential therapeutics are required, investigators and clinicians must consider how treatment efficacy can be measured in a way

Conclusion

The current study shows psychometric validation of items pertaining to vision-related anxiety in patients with IRDs and collectively form the MVAQ. The MVAQ measures vision-related anxiety related to dysfunction in either a predominantly cone pathway or a rod pathway. It can be used as a screening tool to direct the attention of a clinician to counseling and psychosocial interventions, as well as to measure baseline and follow-up vision-related anxiety for targeted low vision rehabilitation and

CRediT authorship contribution statement

Gabrielle D. Lacy: Conceptualization, Methodology, Investigation, Writing - original draft, Visualization, Project administration. Maria Fernanda Abalem: Conceptualization, Methodology, Investigation, Writing - original draft, Supervision, Project administration. Chris A. Andrews: Methodology, Formal analysis, Investigation, Writing - original draft, Visualization. Rebhi Abuzaitoun: Investigation, Writing - review & editing. Lilia T. Popova: Conceptualization, Investigation. Erin P. Santos:

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