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✪ Enhancing provider adoption of patient-reported outcome measures (PROMs) through implementation science: insights from two international workshops

Authors:

Angela C. Wolff, Kate Absolom, Sara Ahmed, Susan J. Bartlett, Maria Jose Santana, Angela M. Stover & Elizabeth J. Austin

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2025

Read the full text in the open access journal Journal of Patient Reported Outcomes

Abstract:

Background

Although the use of patient-reported outcome measures (PROMs) in practice is increasing, successful implementation is contingent on engaging healthcare providers (HCPs). Using Implementation Science (IS), we present the content of two workshops hosted at the International Society for Quality-of-Life annual conferences for individuals seeking to implement PROMs collection and use in their settings. Our goals were to provide workshop participants with knowledge, tools, and resources to prepare HCPs for PROM adoption and to demonstrate tailored strategies to meet context-specific needs.

Methods

An interdisciplinary team with diverse expertise in PROMs implementation delivered two workshops guided by the Capability, Opportunity, Motivation – Behavior (COM-B) model and the Theoretical Domains Framework (TDF). Using dotmocracy, participants were asked to consider, for their local context, the factors most important for changing HCPs’ behaviors to adopt PROMs in daily practice.

Results

The workshops incorporated IS theories, models, and frameworks (TMFs) to identify barriers faced by HCPs, support behavior change, and apply tailored theory-informed implementation strategies to prepare HCPs for PROM integration and evaluate adoption success. The factors rated the most important by workshop participants (n = 53) were woven into the discussions to illustrate the most common barriers encountered by HCPs adopting PROMs. Presenters drew on real-world practice and research experiences to identify promising implementation strategies, including education, training, behavioral modeling, persuasion, environmental restructuring, enablement, and audit and feedback to increase the capability, opportunity, and motivation of HCPs.

Conclusion

Given the increasing evidence base supporting the role of PROMs in patient-centered care, it is imperative to understand the mechanisms and best practices for increasing provider adoption of PROMs. This work offers a roadmap for understanding determinants more important to HCPs and systematically selecting theory-informed implementation strategies that may increase the likelihood of HCP adoption of PROMs. Offering tailored HCP training/education programs and implementation strategies can prepare HCPs for timely and effective PROM implementation.

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

✪ When evidence is not enough: A qualitative exploration of healthcare workers’ perspectives on expansion of two-way texting (2wT) for post- circumcision follow-up in South Africa

Authors:

Isabella Fabens, Calsile Makhele, Nelson Igaba, Khumbulani Moyo, Felex Ndebele, Jacqueline Pienaar, Geoffrey Setswe, & Caryl Feldacker

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: June 2025

Read the full text in the open access journal PLOS Digital Health

Abstract:

As per South African national guidelines, in-person follow-up visits after voluntary medical male circumcision (VMMC) are required but may be unnecessary. Two-way texting (2wT), an mHealth platform, engages clients in post-operative care and triages those with complications to in-person review. 2wT was found to be safe, effective, and efficient. In South Africa, to understand provider perspectives on 2wT and potential for expansion, 20 key informant interviews were conducted with management, clinicians, data officials and support staff involved in 2wT scale-up. Interviews were analyzed using rapid qualitative methods and informed by two implementation science frameworks: the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework and the Pragmatic, Robust, Implementation and Sustainability Model (PRISM). Participants shared mixed and multi-faceted feedback, including that 2wT improves monitoring and evaluation of clients and clinical outcomes while also reducing follow-up visits. Challenges included duplicative routine and 2wT reporting systems and perceptions that 2wT increased workload. To improve the likelihood of successful 2wT scale-up in routine VMMC settings, participants suggested: further 2wT sensitization to ensure clinician and support staff buy-in; a dedicated clinician or nurse to manage telehealth clients; improved dashboards to better visualize 2wT client data; mobilizing 2wT champions at facilities to garner support for 2wT as routine care; and updating VMMC guidelines to support VMMC telehealth. As attendance at follow-up visits may not be as high as reported, implementing 2wT may require more effort but also brings added benefits of client verification and documented follow-up. The transition from research to routine practice is challenging, but use of RE-AIM and PRISM indicate that it is not impossible. As VMMC funding is decreasing, more effort to share the evidence base for 2wT as a safe, cost-effective, high-quality approach for VMMC follow-up is needed to encourage widespread uptake and adoption.

Author summary

South Africa has a high prevalence of HIV, and voluntary medical male circumcision is a prevention method recommended by the World Health Organization. Two-way texting (2wT) is a digital health intervention that allows males to receive educational messages after circumcision about healing and send messages directly to a provider via SMS or WhatsApp. This system detects as many complications as routine follow-up care, though is more efficient. As we scale up to new locations in South Africa, we wanted to ensure the approach is well-adapted for health workers. Through 20 interviews with health workers, we found that it saves clients in-person visits and helps with data collection. However, more effort is needed to introduce the intervention to clinicians, including providing better training and appointing champions to help motivate clinicians. Funding for HIV and VMMC programs is decreasing, so it is important to find tools such as digital health to reduce the burden on facilities while maintaining quality client care.

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

✪ “If he returns, receive him because he has realized that he needs assistance”: A qualitative study exploring preferences for retention on antiretroviral therapy support in Malawi among Lighthouse Clinic clients

Authors:

Gillian O’Bryan, Jacqueline Huwa, Odala Sande, Agness Thawani, Astrid Berner-Rodoreda, Hannock Tweya, Christine Kiruthu-Kamamia, Geldert Chiwaya & Caryl Feldacker

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2025

Read the full text in the open access journal PLOS One

Abstract:

Introduction

Retention of people living with HIV (PLHIV) on antiretroviral therapy (ART) is critical. Retention is not static: clients cycle in and out of care over the course of treatment. Retention support is also evolving, with interventions like mobile health (mHealth) gaining traction. We aimed to explore ART clients’ perspectives and recommend strategies for improved retention support including a two-way-texting (2wT) mHealth intervention in two clinics in Malawi.

Materials and methods

We conducted focus group discussions (FGDs) with PLHIV on ART receiving 2wT or standard of care (SoC) retention support to understand client perspectives. FGDs were audio-recorded in Chichewa, translated and transcribed into English. We used the RE-AIM implementation science framework to report findings on the reach, effectiveness, adoption, implementation, and maintenance potential of retention interventions considering individual, clinic/organization, and community factors. Through rapid qualitative analysis, we identified key themes and subthemes.

Results

Ten FGDs were conducted with 89 ART clients (aged ≥18 years; 55% female): four FGDs among 2wT participants and six among SoC participants. Few differences were observed between 2wT and SoC clients. All clients appreciated accessing at least one form of support and recommended continuous assistance, regardless of age, sex, or duration on ART. Clients wished to be encouraged by other PLHIV to allay common fears. Groups discussed the need for intensified support to retain young clients or those out of care longer. Individual responsibility was identified as necessary, but insufficient, to improve retention: respondents desired a more positive clinic environment to encourage persistence in care. Fear of stigma, unintended status disclosure, and negative interactions with clinic staff prevent some clients from returning to care.

Conclusion

PLHIV want differentiated, continuous retention support from other PLHIV coupled with a positive clinic environment to promote retention and reengagement in care. As differentiated retention support is expensive, consideration of cost, feasibility, and sustainability is needed.

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

✪ Determinants of implementation of a stepped care intervention for adolescents and youth living with HIV in Kenya: a qualitative evaluation

Authors:

Nok Chhun, Dorothy I. Mangale, Kawango Agot, Winnie A. Owade, Julie Kadima, Jacinta Badia, James K. Kibugi, Pamela K. Kohler, Grace John-Stewart & Kristin Beima-Sofie

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2025

Read the full text in the open access journal BMC Health Service Research

Abstract:

Background

Differentiation of HIV services, a client-centered strategy, may improve care outcomes among adolescents and youth living with HIV (AYLHIV). Understanding health provider perceptions of barriers and facilitators that influence implementation can optimize adoption and sustainment of health systems interventions.

Methods

The Data-informed Stepped Care (DiSC) study was a cluster randomized controlled trial of a stepped care intervention in 24 HIV care facilities in Kenya. At each visit, providers used an assessment tool to allocate AYLHIV to services according to level of need. Stable clients were allocated to differentiated service delivery (DSD) with less frequent visits. Intensified services, including behavioral counseling, were provided for those with greater likelihood of loss to follow-up, mental health issues, or viral non-suppression. We conducted focus group discussions (FGDs) with providers across 12 intervention sites between January-February 2023. FGDs used a semi-structured interview guide, grounded in the Consolidated Framework for Implementation Research, which were audio-recorded and transcribed. Transcripts were analyzed using a team-based rapid turnaround approach to characterize key determinants influencing adoption, reach, and fidelity.

Results

Providers were enthusiastic about, and quick to adopt, the DiSC intervention. They found the DiSC tool easy to use and felt it provided a relative advantage by improving service delivery efficiency and prioritizing time with higher need AYLHIV. Providers noted the importance of tool flexibility to align with changing national guidelines. They expressed concerns about compatibility with existing workflows at facilities exclusively using electronic medical record (EMR) systems, suggesting EMR integration will be needed for intervention sustainment. AYLHIV eligible for DSD benefited from clinic visit intervals that aligned with the school calendar, which posed a challenge for reaching AYLHIV in more intensive steps. Provider collective efficacy was important in consistent implementation of DiSC and was facilitated by continuous quality improvement meetings, access to knowledge and information, and perceived intervention effectiveness. Supportive leadership was an important driver of implementation success, through availing space for mental health counseling sessions and time for client-provider interactions outside standard operating hours.

Conclusions

Consideration of alignment with national policy, integration into clinic workflows, school schedules, and leadership engagement, will be important for sustained use of differentiated care interventions.

Trial registration

ClinicalTrials.gov, NCT05007717. Registration date: July 13, 2021.

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

✪ Development of a method for qualitative data integration to advance implementation science within research consortia

Authors:

Lisa DiMartino, Allison J. Carroll, Jennifer L. Ridgeway, Anna Revette, Joan M. Griffin, Bryan J. Weiner, Sandra A. Mitchell, Wynne E. Norton, Christine Cronin, Andrea L. Cheville, Ann Marie Flores, Justin D. Smith on behalf of the IMPACT Consortium

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2025

Read the full text in the open access journal Implementation Science Communications

Abstract:

Background

Methods of integrating qualitative data across diverse studies and within multi-site research consortia are less developed than those for integrating quantitative data. The development ofsuchmethods is essential to support the data exchange needed for cross-study qualitative inquiry and given the increasing emphasis on data sharing and open science. We describe methods for qualitative data integration within the National Cancer Institute’s Improving the Management of symPtoms During And following Cancer Treatment (IMPACT) Consortium funded by the Cancer MoonshotSM. Data collection and analysis were guided by the Consolidated Framework for Implementation Research (CFIR). Our case study highlights potential solutions for unique challenges faced when integrating qualitative data across multiple settings in a research consortium.

Methods

The IMPACT consortium is comprised of three research centers (RCs) each conducting pragmatic trials examining the effectiveness of routine symptom management on patient-centered outcomes. After reaching consensus on use of CFIR as the common implementation determinant framework, RCs developed a semi-structured interview guide and tailored it to features of their healthcare setting and symptom management interventions. RCs conducted interviews/focus groups with healthcare system partners to examine contextual factors impacting implementation. RCs exchanged 1–2 transcripts (n = 5 total) for purposes of pilot testing the methodology.

Results

Given the heterogeneity of study settings and contexts, it was challenging to simultaneously assign codes at both domain and construct levels and the process was resource intensive. Recommendations include employing a common framework for data collection and analyses from the outset, coding at domain level first and then incorporating construct codes, and centralizing processes via a coordinating center (or similar entity) and combining coded transcripts using qualitative software. We also generated an iteratively refined codebook that employed the CFIR schema and incorporated CFIR 2.0 to provide detailed guidance for coders conducting cross-study qualitative inquiry.

Conclusions

Limited guidance exists on how to support qualitative data integration, data exchange, and sharing across multiple studies. This paper describes a systematic method for employing an implementation determinant framework-guided approach to foster data integration. This methodology can be adopted by other research consortia to support qualitative data integration, cross-site qualitative inquiry, and generate improved understanding of evidence-based intervention implementation.

Contributions to the literature
  • Few standard practices exist for integrating qualitative data across different studies to conduct cross-study qualitative inquiry. Developing data integration procedures is critical to generating insights about practice improvement across settings and achieving goals of open science.
  • This report describes a method for integrating qualitative data using the Consolidated Framework for Implementation Research illustrated within the context of NCI’s Improving the Management of symPtoms During And following Cancer Treatment (IMPACT) Consortium.
  • The method describedcan be applied within research consortia and across multi-site studies to support qualitative data integration, thereby producing valuable insights to improve implementation of evidence-based interventions.

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

✪ Systems analysis and improvement to optimize opioid use disorder care quality and continuity for patients exiting jail (SAIA-MOUD)

Authors:

Sarah Gimbel, Anirban Basu, Emily Callen, Abraham D. Flaxman, Omeid Heidari, Julia E. Hood, Anna Kellogg, Eli Kern, Judith I. Tsui, Ericka Turley, and Kenneth Sherr

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: December 2024

Read the full text in the open access journal Implementation Science

Abstract:

Background

Between 2012–2022 opioid-related overdose deaths in the United States, including Washington State, have risen dramatically. Opioid use disorder (OUD) is a complex, chronic, and criminalized illness with biological, environmental, and social causes. One-fifth of people with OUD have recent criminal-legal system involvement; > 50% pass through WA jails annually.

Medications for Opioid Use Disorder (MOUD) can effectively treat OUD. WA has prioritized improving access to MOUD, including for those in jails. As patients in jail settings are systematically marginalized due to incarceration, it is critical to foster connections to MOUD services upon release, an acknowledged period of high overdose risk. Currently, there is insufficient focus on developing strategies to foster linkages between jail-based MOUD and referral services.

The Systems Analysis and Improvement Approach (SAIA), an evidence-based implementation strategy, may optimize complex care cascades like MOUD provision and improve linkages between jail- and community-based providers. SAIA bundles systems engineering tools into an iterative process to guide care teams to visualize cascade drop-offs and prioritize steps for improvement; identify modifiable organization-level bottlenecks; and propose, implement, and evaluate modifications to overall cascade performance. The SAIA-MOUD study aims to strengthen the quality and continuity of MOUD care across jail and referral clinics in King County, WA, and ultimately reduce recidivism and mortality.

Methods

We will conduct a quasi-experimental evaluation of SAIA effectiveness on improving MOUD care cascade quality and continuity for patients receiving care in jail and exiting to referral clinics; examine determinants of SAIA-MOUD adoption, implementation, and sustainment; and determine SAIA-MOUD’s cost and cost-effectiveness. Clinic teams with study team support will deliver the SAIA-MOUD intervention at the jail-based MOUD program and three referral clinics over a two-year intensive phase, followed by a one-year sustainment phase where SAIA implementation will be led by King County Jail MOUD staff without study support to enable pragmatic evaluation of sustained implementation.

Discussion

SAIA packages user-friendly systems engineering tools to guide decision-making by front-line care providers to identify low-cost, contextually appropriate health care improvement strategies. By integrating SAIA into MOUD care provision in jail and linked services, this pragmatic trial is designed to test a model for national scale-up.

Trial registration

ClinicalTrials.gov NCT06593353 (registered 09/06/2024).

Contributions to the literature
  • Our study examines whether the introduction of an evidence-based, user-friendly, low-cost package of systems engineering tools can optimize investments in providing medications for opioid use disorder for individuals during the high-risk period immediately after exiting jail.
  • This is the first application of the Systems Analysis and Improvement Approach (SAIA) across health system levels to optimize both care delivery and continuity of care.
  • Our study is designed to provide decision-makers with evidence they need to decide whether to invest in systems engineering approaches during the expansion of MOUD in jail settings, including information on acceptability, feasibility, effectiveness and cost.

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

Peer Review reports

✪ Formative evaluation of the implementation of digital therapeutics for opioids and other substance use disorders in primary care (DIGITS trial)

Authors:

Lorella Palazzo, Caitlin N Dorsey, Jess Mogk, Tara Beatty, Deborah King, Kelsey Stefanik-Guizlo, Dustin Key, Tessa E Matson, Mary Shea, Ryan M Caldeiro, Angela Garza McWethy, Edwin S Wong, Abisola E Idu, and Joseph E Glass

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: December 2024

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

Abstract:

Background

Substance use disorders (SUDs) result in individual and societal burden. However, most individuals with SUD receive no treatment. Implementing SUD interventions in primary care could address this population's treatment needs. In the USA, reSET® and reSET-O® were the first prescription digital therapeutics (PDTs) for SUDs and opioid use disorder (OUD), respectively. The Digital Treatments for Substance Use Disorder (DIGITS) study tested the effectiveness of practice facilitation and health coaching strategies to support reSET and reSET-O implementation into primary care. A formative evaluation was conducted to monitor implementation, inform adaptations, and learn what promotes PDT sustainment.

Method

The Dynamic Sustainability Framework and the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies guided the evaluation. Using rapid qualitative methods, we collected and analyzed observational fieldnotes, key informant interviews, and document sources (e.g., meeting minutes) for synthesis and dissemination to clinical partners and the study team via formative reports. We analyzed the reports to generate evaluation results.

Results

Twenty-four primary care clinics participated. Evaluation data included 98 observational fieldnotes, 16 interviews, and 253 document sources. We produced nine formative reports. The study encountered barriers and facilitators in each DSF domain (ecological system, practice setting, and intervention). In the ecological system, the PDT vendor enabled the study, but the COVID-19 pandemic, laws, regulations, and contracting delayed implementation. In the practice setting, staff shortages and low clinic capacity were implementation challenges, while electronic health record capabilities were both barriers and facilitators. At the intervention level, non-routine workflows, clinician burden, and low patient engagement were barriers despite clinicians’ efforts.

Conclusions

Digital therapeutics are promising SUD and OUD treatments, but integration into primary care requires conducive laws and regulations, organizational capacity, and patient and clinician engagement. Formative evaluation identified important lessons for future PDT implementation.

Plain Language Summary

Evaluation of the integration of digital treatments for opioid and other substance use disorders in primary care

Most people with substance use disorders (SUDs) receive no treatment. In the USA, two smartphone app-based digital treatments for SUD and opioid use disorders (OUDs) became available by prescription. The Digital Treatments for Substance Use Disorder (DIGITS) study, a randomized implementation trial, tested how best to integrate these digital treatments for SUD and OUD into primary care. Throughout the study, we conducted a formative evaluation to observe progress, recommend implementation improvements, and understand how digital treatments could be offered to patients after the study ended. For this evaluation, we collected qualitative data through observing study meetings and interviewing primary care leaders, clinicians, and clinical and study staff. The data were regularly summarized and reported to our clinical partners and the study team. We used two implementation frameworks to interpret the data: the Dynamic Sustainability Framework and the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies. The evaluation revealed factors that helped and hindered implementation. Obstacles from outside the health care system included the COVID-19 pandemic, laws, regulations, and delays in setting up contractual agreements, whereas a partnership with the digital treatment vendor proved helpful. Clinics had difficulties with clinician burden, staff shortages, lack of time and available appointments, and performing new and unfamiliar tasks. The electronic health record system both supported and impended implementation. Last, few patients accepted the offered digital treatment, or used it persistently. Formative evaluation results suggest that digital treatments for SUD and OUD in primary care are promising, however their successful use requires supportive laws and regulations, health system resources, and increased patient and clinician engagement.

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

✪ Reimagining policy implementation science in a global context: a theoretical discussion

Authors:

Kellie List, Peter Agamile, Didier Yélognissè Alia, Peter Cherutich, Kristen Danforth, John Kinuthia, Arianna Rubin Means, Irene Mukui, Nancy Ngumbau, Yanfang Su, Anjuli Dawn Wagner, Bryan J Weiner, and Sarah Masyuko

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

Read the full text in the open access journal Frontiers in Health Services

Abstract:

Introduction

Policy implementation science (IS) is defined here as generating knowledge and deploying implementation strategies to effectively adopt and integrate evidence-based interventions (EBIs) into policy designs and improve policy implementation and effectiveness (1–3). Most existing policy IS scholarly works originate from the Global North (United States, Canada, and Western Europe) and describe or evaluate strategies to increase the uptake of EBIs (4). The existing Global North-generated frameworks focus less on the critical resources needed to formulate and implement a policy in diverse settings. Current approaches to policy IS lack sufficient contextual nuance to be applicable to...[read more].

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

✪ Implementation of collaborative care for depression in VA HIV clinics: Translating Initiatives for Depression into Effective Solutions (HITIDES): protocol for a cluster-randomized type 3 hybrid effectiveness-implementation trial

Authors:

Jacob T. Painter, Jeffrey Pyne, Geoffrey Curran, Rebecca A. Raciborski, Shane Russell, John Fortney, Allen L. Gifford, Michael Ohl & Eva N. Woodward

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

Read the full text in the open access journal Implementation Science Communications

Abstract:

Background

Depression is the most diagnosed mental health condition among people living with HIV. Collaborative care is an effective intervention for depression, typically delivered in primary care settings. The HIV Translating Initiatives for Depression into Effective Solutions (HITIDES) clinical intervention involves a depression care team housed off-site that supports depression care delivery by HIV care providers. In a randomized controlled trial, HITIDES significantly improved depression symptoms for veterans living with HIV and delivered cost savings. However, no HIV clinics in the Veterans Health Administration (VHA) have implemented HITIDES; as such, it is unclear what implementation strategies are necessary to launch and sustain this intervention.

Methods

This hybrid type-3 effectiveness-implementation trial examines the implementation and effectiveness of HITIDES in 8 VHA HIV clinics randomly assigned to one of two implementation arms. Each arm uses a different implementation strategy package. Arm 1 includes an intervention operations guide; an on-site clinical champion who, with the help of a peer community of practice, will work with local clinicians and leadership to implement HITIDES at their site; and patient engagement in implementation tools. Arm 2 includes all strategies from Arm 1 with assistance from an external facilitator. The primary implementation outcomes is reach; secondary outcomes include adoption, implementation dose, depressive symptoms, and suicidal ideation. We will conduct a budget impact analysis of the implementation strategy packages. We hypothesize that Arm 2 will be associated with greater reach and adoption and that Arm 1 will be less costly.

Discussion

Preliminary work identified implementation strategies acceptable to veterans living with HIV and HIV care providers; however, the effectiveness and cost of these strategies are unknown. While the depression care team can deliver services consistently with high quality, the ability of the depression care team to engage with HIV care providers at sites is unknown. Findings from this study will be used to inform selection of implementation strategies for a broad rollout to enhance depression and suicide care for people living with HIV.

Trial registration

ClinicalTrials.gov ID: NCT05901272, Registered 10 May 2023, https://clinicaltrials.gov/study/NCT05901272

Contributions to the literature

  • It is well-recognized that those with HIV infections need greater access to mental healthcare for depression. But it is not known how best to support deployment of evidence-based mental healthcare to them.
  • This paper describes an implementation trial to roll out depression care in HIV clinics.
  • With the fragmentation of care among so many subspecialties, understanding how to roll out mental health support across specialty medical settings is crucial.
  • Results will be relevant to mental health and suicide support not only for those with HIV but across many sectors of care for adults receiving care in specialty medical settings.

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

✪ Protocol for the Australian Type 1 Diabetes National Screening Pilot: Assessing the feasibility and acceptability of three general population screening models in children

Authors:

Kirstine J. Bell, Shannon Brodie, Jennifer J. Couper, Peter Colman, Elizabeth Davis, Gary Deed, William Hagopian, Aveni Haynes, Christel Hendrieckx, Amanda Henry, Adrienne Gordon, Kirsten Howard, Tony Huynh, Bernadette Kerr, Kara Mikler, Natasha Nassar, Sarah Norris, Richard Oram, Dorota Pawlak, Antonia Shand, Richard O. Sinnott, Bethany Wadling, John M. Wentworth, Maria E. Craig & the Type 1 Diabetes National Screening Pilot Study Group

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2024

Read the full text in the open access journal Diabetes Medicine

Abstract:

Aim

One third of Australian children diagnosed with type 1 diabetes present with life-threatening diabetic ketoacidosis (DKA) at diagnosis. Screening for early-stage, presymptomatic type 1 diabetes, with ongoing follow-up, can substantially reduce this risk (<5% risk). Several screening models are being trialled internationally, without consensus on the optimal approach. This pilot study aims to assess three models for a routine, population-wide screening programme in Australia.

Methods

An implementation science-guided pilot study to evaluate the feasibility, acceptability and costs of three screening models in children will be conducted between July 2022 and June 2024. These models are as follows: (1) Genetic risk-stratified screening using newborn heel prick dried bloodspots, followed by autoantibody testing from 11 months of age; (2) genetic risk-stratified screening of infant (6–12 months) saliva followed by autoantibody testing from 10 months of age; and (3) autoantibody screening using capillary dried bloodspots collected from children aged 2, 6 or 10 years. Cohorts for each model will be recruited from targeted geographic areas across Australia involving ≥2 states per cohort, with a recruitment target of up to 3000 children per cohort (total up to 9000 children). The primary outcome is screening uptake for each cohort. Secondary outcomes include programme feasibility, costs, parental anxiety, risk perception, satisfaction, well-being and quality of life, and health professional attitudes and satisfaction.

Conclusions

This pilot is the first direct comparison of three screening implementation models for general population screening. Findings will provide evidence to inform a potential national screening programme for Australian children.

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