Bilingual randomized controlled trial design, of a telephone-based intervention to promote rehabilitation adherence; A study focus on recruitment of Hispanic children with traumatic brain injury.

BACKGROUND: While Hispanic children experience large long-term disparities in disability after traumatic Brain Injury (TBI), there is a gap in evidenced-based interventions to improve outcomes among this rapidly growing and at high-risk population. We developed and pilot tested a bilingual/bicultural intervention informed by Hispanic families consisting of Brain Injury Education and outpatient Navigation (1st BIEN). It integrates bilingual in-person education enriched by video content delivered through mobile phone devices, with outpatient navigation by bilingual and bicultural navigators during transitions of care and school return. METHODS: Randomized controlled trial to test the efficacy of 1st BIEN to maintain long-term adherence to rehabilitation and determine its effect on children's functional outcomes. The primary outcome is treatment adherence at 6 months post-discharge at centralized acute facilities and community providers. Secondary outcomes are functional status of the child using PROMIS parental report measures and parental health literacy, self-efficacy, and mental health; measured at baseline (pre-injury and discharge) 3-,6- and 12- months post discharge. Children's academic performance is assessed using school records the year before and the year after injury. DISCUSSION: Our study evaluates a novel, flexible and scalable approach using mobile phone devices to aid transitions of care, increase treatment adherence and improve TBI outcomes. It addresses the needs of an understudied population and builds upon their strengths. It is implemented by a bilingual and bicultural team with a deep understanding of the study population. It can serve as a model for TBI family centered interventions for at risk groups. TRIAL REGISTRATION: ClinicalTrials.govNCT05261477. Registered on March 2, 2022.

Web-Based Survey Piloting Process as a Model for Developing and Testing Past Contraceptive Use and Pregnancy History: Cystic Fibrosis Case Study.

BACKGROUND: Individuals with complex, chronic diseases are now living longer, making reproductive health an important topic to address in the health care setting. Self-respondent surveys are a feasible way to collect past contraceptive use and pregnancy history to assess contraceptive safety and effectiveness. Because sensitive topics, such as contraception and pregnancy outcomes, can vary across social groups or cultures, piloting questions and evaluating survey administration procedures in the target population are necessary for precise and reliable responses before wide distribution. OBJECTIVE: This study aimed to develop a precise and reliable survey instrument and related procedures among individuals with cystic fibrosis regarding contraceptive use and obstetrical history. METHODS: We piloted and tested web-based questions related to contraceptive use and pregnancy history among 50 participants with and those without cystic fibrosis aged 18 to 45 years using a 3-tier process. Findings from each tier informed changes to the questionnaire before testing in the subsequent tier. Tier 1 used cognitive pretesting to assess question understanding and the need for memory prompts. In tier 2, we used test-retest self- and interviewer-administered approaches to assess question reliability, evaluate response missingness, and determine confidence between 2 types of survey administration approaches. In tier 3, we tested the questionnaire for clarity, time to complete, and whether additional prompts were necessary. RESULTS: In tier 1, respondents suggested improvements to the web-based survey questions and to the written and visual prompts for better recall regarding past contraceptive use. In tier 2, the test-retest reliability between self- and interviewer-administrative procedures of "ever use" contraceptive method questions was similar, with percent absolute agreement ranging between 84% and 100%. When the survey was self-administered, the percentage of missing responses was higher and respondent confidence about month and year when contraceptive methods were used was lower. Most respondents reported that they preferred the self-administered survey because it was more convenient and faster to complete. CONCLUSIONS: Our 3-tier process to pilot web-based survey questions related to contraceptive and obstetrical history in our complex disease population helped us tailor content and format questions before wide dissemination to our target population. Results from this pilot study informed the subsequent larger study design to include a 10% respondent test-retest self- and interviewer-administered quality control component to better inform imputation procedures of missing data.

Planning for Long-Term Follow-Up: Strategies Learned from Longitudinal Studies.

Preventive interventions are often designed and tested with the immediate program period in mind, and little thought that the intervention sample might be followed up for years or even decades beyond the initial trial. However, depending on the type of intervention and the nature of the outcomes, long-term follow-up may well be appropriate. The advantages of long-term follow-up of preventive interventions are discussed and include the capacity to examine program effects across multiple later life outcomes, the ability to examine the etiological processes involved in the development of the outcomes of interest, and the ability to provide more concrete estimates of the relative benefits and costs of an intervention. In addition, researchers have identified potential methodological risks of long-term follow-up such as inflation of type 1 error through post hoc selection of outcomes, selection bias, and problems stemming from attrition over time. The present paper presents a set of seven recommendations for the design or evaluation of studies for potential long-term follow-up organized under four areas: Intervention Logic Model, Developmental Theory and Measurement Issues; Design for Retention; Dealing with Missing Data; and Unique Considerations for Intervention Studies. These recommendations include conceptual considerations in the design of a study, pragmatic concerns in the design and implementation of the data collection for long-term follow-up, as well as criteria to be considered for the evaluation of an existing intervention for potential for long-term follow-up. Concrete examples from existing intervention studies that have been followed up over the long term are provided.

Use of Web and Phone Survey Modes to Gather Data From Adults About Their Young Adult Children: An Evaluation Based on a Randomized Design.

Mode effects on responses to survey items may introduce bias to data collected using multiple modes of administration. The present study examines data from 704 surveys conducted as part of a longitudinal study in which parents and their children had been surveyed at multiple prior time points. Parents of 22-year-old study participants were randomly assigned to one of two mixed-mode conditions: (a) Web mode first followed by the offer of an interviewer-administered telephone mode; or (b) telephone mode first followed by the offer of the Web mode. Comparison of responses by assigned condition on 12 measures showed one statistically significant difference. Analyses that modeled differences by completed mode and the interaction between assigned condition and completed mode found significant differences on six measures related to completed mode. None of the differences indicated that more socially desirable responses were given in interviewer-administered surveys.