Many interventions found to be effective in health services research studies fail to translate into meaningful patient care outcomes across multiple contexts. Health services researchers recognize the need to evaluate not only summative outcomes but also formative outcomes to assess the extent to which implementation is effective in a specific setting, prolongs sustainability, and promotes dissemination into other settings. Many implementation theories have been published to help promote effective implementation. However, they overlap considerably in the constructs included in individual theories, and a comparison of theories reveals that each is missing important constructs included in other theories. In addition, terminology and definitions are not consistent across theories. We describe the Consolidated Framework For Implementation Research (CFIR) that offers an overarching typology to promote implementation theory development and verification about what works where and why across multiple contexts. We used a snowball sampling approach to identify published theories that were evaluated to identify constructs based on strength of conceptual or empirical support for influence on implementation, consistency in definitions, alignment with our own findings, and potential for measurement. We combined constructs across published theories that had different labels but were redundant or overlapping in definition, and we parsed apart constructs that conflated underlying concepts. The CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Eight constructs were identified related to the intervention (e.g., evidence strength and quality), four constructs were identified related to outer setting (e.g., patient needs and resources), 12 constructs were identified related to inner setting (e.g., culture, leadership engagement), five constructs were identified related to individual characteristics, and eight constructs were identified related to process (e.g., plan, evaluate, and reflect). We present explicit definitions for each construct. The CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings.

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Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science

Objectives:This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies,

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Effectiveness-implementation Hybrid Designs: Combining Elements of Clinical Effectiveness and Implementation Research to Enhance Public Health Impact

Although there is a large and growing literature on tailored print health behavior change interventions, it is currently not known if or to what extent tailoring works. The current study provides a meta-analytic review of this literature, with a primary focus on the effects of tailoring. A comprehensive search strategy yielded 57 studies that met inclusion criteria. Those studies-which contained a cumulative N = 58,454-were subsequently meta-analyzed. The sample size-weighted mean effect size of the effects of tailoring on health behavior change was found to be r = .074. Variables that were found to significantly moderate the effect included (a) type of comparison condition, (b) health behavior, (c) type of participant population (both type of recruitment and country of sample), (d) type of print material, (e) number of intervention contacts, (f) length of follow-up, (g) number and type of theoretical concepts tailored on, and (h) whether demographics and/or behavior were tailored on. Implications of these results are discussed and future directions for research on tailored health messages and interventions are offered.

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Does tailoring matter? Meta-analytic review of tailored print health behavior change interventions.

Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest; systematic review--guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.

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Clinical Practice Guidelines We Can Trust

One of the most critical issues in mental health services research is the gap between what is known about effective treatment and what is provided to consumers in routine care. Concerted efforts are required to advance implementation science and produce skilled implementation researchers. This paper seeks to advance implementation science in mental health services by over viewing the emergence of implementation as an issue for research, by addressing key issues of language and conceptualization, by presenting a heuristic skeleton model for the study of implementation processes, and by identifying the implications for research and training in this emerging field.

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Implementation Research in Mental Health Services: an Emerging Science with Conceptual, Methodological, and Training challenges

This study describes the sensations and pain reported by persons with unilateral lower extremity amputations. Participants (n = 92) were recruited from two hospitals to complete the Prosthesis Evaluation Questionnaire which included questions about amputation related sensations and pain. Using a visual analog scale, participants reported the frequency, intensity, and bothersomeness of phantom limb, residual limb, and back pain and nonpainful phantom limb sensations. A survey of medication use for each category of sensations also was included. Statistical analyses revealed that nonpainful phantom limb sensations were common and more frequent than phantom limb pain. Residual limb pain and back pain were also common after amputation. Back pain surprisingly was rated as more bothersome than phantom limb pain or residual limb pain. Back pain was significantly more common in persons with above knee amputations. These results support the importance of looking at pain as a multidimensional rather than a unidimensional construct. They also suggest that back pain after lower extremity amputation may be an overlooked but very important pain problem warranting additional clinical attention and study.

Phantom limb, residual limb, and back pain after lower extremity amputations : Amputation and new prosthetic devices

Implementation of research into practice in health care systems is a challenging and often unsuccessful endeavor. The United States Department of Veterans Affairs (VA) Quality Enhancement Research Initiative (QUERI) research teams include formative evaluations (FE) in their action-oriented VA implementation projects to identify critical information about the processes of implementation that can guide adjustments to project activities, in order to better meet project goals. This article describes the development and use of FE in an action-oriented implementation research project. This two-year action-oriented implementation research project was conducted at 23 VA Spinal Cord Injury (SCI) Centers, and targeted patients, staff and the system of care, such as administration and information technology. Data for FE were collected by electronic and paper surveys, semi-structured and open-ended interviews, notes during conference calls, and exchange of e-mail messages. Specific questions were developed for each intervention (designed to improve vaccination rates for influenza in veterans with spinal cord injury and disorder); informants were selected for their knowledge of interventions and their use in SCI Centers. Data from FE were compiled separately for each intervention to describe barriers to progress and guide adjustments to implementation activities. These data addressed the processes of implementing the interventions, problem-solving activities and the status of interventions at SCI Centers. Formative evaluations provided the project team with a broad view of the processes of implementing multi-targeted interventions as well as the evolving status of the related best practice. Using FE was useful, although the challenges of conducting FE for non-field researchers should be addressed. Work is needed to develop methods for conducting FE across multiple sites, as well as acknowledging variations in local contexts that affect implementation of interventions.

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Using formative evaluation in an implementation project to increase vaccination rates in high-risk veterans: QUERI Series

This article presents "lessons learned" about using a computerized clinical reminder (CCR) for influenza in spinal cord injury (SCI) centers in the Veterans Health Administration (VHA). Although research has shown that use of a CCR increases adherence to preventive care measures, technical and administrative issues affect its use by nurses. CCR is a term for a reminder in a patient's electronic medical record to initiate a preventive care activity. Qualitative data about using the CCR for influenza were collected from staff using semi-structured interviews, e-mail questionnaires, and telephone calls. Once issues were identified, follow-up activities included discussions with local and national experts and problem-solving activities. The investigators identified two national issues about the CCR for influenza: the taxonomy to identify patients with SCI, and the "due date" for influenza vaccine. Local issues included authorization for nurses to use the CCR, ease of use of the CCR for inpatients and outpatients, connectivity of the medication tracking program for inpatients with the electronic medical record, configuration of the CCR in the electronic medical record, training, and technical support.

Understanding a VA preventive care clinical reminder: lessons learned.

Background/Objective: Persons with spinal cord injury and disorders (SCID) are at increased risk of developing influenza, pneumonia, and ensuing complications. Influenza vaccine has been shown to be effective, yet vaccination rates have been low in this population. To improve these rates, barriers and facilitators to receiving influenza vaccine in this population were identified.Methods: A cross-sectional telephone survey was conducted with a convenience sample of patients at 1 3 Department of Veterans Affairs (VA) Spinal Cord Injury (SCI) Centers between September and November 2000. Survey questions assessed perceptions regarding the influenza vaccine.Results: Participants interviewed (N = 377) had a mean age of 5 8.6 years and were predominantly male and white. Most had had received the influenza vaccine at some time in the past; however, 3 5% had not received it in the previous year. The most common reason reported for not being vaccinated was the belief that it was not important. Those who kne...

Marcia W. Legro

Papers

Phantom limb, residual limb, and back pain after lower extremity amputations : Amputation and new prosthetic devices

Using formative evaluation in an implementation project to increase vaccination rates in high-risk veterans: QUERI Series

Understanding a VA preventive care clinical reminder: lessons learned.

Influenza vaccination among veterans with spinal cord injury: Part 1. A survey of attitudes and behavior.

Prosthesis Evaluation Questionnaire