Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training.

The Joint Task Force for Clinical Trial Competency (JTF) conducted a global survey of clinical research professionals requesting respondents to self-assess their competencies in each of the eight domains of its Core Competency Framework version 3.1. The results were analyzed based upon role, years of experience, educational level, professional certification, institutional affiliation, and continuing education participation. Respondents with professional certification self-assessed their competencies in all domains at higher levels than those without professional certification. The survey demonstrated that irrespective of role, experience, or educational level, training curricula in both pre-professional and continuing professional education should include additional content relating to research methods, protocol design, medical product development and regulation, and data management and informatics. These results validate and extend the recommendations of a similar 2016 JTF and other surveys. We further recommend that clinical and translational research organizations and clinical sites assess training needs locally, using both subjective and objective measures of skill and knowledge.

Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals.

In 2014, the Joint Task Force for Clinical Trial Competency (JTF) published its Core Competency Framework. The Framework has been utilized internationally by academic institutions, corporate entities, professional associations, educational and training programs, and regulatory agencies and integrated into their activities. The JTF has continually updated and expanded the scope of the Framework to reflect changes in the scientific understanding and methodology utilized in conducting clinical research. In 2019, representatives from the Drug Information Association Professional Development and Project Management Leadership Communities approached the JTF reflecting the importance of clinical project managers and the project management skill set to the clinical research enterprise. In response, the JTF created a Project Management Competency Task Force to define and document these core competencies with recommendations for their inclusion as a revision to the Framework 3.0. Two new specific competencies with related examples were incorporated into Revision 3.1 and expressed at the Basic, Skilled and Advanced levels. In addition, the wording of several existing competencies was modified, and related examples added to reflect the knowledge, skills, and attitudes of clinical project managers.

Leveling the Joint Task Force Core Competencies for Clinical Research Professionals.

Competency standards for clinical research professionals are being developed across the enterprise, based largely on the Core Competency Framework put forth by the Joint Task Force for Clinical Trial Competency (JTF). In late 2016, representatives from organizations around the world convened at a workshop hosted by the Multi-Regional Clinical Trial Center of Brigham and Women's Hospital and Harvard (MRCT Center) to discuss their use of the standards. A number of modifications were suggested that resulted in the publication of JTF Framework 2.0. Another suggested evolution of the Framework was to consider "leveling" the competencies, to reflect the increase in competency that occurs as individuals progress in their careers. This paper describes the process utilized and final outcome of this work. The leveled competencies, defined as the Fundamental, Skilled, and Advanced levels, and the included examples are expected to provide better-defined tools and resources to organizations that are creating educational and training programs, standardized role descriptions, or professional progression planning for clinical research professionals.

Returning aggregate results of clinical trials: Empirical data of patient preferences.

INTRODUCTION: The purpose of this research was to understand the preferences of patients receiving integrative medicine services for return of aggregate study results. METHODS: A brief online survey (survey 1) was sent to 341 cancer patients receiving integrative medicine interventions; subsequently, a minimally revised survey (survey 2) was sent to 812 individuals with various medical conditions who had been either research participants in integrative medicine studies (n = 446) or patients (n = 346) of mind-body medicine. RESULTS: Feedback to a model plain language summary was elicited from survey 1 and survey 2 respondents. Seventy-seven survey recipients (23%) responded to survey 1, and 134 survey recipients (17%) responded to survey 2. The majority of respondents to the surveys were female and 51-70 years of age. Ninety percent of responders to survey 1 and 89% of responders to survey 2 indicated that researchers should share overall results of a study with participants. In terms of the means of result distribution, 37%-47% preferred email, while 22%-27% indicated that, as long as the results are shared, it did not matter how this occurred. Of 38 survey 1 respondents who had previously participated in a clinical trial, 37% had received the results of their study. In survey 2, 63 individuals indicated that they previously participated in clinical trials, but only 16% recalled receiving results. CONCLUSIONS: These results confirm that the majority (89%-90%) of integrative medicine patients are interested in receiving the results of clinical trials. The majority (82%-94%) of respondents felt the model plain language summary of results provided was helpful.

No sex for fish: empowering women to promote health and economic opportunity in a localized place in Kenya.

A pervasive cultural practice called 'jaboya' or women trading sex for fish exists at Nyamware Beach, on Lake Victoria in Kenya, where the fishing industry is the primary source of income. This case study describes how an innovative market-based solution succeeded in changing the gender dynamics on Nyamware beach and empowering women with the means of production in the industry. Over the course of 6 months, three boats were built for women to own and manage, and 29 women and 20 men received business skills training while establishing local community savings and loans associations. This project succeeded in quickly adjusting the economic imbalance that previously left women few options but to exchange sex to purchase the best fish for food and for distribution. Participating women applied resulting increased income to school fees for children and toward their households and businesses. Women owning businesses, earning income and gaining a voice in the community has changed the gender dynamics of men working on the boats for women and has positively altered the perception of women in the community. Additionally, this project offers potential health benefits such as a reduction in the transmission of HIV/AIDS and other sexually transmitted infections due to reduced rates of transactional sex, and reduced rates of depression, alcohol abuse and post-traumatic stress disorder from transactional sex, which can be traumatic. The success of this project demonstrates that small and innovative approaches addressing root causes of economic and social inequality can improve health and promote sustainable economic development.

Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.

A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval.

Responsibilities of Data Monitoring Committees: Consensus Recommendations.

BACKGROUND: A data monitoring committee (DMC) has special responsibilities for protecting the safety of clinical trial participants. Few guidance documents are available that address the operations and mechanics of establishing, serving on, or reporting to a DMC. This article provides a practical guide to sponsors, institutions, and individuals responsible for, or serving on, a DMC. METHODS: A workgroup of professionals from academia and not-for-profit and commercial organizations that included investigators, statisticians, patient advocates, and ethicists met to define the essential elements of planning, coordinating, and populating a DMC. All members of the group have formed, served on, advised, or worked with DMCs. RESULTS: The group outlined the objectives and mechanics of running a DMC, including operational and practical considerations, membership characteristics, roles, members' liability, and indemnification. Further, it delineated the roles and responsibilities of each DMC member. CONCLUSIONS: The group recommended practices for each phase of the DMC process from inception through execution of a clinical trial, with appropriate considerations for confidentiality. The group's practical guidance should assist in comprehensive oversight of appropriate clinical trials and should help DMC members execute their obligations with greater assurance.

Schools for health, education and development: a call for action.

In 2007, the World Health Organization, together with United Nations and international organization as well as experts, met to draw upon existing evidence and practical experience from regions, countries and individual schools in promoting health through schools. The goal of the meeting was to identify current and emerging global factors affecting schools, and to help them respond more effectively to health, education and development opportunities. At the meeting, a Statement was developed describing effective approaches and strategies that can be adopted by schools to promote health, education and development. Five key challenges were identified. These described the need to continue building evidence and capturing practical experience in school health; the importance of improving implementation processes to ensure optimal transfer of evidence into practice; the need to alleviating social and economic disadvantage in access to and successful completion of school education; the opportunity to harness media influences for positive benefit, and the continuing challenge to improve partnerships among different sectors and organizations. The participants also identified a range of actions needed to respond to these challenges, highlighting the need for action by local school communities, governments and international organizations to invest in quality education, and to increase participation of children and young people in school education. This paper describes the rationale for and process of the meeting and the development of the Statement and outlines some of the most immediate efforts made to implement the actions identified in the Statement. It also suggests further joint actions required for the implementation of the Statement.

Health-promoting school development in Zhejiang Province, China.

In 2003, after three pilot projects successfully implemented WHO's Health-Promoting Schools (HPS) concept, officials in Zhejiang Province, China, expanded to additional 51 schools (93,000 students and their families and 6800 school personnel). Each school identified a health issue to begin HPS development, followed by conceptual orientation, resource mobilization, teacher training, surveys, interventions, outreach and evaluation. This study focused on the extent to which participating schools implemented the HPS concept and improved their psycho-social environments (PSEs). Forty-nine of the 51 schools met China's HPS criteria. Schools with fewer resources and with substantial resources, i.e. schools in both rural and urban areas, met the criteria. Schools' PSEs, as measured by the PSE Profile, improved as they became HPS. Findings from interviews and observations identified strong encouragement and support from officials, school personnel, students, parents and community leaders, and consistency of HPS with the national policy on quality education, as success factors.

Strategies to address mental health through schools with examples from China.

The World Health Organization estimates that approximately one in five young people under the age of 18 experiences some form of developmental, emotional or behavioural problem, and one in eight experiences a mental disorder. Because research shows that half of adult mental disorders begin before the age of 14 and that early intervention can prevent and reduce more serious consequences later in life, it is critical to expand the role of mental health professionals with schools worldwide. Schools have the potential to affect the mental health of millions of young people, as well as those who work in schools. Research indicates that programmes promoting mental health are among the most effective of health promoting school efforts. This paper discusses the health promoting schools framework, reviews effective strategies for promoting mental health in schools, and provides examples from Zhejiang Province, China. This article also discusses the key roles that mental health professionals can play in promoting mental health through schools. As advocates, policy makers, researchers and teachers, mental health professionals can bridge the sectors of education, mental health and public health. Developing common frameworks and interdisciplinary training will create a foundation of shared understanding to achieve this goal.

Changes in attitudes, knowledge and behavior associated with implementing a comprehensive school health program in a province of China.

After successful pilot projects, Zhejiang Province, China, decided to systematically scale-up health promoting schools (HPS) over the entire province of 47 million. This study describes the interventions and self-reported changes in attitudes, knowledge and behavior during the first phase of scaling-up. Group interviews were conducted with a sample of 191 participants (school administrators, teachers, students and parents) from nine schools with a total of approximately 15 200 students. Grounded theory guided data analysis. Schools implemented all HPS components (school health policy, physical school environment, psychosocial school environment, health education, health services, nutrition services, counseling/mental health, physical exercise, health promotion for staff and outreach to families and communities), adapted to local circumstances. Participants reported a range of changes in attitudes (paying more attention to health, attaining better 'psychological quality' and confidence, forming friendships between teachers and students and feeling more relaxed), knowledge and concepts (increasing knowledge about various health issues, developing a broader concept of health and gaining better understanding about the HPS concept) and behavior (actively participating, increasing physical activity, improving sanitary habits, reducing or quitting smoking, eating more nutritiously, increasing safety behavior, sustaining less injuries and improving parent-child communication). This qualitative study shows the feasibility and efficacy of implementing HPS in Zhejiang Province, China.

Strategies for implementing Health-Promoting Schools in a province in China.

After successful pilot projects in 10 schools (four schools with tobacco control and six schools with nutrition interventions, plus 10 control schools), Health and Education officials in Zhejiang Province, China, decided to scale up Health-Promoting Schools (HPS) systematically over the entire province, starting with an initial cohort of 51 additional schools, reaching from primary to vocational schools. Interviews with school personnel during the first phase of scaling up illuminated the key pre-implementation, implementation, and monitoring and evaluation activities. Pre-implementation activities included choosing an entry point, setting up a special HPS committee, and establishing a work plan. Implementation activities included conducting mobilization meetings, prioritizing health, popularizing the HPS concept, ensuring community cooperation and participation, acting as role models, offering training, and using new teaching and learning methods. Monitoring and evaluation activities included process, baseline, and final evaluations and changing standards of evaluation to a more holistic evaluation that schools go through to become Health-Promoting Schools. Schools also reported that they faced - and overcame - a number of challenges including understanding and integrating the HPS concept and lack of professional development and support. Results revealed that schools transitioned from a passive model of education to interactive pedagogy put priority on health and viewed it as a co-responsibility, reshaped assessment to a more holistic approach and called for more training and technical support. Participants mentioned that they gained knowledge and skills and developed a deeper understanding about health. Health impact was also demonstrated, for instance in reduced injuries and reduced smoking, and educational impact was demonstrated, for instance in improved relationships of children to parents and teachers, improved social qualities, and improved teacher satisfaction.

Strategies for implementing health-promotion schools in a province in China

After successful pilot projects in 10 schools (four schools with tobacco control and six schools with nutrition interventions, plus 10 control schools), Health and Education officials in Zhejiang Province, China, decided to scale up Health Promoting Schools (HPS) systematically over the entire province, starting with an initial cohort of 51 additional schools, reaching from primary to vocational schools. Interviews with school personnel during the first phase of scaling up illuminated the key pre implementation, implementation, and monitoring and evaluation activities. Pre implementation activities included choosing an entry point, setting up a special HPS committee, and establishing a work plan. Implementation activities included conducting mobilization meetings, prioritizing health, popularizing the HPS concept, ensuring community cooperation and participation, acting as role models, offering training, and using new teaching and learning methods. Monitoring and evaluation activities included process, baseline, and final evaluations and changing standards of evaluation to a more holistic evaluation that schools go through to become Health Promoting Schools. Schools also reported that they faced, and overcame, a number of challenges including understanding and integrating the HPS concept and lack of professional development and support. Results revealed that schools transitioned from a passive model of education to interactive pedagogy put priority on health and viewed it as a co-responsibility, reshaped assessment to a more holistic approach and called for more training and technical support. Participants mentioned that they gained knowledge and skills and developed a deeper understanding about health. Health impact was also demonstrated, for instance in reduced injuries and reduced smoking, and educational impact was demonstrated, for instance in improved relationships of children to parents and teachers, improved social qualities, and improved teacher satisfaction. (AU)

Creating health-promoting schools in China with a focus on nutrition.

This pilot project in Zhejiang Province, China, aimed at improving the nutrition and health status of students, school personnel and parents, and developing a model project for nutrition interventions for the development of health-promoting schools (HPS) in China. Three primary and three secondary schools participated. Interventions included establishing school-based working groups, nutrition training for school staff, distribution of materials on nutrition, nutrition education for students, student competitions, school-wide health promotion efforts and outreach to families and communities. Results of a pre- and post-intervention survey one and a half years apart showed improvements in nutrition knowledge, attitudes and behavior among all target groups. Primary school students at the pilot schools made the greatest knowledge gains in the areas of Chinese dietary guidelines (increased from 49.2 to 78.0%, p < 0.01) and adequate dietary principles (increased from 42.9 to 68.0%, p < 0.01). Scores of secondary school students who reported liking school lunches rose at pilot schools from 17.9 to 45.2% (p < 0.01). School staff at control schools who reported taking breakfast declined from 81.4 to 66.6% (p < 0.01), while staff who reported taking lunch at school increased in pilot schools from 87.5% at baseline to 93.9% (p < 0.01). The largest increases in nutrition knowledge among all target groups occurred among parents and guardians. At the pilot schools parents increased their knowledge in the areas of nutritional deficiencies (from 35.0 to 66.2%, p < 0.01) and nutrient-rich foods (from 38.8 to 66.8%, p < 0.01). Talks with target groups confirmed changes in attitudes and behavior, and school visits revealed improvements to school facilities and school health services, establishing of school policies and a positive school climate. This study suggests that nutrition can effectively serve as an entry point to establish HPS in China and that the HPS concept is feasible to improve the dietary knowledge, attitudes and behavior of students, parents and school personnel.