[The Medical Informatics Initiative at a glance-establishing a health research data infrastructure in Germany]. / Die Medizininformatik-Initiative im Überblick ­ Aufbau einer Gesundheitsforschungsdateninfrastruktur in Deutschland.

The Medical Informatics Initiative (MII) funded by the Federal Ministry of Education and Research (BMBF) 2016-2027 is successfully laying the foundations for data-based medicine in Germany. As part of this funding, 51 new professorships, 21 junior research groups, and various new degree programs have been established to strengthen teaching, training, and continuing education in the field of medical informatics and to improve expertise in medical data sciences. A joint decentralized federated research data infrastructure encompassing the entire university medical center and its partners was created in the form of data integration centers (DIC) at all locations and the German Portal for Medical Research Data (FDPG) as a central access point. A modular core dataset (KDS) was defined and implemented for the secondary use of patient treatment data with consistent use of international standards (e.g., FHIR, SNOMED CT, and LOINC). An officially approved nationwide broad consent was introduced as the legal basis. The first data exports and data use projects have been carried out, embedded in an overarching usage policy and standardized contractual regulations. The further development of the MII health research data infrastructures within the cooperative framework of the Network of University Medicine (NUM) offers an excellent starting point for a German contribution to the upcoming European Health Data Space (EHDS), which opens opportunities for Germany as a medical research location.

Proposed CMS Data Access Changes May Hamper Health Services Research.

This Viewpoint discusses how proposed Centers for Medicare & Medicaid Services data access changes may impede health services research.

Practice-Oriented Research: An Introduction to New Developments and Future Directions.

Aimed at understanding and improving psychological therapies as they are conducted in clinical routine, practice-oriented research (POR) is now a well-established approach to the scientific foundations of mental health care services. Resting on the accumulation of a wide range of practice-based evidence related to treatment outcome and process, as well as factors associated with the participants of psychotherapy and its context, POR is ripe for new developments - regarding what to investigate and how to investigate it. This paper is the introduction of a series devoted to recent advances and future directions of POR as their pertained to routine outcome monitoring, technologies and artificial intelligence, the integration of constructs and methods from program evaluation and implementation science, and the investigation of populations with limited financial resources across various regions of the world. The series also includes commentaries from two leaders of POR.

How primary care research can be improved in clinical practice? An Italian case study.

BACKGROUND: Primary care is considered essential for the sustainability of the Health System. Practice-Based Research Networks (PBRN) play a strategic role in translation of primary care research into practice. Research Capacity Building in primary care requires a improvement and development strategy and well-developed research infrastructures to support physicians. METHODS: We used the system development methodology referring to the Lean Thinking to create and support a research team in primary and pediatric care. In particular a "cascade" deployment model and the X-Matrix, a framework used in management studies to support strategy definition and management process. RESULTS: A research unit in primary and pediatric care has been created, by sharing vision, mission, core values, long-term strategies. The definition of a annual planning led to monitoring actions to guarantee the expected goals. CONCLUSIONS: Lean methodology is useful to adapt to various managerial and operational contexts, including healthcare. In our case it allowed team members to spread the culture of research, its importance and role to improve the health of patients, thank to the organizational support of a hospital IR, the Research and Innovation Department.

The Promise and Challenges of Practice-Oriented Research: A Commentary on the Special Issue.

At the centre of POR is the concept of collaboration between patients, therapists, agencies, and third-party payers. For this commentary, I review the articles of the special issue with attention to both the opportunities and challenges offered by practice-oriented research (POR). I also reviewed some previous research on practice-research networks and how that research might inform POR. The use of routine outcome monitoring (ROM), artificial intelligence (AI), and program evaluation (PE) models show promise for advancing POR. However, each comes with its challenges. The use of ROM to improve patient outcomes has research support. However, researchers have identified problems with implementing ROM because of low uptake by clinicians and because clinicians may see ROM as a potential intrusion. AI shows promise to improve patient outcomes by potentially providing therapists with immediate and nuanced data to inform interventions and interpersonal stances specific to each patient. However, the scaling up of AI runs the risk of dehumanizing psychological interventions. PE may provide a context for allowing therapists to engage in POR to address real-world processes and outcomes of mental health interventions. However, like ROM PE faces the challenge of trust among clinicians and patients who may be reluctant to participate. Despite these challenges, and because of efforts to nurture and maintain respectful collaborations, articles in this special issue highlight how POR can play a pivotal role in bridging the gap between theory and practice.

[Focusing on intersectorality-strategies and current research projects for the care of geriatric people]. / Intersektoralität im Fokus ­ Strategien und aktuelle Forschungsprojekte zur Versorgung geriatrischer Personen.

In view of the demographic change, the need for intersectoral care of the aging population has already been identified. The strategies for implementation are diverse and address different approaches, each of which requires different sectors to overlap. This article provides an overview of already completed and ongoing projects for the care of geriatric patients. It becomes apparent that the development of networks as an indispensable basis for intersectoral care cannot be measured in terms of direct intervention effects and therefore makes it difficult to prove the cost-benefit. It is also evident that some research projects fail to be implemented into standard care due to financial and staff shortages.Do we need a rethinking in Germany or less innovation-related funding lines for better implementation and research of existing concepts? International role models such as Japan show that cost reduction for the care of the aging population should be considered in the long term, which requires increased financial volumes in the short term. For a sustainable implementation of cross-sectoral approaches into everyday life, research should therefore reorganize tight and/or entrenched structures, processes, and financing. By linking the countless existing projects and integrating ideas from different sectors, future demands of intersectoral geriatric care may be achieved.

The Importance of Conducting Practice-oriented Research with Underserved Populations.

There has been a growing emphasis on dissemination of empirically supported treatments. Dissemination, however, should not be restricted to treatment. It can and, in the spirit of the scientific-practitioner model, should also involve research. Because it focuses on the investigation of clinical routine as it takes place in local settings and because it can involve the collaboration of several stakeholders, practice-oriented research (POR) can be viewed as an optimal research method to be disseminated. POR has the potential of addressing particularly relevant gaps of knowledge and action when implemented in regions of the world that have limited resources for or experiences with empirical research, and/or in clinical settings that are serving clinical populations who are not typically receiving optimal mental care services - specifically, individuals in rural and inner cities that have limited economic and social resources. The establishment and maintenance of POR in such regions and/or settings, however, come with specific obstacles and challenges. Integrating the experiences acquired from research conducted in various continents (Africa, Europe, Latin America, and North America), the goal of this paper is to describe some of these challenges, strategies that have been implemented to address them, as well as new possible directions to facilitate the creation and growth of POR. It also describes how these challenges and ways to deal with them can provide helpful lessons for already existing POR infrastructures.

Bridges and Mechanisms: Integrating Systems Science Thinking into Implementation Research.

We present a detailed argument for how to integrate, or bridge, systems science thinking and methods with implementation science. We start by showing how fundamental systems science principles of structure, dynamics, information, and utility are relevant for implementation science. Then we examine the need for implementation science to develop and apply richer theories of complex systems. This can be accomplished by emphasizing a causal mechanisms approach. Identifying causal mechanisms focuses on the "cogs and gears" of public health, clinical, and organizational interventions. A mechanisms approach focuses on how a specific strategy will produce the implementation outcome. We show how connecting systems science to implementation science opens new opportunities for examining and addressing social determinants of health and conducting equitable and ethical implementation research. Finally, we present case studies illustrating successful applications of systems science within implementation science in community health policy, tobacco control, health care access, and breast cancer screening.

Recruitment of patients, carers and members of the public to advisory boards, groups and panels in public and patient involved health research: a scoping review.

OBJECTIVES: The objectives of this scoping review are to: (1) identify the distribution of and context of the recruitment strategies used, (2) explore the facilitators, benefits, barriers and ethical issues of the identified recruitment strategies, (3) distinguish the varying terminology for involvement (ie, panels, boards, individual) and (4) determine if the individual recruitment strategies used were to address issues of representation or bias. DESIGN: A scoping review. SETTING: This scoping review follows the framework by Peters et al. Seven electronic databases were explored including Scopus, Medline, PubMed, Web of Science, CINAHL, Cochrane Library and PsycINFO (conducted July 2021). The search strategy was codeveloped among the research team, PPI research experts and a faculty librarian. Two independent reviewers screened articles by title and abstract and then at full text based on predetermined criteria. PRIMARY AND SECONDARY OUTCOME MEASURES: Explore recruitment strategies used, facilitators, benefits, barriers and ethical issues of the identified recruitment strategies. Identify terminology for involvement. Explore recruitment strategies used to address issues of representation or bias. RESULTS: The final sample was from 51 sources. A large portion of the extracted empirical literature had a clinical focus (37%, n=13) but was not a randomised control trial. The most common recruitment strategies used were human networks (78%, n=40), such as word of mouth, foundation affiliation, existing networks, clinics or personal contacts. Within the reviewed literature, there was a lack of discussion pertaining to facilitators, benefits, barriers and ethical considerations of recruitment strategies was apparent. Finally, 41% (n=21) of studies employed or proposed recruitment strategies or considerations to address issues of representation or bias. CONCLUSION: We conclude with four key recommendations that researchers can use to better understand appropriate routes to meaningfully involve patients, carers and members of the public to cocreate the evidence informing their care.

Ética en investigación: desafíos durante la pandemia / Research ethics: challenges during the pandemic

Durante la pandemia de Covid-19 los hospitales pediatricos se vieron menos afectados, debido a la menor infección en niños, y sus recursos fueron reasignados en distintas tareas.. El Comité de Ética en Investigación del Hospital General de Niños Pedro de Elizalde presenta los distintos procedimientos implementados en esta emergencia, para sostener diferentes investigaciones, y que les permitió una rápida respuesta a esta situación.

The Value of and Need for Health Services and Policy Research that Focuses on Macro System-Level Challenges.

Much of health services and policy research is applied. We offer four provocations to stimulate thinking about the relationship between research and the "systems" it aims to influence. We conclude that a focus on partnership implies that researchers need to be empathetic to the timelines and needs of policy makers, while true relationships are bidirectional. Focusing on the priorities of "systems" will emphasize short-term issues. This leads to researchers often conducting post-implementation evaluation, where they have had little involvement in policy or intervention design. Finally, a focus on single-project return of investment will tend to undervalue riskier - but also potentially more rewarding - research.

Developing an obesity research agenda with British Pakistani women living in deprived areas with involvement from multisectoral stakeholders: Research priority setting with a seldom heard group.

INTRODUCTION: British Pakistani women have exceptionally high rates of obesity and yet are seldom heard in a research priority setting concerning weight management. The objectives of this study were (i) to ascertain what multisectoral professionals perceive to be the most pressing unmet obesity needs or topic areas that need more research in relation to Pakistani women living in deprived areas of Bradford and (ii) to determine the top 10 obesity health priorities for this group to develop an obesity research agenda. METHODS: A two-step process was adopted using the following: (i) a survey of a wide range of multisectoral professional stakeholders (n = 159) and (ii) a ranking exercise involving Pakistani women living in deprived areas of Bradford (n = 32) to select and prioritize their top 10 obesity health concerns and unmet needs from a list of 31 statements identified in the survey and previous research. Survey data were analysed using inductive content analysis and themes were identified. Themes were translated into statements to be ranked by Pakistani women. The ranking exercise was conducted by telephone either via voice or video call. Data were analysed using a reverse scoring system. RESULTS: Survey responses were grouped into statements reflecting the following three categories: education needs; healthy behaviour barriers and mental well-being. The highest rankings were given by Pakistani women to statements on mental health and the need for education. The top 10 prioritized statements were developed with members of the public into an obesity research agenda that reflected the target population. CONCLUSION: Actively engaging British Pakistani women in setting research priorities provided a unique opportunity to understand the key areas they think are important for future research. The culminating research agenda can be used by researchers to advance the field of obesity research in Pakistani communities, thus producing research outputs that are relevant to and have impact in this population. PATIENT OR PUBLIC CONTRIBUTION: Participants in the ranking exercise collected data. Public contributors were involved in developing the prioritized statements into a research agenda.

Prevention Research Centers and COVID-19: Models of a Community-Engaged Response to a Public Health Emergency.

For more than 30 years, the network of Centers for Disease Control and Prevention (CDC)-funded Prevention Research Centers (PRCs) has worked with local communities and partners to implement and evaluate public health interventions and policies for the prevention of disease and promotion of health. The COVID-19 pandemic tested the PRC network's ability to rapidly respond to multiple, simultaneous public health crises. On April 28, 2020, to assess the network's engagement with activities undertaken in response to the early phase of the pandemic, PRC network leadership distributed an online survey to the directors of 34 currently or formerly funded PRCs, asking them to report their PRCs' engagement with predetermined activities across 9 topical areas and provide case studies exemplifying that engagement. We received responses from 24 PRCs, all of which reported engagement with at least 1 of the 9 topical areas (mean, 5). The topical areas with which the greatest number of PRCs reported engagement were support of frontline agencies (21 of 24, 88%) and support of activities related to health care (21 of 24, 88%). The mean number of activities with which PRCs reported engagement was 11. The PRCs provided more than 90 case studies exemplifying their work. The results of the survey indicated that the PRCs mobilized their personnel and resources to support the COVID-19 response in less than 6 weeks. We posit that the speed of this response was due, in part, to the broad and diverse expertise of PRC personnel and long-standing partnerships between PRCs and the communities in which they work.

Weak correlations in health services research: Weak relationships or common error?

OBJECTIVE: To examine whether the correlation between a provider's effect on one population of patients and the same provider's effect on another population is underestimated if the effects for each population are estimated separately as opposed to being jointly modeled as random effects, and to characterize how the impact of the estimation procedure varies with sample size. DATA SOURCES: Medicare claims and enrollment data on emergency department (ED) visits, including patient characteristics, the patient's hospitalization status, and identification of the doctor responsible for the decision to hospitalize the patient. STUDY DESIGN: We used a three-pronged investigation consisting of analytical derivation, simulation experiments, and analysis of administrative data to demonstrate the fallibility of stratified estimation. Under each investigation method, results are compared between the joint modeling approach to those based on stratified analyses. DATA COLLECTION/EXTRACTION METHODS: We used data on ED visits from administrative claims from traditional (fee-for-service) Medicare from January 2012 through September 2015. PRINCIPAL FINDINGS: The simulation analysis demonstrates that the joint modeling approach is generally close to unbiased, whereas the stratified approach can be severely biased in small samples, a consequence of joint modeling benefitting from bivariate shrinkage and the stratified approach being compromised by measurement error. In the administrative data analyses, the estimated correlation of doctor admission tendencies between female and male patients was estimated to be 0.98 under the joint model but only 0.38 using stratified estimation. The analogous correlations for White and non-White patients are 0.99 and 0.28 and for Medicaid dual-eligible and non-dual-eligible patients are 0.99 and 0.31, respectively. These results are consistent with the analytical derivations. CONCLUSIONS: Joint modeling targets the parameter of primary interest. In the case of population correlations, it yields estimates that are substantially less biased and higher in magnitude than naive estimators that post-process the estimates obtained from stratified models.

Developing a national trauma research action plan: Results from the Burn Research Gap Delphi Survey.

BACKGROUND: The 2016 National Academies of Science, Engineering and Medicine call for a national integrated, military-civilian trauma action plan to achieve zero preventable deaths and disability after injury included a proposal to establish a National Trauma Research Action Plan to "strengthen trauma research and ensure that the resources available for this research are commensurate with the importance of injury and the potential for improvement in patient outcomes." The Department of Defense funded the Coalition for National Trauma Research to generate a comprehensive research agenda spanning the continuum of trauma/burn care from prehospital to rehabilitation. The Burn/Reconstructive Surgery group represents one focus area for this research agenda development. METHODS: Experts in burn and reconstructive surgery research identified gaps in knowledge, generated research questions and prioritized questions using a consensus driven Delphi survey approach. Participants were identified using established Delphi recruitment guidelines to ensure heterogeneity and generalizability with military and civilian representatives. Literature reviews informed the panel. Panelists were encouraged to use a PICO format to generate research questions: Patient/Population; Intervention; Compare/Control; Outcome. Participants ranked the priority of each question on a nine-point Likert scale, which was categorized to represent low, medium, and high priority items. Consensus was defined based on ≥60% panelist agreement. RESULTS: Subject matter experts generated 949 research questions in 29 Burn & 26 Reconstruction topics. Five hundred ninety-seven questions reached consensus. Of these, 338 (57%) were high-priority, 180 (30%), medium-priority, and 78 (13%) low-priority questions. CONCLUSION: Many high-priority questions translate to complex wound management and outcomes. Panel recognition that significant gaps in knowledge exist in understanding functional outcomes after injury underscores the importance of long-term recovery metrics even when studying acute injury or interventions such as resuscitation or inhalation injury. Funding agencies and burn/reconstructive surgery researchers should consider these gaps when they prioritize future research. LEVEL OF EVIDENCE: Expert consensus, Level IV.

Building the foundation for a practice-based research network: supporting primary care research across Canada.

Context: The Strategy for Patient Oriented Research (SPOR) was designed to engage previously passive stakeholders in the research process to ensure that the most urgent health challenges are addressed with evidence-based solutions that are feasible and scalable. The Primary and Integrated Health Care Innovations Network (PIHCIN), one of multiple SPOR entities, is rooted in community-based primary health care and meant to support transformation of primary and integrated care to improve patient experiences and health. Objective: To describe key components of building the foundation for a cross-jurisdictional, practice-based research network. Design: Cross-sectional survey and PIHCI network documentation review. Setting: SPOR PIHCI networks within British Columbia; Alberta; Saskatchewan; Manitoba; Ontario; Quebec; New Brunswick; Nova Scotia; Prince Edward Island; Newfoundland and Labrador; and the Northwest Territories. Participants: Responses were received from 11 networks who completed a template asking about their governance, capacity building, stakeholder engagement and patient partners. Responses were also received from the SPOR PIHCIN Pan-Canadian Patient Council. Outcome Measures: Thematic analysis across responses and documents for key components foundational to PIHCIN: types of stakeholders engaged, types of capacity building activities, knowledge translation and exchange activities. Results: Tripartite (clinician, scientist, decision-maker) leadership was used to align more closely with provincial and territorial needs in bringing practice and research closer together. PIHCIN enabled a unique pan-Canadian forum for government staff responsible for primary care. Individual networks and the PIHCIN patient-partners were actively engaged in research and governance on all levels including leading their own research. PIHCIN built research capacity by partnering with the Transdisciplinary Understanding and Training on Research Primary Health Care (TUTOR-PHC) and embedding fellows within the network. The PIHCI network undertook two separate learning series featuring patients, policy makers and scientists that were open to the public and demonstrated clear impact. Conclusion: Foundational components of embedded patients-partners, tripartite leadership, capacity building and knowledge translation and exchange have led to the formation of the PIHCI network providing an excellent base to build a pan-Canadian practice-based research and learning platform.