Consensus Process Research Articles

When, where and how should we assess professionalism in undergraduate medical education? Practical tips from an international conference roundtable discussion

The assessment of professionalism in healthcare disciplines is a challenging and nuanced topic in medical education. The literature, although continually emerging, remains in its infancy in regards to the role of the assessment of professionalism, appropriate timing for assessment, methods to assess professionalism and the benefits and implications of assessment of professionalism. With emergence of healthcare professionalism in both undergraduate and postgraduate curricula and increasing awareness of professionalism’s pertinent role in developing as a healthcare practitioner, the concept of assessing this topic is being discussed regularly in international fora, but as yet there is no consensus decision in how best to proceed. The authors have over a decade of experience researching, promoting and delivering healthcare professionalism education. They presented a roundtable discussion to an international panel of medical educators at an international conference. The attendees represented multiple healthcare disciplines. Breakout rooms and pre-determined introductory questions were used to explore the international consensus on current thinking about assessment in healthcare professionalism. This paper presents these findings as practical tips for educators who are considering introducing or extending their assessment of undergraduate professionalism, all of which were taken from the main themes of the discussion. The aim of the paper is to support educators to think about their stance on this often divisive issue, consider their approaches and focus future research to clarify the remaining unknowns.

Understanding 'quality' in adult traumatic brain injury rehabilitation from the perspectives of different stakeholders: a participatory mixed methods study.

The purpose of this study was to explore how 'quality' is understood for traumatic brain injury (TBI) rehabilitation from the perspectives of the rehabilitation recipients, their families and the providing clinicians. A participatory study using a mixed-methods, triangulation design. The study involved 1. a systematic literature search; 2. Individual semi-structured interviews with people with TBI and/or their caregivers and TBI rehabilitation clinicians, and 3. an online consensus process. 22 participants (7 people with TBI, 8 caregivers, 7 clinicians) participated in individual interviews. Their transcribed data were coded into broad categories via in-depth reflexive, thematic analysis; these categories were then mapped to 13 quality domains extracted from the literature. The emergent themes were then presented to the individuals, via an electronic consensus tool in two rounds. This resulted in 12 prioritized domains of quality that encompass service features, staff qualities and effectiveness. These evidence-informed and consensus-agreed indicators for quality may help guide both the provision and evaluation of TBI rehabilitation, that is valued and meaningful.

Embracing Controversy: A Second Look at CDC Reform Efforts in the Wake of COVID-19.

Addressing criticism that the agency's Covid-19 response was lacking, the US Centers for Disease Control and Prevention (CDC) has proposed internal agency reforms intended to improve its performance during the next pandemic. They are aimed at improving surveillance and analytic capacity and agency communications. This essay, via a counterfactual analysis of the CDC's proposed reforms, asks how, if completed in advance of Covid-19, they might have changed outcomes in four cases of guidance controversy during the pandemic. CDC planned reforms, though they have merit, are predicated on the ability to come to "scientific closure" in a highly charged political environment. To improve outcomes in a future pandemic, the agency should consider how it plans to communicate with the public when recovering from error and when addressing controversy spurred by criticism from credible experts. However, the ability of future presidents to limit CDC performance and communications in the next pandemic and the lack of political consensus around the value of independent public health expertise threaten the agency's reform goals.

BN SO16 - Gastro-gastric intussusception without any lead point – a case report and review of literature

Abstract Background Gastrogastric intussusception in a rare condition in adults. The underlying aetiologies include pathological lead points, anatomical abnormalities, previous foregut surgery or foreign body. The management of symptomatic gastrogastric intussusception in the absence of these aetiologies remains poorly defined and is highlighted by the paucity of evidence available for guidance. We present a case of idiopathic gastrogastric intussusception and a review of the literature. Method A 34-year-old male patient with a background of thrombocytopenia-absent radius (TAR) syndrome presented with recurrent episodes of upper abdominal pain and vomiting. Investigations with a CT abdomen revealed proximal gastrogastric intussusception. Subsequent endoscopy showed oedematous mucosa along the lesser curve and no pathological lead points or anatomical abnormalities. Histological findings were normal. Results The patient remained symptomatic despite a normal subsequent CT abdomen. A consensus decision was reached, and the patient was counselled for a laparoscopic gastropexy. Laparoscopic findings showed a central area of scar tissue circumferentially along the mid-body of the stomach highlighting the chronicity of the condition. No hiatal abnormalities were identified. A gastropexy was performed in two layers along the greater curvature of the stomach with non-absorbable interrupted sutures. The postoperative course was unremarkable. The patient remained asymptomatic on 6-week clinic follow up. Conclusion No previous case reports of idiopathic gastrogastric intussusception were identified on our literature search. It is our impression that this is the first such case-report to illustrate the diagnostic challenges of this rare, intermittently symptomatic condition and the successful management of it.

Limitations of trust and legitimacy in blockchain: exploring the effectiveness of decentralisation, immutability and consensus mechanisms in blockchain governance

PurposeThis paper examines to what extent blockchain creates legitimacy and trust in different modes of public governance. It posits that while blockchain aims for political legitimacy through decentralising, immutable and consensus-based mechanisms, the execution of these mechanisms is limited in legitimating governance, which has knock-on effects on trust. It provides an original contribution by recontextualising and reframing blockchain as a governance mechanism that should, and must, perform a legitimating function in order to engender trust.Design/methodology/approachThe research adopts a comprehensive framework for understanding the legitimacy of blockchain governance, positioning it in terms of co-governance, self-governance and hierarchical governance modes. It systematically analyses blockchain whitepapers, legislation, government documents and other sources in three paradigmatic case studies where blockchain governance failed. These cases are then used to assess blockchain according to three key characteristics of decentralisation, immutability and consensus.FindingsThe research finds that blockchain’s use in governance settings still relies on legitimacy conferred from other sources – namely state – in order to generate trust. Significant limitations in its de facto political decentralisation, immutability and consensus protocols can create failures in co-governance, self-governance and hierarchical-governance applications, thus limiting the legitimation function of blockchain in facilitating political trust.Originality/valueThese findings are significant in highlighting blockchain’s limitations as a decentralised, immutable and consensus-driven legitimating tool, which has knock-on effects on trust in technology and governance more broadly. It also has broader implications in more clearly highlighting the interconnectedness of political trust and legitimacy in governance processes.

NCOG-17. THE COMBAT PROJECT - CORE POST OPERATIVE MORBIDITY SET FOR PAEDIATRIC BRAIN TUMOURS

Abstract BACKGROUND Brain tumours are associated with high morbidity both from the tumour and the medical and surgical interventions used to treat them. Post operative morbidity reporting following surgery for paediatric brain tumours is poor due to the lack of a common language when reporting harms. One solution is to develop a core outcome set to stipulate the minimum post operative adverse outcomes that should be reported. The COMBAT (Core Post Operative Morbidity Set for Paediatric Brain Tumours) Project will develop a core outcome set that can be applied to post operative paediatric brain tumour patients to harmonise how adverse outcomes are measured and reported, enabling comparison between different trials, studies and clinical services. We aim to generate interest in The COMBAT Project and invite participation in the project from healthcare professionals and researchers experienced in paediatric neuro-oncology for the consensus process. METHODS AND ANALYSIS We will engage with national and international stakeholders including patients and their carers, healthcare professionals and researchers. A systematic review will identify harms reported in post operative paediatric brain tumour patients and how they are measured. Qualitative interviews with patients and carers will identify any harms of importance to them. A Delphi survey will be created from the harms identified. A consensus meeting will be held to finalise the core outcome set. The final core outcome set will be published and disseminated to encourage uptake. DISCUSSION There is a clear need for a common language to harmonise measurement and reporting of harms following surgery for paediatric brain tumour patients. This project will define post operative adverse outcomes that are of critical importance to key stakeholders. It will be used to standardise surgical morbidity outcome measurement and reporting in trials, studies and clinical practice and will inform future research in this field.

QOL-20. NATIONAL BRAIN TUMOR SOCIETY BRAIN TUMOR QUALITY OF LIFE RESEARCH AGENDA

Abstract BACKGROUND QoL is a critical aspect of health care outcomes, particularly in the context of brain tumor treatment and survivorship. There are evidence gaps in optimal strategies for improving QoL among brain tumor patients and care partners. Understanding the multifaceted dimensions of QoL and identifying key areas for brain tumor QoL research can significantly enhance patient care and support. Engaging the brain tumor community in defining QoL outcomes and determining research priorities can help orient research resources to community needs and perspectives. OBJECTIVE To summarize the process and outcomes of an NBTS-led collaborative effort to co-design a comprehensive research agenda on QoL for brain tumor patients and care partners, as outlined in the “Brain Tumor QoL Research Agenda.” METHODS The agenda was developed through a collaborative effort involving experts in neuro-oncology, patients, care partners, patient advocacy groups, and healthcare professionals over a two-year period. A review of existing literature, patient experiences, and expert opinions informed the identification of key research priorities. A multistakeholder advisory group held monthly meetings where brain tumor QoL was defined. In 2023, we conducted two “Research Roundtables” for adults and pediatric/AYA. The World Cafe method captured data and a survey consensus process to validate findings. RESULTS The QoL research agenda delineates a multifaceted framework encompassing domains crucial for understanding and improving QoL in brain tumor patients. Key focus areas include symptom management, psychosocial support, care burden, treatment decision-making, survivorship issues, and health care delivery models. An RFP was released by NBTS with input from stakeholder advisors in April 2024. CONCLUSION The Brain Tumor QoL Research Agenda created a roadmap for advancing research efforts aimed at enhancing the QoL of individuals affected by brain tumors. By addressing the identified research priorities, healthcare stakeholders can work towards implementing effective interventions and policies to optimize patient outcomes and well-being. This program was funded through a Patient-Centered Outcomes Research Institute® (PCORI®) Eugene Washington PCORI Engagement Award (EACB-23261).

Development and Validation of the Midwifery Interventions Classification for a Salutogenic Approach to Maternity Care: A Delphi Study

Background/Objectives: This study aims to develop and validate a Midwifery Interventions Classification (MIC), which is an evidence-based, standardized taxonomy and classification of core midwifery interventions based on a salutogenic perspective for maternity care. Methods: This study described the consensus process up to the results regarding the validation of the MIC through a two-round Delphi survey involving three panels of stakeholders: Midwives, Healthcare Researchers, and Maternity Service Users. Results: The resulting MIC comprises 135 core midwifery interventions classified into Direct Midwifery care (n = 101 interventions), Indirect Midwifery Care (n = 52 interventions), and Community Midwifery Care (n = 13 interventions), reaching an overall consensus rate among experts equal to 87%. These interventions were, therefore, adapted specifically for the Italian midwifery care context, with potential for international transferability, implementation, and scalability. Conclusions: The MIC is pivotal to boosting quality improvement, education, and comparable data collection for research, sustaining midwives’ role in promoting optimal health for women, newborns, and families at large.

Initial surgical management of injuries to the lower extremities in patients with multiple and/or severe injuries - A systematic review and clinical practice guideline update.

Our aim was to develop new evidence-based and consensus-based recommendations for the initial inhospital management of lower-extremity injuries in patients with multiple and/or severe trauma. This guideline topic is part of the 2022 update of the German Guideline on the Treatment of Patients with multiple and/or severe Injuries. MEDLINE and Embase were systematically searched to May 2021. Randomised controlled trials, prospective cohort studies, and comparative registry studies were included if they compared interventions for the initial surgical and non-surgical management of fractures, dislocations or vascular injuries of the lower extremities in patients with multiple and/or severe trauma. We considered patient-relevant clinical outcomes such as mortality, complication rates, length of stay, and function. Risk of bias was assessed using NICE 2012 checklists. The evidence was synthesised narratively, and expert consensus was used to develop recommendations and determine their strength. Eleven studies were identified. They addressed time to definitive fixation (n = 10 studies) and amputation (n = 1). Two new recommendations were developed, one was modified. All recommendations achieved strong consensus. This systematic literature review and subsequent expert consensus process resulted in the following new key recommendations. It is recommended that isolated and multiple lower-extremity fractures are managed with primary definitive fixation in patients whose condition is stable. Patients condition is not considered stable should be managed with primary temporary fixation. In addition, it is recommended that dislocations of the lower extremities are reduced and immobilised as early as possible.

The Power of the Tower: Nicolas Schöffer’s Tour Lumière Cybernétique for La Défense 1962–1973

This paper looks at Nicolas Schöffer’s unrealised Tour Lumière Cybernétique (1962–1973) to explore the interplay between urban data, participation, and political consensus in 1960s France. Envisioned for Paris’s business district La Défense, the purpose of the tower was to help keep the city in a technological equilibrium by employing a set of automated algorithms for collecting and visualising inputs received from the urban environment. Yet Schöffer’s ad-hoc disruptive interventions, the so-called perturbations that he deemed essential to the tower’s program, suggest that he regarded the outcome of data collection to be too monotonous to maintain that desired equilibrium.This article stands at the intersection of histories of architecture and urban data-processing. It aims to suggest that Schöffer’s TLC tower presents an indirect version of participation, one that, rather than fostering self-determinacy or proposing a political agenda, focuses on the extraction as well as abstraction of information ultimately framed as a participatory practice.

Consensus definition of a radiologically healed fistula on magnetic resonance imaging in perianal Crohn’s disease: an international Delphi study

IntroductionPerianal fistulising Crohn’s disease (pfCD) is a distinct and debilitating phenotype seen in around one-third of patients with CD. Clinical trials in pfCD are increasingly using magnetic resonance imaging (MRI) criteria as a primary endpoint, but there is heterogeneity in the radiological definition of a healed perianal fistula that currently limits our ability to perform meaningful meta-analyses of studies. Our aim is to standardise outcomes through the generation of an international consensus definition of a radiologically healed fistula.Methods and analysisThis international Delphi consensus study employs a two-part strategy.The first is a systematic review to identify a longlist of variables used to define radiological healing in pfCD. MRI-based indices used to score fistula severity and healing will be assessed for their methodological quality using Consensus-based Standards for the selection of health Measurement Instruments (COSMIN). The systematic review protocol will be conducted using COSMIN methodology and reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses.The second part will be an online Delphi consensus, guided by the results of the systematic review. Radiologists, gastroenterologists and colorectal surgeons with expertise in the management of pfCD will be invited to take part in two to three rounds of online surveys. Once an a priori threshold of >80% agreement is reached on individual radiological components used to define ‘healing’ and ‘healed’, a final meeting of key stakeholders will be organised to generate a consensus definition of a healed fistula.Ethics and disseminationThe study has been deemed exempt from a formal Research Ethics Committee review as no patients will participate directly in the consensus process, given the technical nature of the research question. The study is registered with the local R&D department (Reference RD24/007). Publication of this study will help standardise radiological endpoint measurement in clinical trials of pfCD and improve the synthesis and meta-analysis of comparative studies.PROSPERO registration numberCRD42024504334.

Ibero-American consensus statement on migraine treatment

Introduction and objectivesMigraine is the most common reason for neurology outpatient consultation; more than 80% of patients with migraine suffer some degree of associated disability. Migraine is an underdiagnosed disorder and patients frequently receive inappropriate treatment, which is why it is necessary to establish recommendations to improve patient management. The objective of this document is to establish a consensus position on the pharmacological treatment of migraine, including general measures and detailed analysis of the different options for the treatment of attacks and their prevention, from the perspective of Ibero-American countries. Methods and resultsBased on the recommendation documents published by the scientific societies of different Ibero-American countries, 2 surveys were prepared; through the application of the Delphi methodology and discussions in subsequent meetings, a document was developed in consensus format, supported by evidence from the literature and expert recommendations. ConclusionsA series of recommendations were agreed upon for the treatment of episodic migraine and chronic migraine, both for the acute management of attacks and for their prevention. These recommendations are based on the consensus process and a literature review, and are adapted to the regional conditions of the Ibero-American countries.

Understanding and improving the quality of primary care for people in prison: a mixed-methods study.

People in prison are generally in poorer health than their peers in the community, often living with chronic illness and multimorbidity. Healthcare research in prisons has largely focused on specific problems, such as substance use; less attention has been paid to conditions routinely managed in primary care, such as diabetes or hypertension. It is important to understand how primary care in prisons is currently delivered in the United Kingdom and how it can be improved, in order to reduce health inequalities. To understand the quality of primary care in prison, including gaps and variations in care, in order to recommend how quality of prison health care can be improved. A mixed-methods study with six interlinked work packages. Predominantly the North of England. Between August 2019 and June 2022, we undertook the following work packages: (1) International scoping review of prison healthcare quality indicators. (2) Stakeholder consensus process to identify United Kingdom focused prison healthcare quality indicators. (3) Qualitative interview study with 21 people who had been in prison and 22 prison healthcare staff. (4) Quantitative analysis of anonymised, routinely collected data derived from prison healthcare records (~ 25,000 records across 13 prisons). (5) Stakeholder deliberation process to identify interventions to improve prison health care. (6a) Secondary analysis of the qualitative data set, focusing on mental health and (6b) analysis of the quantitative data set, focusing on health care of three mental health subgroups. Our scoping review found predominantly only papers from the United States of America and of variable rigour with the main finding being that performance measurement is very challenging in the prison healthcare setting. In collaboration with stakeholders, we prioritised, refined and applied a suite of 30 quality indicators across several healthcare domains. We found considerable scope for improvement in several indicators and wide variations in indicator achievement that could not be attributed to differences in prison population characteristics. Examples of indicators with scope for improvement included: diabetes care, medicines reconciliation and epilepsy review and control. Longer length of stay in prison was generally associated with higher achievement than shorter stays. Indicator achievement was generally low compared to that of community general practice. We found some encouraging trends and relatively good performance for a minority of indicators. Our qualitative interviews found that quality of health care is related to factors that exist at several levels but is heavily influenced by organisational factors, such as understaffing, leading to a reactive and sometimes crisis-led service. Our stakeholder deliberations suggested opportunities for improvement, ideally drawing on data to assess and drive improvement. Our mental health work package found that coded mental illness had mixed associations with indicator achievement, while the interviews revealed that mental distress is viewed by many as an inevitable facet of imprisonment. Our analyses of indicator achievement were limited by the quality and coverage of available data. Most study findings are localised to England so international applicability may differ. Marked variations in the quality of primary care in prisons are likely to be attributable to the local organisation and conditions of care delivery. Routinely collected data may offer a credible driver for change. This study is registered at researchregistry.com (Ref: 5098). This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/05/26) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 46. See the NIHR Funding and Awards website for further award information.

Medical futility at the end of life: the first qualitative study of ethical decision-making methods among Turkish doctors

BackgroundThe swift advancement of intensive care medicine, coupled with technological possibilities, has prompted numerous ethical inquiries regarding decision-making processes concerning the withholding or withdrawal of treatment due to medical futility. This study seeks to delineate the decision-making approaches employed by intensive care physicians in Türkiye when faced with medical futility at the end of life, along with an ethical evaluation of these practices.MethodsGrounded theory, a qualitative analysis method was employed, conducting semi-structured, in-depth interviews with eleven intensive care physicians in Türkiye. The subsequent text analysis was carried out using MAXQDA software.ResultsParticipants assert that the decisions made by Turkish physicians determine whether treatment is futile, rely on medical consensus, and lack a standardized decision-making process. The decisions are influenced by legal and social pressures, resource constraints, and occasional conflicts of interest. The significance of professional hierarchy is notable, with limited consideration given to the opinions of nurses and other staff. The unstructured medical consensus processes are shaped by normative concepts such as benefit, age, justice, and conscience. Furthermore, it was observed that the conscientious opinions of physicians carry more weight than adherence to ethical principles and guidelines.ConclusionTo create optimal conditions for doctors to make ethically justifiable decisions, the dynamics within the treatment team should be improved, emphasizing the minimization of hierarchy, and ensuring the active participation of all team members in the decision-making process. Additionally, efforts should be directed toward narrowing the gap between the conscience of the individual doctor and established ethical principles. A potential solution lies in the nationwide implementation of clinical ethics committees and the establishing of clinical ethics guidelines, aiming to address, and overcome the identified challenges.

Learning from and about scientists: Consensus messaging shapes perceptions of climate change and climate scientists.

Despite overwhelming scientific consensus on the existence of human-caused climate change, public opinion among Americans remains split. Directly informing people of scientific consensus is among the most prominent strategies for climate communication, yet the reasons for its effectiveness and its limitations are not fully understood. Here, we propose that consensus messaging provides information not only about the existence of climate change but also traits of climate scientists themselves. In a large ( ) nationally representative survey experiment, we examine how consensus information affects belief in human-caused climate change by shaping perceptions of climate scientist credibility. In the control group ( ), we first show that people learn both from and about climate scientists when presented with consensus and that perceived scientist credibility (especially skill) mediates up to about 40% of the total effect of consensus information on climate belief. We demonstrate that perceptions of climate scientists are malleable with two novel interventions that increase belief in climate change above and beyond consensus information.

Development of a core predictor set of weaning in critically ill patients: a Delphi-based study protocol.

Prolonged mechanical ventilation in intensive care units (ICUs) leads to increased morbidity, higher mortality rates, and elevated healthcare costs. Predicting successful weaning from mechanical ventilation with accuracy is essential for optimizing resource use and improving patient outcomes. The International Classification of Functioning, Disability and Health (ICF) framework offers a holistic perspective on health conditions and can be adapted to identify key predictors of weaning readiness. This study aims to develop a Delphi-based core predictor set for weaning in critically ill patients, utilizing the ICF model. The core predictor set development comprises three steps: (1) Literature review and expert consultation to gather weaning predictors, (2) Predictor alignment with ICF categories per established rules, and (3) Three-round Delphi survey with a multidisciplinary team. A systematic review across major databases will be conducted to identify predictors related to weaning predictors in critically ill adults from cohort studies, trials, and reviews. Predictors will then be categorized within ICF domains. A multidisciplinary expert panel will evaluate the relevance of each predictor using a 9-point Likert scale to achieve consensus. This study will contribute to the development of a standardized, evidence-based predictor set for weaning readiness in critically ill patients. Using the ICF framework, this study aims to encompass the complex factors that influence weaning, thereby enabling personalized care plans and improving weaning outcomes. The Delphi methodology guarantees a thorough, iterative process for building consensus by integrating diverse clinical perspectives. The proposed Delphi-based study protocol aims to establish a core set of predictors for weaning in the ICU setting, guided by the ICF model. Successful implementation of this predictor set could enhance decision-making around weaning trials, reduce unnecessary ventilation days, and ultimately improve patient outcomes and healthcare efficiency. Future validation and implementation studies will be essential to confirm the utility and generalizability of this predictor set in clinical practice.

Partisan Politics in Finland

Abstract Traditionally, the Finnish party system has involved a high level of fragmentation yet remarkable stability, consensual decision-making, ideologically broad government coalitions, and mostly modest levels of polarization between parties or voters. These features suggest a limited effect of the party composition of government on economic policy. However, based on studies on close local elections, parliamentary speech, and party manifestos, we argue that the link between party politics and policy outcomes likely plays a role in Finland. Most analyses have examined the extent to which the characteristics of local politicians within the parties affect policy outcomes. These studies show that occupation, education, experience, competence, and residential location of local politicians strongly affect local policies, indicating that, in general, politics matters for policy. We also discuss how consensual national politics may have contributed to the recent success of the populist challenger Finns Party. As a new major player, the party has emphasized the role of sociocultural issues and especially affective polarization, which represents a considerable paradigm shift from the catch-all party policies typical of Finland for many decades. It is thus possible that the link between politics and policy will become more pronounced in the future, motivating further research.

The politics of universal health system reform in the context of COVID-19

Abstract Background Implementing universalism is more a political than a technical project. With this in mind, Ireland devised a ten-year plan through political consensus to deliver universal healthcare - Sláintecare. The COVID-19 pandemic occurred early in its implementation. Methods This is qualitative research drawing on international literature on universal health system reform in the context of COVID-19 as well as the politics of health reform. The overall research programme is co-produced with the Irish health system. A timeline and analysis of the reform journey is drawn from documentary analysis of key policy documents, parliamentary reports and key informant interviews. Results Despite a policy commitment since 2005, universal healthcare implementation only became government policy in Ireland 2018. While whole system reform and implementation progress has been slow, the COVID-19 health system response boosted aspects of universalism and reform. All COVID-related services during the pandemic were universal, free at the point of delivery, as are most new services introduced since 2021. Despite the political consensus holding through a change government and the pandemic, and significant additional investment in the public health system, there remain many obstacles to reform. These include different stakeholder understanding of implementing universalism in Ireland especially in the context of COVID-19, how best to implement universal healthcare and the politics of delivering reform. Conclusions Contrary to other countries’ experience during COVID, Ireland pursued its policy aim of delivering universalism and expanded services provided universally, free at the point of delivery, with a focus on enhanced community care. The universalism applied to COVID-related prevention and care, new women’s health and chronic disease management services. Despite progress, government has yet to legislate for a universal entitlement to care and obstacles to reform implementation remain.

Organizational health literacy in hospitals and primary health care - developing innovative tools

Abstract Background Organizational health literacy (OHL), particularly in health systems, is vital for supporting public health. Self-assessment tools (SAT), critical for quality assessment/improvement and for empowering relevant stakeholders, could support hospitals and primary healthcare services to promote their role in health literacy responsiveness, and support organizations in identifying strengths and areas of improvement. Methods The SAT for OHL in hospitals (OHL-Hos) and in primary healthcare (OHL-PHC) were developed via a participatory process, based on the “Vienna Concept of a Health Literate Healthcare Organization”. Piloting of the tools in European countries shed light on the tools’ depth and the need for revision. The development of short versions followed a Delphi process with experts from ten to thirteen European countries, respectively, from December 2023 - April 2024. Healthcare service diversity within and between countries was taken into consideration as well as cultural/language adaptation. Shortening OHL-Hos followed four steps: 1) prioritization of the most relevant indicators, 2) considering additional resources, 3) consensus process, 4) refinement of the tool and wording. Results The SATs for both healthcare settings are now established. The SAT for OHL-Hos includes a matrix model of eight standards, 21 sub-standards and 75 indicators. The SAT for OHL-PHC includes seven standards, 19 sub-standards and 69 indicators, covering OHL in organizational structures and processes for staff, patients and the community served with specific focus on navigation, communication, and participation. Both SATs are accompanied by a guide to direct organizations through in the self-assessment process. Conclusions The process of identifying OHL needs and opportunities in the health system, facilitated by participatory methods for tool development, led to innovative SATs for OHL which are currently ready for piloting and implementation in European countries.

Outcomes and complications of transvenous implantable cardioverter defibrillator systems in the pediatric population: a systematic review and meta-analysis

Abstract Background Implantable cardioverter defibrillators (ICDs) are an important therapy for prevention of sudden cardiac death (SCD). Data on transvenous (TV) ICD therapy rates, complications, and system survival in children ≤ 21 years is limited by absolute numbers and inclusion of adults with congenital heart disease. Purpose To determine ICD therapy rates and complications in pediatric patients ≤ 21 years of age. Methods A systematic review and meta-analysis were conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Medline, Embase, PubMed Ahead-of-Print and in-process records, and Cochrane Database of Systematic Reviews were searched for full-text articles on pediatric ICD. Articles were assessed for inclusion by two authors via a consensus process; the exclusion criteria included: case reports, review articles, abstracts, editorials, articles not in English, articles solely on epicardial or subcutaneous leads, articles on unrelated topics, articles with <50% ICD leads, and articles with any patients >21 years old. Data were extracted by 1 author and verified by a 2nd author. Meta-analysis of aggregate data was performed, where possible. Random effects models were used for pooled inferences. All reported rates are annualized rates based on reported follow-up times in each study. Results Of 1325 articles, 23 met all inclusion and no exclusion criteria (Figure) representing 1700 patients implanted from 1987-2020. The average age of patients was 12.8 years (95% confidence interval [CI]: 11.9 – 13.7) with weight of 51.1 kg (95% CI: 42.2 – 60.0) (Table). Primary prevention was the indication in 56.4 % (95% CI: 45.0% – 67.7%). Only 14.8% (95% CI: 10.6% – 19.0%) of the patients had congenital heart disease while 22.6% (95% CI: 15.8% – 29.3%) had long QT syndrome. The annualized rate of appropriate shock was 7.0% (95% CI: 5.6% – 8.8%) and the rate of inappropriate shock was 4.8% (95% CI: 3.8% – 6.0%). Annualized rates of reported adverse events included lead failure: 2.3% (95% CI: 1.6% – 3.3%) and infection: 0.8% (95% CI: 0.4% – 1.6%), which could have led to system revision: 4.4% (95% CI: 2.1% – 9.4%). The all-cause mortality rate was 0.8% (95% CI: 0.6% – 1.2%) across 17 studies. In 9 studies with 719 patients, the heart transplant rate was 1.6% (95% CI: 0.6% – 3.9%). Conclusion In this first systematic review and meta-analysis of ICDs in pediatric patients, ICD therapy was effective for prevention of SCD with a 7.0% annualized rate of appropriate ICD shocks. This is comparable to the annualized rate of appropriate ICD shock for secondary prevention of SCD in adult randomized controlled trials. Most common adverse events in the pediatric population were lead failure and system revision. Further refinements in patient selection criteria for implantation and improvements in lead and device technology are needed for pediatric patients.FigureTable