Engagement In Clinical Research Research Articles

Design and Implementation of an Infrastructure Program to Support Clinical Research in Surgery

Barriers to active participation in clinical research among academic surgeons include insufficient research training and mentorship, increased clinical demands, lack of protected research time, limited access to resources, complex regulatory requirements, and a highly competitive research funding environment. We describe the development and implementation of a novel clinical research infrastructure program designed to attenuate these barriers and increase clinical research engagement and productivity in a large academic surgery department. Interim outcomes show a high utilization of program services across all divisions within the department, a substantial increase in new clinical research protocols, more applications submitted to funding agencies, and a high level of user satisfaction. We discuss how a departmental infrastructure program can simultaneously address barriers faced by surgeon clinical researchers and foster continuation of the longstanding tradition of innovation and discovery in academic surgery.

Impact of nontreatment oncology research trials on physician engagement in clinical research in an oncology community practice setting.

44 Background: The rapid development of new oncology drugs has created a significant increase in the number of clinical research studies. This underscores the need for greater participation in research by physicians as well as patients. Many physicians hesitate to participate in oncology clinical trials that provide treatment options for their patients given the complexity of the protocols. Non-treatment clinical trials may serve as a bridge for engaging physicians in clinical research and enhance the culture of research in community oncology practices. Methods: A large non-treatment oncology clinical trial was opened in a network of community oncology practices with approximately 1,000 physicians. We evaluated the number of physicians who did not enroll a patient onto a clinical trial in Year 1 but did enroll patients onto the non-treatment study. We further examined the number of physicians who enrolled a patient onto the non-treatment study that also enrolled patients onto a treatment clinical trial. Overall physician engagement in clinical research was measured by comparing practices where non-treatment study was offered to locations that did not participate in the non-treatment study. Negative impact on treatment accruals was also evaluated. Results: There were 105 physicians that practice at a site with the non-treatment study who had 0 accruals in Year 1 but enrolled a patient to any clinical trial in Year 2. Ninety-two of those physicians were responsible for enrolling over 900 patients to the non-treatment study in Year 2. Additionally, 46 of the 0 accruing physicians in Year 1, enrolled a patient to the non-treatment study also enrolled a patient to a treatment clinical trial. We also found that 24 physicians who did not did not enroll a patient in Year 1 and did not enroll a patient to the non-treatment study did enroll patients to a treatment clinical trial in Year 2. Conclusions: Participation in oncology treatment clinical trials can be difficult in the community oncology setting. Participation in a non-treatment study may serve as a bridge to engage more physicians in clinical research and enhance the culture of research within a community oncology practice.

Postface: Meaning of the Experiment and Implications of the Experience.

Discussing specifically on the involvement of social sciences in and on the issue of recruitment in HIV vaccine trials, the postface of this special issue reasserts the importance of social science engagement in clinical research. Three entry themes are underlying the discussion: the relationship between the individual and society in consent, the analysis of consent as a transaction, the examination of the basis, and the context of trust within trials.

Community involvement in biomedical research conducted in the global health context; what can be done to make it really matter?

BackgroundCommunity involvement in research has been advocated by researchers, communities, regulatory agencies, and funders with the aim of reinforcing subjects’ protection and improving research efficiency. Community involvement also has the potential to improve dissemination, uptake, and implementation of research findings. The fields of community based participatory research conducted with indigenous populations and of participatory action research offer a large base of experience in community involvement in research. Rules on involving the population affected when conducting research have been established in these fields. But what is the role of community engagement in clinical research and observational studies conducted in biomedical research outside of these specific areas?Main body of the abstractMore than 20 years ago, in the field of HIV medicine, regulatory bodies and funding agencies (such as the US National Institutes of Health) recommended the constitution of a formal organism, the Community Advisory Board (CAB), as part of the study requirements for HIV trials. More recently, CABs have been adopted and used in other fields of medical research, such as malaria. CABs are not without limitations, however, and there is little research on the effectiveness of their use in achieving community protection and participation. Nevertheless, CABs could be a model to import into clinical trials and observational research where no alternative model of community representation is currently being used.ConclusionsAllocating more resources to training and shifting more power to community representatives could be part of the solution to current CAB limitations. However, for researchers to be able to apply these recommendations on community involvement, certain conditions need to be met. In particular, funding agencies need to recognize the human and financial resources required for serious community involvement, and the academic environment needs to take community involvement into account when appraising, mentoring, and training researchers.

A Program for Promoting Clinical Scholarship in General Surgery

The Accreditation Council for Graduate Medical Education mandates resident physician training in the principles and applications of research. To provide a robust early foundation for effective engagement in scholarship, we designed a novel clinical scholarship program (CSP) for PGY1 general surgery residents. In a general surgery residency training program, we assessed resident academic productivity (i.e., presentations, publications, and sustained engagement in clinical research) and self-efficacy to conduct clinical research, as well as the overall satisfaction of both residents and faculty mentors. The clinical research appraisal inventory was administered both before and after completion of the CSP rotation. Totally, 44 categorical general surgery trainees and 23 faculty research mentors participated in the CSP from 2011 to 2016; 26 residents (59%) presented at regional or national meetings. Of the 35 residents who were 24 or more months beyond their PGY1 training period, 16 (46%) have published their CSP project, 5 (14%) report continued commitment towards publication, and 22 (63%) have ≥1 clinical research publications beyond their CSP participation during residency, excluding publications arising from subsequent formal research fellowships. Clinical research appraisal inventory responses indicate significant improvement (p < 0.005) in clinical research self-efficacy. A structured CSP increases the confidence of trainees to perform clinical research and leads to significant contributions directed at addressing clinically meaningful problems in surgery. Faculty-guided resident research at a very early stage of clinical training supplements other mentorship experiences and encourages the development of surgeons who will engage in life-long clinical problem solving.

Evaluation of 3 approaches for increasing patient engagement in clinical research: Feedback from a community engagement advisory board.

The purpose of this study was to obtain feedback from a diverse group of community advisory board members about different clinic or hospital-based approaches to increasing research participation. Members of an established community engagement advisory board (n=16) provided qualitative and survey data regarding attitudes and preferences for 3 hospital and clinic system strategies to recruit patients into clinical research including universal consent for research, patient registries, and patient portals. Overall, there was moderate support for each of the 3 approaches discussed. Board members described advantages and disadvantages of each method. Based on the qualitative data, universal consent was viewed as the best strategy for consenting high volumes of patients for research. However, patient registries and portals were seen as more acceptable, less-intrusive and more likely to result in higher participation rates. Survey data were consistent with qualitative findings. Input from community stakeholders is needed to identify strategies to enhance participation and increase diversity in clinical research. Members of our CEAB identified patient registries and portals as feasible and nonintrusive approaches to increasing research participation. Additional research is needed to confirm these findings and to establish best practices for supporting patients in using registry approaches.

Public attitudes towards research participation during an infectious disease pandemic: a qualitative study across four European countries

BackgroundPandemics of infectious disease are recurrent events that impact global health and security. International, collaborative planning for future pandemics is a priority for public health officials, the research community, and the general public. However, little is known about the public's attitudes to participating in pandemic research and about their views on associated ethical dilemmas. We aimed to determine public perceptions about involvement in clinical research conducted in primary and critical care during a pandemic. MethodsWe conducted ten, 2 hour focus groups (6–10 participants each) and 16 one-to-one follow-up interviews involving 80 members of the public in Belgium, Poland, Spain, and the UK between Sept 1 and Dec 31, 2015. Recruitment was through local advertisement. Data were collected by local researchers who followed a scenario-based topic guide, transcribed verbatim and translated into English. We used framework analysis to identify the range and diversity of participants' perspectives. FindingsPublic understandings of pandemics were shaped by personal factors (illness during the H1N1 pandemic, experience of life-threatening illness) and social factors (historical references, media, public health information). Motivations to participate in pandemic research were influenced by altruism, therapeutic misconception, trust, and perception of risk. Use of routinely collected data and clinical samples without explicit prior consent was supported in principle, but was less acceptable when a profit motive was perceived. Participants recognised and appreciated the protections provided by ethically robust research procedures. However, they described having become desensitised to the importance and meaning of consent processes because of the frequency with which they authorise terms and conditions in everyday life. Participants proposed different models that might apply in a pandemic context (eg, advanced consent, verbal consent). InterpretationPublic engagement in clinical research on pandemic planning is possible, useful, but as yet underdeveloped in Europe. Effective pandemic preparation for clinical research requires active public engagement to mitigate therapeutic misconception and engender trust. This bottom-up approach to ascertaining public views on pandemic research participation has identified support for minimising disproportionate research protection procedures for publicly funded, low risk studies. FundingEuropean Union Seventh Framework Programme under the project Platform foR European Preparedness Against (Re-)emerging Epidemics (PREPARE) (grant agreement 602525).

Applying a Conceptual Framework to Maximize the Participation of Diverse Populations in Cancer Clinical Trials.

The underrepresentation of ethnically diverse populations in cancer clinical trials results in the inequitable distribution of the risks and benefits of this research. Using a case study approach, we apply a conceptual framework of factors associated with the participation of diverse population groups in cancer clinical trials developed by Dr. Jean Ford and colleagues to increase understanding of the specific strategies, and barriers and promoters addressed by these strategies, that resulted in marked success in accrual of racially and ethnically diverse populations in cancer clinical research. Results indicate that the studies presented were able to successfully engage minority participants due to the creation and implementation of multilevel, multifaceted strategies that included: culturally and linguistically appropriate outreach, education, and research studies that were accessible in local communities; infrastructure to support engagement of key stakeholders, clinicians, and organizations serving minority communities; testimonials by ethnically diverse cancer survivors; availability of medical interpretation services; and providing infrastructure that facilitated the engagement in clinical research of clinicians who care for minority patient populations. These strategic efforts were effective in addressing limited awareness of trials, lack of opportunities to participate, and acceptance of engagement in cancer clinical trials. Careful attention to the context and population characteristics in which cancer clinical trials are conducted will be necessary to address disparities in research participation and cancer outcomes. These studies illustrate that progress on minority accrual into clinical research requires intentional efforts to overcome barriers at all three stages of the accrual process: awareness, opportunity, and acceptance of participation.

Training of breast surgical oncologists.

Breast surgical oncology is a defined sub-specialty of general surgery with focus on the surgical management of breast disease and malignancy within a multidisciplinary context. Much of the training of breast surgical oncologists in the United States exists within a fellowship training structure with oversight and approval by the Society of Surgical Oncology (SSO). Rapid continuous changes in breast oncology practice have further substantiated dedicated expertise in breast surgical oncology. Training programs are structured to develop proficiency in fellows for advanced surgical techniques and clinical decision-making as well as exposure to the multidisciplinary aspects of breast cancer management. Components of a successful program include an intense multidisciplinary curriculum, engagement in clinical research and attention to strong mentorship. National curriculum and training requirements as well as supplemental resources assist in standardizing the fellowship experience. As surgical training and the field of breast oncology continues to evolve, so do fellowship training programs to ensure high quality breast surgical oncologists equipped to deliver high quality evidence based patient care while continuing to drive future research and trainee education.

Engaging Participants in Rare Disease Research: A Qualitative Study of Duchenne Muscular Dystrophy

PurposeClinical trials in Duchenne muscular dystrophy (DMD) are increasing due to technical advances in genetics, muscle biology and muscle imaging, and translational science. Yet the ability to achieve and measure progress in clinical trials in DMD is severely constrained by recruitment difficulties and low levels of patient and family participation. Clinical trials that do not have full inclusion of patients may affect how well new therapies perform in clinical practice. MethodsThis study qualitatively investigated family-centered and clinician-based knowledge, attitudes, and perceptions of engagement in clinical research in DMD. Thirteen focus-group sessions (8 parent based and 5 clinician based) were held at 5 demographically and geographically diverse sites (Houston, Texas; Minneapolis, Minnesota; Pittsburgh, Pennsylvania; Sacramento, California; and Washington, DC). Thematic analysis was used for identifying patterns of meaning across the dataset. FindingsTotals of 28 parents and 33 clinicians participated in innovative and thoughtful discussions regarding clinical research in DMD and approaches to eliciting family engagement. Five overarching themes emerged from our qualitative data. The theme of Information discussed the lack of accessible and coherent information, as well as the overabundance of fragmented information. The theme of Conversation demonstrated the importance of having open and in-depth dialogue about research with families in eliciting trust and obligation toward the research process. The Barriers and Incentives themes presented the parents’ and clinicians’ views of the life-altering sacrifices that families make to participate in research and ways to reduce these burdens. Under the Solutions theme, parents and clinicians also suggested innovative ways to incentivize families and clinics and thoughtful solutions to increase family engagement in research. ImplicationsEffective recruitment for clinical studies in rare diseases requires a truly committed and engaged study team, as well as the necessary resources to overcome the multitude of barriers that families face. A clearly delineated recruitment plan, developed together with families, should be the standard operating procedure during clinical trial development. Protocols utilizing direct family-centered strategies for providing information and for recruiting research participants in studies in rare diseases are essential.

Development, implementation and evaluation of a clinical research engagement and leadership capacity building program in a large Australian health care service

BackgroundHealth professionals need to be integrated more effectively in clinical research to ensure that research addresses clinical needs and provides practical solutions at the coal face of care. In light of limited evidence on how best to achieve this, evaluation of strategies to introduce, adapt and sustain evidence-based practices across different populations and settings is required. This project aims to address this gap through the co-design, development, implementation, evaluation, refinement and ultimately scale-up of a clinical research engagement and leadership capacity building program in a clinical setting with little to no co-ordinated approach to clinical research engagement and education.Methods/DesignThe protocol is based on principles of research capacity building and on a six-step framework, which have previously led to successful implementation and long-term sustainability. A mixed methods study design will be used. Methods will include: (1) a review of the literature about strategies that engage health professionals in research through capacity building and/or education in research methods; (2) a review of existing local research education and support elements; (3) a needs assessment in the local clinical setting, including an online cross-sectional survey and semi-structured interviews; (4) co-design and development of an educational and support program; (5) implementation of the program in the clinical environment; and (6) pre- and post-implementation evaluation and ultimately program scale-up. The evaluation focuses on research activity and knowledge, attitudes and preferences about clinical research, evidence-based practice and leadership and post implementation, about their satisfaction with the program. The investigators will evaluate the feasibility and effect of the program according to capacity building measures and will revise where appropriate prior to scale-up.DiscussionIt is anticipated that this clinical research engagement and leadership capacity building program will enable and enhance clinically relevant research to be led and conducted by health professionals in the health setting. This approach will also encourage identification of areas of clinical uncertainty and need that can be addressed through clinical research within the health setting.

Patient and clinician views on comparative effectiveness research and engagement in research.

Describe and compare patient and primary care clinician attitudes about comparative effectiveness research (CER) and inclusion of patients and clinicians as partners in clinical research. Online survey of patients (n = 900) and primary care clinicians (n = 750) from opt-in survey panels. Nearly half (45%) of clinicians were not familiar with CER, but after reviewing a definition of CER, most (76%) agreed that it can improve patient care. Patients and clinicians indicated interest in engagement as research partners (66% and 55%, respectively). Lack of time was the most commonly endorsed barrier. Attitudes toward CER and engagement in clinical research were generally favorable. Identified facilitators and barriers point to strategies for enhancing patient and clinician engagement in research.

Patient engagement in clinical research through mobile technology

Patient engagement in clinical research through mobile technology

Are Pharmacists a Viable Channel for Education about Clinical Trial Participation?

Clinical research is fundamental to improving public health, yet public awareness of and engagement in clinical research is very low, as is public trust in the clinical research enterprise. Hypothesizing that pharmacists represent an untapped resource to educate and engage the public about clinical research, this study examines public perspectives on receiving clinical research information from pharmacists. In a 19-item survey, the majority (72%) of the 2,650 respondents were very or somewhat interested in receiving clinical trial information from a pharmacist; but <1% currently receive it and <2% ever asked. Primary interests include information about finding a trial, safety of trials, and ways to learn more; printed information provided at the pharmacy or by email are preferred methods of receiving information. Interest varies significantly among respondent groups, but excepting non-pharmacy users, all respondents desire information at rates greater than 65%, regardless of demographics, knowledge or experience of clinical trials, and patient-pharmacist relationships. These results suggest that pharmacy-directed outreach and recruitment strategies could see high rates of success.

Bridging the gap between basic science and clinical practice: a role for community clinicians.

BackgroundTranslating the extraordinary scientific and technological advances occurring in medical research laboratories into care for patients in communities throughout the country has been a major challenge. One contributing factor has been the relative absence of community practitioners from the US biomedical research enterprise. Identifying and addressing the barriers that prevent their participation in research should help bridge the gap between basic research and practice to improve quality of care for all Americans.MethodsWe interviewed over 200 clinicians and other healthcare stakeholders from 2004 through 2005 to develop a conceptual framework and set of strategies for engaging a stable cadre of community clinicians in a clinical research program.ResultsLack of engagement of community practitioners, lack of necessary infrastructure, and the current misalignment of financial incentives and research participation emerged as the three primary barriers to community clinician research participation. Although every effort was made to learn key motivators for engagement in clinical research from interviewees, we did not observe their behavior and self-report by clinicians does not always track with their behavior.ConclusionsA paradigm shift involving acknowledgement of the value of clinicians in the context of community research, establishment of a stable infrastructure to support a cohort of clinicians across time and research studies, and realignment of incentives to encourage participation in clinical research is required.

Promoting public awareness of randomised clinical trials using the media: the ‘Get Randomised’ campaign

AIMTo increase public awareness and understanding of clinical research in Scotland.METHODSA generic media campaign to raise public awareness of clinical research was launched in 2008. The ‘Get Randomised’ campaign was a Scotland-wide initiative led by the University of Dundee in collaboration with other Scottish universities. Television, radio and newspaper advertising showed leading clinical researchers, general practitioners and patients informing the public about the importance of randomised clinical trials (RCTs). ‘Get Randomised’ was the central message and interested individuals were directed to the http://www.getrandomised.org website for more information. To assess the impact of the campaign, cross-sectional surveys were conducted in representative samples of 1040 adults in Scotland prior to campaign launch and again 6 months later.RESULTSThere was an improvement in public awareness of clinical trials following the campaign; 56.7% [95% confidence interval (CI) 51.8, 61.6] of the sample recalled seeing or hearing advertising about RCTs following the campaign compared with 14.8% (10.8, 18.9) prior to the campaign launch (difference = 41.4%; 95% CI for difference 35.6, 48.3; P < 0.01). Of those who recalled the advertising, 49% felt that the main message was that people should take part more in medical research. However, on whether they would personally take part in a clinical trial if asked, there was little difference in response following the campaign [‘yes’ 31.3% (28.4, 34.1) prior; 30.4% (27.6, 33.2) following; difference =−0.9%; 95% CI for difference −4.8, 3.1%; P= 0.92].CONCLUSIONSIt is possible to raise public awareness of clinical research using the media, but further efforts may be required to influence individuals' decisions to take part in clinical research.

Clinical outcomes research from the occupational therapist's perspective.

With increasing costs and scarcity of resources, occupational therapists need to embrace outcomes research to demonstrate the effectiveness of its clinical interventions. To explore clinicians' perspectives on clinical outcomes research a qualitative study was undertaken involving three in-depth group interviews with 15 occupational therapists from the South Western Sydney Area Health Service. Five broad themes permeated participants' perception: (a) defining the process, (b) factors that impact on participation in clinical outcomes research, (c) organizational influences, (d) the value of clinical outcomes research, and (e) potential partnerships with academics. Three conceptual categories are identified: knowledge and understanding about clinical outcomes research, clinicians' experience conducting or participating in clinical outcomes research and the relevance of clinical outcomes research to occupational therapy clinical practice. Similarity to findings in the international literature on occupational therapists' engagement in clinical research suggests that the findings from this small sample of Australian therapists are robust. The implications of the findings for continuing professional education programmes and clinical supervision are presented.