PRACTICE-BASED RESEARCH NETWORKS (PBRNs) AND THE TRANSLATION OF RESEARCH INTO PRACTICE RELEASE DATE: December 18, 2003 PA Number: PAR-04-041 EXPIRATION DATE: January 12, 2005, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov) National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: Center for Primary Care, Prevention and Clinical Partnerships, CP3, (http://www.ahrq.gov) National Cancer Institute (NCI) (http://www.cancer.gov) CFDA NUMBER: 93.226 for AHRQ and 93.399 for NCI APPLICATION RECEIPT DATE(S): April 13, 2004 and January 11, 2005 THIS PAR CONTAINS THE FOLLOWING INFORMATION: o Purpose of the PAR o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations o References PURPOSE OF THIS PAR The Agency for Healthcare Research and Quality (AHRQ) and the National Cancer Institute (NCI) seek research proposals from new or established primary care practice-based research networks (PBRNs) to (1) evaluate scientifically-based strategies for translating evidence into sustainable improvements in clinical practice and outcomes, and/or (2) develop, improve, and/or validate research dissemination methods applicable to cancer control in primary care practice. A PBRN is defined as a group of ambulatory practices devoted principally to the primary care of patients, affiliated with each other in order to investigate questions related to community-based practice. This definition includes a sense of ongoing commitment to the research endeavor, and an organizational structure that transcends a single study. This program announcement builds on earlier RFAs from AHRQ (Translating Research Into Practice I and II; Quality Improvement Strategies in Health Care; Partnerships for Quality) and NCI (Research Dissemination & Diffusion Supplement to R01, P01, U01 & U19 NCI cancer control research grants) by focusing on approaches for promoting the translation of research evidence into practice that are effective specifically in community-based primary care settings. In the context of this announcement, research translation encompasses the use of evidence-informed approaches to primary care practice change (e.g., the systematic but as yet untested application of recommendations from the Guide to Clinical Preventive Services; http://www.preventiveservices.ahrq.gov/), testing the impact of primary care practice tools developed by AHRQ (e.g., Put Prevention Into Practice; http://www.ahrq.gov/clinic/ppipix.htm), and evaluating the dissemination and implementation of evidence-based primary care practice tools previously tested and found to be effective and/or efficacious in peer-reviewed research. PBRNs are invited to apply for funds to modify or adapt evidence-based and/or evidence-informed tools and strategies for implementing sound research evidence and to test their use, sustainability and replicability in diverse primary care practices and among various patient populations. Evidence-based tool refers to a tool whose use has been shown to impact practice through systematic testing and/or evaluation in research. Evidence- informed tool refers to a tool where the content is based on science but the use (and therefore the impact) of the tool has never been systematically tested or evaluated in research. Applicants will be required to develop projects that use rigorous scientific methods to determine the impact of the translational effort and to assess the influence of contextual factors on their findings. Project evaluations should include an assessment of appropriate outcomes related to quality of care. A particular interest of AHRQ is the use of information technology (e.g., hand-held devices, electronic medical records, internet applications) in translating research findings into policy and care. NCI is interested specifically in supporting exploratory/developmental dissemination and diffusion research applications that focus on the adoption of evidence-based cancer control interventions within primary care practices. An additional interest of NCI is to explore the applicability of different theories on the dissemination and diffusion of innovation [e.g., Rogers, 2003; Glasgow, 2003] to primary care cancer control practice, using tools developed in controlled trials (e.g., smoking cessation approaches, reminders, motivational telephone calls, etc.). AHRQ and NCI are strongly committed to supporting research in priority populations, which include women, children, elderly, minority, rural, urban, and low-income populations, as well as patients with special health care needs and disabilities. It is expected that results generated from these projects will serve as a basis for planning future, larger-scale (R01) research. The long-term goal of this initiative is to improve the capacity of primary care practices in the U.S. to establish mechanisms to assure that new knowledge is incorporated into actual practice and that its impact is assessed. RESEARCH OBJECTIVES Background While there is widespread interest in the translation of valid research findings into practice, the most effective methods for accomplishing this goal remain unclear. As a result, Congress has encouraged both the Agency for Healthcare Research and Quality (AHRQ) and the National Cancer Institute (NCI) to develop initiatives that will expand our understanding of the translation of research into practice. In response, AHRQ has since 1999 issued a series of RFAs that support projects on the translation of research findings into sustainable improvement in clinical practice and patient outcomes: the Translating Research Into Practice (TRIP) RFA (http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-99-003.html), published January 8, 1999; the Assessment of Quality Improvement Strategies in Health Care RFA (http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-99-002.html), published January 22, 1999; the Translating Research into Practice II RFA (http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-00-008.html), published December 16, 1999; and Partnerships for Quality RFA (http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-02-010.html) published May 10, 2002. Projects funded under the first TRIP RFA addressed a variety of health care problems primarily through randomized controlled trials, while projects funded by the TRIP II RFA evaluated strategies for translating research into practice through the development of partnerships between researchers and health care systems and organizations. The Assessment of Quality Improvement Strategies in Health Care RFA funded projects that evaluated strategies in widespread use by organized quality improvement systems, and the Partnerships for Quality RFA promotes collaborations among diverse organizations to translate, disseminate and implement research findings. In 2002, the NCI articulated as a key part of its mission the rapid movement of research discoveries through program development into service delivery, to ensure that the considerable investment in cancer research would translate into improved program services to benefit the health and well being of the American public. In that regard, NCI initiated its Translating Research into Improved Outcomes (TRIO) program to: (1) use behavioral risk factor and cancer surveillance data to identify needs, track progress and motivate action; (2) work collaboratively with public and private sector organizations, agencies and healthcare systems to identify, disseminate and promote the adoption of evidence-based (i.e., tested in peer-reviewed research and published in peer-reviewed journals) interventions for cancer prevention and control; and (3) identify and overcome infrastructure barriers to the adoption of evidence-based interventions in clinical and public health systems that serve the American public, with a particular emphasis on reaching those who bear the greatest burden of cancer. NCI has also issued a series of administrative supplement RFAs for NCI grantees to begin the process of exploring how best to disseminate and diffuse cancer control interventions that have been tested within NCI-funded efficacy and effectiveness trials, to the populations and/or settings from which the original study sample was drawn: Disseminate Promising Cancer Control Intervention Tested in Effective Research Projects (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-01-010.html); Notice of Limited Competition Disseminating Evidence-Based Intervention Research Products, published December 31, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-007.html); and Notice of Availability of Administrative Supplements for Disseminating Evidence-Based Intervention Research Products, published May 12, 2003 (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-03-031.html). While a total of 32 applications were submitted and 10 funded in the first three rounds, only one application focused on disseminating an evidence-based intervention (tobacco cessation for teens) in primary care settings. In 2000 and 2001, 54 NCI-funded cancer control intervention research grants, directed towards patients at risk for developing cancer, their health care providers, or both, in primary care or other clinical settings, completed their study. A listing of the research report references from this portfolio of cancer control research in clinical practice settings can be found at http://cancercontrol.cancer.gov/d4d/info.html. While few of the projects funded to date through AHRQ initiatives have focused specifically on translational activities conducted in primary care settings, AHRQ has contributed considerable resources to the support of primary care practice-based research networks (PBRNs), as mandated by Congress. As part of the December, 1999, legislation (P.L. 106-129) reauthorizing and renaming the agency, AHRQ was directed, in amended section 911 (42 U.S.C. 299b), to employ research strategies and mechanisms that link research directly with clinical practice in geographically diverse locations throughout the country, including the use of provider-based research networks especially (in) primary care. To address issues of disparities in the health care quality, outcomes, cost and access for various segments of the U.S. population, amended section 901(b)(2) authorized the agency to implement research strategies and mechanisms that specifically include PBRNs. Since 2000, AHRQ has responded by providing support for primary care PBRN research efforts through the issuance of several requests for applications. Most recently, RFA-HS-02-003 provided funds in September, 2002, for infrastructure support and exploratory projects to 36 PBRNs comprised of over 10,000 primary care clinicians with practices in 50 states serving almost 10 million primary care patients. The current PAR, co-sponsored by AHRQ and NCI, is directed to new or existing primary care PBRNs, including (but not limited to) those previously or currently funded by AHRQ. It is intended to solicit applications that assess the use of interventions to translate research into practice in primary care settings and measure the impact of those interventions. Objectives and Scope While there is broad agreement about the urgent need to accelerate the rate of uptake of evidence-based findings and tools into practice, considerable uncertainty persists about the best strategies for doing this and the setting(s) in which each strategy is most effective. The majority of strategies that have been studied focus on changing clinician behavior. From these trials, it is known that passive diffusion of information (e.g., distribution of educational materials or didactic lectures) is generally ineffective as a method of promoting behavioral change while most of the interactive implementation strategies tested to date (from audit and feedback to computerized decision support systems) have been shown to generate at least modest improvement in practices. However, no single strategy has proven superior. Recent research indicates that multifaceted interventions seem to be more effective in changing clinician behavior than single interventions. [Bero, 1998] Other interventions have been proposed which directly target patient populations or organizational behaviors. Much of the research to date, however, has been conducted in hospitals or academic medical centers. The generalizability of many of the findings to community- based primary care settings is uncertain. It is even less certain whether the successes demonstrated using these methods in a given setting are achievable with different patient populations and are sustainable over time. Studies of the multidimensional challenges of translating research into everyday practice are hampered by the current concentration of clinical research in academic settings. To pursue translational studies outside the academic setting, clinical researchers must be able to work closely over time with community-based providers. They need to study the full range of patient populations cared for in primary care and better understand the realities of community practice (e.g., providing care to a heterogeneous population of patients in busy office settings). At the same time, community providers appear to be more willing to participate in research if they are involved in its design, conduct and analysis. [Nutting, 1999] Through their active participation in the research effort, providers not only develop greater ownership of the entire process but also come to understand the tangible applications of the research to their practice. Since practice-based research networks allow academic researchers access to primary care patients, providers and data while also actively engaging primary care providers in the research effort, they offer a unique opportunity to address important issues related to the translational block. [Genel, 2003] Through the rigorous evaluation of methods of translating research into practice in community settings, PBRNs have the potential to identify and objectively assess implementation strategies that are most likely to be effective and sustainable across the full range of primary care. This PAR is aimed at PBRN efforts to: 1. apply and assess in primary care settings innovative strategies for research translation, dissemination and implementation that are based on sound theoretical constructs; 2. adapt to primary care practice, and evaluate, dissemination and implementation strategies and tools initially developed and tested in non- primary care settings or in different patient populations than those served by the applicant PBRN; and, 3. rigorously assess dissemination and implementation strategies currently being used in primary care practices that are evidence-informed but not as yet fully evaluated. Projects funded under this initiative are expected to assess the conditions under which the strategies being tested can be expected to be sustainable, can be rapidly transferred or adapted to other primary care settings, and can lead to demonstrable improvements in the quality of care and/or patient outcomes. Sustainable efforts are defined as those maintained well beyond the period of investigation and likely to persist despite ongoing changes in the organization, delivery and financing of health care in the U.S. The potential of information technology to assist in translating research findings into clinical practice has long been recognized, but its use for this purpose is underdeveloped and has not been carefully assessed. [Sung, 2003] A few studies have shown that electronic medical records (EMRs) can both increase clinician productivity and improve the quality of care provided [Wager, 2000] although the use of EMRs in primary care settings has yet to become widespread. The use of other computerized modalities such as handheld devices and internet applications are attractive because the technology is affordable and can be implemented rapidly. In support of internet-based approaches to disseminating scientific evidence, NCI and AHRQ have recently collaborated with the Centers for Disease Control and Prevention (CDC), the American Cancer Society (ACS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) to deliver evidence-based and evidence- informed knowledge and programs/tools for cancer surveillance and evaluation through the cancer control PLANET (Plan, Link, Act, Network with Evidence- based Tools; http://cancercontrolplanet.cancer.gov). Further developmental work is needed, however, to make the PLANET more useful in primary care settings. Overall, strategies that incorporate information technology systems in practice are likely to be more easily transferable and sustainable than implementation strategies that are dependent on individuals and personal interactions. [Hunt, 1998] For these reasons, AHRQ and NCI are particularly interested in projects that include the use of information technology in implementing research findings in primary care practices. While more information is needed about the generalizability of effective implementation strategies across primary care practices, local contextual factors are likely to play an important role in determining the effectiveness of interventions in any given practice. Examples of such factors are the clinician’s perception of the clinical importance of the intervention to the patients served by the practice, the perceived complexity/costs of the intervention, external barriers to change (such as lack of reimbursement), and the readiness of individual clinicians to change. The evaluation of projects funded under this initiative should include, when appropriate, a systematic assessment of the relative influence of such contextual factors on the effectiveness of each dissemination and implementation strategy. Research Methods To the extent possible, applicants should submit proposals that build on available knowledge about dissemination and implementation methods, will generate early results, and are modest in terms of time, scale, and cost. Strategies for disseminating and implementing evidence into practice that may be studied include those that focus on changing primary care clinician behavior (e.g., academic detailing, audit and feedback, provider reminder systems, incentives, computer decision support systems), changing patient behavior (e.g., patient education, patient reminder systems), or changing the organizational behaviors of practices (e.g., continuous quality improvement initiatives). Projects that identify which characteristics of the microsystem (clinician-patient-practice unit) are associated with a strong propensity for improvement are of particular interest. Methods can include rigorous qualitative studies, quantitative research, empirical work or a combination of methods. In designing studies, applicants may target specific conditions or diseases (to be treated or prevented), specific patient population groups, specific processes of care, specific components of practice structure/organization or a combination of these. AHRQ and NCI have a particular interest in studies that evaluate two or more implementation strategies (comparing their relative effectiveness) or focus on multifaceted interventions. Applications are encouraged that propose to study methods of implementing in primary care practices evidence-based recommendations for the care and/or prevention of major causes of morbidity and mortality in the U.S. Evidence-based practices that derive from the forthcoming National Healthcare Quality Report, National Healthcare Disparities Report, or recommendations from the U.S. Preventive Services Task Force are the highest priority for this announcement. In addition, NCI has a particular interest in programs and practices that influence the uptake of: (1) tobacco cessation counseling on a regular basis recommended for all persons who use tobacco products; (2) behavioral dietary counseling for adult patients with hyperlipidemia and other known risk factors for cardiovascular and diet-related chronic diseases (e.g., cancer); (3) screening mammography, with or without clinical breast examination (CBE), every 1-2 years for women aged 40 and older; (4) screening for cervical cancer in women ages 21 or who have been sexually active more than three years and have a cervix; (5) screening men and women aged 50 and older for colorectal cancer; and (6) discussion of cancer risk, risk reduction (e.g., identification and referral of women at high risk for breast cancer to genetic counseling, chemoprevention trials, or discussion of surgical interventions), or long-term survival with cancer. Projects that involve the application of information technology to implementation efforts are strongly encouraged. For assessments of the dissemination and implementation of clinical interventions, applicants should employ, if possible, concurrent comparison groups rather than historical controls, especially if secular changes in practice could pose a threat to internal validity. Studies of organizational and structural interventions will also be expected to address challenges to internal validity. Proposals to develop and assess new, or as yet untested, dissemination and implementation strategies are expected to describe a conceptual framework supporting the proposed dissemination/implementation method. The ultimate goal of dissemination and implementation efforts is improvement in health status and reduction in disease burden through changes in our health care system, as called for in a recent report from the Institute of Medicine [IOM, 2000]. As much as possible, specific patient outcomes directly related to the evidence being implemented in primary care practices should be measured. Applicants may also choose to measure outcomes related to other national aims for improving the health care system outlined in the IOM report (e.g., patient safety, patient centeredness, closing racial and ethnic gaps in health care). Alternatively, applicants may choose to focus on specific processes of care such as provider or patient behavior. While not required, attempts to assess in any way resource utilization or the cost effectiveness of different strategies for implementation are strongly encouraged. Plans for intervention studies need to include some attempt to disentangle the effects of the intervention from the influence of contextual factors. Examples of such factors include the expertise and attitudes of health care providers and the demographics of patient populations. Qualitative methods such as case studies, interviews and focus groups may be appropriate for this purpose. In describing analysis plans, applicants should clearly identify the proposed unit of analysis. Given the expectation of small to moderate effect sizes, unit of analysis errors (such as analyzing at the patient level when randomization occurred at the level of health care providers) can lead to false conclusions about the significance of the effectiveness of interventions. Applicants should be aware of the issues related to cluster randomization and should ensure that proposed studies will have adequate power and will be analyzed using appropriate methods. Sub-group analyses may be necessary to evaluate the effectiveness of interventions to improve care for specific racial and ethnic minorities or patients from specific socio- economic strata. MECHANISM OF SUPPORT This PAR will use the R21 (Exploratory/Developmental Research) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted in response to this PAR may not exceed two years. Though the size of awards may vary with the scope of research proposed, direct costs are limited to $150,000 in total direct costs per year. Applications that include a request for more than $150,000 in total direct costs per year will be returned without review. Two annual receipt dates (April 13, 2004 and January 11, 2005) have been established. The program announcement may subsequently be reissued. AHRQ and NCI do not require cost sharing for applications submitted in response to this PAR. AHRQ and NCI have agreed not to use the Modular Grant Application and Award Process. A detailed budget with full justification is required. Applications that included a modular budget will be returned without review. ELIGIBLE INSTITUTIONS Any non-profit institution affiliated with a primary care PBRN may submit an application if it is included in any one the following categories: o Domestic institutions o Public or private non-profit institutions, such as universities, colleges, hospitals, clinics and professional associations o Units of State and local governments o Eligible components of agencies of the Federal government (e.g., VA) o Tribes and Tribal Organizations o Faith-based or community-based organizations While foreign organizations are not eligible, the research network supported by the applicant organization may include individual clinical practices located outside the United States. For the purpose of this PAR, AHRQ and NCI will make grants only to non-profit organizations. For-profit organizations may participate in projects as members of consortia or as subcontractors. Organizations described in sections 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible. PBRNs interested in dissemination and diffusion research to explore/develop better methods to translate evidence-based cancer control interventions within primary care practice settings are encouraged to consider collaborations with NCI-funded cancer control intervention research scientists based within NCI-designated cancer centers (http://www3.cancer.gov/cancercenters/centerslist.html) or other academic medical centers and universities. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with a primary care PBRN to develop an application for support. AHRQ and NCI encourage new investigators (as defined in the PHS 398 application instructions) to apply as Principal Investigators. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ and NCI grants. SPECIAL REQUIREMENTS Applications are encouraged from newly formed PBRNs as well as existing networks, including (but not limited to) those that are currently receiving, or have in the past received, funds from AHRQ, NCI, other Governmental agencies, or private sources. The application must provide a description of the PBRN’s current state of development as well as its size, patient population served, leadership/management staff, and affiliations (if any). Applications must comply with the above special requirements as well as the Qualifications requirements (below) in order to be considered responsive to this PAR. PBRN Resource Center Recognizing the diverse needs of individual networks and the importance of regular communication with and among funded PBRNs, AHRQ has established a PBRN Resource Center through Indiana University and the National Opinion Research Center. The Resource Center has performed a needs assessment of each PBRN funded to date by AHRQ and intends to conduct a similar assessment of all new networks funded through this initiative. This assessment helps define and prioritize the specific resources (consultative services and technical expertise) that will be provided by the Resource Center, as appropriate, to each PBRN. In addition, the Resource Center assists AHRQ in convening two annual meetings of representatives of recipient PBRNs during the period of funding. Funded networks will be expected to cooperate fully with the Resource Center in the assessment process and to assure that at least one representative attends the two annual meetings. Required Elements The applicant is expected to describe: 1) the clinicians who have agreed to participate in the proposed demonstration/evaluation project and the steps taken to optimize levels of study participation among network members; 2) the efforts (if any) to determine the types of dissemination/implementation methods currently employed by network practices and the extent to which each method is being actively used; 3) the potential for the network membership (including those clinicians not active in this project) to adopt and sustain in practice the use of dissemination/implementation method(s) shown to be effective through this research; and, 4) evidence of a commitment by network leaders and affiliated institutions to ongoing support of this effort and other research activities. The responsibility for directing the dissemination/implementation project should be assigned to a senior level person with appropriate research training and experience. This person may be the network director or another investigator. He/she must be directly affiliated with the applicant organization and should devote not less than 10% of his/her time to the project over the period of funding, although salary support for the principal investigator’s effort may be cost-shared by the applicant organization. This PAR does not require cost sharing in order to be eligible for funding. Appropriate research assistant(s) or coordinator(s) may be hired to oversee the daily activities of the project. Support should also be requested, as needed and appropriate, for individuals with expertise in a variety of disciplines, including clinical medicine, dissemination, social science and statistics. Qualifications Applicants should document in their proposals that the PBRN involved in the dissemination/implementation project meets, at minimum, the following qualifications: o The PBRN organizational structure includes a core of at least 15 ambulatory practices and/or 15 clinicians devoted to the primary care of patients. The majority of the practices should be located in the U.S. Applicants should refer to the Institute of Medicine report on primary care [Donaldson, 1996] for definitions of primary care and primary care clinicians. o The network has a statement of its purpose and mission that has been accepted by clinicians enrolled in the PBRN and includes an ongoing commitment to the research endeavor. o A director has been identified who is responsible for most administrative, financial and planning functions. o The director is, or will be, supported by a staff of at least one person. o A mechanism (such as a community advisory board) is in place to solicit advice/feedback from the communities of patients served by the PBRN clinicians. o An organizational structure exists that transcends any single study, including multiple systems of communication with and among participating practices in the form of regularly produced newsletters, e-mail or listservs, conference calls, and/or face-to-face meetings of various combinations of network members. Priority Populations The Healthcare Research and Quality Act of 1999 (See http://www.ahrq.gov/hrqa99a.htm) reauthorized the Agency and directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas); and health care for priority populations, which include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. To implement this directive, AHRQ published a notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this PAR should address the requirements of including priority populations as specified in the Notice. Publication Transmittal: General AHRQ and NCI Requirements In keeping with the Agency’s efforts to translate the results of AHRQ-funded research into practice and policy, grantees and/or contractors are to inform the Office of Communications and Knowledge Transfer (OCKT) when articles from their studies are accepted for publication in the professional literature. Grantees and contractors should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Contact with the media will take place in close coordination with OCKT and the press offices of the grantee’s or contractor’s institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees and contractors will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PAR and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues, including information on the inclusion of women, minorities, and children in study populations to: David Lanier, MD Center for Primary Care, Prevention and Clinical Partnerships Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1567 Fax: (301) 427-1595 Email: dlanier@ahrq.gov Stephen Taplin, MD Outcomes Research Branch Applied Research Program Division of Cancer Control & Population Sciences National Cancer Institute 6130 Executive Blvd. Bethesda, MD 20892 Telephone: (301) 496-8500 FAX: (301) 435-3710 Email: taplins@mail.nih.gov o Direct your questions about peer review to: Carl Ohata, PhD Agency for Healthcare Research and Quality 540 Gaither Road, Rockville, MD 20850 Telephone: (301) 427-1549 Email: cohata@AHRQ.gov o Direct your questions about financial or grants management matters to: George Gardner OPART/Grants Management Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1453 FAX: (301) 427-1462 Email: ggardner@ahrq.gov Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Boulevard EPS 243 Bethesda, MD 20892 Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: wolfreyC@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. Specific application instructions included in this PAR related to the organization of the application supercede those included in the form PHS 398. To ensure equity, all applicants using this form must observe page number and font size requirements specified in the Form PHS 398. SUPPLEMENTARY INSTRUCTIONS: The following supplemental instruction to the form PHS 398 should be used to guide the preparation of the R21 application: 1) Under Performance Sites (page 2), list only the official name of the PBRN and the address of the PBRN office. A complete list of the clinicians and practice sites to be involved in the demonstration/evaluation project should be attached to the application as an appendix. Not sure why they want to do this. 2) If the proposed activities will involve human subjects (including surveys or interviews of network clinicians), the application should include documentation of Federalwide Assurance (FWA), if known. Applicants not having a Human Subjects Assurance should refer to the OHRP website http://www.hhs.gov/ohrp/assurances/assurances_index.html for information regarding Human Subject Assurances. 2) Detailed Budget. Budget requests may not exceed $150,000 total direct costs per year of the project, and the project period cannot exceed two years. Requests for general support of the infrastructure of the PBRN are allowable, although these requests must (1) be well justified in terms of the specific needs and stage of development of the network, (2) contribute in some tangible way to the successful completion of the exploratory/developmental project, and (3) not result in yearly direct costs for the entire project that exceed the $150,000 limit. Allowable infrastructure requests include support of salaries and travel of administrative staff, development or maintenance of network communication systems, annual meetings of the network membership, and research-related education of key network members (provided such training costs are not already included in the Facilities and Administrative costs of the applicant organization). Requests for computer-related or other equipment must be well justified and within the scope of work proposed for the exploratory/developmental project. Applications submitted in response to this PAR that include only infrastructure support will not be acceptable and will be returned without review. Since successful applicants will be required to have at least one network representative attend up to two collaborative meetings of funded PBRNs annually in Rockville, MD, travel and lodging expenses for this representative should be included in the budget request. 3) Biographical Sketches. A biographical sketch of the network director must be included, as well as sketches of other key personnel and consultants to be involved in the project. If an individual (other than the network director) will be serving as the Principal Investigator, his/her biographical sketch must also be included. 4) Research Plan. This narrative part of the application is limited to twenty five pages of text. It should be organized into two sections, as follows. Section I. The Practice-Based Research Network a) Description of the PBRN. Describe the practices included in the network, including geographical distribution of practices and types of clinicians. The applicant should provide any reliable information about the characteristics of the patient population currently served by network clinicians, including (if available) the percentages of minority and underserved patients. This description should document that the PBRN meets, at minimum, the qualifications outlined under SPECIAL REQUIREMENTS, Qualifications, and should include the accepted mission/purpose statement of the network. As noted above, a complete listing of network clinicians and practice addresses of those who have agreed to participate in the demonstration/evaluation project should be included as an appendix to the application. b) Current institutional or other resources available to the PBRN. This discussion (which may alternatively be included in the Resources section of the application) should describe the relationships between the network and any affiliated academic department or other organizational unit. A list of the consultants, co-investigators and other resources available to the network as a result of the affiliation should be included. Senior officials in any PBRN-affiliated organization(s) should provide a letter documenting support for the network’s activities. These and other letters of support should be included as an appendix and referenced in this section of the application. A brief description of any computer-based or other information systems currently in use across the network should be included. The discussion should also include a description of the mechanism used for obtaining advice/feedback from the patient communities served by the network practices. c) Network director and staff. The PBRN director and any network support staff should be identified, including a description of their qualifications. d) Evaluation. Include a statement indicating the willingness of the PBRN to cooperate with the PBRN Resource Center in their assessment of the network’s resource needs and to send at least one representative to up to two collaborative meetings of PBRNs annually in Rockville, MD, should the applicant be funded. Section II. Proposed Demonstration/Evaluation Of Methods to Translate Research Into Practice a) Dissemination/implementation strategies to be addressed. Define the specific scientific evidence or the evidence-based tool(s) that the network intends to implement and evaluate within primary care practices. Background literature and a conceptual framework supporting the proposed implementation strategy should be presented, describing how the proposed project will build on current dissemination/implementation research findings. This information is critical for methods that are newly developed or as yet untested in primary care settings. Present any information available to the network about dissemination/implementation strategies used currently or in the past by member practices and reasons the use of these methods have been sustained or abandoned by the clinicians. Describe the mechanism used to reach consensus among participating practices on the dissemination/implementation strategies to be addressed in this project. b) Methods and plan. A detailed plan for introducing and assessing the impact of dissemination/implementation strategies must be presented. Any proposed dissemination/implementation tools or systems must be specified, as well as instruments and methods for collecting assessment data. Applicants should provide a timeline for completing each phase of the project. c) Analytic plan. Identify the intended unit(s) of analysis and discuss the expected sample size. Provide a contingency plan in the event study enrollment is less than anticipated. Describe in detail the plan to analyze the study data and any issues related to cluster randomization. Indicate, when appropriate, if the sample will be sufficient for subgroup analysis of the study population by race/ethnicity, insurance status, or other subject- specific variables. d) Contextual factors and sustainability. Describe proposed methods for assessing the conditions under which the dissemination/implementation strategies being evaluated can be expected to be sustainable and how easily they can be transferred to other primary care settings. Provide a plan for determining the contextual factors that appear to play a role in determining the effectiveness of each dissemination/implementation strategy in practices, and for assessing the relative influence of each factor. e) Potential problem areas. Discuss any methodological or logistical problems that could affect the timely completion of the dissemination/implementation research project. Describe any backup plans or methods being proposed to address or resolve these problems, if needed. f) Investigators. Describe the training and experience of the principal investigator (and any co-investigators) that quality him/her to direct the proposed project. g) Human subjects protections. Identify the group(s) of human subjects who are the focus of the investigation: clinicians? patients (or parents/guardians)? clinical or administrative practice staff? Describe the measures proposed to ensure the protection of all subjects and/or individually identifiable data related to subjects. Other Instruction Applicants are encouraged to make use of AHRQ’s Healthcare Cost and Utilization Program (HCUP). The HCUP includes databases covering 1988-1997, with 1998 and 1999 data available in 2001. These all-payer databases were created through a Federal- State-industry partnership to build a multistate healthcare data system. The main HCUP databases contain discharge-level information for inpatient hospital stays in a uniform format with privacy protections. The Nationwide Inpatient Sample (NIS) is a nationwide probability sample of about 1000 hospitals. The State Inpatient Databases (SID) contain inpatient records for all community hospitals in 22 states. Other HCUP databases contain ambulatory surgery data from nine states. These databases can be directly linked to county-level data form the Health Resources and Services Administration’s Area Resource File and to hospital- level data from the Annual Survey of the American Hospital Association. This does not preclude the use of secondary data sources or primary data collection. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: AHRQ and NCI will not use the Modular Grant Application and Award Process for this PAR. Applicants for funding through this PAR should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications according to instructions provided in form PHS 398. Applications submitted in the Modular format will be returned without review. SENDING AN APPLICATION TO THE NIH and AHRQ (if appropriate): Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express/courier service) At the time of submission, two additional copies of the application, must also be sent to: Natalie Alter Center for Primary Care, Prevention and Clinical Partnerships Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1569 FAX: (301) 427-1595 Email: nalter@ahrq.gov APPLICATION PROCESSING: Applications must be received on or before the receipt dates listed on the first page of this announcement. The CSR will not accept an application in response to this PAR that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgment of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. Applicants are encouraged to read all PHS Forms 398 instructions prior to preparing an application in response to this PAR. The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned. It is very important to note that limitations on number of pages and size of font must be observed; applications violating these requirements will be returned without review. Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application. The AHRQ Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications was published in the NIH Guide on September 27, 2000. (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). The PAR is also available on AHRQ’s Web site, http://www.AHRQ.gov, and NCI’s Web site, http://cancercontrol.cancer.gov (see under Funding Opportunities). In carrying out its stewardship of funded programs, the AHRQ and NCI may request information essential to an assessment of the effectiveness of agency programs. Accordingly, grant recipients are hereby notified that they will be asked for periodic updates on publications resulting from AHRQ or NCI grant awards, and other information AHRQ or NCI requires in order to evaluate the impact of AHRQ- and NCI-sponsored projects. AHRQ and NCI expect grant recipients to keep the agency informed of publications as well as the known uses and impact of their Agency-sponsored work. Applicants are to agree to notify AHRQ and/or NCI immediately when a manuscript based on work supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active. To receive an award, applicants must agree to submit an original and 2 copies of an abstract, executive summary, and full report of the results in the format prescribed by AHRQ no later than 90 days after the end of the project period. The executive summary should be sent at the same time on a computer disk which specifies on the label the format uses (WP5.1 or WP6.0 is preferable). Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. Purchase of CMS public-use data, if required, should be discussed in the application narrative and included in the budget. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by AHRQ and NCI. Incomplete and/or non-responsive applications or applications not following instructions given in this PAR will be returned to the applicant without further consideration. Applications that are complete and responsive to the PAR will be evaluated for scientific and technical merit by an appropriate peer review group convened by AHRQ in accordance with standard AHRQ and NCI peer review procedures. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. o Receive a written critique o If selected by NCI it will receive a second level review by the National Cancer Advisory Board. REVIEW CRITERIA In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the scientific merit of the proposed demonstration/evaluation project and the potential of the PBRN to complete the proposed activities successfully. The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Technical merit of the proposal a) Significance. If the aims of this dissemination/implementation project are achieved, how will knowledge about translating research into practice in primary care settings be advanced? What will be the effect of this study on the concepts or methods that drive this field? b) Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? c) Innovation. To what extent does the proposed dissemination/implementation project take advantage of unique features/strengths of the PBRN or employ innovative evaluative methods? d) Investigator(s). Has the PBRN identified individuals with the appropriate expertise to assist in each phase of the project? Is the proposed work appropriate to the training and experience level of the P.I. and other researchers (if any)? e) Budget. Is the proposed budget reasonable for the proposed project and for the requested period of support? 2. Potential for success a) PBRN readiness. To what extent has the work completed to date by the PBRN prepared it to take on this dissemination/implementation project? To what extent has the P.I. involved network clinicians in the design and plan for this project? b) Scope of work. Is the proposed project sufficiently (or overly) ambitious for the PBRN, given its level of development? Will the PBRN realistically be able to complete the entire project within the proposed timeline? c) Environment. Is the administrative, organizational and management environment of the PBRN well established and stable enough to make the project’s success likely? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: o PROTECTION: The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to address the need of both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the aims of the project. Adequacy of attention to other populations of special priority to AHRQ and NCI (see discussion on Priority Populations in the section on Special Requirements, above, and Inclusion Criteria included in the section on Agency policies and Requirements, below.) DATA SHARING: 1) Data Confidentiality Pursuant to section 924(c) of the Public Health Service Act (42 USC 299c- 3(c)), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are now civil monetary penalties for violation of this confidentiality statute (42 U.S.C.299c-3(d)). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this PA will also be managed in accordance with 42 CFR Parts 160 and 164, federal regulations pertaining to the privacy of patient-related health information. These privacy regulations, developed by the Department of Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), are scheduled to be effective and enforceable in April 2003. These regulations serve to limit the disclosure of personally identifiable patient information and define when and how such information can be disclosed. Thus, for example, health care plans and providers will require either patient authorization of disclosures of identifiable information to be made to researchers who are not their health care providers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) upon being satisfied that any identifiable health information will be appropriately safeguarded by the investigators. Additional information about the regulations and their implementation can be obtained from: http://www.aspe.hhs.gov/admnsimp. The awardee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application. 2) Rights in Data AHRQ and NCI grantees may copyright unless otherwise provided in grant awards, or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ or NCI funds. Such copyrights and patents are subject to a worldwide irrevocable Federal government license to use and permit others to use these products and materials for government purposes. In accordance with legislative dissemination mandates, AHRQ and NCI purposes may include, subject to statutory confidentiality protections, making project materials, data bases, results, and algorithms available for verification or replication by other researchers; and subject to AHRQ and NCI budget constraints, final products may be made available to the health care community and the public by AHRQ and/or NCI or their agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHRQ and NCI publicize research findings but rely on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer wishes to be consulted in advance of publication in order to coordinate these issuances with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO's website http://www.gpoaccess.gov/cfr/index.html). NCI will approach its grantees with efficacious dissemination/implementation approaches to list their programs and products on the Research-Tested Intervention Programs (RTIPs; http://cancercontrol.cancer.gov/rtips/) website of the Cancer Control PLANET. Grantees will be required to submit the programs and products for RTIPs review, but will retain the right to refuse posting on the RTIPs website after reviewing the content of the RTIPs posting. AWARD CRITERIA Applications submitted in response to a PAR will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Program balance among awardees with respect to nature and type of dissemination/implementation strategies/methods o The distribution of funded PBRNs by predominant provider types and geographical location may be special considerations REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS: It is the policy of AHRQ and NCI that women and members of minority groups be included in all agency-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ and NCI require adherence to these NIH Guidelines. Investigators may obtain copies from the above sources or from the AHRQ Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web site http://grants.nih.gov/grants/guide/index.html. AHRQ and NCI Program staff may also provide additional information concerning these policies (see INQUIRIES). AHRQ also encourages investigators to consider including children in study populations, as appropriate. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. If no Federal act is taken, having the force and effect of law, in reliance upon an AHRQ- or NCI-supported research project, the underlying data is not subject to this disclosure requirement. Furthermore, even if a Federal regulation action is taken in reliance on AHRQ- or NCI-supported data under FOIA, 5 USC 552(b), disclosure of statutorily protected confidential identifiable data from such study is exempted from disclosure under "the (b)(3) exemption." It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ or NCI support. Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", for example, if it constituted trade secrets or commercial information collected. NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ’s authorities. Should applicants wish to place data collected under this PAR in a public archive, which can provide protections for the data (e.g., as required by the confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 299c-3(c)) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued the last modification the "Standards for Privacy of Individually Identifiable Health Information", was mandated by the "Privacy Rule," on August 14, 2002. This regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). Mandatory compliance with the Privacy Rule (for those classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with covered entities. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff of a covered entity. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ and NCI encourage applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under Title IX of the Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106-129 (1999). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 92. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES Bero LA, Grilli R, Grimshaw JM, et al. Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings. BMJ 1998;317:465-468. Donaldson MS, Yordy KD, Lohr KN, Vanselow NA, eds. Primary Care: America’s Health in a New Era. National Academy Press, Washington, D.C. 1996. Genel M, Dobs S. Translating clinical research into practice: practice- based research networks a promising solution. J Invest Med 2003;51(2):64- 71. Glasgow RE, Lictenstein E, Marcus AC. Why don t we see more translation of health promotion research to practice? Rethinking the efficacy to effectiveness transition. AJPH 2003;93(8):1261-67. Hunt DL, Haynes RB, Hanna SE, Smith K. Effects of computer-based decision support systems on physician performance and patient outcomes. JAMA 1998;280:1339-46. Institute of Medicine, 2000. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy of Sciences. Nutting PA, Beasley JW, Werner JJ. Practice-based research networks answer primary care questions. JAMA 1999;37:1092-1104. Rogers EM. Diffusion of Innovations. New York, NY: Free Press, 2003. Wager KA, Lee FW, White AW, Ward DM, Ornstein SM. Impact of an electronic medical record system on community-based primary care practices. JABFP 2000;13(5):338-348.

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