Advancing the utilization of real-world data and real-world evidence in clinical pharmacology and translational research-Proceedings from the ASCPT 2023 preconference workshop.

Real-world data (RWD) and real-world evidence (RWE) are now being routinely used in epidemiology, clinical practice, and post-approval regulatory decisions. Despite the increasing utility of the methodology and new regulatory guidelines in recent years, there remains a lack of awareness of how this approach can be applied in clinical pharmacology and translational research settings. Therefore, the American Society of Clinical Pharmacology & Therapeutics (ASCPT) held a workshop on March 21st, 2023 entitled "Advancing the Utilization of Real-World Data (RWD) and Real-World Evidence (RWE) in Clinical Pharmacology and Translational Research." The work described herein is a summary of the workshop proceedings.

Building prevention research science communication and knowledge translation capacity through multidisciplinary collaboration.

OBJECTIVE: To document the outcomes of a dedicated Science Communication Community of Practice (CoP) for increasing prevention-focused knowledge translation (KT) and evidence uptake. Type of program: Shared priorities and a united vision to communicate the value of prevention research led to the formation of a dedicated Science Communication CoP within an Australian public health prevention-focused research collaboration. Members of the CoP included science communication experts and early- and mid-career researchers (EMCRs) with KT-focused roles. METHODS: The CoP met monthly, with semi-structured meetings led by an experienced science communication professional. A priority of the CoP was to develop resources that could help members and external parties to communicate their findings, especially EMCRs and those working on low-resourced projects. Insights from CoP members were synthesised to document if, and how, the CoP increased communication and KT capacity. RESULTS: CoP members found that participatory dialogue - dialogue that involves sharing perspectives and listening to others in order to develop a shared understanding - helped promote a greater understanding of science communication techniques and led to KT being embedded within projects. The CoP itself resulted in shared narratives and communication outputs that could not have been produced by individual members, primarily due to a lack of dedicated resourcing. Members found that engaging in the CoP increased their use of a range of science communication skills, tactics, and methods (e.g., targeted messaging for policy and practice, use of media and social media, and event management to engage audiences and build trust). LESSONS LEARNT: The CoP helped build a greater working knowledge of science communication among its members, leading to increased KT activities. Within an environment of low resourcing for science communication, bringing researchers together with science communication experts can help promote the communication of synthesised evidence and unified messaging on 'what works for prevention'.

Evaluative study of a MOOC on knowledge translation in five French-speaking countries.

Over the past few years, the RENARD research team has observed a sharp increase in the need for knowledge translation (KT) training. Given the high demand, it has been nearly impossible for the team to provide training entirely in person, and so a massive open online course (MOOC) was developed. Its aim is to promote the use and appropriation of the KT process by practitioners, decision-makers, and others in the public sphere. The goal of this study was to evaluate the MOOC by collecting users' opinions, reactions, appropriation, and practice changes. A qualitative research design was used. Data were collected through semi-structured individual interviews (n = 16) with professionals from Canada, France, and three West African countries (Burkina Faso, Mali, and Senegal) who had taken the MOOC. All interviews were subjected to thematic content analysis. The MOOC content was generally appreciated and reused by the respondents. The results revealed one main motive for completing the course: the immediate opportunity to apply their learning in their practice environments. However, most respondents deplored the lack of interaction among learners and expressed the need for coaching with an instructor to deepen the topics covered during the course. The results also revealed connection and accessibility issues linked to the Internet network and unstable access to electricity in West African countries. The study highlights the potential of MOOCs for the acquisition of knowledge and competencies by KT professionals. Several recommendations and avenues of exploration were formulated to optimize and improve future designs of MOOCs on KT.

Putting weight-related conversations into practice: Lessons learned from implementing a knowledge translation casebook in a disability context.

BACKGROUND: Due to reported challenges experienced by healthcare providers (HCPs) when having weight-related conversations with children with disabilities and their families, a knowledge translation (KT) casebook was developed, providing key communication principles with supportive resources. Our aim was to explore how the KT casebook could be implemented into a disability context. Study objectives were to develop and integrate needs-based implementation supports to help foster the uptake of the KT casebook communication principles. METHODS: A sample of nurses, physicians, occupational therapists and physical therapists were recruited from a Canadian paediatric rehabilitation hospital. Informed by the Theoretical Domains Framework, group interviews were conducted with participants to understand barriers to having weight-related conversations in their context. Implementation strategies were developed to deliver the KT casebook content that addressed these identified barriers, which included an education workshop, simulations, printed materials, and a huddle and email strategy. Participant experiences with the implementation supports were captured through workshop evaluations, pre-post surveys and qualitative interviews. Post-implementation interviews were analysed using descriptive content analysis. RESULTS: Ten HCPs implemented the KT casebook principles over 6 months. Participants reported that the workshop provided a clear understanding of the KT casebook content. While HCPs appreciated the breadth of the KT casebook, they found the abbreviated printed educational materials more convenient. Strategies developed to address participants' need for a sense of community and opportunities to learn from each other did not achieve their aim. Increased confidence in integrating the KT casebook principles into practice was not demonstrated, due, in part, to having few opportunities to practice. This was partly because of the increase in competing clinical demands at the onset of the COVID-19 pandemic. CONCLUSIONS: Despite positive feedback on the product itself, changes in the organisational and environmental context limited the success of the implementation plan. Monitoring and adapting implementation processes in response to unanticipated changes is critical to the success of implementation efforts.

Systematic synthesis of intersectional best practices: knowledge translation for circumpolar indigenous disability.

Numerous theories, models, and frameworks (TMFs) currently exist for knowledge translation (KT), with scholarship that is increasingly inclusive of populations experiencing health inequalities. This study proposes two objectives: 1) exploring a nine-step method for synthesising best practices, acknowledging existing syntheses in the form of tailored-databases and review-style publications; and 2) collating best practices to inform KT that is inclusive to indigenous individuals living with disabilities in circumpolar regions. The resulting synthesis emphasises 10 best practices: explicitly connect the accountability of stakeholders to the wellbeing of the people they serve; recognise entanglement with existing neoliberal systems; assess impacts of KT on indigenous treatment providers; employ personal outreach visits; rectify longstanding delegitimization; avoid assuming the target group to be homogeneous, critically examine inequitable distribution of benefits and risks; consider how emphasis on a KT initiative can distract from historical and systemic inequalities; target inequitable, systemic social and economic forces; consider how KT can also be mobilised to gain power and control; assess what is selected for KT, and how it intersects with power position of external stakeholders and internal champions; and, allow people access-to-knowledge which changes inequitable systems.

Through the big top: An exploratory study of circus-based artistic knowledge translation in rural healthcare services, Québec, Canada.

BACKGROUND: The conventional methods and strategies used for knowledge translation (KT) in academic research often fall short in effectively reaching stakeholders, such as citizens, practitioners, and decision makers, especially concerning complex healthcare issues. In response, a growing number of scholars have been embracing arts-based knowledge translation (ABKT) to target a more diverse audience with varying backgrounds and expectations. Despite the increased interest, utilization, and literature on arts-based knowledge translation over the past three decades, no studies have directly compared traditional knowledge translation with arts-based knowledge translation methods. Thus, our study aimed to evaluate and compare the impact of an arts-based knowledge translation intervention-a circus show-with two traditional knowledge translation interventions (webinar and research report) in terms of awareness, accessibility, engagement, advocacy/policy influence, and enjoyment. METHODS: To conduct this exploratory convergent mixed method study, we randomly assigned 162 participants to one of the three interventions. All three knowledge translation methods were used to translate the same research project: "Rural Emergency 360: Mobilization of decision-makers, healthcare professionals, patients, and citizens to improve healthcare and services in Quebec's rural emergency departments (UR360)." RESULTS: The findings revealed that the circus show outperformed the webinar and research report in terms of accessibility and enjoyment, while being equally effective in raising awareness, increasing engagement, and influencing advocacy/policy. Each intervention strategy demonstrates its unique array of strengths and weaknesses, with the circus show catering to a diverse audience, while the webinar and research report target more informed participants. These outcomes underscore the innovative and inclusive attributes of Arts-Based Knowledge translation, showcasing its capacity to facilitate researchers' engagement with a wider array of stakeholders across diverse contexts. CONCLUSION: As a relevant first step and a complementary asset, arts-based knowledge translation holds immense potential in increasing awareness and mobilization around crucial health issues.

National strategies for knowledge translation in health policy-making: A scoping review of grey literature.

BACKGROUND AND OBJECTIVES: Without strategic actions in its support, the translation of scientific research evidence into health policy is often absent or delayed. This review systematically maps and assesses national-level strategic documents in the field of knowledge translation (KT) for health policy, and develops a practical template that can support Evidence-informed Policy Network (EVIPNet) Europe countries in producing national strategies for evidence-informed policy-making. METHODS: Websites of organizations with strategic responsibilities in KT were electronically searched, on the basis of pre-defined criteria, in July-August 2017, and an updated search was carried out in April-June 2021. We included national strategies or elements of national strategies that dealt with KT activities, as well as similar strategies of individual institutions with a national policy focus. Two reviewers screened the strategies for inclusion. Data were analysed using qualitative content analysis. RESULTS: A total of 65 unique documents were identified, of which 17 were eligible and analysed for their structure and content. Of the 17, 1 document was a national health KT action plan and 6 documents were institution-level KT strategies. The remaining 10 strategies, which were also included were 2 national health strategies, 5 national health research strategies and 3 national KT strategies (not specific to the field of health alone). In all, 13 structural elements and 7 major themes of health policy KT strategies were identified from the included documents. CONCLUSION: KT in health policy, as emerged from the national strategies that our mapping identified, is based on the production and accessibility of policy-relevant research, its packaging for policy-making and the activities related to knowledge exchange. KT strategies may play different roles in the complex and context-specific process of policy-making. Our findings show that the main ideas of health-specific evidence-informed policy literature appear in these strategies, but their effectiveness depends on the way stakeholders use them. Specific knowledge-brokering institutions and organizational capacity, advocacy about the use of evidence, and close collaboration and co-decision-making with key stakeholders are essential in furthering the policy uptake of research results.

Knowledge Translation Task Force for core measures clinical practice guideline: a short report on the process and utilization.

BACKGROUND: As part of the 2018 Clinical Practice Guideline (CPG): A Core Set of Outcome Measures for Adults with Neurologic Conditions Undergoing Rehabilitation, a Knowledge Translation (KT) Task Force was convened. The purpose of this short report was to (1) demonstrate the potential impact of a CPG KT Task Force through a practical example of efforts to implement a CPG into neurologic physical therapy practice and (2) describe the process to convene a KT Task Force and develop products (KT Toolkit) to facilitate implementation of the CPG. METHODS: To describe the process used by the KT Task Force to develop and review a KT Toolkit for implementation of the CPG. RESULTS: Utilizing the Knowledge-To-Action Cycle framework, eight tools were developed as part of the KT Toolkit and are available with open access to the public. Findings indicate that the Core Outcome Measures Homepage, which houses the KT Toolkit, has had greater than 70,000 views since its publication. CONCLUSIONS: This short report serves as an example of the efforts made to implement a CPG into physical therapy practice. The processes to facilitate KT and the tools developed can inform future implementation efforts and underscore the importance of having a KT Task Force to implement a CPG. Moving forward, KT Task Forces should be convened to implement new or revised guidelines. TRIAL REGISTRATION: N/A.

Promoting knowledge translation: An ecosystem approach to evidence in health.

The dissemination and implementation of evidence in health contexts have been a concern of several international organizations responsible for recommending actions to health policymakers. World Health Organization has been advocating for an ecosystem of evidence to improve clinical practice and health professional education. Thus, in this article, we address the challenges to developing the evidence ecosystem from the point of view of health professional education, considering the contexts of practice and teaching, focused on knowledge translation. There are three pivotal challenges: producing qualified knowledge; adequate communication of the synthesized evidence; and institutional policy to sustain the implemented evidence in continuous and updated flow. The evidence ecosystem helps to understand these flows between the production and implementation of knowledge, based on the capacity and resources of different health systems. It needs to be developed in the field of health professional education, feedback in the contexts of practice and teaching, to contribute to third-generation knowledge being used by different users of health services.

Using stated preference methods to facilitate knowledge translation in implementation science.

Enhancing the arsenal of methods available to shape implementation strategies and bolster knowledge translation is imperative. Stated preference methods, including discrete choice experiments (DCE) and best-worst scaling (BWS), rooted in economics, emerge as robust, theory-driven tools for understanding and influencing the behaviors of both recipients and providers of innovation. This commentary outlines the wide-ranging application of stated preference methods across the implementation continuum, ushering in effective knowledge translation. The prospects for utilizing these methods within implementation science encompass (1) refining and tailoring intervention and implementation strategies, (2) exploring the relative importance of implementation determinants, (3) identifying critical outcomes for key decision-makers, and 4) informing policy prioritization. Operationalizing findings from stated preference research holds the potential to precisely align health products and services with the requisites of patients, providers, communities, and policymakers, thereby realizing equitable impact.

Transfusion Camp Rwanda 2023: A train-the-trainer workshop establishing locally driven leadership in knowledge translation and sustainability in transfusion medicine education.

BACKGROUND AND OBJECTIVES: Blood transfusion is performed daily in hospitals. Gaps exist between transfusion guidelines and day-to-day clinical care. These gaps are prevalent in resource-limited settings due to scarce continuing medical education. Transfusion Camp Rwanda aims to bridge this gap by (1) delivering context-appropriate up-to-date education, (2) teaching participants how to independently deliver a case-based curriculum and (3) identifying strategies to promote change in transfusion practice in Rwanda. MATERIALS AND METHODS: In May 2023, a multidisciplinary team from Canada and Rwanda carried out a Transfusion Camp train-the-trainer workshop for clinicians from all five provinces in Rwanda. Participants attended in-person lectures, seminars and workshop group discussions on the implementation of the Rwanda National Directives on Rational Use of Blood and Blood Components. Course feedback was based on the Kirkpatrick Model of Training and Evaluation. RESULTS: Fifty-one physicians and laboratory technicians participated in the course. Confidence in caring for patients based on transfusion guidelines was self-rated as 'excellent' by 23% of participants before and 77% after, while 84% reported they planned to teach Transfusion Camp to others and 100% responded that they will apply course content to clinical practice. Workshop groups recommended strategies to improve transfusion medicine practice in Rwanda in four domains: Communication, Institutional Approval, Practice Audits and Education. CONCLUSION: Transfusion medicine education in Rwanda using a train-the-trainer approach was well-received by participants and allowed for a more detailed understanding of the local medical and educational environment. These observations can inform the further expansion of the Transfusion Camp Rwanda project.

Supporting children's participation in active travel: developing an online road safety intervention through a collaborative integrated knowledge translation approach.

Even though regular engagement in physical activity (PA) among children can support their development and encourage the adoption of healthy lifelong habits, most do not achieve their recommended guidelines. Active travel (AT), or any form of human-powered travel (e.g., walking), can be a relatively accessible, manageable, and sustainable way to promote children's PA. One common barrier to children's engagement in AT, however, is a reported lack of education and training. To support children's participation in AT, this paper presents the development of a comprehensive 4-module online road safety education intervention designed to improve children's knowledge and confidence regarding AT. Using a qualitative integrated knowledge translation (iKT) approach undertaken with community collaborators (n = 50) containing expertise in health promotion, public safety, school administration, and transportation planning, our inductive thematic analysis generated fourth themes which constituted the foundation of the intervention modules: Active Travel Knowledge: Awareness of Benefits and Participation; Pedestrian Safety and Skills: Roles, Responsibilities, and Rules; Signs and Infrastructure: Identification, Literacy, and Behaviour; Wheeling Safety and Skills: Technical Training and Personal Maneuvers. Each theme/module was then linked to an explicit learning objective and connected to complementary knowledge activities, resources, and skill development exercises. Implications for research and practice are discussed.

Evaluating the delivery of physical activity for people with developmental disabilities using an online knowledge translation approach: part 1 - web accessibility.

Background: Knowledge-to-action gap exists in delivering physical activity (PA) to people with developmental disabilities via online platforms. Although web-based platforms have great potential in facilitating the delivery of PA for this target group, the lack of knowledge regarding web accessibility poses a challenge in accessing PA-related information online.Objective: This study evaluates the delivery of PA in terms of web accessibility. It also aims to identify barriers and facilitators in delivering PA knowledge to people with developmental disabilities online to improve web accessibility for the target user group.Methods: The study employs a concurrent nested design incorporating both quantitative (web usability questionnaire) and qualitative data (in-depth interviews). Fifteen pairs of individuals consisting of a person with developmental disabilities and a primary caregiver participated in the study, and three web-based platforms were selected for web accessibility tests and in-depth interviews.Results: The nested analysis provides a quantitative comparison of web accessibility and identifies barriers and facilitators of delivering PA for the target user group from the web accessibility perspective. Conclusion: The study findings could inform the development of accessible online platforms that distribute health-related knowledge to populations with developmental disabilities. Additionally, they could help enhance the design of other platforms intended for these populations.

Online platforms have significant potential to improve the delivery of physical activity information to individuals with developmental disabilities.Barriers to accessing online platforms due to poor web usability impede the process of online knowledge translation to end-users.Web usability can be enhanced by implementing appropriate interventions, such as restructuring navigation and redesigning the user interface.Improving web usability will enhance the accessibility of physical activity knowledge for individuals with developmental disabilities, which consequently will positively impact their health.

International consensus is needed on a core outcome set to advance the evidence of best practice in cancer prehabilitation services and research.

Prehabilitation aims to optimise patients' physical and psychological status before treatment. The types of outcomes measured to assess the impact of prehabilitation interventions vary across clinical research and service evaluation, limiting the ability to compare between studies and services and to pool data. An international workshop involving academic and clinical experts in cancer prehabilitation was convened in May 2022 at Sheffield Hallam University's Advanced Wellbeing Research Centre, England. The workshop substantiated calls for a core outcome set to advance knowledge and understanding of best practice in cancer prehabilitation and to develop national and international databases to assess outcomes at a population level.

Precision nutrition in pediatric IBD: A position paper from the ESPGHAN special interest group for basic science and translational research, the IBD Porto group, and allied health professionals.

Stratified and precision nutrition refers to disease management or prevention of disease onset, based on dietary interventions tailored to a person's characteristics, biology, gut microbiome, and environmental exposures. Such treatment models may lead to more effective management of inflammatory bowel disease (IBD) and reduce risk of disease development. This societal position paper aimed to report advances made in stratified and precision nutritional therapy in IBD. Following a structured literature search, limited to human studies, we identified four relevant themes: (a) nutritional epidemiology for risk prediction of IBD development, (b) food-based dietary interventions in IBD, (c) exclusive enteral nutrition (EEN) for Crohn's disease (CD) management, and (d) pre- and probiotics for IBD management. There is scarce literature upon which we can make recommendations for precision or stratified dietary therapy for IBD, both for risk of disease development and disease management. Certain single-nucleotide polymorphisms related to polyunsaturated fatty acid (PUFA) metabolism may modify the effect dietary PUFA have in increasing the risk of IBD development. Non-colonic CD, mild-to-moderate CD, and high microbiota richness may predict success of EEN and may be used both for prediction of treatment continuation, but also for early cessation in nonresponders. There is currently insufficient evidence to make recommendations for precision or stratified dietary therapy for patients with established IBD. Despite the great interest in stratified and precision nutrition, we currently lack data to support conclusive recommendations. Replication of early findings by independent research groups and within structured clinical interventions is required.

Evaluation of an integrated knowledge translation approach used for updating the Cochrane Review of Patient Decision Aids: a pre-post mixed methods study.

BACKGROUND: When people who can use or benefit from research findings are engaged as partners on study teams, the quality and impact of findings are better. These people can include patients/consumers and clinicians who do not identify as researchers. They are referred to as "knowledge users". This partnered approach is called integrated knowledge translation (IKT). We know little about knowledge users' involvement in the conduct of systematic reviews. We aimed to evaluate team members' degree of meaningful engagement and their perceptions of having used an IKT approach when updating the Cochrane Review of Patient Decision Aids. METHODS: We conducted a pre-post mixed methods study. We surveyed all team members at two time points. Before systematic review conduct, all participating team members indicated their preferred level of involvement within each of the 12 steps of the systematic review process from "Screen titles/abstracts" to "Provide feedback on draft article". After, they reported on their degree of satisfaction with their achieved level of engagement across each step and the degree of meaningful engagement using the Patient Engagement In Research Scale (PEIRS-22) across 7 domains scored from 100 (extremely meaningful engagement) to 0 (no meaningful engagement). We solicited their experiences with the IKT approach using open-ended questions. We analyzed quantitative data descriptively and qualitative data using content analysis. We triangulated data at the level of study design and interpretation. RESULTS: Of 21 team members, 20 completed the baseline survey (95.2% response rate) and 17/20 (85.0% response rate) the follow-up survey. There were 11 (55%) researchers, 3 (15%) patients/consumers, 5 (25%) clinician-researchers, and 1 (5%) graduate student. At baseline, preferred level of involvement in the 12 systematic review steps varied from n = 3 (15%) (search grey literature sources) to n = 20 (100%) (provide feedback on the systematic review article). At follow-up, 16 (94.1%) participants were totally or very satisfied with the extent to which they were involved in these steps. All (17, 100%) agreed that the process was co-production. Total PEIRS-22 scores revealed most participants reported extremely (13, 76.4%) or very (2, 11.8%) meaningful degree of engagement. Triangulated data revealed that participants indicated benefit to having been engaged in an authentic research process that incorporated diverse perspectives, resulting in better and more relevant outputs. Reported challenges were about time, resources, and the logistics of collaborating with a large group. CONCLUSION: Following the use of an IKT approach during the conduct of a systematic review, team members reported high levels of meaningful engagement. These results contribute to our understanding of ways to co-produce systematic reviews.

When people who can use or benefit from research findings are engaged as partners on study teams, the quality and impact of findings are better. These people can include patients/consumers and clinicians who do not identify as researchers. This partnered approach is called integrated knowledge translation (IKT). This approach is rarely used and there is little information about using it with systematic reviews. A systematic review is a type of study that provides the best available evidence on a given topic by combining data from all existing studies. The aim of this study was to find out how engaged our team members felt when partnering on our systematic review about patient decision aids. Twenty of 21 team members participated in the study, including 11 researchers, 3 patients/consumers, 5 clinician-researchers, and 1 graduate student. We asked our team members to complete a survey about their experience as part of our IKT research process at two time points: before starting the study and after the study was done. Most team members felt extremely or very engaged in the process. All team members felt like partners. They gave examples of how this was achieved. Advantages to using the IKT approach included knowledge sharing, inclusion of more diverse voices, a more authentic research process, better and more relevant results, and personal benefits (e.g. enjoyment from being involved). Disadvantages to using this approach was that it took more time and resources. Three team members said there were no disadvantages. It is possible for patients/consumers and clinicians to partner and feel engaged with research teams doing systematic reviews. Our findings may help researchers engage knowledge users as equal partners on study teams.

The Knowledge Translation of Early Cerebral Palsy (KiTE CP) study: Implementing Screening among a High-risk Prospective Cohort of Australian Infants.

OBJECTIVE: To describe the implementation of the international guidelines for the early diagnosis of cerebral palsy (CP) and engagement in the screening process in an Australian cohort of infants with neonatal risk factors for CP. STUDY DESIGN: Prospective cohort study of infants with neonatal risk factors recruited at <6 months corrected age from 11 sites in the states of Victoria, New South Wales, and Queensland, Australia. First, we implemented a multimodal knowledge translation strategy including barrier identification, technology integration, and special interest groups. Screening was implemented as follows: infants with clinical indications for neuroimaging underwent magnetic resonance imaging and/or cranial ultrasound. The Prechtl General Movements Assessment (GMA) was recorded clinically or using an app (Baby Moves). Infants with absent or abnormal fidgety movements on GMA videos were offered further assessment using the Hammersmith Infant Neurological Examination (HINE). Infants with atypical findings on 2/3 assessments met criteria for high risk of CP. RESULTS: Of the 597 infants (56% male) recruited, 95% (n = 565) received neuroimaging, 90% (n = 537) had scorable GMA videos (2% unscorable/8% no video), and 25% (n = 149) HINE. Overall, 19% of the cohort (n = 114/597) met criteria for high risk of CP, 57% (340/597) had at least 2 normal assessments (of neuroimaging, GMA or HINE), and 24% (n = 143/597) had insufficient assessments. CONCLUSIONS: Early CP screening was implemented across participating sites using a multimodal knowledge translation strategy. Although the COVID-19 pandemic affected recruitment rates, there was high engagement in the screening process. Reasons for engagement in early screening from parents and clinicians warrant further contextualization and investigation.

Digital Knowledge Translation Tools for Disseminating Sexual and Reproductive Health Information to Adolescents: Protocol for an Evidence Gap Map Review.

BACKGROUND: Digital or eHealth knowledge translation (KT) interventions have been identified as useful public health tools, particularly to advance sexual and reproductive health (SRH) among adolescents. Existing literature reviews on digital health interventions for adolescents' SRH demonstrate limitations, including shortcomings in reporting and comprehensiveness that limit the utility and trustworthiness of findings. However, there is a lack of evidence synthesis on the effectiveness of available digital or mobile health KT tools to promote SRH interventions for adolescents. OBJECTIVE: We aim to identify, map, and describe existing empirical evidence on the digital KT tools developed to improve adolescent SRH outcomes globally. METHODS: This study will be conducted using an evidence gap map (EGM) approach to address the objectives, including reviewing relevant literature and a landscape analysis of the outcomes of interest. The following electronic databases will be searched for retrieval of literature: MEDLINE (1946-present), Embase (1974-present), and Global Health (1910-present) via OVID; CINAHL (1936-present) via EBSCOhost; Scopus (1976-present); and Cochrane Library (1993-present) via Wiley. We will include only those studies that focused on adolescents aged 10-19 years and addressed SRH outcomes. We will include experimental studies (randomized or cluster randomized and nonrandomized controlled trials, including quasi-randomized, controlled before-after, and interruptive time series) and observational studies, that is, including prospective cohort and case-control studies. The experimental and observational studies will only be included in the presence of control or comparison arms. Studies with a historical control arm will be excluded. The systematic review software, Covidence (Ventas Health Innovation), will be used to screen and select the studies. Further, 2 independent reviewers will complete the first and second levels of screening of studies and any conflicts arising will be resolved by consensus between the 2 reviewers or by involving the third reviewer. We will conduct the quality assessment of all included studies using the Risk of Bias tool for randomized controlled trials and nonrandomized controlled trials, and AMSTAR2 for systematic reviews. RESULTS: Papers screening, data extraction, and synthesis will be completed by March 2024. We will use EPPI-Mapper (The International Public Policy Observatory) software to generate an online evidence map and to produce the tables and figures for the descriptive report. This EGM review will identify areas with high-quality, evidence-based digital KT tools (for immediate scale and spread) and areas where few or no KT tools exist (for targeted KT tool development and research or policy prioritization). CONCLUSIONS: This protocol focused on mapping eHealth KT tools that have been used in the literature to address SRH among adolescents. This will be the first EGM exercise to map digital KT tools to promote adolescents' SRH and will incorporate a range of published sources. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55081.

BioMEL: a translational research biobank of melanocytic lesions and melanoma.

INTRODUCTION: Diagnosing invasive cutaneous melanoma (CM) can be challenging due to subjectivity in distinguishing equivocal nevi, melanoma in situ and thin CMs. The underlying molecular mechanisms of progression from nevus to melanoma must be better understood. Identifying biomarkers for treatment response, diagnostics and prognostics is crucial. Using biomedical data from biobanks and population-based healthcare data, translational research can improve patient care by implementing evidence-based findings. The BioMEL biobank is a prospective, multicentre, large-scale biomedical database on equivocal nevi and all stages of primary melanoma to metastases. Its purpose is to serve as a translational resource, enabling researchers to uncover objective molecular, genotypic, phenotypic and structural differences in nevi and all stages of melanoma. The main objective is to leverage BioMEL to significantly improve diagnostics, prognostics and therapy outcomes of patients with melanoma. METHODS AND ANALYSIS: The BioMEL biobank contains biological samples, epidemiological information and medical data from adult patients who receive routine care for melanoma. BioMEL is focused on primary and metastatic melanoma, but equivocal pigmented lesions such as clinically atypical nevi and melanoma in situ are also included. BioMEL data are gathered by questionnaires, blood sampling, tumour imaging, tissue sampling, medical records and histopathological reports. ETHICS AND DISSEMINATION: The BioMEL biobank project is approved by the national Swedish Ethical Review Authority (Dnr. 2013/101, 2013/339, 2020/00469, 2021/01432 and 2022/02421-02). The datasets generated are not publicly available due to regulations related to the ethical review authority. TRIAL REGISTRATION NUMBER: NCT05446155.