Development and Validation of a Visual Symptom-Specific Patient-Reported Outcomes Instrument for Adults With Cataract Intraocular Lens Implants.

PURPOSE: To develop a patient-reported outcome measure for capturing visual and ocular symptoms before and after implantation of intraocular lenses (IOLs) for treatment of cataracts. DESIGN: Questionnaire development and validation study. METHODS: The Questionnaire for Visual Disturbances (QUVID) was developed based on a literature and instrument review; 13 clinician interviews among ophthalmologists in the United States and Europe; and 67 hybrid qualitative patient interviews among adult patients in the United States and Australia before and/or after monofocal, traditional multifocal, or trifocal IOL implantation. Assessment of the QUVID's psychometric properties was conducted via a noninterventional cross-sectional study of previously treated cataract patients in the United States, Canada, and Australia (n = 150), and assessment of ability to detect meaningful change via 2 pivotal US clinical trials among patients with trifocal or extended vision IOL compared with monofocal IOL controls (n = 457). RESULTS: The QUVID includes subitems about the bothersomeness of 7 visual symptoms: starburst, halo, glare, hazy vision, blurred vision, double vision, and dark areas. The postoperative version contains 1 item asking the respondents whether their symptoms bothered them enough to want another surgery, if the IOL was the cause. CONCLUSIONS: The QUVID was reviewed by the US Food and Drug Administration and found appropriate as a fit-for-purpose measure, demonstrating requisite evidence for content validity, construct validity, reliability, and ability to detect change.

Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation.

PURPOSE: To develop a questionnaire quantifying spectacle independence following cataract surgery. DESIGN: Questionnaire design and validation study. METHODS: A literature review, expert clinical interviews, and patient interviews were undertaken to develop a patient-reported questionnaire assessing spectacle independence. Draft items were assessed and revised in a series of cognitive interviews where the instructions, recall period, and response categories were evaluated for understandability and consistency. The final draft items were evaluated in 2 quantitative studies. Confirmatory factor analyses, including item response theory calibration, were performed; reliability estimates were obtained; and validity analyses of the resulting scores were carried out. RESULTS: Qualitative research demonstrated that patients often considered themselves spectacle independent yet, when probed, it was determined that the respondent actually wore correction for certain activities. Moreover, despite what the respondents claimed about needing to wear correction and their actual use of correction, there were various levels of function reported when carrying out activities at several different distances without the use of correction. Using the qualitative results, the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) was developed to assess spectacle independence via items that assess what patients say and do, and how they function at various distances. All quantitative analyses (eg, discriminant and convergent validity correlations, known-groups analyses) conform to predictions and support the use of the PRSIQ as a measure of spectacle independence. CONCLUSIONS: The PRSIQ is a patient-reported measure assessing spectacle independence following cataract surgery. The analyses conducted provide evidence for the use of the PRSIQ total score as a measure of spectacle independence.

Multiple trajectories of cigarette smoking and the intergenerational transmission of smoking: a multigenerational, longitudinal study of a Midwestern community sample.

OBJECTIVE: To investigate the relation between developmental phenotypes of parental smoking (trajectories of smoking from adolescence to adulthood) and the intergenerational transmission of smoking to their adolescent children. DESIGN: A longitudinal, multigenerational study of a midwestern community sample followed individuals from adolescence into adulthood and was combined with Web-based assessment of participants' spouses and adolescent children. Mixture modeling identified multiple trajectories of smoking, and path analyses related these trajectories to adolescents' smoking (beyond both parents' current smoking). Potential mediations were parental education and adolescents' personality characteristics. MAIN OUTCOME MEASURE: The outcome measure was adolescent smoking. RESULTS: A parent's smoking trajectory had a unique effect on their adolescent's smoking, beyond both parents' current smoking and the parent's educational attainment. However, although adolescents' personality characteristics were related both to adolescent smoking and to their parents' smoking, these characteristics could not explain the effects of the parent's smoking trajectory. CONCLUSION: Parents whose smoking had an early onset, steep acceleration, high levels of smoking, and persistence over time had the highest risk for intergenerational transmission of smoking to their adolescent children.

Coping skills and parent support mediate the association between childhood attention-deficit/hyperactivity disorder and adolescent cigarette use.

OBJECTIVE: To examine mediators of the association between childhood attention-deficit/hyperactivity disorder (ADHD) and adolescent cigarette use. METHOD: Participants were 142 adolescents diagnosed with ADHD in childhood and 100 adolescents without ADHD. RESULTS: Among probands, cigarette smoking was more frequent, adaptive coping skills (behavioral and cognitive) were fewer, and parental support was lower. Coping and support partially mediated the ADHD association with smoking. Persistence of ADHD and adolescent conduct disorder were also important. CONCLUSIONS: Vulnerability to smoking among probands may be partly due to fewer problem-solving resources. Coping skill deficits and parent-child communication may be important treatment targets for smoking prevention.