Article type
Abstract
"Background: CONSORT-EHEALTH highly recommends the reporting of participants’ digital literacy and recruitment strategies in digital health intervention (DHI) trials. Given the critical role of patients’ motivation in engaging with DHIs and the significant influence of expectations on treatment effects, paying attention to these factors is important.
Objectives: To develop a rating to capture patient motivation at baseline as study level information in DHI trials.
Methods: The rating was developed in a bottom-up approach using information that potentially reflects participants’ baseline motivation from a collection of DHI studies. Finally, we specified three indicators: indicator 1 captures whether the study team actively selects or enhances the motivation of the potential study participants; indicator 2 captures the study participants’ active engagement before the intervention allocation; and indicator 3 captures the potential bond and trust between the study participants and the person/institution referring to the study. The rating of each indicator and overall rating vary between high, moderate, and low motivation. We applied the rating across 27 DHI RCTs with cancer patients to pilot applicability.
Results: Through training, we achieved moderate interrater reliability between four raters. Although some studies provided limited information on motivational issues within the study sample, we implemented a standardized and reliable procedure to address the lack of information. Most of the studies were rated as having populations with high motivation levels: 70% (overall rating), 59% (indicator 1), 44% (indicator 2), and 48% (indicator 3).
Conclusions: Our work complements the reporting guideline of CONSORT-EHEALTH by emphasizing the importance of reporting the motivational aspects of study participants in DHI.
Relevance and importance to patients: Better information about patients' motivation in DHI may allow a more precise picture of whether results from clinical studies can be transferred to clinical practice with patients of different motivation levels."
Objectives: To develop a rating to capture patient motivation at baseline as study level information in DHI trials.
Methods: The rating was developed in a bottom-up approach using information that potentially reflects participants’ baseline motivation from a collection of DHI studies. Finally, we specified three indicators: indicator 1 captures whether the study team actively selects or enhances the motivation of the potential study participants; indicator 2 captures the study participants’ active engagement before the intervention allocation; and indicator 3 captures the potential bond and trust between the study participants and the person/institution referring to the study. The rating of each indicator and overall rating vary between high, moderate, and low motivation. We applied the rating across 27 DHI RCTs with cancer patients to pilot applicability.
Results: Through training, we achieved moderate interrater reliability between four raters. Although some studies provided limited information on motivational issues within the study sample, we implemented a standardized and reliable procedure to address the lack of information. Most of the studies were rated as having populations with high motivation levels: 70% (overall rating), 59% (indicator 1), 44% (indicator 2), and 48% (indicator 3).
Conclusions: Our work complements the reporting guideline of CONSORT-EHEALTH by emphasizing the importance of reporting the motivational aspects of study participants in DHI.
Relevance and importance to patients: Better information about patients' motivation in DHI may allow a more precise picture of whether results from clinical studies can be transferred to clinical practice with patients of different motivation levels."