A randomised trial of oral prednisone for cystic fibrosis pulmonary exacerbation treatment.

BACKGROUND: Elevated markers of systemic and pulmonary inflammation are associated with failure to recover lung function following pulmonary exacerbations in people with cystic fibrosis (pwCF). Our aim was to determine whether adjuvant oral prednisone treatment would improve recovery of forced expiratory volume in 1 s (FEV1) % pred in CF pulmonary exacerbations not responding to antibiotic therapy. METHODS: This was a randomised, double-blind, placebo-controlled trial in pwCF treated with intravenous antibiotics for a pulmonary exacerbation. At day 7, those who had not returned to >90% baseline FEV1 % pred were randomised to adjuvant prednisone 1 mg·kg-1 twice daily (maximum 60 mg·day-1) or placebo for 7 days. The primary outcome was the difference in proportion of subjects who recovered >90% baseline FEV1 % pred at day 14 of i.v. antibiotic therapy. RESULTS: 173 subjects were enrolled, with 76 randomised. 50% of subjects in the prednisone group recovered baseline FEV1 on day 14 compared with 39% of subjects in the placebo group (difference of 11%, 95% CI -11-34%; p=0.34). The mean±sd change in FEV1 % pred from day 7 to day 14 was 6.8±8.8% predicted in the prednisone group and 4.6±6.9% predicted in the placebo group (mean difference 2.2% predicted, 95% CI -1.5-5.9%; p=0.24). Time to subsequent exacerbation was not prolonged in prednisone-treated subjects (hazard ratio 0.83, 95% CI 0.45-1.53; p=0.54). CONCLUSIONS: This study failed to detect a difference in FEV1 % pred recovery between adjuvant oral prednisone and placebo treatment in pwCF not responding at day 7 of i.v. antibiotic therapy for pulmonary exacerbations.

Physician's perspective regarding asthma guided self-management: directives or guidance?

INTRODUCTION: Asthma guided self-management enhances patients' control of their condition under the guidance of the treating physician. The aim of the present study was to understand how physicians perceive, endorse, uptake, and support asthma guided self-management. METHODS: We conducted a secondary supplementary analysis of data originally collected as part of a multicenter collective case study in which physicians treating patients with asthma were interviewed. Using reflective thematic analysis, we aimed to explore physicians' understanding of guided asthma self-management as related to four ideas, namely: (a) understanding of the disease management and treatment goals; (b) defining medical frame and guidance; (c) describing the importance of patient-physician relationship; and (d) implementing asthma guided self-management. RESULTS: Evidence indicates that physicians perceived optimal guided self-management as related to patients' adherence to physician's instructions and recommendations, supported by the adjustment of prescribed pharmaceutical therapy contingent upon patient's symptoms. Some physicians also perceived behavior change and environmental control along with the medical recommendations. While physicians' perception of asthma and its treatment were aligned with the recommended guidelines-i.e., patient-centered care approach based on guided self-management, the actual guidance offered to patients remained primarily directive and paternalistic. Non-pharmacological approaches, such as exercise, smoking cessation, patient self-monitoring, and self-management supported by education and written self-management plans, were given little consideration in the context of the recommended treatment plan.

Patients' perspective of barriers and facilitators to taking long-term controller medication for asthma: a novel taxonomy.

BACKGROUND: Although asthma morbidity can be prevented through long-term controller medication, most patients with persistent asthma do not take their daily inhaled corticosteroid. The objective of this study was to gather patients' insights into barriers and facilitators to taking long-term daily inhaled corticosteroids as basis for future knowledge translation interventions. METHODS: We conducted a collective qualitative case study. We interviewed 24 adults, adolescents, or parents of children, with asthma who had received a prescription of long-term inhaled corticosteroids in the previous year. The one-hour face-to-face interviews revolved around patients' perceptions of asthma, use of asthma medications, current self-management, prior changes in self-management, as well as patient-physician relationship. We sought barriers and facilitators to optimal asthma management. Interviews were transcribed verbatim and transcripts were analyzed using a thematic approach. RESULTS: Patients were aged 2-76 years old and 58% were female. Nine patients were followed by an asthma specialist (pulmonologist or allergist), 13 patients by family doctors or pediatricians, and two patients had no regular follow-up. Barriers and facilitators to long-term daily inhaled corticosteroids were classified into the following loci of responsibility and its corresponding domains: (1) patient (cognition; motivation, attitudes and preferences; practical implementation; and parental support); (2) patient-physician interaction (communication and patient-physician relationship); and (3) health care system (resources and services). Patients recognized that several barriers and facilitators fell within their own responsibility. They also underlined the crucial impact (positive or negative) on their adherence of the quality of patient-physician interaction and health care system accessibility. CONCLUSIONS: We identified a close relationship between reported barriers and facilitators to adherence to long-term daily controller medication for asthma within three loci of responsibility. As such, patients' adherence must be approached as a multi-level phenomenon; moreover, interventions targeting the patient, the patient-physician interaction, and the health care system are recommended. The present study offers a potential taxonomy of barriers and facilitators to adherence to long-term daily inhaled corticosteroids therapy that, once validated, may be used for planning a knowledge translation intervention and may be applicable to other chronic conditions.

Canadian Cystic Fibrosis-related Diabetes Clinical Practice Survey: Analysis of Current Practices and Gaps in Clinical Care.

OBJECTIVES: Our aim in this study was to identify challenges and gaps in Canadian practices in screening, diagnosis, and treatment of cystic fibrosis-related diabetes (CFRD), with the goal of informing a Canadian-specific guideline for CFRD. METHODS: We conducted an online survey of health-care professionals (97 physicians and 44 allied health professionals) who care for people living with CF (pwCF) and/or CFRD (pwCFRD). RESULTS: Most pediatric centres followed <10 pwCFRD and adult centres followed >10 pwCFRD. Children with CFRD are usually followed at a separate diabetes clinic, whereas adults with CFRD may be followed by respirologists, nurse practitioners, or endocrinologists in a CF clinic or in a separate diabetes clinic. Less than 25% of pwCF had access to an endocrinologist with a special interest or expertise in CFRD. Many centres perform screening oral glucose tolerance testing with fasting and 2-hour time points. Respondents, especially those working with adults, also indicate use of additional tests for screening not currently recommended in CFRD guidelines. Pediatric practitioners tend to only use insulin to manage CFRD, whereas adult practitioners are more likely to use repaglinide as an alternative to insulin. CONCLUSIONS: Access to specialized CFRD care may be a challenge for pwCFRD in Canada. There appears to be wide heterogeneity of CFRD care organization, screening, and treatment among health-care providers caring for pwCF and/or pwCFRD across Canada. Practitioners working with adult pwCF are less likely to adhere to current clinical practice guidelines than practitioners working with children.

Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study.

OBJECTIVE: Antibiotic eradication treatment is the standard-of-care for cystic fibrosis (CF) patients with early Pseudomonas aeruginosa (Pa)-infection; however, evidence from placebo-controlled trials is limited. METHODS: This double-blind, placebo-controlled trial randomised CF patients <7 years (N = 51) with early Pa-infection to tobramycin inhalation solution (TOBI 300 mg) or placebo (twice daily) for 28 days with an optional cross-over on Day 35. Primary endpoint was proportion of patients having throat swabs/sputum free of Pa on Day 29. RESULTS: On Day 29, 84.6% patients in the TOBI versus 24.0% in the placebo group were Pa-free (p < 0.001). At the end of the cross-over period, 76.0% patients receiving TOBI in the initial 28 days were Pa-free compared to 47.8% receiving placebo initially. Adverse events were consistent with the TOBI safety profile with no differences between TOBI and placebo. CONCLUSION: TOBI was effective in eradicating early Pa-infection with a favourable safety profile in young CF patients. TRIAL REGISTRATION NUMBER: NCT01082367.

Guided asthma self-management or patient self-adjustment? Using patients' narratives to better understand adherence to asthma treatment.

PURPOSE: The purpose of this study was to better understand patients' perspective of asthma self-management by focusing on the sociocultural and medical context shaping patients' illness representations and individual decisions. PATIENTS AND METHODS: We conducted a secondary analysis of semi-structured interviews carried out as part of a multicentered collective qualitative case study. In total, 24 patients, aged 2-76 years with a confirmed diagnosis of asthma (or were parents of a child), who renewed the prescription for inhaled corticosteroids in the past year, participated in this study. The thematic analysis focused on asthma-related events and experiences reported by the patients. Consistent with narrative inquiry, similar patterns were grouped together, and three vignettes representing the different realities experienced by the patients were created. RESULTS: The comparison of experiences and events reported by the patients suggested that patients' perceptions and beliefs regarding asthma and treatment goals influenced their self-management-related behaviors. More specifically, the medical context in which the patients were followed (ie, frame in which the medical encounter takes place, medical recommendations provided) contributed to shape their understanding of the disease and the associated treatment goals. In turn, a patient's perception of the disease and the treatment goals influenced asthma self-management behaviors related to environmental control, lifestyle habits, and medication intake. CONCLUSION: Current medical recommendations regarding asthma self-management highlight the importance of the physicians' guidance through the provision of a detailed written action plan and asthma education. These data suggest that while physicians contribute to shaping patients' beliefs and perceptions about the disease and treatment goals, patients tend to listen to their own experience and manage the disease accordingly. Thus, a medical encounter between the patient and the physician, aiming at enhancing a meaningful conversation about the disease, may lead the patient to approach the disease in a more effective manner, which goes beyond taking preventative paths to avoid symptoms.

Epidemiology of Clonal Pseudomonas aeruginosa Infection in a Canadian Cystic Fibrosis Population.

RATIONALE: The extent of the genetic relatedness among Pseudomonas aeruginosa isolates and its impact on clinical outcomes in the cystic fibrosis (CF) population is poorly understood. OBJECTIVES: The objectives of this study were to determine the prevalence of clonal P. aeruginosa infection in Canada and to associate P. aeruginosa genotypes with clinical outcomes. METHODS: This was an observational study of adult and pediatric patients with CF across Canada. Isolates were typed using multilocus sequence typing. A clone was defined as sharing at least six of seven alleles. Genotyping results were associated with clinical outcomes, including forced expiratory volume in 1 second, body mass index, rate of pulmonary exacerbation, and death/transplant. RESULTS: A total of 1,537 P. aeruginosa isolates were genotyped to 403 unique sequence types (STs) in 402 individuals with CF. Although 39% of STs were shared, most were shared only among a small number of subjects, and the majority (79%) of the genetic diversity in P. aeruginosa isolates was observed between patients. There were no significant differences in clinical outcomes according to genotype. However, patients with a dynamic, changing ST infection pattern had both a steeper decline in forced expiratory volume in 1 second (-2.9% predicted change/yr, 95% confidence interval [CI] = -3.8 to -1.9 compared with 0.4, 95% CI = -0.3 to 1.0; P < 0.001) and body mass index (-1.0 percentile change/yr, 95% CI = -1.6 to -0.3 compared with -0.1, 95% CI = -0.7 to 0.5; P = 0.047) than those with a stable infection with the same ST. CONCLUSIONS: There was no widespread sharing of dominant clones in our CF population, and the majority of the genetic diversity in P. aeruginosa was observed between patients. Changing genotypes over time within an individual was associated with worse clinical outcomes.

Determinants of implementation effectiveness: adapting a framework for complex innovations.

Many innovations in the health sector are complex, requiring coordinated use by multiple organizational members to achieve benefits. Often, complex innovations are adopted with great anticipation only to fail during implementation. The health services literature provides limited conceptual guidance to researchers and practitioners about implementation of complex innovations. In the present study, we adapt an organizational framework of innovation implementation developed and validated in a manufacturing setting and explore the extent to which it aptly characterizes implementation in health sector organizations. Through comparative case studies of four cancer clinical research networks, we illustrate how this conceptual framework captures key determinants of the implementation of new programs in cancer prevention and control (CP/C) research and helps explain observed differences in implementation effectiveness. Key determinants include management support and innovation-values fit, which contribute to an organizational "climate" for implementation. We explore the implications for researchers and managers.

Physician agreement regarding the expansion of pharmacist professional activities in the management of patients with asthma.

BACKGROUND: Asthma control remains suboptimal in Canada. Expansion of pharmacist's professional activities offers the opportunity to improve the interdisciplinary management of patients with asthma. OBJECTIVE: The aim of this study was to determine the level of agreement of physicians regarding the expansion of pharmacists' professional activities in the management of asthma patients. METHODS: We conducted a survey of randomly selected Quebec physicians in family medicine, paediatrics and emergency medicine. A 102-item questionnaire, including 10 questions regarding pharmacist's expanded professional activities, was sent using the Tailored Design Method. Questions were answered on a 6-point Likert-like scale (0 - strong disagreement to 5 - strong agreement). RESULTS: With a 56% response rate, 421 (250 family medicine, 115 paediatric and 56 emergency medicine) physicians participated; the median years of practice (25%, 75%) was 13 (5-21) years and 69% of respondents were women. Physicians were in favour of the expansion of pharmacist's professional activities with strong endorsement rates (rating of ≥4 on a maximum of 5) exceeding 60% for all but three activities: suggesting a written action plan to the physician (55%), adjusting the dose of prescribed asthma medication to achieve a therapeutic target (52%) and offering spirometry testing in pharmacies (45%). Emergency physicians, physicians with fewer years of practice, and those with a favourable perception of an interprofessional approach were associated with higher endorsement of these activities. CONCLUSION: Physicians are favourable to the expansion of pharmacist activities in the management of patients with asthma. More complex activities were less frequently endorsed. The characteristics of strong intenders have been identified.

Enablers and determinants of the provision of written action plans to patients with asthma: a stratified survey of Canadian physicians.

Despite national recommendations, most patients with asthma are not given a written action plan . The objectives were to ascertain physicians' endorsement of potential enablers to providing a written action plan, and the determinants and proportion, of physician-reported use of a written action plan. We surveyed 838 family physicians, paediatricians, and emergency physicians in Quebec. The mailed questionnaire comprised 102 questions on asthma management, 11 of which pertained to written action plan and promising enablers. Physicians also selected a case vignette that best corresponded to their practice and reported their management. The survey was completed by 421 (56%) physicians (250 family physicians, 115 paediatricians and 56 emergency physicians); 43 (5.2%) reported providing a written action plan to ≥70% of their asthmatic patients and 126 (30%) would have used a written action plan in the selected vignette. Most (>60%) physicians highly endorsed the following enablers: patients requesting a written action plan, adding a blank written action plan to the chart, receiving a copy of the written action plan completed by a consultant, receiving a monetary compensation for its completion, and having another healthcare professional explain the completed written action plan to patients. Four determinants were significantly associated with providing a written action plan: being a paediatrician (RR:2.1), treating a child (RR:2.0), aiming for long-term asthma control (RR:2.5), and being aware of national recommendations to provide a written action plan to asthmatic patients (RR:2.9). A small minority of Quebec physicians reported providing a written action plan to most of their patients, revealing a huge care gap. Several enablers to improve uptake, highly endorsed by physicians, should be prioritised in future implementation efforts. ASTHMA: ENCOURAGING DOCTORS TO PROVIDE WRITTEN ACTION PLANS: Changes to practice organization and doctors' perceptions should encourage the provision of written action plans for all asthma patients. International guidelines state that effective long-term treatment of asthma requires educated self-management, regular reviews and provision of a written action plan (WAP). However, many patients have poor asthma control and as few as 30 per cent have a WAP. Fabienne Djandji at the Saint-Justine University Central Hospital in Montreal, Canada, and co-workers conducted a survey of 421 doctors to determine their attitudes and provision of WAPs. Only 5.2 per cent of respondents provided WAPs to patients; those treating children or aiming for long-term asthma control were more likely to do so. The doctors said that incentives to provide WAPs would include requests from patients themselves, being paid to complete WAPs and having extra support from specialists or other health care professionals such as pharmacists.

Increasing minority participation in cancer clinical trials: the minority-based community clinical oncology program experience.

PURPOSE: The National Cancer Institute's (NCI) Minority-Based Community Clinical Oncology Program (MBCCOP) seeks to enhance minority participation in cancer clinical trials by building clinical trials outreach and management capacity in healthcare institutions serving large numbers of minority cancer patients. This article examines temporal trends in MBCCOP accruals to cancer prevention and control (CP/C) and cancer treatment trials and the racial distribution of study participants, along with the major factors affecting minority enrollment. METHODS: We used NCI databases to analyze temporal trends in overall accruals and accruals by race. We analyzed transcripts from an NCI-sponsored meeting with MBCCOP principal investigators and data from a follow-up survey to identify factors affecting minority enrollment. RESULTS: Between 1992 and 2003, annual patient accruals to treatment trials increased 39% despite little change in the number of MBCCOP grantees. During this same period, annual participant accruals to CP/C trials more than doubled. Between 1995 and 2003, minorities comprised 51% to 67% of the MBCCOP patients accrued to cooperative group treatment trials compared with < or = 23% of the patients accrued by other cooperative group members and affiliates. Major factors affecting minority enrollment include the availability of "clinically relevant" protocols, regulatory requirements, characteristics of the patient population, and the level of support from sponsoring institutions and community physicians. CONCLUSION: MBCCOPs have demonstrated their ability to facilitate the participation of racial/ethnic minorities in clinical trials. However, the contributions that they could make to the design and conduct of minority-focused research studies merit further exploration.

Enablers of Physician Prescription of a Long-Term Asthma Controller in Patients with Persistent Asthma.

Objective. We aimed to identify key enablers of physician prescription of a long-term controller in patients with persistent asthma. Methods. We conducted a mailed survey of randomly selected Quebec physicians. We sent a 102-item questionnaire, seeking reported management regarding one of 4 clinical vignettes of a poorly controlled adult or child and endorsement of enablers to prescribe long-term controllers. Results. With a 56% participation rate, 421 physicians participated. Most (86%) would prescribe a long-term controller (predominantly inhaled corticosteroids, ICS) to the patient in their clinical vignette. Determinants of intention were the recognition of persistent symptoms (OR 2.67), goal of achieving long-term control (OR 5.31), and high comfort level in initiating long-term ICS (OR 2.33). Decision tools, pharmacy reports, reminders, and specific training were strongly endorsed by ≥60% physicians to support optimal management. Physicians strongly endorsed asthma education, lung function testing, specialist opinion, accessible asthma clinic, and paramedical healthcare professionals to guide patients, as enablers to improve patient adherence to and physicians' comfort with long-term ICS. Interpretation. Tools and training to improve physician knowledge, skills, and perception towards long-term ICS and resources that increase patient adherence and physician comfort to facilitate long-term ICS prescription should be considered as targets for implementation.

Delivering HIV services to vulnerable populations: a review of CARE Act-funded research.

This article summarizes key findings from evaluation and research studies that have received financial support from the HIV/AIDS Bureau of the Health Resources and Services Administration or from Ryan White Comprehensive AIDS Resources Emergency (CARE) Act grantees. These studies suggest that the CARE Act has improved but not equalized service accessibility, quality, and outcomes for different populations living with HIV disease. Evaluations of access to highly active antiretroviral therapy (HAART) found that uninsured patients, women, people of color, and injection drug users waited much longer than others to receive the new therapies. These disparities were not uniform across study sites, suggesting that clinic characteristics and geographic location have a major influence on prescribing patterns. Once patients gained access to HAART, health insurance status made little difference in clinical outcomes.

Delivering HIV services to vulnerable populations: an evaluation and research agenda.

In May 2000, the HIV/AIDS Bureau of the Health Resources and Services Administration convened HIV experts from throughout the country to identify new and emerging areas of research needed to guide policy and programmatic decisions on HIV service delivery to vulnerable populations. This article describes the process used to develop an evaluation/research agenda, discusses key findings and recommendations of the conference, and proposes a set of principles to guide the design and conduct of future investigations. Conference participants identified nine major evaluation/research themes that span the continuum of HIV behavioral prevention services and treatment. They recommended focusing future research on questions relevant to populations experiencing rapid rates of increase in HIV infection (for example, women, people of color, and adolescents and young adults) and considering explanatory factors at multiple levels of analysis (individual, clinician, organization, service delivery system, and environment).

Variations in rural AIDS epidemiology and service delivery models in the United States.

This article reviews AIDS surveillance data and the rural health literature to summarize what is known about the rural AIDS epidemic, characteristics of rural environments that affect HIV service delivery, and approaches that rural areas are using to address the health and support service needs of HIV-positive residents. During 1999, nonmetropolitan (non-MSA) adult/adolescent AIDS rates were highest in the South (11 per 100,000) and Northeast (9 per 100,000). The South had the highest non-MSA proportion of adult/adolescent AIDS cases (12%), followed by the North Central region (9%), the West (4%), and the Northeast (3%). Variations in rural HIV/AIDS epidemiologic patterns and the demographic, socio-economic, and cultural characteristics of rural environments are likely to require different levels of resource investment and different methods of organizing and delivering HIV services. Currently, many HIV-positive rural residents are traveling to metropolitan areas for medical care because of concerns about confidentiality or a lack of confidence in the HIV management capabilities of local physicians. Rural communities are attempting to address these problems by developing the HIV care capacity of existing clinics, building local networks of physicians with HIV management experience, and cultivating "shared care" arrangements with urban-based specialists.

Development and pretesting of an electronic learning module to train health care professionals on the use of the Pediatric Respiratory Assessment Measure to assess acute asthma severity.

BACKGROUND: Severity-specific guidelines based on the Pediatric Respiratory Assessment Measure (PRAM), a validated clinical score, reduce pediatric asthma hospitalization rates. OBJECTIVE: To develop, pretest the educational value of and revise an electronic learning module to train health care professionals on the use of the PRAM. METHODS: The respiratory efforts of 32 children with acute asthma were videotaped and pulmonary auscultation was recorded. A pilot module, composed of a tutorial and 18 clinical cases, was developed in French and English. Health care professionals completed the module and provided feedback. The performance of participants, case quality and difficulty, and learning curve were assessed using the Rasch test; quantitative and qualitative feedback served to revise the module. RESULTS: Seventy-two participants (19 physicians, 22 nurses, four respiratory therapists and 27 health care trainees) with a balanced distribution across self-declared expertise (26% beginner, 35% competent and 39% expert) were included. The accuracy of experts was superior to beginners (OR 1.79, 1.15 and 2.79, respectively). Overall performance significantly improved between the first and latter half of cases (P<0.001). Participants assessed the module to be clear (96%), relevant (98%), realistic (94%) and useful (99%) to learn the PRAM. The qualitative/quantitative analysis led to the deletion of three cases, modification of remaining cases to further enhance quality and reordering within three levels of difficulty. DISCUSSION: Using rigorous educational methods, an electronic module was developed to teach health care professionals on use of the PRAM score. Using the back-translation technique, both French and English versions were developed and validated simultaneously. The pilot module comprised a tutorial and three case-scenario sections, and was tested on a target audience of physicians, nurses, respiratory therapists and medical trainees. CONCLUSION: The final electronic learning module met the clarity and quality requirements of a good teaching tool, with a demonstrated learning effect and high appreciation by health care professionals. Available in French and English, it is offered to facilitate implementation of PRAM-based acute pediatric asthma guidelines.

Facilitators and solutions for practicing optimal guided asthma self-management: the physician perspective.

OBJECTIVE: To identify key solutions that facilitate the prescription of long-term asthma controller and provision of written self-management plans by physicians. METHODS: One hour individualized semistructured interviews were conducted with physicians. Interviews were transcribed verbatim and analyzed independently by two trained qualitative researchers. A taxonomy of facilitators (contemplated solutions) and experienced solutions was achieved by consensus within the research team. RESULTS: Forty-two physicians (family physicians, pediatricians, emergency physicians, pulmonologists and allergists) were interviewed. The 867 facilitators and solutions, grouped in 10 categories, addressed three physician needs: support physicians in delivering optimal care (guideline dissemination, workplace culture, physician training and experience, physician attitudes toward optimal practice, tools and resources supporting physicians' decision making); assist patients with following recommendations (patient characteristics, experiences and attitudes; physician behaviour; and tools and resources supporting patient self-management); and offer efficient services (reorganization of care; interprofessional patient management). Suggestions pertaining to the latter two categories were most frequently cited to optimize asthma management and use of self-management plans (e.g., access to self-management plans; education by allied health care professionals). The most cited suggestions to support prescribing long-term controller pertained to physician behaviour (e.g., involvement in patient education, personalization of prescriptions, feedback to patients of the benefits of long-term controller). The distribution of facilitators and solutions varied across specialties. CONCLUSIONS: Physicians proposed multiple facilitators and solutions to support optimal practice, leading to the development of a novel taxonomy. Key suggestions varied across physician specialties and behaviours sought, emphasizing the need to carefully select the most promising knowledge translation interventions.

Adapting clinical trials networks to promote cancer prevention and control research.

BACKGROUND: Since 1987, cancer centers and clinical cooperative groups serving as 'research bases' for the National Cancer Institute's (NCI) Community Clinical Oncology Program (CCOP) have been required to design and conduct cancer prevention and control (CP/C) clinical trials in addition to therapeutic trials. The study describes the structural and strategic adaptations that CCOP research bases have made to incorporate CP/C research into their scientific agendas and operations. METHODS: Approaches to CP/C research in four cooperative groups with different scientific agendas were investigated: the Eastern Cooperative Oncology Group, the National Surgical Adjuvant Breast and Bowel Project, the North Central Cancer Treatment Group, and the Southwest Oncology Group. Sixty-five individual interviews with group leaders and investigators were conducted. Data were coded and thematically analyzed from transcribed interviews, observations of scientific sessions, and secondary documents. RESULTS: The cooperative groups have tailored CP/C research programs to fit the interests, skills, and practice settings of their investigators without making significant adaptations in administrative and statistical infrastructures. Ongoing challenges include finding ways to broaden the pool of investigators designing CP/C protocols, involve more nononcologists in protocol design, and secure more stable and adequate funding for CP/C research. CONCLUSION: The cooperative groups' experiences with CP/C research suggest that, with adequate resource investments, existing clinical research networks can expand into new areas of scientific investigation.