AE Reporting and Causality

Adverse effects may be related, unrelated, or unknown in relation to a vaccine and may range from self-limited mild reactions to permanent sequelae. The causal inference of any adverse effect to a vaccine is based on assessing the strength of association, temporal response, consistency and specificity of the association, and biological plausibility. Safety evaluation depends on accurate reporting of adverse events during pre-licensure studies and post-licensure surveillance.

Developing a Framework for the Examination of Anchoring Vignette Assumptions Using Cognitive Interviews: A Demonstration in the ICT Skills Domain

Self-assessment measures are commonly used in questionnaire surveys. However, one of the problems with self-reports is that they may be prone to differences in scale usage among respondents. The anchoring vignette method addresses this issue. It relies on two assumptions: response consistency and vignette equivalence. Here we aim to develop a framework for the examination of these assumptions using cognitive interviews and demonstrate it in the Information and Communications Technology (ICT) skills domain. First, we develop new anchoring vignettes describing various ICT skill domains. Second, we examine both assumptions using cognitive interviews with students who are studying different fields. Our analysis shows that the assumptions are indeed not adhered to, especially the assumption of vignette equivalence. Third, we develop a general framework for the examination of the method’s assumptions.

Comparisons of Auditory Brainstem Responses Between a Laboratory and Simulated Home Environment

Purpose Miniaturization of digital technologies has created new opportunities for remote health care and neuroscientific fieldwork. The current study assesses comparisons between in-home auditory brainstem response (ABR) recordings and recordings obtained in a traditional lab setting. Method Click-evoked and speech-evoked ABRs were recorded in 12 normal-hearing, young adult participants over three test sessions in (a) a shielded sound booth within a research lab, (b) a simulated home environment, and (c) the research lab once more. The same single-family house was used for all home testing. Results Analyses of ABR latencies, a common clinical metric, showed high repeatability between the home and lab environments across both the click-evoked and speech-evoked ABRs. Like ABR latencies, response consistency and signal-to-noise ratio (SNR) were robust both in the lab and in the home and did not show significant differences between locations, although variability between the home and lab was higher than latencies, with two participants influencing this lower repeatability between locations. Response consistency and SNR also patterned together, with a trend for higher SNRs to pair with more consistent responses in both the home and lab environments. Conclusions Our findings demonstrate the feasibility of obtaining high-quality ABR recordings within a simulated home environment that closely approximate those recorded in a more traditional recording environment. This line of work may open doors to greater accessibility to underserved clinical and research populations.

Sexually Transmitted Infection Knowledge among Older Adults: Psychometrics and Test–Retest Reliability

Sexually transmitted infections (STI) among older adults have dramatically increased in recent years, especially among those who are widowed and divorced. The purposes of this study were to: (1) identify STI-related knowledge among older adults; (2) report the psychometric properties of a tool commonly used to assess STI-related knowledge among younger populations using data from adults 65 years and older; and (3) determine test-retest reliability of the tool. Data were analyzed from 43 adults, aged 65–94 years, using the 27-item Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ). Participants completed identical instruments on two separate days with approximately two weeks between. After responses were coded for correctness, composite scores were created. Cronbach’s reliability coefficients were calculated to determine response consistency, and Pearson’s r coefficients were used to assess test–retest reliability. Of 27 possible correct answers, participants reported an average of 11.47 (±6.88) correct responses on Day 1 and 11.67 (±7.33) correct responses on Day 2. Cronbach’s alpha coefficients for the 27-item composite scale were high for both days (0.905 and 0.917, respectively), which indicates strong response consistency. Pearson’s r coefficients were high between responses for the 27-item composite scale on Days 1 and 2 (r = 0.882, P < 0.01), which indicates strong test–retest reliability. Pearson’s r coefficients were high between responses for all but three of the 27 items when assessed separately. Findings suggest the utility of the STD-KQ to assess STI knowledge among older adults. However, the consistently low knowledge scores highlight the need for educational interventions among this population.

Intelligence, consistency, and Emerson's dilemma

In a large representative sample of Swedish male conscripts (N = 49,246), we demonstrate a positive association between intelligence and response consistency on items measuring endorsement of a strong military defense. This association is accentuated, to some degree, by an apparent difficulty to handle reversed items among those with low intelligence. Consequently, due to regression toward the mean, reversed items in measurement instruments would tend to have a negative effect on statistical power when analyzing the association between whatever the instrument is measuring and intelligence. On the other hand, the presence of reversed items could mitigate bias in the measurement due to an acquiescent response style among those with low intelligence. Lack of motivation/carelessness and inadequate reading ability among some subjects are two possible confounders for the found association in the present study.

SEXUALLY TRANSMITTED INFECTION KNOWLEDGE AMONG OLDER ADULTS: PSYCHOMETRICS AND TEST-RETEST RELIABILITY

Sexually transmitted infections (STI) among older adults have dramatically increased in recent years, especially among those who are widowed and divorced. The purposes of this study were to: (1) identify STI-related knowledge among older adults; (2) report the psychometric properties of a tool commonly used to assess STI-related knowledge among youth and young adults; and (3) determine the test-retest reliability of the tool. Data were analyzed from 43 adults between the ages of 65 and 94 using a 27-item Sexually Transmitted Disease Knowledge Questionnaire (STD-KQ). Participants completed identical instruments on two separate days with approximately two weeks between. After responses were coded for correctness, composite scores were created. Cronbach’s reliability coefficients were calculated to determine response consistency, and Pearson’s r coefficients were used to assess test-retest reliability. Of 27 possible correct answers, participants reported an average of 11.6 (±6.6) correct responses on Day 1 and 11.7 (±7.3) correct responses on Day 2. Cronbach’s alpha coefficients for the 27-item composite scale were high for both days (0.89 and 0.92, respectively), which indicates strong response consistency. Pearson’s r coefficients were high between responses for the 27-item composite scale on Days 1 and 2 (r=0.88, P&lt;0.01), which indicates strong test-retest reliability. Pearson’s r coefficients were high between responses for all but three of the 27 items when assessed separately. Findings suggest the utility of the STD-KQ to assess STI knowledge among older adults. However, the consistently low knowledge scores highlight the need for educational interventions among this population.

Personal Problems Questionnaire (PPQ): Normative Data and Utility in Assessing Acquired Neurological Impairment

Objective The Personal Problems Questionnaire (PPQ) is a measure designed to assess acquired cognitive, emotional, and physical complaints. The present study sought to develop a normative database to allow clinicians and researchers to assess self-reported complaints among people with disabilities, and evaluate the response consistency and validity of their self-report. Method 404 community-dwelling participants (n 200 males, 204 females) completed the PPQ, as well as an acquired brain injury (ABI) group (n 59), mainly following stroke and traumatic brain injuries, and seen for clinical (i.e., non-forensic) evaluations. Multiple regression analyses were conducted to derive norms from the healthy community sample taking into account age, gender, and educational level. Results Normative T scores and cut-off points for the Clinical and Validity scales were derived, respectively, and used to assess the responses of the ABI group. The results indicated that the ABI group showed good response consistency and elevated scores on the Clinical scales, indicating that the PPQ is likely to be useful in detecting acquired disabilities. On the other hand, scores on the Validity scales were not elevated, indicating that the measures were unaffected by the ABI participants’ cognitive difficulties. Conclusions The PPQ provides a comprehensive assessment of complaints and response validity and the present study provides further data to assist with its use and interpretation.