Quantifying burden of intravitreal injections: questionnaire assessment of life impact of treatment by intravitreal injections (QUALITII).

AIM: To quantify the areas of burden experienced by patients requiring repeated intravitreal injections (IVI) in the management of exudative retinal diseases. METHODS: The validated Questionnaire to Assess Life Impact of Treatment by Intravitreal Injections survey was administered to patients at four retina clinical practices across four US states. The primary outcome measure was Treatment Burden Score (TBS), a single score assessing overall burden. RESULTS: Of 1416 (n=657 age-related macular degeneration; n=360 diabetic macular oedema/diabetic retinopathy; n=221 retinal vein occlusion; n=178 other/uncertain) patients, 55% were women with an average age of 70 years. Patients most frequently reported receiving IVI every 4-5 weeks (40%). The mean TBS was 16.1±9.2 (range 1-48; scale of 1-54), and the TBS was higher in patients with diabetic macular oedema and/or diabetic retinopathy (DMO/DR) (17.1) compared with those with age-related macular degeneration (15.5) or retinal venous occlusive (15.3) (p=0.028). Though the mean level of discomfort was quite low (1.86) (scale 0-6), 50% of patients reported experiencing side effects more than half of the visits. Patients having received fewer than 5 IVI reported higher mean anxiety levels before (p=0.026), during (p=0.050) and after (p=0.016) treatment compared with patients having received more than 50 IVI. After the procedure, 42% of patients reported restrictions from usual activities due to discomfort. Patients reported a high mean satisfaction rating of 5.46 (scale 0-6) with the care of their diseases. CONCLUSIONS: The mean TBS was moderate and highest among patients with DMO/DR. Patients with more total injections reported lower levels of discomfort and anxiety but higher disruption to daily life. Despite the challenges related to IVI, the overall satisfaction with treatment remained high.

Questionnaire to Assess Life Impact of Treatment by Intravitreal Injections (QUALITII): Development of a patient-reported measure to assess treatment burden of repeat intravitreal injections.

OBJECTIVE: To understand patient burden of treatment of repeated intravitreal injections (IVI) in the management of exudative retinal diseases. METHODS AND ANALYSIS: Participants were sampled from a large urban retina specialty practice in Houston, Texas, USA, based on history of ongoing receipt of IVI. The 50-item Questionnaire to Assess Life Impact of Treatment by Intravitreal Injections questionnaire was developed to evaluate the patient experience including discomfort, anxiety, inconvenience and satisfaction. Categorial principal components analysis (CATPCA) was performed to assess construct validity and internal consistency. A subset of these items was used to establish a measure of total treatment burden, referred to as the IVI Treatment Burden Score (TBS). RESULTS: 142 patients participated in this study. CATPCA analysis revealed five dimensions of patient burden: disruption of normal routine or capacity, anxiety, frequency of visits, chronicity of disease and perceived treatment value or satisfaction. Together, these dimensions accounted for 67% of variance explained. Cronbach's alpha was 0.97. The most frequently cited cause of discomfort was the feeling after anaesthetic wore off. The most common source of anxiety was fear of injection and associated discomfort or pain. Regarding inconvenience, patients reported temporary postinjection debilitation, requiring an average of 8 hours for recovery per treatment. The most frequently identified sources of satisfaction were confidence in the provider or treatment and interactions with staff. CONCLUSIONS: Understanding and quantifying the patient burden associated with repeated IVI for exudative retinal diseases can reveal opportunities to improve delivery methods. The TBS could serve to inform strategies to maximise treatment adherence and optimise patient experiences.

Factor structure models for the Post-Concussion Syndrome Scale with monolingual Spanish-speaking adults from Colombia.

PRIMARY OBJECTIVE: The Post-Concussion Syndrome Scale (PCSS) is a self-report questionnaire that measures post-concussive symptom severity and has been primarily normed on young Caucasian samples. This study aims to explore the factor structure models of a Spanish translation of the PCSS at a chronic post-traumatic brain injury (TBI) time point. RESEARCH DESIGN: Descriptive and exploratory research designs were utilized. METHODS AND PROCEDURES: The study consisted of a monolingual sample of Spanish-speaking adults from Colombia, with 100 subjects in the control group and 70 subjects in the TBI group. A t-test, chi-square, and MANOVA were calculated to compare group differences. Cronbach's alpha was calculated to investigate reliability. Confirmatory factor analysis compared item loadings onto an existing four-factor model. Exploratory factor analysis sought to identify a new factor model if the loadings did not fit. MAIN OUTCOMES AND RESULTS: There were no group differences in demographic variables. Internal consistency was acceptable. Model fit indices revealed a poor fit with the original four factors. Item loadings revealed a novel six-structure model. CONCLUSIONS: While the PCSS appears to capture general post-TBI sequelae, the underlying factors may differ due to cultural and linguistic differences in Spanish-speaking individuals. Clinical implications and future directions are further discussed.