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Measuring perceived utility of genomic sequencing: Development and validation of the GENEtic Utility (GENE-U) scale for adult screening

Authors:

Hadley Stevens Smith, Caryn Kseniya Rubanovich, Jill Oliver Robinson, Ariel N. Levchenko, Sarah A. Classen, Janet Malek, Adam H. Buchanan, Barbara Biesecker, Kyle B. Brothers, Benjamin S. Wilfond, Christine Rini, Cinnamon S. Bloss, Amy L. McGuire & Sara J. Knight

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: August 2024

Read the full text in the subscription access journal Genetics in Medicine

Employing user-centered design to develop a remote technology kit for studying young children’s social communication skills

Authors:

Marisa Petruccelli, Mya Howard, Andres Morelos, Allison Wainer, Sarabeth Broder-Fingert, Brooke Ingersoll, Wendy L Stone & Alice S Carter

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: August 2024

Read the full text in the subscription access journal Journal of Pediatric Psychology

Measuring perceived utility of genomic sequencing: Development and validation of the GENEtic Utility (GENE-U) scale for pediatric diagnostic testing

Authors:

Hadley Stevens Smith, Caryn Kseniya Rubanovich, Jill Oliver Robinson, Ariel N. Levchenko, Sarah A. Classen, Janet Malek, Barbara Biesecker, Kyle B. Brothers, Benjamin S. Wilfond, Christine Rini, Sara J. Knight, Amy L. McGuire & Cinnamon S. Bloss

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: August 2024

Read the full text in the subscription access journal Genetics in Medicine

✪ Virtual versus usual in-office care for multiple sclerosis: The VIRTUAL-MS multi-site randomized clinical trial study protocol

Authors:

Marisa McGinley, Josh J Carlson, Jennifer Reihm, Matthew Plow, Megan Roser, Nikki Sisodia, Jeffrey A Cohen, Anita D Misra-Hebert, Ann A Lazar & Riley Bove

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

Read the full text in the open access journal Contemporary Clinical Trials

Abstract:

Background

Multiple sclerosis (MS) affects nearly 1 million people and is estimated to cost $85.4 billion in the United States annually. People with MS have significant barriers to receiving care and telemedicine could substantially improve access to specialized, comprehensive care. In cross-sectional analyses, telemedicine has been shown to be feasible, have high patient and clinician satisfaction, reduce patient costs and burden, and enable a reasonable assessment of disability. However, no studies exist evaluating the longitudinal impact of telemedicine care for MS. Here we describe the study protocol for VIRtual versus UsuAL In-office care for Multiple Sclerosis (VIRTUAL-MS). The main objective of the study is to evaluate the impact of telemedicine for MS care on: patient clinical outcomes, economic costs, patient, and clinician experience.

Methods

This two-site randomized clinical trial will enroll 120 adults with a recent diagnosis of MS and randomize 1:1 to receive in-clinic vs. telemedicine care for 24 months. The primary outcome of the study is worsening in any one of the four Multiple Sclerosis Functional Composite 4 (MSFC4) measures at 24 months. Other study outcomes include patient and clinician satisfaction, major healthcare costs, Expanded Disability Status Scale, treatment adherence, and digital outcomes.

Conclusion

The results of this study will directly address the key gaps in knowledge about longitudinal telemedicine-enabled care in an MS population. It will inform clinical care implementation as well as design of trials in MS and other chronic conditions.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Helping Educational Leaders Mobilize Evidence (HELM): The iterative redesign of the Leadership and Organizational Change for Implementation (LOCI) intervention for use in schools

Authors:

Jill Locke, Cathy M. Corbin, Vaughan K. Collins, Mark G. Ehrhart, Roger Goosey, Kurt Hatch, Christine Espeland, Clayton R. Cook, and Aaron R. Lyon

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

Read the full text in the open access journal Implementation Research and Practice

Abstract:

Background

Few “intervention agnostic” strategies have been developed that can be applied to the broad array of evidence-based practices (EBPs) in schools. This paper describes two studies that reflect the initial iterative redesign phases of an effective leadership-focused implementation strategy—Leadership and Organizational Change for Implementation (LOCI)—to ensure its acceptability, feasibility, contextual appropriateness, and usability when used in elementary schools. Our redesigned strategy—Helping Educational Leaders Mobilize Evidence (HELM)—is designed to improve principals’ use of strategic implementation leadership to support the adoption and high-fidelity delivery of a universal EBP to improve student outcomes.

Method

In Study 1, focus groups were conducted (n = 6) with 54 district administrators, principals, and teachers. Stakeholders provided input on the appropriateness of original LOCI components to maximize relevance and utility in schools. Transcripts were coded using conventional content analysis. Key themes referencing low appropriateness were summarized to inform LOCI adaptations. We then held a National Expert Summit (Study 2) with 15 research and practice experts. Participants provided feedback via a nominal group process (NGP; n = 6 groups) and hackathon (n = 4 groups). The research team rated each NGP suggestion for how actionable, impactful/effective, and feasible it was. We also coded hackathon notes for novel ideas or alignment with LOCI components.

Results

Study 1 suggestions included modifications to LOCI content and delivery. Study 2's NGP results revealed most recommendations to be actionable, impactful/effective, and feasible. Hackathon results surfaced two novel ideas (distributed leadership teams and leaders’ knowledge to support educators EBP use) and several areas of alignment with LOCI components.

Conclusion

Use of these iterative methods informed the redesign of LOCI and the development of HELM. Because it was collaboratively constructed, HELM has the potential to be an effective implementation strategy to support the use of universal EBP in schools.

Plain Language Summary

Our research team designed a strategy (HELM) for school principals to improve the support they provide to staff to implement practices proven to work in research for improving student outcomes. We designed HELM by conducting focus groups with school district administrators, principals, and teachers. Participants were asked for their feedback on how to adapt an existing leadership strategy (LOCI) to the school context. After collecting this feedback, we held a meeting with 15 research and practice experts. During this meeting, the group of experts reviewed the focus group feedback and decided how to incorporate it into the design of the HELM strategy. We believe that collecting this feedback and involving research and practice experts in interpreting and integrating participant feedback into the HELM strategy will make HELM a more effective strategy for supporting school principals’ in implementing supports in their schools.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Centering School Leaders’ Expertise: Usability Evaluation of a Leadership-Focused Implementation Strategy to Support Tier 1 Programs in Schools

Authors:

Vaughan K. Collins, Catherine M. Corbin, Jill J. Locke, Clayton R. Cook, Mark G. Ehrhart, Kurt D. Hatch & Aaron R. Lyon

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2024

Read the full text open access in the journal School Mental Health

Abstract:

Although there are a growing number of implementation strategies to increase the adoption, fidelity, and sustainment of evidence-based practices (EBP), they are often complex and bulky, which can interfere with their widespread application. To address these challenges, the Helping Educational Leaders Mobilize Evidence (HELM) strategy was created as an adaptation of the evidence-based Leadership and Organizational Change for Implementation (LOCI) implementation strategy to enhance elementary school principals’ use of strategic implementation leadership to support the adoption and delivery of Tier 1 (i.e., universal social, emotional, and behavioral) EBP. In service of its iterative development, a human-centered design methodology was employed to increase the successful uptake and use of HELM. The Cognitive Walkthrough for Implementation Strategies (CWIS), a novel mixed-methods approach to evaluate implementation strategy usability, was applied to identify and test HELM strategy tasks of critical importance. A sample of 15 elementary school principals participated in group cognitive walkthrough testing as either school principal recipients or HELM coaches. Both user types rated the strategy as acceptable (principal M = 77.8, SD = 15.5; coach M = 87.5, SD = 7.9). Five usability issues were identified using a highly structured common usability issue framework and provided direction for the generation of redesign solutions to be incorporated in a subsequent version of the HELM strategy. The evaluation of the strategy’s usability improved its alignment with user needs, expectations, and contextual constraints, rendering a more usable strategy and broadly applicable information surrounding the development of psychosocial implementation strategies in real-world settings.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Acceptability and Utility of a Digital Group Intervention to Prevent Perinatal Depression in Youths via Interactive Maternal Group for Information and Emotional Support (IMAGINE): Pilot Cohort Study

Authors:

Keshet Ronen, Anupa Gewali, Kristin Dachelet, Erica White, Marimirca Jean-Baptiste, Yolanda N Evans, Jennifer A Unger, S. Darius Tandon, Amritha Bhat

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2024

Read the full text in the open access journal JMIR Formative Research

Abstract:

Background

Perinatal depression (depression during pregnancy or the first year postpartum) affects 10%-25% of perinatal individuals, with a higher risk among youths aged <25 years. The Mothers and Babies Course (MB) is an evidence-based intervention for the prevention of perinatal depression, grounded in cognitive behavioral therapy, attachment theory, and psychoeducation.

Objective

We developed a digital adaptation of MB (Interactive Maternal Group for Information and Emotional Support [IMAGINE]) and evaluated it in a pre-post mixed methods pilot among young perinatal people in the United States

Methods

IMAGINE was a structured digital group of up to 7 participants, with scheduled MB content and open discussion for 12 weeks, facilitated by a social worker. Scheduled content included asynchronous SMS text messages, graphics, prerecorded videos, mood polls, and optional weekly synchronous video calls. Eligible participants were pregnant or ≤80 days postpartum, aged 16 to 24 years, had access to a smartphone, spoke English, and had a Patient Health Questionnaire score <10. Participants were recruited throughout the United States from August 2020 to January 2021 through paid social media ads, in-person outreach at clinics, and respondent-driven sampling. Participants completed quantitative questionnaires at enrollment and 3 months, and qualitative interviews at 3 months. We determined uptake, acceptability (by Acceptability of Intervention Measure score), and utility (by use of cognitive behavioral therapy skills). We compared depression symptoms (by Patient Health Questionnaire score), social support (by abbreviated Social Support Behavior score), and perceived stress (by Perceived Stress Score) between enrollment and follow-up by paired 2-tailed t test.

Results

Among 68 individuals who contacted this study, 22 were screened, 13 were eligible, and 10 enrolled, for an uptake of 76.9%. Furthermore, 4 (40%) participants were pregnant at enrollment. Participants had a median age of 17.9 (IQR 17.4-21.7) years, 6 (67%) identified as Black, 5 (56%) Latinx, and 6 (67%) using Medicaid health insurance. Further, 9 (90%) participants completed follow-up. Among these, the mean acceptability score was 4.3 out of 5 (SD 0.6) and all participants said they would recommend IMAGINE to a friend. Participants reported using a median of 7 of 11 skills (IQR 5-7 skills) at least half the days. We found no significant changes in depression symptoms, perceived stress, or social support. Qualitatively, participants reported one-to-one support from the facilitator, connection with other parents, and regular mood reflection were especially helpful aspects of the intervention. Additionally, participants reported that the intervention normalized their mental health challenges, improved their ability to manage their mood, and increased their openness to mental health care.

Conclusions

This pilot study provides promising evidence of the acceptability and utility of IMAGINE among perinatal youths. Our study’s small sample size did not detect changes in clinical outcomes; our findings suggest IMAGINE warrants larger-scale evaluation.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ A case study of pragmatic measure development of the Treatment Integrity for Elementary Settings self-report measure for teachers

Authors:

Emma R Dear, Bryce D McLeod, Nicole M Peterson, Kevin S Sutherland, Michael D Broda, Alex R Dopp & Aaron R Lyon

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2024

Read the full text in the open access journal Implementation Research and Practice

Abstract:

Introduction

Due to usability, feasibility, and acceptability concerns, observational treatment fidelity measures are often challenging to deploy in schools. Teacher self-report fidelity measures with specific design features might address some of these barriers. This case study outlines a community-engaged, iterative process to adapt the observational Treatment Integrity for Elementary Settings (TIES-O) to a teacher self-report version designed to assess the use of practices to support children's social-emotional competencies in elementary classrooms.

Method

Cognitive walkthrough interviews were conducted with teachers to improve the usability of the teacher self-report measure, called the Treatment Integrity for Elementary Schools–Teacher Report (TIES-T). Qualitative content analysis was used to extract themes from the interviews and inform changes to the measure.

Results

Increasing clarity and interactive elements in the measure training were the dominant themes, but suggestions for the measure format and jargon were also suggested.

Conclusion

The suggested changes resulted in a brief measure, training, and feedback system designed to support the teacher's use of practices to support children's social-emotional competencies in elementary classrooms. Future research with the TIES-T will examine the score reliability and validity of the measure.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Formative Evaluation of a Comprehensive Self-Management Intervention for Irritable Bowel Syndrome, Comorbid Anxiety, and Depression: Mixed Methods Study

Authors:

Kendra Kamp, Pei-Lin Yang, Emily Friedman, Alejandra Lopez, Sarah Iribarren, Pamela Barney, Sean Munson, Margaret Heitkemper, & Rona Levy

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2023

Read the full text in the open access journal JMIR Formative Research

Abstract:

Background

Irritable bowel syndrome (IBS) is a disorder of the gut-brain interaction that is associated with abdominal pain, altered bowel patterns, and reduced quality of life. Up to 50% of patients with IBS also report anxiety or depressive symptoms. Although effective self-management interventions exist for individuals with IBS, few have been effectively implemented, and most do not consider the unique needs of patients with comorbid IBS and anxiety or depression.

Objective

This study aimed to determine the anticipated acceptability, appropriateness, feasibility, and usability of a comprehensive self-management intervention using an implementation science and human-centered design approach among individuals with comorbid IBS and anxiety or depression and health care providers.

Methods

A convergent mixed methods design was used to elicit feedback on the comprehensive self-management intervention outline and content to identify refinement needs before testing. Patients with IBS and moderate to severe anxiety or depression and health care providers were purposefully sampled from primary care and gastroenterology settings. Participants completed semistructured interviews and surveys on anticipated acceptability, appropriateness, feasibility, and usability.

Results

Patient participants (n=12) were on average 36.8 (SD 12.2) years of age, and 42% (5/12) were currently receiving psychological therapy. Health care providers (n=14) were from primary care (n=7) and gastroenterology (n=7) settings. The mean usability scores (out of 100) were 52.5 (SD 14.5) for patients and 45.6 (SD 11.6) for providers. For patients and providers, qualitative data expanded the quantitative findings for acceptability and appropriateness. Acceptability findings were the comprehensive nature of the intervention and discussion of the gut-brain interaction. For appropriateness, participants reported that the intervention provided structure, accountability, and support. Feasibility was confirmed for patients, but there was a divergence of findings between quantitative and qualitative measures for providers. Patients focused on intervention feasibility, while providers focused on implementation feasibility in the clinic. Identified usability issues to address before implementation included the intervention delivery format, length, and lack of integration into health care settings that, if not addressed, may limit the reach of the intervention

Conclusions

Patients and health care providers found the intervention acceptable and appropriate. Several feasibility and usability issues were identified, including intervention delivery methods, length of intervention, and the best methods to implement in the clinic setting. The next steps are to refine the intervention to address the identified issues and test in a pilot study whether addressing usability issues leads to the anticipated improvements in implementation and uptake.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ ‘I understood the texting process well’ – Participant perspectives on usability and acceptability of SMS-based telehealth follow-up after voluntary medical male circumcision in South Africa

Authors:

Jacqueline Pienaar, Sarah Day, Geoffrey Setswe, Beatrice Wasunna, Vuyolwethu Ncube, Felex Ndebele, Femi Oni, Evelyn Waweru, Calsile Khumalo, Hannock Tweya, Kenneth Sherr, Yanfang Su, and Caryl Feldacker

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2023

Read the full text in the open access journal Digital Health

Abstract:

Background

Voluntary medical male circumcision (MC) is a biomedical HIV prevention method that requires post-operative follow-up for healing confirmation. Recent research found that a two-way texting (2wT) app providing SMS-based telehealth for MC patients was safe and reduced provider workload. We evaluated 2wT usability among MC clients in South Africa assigned the 2wT intervention within a larger randomized controlled trial (RCT) of 2wT safety and workload.

Methods

This quantitative usability study is within an RCT where 547 men used 2wT to interact with an MC provider via SMS. The sub-study involved the first 100 men assigned to 2wT who completed a usability survey 14 days after surgery. Acceptability was assessed through 2wT response rates of the 547 men. Regression models analyzed associations between age, wage, location, potential adverse events (AEs), and 2wT responses.

Results

Men assigned to 2wT found it safe, comfortable, and convenient, reporting time and cost savings. High response rates (88%) to daily messages indicated acceptability. Age, wage, and location didn't affect text responses or potential AEs.

Conclusion

2wT for post-MC follow-up was highly usable and acceptable, suggesting its viability as an alternative to in-person visits. It enhanced confidence in wound self-management. This SMS-based telehealth can enhance MC care quality and be adapted to similar contexts for independent healing support, particularly for men.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**