Developing a Conceptual Disease Model of Patient Experiences and Identifying Patient-Reported Clinical Outcome Assessments for Use in Trials of Treatments for Focal Onset Seizures.

Purpose: To identify concepts important to understanding the experiences of adults with focal onset seizures (FOS) and evaluate clinical outcome assessments (COAs) for measuring these concepts in clinical trials of treatments for FOS. Methods: A search of published qualitative research, clinical trials, and approved product labels for FOS treatments was performed to develop a conceptual disease model (CDM) of patients' experience of living with FOS. Concepts of interest (COI) were selected, and a second literature search was conducted to identify COAs measuring these concepts. Ten COAs were selected and reviewed to document their development process, evidence of measurement properties, and methods for interpreting change scores using criteria proposed in regulatory guidelines for patient-reported outcomes to support label claims. Results: Concepts identified from the published literature (13 articles, 1 conference abstract), 24 clinical trials, and 8 product labels were included in a novel CDM. Impacts on physical, cognitive, and social and emotional function were chosen as COI for evaluating treatment outcomes for FOS; the additional concept of social support and coping strategies was chosen to understand patients' lived experiences. From 51 unique COAs identified, 10 were selected based on their potential coverage of the COI; some symptom severity and health-related quality of life (HRQoL) COAs covered multiple COI. Of these 10, 8 COAs evaluated impacts/limitations on physical function, 8 measured social and emotional impacts, and 5 assessed social support and coping strategies. While most assessments had gaps in evidence validating their measurement properties, 2 COAs measuring symptom severity and 1 COA measuring HRQoL had evidence confirming their potential utility in clinical trials to support label claims. Conclusion: This research provides insights into the experience of patients with FOS and identifies COAs that measure concepts considered to support endpoints in clinical trials for FOS.

Exploring content and psychometric validity of newly developed assessment tools for itch and skin pain in atopic dermatitis.

BACKGROUND: Atopic dermatitis (AD) is a common skin disorder characterized by chronic inflammation, altered skin barrier function, and inflammatory cell skin infiltration that decreases health-related quality of life (HRQoL). The study objective was to understand the patient perspective of AD burden and determine suitable patient-reported outcome (PRO) measures. METHODS: This mixed methods study involved the collection of qualitative and quantitative information from adults (≥ 18 years old) and adolescents (12 - 17 years old) with clinician-confirmed AD regarding their experiences of AD symptoms and its impact on HRQoL. The first part of the study included three stages: in-person concept elicitation (CE) interviews, a 2-week daily electronic diary (eDiary) study, and in-person cognitive debriefing (CD) interviews. An Itch numeric rating scale (NRS) (v1.0) and a Skin Pain NRS (v1.0) evaluation during CD interviews required participants to think about their 'worst' itch and 'worst' skin pain in the past 24 h. Other PRO measures allowed for psychometric testing. The second part of the study involved telephone-depth interviews (TDIs) and qualitative feedback from participants who had not participated in the CD interviews. Qualitative data were thematically analyzed. Psychometric evaluation of NRS measures was performed using eDiary data. RESULTS: In the CE interviews, itch and/or itching and skin pain were the most prevalent symptoms consistently discussed by participants. Both NRS measures demonstrated strong psychometric reliability and were applicable across ages with suitable concurrent validity. During the CD interviews, some participants focused their answers on their 'average' itch/itching in the past 24 h, rather than their 'worst' itch. Some participants answered the Skin Pain NRS thinking about general pain or other types of pain, rather than skin pain specifically. Consequently, modifications to both measures addressed these issues and re-tested as paper-and-pen versions in subsequent TDIs. Itch NRS (v2.0) modifications helped participants focus on their worst itching. Most participants preferred Skin Pain NRS v2.0b, which included skin pain descriptors. CONCLUSIONS: Itching and skin pain are the most important and relevant AD symptoms. The Itch NRS (v2.0) and Skin Pain NRS (v2.0b) appear to be appropriate endpoints for the assessment of itching and skin pain severity for clinical trials with adults and adolescents with AD.

An Exploratory Pilot Study to Describe Shared Decision-Making for PTSD Treatment Planning: The Provider Perspective.

OBJECTIVE: To describe current practices used by Veterans Administration (VA) mental health (MH) providers involved in post-traumatic stress disorder (PTSD) treatment planning to support engagement of veterans with PTSD in shared decision-making (SDM). METHODS: Semi-structured interviews with MH providers (n = 9) were conducted at 1 large VA, audio-recorded, and transcribed verbatim. Transcripts were analyzed deductively, guided by a published account of the integral SDM components for MH care. RESULTS: While discussing forming a cohesive team with patients, providers noted the importance of establishing rapport and assessing treatment readiness. Providers' clinical knowledge/expertise, knowledge of the facility's treatment options, knowledge of how to navigate the VA MH care system, and patient factors (goals/preferences, factors influencing treatment engagement) were noted as important to consider when patients and providers exchange information. When negotiating the treatment plan, providers indicated that conversations should include treatment recommendations and concurrent opportunities for personalization. They also emphasized the importance of discussions to finalize a mutually agreeable patient- and provider-informed treatment plan and measure treatment impact. CONCLUSION: These results offer a preliminary understanding of VA MH providers' facilitation of SDM for PTSD care. Findings may provide insights for MH providers who wish to engage patients with PTSD in SDM.

Prevention and management of osteoporosis and osteoporotic fractures in persons with a spinal cord injury or disorder: A systematic scoping review.

Objectives: The primary objective was to review the literature regarding methodologies to assess fracture risk, to prevent and treat osteoporosis and to manage osteoporotic fractures in SCI/D.Study Design: Scoping review.Settings/Participants: Human adult subjects with a SCI/D.Outcome measures: Strategies to identify persons with SCI/D at risk for osteoporotic fractures, nonpharmacological and pharmacological therapies for osteoporosis and management of appendicular fractures.Results: 226 articles were included in the scoping review. Risk of osteoporotic fractures in SCI is predicted by a combination of DXA-defined low BMD plus clinical and demographic characteristics. Screening for secondary causes of osteoporosis, in particular hyperparathyroidism, hyperthyroidism, vitamin D insufficiency and hypogonadism, should be considered. Current antiresorptive therapies for treatment of osteoporosis have limited efficacy. Use of surgery to treat fractures has increased and outcomes are good and comparable to conservative treatment in most cases. A common adverse event following fracture was delayed healing.Conclusions: Most of the research in this area is limited by small sample sizes, weak study designs, and significant variation in populations studied. Future research needs to address cohort definition and study design issues.

Experience and Utility of Using the Participatory Research Method, Photovoice, in Individuals With Spinal Cord Injury.

Background: There is a need to engage persons with spinal cord injuries/disorders (SCI/D) in research methodologies beyond traditional approaches. This provides an opportunity for individuals to convey their perspectives in a variety of ways. Photovoice empowers people to share their perspectives through photographs and narrative; this is well-suited for individuals who are less comfortable speaking up when other methods are used, such as focus groups. Objective: To examine photovoice methodology in US Veterans with SCI/D to describe their experiences with and the utility of photovoice. We also provide a sample of content (qualitative data) to illustrate how individuals with SCI/D conceptualized function and factors important to them. Methods: Photovoice, a qualitative participatory research method, was used to collect photographs from Veterans with SCI/D, which was followed by personal narratives describing the meaning of their photos. Results: Participants (N = 9) were 64 years old, on average, and 75% had paraplegia. Participants discussed the challenges with taking photographs, but they enjoyed participating, appreciated inclusion, and hoped the information they provided would help others with disabilities. Conclusion: These findings suggest that despite challenges and ethical barriers, individuals with SCI/D are interested in, highly capable of, and should be given the opportunity to be included in studies like this that empower participants to share their views using novel ways of expression. These findings demonstrate the desirability, feasibility, and utility of using photovoice in individuals with SCI/D. This method may be used to understand factors impacting health and well-being and can be made available to individuals with SCI/D to minimize inequalities in research opportunities.

Evaluating broad-scale system change using the Consolidated Framework for Implementation Research: challenges and strategies to overcome them.

OBJECTIVE: The objective of this paper is to demonstrate the utility of the CFIR framework for evaluating broad-scale change by discussing the challenges to be addressed when planning the assessment of broad-scale change and the solutions developed by the evaluation team to address those challenges. The evaluation of implementation of Patient-centered Care and Cultural Transformation (PCC&CT) within the Department of Veterans Affairs (VA) will be used as a demonstrative example. Patient-Centered Care (PCC) is personalized health care that considers a patient's circumstances and goals. The Department of Veterans Affairs (VA) is working towards implementing PCC throughout its healthcare system, comprised of multiple interventions with a singular long-term goal of cultural transformation, however little is known about the factors influencing its implementation. This paper discusses the issues that arose using CFIR to qualitatively assess the factors influencing implementation of cultural transformation. RESULTS: Application of CFIR to this broad-scale evaluation revealed three strategies recommended for use in evaluating implementation of broad-scale change: (1) the need for adapted definitions for CFIR constructs (especially due to new application to broad-scale change), (2) the use of a mixed deductive-inductive approach with thematic coding to capture emergent themes not encompassed by CFIR, and (3) its use for expedited analysis and synthesis for rapid delivery of findings to operational partners. This paper is among the first to describe use of CFIR to guide the evaluation of a broad-scale transformation, as opposed to discrete interventions. The processes and strategies described in this paper provide a detailed example and structured approach that can be utilized and expanded upon by others evaluating implementation of broad-scale evaluations. Although CFIR was the framework selected for this evaluation, the strategies described in this paper including: use of adapted definitions, use of mixed deductive-inductive approach, and the approach for expedited analysis and synthesis can be transferred and tested with other frameworks.

How can healthcare organizations implement patient-centered care? Examining a large-scale cultural transformation.

BACKGROUND: Healthcare organizations increasingly are focused on providing care which is patient-centered rather than disease-focused. Yet little is known about how best to transform the culture of care in these organizations. We sought to understand key organizational factors for implementing patient-centered care cultural transformation through an examination of efforts in the US Department of Veterans Affairs. METHODS: We conducted multi-day site visits at four US Department of Veterans Affairs medical centers designated as leaders in providing patient-centered care. We conducted qualitative semi-structured interviews with 108 employees (22 senior leaders, 42 middle managers, 37 front-line providers and 7 staff). Transcripts of audio recordings were analyzed using a priori codes based on the Consolidated Framework for Implementation Research. We used constant comparison analysis to synthesize codes into meaningful domains. RESULTS: Sites described actions taken to foster patient-centered care in seven domains: 1) leadership; 2) patient and family engagement; 3) staff engagement; 4) focus on innovations; 5) alignment of staff roles and priorities; 6) organizational structures and processes; 7) environment of care. Within each domain, we identified multi-faceted strategies for implementing change. These included efforts by all levels of organizational leaders who modeled patient-centered care in their interactions and fostered willingness to try novel approaches to care amongst staff. Alignment and integration of patient centered care within the organization, particularly surrounding roles, priorities and bureaucratic rules, remained major challenges. CONCLUSIONS: Transforming healthcare systems to focus on patient-centered care and better serve the "whole" patient is a complex endeavor. Efforts to transform healthcare culture require robust, multi-pronged efforts at all levels of the organization; leadership is only the beginning. Challenges remain for incorporating patient-centered approaches in the context of competing priorities and regulations. Through actions within each of the domains, organizations may begin to truly transform to patient-driven care.

Potential of personal health record portals in the care of individuals with spinal cord injuries and disorders: Provider perspectives.

CONTEXT/OBJECTIVE: Although personal health record (PHR) portals are designed for patients, healthcare providers are a key influence in how patients use their features and realize benefits from them. A few studies have examined provider attitudes toward PHR portals, but none have focused on those who care for individuals with spinal cord injuries and disorders (SCI/D). We characterize SCI/D provider perspectives of PHR portals, including perceived advantages and disadvantages of PHR portal use in SCI/D care. DESIGN: Cross-sectional; semi-structured interviews. SETTING: Spinal Cord Injury (SCI) Centers in the Veterans Health Administration. PARTICIPANTS: Twenty-six SCI/D healthcare providers. INTERVENTIONS: None. OUTCOME MEASURES: Perceived advantages and disadvantages of PHR portals. RESULTS: The complex situations of individuals with SCI/D shaped provider perspectives of PHR portals and their potential role in practice. Perceived advantages of PHR portal use in SCI/D care included the ability to coordinate information and care, monitor and respond to outpatient requests, support patient self-management activities, and provide reliable health information to patients. Perceived disadvantages of PHR portal use in SCI/D care included concerns about the quality of patient-generated health data, other potential liabilities for providers and workload burden, and the ability of individuals with SCI/D to understand clinical information accessed through a portal. CONCLUSION: Our study highlights advantages and disadvantages that should be considered when promoting engagement of SCI/D healthcare providers in use of PHR portals, and portal features that may have the most utility in SCI/D care.

Patient-centred care is a way of doing things: How healthcare employees conceptualize patient-centred care.

BACKGROUND: Patient-centred care is now ubiquitous in health services research, and healthcare systems are moving ahead with patient-centred care implementation. Yet, little is known about how healthcare employees, charged with implementing patient-centred care, conceptualize what they are implementing. OBJECTIVE: To examine how hospital employees conceptualize patient-centred care. RESEARCH DESIGN: We conducted qualitative interviews about patient-centred care during site four visits, from January to April 2013. SUBJECTS: We interviewed 107 employees, including leadership, middle managers, front line providers and staff at four US Veteran Health Administration (VHA) medical centres leading VHA's patient-centred care transformation. MEASURES: Data were analysed using grounded thematic analysis. Findings were then mapped to established patient-centred care constructs identified in the literature: taking a biopsychosocial perspective; viewing the patient-as-person; sharing power and responsibility; establishing a therapeutic alliance; and viewing the doctor-as-person. RESULTS: We identified three distinct conceptualizations: (i) those that were well aligned with established patient-centred care constructs surrounding the clinical encounter; (ii) others that extended conceptualizations of patient-centred care into the organizational culture, encompassing the entire patient-experience; and (iii) still others that were poorly aligned with patient-centred care constructs, reflecting more traditional patient care practices. CONCLUSIONS: Patient-centred care ideals have permeated into healthcare systems. Additionally, patient-centred care has been expanded to encompass a cultural shift in care delivery, beginning with patients' experiences entering a facility. However, some healthcare employees, namely leadership, see patient-centred care so broadly, it encompasses on-going hospital initiatives, while others consider patient-centred care as inherent to specific positions. These latter conceptualizations risk undermining patient-centred care implementation by limiting transformational initiatives to specific providers or simply repackaging existing programmes.

Use of the PARIHS Framework for Retrospective and Prospective Implementation Evaluations.

BACKGROUND: The Promoting Action on Research Implementation in Health Services (PARIHS) framework has been used by implementation researchers to assess factors impacting implementation and to use that information to identify optimal interventions and implementation strategies. In this paper, two studies are presented demonstrating the utility of PARIHS as a tool for retrospective and prospective evaluation of implementation in the health care setting. STUDY DESIGN: Descriptive case study. METHODS: A qualitative consensus process was used to evaluate provider perceptions of PARIHS constructs of evidence, context, and facilitation and their subelements which were scored on a continuum of low to high. RESULTS: The first example demonstrates retrospective use of PARIHS which provided insight into the factors contributing to variations in implementation across sites in an ongoing program. Evidence was strong (high), whereas context noted some challenges in culture and measurement (mixed), and the presence of dedicated program facilitators was positive but dual roles limited their ability to fully support implementation (mixed). The second example demonstrates prospective use of PARIHS for evaluation which gathered information about intervention sites for the purposes of selecting implementation strategies responsive to site needs. Evidence supporting the intervention was limited (low), context noted that limited awareness of the intervention was a challenge (low), and that a strong internal facilitator supported implementation (high). LINKING EVIDENCE TO ACTION: The descriptive case study presented here underscores the value of a theory-guided approach to implementation and highlights that PARIHS can help implementers understand factors impacting implementation, identify areas for future intervention, and inform selection of strategies to support or enhance implementation efforts.

Starting a new conversation: Engaging Veterans with spinal cord injury in discussions of what function means to them, the barriers/facilitators they encounter, and the adaptations they use to optimize function.

BACKGROUND: Assessments of function in persons with spinal cord injury (SCI) often utilize pre-defined constructs and measures without consideration of patient context, including how patients define function and what matters to them. OBJECTIVES/HYPOTHESIS: We utilized photovoice to understand how individuals define function, facilitators and barriers to function, and adaptations to support functioning. METHODS: Veterans with SCI were provided with cameras and guidelines to take photographs of things that: (1) help with functioning, (2) are barriers to function, and (3) represent adaptations used to support functioning. Interviews to discuss photographs followed and were audio-recorded, transcribed, and analyzed using grounded-thematic coding. Nvivo 8 was used to store and organize data. RESULTS: Participants (n = 9) were male (89%), Caucasian (67%), had paraplegia (75%), averaged 64 years of age, and were injured, on average, for 22 years. Function was described in several ways: the concept of 'normalcy,' aspects of daily living, and ability to be independent. Facilitators included: helpful tools, physical therapy/therapists, transportation, and caregivers. Barriers included: wheelchair-related issues and interior/exterior barriers both in the community and in the hospital. Examples of adaptations included: traditional examples like ramps, and also creative examples like the use of rubber bands on a can to help with grip. CONCLUSION(S): Patient-perspectives elicited in-depth information that expanded the common definition of function by highlighting the concept of "normality," facilitators and barriers to function, and adaptations to optimize function. These insights emphasize function within a patient-context, emphasizing a holistic definition of function that can be used to develop personalized, patient-driven care plans.

Patient prioritization of comorbid chronic conditions in the Veteran population: Implications for patient-centered care.

OBJECTIVE: Patients with comorbid chronic conditions may prioritize some conditions over others; however, our understanding of factors influencing those prioritizations is limited. In this study, we sought to identify and elaborate a range of factors that influence how and why patients with comorbid chronic conditions prioritize their conditions. METHODS: We conducted semi-structured, one-on-one interviews with 33 patients with comorbidities recruited from a single Veterans Health Administration Medical Center. FINDINGS: The diverse factors influencing condition prioritization reflected three overarching themes: (1) the perceived role of a condition in the body, (2) self-management tasks, and (3) pain. In addition to these themes, participants described the rankings that they believed their healthcare providers would assign to their conditions as an influencing factor, although few reported having shared their priorities or explicitly talking with providers about the importance of their conditions. CONCLUSION: Studies that advance understanding of how and why patients prioritize their various conditions are essential to providing care that is patient-centered, reflecting what matters most to the individual while improving their health. This analysis informs guideline development efforts for the care of patients with comorbid chronic conditions as well as the creation of tools to promote patient-provider communication regarding the importance placed on different conditions.

Do perceptions of family-centered care differ in older and younger family/caregivers of U.S. veterans?

INTRODUCTION: Family-centered care (FCC) involves partnering with patients and family/caregivers ("caregivers"), engaging them in decisions, and providing support. FCC may be measured across 3 dimensions: respect, collaboration, and support and needs likely vary by caregiver age. The objective was to examine and compare caregiver perceptions of FCC by age. METHOD: We mailed surveys to family/caregivers of Veterans. We collected demographics and measured respect, collaboration, and support using the Family-Centered Care Survey (FCCS). We calculated mean values and conducted bivariate comparisons, dichotomized by caregiver age (≥60 vs. <60), of demographics and FCC constructs. We completed thematic analysis on open-ended text. RESULTS: Caregivers (n = 2,111) aged ≥60 versus <60 were more likely to be spouses (81% vs. 62%, p < .0001) and White (74% vs. 50%, p < .0001). Overall FCC subscales values were high: respect (3.30), collaboration (3.07), and support (2.99). Older caregivers reported higher respect (3.36 vs. 3.22, p < .001), collaboration (3.12 vs. 2.98, p < .0001), and support (3.06 vs. 2.88, p < .0001). Qualitative analysis revealed collaboration, communication, hospital climate, and physical environment as important to FCC and supplemented quantitative findings on age. Examples highlighted both positive perceptions of FCC and areas of concern, such as feeling "unheard" and "like I am bothering providers," and needing "more comfortable seating" and "better parking." DISCUSSION: Caregivers perceived high FCC levels at VA facilities, reporting highest on respect and lowest on support. Older caregivers perceived better FCC compared with younger caregivers. Several concerns identified can be used to target improvements to FCC including: improved support, collaboration between patient/family/provider, and climate/environmental enhancements. (PsycINFO Database Record

The Feasibility of an Infection Control "Safe Zone" in a Spinal Cord Injury Unit.

We report on healthcare worker use of a safe zone (outside a 3-foot perimeter around the patient's bed) and personal protective equipment in 2 inpatient spinal cord injury/disorder units. Workers remained within the safe zone during 22% of observations but were less compliant with personal protective equipment inside the zone. Infect Control Hosp Epidemiol 2016;37:714-716.

Patient Perceptions of the Environment of Care in Which Their Healthcare is Delivered.

OBJECTIVE: To measure patients' perceptions of the environment of care (EOC), with a focus on the physical environment, in which healthcare is delivered. BACKGROUND: The EOC may impact patient experiences, care perceptions, and health outcomes. EOC may be improved through redesign of existing physical structures or spaces or by adding nurturing amenities. METHODS: Demographics, health status, hospital use, and data on the environment (physical, comfort, orientation, and privacy) were collected via a mailed cross-sectional survey sent to patients seen at four hospital Centers of Innovation (COIs; that implemented many modifications to the healthcare environment to address physical, comfort, orientation, and privacy factors) and four matched controls, supplemented with checklist and VA administrative data. A modified Perceived Hospital Environment Quality Indicators instrument was used to measure patients' EOC perceptions. RESULTS: Respondents (3,321/5,117; 65% response) rated, [mean (SD)], exterior space highest, 3.09 (0.73), followed by interior space, 2.96 (0.74), and privacy, 2.44 (1.01). COIs had significantly higher ratings than controls on interior space (2.99 vs. 2.96, p = .02) and privacy (2.48 vs. 2.38, p = .005) but no differences for exterior space. Subscales with significantly higher ratings in COIs (vs. controls) in interior space were "spatial-physical comfort" and "orientation," for example, clean, good signage, spacious rooms, and for privacy included "not too crowded" and "able to talk without being overheard." Checklist findings confirmed the presence of EOC innovations rated highly by patients. CONCLUSIONS: Patients identified cleanliness, good signs/information points, adequate seating, nonovercrowding, and privacy for conversations as important. Hospital design modifications, with particular attention to the physical environment, can improve patient EOC perceptions.

Health Information Seeking and Technology Use Among Veterans With Spinal Cord Injuries and Disorders.

BACKGROUND: Access to health information is crucial to persons living with a spinal cord injury or disorder (SCI/D). Although previous research has provided insights on computer and Internet use among persons with SCI/D, as well as how and where persons with SCI/D gather health information, few studies have focused on U.S. veterans with SCI/D. OBJECTIVE: To characterize health information seeking among veterans with SCI/D and to examine the association between technology use and the characteristics of veterans with SCI/D. DESIGN: Cross-sectional. SETTING: Veterans Health Administration (VHA). PARTICIPANTS: Sample of 290 veterans with SCI/D who utilize services at 2 VHA SCI/D Centers. METHODS: Postal mail survey. MAIN OUTCOME MEASUREMENTS: Extent of computer, Internet, and text messaging use, information source use, and e-Health literacy rates. RESULTS: The survey response rate was 38%. The majority of respondents were male (97.2%), younger than 65 years (71.0%), and white (71.7%). Of the respondents, 64.8% indicated that they use a computer, 62.9% reported use of the Internet, and 26.2% reported use of text messaging. The mean overall e-Health Literacy Scale score was 27.3 (standard deviation = 7.2). Similar to findings reported in studies focused outside the veteran population, the most frequent source that veterans turned to for information about SCI/D was a health professional (85.1%); this was also the most frequent source that veterans indicated they would turn to first to get information about SCI/D (75.9%). Other frequently reported sources of information included other persons with SCI/D (41.0%), Internet resources (31.0%), and family and friends (27.9%). CONCLUSIONS: Fairly high levels of computer and Internet use exist among veterans with SCI/D. Veterans with SCI/D also have a strong preference for people-particularly health professionals, and to a lesser extent peers and family and friends-as sources of information about SCI/D. These findings highlight the importance of combining technology and human interaction to meet the information needs of this population.

Provider perspectives on and experiences with engagement of patients and families in implementing patient-centered care.

OBJECTIVE: To study of the efforts of four Veterans Affairs (VA) medical centers to engage patients and families in patient-centered care (PCC) transformation. METHODS: Interviews with 107 providers/employees involved in implementation of PCC innovations. Coding used a mixed inductive-deductive approach. RESULTS: Patient and family engagement was considered to be a key element of the design and implementation of PCC innovations. Participants identified formal (e.g., advisory committees, walkthroughs), and informal (e.g., real-time feedback, discussions) methods of engaging patients and families. Asking patients and families what matters most shaped effective, targeted interventions. Participants noted providing a venue for patients and families to engage with planning often became an intervention itself. CONCLUSION: Participants felt that patient and family involvement were beneficial for planning and implementing PCC innovations. Patients and families offer a unique perspective and key understanding of Veterans' needs, and allow employees/providers to discover unexpected outcomes. Offering multiple engagement options maximizes patients and families involved and ensures feedback is sought from a variety of sources.

What is the extent and quality of documentation and reporting of fidelity to implementation strategies: a scoping review.

BACKGROUND: Implementation fidelity is critical to the internal and external validity of implementation research. Much of what is written about implementation fidelity addresses fidelity of evidence-informed interventions rather than fidelity of implementation strategies. The documentation and reporting of fidelity to implementation strategies requires attention. Therefore, in this scoping review, we identify the extent and quality of documentation and reporting of fidelity of implementation strategies that were used to implement evidence-informed interventions. METHODS: A six-stage methodological framework for scoping studies guided our work. Studies were identified from the outputs of the Effective Practice and Organization of Care (EPOC) review group within the Cochrane Database of Systematic Reviews. EPOC's primary focus, implementation strategies influencing provider behavior change, optimized our ability to identify articles for inclusion. We organized the retrieved articles from the systematic reviews by journal and selected the three journals with the largest number of retrieved articles. Using a data extraction tool, we organized retrieved article data from these three journals. In addition, we summarized implementation strategies using the EPOC categories. Data extraction pertaining to the quality of reporting the fidelity of implementation strategies was facilitated with an "Implementation Strategy Fidelity Checklist" based on definitions adapted from Dusenbury et al. We conducted inter-rater reliability checks for all of the independently scored articles. Using linear regression, we assessed the fidelity scores in relation to the publication year. RESULTS: Seventy-two implementation articles were included in the final analysis. Researchers reported neither fidelity definitions nor conceptual frameworks for fidelity in any articles. The most frequently employed implementation strategies included distribution of education materials (n = 35), audit and feedback (n = 32), and educational meetings (n = 25). Fidelity of implementation strategies was documented in 51 (71 %) articles. Inter-rater reliability coefficients of the independent reviews for each component of fidelity were as follows: adherence = 0.85, dose = 0.89, and participant responsiveness = 0.96. The mean fidelity score was 2.6 (SD = 2.25). We noted a statistically significant decline in fidelity scores over time. CONCLUSIONS: In addition to identifying the under-reporting of fidelity of implementation strategies in the health literature, we developed and tested a simple checklist to assess the reporting of fidelity of implementation strategies. More research is indicated to assess the definitions and scoring schema of this checklist. Careful reporting of details about fidelity of implementation strategies will make an important contribution to implementation science.