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Rationale: Shared decision-making (SDM) for lung cancer screening (LCS) is recommended in guidelines and required by Medicare, yet it is seldom achieved in practice. The best approach for implementing SDM for LCS remains unknown, and the 2021 U.S. Preventive Services Task Force calls for implementation research to increase uptake of SDM for LCS. Objectives: To develop a stakeholder-prioritized research agenda and recommended outcomes to advance implementation of SDM for LCS. Methods: The American Thoracic Society and VA Health Services Research and Development Service convened a multistakeholder committee with expertise in SDM, LCS, patient-centered care, and implementation science. During a virtual State of the Art conference, we reviewed evidence and identified research questions to address barriers to implementing SDM for LCS, as well as outcome constructs, which were refined by writing group members. Our committee (n = 34) then ranked research questions and SDM effectiveness outcomes by perceived importance in an online survey. Results: We present our committee's consensus on three topics important to implementing SDM for LCS: 1) foundational principles for the best practice of SDM for LCS; 2) stakeholder rankings of 22 implementation research questions; and 3) recommended outcomes, including Proctor's implementation outcomes and stakeholder rankings of SDM effectiveness outcomes for hybrid implementation-effectiveness studies. Our committee ranked questions that apply innovative implementation approaches to relieve primary care providers of the sole responsibility of SDM for LCS as highest priority. We rated effectiveness constructs that capture the patient experience of SDM as most important. Conclusions: This statement offers a stakeholder-prioritized research agenda and outcomes to advance implementation of SDM for LCS. [ABSTRACT FROM AUTHOR]

Background Clostridium difficile is a pathogen of rapidly increasing public health importance. An estimated quarter of a million Clostridium difficile infections (CDI) occur in the United States annually, at a resultant cost of 14,000 deaths and 1 billion dollars. Clostridium difficile related deaths have risen 400% over the last decade, and current standard antibiotic treatments are only 75 to 85% successful. Besides increasing the risk of antibiotic resistance and side effects, these treatments are very expensive. The most vulnerable population for Clostridium difficile is older adults, who make up approximately half of the cases, but account for 90% of the related deaths. Probiotics may have potential as adjunctive therapeutic agents for CDIs, however, current data is limited. Methods This pilot study is a single-site, randomized, placebo-controlled, double-blind, phase two clinical trial. The trial primarily evaluates the effect of four weeks of probiotic therapy in addition to standard of care on Clostridium difficile diarrhea duration and recurrence. Secondary outcomes include effect on fecal cytokines, fecal lactoferrin, and Clostridium difficile toxin density in stool, as well as patient functional status. Discussion This pilot study will determine the feasibility and effect size to conduct larger randomized controlled trials of probiotic interventions in patients with CDI, to determine the impact of probiotics on the symptoms of CDI. ClinicalTrials.gov Identifier: NCT01680874 [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Since access to high-quality human biospecimens is a critical resource to support genomic- and proteomic-base studies, the NCI established the Office of Biorepositories and Biospecimen Research (OBBR) to coordinate biospecimen research-related policies and practices. The NCI Biospecimen Research Network (BRN) of the OBBR is conducting bimolecular studies for the development of data-driven, evidence-based protocols for various specimen types and molecular analysis platforms. Two current projects examine the effects of pre-analytical variables on downstream gene expression. The first project examines the effect of intra-operative ischemic times-from 20 to 50 minutes on gene expression profiles in colon cancer tissues. Tissue samples were microdissected, RNA purified, and quantity/quality determined. After RNA amplification and labeling, differential gene expression for ischemia were determined using Affymetrix Human Genome U133 GeneChips. Genes differentially expressed will be validated using quantitative RT-PCR. The second project compares histology and recovery of RNA for frozen, FineFix-fixed, paraffin-embedded (FiFPE), ethanol-fixed, paraffin-embedded (EFPE), and formalin-fixed, paraffin-embedded (FFPE) kidney and prostate tissue. Histological quality is comparable for FiFPE, EFPE, and FFPE tissue and is superior to frozen tissue. By RT-PCR for beta actin, RNA recovery is comparable for frozen and FiPE and are both superior to EFPE and FFPE. RNA recovery will be further assessed by qRT-PCR for cyclophilin A, beta actin, HPRT, and GAPDH. [ABSTRACT FROM AUTHOR]

We are in the midst of a technological revolution that is providing new insights into human biology and cancer. In this era of big data, we are amassing large amounts of information that is transforming how we approach cancer treatment and prevention. Enactment of the Cancer Moonshot within the 21st Century Cures Act in the USA arrived at a propitious moment in the advancement of knowledge, providing nearly US$2 billion of funding for cancer research and precision medicine. In 2016, the Blue Ribbon Panel (BRP) set out a roadmap of recommendations designed to exploit new advances in cancer diagnosis, prevention, and treatment. Those recommendations provided a high-level view of how to accelerate the conversion of new scientific discoveries into effective treatments and prevention for cancer. The US National Cancer Institute is already implementing some of those recommendations. As experts in the priority areas identified by the BRP, we bolster those recommendations to implement this important scientific roadmap. In this Commission, we examine the BRP recommendations in greater detail and expand the discussion to include additional priority areas, including surgical oncology, radiation oncology, imaging, health systems and health disparities, regulation and financing, population science, and oncopolicy. We prioritise areas of research in the USA that we believe would accelerate efforts to benefit patients with cancer. Finally, we hope the recommendations in this report will facilitate new international collaborations to further enhance global efforts in cancer control. [ABSTRACT FROM AUTHOR]

Background: Whole Health (WH) is a patient-centered model of care being implemented by the Veterans Health Administration. Little is known about how use of WH services impacts patients' health and well-being., Objective: We sought to assess the association of WH utilization with pain and other patient-reported outcomes (PRO) over 6 months., Design: A longitudinal observational cohort evaluation, comparing changes in PRO surveys for WH users and Conventional Care (CC) users. Inverse probability of treatment weighting was used to balance the two groups on observed demographic and clinical characteristics., Participants: A total of 9689 veterans receiving outpatient care at 18 VA medical centers piloting WH., Interventions: WH services included goal-setting clinical encounters, Whole Health coaching, personal health planning, and well-being services., Main Outcome Measures: The primary outcome was change in pain intensity and interference at 6 months using the 3-item PEG. Secondary outcomes included satisfaction, experiences of care, patient engagement in healthcare, and well-being., Key Results: By 6 months,1053 veterans had utilized WH and 3139 utilized only CC. Baseline pain PEG scores were 6.2 (2.5) for WH users and 6.4 (2.3) for CC users (difference p = 0.028), improving by - 2.4% (p = 0.006) and - 2.3% (p < 0.001), respectively. In adjusted analyses, WH use was unassociated with greater improvement in PEG scores compared to CC - 1.0% (- 2.9%, 1.2%). Positive trends were observed for 8 of 15 exploratory outcomes for WH compared to CC. WH use was associated with greater improvements at 6 months in likelihood to recommend VA 2.0% (0.9%, 3.3%); discussions of goals 11.8% (8.2%, 15.5%); perceptions of healthcare interactions 2.5% (0.4%, 4.6%); and engagement in health behaviors 2.2% (0.3%, 3.9%)., Conclusion: This study provides early evidence supporting the delivery of WH patient-centered care services to improve veterans' experiences of and engagement in care. These are important first-line impacts towards the goals of better overall health and well-being outcomes for Veterans., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Background: Shared Decision-Making to discuss how the benefits and harms of lung cancer screening align with patient values is required by the US Centers for Medicare and Medicaid and recommended by multiple organizations. Barriers at organizational, clinician, clinical encounter, and patient levels prevent SDM from meeting quality standards in routine practice. We developed an implementation plan, using the socio-ecological model, for Shared Decision-Making for lung cancer screening for the Department of Veterans Affairs (VA) New England Healthcare System. Because understanding the local context is critical to implementation success, we sought to proactively tailor our original implementation plan, to address barriers to achieving guideline-concordant lung cancer screening., Methods: We conducted a formative evaluation using an ethnographic approach to proactively identify barriers to Shared Decision-Making and tailor our implementation plan. Data consisted of qualitative interviews with leadership and clinicians from seven VA New England medical centers, regional meeting notes, and Shared Decision-Making scripts and documents used by providers. Tailoring was guided by the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS)., Results: We tailored the original implementation plan to address barriers we identified at the organizational, clinician, clinical encounter, and patient levels. Overall, we removed two implementation strategies, added five strategies, and modified the content of two strategies. For example, at the clinician level, we learned that past personal and clinical experiences predisposed clinicians to focus on the benefits of lung cancer screening. To address this barrier, we modified the content of our original implementation strategy Make Training Dynamic to prompt providers to self-reflect about their screening beliefs and values, encouraging them to discuss both the benefits and potential harms of lung cancer screening., Conclusions: Formative evaluations can be used to proactively tailor implementation strategies to fit local contexts. We tailored our implementation plan to address unique barriers we identified, with the goal of improving implementation success. The FRAME-IS aided our team in thoughtfully addressing and modifying our original implementation plan. Others seeking to maximize the effectiveness of complex interventions may consider using a similar approach., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Background: Engagement in evidence-based psychotherapy (EBP) among veterans with behavioral health conditions is often low. The Veterans Health Administration (VHA) is implementing a "Whole Health (WH)" system of care, to identify veteran personal health goals, align care with those goals, and offer services designed to engage and empower veterans to achieve well-being., Objective: To examine the relationship between veteran WH utilization and subsequent engagement in EBP., Design: Retrospective analysis of VHA administrative records from 18 facilities implementing WH., Subjects: Veterans (n = 265,364) with a diagnosis of depression, post-traumatic stress disorder (PTSD), and/or anxiety who had a mental healthcare encounter but no EBP use in fiscal year (FY) 2018. Among this cohort, 33,146 (12.5%) began using WH in FY2019., Main Measures: We examined use of an EBP for depression, anxiety, and/or PTSD within 1 year of the index date of WH use compared to use of an EBP anytime during FY2019 for veterans not identified as using WH. We used multiple logistic regression to examine the association between veteran WH use and EBP engagement., Key Results: Approximately 3.0% (n = 7,860) of the veterans in our overall cohort engaged in an EBP in the year following their index date. Controlling for key demographic, health, and utilization variables, WH users had 2.4 (95% CI: 2.2-2.5) times higher odds of engaging in an EBP the following year than those with no WH utilization. Associations between utilization of specific WH services (vs. no utilization of that service) and engagement in an EBP in the subsequent year ranged from 1.6 (95% CI: 1.0-2.6) to 3.5 (95% CI: 3.2-3.9) across the different types of WH services used., Conclusions: WH use was associated with increased engagement in EBPs among veterans with depression, anxiety, and/or PTSD. Future interventions intended to promote veteran engagement in EBPs may benefit from leveraging WH services and therapies., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Background: The Veterans Health Administration (VHA) is building a Whole Health system of care that aspires to empower and equip each Veteran to pursue a personally meaningful vision of health and well-being. As part of this effort, VHA has developed Taking Charge of My Life and Health (TCMLH), a peer-led, group-based programme that seeks to support Veterans in setting and pursuing health and well-being goals. Prior research showed TCMLH groups to positively impact Veteran outcomes; yet, little is known about Veterans' own experiences and perspectives., Methods: We completed semi-structured telephone interviews with 15 Veterans across 8 sites who had participated in TCMLH groups offered by the VHA in the virtual format between Summer 2020 and Fall 2021. Inductive thematic analysis was applied to interview transcripts to generate themes., Findings: We identified five themes regarding Veterans' experiences with TCMLH: (1) navigating the virtual format; (2) internalizing the value of health engagement; (3) making healthy lifestyle changes; (4) forging social connections; and (5) taking on a more active role in healthcare., Conclusion: Veterans perceived virtual TCMLH groups as meaningful and beneficial, yet also highlighted several challenges. Their perspectives speak to the need to supplement time-limited programmes like TCMLH with ongoing, community-based support. Virtual group-based well-being programmes are a promising innovation. Other healthcare systems may draw on VHA's experience while tailoring format and content to the needs of their patient populations., Patient or Public Contribution: Veterans were involved as evaluation participants. A Veteran consultant, who is a coauthor on this paper, was engaged through the conceptualization of the evaluation, development of data collection materials (interview guide) and writing., (© 2022 Published 2022. This article is a U.S. Government work and is in the public domain in the USA. Health Expectations published by John Wiley & Sons Ltd.)

Objective: To describe how a partnered evaluation of the Whole Health (WH) system of care-comprised of the WH pathway, clinical care, and well-being programs-produced patient outcomes findings, which informed Veterans Health Administration (VA) policy and system change., Data Sources: Electronic health records (EHR)-based cohort of 1,368,413 patients and a longitudinal survey of Veterans receiving care at 18 WH pilot medical centers., Study Design: In partnership with VA operations, we focused the evaluation on the impact of WH services utilization on Veterans' (1) use of opioids and (2) care experiences, care engagement, and well-being. Outcomes were compared between Veterans who did and did not use WH services identified from the EHR., Data Collection: Pharmacy records and WH service data were obtained from the VA EHR, including WH coaching, peer-led groups, personal health planning, and complementary, integrative health therapies. We surveyed veterans at baseline and 6 months to measure patient-reported outcomes., Principal Findings: Opioid use decreased 23% (31.5-6.5) to 38% (60.3-14.4) among WH users depending on level of WH use compared to a secular 11% (12.0-9.9) decrease among Veterans using Conventional Care. Compared to Conventional Care users, WH users reported greater improvements in perceptions of care (SMD = 0.138), engagement in health care (SMD = 0.118) and self-care (SMD = 0.1), life meaning and purpose (SMD = 0.152), pain (SMD = 0.025), and perceived stress (SMD = 0.191)., Conclusions: Evidence developed through this partnership yielded key VA policy changes to increase Veteran access to WH services. Findings formed the foundation of a congressionally mandated report in response to the Comprehensive Addiction and Recovery Act, highlighting the value of WH and complementary, integrative health and well-being programs for Veterans with pain. Findings subsequently informed issuance of an Executive Decision Memo mandating the integration of WH into mental health and primary care across VA, now one lane of modernization for VA., (Published 2022. This article is a U.S. Government work and is in the public domain in the USA.)

Objectives: Veterans often suffer from multiple chronic illnesses, including mental health disorders, diabetes, obesity, and cardiovascular disease. The improvement of engagement in their own health care is critical for enhanced well-being and overall health. Peer-led group programs may be an important tool to provide support and skill development. We conducted a pilot study to explore the impact of a peer-led group-based program that teaches Veterans to become empowered to engage in their own health and well-being through mindful awareness practices, self-care strategies, and setting life goals. Design: Surveys were collected before and immediately after participation in the Taking Charge of My Life and Health (TCMLH) peer-led group program. Settings/location: Sessions were held in non-clinical settings within a VA medical center in the Midwest. Subjects: Our sample comprised 48 Veteran participants who were enrolled in TCMLH and completed a pretest and post-test survey. Intervention: TCMLH is a 9-week peer-led group program with an established curriculum that leverages the power of peer support to improve patient engagement, empowerment, health, and well-being among Veterans through Whole Health concepts, tools, and strategies. Programs were led by 1 of 12 trained Veteran peer facilitators. Outcome measures: Program impact on Veteran well-being was assessed by pre-post measures, including the Patient Activation Measure (PAM), the Perceived Stress Scale (PSS), the Patient-Reported Outcomes Measurement Information System Scale (PROMIS-10), the Perceived Health Competency Scale (PHCS), and the Life Engagement Test (LET). Results: There was a significant decrease in perceived stress (PSS score). Significant improvements were also seen in mental health and quality of life (PROMIS-10), participant accordance with the statement "I have a lot of reasons for living" (LET), and patient engagement (PAM score). Conclusions: As the Whole Health movement expands-both in VA and elsewhere-our findings suggest that guiding patients in an exploration of their personal values and life goals can help in key areas of patient engagement and mental and physical health outcomes. Further study is warranted, and expansion of the TCMLH program will allow for a more rigorous evaluation with a larger sample size.

Background: Nurse contributions to patient-centered care in primary care clinics are all but ignored in standard patient experience surveys., Purpose: The purpose was to conduct a pilot study to develop and psychometrically assess a scale measuring nurses' and other providers' patient-centered care in Veteran Affairs primary care clinics., Method: We developed a patient experience survey composed of original items and previous studies' items and scales. The survey was field tested online with patients who had a recent clinic appointment. The nonrandom analytic sample comprised 221 patients., Results: Exploratory factor analyses yielded a 36-item, 4-factor solution explaining 76% of the variance. The factors were: (1) Provider Knowing the Person/Individualizing Care (18 items; α = 0.98); (2) Nurse Knowing the Person (8; 0.95); (3) Nurse Individualizing Care (7; 0.94); and (4) Continuity of Care (3; not calculated). A short form with 23 items was created using stepwise regression. It had the same 4 factors as the long form with 76% of the variance explained., Conclusions: Patients reported distinctive nurse contributions that have not been routinely measured.

Background: Percutaneous coronary intervention (PCI) is a common cardiac procedure used to treat obstructive coronary artery disease. Patient-centred care is a priority in cardiovascular health having been shown to increase patient satisfaction, engagement with rehabilitation activities and reduce anxiety. Evidence indicates that patient-centred care is best achieved by routine collection of patient-reported outcomes (PROs). However, existing patient-reported outcome measures (PROMs) have limited the patient involvement in their development., Aims: To identify and explore outcomes, patients perceive as important following PCI., Methods: A qualitative design was adopted. Eight focus groups and five semi-structured interviews were conducted with 32 patients who had undergone PCI in the previous 6 months. Outcomes were identified and mapped under the U.S. Food and Drug Administration (FDA) patient-reported outcome (PROs) domains of feeling (physical and psychological outcomes), function and evaluation. Inductive and deductive analysis methods were used with open, axial and thematic coding., Results: Consistent with prior studies, patients identified feeling and function outcomes such as reductions in physical and psychological symptoms and the ability to perform usual activities as important. Participants also identified a range of new outcomes, including confidence to return to usual activities and evaluation domains such as adverse effects of medications and the importance of patient communication., Conclusion: The findings of this research should be considered in the design of a cardiac PROM for PCI patients. A PROM which adequately assesses these outcomes can provide clinicians and hospital staff with a foundation in which to address these concerns or symptoms., (© 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.)

Nanotechnology is a 'disruptive technology', which can lead to a generation of new diagnostic and therapeutic products, resulting in dramatically improved cancer outcomes. The National Cancer Institute (NCI) of National Institutes of Health explores innovative approaches to multidisciplinary research allowing for a convergence of molecular biology, oncology, physics, chemistry, and engineering and leading to the development of clinically worthy technological approaches. These initiatives include programmatic efforts to enable nanotechnology as a driver of advances in clinical oncology and cancer research, known collectively as the NCI Alliance for Nanotechnology in Cancer (ANC). Over the last 5 years, ANC has demonstrated that multidisciplinary approach catalyzes scientific developments and advances clinical translation in cancer nanotechnology. The research conducted by ANC members has improved diagnostic assays and imaging agents, leading to the development of point-of-care diagnostics, identification and validation of numerous biomarkers for novel diagnostic assays, and the development of multifunctional agents for imaging and therapy. Numerous nanotechnology-based technologies developed by ANC researchers are entering clinical trials. NCI has re-issued ANC program for next 5 years signaling that it continues to have high expectations for cancer nanotechnology's impact on clinical practice. The goals of the next phase will be to broaden access to cancer nanotechnology research through greater clinical translation and outreach to the patient and clinical communities and to support development of entirely new models of cancer care.