This report describes state policy and legislation related to clinical trials participation and Maryland's model to enhance clinical trial availability and participation.
Descriptive review of state policy and legislation related to coverage for clinical trials costs based on data from the National Cancer Institute (NCI) State Cancer Legislative Database, the American Cancer Society, and NCI; additionally, discussion of Maryland's comprehensive multilevel clinical trial model comprising policy initiatives, community engagement, research, education, and infrastructure support.
Twenty-four states have mandated clinical trial coverage through specific legislation or agreements since 1994. Covered benefits varied among the states.
Besides cost and insurance barriers, there is a need to address important patient, physician and researcher, and structural barriers to clinical trial participation. Maryland provides a comprehensive model to address the multi-faceted clinical trial participation determinants as it tracks state and federal policy, documents trial barriers, and conducts community education.
Clinical trials participation; policy; legislation; insurance coverage; Maryland clinical trials; diversity
Walking Forward is a community-based participatory research program in western South Dakota funded by the National Cancer Institute (NCI). The primary goal of this initiative is to address the high and ominously increasing cancer mortality rates among American Indians by facilitating access to innovative clinical trials, behavioral and genetic research and tailored patient navigation. The critical outcomes include: an unprecedented accrual rate of 25 percent in clinical trials, including cancer treatment and cancer control trials; a significant reduction in the number of missed treatment days among navigated American Indian cancer patients undergoing radiation therapy; and most importantly, establishment of trusting partnerships with the American Indian communities as reflected in enrollment in a genetic study involving the ataxia telangiectasia mutated gene. The results indicate that the Walking Forward approach presents an effective strategy to overcome the barriers to cancer care in this underserved community.
Disparities in anal cancer incidence among Hawaii’s HIV-infected minority population is an emerging health concern. Although anal cytology/anoscopy are effective anal cancer screening tools, social barriers exist that prevent individuals from seeking appropriate care.
Community based participatory research (CBPR) principles were applied to develop resources, including testing a self-obtained anal specimen procedure, to increase anal cancer screening among Hawaii’s underserved/ minority populations.
A team of community members, academic researchers, and health care providers developed culturally-sensitive educational/recruitment materials regarding anal cancer risk targeting underserved/minority HIV-infected individuals. Self- and health care provider (HCP)-obtained anal cancer screening specimens were reviewed for cytology and tested for human papillomavirus DNA. A follow-up evaluation elicited feedback on attitudes and experiences.
Community discussion sessions identified key messages about anal cancer, anal cancer screening, and HPV infection for materials and were used, that successfully recruited 46 individuals (38 males/8 females; 9 Native Hawaiians/Pacific Islanders/Asians, 2 Blacks, 6 Hispanics, 6 American Indian/Alaskan Natives, 23 Whites). Concordance in cytology results between self- and HCP-obtained specimens was moderated (kappa=0.37) with the perception that the self-obtained specimen procedure was private (93%), safe (100%), and easy to manage (100%); and a majority (92%) willing to use the self-obtained method again.
CBPR was a practical approach in engaging Hawaii’s HIV-infected minority participation in anal cancer screening research. Community outreach and recruitment efforts suggested that self-obtained screening specimens could be an acceptable and effective means to reach Hawaii’s HIV-infected ethnic minorities.
Human papillomavirus; Anal neoplasia; Anal dysplasia; Human immunodeficiency virus
The authors present a guide to the necessary infrastructure and institutional support that must be in place before considering a program like the Minority-Based Community Clinical Oncology Program.
The Minority-Based Community Clinical Oncology Program (MB-CCOP) at University of Medicine and Dentistry of New Jersey, New Jersey Medical School–University Hospital Cancer Center was established to serve an unmet need in a medically, educationally, and socioeconomically underserved community of primarily African American and Latino patients in Newark and Essex County, New Jersey. The MB-CCOP was built on an existing infrastructure of multidisciplinary teams of cancer specialists who collaborated in patient care and an existing clinical research program, which included multilingual staff and a breast cancer navigator. This article highlights some of the unique opportunities and challenges involved in the startup of an MB-CCOP specifically relevant to an academic setting. We present a guide to the necessary infrastructure and institutional support that must be in place before considering such a program and some of the steps an institution can take to overcome barriers preventing successful enrollment of patients onto clinical trials.
Millions of Americans have unmet oral healthcare needs and profound oral health disparities persist in vulnerable and underserved populations, especially poor children, older adults, and racial and ethnic minorities. Nurses can play a significant role in improving the quality of oral health including access to care with appropriate education and training. The purpose of this paper is to describe New York University College of Nursing's response to this challenge. The Oral Health Nursing Education and Practice (OHNEP) program is a national initiative aimed at preparing a nursing workforce with the competencies to prioritize oral disease prevention and health promotion, provide evidence-based oral healthcare in a variety of practice settings, and collaborate in interprofessional teams across the healthcare system. The overarching goal of this national initiative is to create an educational infrastructure for the nursing profession that advances nursing's contribution to reducing oral health disparities across the lifespan.
Reduction of health disparities in the United States is a high priority. One means of effecting such a reduction is to enroll persons of groups that are subject to health disparities in clinical trials. One barrier to minorities enrolling in clinical research is distrust of the medical establishment based on past abuses and perceived discrimination. We hypothesized that another barrier is a lack of investigators' understanding and skill in effectively communicating with members of minority cultures. We therefore assessed the cultural competency of faculty and staff involved in clinical care and research at Creighton University Medical Center (CUMC). Thirty-seven faculty and staff members participated. We found that the majority are reasonably culturally competent, but there are areas in which proficiency can be enhanced and recruitment of participants in clinical research can be improved. Most CUMC faculty and staff respect and have reasonable knowledge of the several cultures of the patients for whom they provide care and with whom they conduct research. But there is a need for continued cultural sensitivity/competency training to enhance understanding of certain aspects of minority cultures, group and interpersonal relationships, perceptions of disease and wellness and to improve their access to minority communities.
PROTECT DC examines whether stroke navigators can improve cardiovascular risk factors in urban underserved individuals newly hospitalized for stroke or ischemic attack. Within one year of hospital discharge, up to one third of patients no longer adhere to secondary prevention behaviors. Adherence rates are lower in minority-underserved groups, contributing to health disparities. In-hospital programs increase use of stroke prevention therapies but may not be as successful in underserved individuals. In these groups, low literacy, limited health care access, and sparse community resources may reduce adherence. Lay community health workers (‘navigators’) improve adherence in other illnesses through education and assisting in overcoming barriers to achieving desired health behaviors and obtaining needed healthcare services.
Aims and design
PROTECT DC is a Phase II, single-blind, randomized, controlled trial comparing in-hospital education plus stroke navigators to usual care. Atherogenic ischemic stroke and transient ischemic attack survivors are recruited from Washington DC hospitals. Navigators meet with participants during the index hospitalization, perform home visits, and meet by phone. They focus on stroke education, medication compliance, and overcoming practical barriers to adherence. The interventions are driven by the theories of reasoned action and planned behavior.
The primary dependent measure is a summary score of four objective measures of stroke risk factor control: systolic blood pressure, low-density lipoprotein, hemoglobin Hb A1C, and antiplatelet agent pill counts. Secondary outcomes include stroke knowledge, exercise, dietary modification, smoking cessation.
PROTECT DC will determine whether a Phase III trial of stroke navigation for urban underserved individuals to improve adherence to secondary stroke prevention behaviors is warranted.
stroke; secondary prevention; community health education; healthcare disparities; clinical trials; health behavior; patient adherence; patient compliance
Reducing mental health disparities among underserved populations, particularly African American elders, is an important public health priority. The authors describe the process and challenges of developing a community/academic research partnership to address these disparities.
The authors are using a Community-Based Participatory Research approach to gain access to underserved populations in need of depression treatment. The authors identify six stages: 1) Collaborating to Secure Funding; 2) Building a Communications Platform and Research Infrastructure; 3) Fostering Enduring Relationships; 4) Assessing Needs/Educating about Research Process; 5) Initiating Specific Collaborative Projects (meeting mutual needs/interests); and 6) Maintaining a Sustainable and Productive Partnership. Data from a needs assessment developed collaboratively by researchers and community agencies facilitated agreement on mutual research goals, while strengthening the partnership.
A community/academic-based partnership with a solid research infrastructure has been established and maintained for 3 years. Using the results of a needs assessment, the working partnership prioritized and launched several projects. Through interviews and questionnaires, community partners identified best practices for researchers working in the community. Future research and interventional projects have been developed, including plans for sustainability that will eventually shift more responsibility from the academic institution to the community agencies.
To reach underserved populations by developing and implementing models of more effective mental health treatment, it is vital to engage community agencies offering services to this population. A successful partnership requires “cultural humility,” collaborative efforts, and the development of flexible protocols to accommodate diverse communities.
Community partnerships; depression; community-based participatory research
The Seattle Cancer Care Alliance (SCCA) is a Pacific Northwest regional network that enables patients from community cancer centers to participate in multicenter oncology clinical trials where patients can receive some trial-related procedures at their local center. Results of positron emission tomography (PET) scans performed at community cancer centers are not currently used in SCCA Network trials since clinical trials customarily accept results from only trial-accredited PET imaging centers located at academic and large hospitals. Oncologists would prefer the option of using standard clinical PET scans from Network sites in multicenter clinical trials to increase accrual of patients for whom additional travel requirements for imaging is a barrier to recruitment. In an effort to increase accrual of rural and other underserved populations to Network trials, researchers and clinicians at the University of Washington, SCCA and its Network are assessing feasibility of using PET scans from all Network sites in their oncology clinical trials. A feasibility study is required because the reproducibility of multicenter PET measurements ranges from approximately 3% to 40% at national academic centers. Early experiences from both national and local PET phantom imaging trials are discussed and next steps are proposed for including patient PET scans from the emerging regional quantitative imaging network in clinical trials. There are feasible methods to determine and characterize PET quantitation errors and improve data quality by either prospective scanner calibration or retrospective post hoc corrections. These methods should be developed and implemented in multicenter clinical trials employing quantitative PET imaging of patients.
Multicenter trials; Quantitative imaging; PET
Objective: We aimed to develop a telehealth network to deliver postdiagnosis cancer care clinical services and education to American Indian and Alaska Native patients, their families, and their healthcare providers. We also sought to identify the challenges and opportunities of implementing such a telehealth-based application for this rural and underserved population. Materials and Methods: We followed a participatory formative evaluation approach to engage all stakeholders in the telehealth network design and implementation. This approach allowed us to identify and address technical and infrastructure barriers, lack of previous experience with telehealth, and political, legal, and historical challenges. Results: Between September 2006 and August 2009, nine tribal clinics in Washington and 26 clinical sites in Alaska had participated in the telehealth network activities. Network programming included cancer education presentations, case conferences, and cancer survivor support groups. Twenty-seven cancer education presentations were held, with a total provider attendance of 369. Forty-four case conferences were held, with a total of 129 cases discussed. In total, 513 patient encounters took place. Keys to success included gaining provider and community acceptance, working closely with respected tribal members, understanding tribal sovereignty and governance, and working in partnership with cultural liaisons. Conclusion: The telehealth network exceeded expectations in terms of the number of participating sites and the number of patients served. Following a participatory formative evaluation approach contributed to the success of this telehealth network and demonstrated the importance of community involvement in all stages of telehealth system design and implementation.
distance learning; telehealth; telemedicine
Throughout the world there are problems recruiting ethnic minority patients into cancer clinical trials. A major barrier to trial entry may be distrust of research and the medical system. This may be compounded by the regulatory framework governing research with an emphasis on written consent, closed questions and consent documentation, as well as fiscal issues. The Leicester UK experience is that trial accrual is better if British South Asian patients are approached by a senior doctor rather than someone of perceived lesser hierarchical status and a greater partnership between the hospital and General Practitioner may increase trial participation of this particular ethnic minority. In Los Angeles, USA, trial recruitment was improved by a greater utilisation of Hispanic staff and a Spanish language-based education programme. Involvement of community leaders is essential. While adhering to national, legal and ethnical standards, information sheets and consent, it helps if forms can be tailored towards the local ethnic minority population. Written translations are often of limited value in the recruitment of patients with no or limited knowledge of English. In some cultural settings, tape-recorded verbal consent (following approval presentations) may be an acceptable substitute for written consent, and appropriate legislative changes should be considered to facilitate this option. Approaches should be tailored to specific minority populations, taking consideration of their unique characteristics and with input from their community leadership.
clinical trials; ethnic minorities; cancer clinical trials
The community alliance for Research Empowering Social Change (CARES) is an academic-community research partnership designed to: (1) train community members about evidence-based public health, (2) increase community members’ scientific literacy, and (3) develop the infrastructure for community-based participatory research so that local stakeholders can examine and address racial/ethnic health disparities in their communities. Nineteen community members enrolled in the CARES training. The training consisted of 11 didactic training sessions and 4 experiential workshops, taught by a multidisciplinary faculty from research institutions. Results suggest that the training increased research literacy, prepared community members for collaborative work with academic researchers, and empowered them to utilize scientific research methods to create social change in their communities.
community-based participatory research; public health training; academic-community partnership; research literacy; evidence-based public health
Translating 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.
We 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.
Lack 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.
A 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.
Cancer health disparities affecting low-income and minority patients are well documented. Root-causes are multifactorial, including diagnostic and treatment delays, social and financial barriers, and poor communication. Patient navigation and communication coaching (activation) are potential interventions to address disparities in cancer treatment. The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to improve cancer treatment.
The Rochester Patient Navigation Research Program (PNRP) is a National Cancer Institute-sponsored, patient-level randomized trial (RCT) of patient navigation and activation, targeting newly-diagnosed breast and colorectal cancer patients in Rochester, NY. The goal of the program is to decrease cancer health disparities by addressing barriers to receipt of cancer care and promoting patient self-efficacy. The intervention uses trained, paraprofessional patient navigators recruited from the target community, and a detailed training and supervisory program. Recruited patients are randomly assigned to receive either usual care (except for baseline and follow-up questionnaires and interviews) or intervention. The intervention patients receive tailored assistance from their patient navigators, including phone calls, in-person meetings, and behind-the-scenes coordination of care. A total of 344 patients have been recruited. Outcomes measured at three month intervals include timeliness of care, patient adherence, patient satisfaction, quality of life, self-efficacy, health literacy, and cancer knowledge.
This unique intervention combining patient navigation and patient activation is designed to address the multifactorial problem of cancer health disparities. If successful, this study will affect the design and implementation of patient navigation programs.
clinicaltrials.gov identifier NCT00496678
Patients with chronic conditions often use complex medical regimens. A nurse‐led strategy to support medication therapy management incorporated into primary care teams may lead to improved use of medications for disease control. Electronic health record (EHR) tools may offer a lower‐cost, less intensive approach to improving medication management.
Methods and Results
The Northwestern and Access Community Health Network Medication Education Study is a health center–level cluster‐randomized trial being conducted within a network of federally qualified community health centers. Health centers have been enrolled in groups of 3 and randomized to (1) usual care, (2) EHR‐based medication management tools alone, or (3) EHR tools plus nurse‐led medication therapy management. Patients with uncontrolled hypertension who are prescribed ≥3 medications of any kind are recruited from the centers. EHR tools include a printed medication list to prompt review at each visit and automated plain‐language medication information within the after‐visit summary to encourage proper medication use. In the nurse‐led intervention, patients receive one‐on‐one counseling about their medication regimens to clarify medication discrepancies and identify drug‐related concerns, safety issues, and nonadherence. Nurses also provide follow‐up telephone calls following new prescriptions and periodically to perform medication review. The primary study outcome is systolic blood pressure after 1 year. Secondary outcomes include measures of understanding of dosing instructions, discrepancies between patient‐reported medications and the medical record, adherence, and intervention costs.
The Northwestern and Access Community Health Network Medication Education Study will assess the effects of 2 approaches to support outpatient medication management among patients with uncontrolled hypertension in federally qualified health center settings.
Clinical Trial Registration
URL: clinicaltrials.gov. Unique identifier: NCT01578577.
adherence; electronic health records; hypertension; medication reconciliation; medication therapy management; nurse educator
Cardiovascular disease leads in overall mortality and morbidity in the United States. Cardiovascular disparities remain high among minority and underserved groups. Deaf American Sign Language (ASL) users are an underserved and understudied group that receives little attention from researchers due to language and communication barriers. A recent ASL survey in Rochester, NY, indicated greater cardiovascular risk among Deaf participants.
To investigate risk perceptions of cardiovascular disease among Deaf ASL users, linking perceptions to features of Deaf culture and communication. This information will be used to inform future strategies to promote cardiovascular health among Deaf adults.
Methods and Participants
Four focus groups were conducted in Rochester, New York, with 22 Deaf participants in ASL. Videotaped sessions were translated and transcribed by a bilingual researcher. A team of investigators coded, analyzed and identified key themes from the data.
Themes centered on five major domains: knowledge, barriers, facilitators, practices, and dissemination. The majority of themes focused on barriers and knowledge. Barriers included lack of health care information access due to language and communication challenges, financial constraints, and stress. Inconsistent knowledge emerged from many key areas of cardiovascular health.
The study outlines key themes for improving cardiovascular health knowledge and perceptions among Deaf ASL users. Findings suggest the importance of providing health educational programs and information in ASL to maximize understanding and minimize misconceptions. When caring for Deaf ASL users, providers should take extra effort to ask about cardiovascular risk factors and confirm patients’ understanding of these factors.
ASL; Deaf; Deaf culture; cardiovascular health; risk perceptions
PROBLEM BEING ADDRESSED
Medical care in rural Canada has long been hampered by insufficient numbers
of physicians. How can a rural community’s physicians change the local
medical culture and create a new approach to sustaining their practice?
OBJECTIVE OF PROGRAM
To create a sustainable, collegial family practice group and address one
rural community’s chronically underserviced health care needs.
Elements important to physicians’ well-being were incorporated into the
health care group’s functioning to enhance retention and recruitment. The
intentional development of a consensus-based approach to decision making has
created a supportive team of physicians. Ongoing communication is kept up
through regular meetings, retreats, and a Web-based discussion board.
Individual physicians retain control of their hours worked each year and
their schedules. A novel obstetric call system was introduced to help make
schedules more predictable. An internal governance agreement on an
alternative payment plan supports varied work schedules, recognizes and
funds non-clinical medical work, and pays group members for undertaking
This approach has helped maintain a stable number of physicians in Marathon,
Ont, and has increased the number of health care services delivered to the
We describe the history, development, and success of the recruitment and screening procedures used by researchers at the University of California, Davis Alzheimer's Disease Center (UCD ADC) to facilitate minority enrollment in research. After an initial, unsuccessful approach with satellite clinics in minority neighborhoods, the ADC shifted to an active community outreach approach. Multiple strategies were implemented to remove barriers to research participation such as providing transportation to clinical appointments and offering in-home cognitive screening. Considerable resources were directed towards hiring and training bicultural and bilingual individuals with knowledge of the target populations, both as recruiters and staff involved in clinical assessment. Implementation of these methods resulted in a dramatic increase in the number of ethnic minorities enrolled (and retained) in research protocols, including protocols that are complex and longitudinal. Diversity was achieved on other variables as well; years of education in the cohort ranges from 0 – 21, with 26% having 8 years or less. The community screen identified candidates for an in depth clinical evaluation and enrollment in longitudinal research, and we examined factors that predicted a positive response to invitation for the clinical evaluation. Individuals with a broader fund of knowledge were more likely to participate independent of other variables including ethnicity and education. When diversity is an important goal active outreach is far more efficacious than clinic-based and advertising-based approaches to recruitment.
minority recruitment; minority enrollment; bilingual; bicultural; community screen; longitudinal
Public health research and practice is faced with three problems: 1) a focus on disease instead of health, 2) consideration of risk factor/disease relationships one at a time, and 3) attention to individuals with limited regard for the communities in which they live. We propose a framework for health-focused research and practice. This framework encompasses individual and community pathways to health while incorporating the dynamics of context and overall population vulnerability and resilience. Individual pathways to health may differ, but commonalities will exist. By understanding these commonalities, communities can work to support health-promoting pathways in addition to removing barriers. The perspective afforded by viewing health as a dynamic process instead of as a collection of risk factors and diseases expands the number of approaches to improving health globally. Using this approach, multidisciplinary research teams working with active community participants have the potential to reshape health and intervention sciences.
Science has developed from a solitary pursuit into a team-based collaborative activity and, more recently, into a multidisciplinary research enterprise. The increasingly collaborative character of science, mandated by complex research questions and problems that require many competencies, requires that researchers lower the barriers to the creation of collaborative networks of experts, such as communities of practice (CoPs).
The aim was to assess the information needs of prospective members of a CoP in an emerging field, dental informatics, and to evaluate their expectations of an e-community in order to design a suitable electronic infrastructure.
A Web-based survey instrument was designed and administered to 2768 members of the target audience. Benefit expectations were analyzed for their relationship to (1) the respondents’ willingness to participate in the CoP and (2) their involvement in funded research. Two raters coded the respondents’ answers regarding expected benefits using a 14-category coding scheme (Kappa = 0.834).
The 256 respondents (11.1% response rate) preferred electronic resources over traditional print material to satisfy their information needs. The most frequently expected benefits from participation in the CoP were general information (85% of respondents), peer networking (31.1%), and identification of potential collaborators and/or research opportunities (23.2%).
The competitive social-information environment in which CoPs are embedded presents both threats to sustainability and opportunities for greater integration and impact. CoP planners seeking to support the development of emerging biomedical science disciplines should blend information resources, social search and filtering, and visibility mechanisms to provide a portfolio of social and information benefits. Assessing benefit expectations and alternatives provides useful information for CoP planners seeking to prioritize community infrastructure development and encourage participation.
Dental informatics; Internet; faculty, dental; education, dental, continuing; education, dental, graduate
This paper highlights a descriptive study of the challenges and lessons learned in the recruitment of rural primary care physicians into a randomized clinical trial using an Internet-based approach.
A multidisciplinary/multi-institutional research team used a multilayered recruitment approach, including generalized mailings and personalized strategies such as personal office visits, letters, and faxes to specific contacts. Continuous assessment of recruitment strategies was used throughout study in order to readjust strategies that were not successful.
We recruited 205 primary care physicians from 11 states. The 205 lead physicians who enrolled in the study were randomized, and the overall recruitment yield was 1.8% (205/11 231). In addition, 8 physicians from the same practices participated and 12 nonphysicians participated. The earlier participants logged on to the study Web site, the greater yield of participation. Most of the study participants had logged on within 10 weeks of the study.
Despite successful recruitment, the 2 major challenges in recruitment in this study included defining a standardized definition of rurality and the high cost of chart abstractions. Because many of the patients of study recruits were African American, the potential implications of this study on the field of health disparities in diabetes are important.
recruitment; physicians; diabetes; Internet intervention
Barriers to randomised clinical trial (RCT) recruitment include failure to identify eligible patients, reluctance of staff to approach them and attitudes of some health-care professionals and patients. As part of a larger UK prospective study examining the communication and involvement in RCTs of 22 multidisciplinary teams in Wales, we also assessed the attitudes of patients they treat towards trials.
Out of 1146 patients attending outpatient departments who were approached, 1146 (93%) completed the seven-item Attitudes to Randomised Trials Questionnaire (ARTQ), probing their general attitudes towards medical research and likely participation in a hypothetical two-arm RCT.
Randomisation initially deterred many patients from endorsing a willingness to participate. However, if information about the trial logic, voluntary nature and rights to withdraw were provided, together with further treatment details, 83% (886 out of 1066) would potentially participate. Other variables associated with a positive inclination towards participation included previous trial experience (P<0.01), male gender (P<0.01) and younger age, with patients ⩾70 years less likely to consider trial entry (P<0.01).
The majority of patients were receptive to RCT participation. Many of those initially disinclined because of randomisation would consider joining if given further details that form part of standard GCP consent guidelines. These data show the importance and need for clear communication and information to encourage RCT participation. Evidence-based training courses are available to assist with this.
patients' attitudes; RCTs
The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of clinical research studies that highlights the need for greater participation in research by physicians as well as patients. Furthermore, the potential of clinical research is unlikely to be reached without greater participation of physicians in research. Physicians face a variety of barriers with regard to participation in clinical research. These barriers are system-or organization-related as well as research-and physician-related. To encourage physician participation, appropriate organizational and operational infrastructures are needed in health care institutes to support research planning and management. All physicians should receive education and training in the fundamentals of research design and methodology, which need to be incorporated into undergraduate medical education and postgraduate training curricula and then reinforced through continuing medical education. Medical schools need to analyze current practices of teaching–learning and research, and reflect upon possible changes needed to develop a ‘student-focused teaching–learning and research culture’. This article examines the barriers to and benefits of physician participation in clinical research as well as interventions needed to increase their participation, including the specific role of undergraduate medical education. The main challenge is the unwillingness of many physicians and patients to participate in clinical trials. Barriers to participation include lack of time, lack of resources, trial-specific issues, communication difficulties, conflicts between the role of clinician and scientist, inadequate research experience and training for physicians, lack of rewards and recognition for physicians, and sometimes a scientifically uninteresting research question, among others. Strategies to encourage physician participation in clinical research include financial and nonfinancial incentives, adequate training, research questions that are in line with physician interests and have clear potential to improve patient care, and regular feedback. Finally, encouraging research culture and fostering the development of inquiry and research-based learning among medical students is now a high priority in order to develop more and better clinician-researchers.
physician; clinical research; clinical trial; medical education
Recruitment and retention of study subjects are key to the success of a clinical trial. In the case of minority patients, this may be challenging as minority patients have been underserved by the medical health-care system. Furthermore, minority patients are more likely to experience barriers to entry into a clinical trial such as mistrust of the medical system, economic disadvantages, lack of awareness of study programs, and communication barriers. An open-ended questionnaire was used to determine reasons why subjects in the African-American Antiplatelet Stroke Prevention Study (AAASPS) remained in the study or voluntarily withdrew in the absence of an adverse event. Potential enrollees who refused to participate in the AAASPS also were queried. Enrollees who remained in the program consistently stated that they participated to reduce the risk of stroke recurrence and to help others by finding a "cure" for stroke. Those who withdrew or refused to participate consistently stated that they were afraid of being used as "guinea pigs." A "recruitment triangle" emerged that might predict a patient's likelihood of participation in a clinical trial. The sides of the triangle include the patient, key family members and friends, and the primary medical doctor and other medical personnel. The organizers of a clinical trial need to be aware of the "recruitment triangle" and establish strategies to heighten and maintain its integrity.
The Electronic Communications and Home Blood Pressure Monitoring trial (e-BP) demonstrated that team care incorporating a pharmacist to manage hypertension using secure E-mail with patients resulted in almost twice the rate of blood pressure (BP) control compared with usual care. To translate e-BP into community practices, we sought to identify contextual barriers and facilitators to implementation.
Interviews were conducted with medical providers, staff, pharmacists, and patients associated with community-based primary care clinics whose physician leaders had expressed interest in implementing e-BP. Transcripts were analyzed using qualitative template analysis, incorporating codes derived from the Consolidated Framework for Implementation Research (CFIR).
Barriers included incorporating an unfamiliar pharmacist into the health care team, lack of information technology resources, and provider resistance to using a single BP management protocol. Facilitators included the intervention’s perceived potential to improve quality of care, empower patients, and save staff time. Sustainability of the intervention emerged as an overarching theme.
A qualitative approach to planning for translation is recommended to gain an understanding of contexts and to collaborate to adapt interventions through iterative, bidirectional information gathering. Interviewees affirmed that web pharmacist care offers small primary care practices a means to expand their workforce and provide patient-centered care. Reproducing e-BP in these practices will be challenging, but our interviewees expressed eagerness to try and were optimistic that a tailored intervention could succeed.
Evidence-based Medicine; Community Medicine; Home Blood Pressure Monitoring; Primary Health Care; Qualitative Research