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Table 3 Study outcomes, outcome measures, and data analysis methods by domain

From: Evaluating a knowledge translation tool for parents about pediatric acute gastroenteritis: a pilot randomized trial

Study domain

Outcomes and outcome measures

Data analysis methods

Scientific domain

Quantitative: Parental knowledge will be evaluated using an 8-item knowledge questionnaire developed by the research team. This questionnaire was informed by the abridged Caregiver Gastroenteritis Knowledge Questionnaire (CGKQ) [55] and tailored to key content in the experimental intervention video. It has been piloted with the target population (n = 15) and revised for clarity. It takes approximately 2.5 min to complete.

Correct responses will be given a score of one and are summed for a final score (0–8).

Quantitative: Decision regret will be measured by the Decision Regret Scale comprised of five, 5-point Likert items. Internal consistency and validity have been demonstrated and it is a useful tool for measuring regret after health care treatment decisions, is easy to administer, takes less than 1 min to complete, and results in very few missing responses [56].

Items are scored individually and converted to a 0–100 scale following instructions in the user manual [57]. Items are summed and averaged for a final score, with regret increasing with a higher score.

Quantitative: MCIDs will be calculated for the parental knowledge questionnaire and the decision regret scale using two methods: (1) data-driven approach and (2) patient-perspective [58].

Using a data driven approach, the standard error of measurement will be used as a proxy for the MCID. Using a patient perspective, patients will make global ratings on their own change via Likert items in post-intervention questionnaires 1 and 2. Both approaches will be compared to quantified changes in outcome measures and absolute change for both will be calculated [58].

Quantitative: Post-ED healthcare utilization will be assessed by three items developed by the research team.

Descriptive statistics will be calculated.

Quantitative: The perceived benefit and value of the KT intervention for pediatric AGE will be evaluated using four items developed by the research team and by examining the number of participants that request a video link after questionnaire 1.

Descriptive statistics will be calculated.

Qualitative: The perceived benefit and value of the KT intervention for pediatric AGE will be also evaluated via a qualitative interview with a convenience sample of volunteer parents from the experimental intervention group.

Thematic analysis of interview data will be conducted.

Process domain

Quantitative: Consent rate will be measured by (1) percentage of people approached who consent to participate and (2) timing (date, time of day) of refusals.

Descriptive statistics will be calculated.

Quantitative: Recruitment rate will be measured by (1) percentage of people who consented to participate and complete pre-intervention questionnaire, post-intervention questionnaire 1, post intervention questionnaire 2, and qualitative interview; and (2) timing (date, time of day) of recruitment.

Descriptive statistics will be calculated.

Quantitative: Data completion will be measured by (1) percentage of missing/blank survey items and (2) percentage of drop-outs at post-intervention questionnaire 2.

Descriptive statistics will be calculated.

Qualitative: Satisfaction with electronic platform will be evaluated in the qualitative semi-structured interview with a convenience sample of volunteer parents from the experimental intervention group.

Thematic analysis of interview data will be conducted.

Management domain

Quantitative: Data quality will be measured by number, type, and duration of technical problems (i.e., error messages, problems with internet connectivity, and lost data) with an online platform throughout the study period.

Descriptive statistics will be calculated.

Qualitative: Parents’ willingness to participate in future, similar research will be evaluated by a qualitative interview with a convenience sample of volunteer parents from the experimental intervention group.

Thematic analysis of interview data will be conducted.

Resource domain

Quantitative: Time to collect data will be measured by (1) average length of time to complete study questionnaires and (2) average length of time (days) to complete post-intervention questionnaire 2 post-discharge.

Descriptive statistics will be calculated.

Quantitative: The feasibility of using iPads to collect data in the ED with parents/caregivers will be measured by tracking the number of broken, lost, or stolen iPads, iPad chargers (including cord and plug), iPad cases, and WiFi hubs.

Descriptive statistics will be calculated.