Job description and perception of clinical research personnel working in a network of French intensive care units.

BACKGROUND: There is a lack of information about the organisation and management of clinical research personnel in Europe and of their professional activity in intensive care. We therefore conducted a cross-sectional survey among personnel currently working in a French intensive care research network that involves 41 centres nationwide. The aim of the survey was to describe the personnel's personal and institutional organisation and management, their job perception in terms of satisfaction and stress, and suggestions for improvement. METHODS: Over 3 months in 2023, the research personnel received an electronic questionnaire on their personal and professional profile, past and present training, workplace and functions currently performed, personal knowledge about job skills required, job satisfaction and stress by as measured on a rating scale, and suggested ways of improvement. RESULTS: Ninety seven people replied to the questionnaire (a response rate of 71.3%), of whom 78 (57.3%) were sufficiently involved in intensive care to provide complete answers. This core sample had profiles in line with French recruitment policies and comprised mainly Bachelor/Master graduates, with nurses accounting for only 21.8%. The female to male ratio was 77:23%. Many responders declared to have a shared activity of technician (for investigation) and assistant (for quality control). More than 70% of the responders considered that most of the tasks required of each worker were major. Figures were much lower for project managers, who were few to take part in the survey. On a scale of 10, the median of job satisfaction was 7 for personal work organisation, 6 for training and for institutional organisation, and only 5 for personal career management. The median of job stress was 5 and was inversely correlated with satisfaction with career management. Respect of autonomy, work-sharing activity between investigation and quality control, a better career progression, financial reward for demanding tasks, and participation in unit staff meetings were the main suggestions to improve employee satisfaction. CONCLUSION: This nationwide survey provides a new insight into the activity of French clinical research personnel and points to ways to improve the quality and efficiency of this workforce.

Undertaking Studies Within A Trial to evaluate recruitment and retention strategies for randomised controlled trials: lessons learnt from the PROMETHEUS research programme.

Background: Randomised controlled trials ('trials') are susceptible to poor participant recruitment and retention. Studies Within A Trial are the strongest methods for testing the effectiveness of strategies to improve recruitment and retention. However, relatively few of these have been conducted. Objectives: PROMoting THE Use of Studies Within A Trial aimed to facilitate at least 25 Studies Within A Trial evaluating recruitment or retention strategies. We share our experience of delivering the PROMoting THE Use of Studies Within A Trial programme, and the lessons learnt for undertaking randomised Studies Within A Trial. Design: A network of 10 Clinical Trials Units and 1 primary care research centre committed to conducting randomised controlled Studies Within A Trial of recruitment and/or retention strategies was established. Promising recruitment and retention strategies were identified from various sources including Cochrane systematic reviews, the Study Within A Trial Repository, and existing prioritisation exercises, which were reviewed by patient and public members to create an initial priority list of seven recruitment and eight retention interventions. Host trial teams could apply for funding and receive support from the PROMoting THE Use of Studies Within A Trial team to undertake Studies Within A Trial. We also tested the feasibility of undertaking co-ordinated Studies Within A Trial, across multiple host trials simultaneously. Setting: Clinical trials unit-based trials recruiting or following up participants in any setting in the United Kingdom were eligible. Participants: Clinical trials unit-based teams undertaking trials in any clinical context in the United Kingdom. Interventions: Funding of up to £5000 and support from the PROMoting THE Use of Studies Within A Trial team to design, implement and report Studies Within A Trial. Main outcome measures: Number of host trials funded. Results: Forty-two Studies Within A Trial were funded (31 host trials), across 12 Clinical Trials Units. The mean cost of a Study Within A Trial was £3535. Twelve Studies Within A Trial tested the same strategy across multiple host trials using a co-ordinated Study Within A Trial design, and four used a factorial design. Two recruitment and five retention strategies were evaluated in more than one host trial. PROMoting THE Use of Studies Within A Trial will add 18% more Studies Within A Trial to the Cochrane systematic review of recruitment strategies, and 79% more Studies Within A Trial to the Cochrane review of retention strategies. For retention, we found that pre-notifying participants by card, letter or e-mail before sending questionnaires was effective, as was the use of pens, and sending personalised text messages to improve questionnaire response. We highlight key lessons learnt to guide others planning Studies Within A Trial, including involving patient and public involvement partners; prioritising and selecting strategies to evaluate and elements to consider when designing a Study Within A Trial; obtaining governance approvals; implementing Studies Within A Trial, including individual and co-ordinated Studies Within A Trials; and reporting Study Within A Trials. Limitations: The COVID-19 pandemic negatively impacted five Studies Within A Trial, being either delayed (n = 2) or prematurely terminated (n = 3). Conclusions: PROMoting THE Use of Studies Within A Trial significantly increased the evidence base for recruitment and retention strategies. When provided with both funding and practical support, host trial teams successfully implemented Studies Within A Trial. Future work: Future research should identify and target gaps in the evidence base, including widening Study Within A Trial uptake, undertaking more complex Studies Within A Trial and translating Study Within A Trial evidence into practice. Study registration: All Studies Within A Trial in the PROMoting THE Use of Studies Within A Trial programme had to be registered with the Northern Ireland Network for Trials Methodology Research Study Within A Trial Repository. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/55/80) and is published in full in Health Technology Assessment; Vol. 28, No. 2. See the NIHR Funding and Awards website for further award information.

A Study Within A Trial is a research study nested inside a larger 'host trial', promoting the use of Studies Within A Trial aimed to do Study Within A Trial routine practice in clinical trial units by funding and supporting at least 25 Studies Within A Trial. The best way to test health and social care treatments is to do a randomised controlled trial ('trial'), where some patients get the treatment being tested and some do not. The results of different groups are compared to see if the treatment improves care. Recruiting patients and keeping them involved in trials is often very difficult. Research teams often do not know how best to recruit and keep patients engaged as the methods have not been tested to see if they work. The best way to test these methods is by doing a Study Within A Trial. We test a programme of Studies Within A Trial for recruiting and keeping patients engaged in trials. Trial teams were able to apply for funding of up to £5000 and receive support from Promoting the use of Study Within A Trial team to do Studies Within A Trial. We used our experience of doing Studies Within A Trial to outline lessons learnt for doing Studies Within A Trial. We funded 42 Studies Within A Trial and gave teams necessary advice to do them. We significantly increased the knowledge for both recruitment and retention strategies, and found 'pre-notifying' before sending questionnaires, sending pens and personalised text messages were all effective for increasing responses by participants. We tested Studies Within A Trial across several different trials at the same time to find out more quickly whether their methods worked. We highlight key lessons learnt to guide others doing Studies Within A Trial, including involving patient partners; picking the right strategy to test; getting ethical approvals; how to do and report Studies Within A Trial. Promoting the use of studies within a trial was successful and supported more Studies Within A Trial than planned. We hope our experience will support those doing Studies Within A Trial in the future.

Aprendizaje en investigación clínica: experiencia de enseñanza híbrida con estudiantes de medicina / Learning in Clinical Research: Hybrid Teaching Experience with Medical Students

Introducción: la pandemia de COVID-19 indujo un cambio en nuestro sistema de salud y de educación. Los programas formativos también tuvieron que adaptarse y exigieron un cambio rápido. Objetivos: describir una experiencia educativa de enseñanza virtual/híbrida en investigación clínica, entre docentes del Servicio de Clínica de un hospital universitario y estudiantes de Medicina de una institución privada, que participaron del Programa ESIN (EStudiantes en INvestigación). Metodología: los contenidos y las estrategias educativas incluyeron las clases teóricas audiograbadas o videograbadas (asincrónicas y autoadministradas), el aprendizaje basado en proyectos, los talleres prácticos (encuentros sincrónicos virtuales y grupales), mediante la adopción de modelos de aprendizaje como el aula invertida, y la tutoría individual entre docente-estudiante. Los datos se recopilaron mediante la observación en contextos académicos, y basándonos en elementos de encuestas anónimas de satisfacción, previo consentimiento informado de los participantes. Resultados: participaron 14 estudiantes, 6 durante el año 2021 y 8 durante 2022. Todas mujeres y estudiantes de medicina (50% de cuarto año, 35% de sexto año y 15% de quinto año). Las técnicas implementadas favorecieron la participación y promovieron el aprendizaje activo, basado en proyectos. Mencionaron aspectos positivos como el enfoque académico práctico, la disponibilidad del equipo docente para atender cualquier duda, el tiempo y el entusiasmo por enseñar y fomentar la participación. Los videos teóricos resultaron útiles como herramientas de repaso, y los encuentros grupales fueron especialmente valorados, si bien los encuentros individuales fueron destacados como ayuda y apoyo previo a los congresos científicos. En general, manifestaron que fue una experiencia enriquecedora que demostró que se puede lograr lo que se creía imposible. Todas participaron activamente de al menos un congreso científico, y el 50% resultó coautora de una publicación académica. Conclusión: los estudiantes asumieron compromisos y responsabilidades, e incorporaron competencias y habilidades en la implementación y en la difusión de los proyectos. Esta experiencia educativa facilitó que el tiempo de clase pudiera optimizarse para intercambio, discusión y dudas. Los recursos producidos, las actividades desarrolladas y los contenidos abordados quedan disponibles a nivel institución. (AU)

Introduction: the COVID-19 pandemic brought about a change in our health and education system. Training programs also had to adapt and required rapid change. Objectives: to describe an educational experience of virtual/hybrid teaching in clinical research between teachers of the Clinical Service of a university hospital and medical students of a private institution who participated in the ESIN Program (Students in Research). Methodology: the contents and educational strategies included audio or videotaped lectures (asynchronous and self-administered), project-based learning, practical workshops (virtual and group synchronous meetings) by adopting learning models such as the inverted classroom, and individual tutoring between teacher and student. We gathered the data through observation in academic contexts and based on elements of anonymous satisfaction surveys, with prior informed consent of participants. Results: fourteen students participated, six in 2021 and eight in 2022. All were women and medical students (50% fourth year, 35% sixth year, and 15% fifth year). The techniques implemented favored participation and promoted active, project-based learning. They mentioned positive aspects such as the practical academic approach, the availability of the teaching team for any doubts, the time and enthusiasm for teaching, and encouraging participation. The theory videos were a valuable review tool, and team meetings received high praise even if the one-on-one meetings received much attention as help and support before the scientific congresses. In general, they stated that it was an enriching experience that showed that you can achieve what you thought impossible. All of them actively participated in at least one scientific congress, and 50% were co-authors of an academic publication. Conclusion: the students assumed commitments and responsibilities and incorporated competencies and skills in project implementation and dissemination. This educational experience helped to optimize class time for exchange, discussion, and doubts. The resources produced, the activities developed, and the contents addressed are now available at the institutional level. (AU)

Anxiety, Depression, Perceived Stress, and Burnout Among Chinese Researchers: A Cross-Sectional Nationwide Study.

Purpose: Depression and anxiety have a significant impact on an individuals' work and personal life alike. The mental health of researchers is a significant concern worldwide. This study investigated the mental health status of Chinese researchers specifically and explored the moderating effects of perceived stress on the influence of low self-accomplishment on anxiety and depression. Methods: The online survey platform "Survey Star" was used to create a questionnaire to be distributed to researchers, with 949 questionnaires retrieved. The general information questionnaire, 10-item Perceived Stress Scale (PSS-10), Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and Maslach Burnout Inventory General Survey (MBI-GS) were used for this investigation. Pearson's correlation analysis was performed to investigate correlations among the relevant variables. Model 8 of PROCESS 3.3 program was used to analyze the moderating effects of perceived stress. Results: Among the 949 participants, 570 (60.1%) reported symptoms of depression and 431 (45.4%) had symptoms of anxiety, with about one in six reporting symptoms of self-harm or suicidal ideation. Perceived stress was found to moderate the effect of low self-accomplishment on depression and anxiety. Conclusion: Here we show that researchers exhibit a high rate of depression and anxiety symptoms. Perceived stress is also shown to play a moderating role on the influence of low self-accomplishment on anxiety and depression. Thus, reducing perceived stress levels can help to improve the mental health of researchers.

Preparing clinicians to be site investigators in multicenter clinical trials: A training program at an academic medical center.

Clinical trials are essential in the translation of biomedical discoveries to new clinical interventions and therapeutics. Successful multisite clinical trials require qualified site investigators with an understanding of the full spectrum of processes and requirements from trial identification through closeout. New site investigators may be deterred by competing demands on their time, the complexity of administrative and regulatory processes for trial initiation and conduct, and limited access to experienced mentor networks. We established a Clinical Trialist Training Program (CTTP) and complimentary Clinical Trials Bootcamp at our institution to address these barriers and increase the number of local site investigators enabled to lead successful clinical trials. An initial cohort of four CTTP scholars received salary support with protected time, didactic training, assistance with study identification and start-up navigation, and quarterly progress meetings. By the end of the 12-month program, this initial cohort identified 33 new trials, utilized feasibility assessments, and reported being on target to sustain their protected time from new clinical trials. Bootcamp attendees demonstrated increased knowledge of resources, offices, and processes associated with clinical trial conduct. Our results support providing compensated protected time, training, and access to experienced clinical research professionals to enable clinicians to become successful site investigators.

Exploring the merits of research performance measures that comply with the San Francisco Declaration on Research Assessment and strategies to overcome barriers of adoption: qualitative interviews with administrators and researchers.

BACKGROUND: In prior research, we identified and prioritized ten measures to assess research performance that comply with the San Francisco Declaration on Research Assessment, a principle adopted worldwide that discourages metrics-based assessment. Given the shift away from assessment based on Journal Impact Factor, we explored potential barriers to implementing and adopting the prioritized measures. METHODS: We identified administrators and researchers across six research institutes, conducted telephone interviews with consenting participants, and used qualitative description and inductive content analysis to derive themes. RESULTS: We interviewed 18 participants: 6 administrators (research institute business managers and directors) and 12 researchers (7 on appointment committees) who varied by career stage (2 early, 5 mid, 5 late). Participants appreciated that the measures were similar to those currently in use, comprehensive, relevant across disciplines, and generated using a rigorous process. They also said the reporting template was easy to understand and use. In contrast, a few administrators thought the measures were not relevant across disciplines. A few participants said it would be time-consuming and difficult to prepare narratives when reporting the measures, and several thought that it would be difficult to objectively evaluate researchers from a different discipline without considerable effort to read their work. Strategies viewed as necessary to overcome barriers and support implementation of the measures included high-level endorsement of the measures, an official launch accompanied by a multi-pronged communication strategy, training for both researchers and evaluators, administrative support or automated reporting for researchers, guidance for evaluators, and sharing of approaches across research institutes. CONCLUSIONS: While participants identified many strengths of the measures, they also identified a few limitations and offered corresponding strategies to address the barriers that we will apply at our organization. Ongoing work is needed to develop a framework to help evaluators translate the measures into an overall assessment. Given little prior research that identified research assessment measures and strategies to support adoption of those measures, this research may be of interest to other organizations that assess the quality and impact of research.

Cómo crear un perfil digital de investigador a través de diferentes plataformas online. Una revisión narrativa / How to create a digital researcher profile by means of different online platforms: a narrative review

Introducción: el aumento de la producción científica se ha acompañado de plataformas para autores donde pueden compartir el curriculum vitae y los artículos publicados. El objetivo de este artículo es hacer una revisión narrativa en relación con los perfiles digitales, el uso de redes sociales (RRSS) profesionales y gestores bibliográficos de utilidad para la investigación en profesionales de Atención Primaria. Material y métodos: se realizó una búsqueda en la literatura médica para identificar estudios que informaran sobre temas relacionados con perfil investigador, plataformas online para perfiles digitales y gestores de referencias bibliográficas. Resultados: se recomienda incluir en un perfil: formación, actividad laboral, membresía a instituciones o sociedades científicas, artículos publicados, índice H, citaciones, proyectos financiados, premios recibidos y revisión de artículos en revistas indexadas. Las plataformas más frecuentes son ResearchGate, ORCID, Scopus y Publons, esta última integrada ya en la Web of Science. Todas ellas permiten compartir filiación, artículos publicados y premios recibidos. Las citaciones recibidas solo están disponibles en Scopus y Publons. El índice H está presente en todas las plataformas menos en ORCID. Los proyectos financiados pueden encontrarse en todas las plataformas menos en Publons. ORCID y Publons recogen las revisiones por pares en artículos indexados. Otras plataformas son: Pubmed y Google Scholar que comparten algunas funcionalidades. Los gestores bibliográficos permiten perfiles personales (Zotero), pero ofrecen menos funciones que otras plataformas, aunque sí la creación de grupos de trabajo (Mendeley y Zotero). Conclusión: tener un perfil investigador permite visibilizar la producción científica en Atención Primaria y contactar con otros investigadores.(AU)

Introduction: the increase in scientific production has been accompanied by platforms for authors where they can share their curriculum vitae and published articles. The aim of this article is to perform a narrative review in regard to digital profiles, the use of professional social networks and useful bibliographical managers for research into primary care professionals. Material and Methods: the medical literature was searched to identify studies that reported topics related to researcher profile, online platforms for digital profiles and bibliographical reference managers. Results: it is recommended including in a profile: training, work activity, membership in scientific institutions or societies, published articles, H index, citations, funded projects, awards received and review of articles in indexed journals. The most common platforms are ResearchGate, ORCID, Scopus and Publons, the latter already integrated into the Web of Science. All of them allow you to share affiliation, published articles and awards received. The citations received are only available in Scopus and Publons. The H-index is present on all platforms except ORCID. Funded projects can be found on all platforms except Publons. ORCID and Publons collects peer reviews on indexed articles. Other platforms are: PubMed and Google Scholar that share some functionalities. Bibliographical managers enable personal profiles (Zotero) but offer fewer functions than other platforms, although they do create work groups (Mendeley and Zotero). Conclusion: having a research profile enables scientific production to be visible in primary care and contact with other researchers.(AU)

Programa de Mentoría: acompañando tus primeros pasos hacia la excelencia científica / Mentoring Programme: Guiding your first steps towards scientific excellence

El primer Programa de Mentoría de SEMICYUC tiene como objetivo apoyar la carrera investigadora de los miembros más jóvenes de la Sociedad. Como beneficios añadidos está la adquisición de nuevas capacidades de investigación y/o clínicas, incrementar la capacidad de reflexión y fomentar el desarrollo de la próxima generación de líderes en la investigación. Este proyecto no sería posible sin el equipo excepcional de mentores o expertos investigadores dispuestos a emprender el viaje con los jóvenes aprendices. El presente artículo expone las bases de dicho programa, además de proponer futuros cambios en haz de una mejora continua (AU)

SEMICYUC's first Mentoring Programme aims to support the research careers of the Society's youngest members. Added benefits include acquiring new research and/or clinical skills, increasing the ability of critical thought, and fostering the development of the next generation of research leaders. This project would not be possible without the exceptional team of mentors or research experts willing to embark on the journey with the young trainees. This article sets out the foundations of such a programme and proposes future changes for continuous improvement (AU)

Mentoring Programme: Guiding your first steps towards scientific excellence.

SEMICYUC's first Mentoring Programme aims to support the research careers of the Society's youngest members. Added benefits include acquiring new research and/or clinical skills, increasing the ability of critical thought, and fostering the development of the next generation of research leaders. This project would not be possible without the exceptional team of mentors or research experts willing to embark on the journey with the young trainees. This article sets out the foundations of such a programme and proposes future changes for continuous improvement.

Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials.

BACKGROUND: In order to improve quality and efficiency of surgical trials, we assessed protocols complexity and examined whether it influenced the conduct, as measured by the number and types of deviations that occurred during the execution phase. Knowledge of these facts and performance of research team would allow to effectively mitigate the occurrence of deviations. METHODS: Thirty-five research protocols were rated according to a previously established complexity scoring model. Statistical analyses were performed to examine associations between protocol complexity, number of protocol/informed consent amendments vs. number/types of protocol deviations; as well as correlations with phase of the study, type of investigational product, personnel changes/experience level were assessed. RESULTS: Assessment of complexity score in Pearson's correlation test with the number of protocol deviations showed weak correlation, suggesting that other factors can influence protocol adherence. There was no correlation observed between number of deviations and type of study by investigational product category. In examining association between protocol deviations and number of subjects enrolled a trend was observed towards increased number of deviations once more subjects have entered the study. The higher number of protocol deviations was associated with increased number of protocol amendments (p = 0.0396), and there was no statistical significance observed between number of deviations and informed consent amendments (p = 0.5083). There was a moderate correlation detected between increased number of protocol deviations and total number of investigators on the study. CONCLUSION: Protocol adherence can be improved with effective training and retention of research coordinators, investigators and frequent internal auditing to address discrepancies and effectively implement corrective actions. Upfront training of research personnel, with subsequent monitoring of performance metrics throughout the execution phase can reduce the total number of protocol deviations, ensure data integrity and improve quality of research conducted. Engagement of all stakeholders upfront, including clinical site personnel, can help develop well-designed clinical trial protocol, avoid time consuming and costly protocol and informed consent amendments at execution phase and ensure higher quality of research conducted, while allowing to meet objectives of the trial in a more efficient manner.

Conducting Multicenter Residency Research.

PURPOSE: Conducting well designed pharmacy resident research projects has inherent challenges including inadequate sample size, a lack of time, decreased generalizability, and inadequate research support. A way to overcome these barriers is through conducting multicenter research projects. However, this approach may also bring new challenges. Therefore, the purpose of this article is to provide a general approach for pharmacy preceptors and leaders on implementation of multicenter residency research. SUMMARY: This article includes a general approach to conducting multicenter research from experienced individuals based upon their successes and failures. A timeline-based format is presented to lay the groundwork for implementation of this approach. Key topics in this paper include establishing a research overview committee, research question development, Institutional Review Board considerations, site recruitment, authorship discussions, resident coordination, protocol development, data collection, manuscript development, and considerations after residency. The approach maintains a critical focus on the individual residents ability to achieve American Society of Health-System Pharmacists accreditation standards for conducting research while operating in a collaborative manner. CONCLUSION: Conducting multicenter residency research projects requires a team-based approach and advanced planning. This approach has the potential to improve pharmacy resident project quality.

Scientific production of CNPq researchers in the areas of physical therapy and occupational therapy, Brazil / Produção científica dos pesquisadores do CNPq nas áreas de fisioterapia e terapia ocupacional, Brasil

Abstract Introduction : The scientific production of the areas of physical therapy and occupational therapy presented important growth and international visibility. Objective : To evaluate technical and scientific indicators, in addition to the training of human resources, of scholarship researchers of scientific productivity of CNPq (PQ), in the area of physical therapy and occupational therapy. Methods : A cross-sectional, census and quantitative study was conducted from the Lattes curricula of CNPq researchers with active scholarships in December 2021. The information was extracted through the Lattes Platform of CNPq, including three dimensions of variables for analysis: a) researcher profile; b) scientific production; c) training of human resources. Results : The evaluation included 73 PQ CNPq, in the areas of physical therapy and occupational therapy. The majority were female (n = 42; 57.5%), distributed in 26 different institutions in the country, with the Southeast region being the most prevalent. The largest portion of the PQ completed their doctorate between 11 and 20 years ago (n = 41; 56.2%) and did postdoctoral work (n = 55; 75.3%) abroad (n = 32; 58.2%). The group published 9,486 scientific articles throughout its career, averaging 129.94 scientific articles per PQ. The group of PQ supervised a total of 2,561 undergraduate students, 1,748 master's and 800 doctoral students. The mean H index of PQ was 19.74 (CI 95% = 18.40-21.11; SD = 5.71; median = 19). Conclusion : The PQ scholarship researchers presented significant scientific production and training of human resources, which confirms the important development of the areas in the last ten years. However, a strong nucleation of this production was observed.

Resumo Introducão : A produção científica das áreas de fisioterapia e terapia ocupacional apresentou importante crescimento e visibilidade internacional. Objetivo : Avaliar indicadores técni-cos e científicos, além da formação de recursos humanos, de pesquisadores bolsistas de produtividade científica do CNPq (PQ), nas área de fisioterapia e terapia ocupacional. Métodos : Realizou-se estudo transversal, censitário e quantitativo, a partir dos currículos Lattes dos pesquisadores do CNPq, nas áreas mencionadas, com bolsas ativas em dezembro de 2021. As informações foram extraídas da Plataforma Lattes do CNPq, incluindo três dimensões de variáveis para análise: a) perfil do pesquisador; b) produção científica; c) formação de recursos humanos. Resultados : Foram incluídos na avaliação 73 PQ do CNPq, nas áreas de fisioterapia e terapia ocupacional. A maioria foi do sexo feminino (n = 42; 57,5%), distribuída em 26 instituições distintas no país, sendo a região Sudeste a mais prevalente. A maior parcela dos PQ finalizou o doutorado entre 11 e 20 anos atrás (n = 41; 56,2%) e realizou pós-doutorado (n = 55; 75,3%) no exterior (n = 32; 58,2%). O grupo publicou 9.486 artigos científicos durante toda a carreira, com média de 129,94 artigos científicos por PQ. O conjunto dos PQ orientou um total de 2.561 estudantes de iniciação científica, 1.748 de mestrado e 800 de doutorado. O índice H médio dos PQ foi de 19,74 (IC 95% = 18,40-21,11; DP = 5,71; mediana = 19). Conclusão : Os bolsistas PQ apresentaram significativa produção científica e formação de recursos humanos, o que confirma o importante desenvolvimento das áreas nos últimos dez anos. Observou-se, entretanto, forte nucleação dessa produção.

Next Generation Leaders Programme: A Multi-Methods Evaluation of a Leadership Development Programme for Biomedical Researchers.

Background: Biomedical scientists have become de facto leaders for their research teams. Theories of expert leadership suggest that the specialist knowledge and credibility these researcher-leaders bring to their roles can lead to improved performance. Formal leadership development for biomedical researchers remains uncommon, and it is unclear whether existing leadership development programmes achieve improved individual and organisational outcomes. Our study evaluates the effectiveness of a single centre leadership development programme for biomedical researchers using a mixed-methods approach. Methods: 26 biomedical researchers participated in an 8 month single centre multidisciplinary leadership development programme. Participants completed prospective pre-test, retrospective then-test and traditional post-test self-assessments using the Primary Colours Questionnaire (PCQ) and Medical Leadership Competency Framework Self-Assessment Tool (MLCFQ). Pre-post pairs and then-post pairs were analysed for changes using Wilcoxon signed-rank tests and compared with a parallel mixed-methods evaluation organised by Kirkpatrick levels. Results: There were significant increases in 3/7 domains and 1/5 tasks of leadership in the PCQ, in both pre-post and then-post paired assessments. There were statistically significant but small increases in 2/7 domains of the MLCFQ. The mixed-methods data showed positive outcomes at all Kirkpatrick levels. Participants said the programme was relevant, interesting and well-organised, with 63% reporting increased confidence and motivation. Participants had a significant change in behaviour, spending 1-2 hours per week on group projects, which were successfully implemented locally. 42% of participants expected these projects to continue beyond the programme. Discussion: This study demonstrates a local leadership programme can have positive impact within a biomedical research centre despite time and financial constraints. We encourage future studies to utilise a mixed-methods approach to evaluating the impact of leadership development programmes.

Primary Care Research Is Hard to Do During COVID-19: Challenges and Solutions.

Conducting research in primary care during the COVID-19 pandemic is hard, due to baseline stresses on primary care, which have been compounded by the pandemic. We acknowledge and validate primary care researchers' frustrations. Using our experience on over 15 individual projects during the pandemic we identify 3 key challenges to conducting primary care research: (1) practice delivery trickle-down effects, (2) limited/changing resources and procedures for research, and (3) a generally tense milieu in US society during the pandemic. We present strategies, informed by a set of questions, to help researchers decide how to address these challenges observed during our studies. In order to overcome and grow from these challenging times we encourage normalization and self-compassion, and encourage researchers and funders to embrace pragmatic and adaptive research designs as the circumstances with COVID-19 evolve over time.

Strategies, facilitators, and barriers to interaction between health researchers and policy makers: Protocol for a systematic review.

This systematic review protocol is developed with the objective to identify the strategies, facilitators, and barriers to interaction between researchers and policy makers to use research evidence in health policy making. It seems that review of interactive methods between researchers and policy makers can help to understand the role of researchers on evidence-informed policy making. Moreover, identifying barriers and facilitators of these interactions can help universities and institutions associated to health policy making in planning to improve the interaction between researchers and policy makers to facilitate evidence-informed policy making.

Participatory Action Research for Tackling Distress and Burnout in Young Medical Researchers: Normative Beliefs before and during the Greek Financial Crisis.

(1) Background: We aimed to explore Young medical researchers (YMR) normative beliefs and perceived causes of distress and burnout, prior and during the financial crisis in Greece, and to assess their views on Participatory Action Research (PAR) interventions towards tackling these disorders. (2) Methods: A Participatory Learning and Action (PLA) methodology was performed in two time periods (prior crisis: December 2008; during crisis: February-March 2017). In both time periods, three different groups (Group 1: females, Group 2: males, Group 3: mixed) of 5-7 participants and two sessions (≈1 h/session) per group took place in each site. Overall, 204 sessions with 1036 YMR were include in the study. (3) Results: Several socio-demographic characteristics of YMR altered during the crisis (lower income, higher smoking/alcohol consumption, etc.). The majority of YMR conceived distress and burnout as serious syndromes requiring professional support. Feeling very susceptible and the necessity for establishing PAR interventions were frequently reported during the crisis. Numerous (a) barriers and (b) cues to action were mentioned: (a) lack of time, money and support from friends/family/colleagues (b) being extensively informed about the intervention, participation of their collaborators, and raising awareness events. (4) Conclusions: The changing pattern of Greek YMR's beliefs and needs during the crisis stresses the necessity of interventions to tackle distress and burnout. Effectiveness of these interventions could be enhanced by the suggested cues to action that emerged from this study.

"We're already doing this work": ethical research with community-based organizations.

BACKGROUND: Public health research frequently relies on collaborations with community-based organizations, and these partnerships can be essential to the success of a project. However, while public health ethics and oversight policies have historically focused on ensuring that individual subjects are protected from unethical or unfair practices, there are few guidelines to protect the organizations which facilitate relationships with - and are frequently composed of - these same vulnerable populations. As universities, governments, and donors place a renewed emphasis on the need for community engaged research to address systematic drivers of health inequity, it is vital that the ways in which research is conducted does not uphold the same intersecting systems of gender, race, and class oppression which led to the very same health inequities of interest. METHODS: To understand how traditional notions of public health research ethics might be expanded to encompass partnerships with organizations as well as individuals, we conducted qualitative interviews with 39 staff members (executive directors and frontline) at community-based organizations that primarily serve people who use drugs, Black men who have sex with men, and sex workers across the United States from January 2016 - August 2017. We also conducted 11 in-depth interviews with professional academic researchers with experience partnering with CBOs that serve similar populations. Transcripts were analyzed thematically using emergent codes and a priori codes derived from the Belmont Report. RESULTS: The concepts of respect, beneficence, and justice are a starting point for collaboration with CBOs, but participants deepened them beyond traditional regulatory concepts to consider the ethics of relationships, care, and solidarity. These concepts could and should apply to the treatment of organizations that participate in research just as they apply to individual human subjects, although their implementation will differ when applied to CBOs vs individual human subjects. CONCLUSIONS: Academic-CBO partnerships are likely to be more successful for both academics and CBOs if academic researchers work to center individual-level relationship building that is mutually respectful and grounded in cultural humility. More support from academic institutions and ethical oversight entities can enable more ethically grounded relationships between academic researchers, academic institutions, and community based organizations.

Research interrupted: applying the CONSERVE 2021 Statement to a randomized trial of rehabilitation during critical illness affected by the COVID-19 pandemic.

RATIONALE: The COVID-19 pandemic disrupted non-COVID critical care trials globally as intensive care units (ICUs) prioritized patient care and COVID-specific research. The international randomized controlled trial CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) was forced to halt recruitment at all sites in March 2020, creating immediate challenges. We applied the CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstance) statement as a framework to report the impact of the pandemic on CYCLE and describe our mitigation approaches. METHODS: On March 23, 2020, the CYCLE Methods Centre distributed a standardized email to determine the number of patients still in-hospital and those requiring imminent 90-day endpoint assessments. We assessed protocol fidelity by documenting attempts to provide the in-hospital randomized intervention (cycling or routine physiotherapy) and collect the primary outcome (physical function 3-days post-ICU discharge) and 90-day outcomes. We advised sites to prioritize data for the study's primary outcome. We sought feedback on pandemic barriers related to trial procedures. RESULTS: Our main Methods Centre mitigation strategies included identifying patients at risk for protocol deviations, communicating early and frequently with sites, developing standardized internal tools focused on high-risk points in the protocol for monitoring patient progress, data entry, and validation, and providing guidance to conduct some research activities remotely. For study sites, our strategies included determining how institutional pandemic research policies applied to CYCLE, communicating with the Methods Centre about capacity to continue any part of the research, and developing contingency plans to ensure the protocol was delivered as intended. From 15 active sites (12 Canada, 2 US, 1 Australia), 5 patients were still receiving the study intervention in ICUs, 6 required primary outcomes, and 17 required 90-day assessments. With these mitigation strategies, we attempted 100% of ICU interventions, 83% of primary outcomes, and 100% of 90-day assessments per our protocol. CONCLUSIONS: We retained all enrolled patients with minimal missing data using several time-sensitive strategies. Although CONSERVE recommends reporting only major modifications incurred by extenuating circumstances, we suggest that it also provides a helpful framework for reporting mitigation strategies with the goal of improving research transparency and trial management. TRIAL REGISTRATION: NCT03471247. Registered on March 20, 2018.