Implementing Whole Person Primary Care: Results from a Year-Long Learning Collaborative.

PURPOSE: The National Academies of Medicine report on Implementing High-Quality Primary Care calls for a transformation of the primary care to a "whole person" model that is person-centered, relationship-based and takes into account the social, spiritual, emotional and behavioral aspects of health. However, our current delivery tools, such as the SOAP Note, do not sufficiently capture and organize the delivery of these elements in practice. To explore how to remedy this, an Integrative Health Learning Collaborative (IHLC) was established to implement and test new tools for changing primary care practices toward whole person care. METHODS: The IHLC comprised primary care practices committed to changing to a whole person care model of care along with a panel of experts in integrative health and change management. The IHLC met virtually monthly. Representatives from each practice and an assigned expert met to strategize and adapt the tools to their environment and practice. The practices used previously developed tools (the HOPE Note toolkit), change management tools, and quality improvement techniques to introduce, implement, and evaluate the changes. RESULTS: Sixteen clinics completed the process after 1 year. Overall, practices used the HOPE Note tools in 942 patients. Participants reported changes on the effectiveness of the collaborative (1) on clinical practice, (2) on the skills and attitudes of participants; and (3) the support in change management. CONCLUSIONS: This online learning collaborative supported practices implementing a whole person care model in primary care and improved the understanding, skills, and delivery ability of whole person care in all clinics completing the program.

Breast Cancer Survivorship and Level of Institutional Involvement Utilizing Integrative Oncology.

OBJECTIVE: Integrative oncology is widely used by patients with breast cancer. This study aims to investigate the relationship between the survival outcomes of breast cancer patients and the level of involvement in integrative oncology at the institutions treating them. METHODS: Claims-based data were used to find 4,815 newly diagnosed breast cancer patients treated between January 2013 and December 2014 for survival analysis. A scoring system was developed by asking oncologists about their institutions' efforts to educate, support, and provide funding for 12 complementary and lifestyle approaches. Cohort analysis using two-tailed chi-square and a separate multivariate model using SMOTE and lasso regression were used. Nine variables across patient and institutional profiles were included. The model coefficients were exponentiated and presented as odds ratios. RESULTS: 173 patients mapped to 103 institutions and 103 oncologists. The median patient age was 51, and 8% were metastatic. Institutions were scored for integrative oncology involvement and placed into four cohorts. Low-scoring institutions showed less effort to educate, support, and provide integrative therapies compared to others. The 5-year survival of patients in the low cohort was directionally but not significantly lower than others. In the multivariate model, a composite integrative oncology score was shown to increase 5-year survival odds three times for institutions in the low-mid cohort and 48% in the mid-high, compared to the low. CONCLUSION: Crossing the threshold beyond 'low' involvement in integrative oncology represents a new path to incremental survival benefit for many cancer patients. Entities invested in the survival of breast cancer patients should increase education, access, and funding for a core set of six therapies: nutrition counselling, exercise counselling, patient support groups, spiritual services, meditation, and psycho-oncology support.

Addressing the Long COVID Crisis: Integrative Health and Long COVID.

While COVID-19 has killed millions of people globally, its lasting effects on the health and well-being of entire populations are just becoming clear. As many as 30% of those diagnosed with COVID-19 report continuing health-related problems, regardless of the severity of the initial infection. Given the infection rate in the world, that translates to between 5.4 and 17.9 million globally; about 700 000 in the US. The syndrome goes by many names; here we call it "long COVID." Patients experience a wide range of symptoms, including serious organ system effects such as pulmonary fibrosis, myocarditis, new diabetes diagnoses, stroke, and other cerebrovascular events. They also experience ongoing pain, fatigue, and cognitive dysfunction. We suggest here that these patients require an integrative health approach, one that combines traditional medical management, non-pharmacological approaches, and behavior and lifestyle changes. Such an approach has been shown to be beneficial in other chronic illnesses such as fibromyalgia, chronic fatigue syndrome, and post-Lyme disease.

The Case for Whole-Person Integrative Care.

Rationale: There is a need for medicine to deliver more whole-person care. This is a narrative review of several models of whole-person care and studies that illustrate the business case for whole-person models in primary care. Objectives: To provide an overview of what whole-person care models exist and explore evidence to support these models. Study Selection: Representative whole-person care models widely used in the United States are summarized and evaluated. Selected studies focused on outpatient primary care with examples from programs that integrate the delivery of conventional medical care, complementary and alternative medicine, and self-care within the context of social and cultural environments. Methods: Pubmed search conducted December 2020-February 2021. Two iterative searches using terms for "Whole Health Veterans Administration," "integrative medicine," "integrative health," "complementary and alternative medicine," and, as they related to the outcomes, of "health outcomes," "cost-effectiveness," "cost reduction," "patient satisfaction," and "physician satisfaction." Additional studies were identified from an initial search and the authors' experience of over 50 years. We looked for studies of whole-person care used in general primary care, those not using a single modality and only from United States practices. Results: A total of 125 (out of 1746) studies were found and met our inclusion criteria. We found that whole-person models of primary care exist, are quite heterogeneous in their approaches, and routinely report substantial benefits for improving the patient experience, clinical outcomes and in reducing costs. Conclusions: Evidence for the benefit of whole-person care models exist but definitions are quite heterogenous and unfocused. There is a need for more standardization of whole-person models and more research using whole systems approaches rather than reductionistic attempts using isolated components.

Human Nasal and Lung Tissues Infected Ex Vivo with SARS-CoV-2 Provide Insights into Differential Tissue-Specific and Virus-Specific Innate Immune Responses in the Upper and Lower Respiratory Tract.

The nasal mucosa constitutes the primary entry site for respiratory viruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). While the imbalanced innate immune response of end-stage coronavirus disease 2019 (COVID-19) has been extensively studied, the earliest stages of SARS-CoV-2 infection at the mucosal entry site have remained unexplored. Here, we employed SARS-CoV-2 and influenza virus infection in native multi-cell-type human nasal turbinate and lung tissues ex vivo, coupled with genome-wide transcriptional analysis, to investigate viral susceptibility and early patterns of local mucosal innate immune response in the authentic milieu of the human respiratory tract. SARS-CoV-2 productively infected the nasal turbinate tissues, predominantly targeting respiratory epithelial cells, with a rapid increase in tissue-associated viral subgenomic mRNA and secretion of infectious viral progeny. Importantly, SARS-CoV-2 infection triggered robust antiviral and inflammatory innate immune responses in the nasal mucosa. The upregulation of interferon-stimulated genes, cytokines, and chemokines, related to interferon signaling and immune-cell activation pathways, was broader than that triggered by influenza virus infection. Conversely, lung tissues exhibited a restricted innate immune response to SARS-CoV-2, with a conspicuous lack of type I and III interferon upregulation, contrasting with their vigorous innate immune response to influenza virus. Our findings reveal differential tissue-specific innate immune responses in the upper and lower respiratory tracts that are specific to SARS-CoV-2. The studies shed light on the role of the nasal mucosa in active viral transmission and immune defense, implying a window of opportunity for early interventions, whereas the restricted innate immune response in early-SARS-CoV-2-infected lung tissues could underlie the unique uncontrolled late-phase lung damage of advanced COVID-19. IMPORTANCE In order to reduce the late-phase morbidity and mortality of COVID-19, there is a need to better understand and target the earliest stages of SARS-CoV-2 infection in the human respiratory tract. Here, we have studied the initial steps of SARS-CoV-2 infection and the consequent innate immune responses within the natural multicellular complexity of human nasal mucosal and lung tissues. Comparing the global innate response patterns of nasal and lung tissues infected in parallel with SARS-CoV-2 and influenza virus, we found distinct virus-host interactions in the upper and lower respiratory tract, which could determine the outcome and unique pathogenesis of SARS-CoV-2 infection. Studies in the nasal mucosal infection model can be employed to assess the impact of viral evolutionary changes and evaluate new therapeutic and preventive measures against SARS-CoV-2 and other human respiratory pathogens.

A new model of care to return holism to family medicine.

Family medicine's leadership in primary care is slipping as it loses its vision of whole-person care. This model of care can help us better manage and combat chronic disease.

Human Nasal Turbinate Tissues in Organ Culture as a Model for Human Cytomegalovirus Infection at the Mucosal Entry Site.

The initial events of viral infection at the primary mucosal entry site following horizontal person-to-person transmission have remained ill defined. Our limited understanding is further underscored by the absence of animal models in the case of human-restricted viruses, such as human cytomegalovirus (HCMV), a leading cause of congenital infection and a major pathogen in immunocompromised individuals. Here, we established a novel ex vivo model of HCMV infection in native human nasal turbinate tissues. Nasal turbinate tissue viability and physiological functionality were preserved for at least 7 days in culture. We found that nasal mucosal tissues were susceptible to HCMV infection, with predominant infection of ciliated respiratory epithelial cells. A limited viral spread was demonstrated, involving mainly stromal and vascular endothelial cells within the tissue. Importantly, functional antiviral and proleukocyte chemotactic signaling pathways were significantly upregulated in the nasal mucosa in response to infection. Conversely, HCMV downregulated the expression of nasal epithelial cell-related genes. We further revealed tissue-specific innate immune response patterns to HCMV, comparing infected human nasal mucosal and placental tissues, representing the viral entry and the maternal-to-fetal transmission sites, respectively. Taken together, our studies provide insights into the earliest stages of HCMV infection. Studies in this model could help evaluate new interventions against the horizontal transmission of HCMV.IMPORTANCE HCMV is a ubiquitous human pathogen causing neurodevelopmental disabilities in congenitally infected children and severe disease in immunocompromised patients. The earliest stages of HCMV infection in the human host have remained elusive in the absence of a model for the viral entry site. Here, we describe the establishment and use of a novel nasal turbinate organ culture to study the initial steps of viral infection and the consequent innate immune responses within the natural complexity and the full cellular repertoire of human nasal mucosal tissues. This model can be applied to examine new antiviral interventions against the horizontal transmission of HCMV and potentially that of other viruses.

Greater Well-Being in More Physically Active Cancer Patients Who Are Enrolled in Supportive Care Services.

Background: Cancers are one of the leading causes of mortality worldwide. Cancer patients are increasingly seeking integrative care clinics to promote their health and well-being during and after treatment. Aim: To examine relationships between physical activity (PA) and quality of life (QoL) in a sample of cancer patients enrolling in integrative care in a supportive care clinic. Also, to explore circulating inflammatory biomarkers and heart rate variability (HRV) in relationship to PA and QoL. Methods: A cross-sectional design of adult patients who sought care in the InspireHealth clinic, Vancouver, British Columbia, Canada. Patients with complete PA data (n = 118) answered psychosocial questionnaires, provided blood samples, and received HRV recordings before enrollment. Patients were stratified into "less" versus "more" active groups according to PA guidelines (150 minutes of moderate or 75 minutes of vigorous PA or an equivalent combination). Results: Breast (33.1%) and prostate (10.2%) cancers were the most prevalent primary diagnoses. Patients engaging in more PA reported better physical (U = 1265.5, P = .013), functional (U = 1306.5, P = .024), and general QoL (U = 1341, P = .039), less fatigue (U = 1268, P = .014), fewer physical cancer-related symptoms (U = 2.338, P = .021), and less general distress (U = 2.061, P = .021). Between PA groups, type of primary cancer diagnosis differed (χ2 = 41.79, P = .014), while stages of cancer did not (χ2 = 3.95, P = .412). Fewer patients reported depressed mood within the more active group (χ2 = 6.131, P = .047). More active patients were also less likely to have ever used tobacco (χ2 = 7.41, P = .025) and used fewer nutritional supplements (χ2 = 39.74, P ≤ .001). An inflammatory biomarker index was negatively correlated with vigorous PA (rs = -0.215, P = .022). Multivariable linear regression (R2 = 0.71) revealed that age (ß = 0.22; P = .001), fatigue (ß = -0.43; P ≤ .001), anxiety (ß = -0.14; P = .048), and social support (ß = 0.38; P = .001) were significant correlates of QoL.

The Myth of the Placebo Response.

The placebo response is a myth. It does not exist in reality, and continuing to name it is hindering the optimal application of science to healing in medicine. On the surface, it is obvious that, when defined as a biological response to an inert pill (like a sugar pill), the idea of a "response" to a placebo is impossible. Inert treatments by definition do not produce responses. So why do we continue to ponder why people get better from taking inert substances and base our acceptance of legitimate treatments on demonstrating that they go beyond that response? The problem arises because we have flawed assumptions of the value that reductionistic science and the demonstration of specific effects has for healing. To support those flawed assumptions, we support the idea of "the placebo response." This causes confusion among patients, clinicians, regulators, and even scientists. Legitimate medical treatments have become defined as those that do more than produce a placebo response. An entire pharmaceutical industry and its regulators attempt to control and profit by proving that small molecules produce a clinical effect greater than the placebo response. Billions of dollars are made when that is proven, often even when the size of the response in the active over the placebo group is miniscule. The fact is people heal and that inherent healing capacity is both powerful and influenced by mental, social, and contextual factors that are embedded in every medical encounter since the idea of treatment began. In this chapter, I argue that our understanding of healing and ability to enhance it will be accelerated if we stop using the term "placebo response" and call it what it is-the meaning response, and its special application in medicine called the healing response.

Healing Veterans Requires Caring For The Whole Person.

A new, integrative approach to care is changing the way veteran and military health care is practiced.

Are Invasive Procedures Effective for Chronic Pain? A Systematic Review.

OBJECTIVE: To assess the evidence for the safety and efficacy of invasive procedures for reducing chronic pain and improving function and health-related quality of life compared with sham (placebo) procedures. DESIGN: Systematic review with meta-analysis. METHODS: Studies were identified by searching multiple electronic databases, examining reference lists, and communicating with experts. Randomized controlled trials comparing invasive procedures with identical but otherwise sham procedures for chronic pain conditions were selected. Three authors independently extracted and described study characteristics and assessed Cochrane risk of bias. Two subsets of data on back and knee pain, respectively, were pooled using random-effects meta-analysis. Overall quality of the literature was assessed through Grading of Recommendations, Assessment, Development, and Evaluation. RESULTS: Twenty-five trials (2,000 participants) were included in the review assessing the effect of invasive procedures over sham. Conditions included low back (N = 7 trials), arthritis (4), angina (4), abdominal pain (3), endometriosis (3), biliary colic (2), and migraine (2). Thirteen trials (52%) reported an adequate concealment of allocation. Fourteen studies (56%) reported on adverse events. Of these, the risk of any adverse event was significantly higher for invasive procedures (12%) than sham procedures (4%; risk difference = 0.05, 95% confidence interval [CI] = 0.01 to 0.09, P = 0.01, I2 = 65%). In the two meta-analysis subsets, the standardized mean difference for reduction of low back pain in seven studies (N = 445) was 0.18 (95% CI = -0.14 to 0.51, P = 0.26, I2 = 62%), and for knee pain in three studies (N = 496) it was 0.04 (95% CI = -0.11 to 0.19, P = 0.63, I2 = 36%). The relative contribution of within-group improvement in sham treatments accounted for 87% of the effect compared with active treatment across all conditions. CONCLUSIONS: There is little evidence for the specific efficacy beyond sham for invasive procedures in chronic pain. A moderate amount of evidence does not support the use of invasive procedures as compared with sham procedures for patients with chronic back or knee pain. Given their high cost and safety concerns, more rigorous studies are required before invasive procedures are routinely used for patients with chronic pain.

Evaluating Integrative Cancer Clinics With the Claim Assessment Profile: An Example With the InspireHealth Clinic.

BACKGROUND: The evaluation of freestanding integrative cancer clinical programs is challenging and is rarely done. We have developed an approach called the Claim Assessment Profile (CAP) to identify whether evaluation of a practice is justified, feasible, and likely to provide useful information. OBJECTIVES: A CAP was performed in order to (1) clarify the healing claims at InspireHealth, an integrative oncology treatment program, by defining the most important impacts on its clients; (2) gather information about current research capacity at the clinic; and (3) create a program theory and path model for use in prospective research. STUDY DESIGN/METHODS: This case study design incorporates methods from a variety of rapid assessment approaches. Procedures included site visits to observe the program, structured qualitative interviews with 26 providers and staff, surveys to capture descriptive data about the program, and observational data on program implementation. RESULTS: The InspireHealth program is a well-established, multi-site, thriving integrative oncology clinical practice that focuses on patient support, motivation, and health behavior engagement. It delivers patient-centered care via a standardized treatment protocol. There arehigh levels of research interest from staff and resources by which to conduct research. CONCLUSIONS: This analysis provides the primary descriptive and claims clarification of an integrative oncology treatment program, an evaluation readiness report, a detailed logic model explicating program theory, and a clinical outcomes path model for conducting prospective research. Prospective evaluation of this program would be feasible and valuable, adding to our knowledge base of integrative cancer therapies.

Claim Assessment Profile: A Method for Capturing Healthcare Evidence in the Scientific Evaluation and Review of Claims in Health Care (SEaRCH).

BACKGROUND: Grounding health claims in an evidence base is essential for determining safety and effectiveness. However, it is not appropriate to evaluate all healthcare claims with the same methods. "Gold standard" randomized controlled trials may skip over important qualitative and observational data about use, benefits, side effects, and preferences, issues especially salient in research on complementary and integrative health (CIH) practices. This gap has prompted a move toward studying treatments in their naturalistic settings. In the 1990s, a program initiated under the National Institutes of Health was designed to provide an outreach to CIH practices for assessing the feasibility of conducting retrospective or prospective evaluations. The Claim Assessment Profile further develops this approach, within the framework of Samueli Institute's Scientific Evaluation and Review of Claims in Health Care (SEaRCH) method. METHODS/DESIGN: The goals of a Claim Assessment Profile are to clarify the elements that constitute a practice, define key outcomes, and create an explanatory model of these impacts. The main objective is to determine readiness and capacity of a practice to engage in evaluation of effectiveness. This approach is informed by a variety of rapid assessment and stakeholder-driven methods. Site visits, structured qualitative interviews, surveys, and observational data on implementation provide descriptive data about the practice. Logic modeling defines inputs, processes, and outcome variables; Path modeling defines an analytic map to explore. DISCUSSION: The Claim Assessment Profile is a rapid assessment of the evaluability of a healthcare practice. The method was developed for use on CIH practices but has also been applied in resilience research and may be applied beyond the healthcare sector. Findings are meant to provide sufficient data to improve decision-making for stakeholders. This method provides an important first step for moving existing promising yet untested practices into comprehensive evaluation.

Scientific Evaluation and Review of Claims in Health Care (SEaRCH): A Streamlined, Systematic, Phased Approach for Determining "What Works" in Healthcare.

BACKGROUND: Answering the question of "what works" in healthcare can be complex and requires the careful design and sequential application of systematic methodologies. Over the last decade, the Samueli Institute has, along with multiple partners, developed a streamlined, systematic, phased approach to this process called the Scientific Evaluation and Review of Claims in Health Care (SEaRCH™). The SEaRCH process provides an approach for rigorously, efficiently, and transparently making evidence-based decisions about healthcare claims in research and practice with minimal bias. METHODS: SEaRCH uses three methods combined in a coordinated fashion to help determine what works in healthcare. The first, the Claims Assessment Profile (CAP), seeks to clarify the healthcare claim and question, and its ability to be evaluated in the context of its delivery. The second method, the Rapid Evidence Assessment of the Literature (REAL©), is a streamlined, systematic review process conducted to determine the quantity, quality, and strength of evidence and risk/benefit for the treatment. The third method involves the structured use of expert panels (EPs). There are several types of EPs, depending on the purpose and need. Together, these three methods-CAP, REAL, and EP-can be integrated into a strategic approach to help answer the question "what works in healthcare?" and what it means in a comprehensive way. DISCUSSION: SEaRCH is a systematic, rigorous approach for evaluating healthcare claims of therapies, practices, programs, or products in an efficient and stepwise fashion. It provides an iterative, protocol-driven process that is customized to the intervention, consumer, and context. Multiple communities, including those involved in health service and policy, can benefit from this organized framework, assuring that evidence-based principles determine which healthcare practices with the greatest promise are used for improving the public's health and wellness.