Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There is one clinical trial.
The purpose of this study is to determine the effects of health literacy on questionnaire-based measurement.
Description: A primary outcome of this study will be the degree of DIF in NIH PROMIS questionnaires observed across adequate versus low health literacy. The outcome will be measured by a McFadden pseudo-R-square, which captures the degree to which health-literacy group determines probability of response type for each item. PROMIS has the following subscales: Physical function, Anxiety, Depression, Fatigue, Sleep disturbance, Ability to participate in social roles and activities, Pain interference, Pain intensity. For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). PROMIS is scaled by T-scores, referenced against the mean of the US population. Items are aggregated using item response theory, but aggregation is not relevant to this study because the McFadden pseudo-R-square is evaluated for each item. Pain intensity will not be included because it is only 1 item and is not amenable to DIF.
Measure: The degree of differential item functioning (DIF) in NIH Patient-Reported Outcomes Measurement Information System (PROMIS Profile 57 v 2.0) Time: 6 monthsDescription: A primary outcome of this study will be the degree of DIF observed in the Berlin Questionnaire across adequate versus low health. The outcome will be measured by a McFadden pseudo-R-square, which captures the degree to which health-literacy group determines probability of response type for each item. For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). Thus, the unit of measure is one standard deviation. Normally items are aggregated by a sum score, but the aggregation is not relevant to this study because the McFadden pseudo-R-square is evaluated for each item, not for aggregate scores.
Measure: The degree of differential item functioning (DIF) in the Berlin Questionnaire (sleep) Time: 6 monthsDescription: A primary outcome of this study will be the degree of DIF observed in the NIH Toolbox - Meaning and Purpose questionnaire across adequate versus low health literacy, determined by Health LiTT. The outcome will be measured by a McFadden pseudo-R-square, which captures the degree to which health-literacy group determines probability of response type for each item. For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). Thus, the unit of measure is one standard deviation. Normally items are aggregated by a score determined by an item response theory scoring algorithm using a two-parameter model. It should be noted that the aggregation is not relevant to this study because the McFadden pseudo-R-square is evaluated for each item, not for aggregate scores. By convention NIH Toolbox scores are rescaled to T scores (mean = 50, Standard Deviation (SD) = 10 by definition), referenced against the mean of the US population.
Measure: NIH Toolbox - Meaning and Purpose Time: 6 monthsDescription: A primary outcome of this study will be the degree of DIF observed in the PCL-5 (PTSD checklist) across adequate versus low health literacy, determined by the Health Literacy Assessment Using Talking Touchscreen Technology (Health LiTT). The PCL-5 is a questionnaire used to determine the presence of PTSD and severity of PTSD. The outcome will be measured by a McFadden pseudo-R-square, which captures the degree to which health-literacy group determines probability of response type for each item. For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). Thus, the unit of measure is one standard deviation. Normally items are aggregated by a sum score, but the aggregation is not relevant to this study because the McFadden pseudo-R-square is evaluated for each item, not for aggregate scores.
Measure: Posttraumatic Stress Disorder Checklist (PTSD Checklist/PCL-5) Time: 6 monthsDescription: A primary outcome of this study will be the degree of DIF observed in the RRS across adequate versus low health literacy, determined by Health LiTT. The RRS is a questionnaire used to quantify the degree to which the participant ruminates. The outcome will be measured by a McFadden pseudo-R-square, which captures the degree to which health-literacy group determines probability of response type for each item. For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). Thus, the unit of measure is one standard deviation. Normally items are aggregated by a sum score, but the aggregation is not relevant to this study because the McFadden pseudo-R-square is evaluated for each item, not for aggregate scores.
Measure: Ruminative Responses Scale (RRS; 10-item version) Time: 6 monthsDescription: A primary outcome of this study will be the degree of DIF observed in the Patient Health Questionnaire (PHQ-9), a questionnaire used to measure depression, across adequate versus low health literacy. The outcome will be measured by a McFadden pseudo-R-square, which captures the degree to which health-literacy group determines probability of response type for each item. For DIF analysis, each scale is normalized to a theta metric (mean = 0, standard dev. = 1 by definition). Thus, the unit of measure is one standard deviation. Normally items are aggregated by a sum score, but the aggregation is not relevant to this study because the McFadden pseudo-R-square is evaluated for each item, not for aggregate scores.
Measure: Patient Health Questionnaire (PHQ-9) Time: 6 monthsDescription: At the end of the 6-month study, each participant will provide information about their experience during testing. There are about 1) Comfort, 2) Difficulty, and 3) Nervousness. Each items is rated on a 5-point scale. Investigators will treat these data as ordinal and thus no unit of measure is assumed. Investigators will evaluate this outcome using non-parametric statistics, that is, a Spearman correlation between rating and whether the participant received the talking touchscreen (coded 0 or 1). These items will be administered verbally by a research coordinator. Investigators predict that participant's receiving the talking touchscreen will report high levels of comfort, less difficulty, and less nervousness. Investigators will evaluate statistical significance using a 99% confidence interval, rejecting the null hypothesis if this interval does not contain zero. The items will not be aggregated; each item will be analyzed separately.
Measure: Exit interview: Participant comfort during assessment Time: 6 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports