EP4218027A1

EP4218027A1 - Viable patient health systems

Info

Publication number: EP4218027A1
Application number: EP20953180.5A
Authority: EP
Inventors: Laura TREMBLAY
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-09-11
Filing date: 2020-09-11
Publication date: 2023-08-02
Also published as: WO2022053853A1; EP4218027A4; CA3197493A1

Abstract

Attempts to create health system sustainability have failed to offset continually rising fiscal pressures, let alone create health system viability. Viable patient health systems comprise sustained, evenly counterbalanced upstream and downstream health system components and operations within an entire primary health care continuum; where patient wellness is a powerful link between that built upstream and used sparingly, downstream. Standardized quantification of patient wellness, informs accurate health measurement in economic evaluations of health interventions, including appropriate technology interventions. Equal patient access upstream and downstream, enables equal access to wellness reserves in both directions, supporting sustained maintenance of patient health system viability. Coordinated, linked networks upstream and downstream, facilitate improved social determinants of health, particularly within vulnerable, marginalized populations, a crucial common factor in jurisdictions that use viable patient health systems; wherein economic patterns in health and non health sectors are regularly monitored and evaluated, informing partnered economies.

Description

Non-Provisional International Patent Application under the Patent Cooperation Treaty for

VIABLE PATIENT HEALTH SYSTEMS by

Inventor: Laura Johanne Tremblay

This patent document contains material which is subject to copyright protection: the copyright owner, Laura Johanne Tremblay, has no objection to the reproduction of the patent document or the patent disclosure by respective Intellectual Property Offices, as it appears in respective Intellectual Property Offices’ files or records, but otherwise reserves all copyright rights whatsoever. Requests for permission to copy this patent application in whole or part may be addressed to: Laura J. Tremblay at 374 Candle Crescent, Saskatoon, SK S7K 5A6, CANADA.

Request is made by applicant Laura Johanne Tremblay for grant of every kind of protection available in a patent or patents for the invention titled VIABLE PATIENT HEALTH SYSTEMS, for which an exclusive privilege and property is claimed by its sole inventor, Laura Johanne Tremblay.

Laura Johanne Tremblay is entitled to apply for and be granted a patent by virtue of the following: Laura Johanne Tremblay is the inventor of the subject matter for which protection is sought by way of this application; there are no co-inventors to VIABLE PATIENT HEALTH SYSTEMS, defined by claims on pages 69 to 86 of this application, wherein claims of VIABLE PATIENT HEALTH SYSTEMS were conceived entirely and solely by Laura Johanne Tremblay.

VIABLE PATIENT HEALTH SYSTEMS

DESCRIPTION Table of Contents

Title, Inventor, Copyright, Request, Statement of Entitlement, Description 1

Table of Contents 2

Glossary 5

Background 13

Prior Art, Related Application Data 16

Methodology of Systematic Review Science 19

Viable Patient Health Systems Summary 20

Viable Patient Health Systems 22

I. Balance Between Upstream and Downstream in PHC Continuum 22

1. Patient First in Upstream Development 22

2. Health Economic Evaluations 23

2.1 QALYs and DALYs in CEAs of Interventions 23

2.2 Health Market in Traditional Healthcare Systems 24

2.3 Health Market in Novel Patient Health Systems 25

2.4 Unique to the New Health Market 25

2.5 Two Paradigms Used in Economic Evaluations 27

3. Value of Wellness: Intrinsic, Retrospective, and Prospective 28

3.1 Intrinsic and Retrospective 28

3.2 Prospective 28

3.3 Wellness Metric within QALYs 29

4. Economic Evaluations Across Jurisdictions 30

II. Maintenance of Even Counterbalance 30

1. Introduction: Immunology, Pharmacology, and Biochemistry Perspectives 30

1.1 Immunology Perspectives 31

1.1.1 Context within Modern Research 31

1.2 Pharmacology Perspectives 32

1.3 B iochemistry Perspectives 32

1.3.1 Future Contexts 33

2. Patients’ Best Interests within Our Living Systems 34

2.1 Axiom in the Molecular Logic of the Living State 34

3. Upstream Attention Relative to Regulation of Cell Metabolism 35 4. Gross Domestic Product (GDP) Production Boundary 36

5. Upstream Attention Balanced with Downstream Demands 37

6. Balance Maintained Creates Viability 37

7. Capacity to Self-Sustain 37

7.1 Wellness Metric in Capacity to Self-Sustain 38

8. Viability within an Entire PHC Continuum 39

9. Social Determinants of Health (SDOH) 43

9.1 Economic Growth 43

9.2 Economic Efficiency 43

9.3 Structural Problems versus Structural Solutions 44

10. Vulnerable, Marginalized Individuals and Populations 44

10.1 Positive Return 45

10.2 Improved Social Determinants of Health (SDOH) 45

10.3 Capacity -Building and Positive Domino Effect 46

III. Appropriate Technology (AT) Embodied in the NP Role 47

1. Patients’ Best Interests for Dominant Strategy of AT Interventions 47

1.1 NP Role Embodies Appropriate Technology (AT) 47

1.2 Historical Research Context 49

1.3 Data Management at Micro and Macro Levels 49

IV. Cost 51

1. Threefold Cost Savings Synergistically Alleviate Downstream Crisis 51

2. Development of Decision Analytical Models for Economic Evaluation 53

2.1 Societal Perspective in Cost-Effectiveness Analyses (CEAs) 53

2.2 Decision Analytical Models Built for Viable Patient Health Systems 55

V. International Systems 55

1. Broad Gauges of Growth 55

2. Informatics 56

3. Developed Countries 57

4. Stateless Populations 60

VI. Global Systems 60

1. Partnerships Built Upon Harmonized International Standards 60

1.1 Indonesia and Canada: Integrated Development of Improved SDOH 61 1.2 Long Term Strategy 61

VII. Meta- Analysis (MA) and Network Meta- Analysis (NMA) 62

VIII. Concluding Remarks 65

Claims 69

Abstract 87

Glossary

Preventive Healthcare - to hinder the occurrence of an illness or to decrease the incidence of a disease; reducing risks or threats to health.

Primary (1°) Prevention - aims to prevent disease or injury before it ever occurs, by preventing exposures to hazards that cause disease or injury, altering unhealthy or unsafe behaviors that can lead to disease or injury, and increasing resistance to disease or injury should exposure occur (examples: legislation of healthy practices such as immunization, use of seatbelts).

Secondary (2°) Prevention - aims to reduce the impact of a disease or injury that has already occurred, by detecting and treating disease or injury as soon as possible, to halt or slow its progress (examples: screening tests to detect disease in its earliest stage; glycated hemoglobin Ale blood tests to assess pre-diabetes / diabetes; diet and exercise programs to prevent further heart attacks or strokes).

Tertiary (3°) Prevention - aims to soften the impact of an ongoing illness or injury that has lasting effects, by helping people manage long-term, often complex health problems and injuries (examples: management of chronic diseases, permanent impairments).

Distinction Between Primary Health Care and Primary Care

Primary Health Care (PHC) - essential health care based on practical, scientifically sound and socially acceptable methods and technology, made universally accessible to individuals and families in the community through their full participation and at a cost that the community and country can afford to maintain at every stage of their development, in the spirit of self-reliance and self-determination

• five principles of PHC include: appropriate technology, health promotion, accessibility, public participation, and intersectoral cooperation

• recognizes the systemic significance of social determinants of health

• a basic level of health care that includes programs directed at the promotion of health, prevention of disease, and early diagnosis of disease or disability, provided in an ambulatory facility to people often living in a particular geographic area. Primary Care - first contact care that leads to a course of action to resolve a health problem; illness oriented, and may include preventive, curative, and rehabilitative care; focuses on services often provided by a physician, but may be provided by a nurse, and may include emergency room visits; a narrow component of the broader concept of primary health care.

Patient - a recipient of a health care service that may involve collaborative client relations at either an individual or group (family, community) level, within any health care setting.

Vulnerable Population - a group of individuals carrying various degrees of inability to anticipate, cope with, resist and recover from impacts of disasters; susceptible to disease, injury, or premature death.

Appropriate Technology (AT) - modes of care that are appropriately adapted to the community’s social, economic and cultural development; as alternatives to high technology, high cost services, through innovative models of health care that disseminate research results, for improved knowledge and ongoing capacity-building to the design and delivery of health care services.

Health Promotion - the process of enabling people to increase their control over their health, and improve their health.

Upstream Health System Components - primary (1°) disease prevention and health promotion strategies, activities, patient services, interventions, patient outcomes, and infrastructure, including digital infrastructure; structures typically occur in primary clinic care and community care settings.

Upstream Health System Operations - functional upstream health system components: primary (1°) disease prevention and health promotion strategies, activities, patient services, interventions, patient outcomes, and infrastructure, including digital infrastructure. (© Tremblay LJ. 2020)

Downstream Health System Components - secondary (2°) disease prevention and tertiary (3°) disease prevention strategies, activities, patient services, interventions, patient outcomes, and infrastructure, including digital infrastructure; structures typically occur in specialized referral / outpatient clinic care, emergency department / acute inpatient care, and long term care settings.

(© Tremblay LJ. 2020) Downstream Health System Operations - functional downstream health system components: secondary (2°) disease prevention and tertiary (3°) disease prevention strategies, activities, patient services, interventions, patient outcomes, and infrastructure, including digital infrastructure.

Primary Health Care (PHC) Continuum - the totality of all upstream and downstream health system components and operations. (© Tremblay LJ. 2020)

Social Determinants of Health (SDOH) - the social and economic factors that influence people's health throughout an entire PHC continuum: healthy child development; gender; culture; physical environments (example: housing); food security; personal health practices and coping skills; social environments; socioeconomic status; education; employment and working conditions; access to health services; and social support networks.

Primary Clinic Care - comprehensive, non-specialist patient care that includes wellness development, in a clinic or other ambulatory care facility. (© Tremblay LJ. 2020)

Long Term Care - provision of medical, social, and personal care services on a recurring or continuing basis to persons with chronic physical or mental disorders, in environments ranging from institutions to private homes, for patients of all age groups.

Specialized Referral / Outpatient Clinic Care - illness treatment of a patient not admitted overnight to a hospital or other healthcare facility, in a clinic or other ambulatory care facility.

Emergency Department (ED) / Acute Inpatient Care - illness treatment in a hospital or other healthcare facility; inpatient care requires patient admission to a hospital or other healthcare facility for at least an overnight stay.

Nurse Practitioner (NP) - Registered Nurse (RN) with additional educational preparation and experience who possesses and demonstrates the competencies to autonomously diagnose, order and interpret diagnostic tests, prescribe pharmaceuticals and perform specific procedures within their legislated scope of practice.

Health - state of complete physical, mental, and social wellbeing and not merely absence of disease; a fundamental human right. Wellness - a dynamic process of progress toward maximizing an individual’s potential.

Wellness Diagnosis - focuses on strengths that reflect an individual’s transition to higher levels of wellness; detects progression from one level of wellness to a higher level of wellness, by facilitating healthy responses for attainment of higher levels of health-oriented goals; example of wellness diagnosis: ‘Health-seeking behavior regarding weight-loss diet.’

Viability - ability to work as intended or to succeed; Biology, ability to continue to exist or to develop as a living being.

Change Agent - a group or individual whose purpose is to bring about a change in existing practices of an organization that have become entrenched routines.

Distinction between Novel Patient Health Systems and Traditional Healthcare Systems

Novel Patient Health Systems - function on the premise of health as an individual and collective, fundamental human right. In a balanced Primary Health Care (PHC) continuum, upstream health system components: primary (1°) disease prevention and health promotion strategies, activities, patient services, interventions, patient outcomes, and infrastructure, including digital infrastructure, operate in even counterbalance with downstream health system components: secondary (2°) and tertiary (3°) disease prevention strategies, activities, patient services, interventions, patient outcomes, and infrastructure, including digital infrastructure; that is, attention upstream balances downstream demands. Even counterbalance created between operation of the upstream and downstream components of the PHC continuum, establishes health system sustainability. Sustained maintenance of even counterbalance between upstream and downstream health system components and operations, throughout the entire PHC continuum, is a viable patient health system. (© Tremblay LJ. 2020)

Traditional Healthcare Systems - function on the premise of prioritized illness-treatment, rather than prioritized balance within the primary health care (PHC) continuum. The term healthcare is largely synonymous with a ‘sick-care system’ that prioritizes illness-treatment over protection of health as a fundamental human right. (© Tremblay LJ. 2020) Quality-adjusted life year (QALY) - a summary outcome measure of intervention effectiveness, used for comparing many different interventions and conditions: ranging from specific patient level interventions to program level interventions delivered to various individuals within a community; providing a 'common currency' that facilitates comparisons across competing interventions, to ultimately help payers prioritize and allocate healthcare resources upon a goal of maximum beneficial outcomes for minimal costs.

QALYs are calculated by estimating the years of life remaining (benefits gained in life expectancy) for a patient following a particular treatment or intervention, weighting each year with a quality of life score, on a 0 (dead) to 1 (perfect health) scale; widely used in economic evaluations since it combines quantitative measurements of both mortality (length of life) and morbidity (quality of life) into a single score: one QALY is equal to 1 year of life in perfect health.

Disability-adjusted life year (DALY) - a measure of the impact of a disease or injury, in terms of healthy years lost.

Economics - the way in which trade, industry, or money is organized; the study of the production, distribution, and consumption of resources, and the management of state income and expenditure; includes classical economics, ecological economics, environmental economics, macroeconomics, and microeconomics.

Gross Domestic Product (GDP) - the total value of goods and services produced by a country in a year; one of the main measures of economic activity: the GDP of a country is defined as the total market value of all final goods and services produced within a country in a given period of time, usually a calendar year.

‘Gross’ indicates that the GDP is calculated without subtracting any allowance for capital consumption; ‘domestic’ that it measures activities located in the country regardless of their ownership, thus including activities carried out in the country by foreign-owned companies, and excluding activities of firms owned by national residents but carried out abroad. ‘Product’ indicates that the GDP measures real output produced rather than output absorbed by residents. GDP is reported at both current and constant prices. Production Boundary - defines what activities are regarded as production and hence included in the compilation of the GDP.

System of National Accounts (SNA) production boundary includes the following activities:

• the production of all goods or services that are supplied to units other than their producers, or intended to be so supplied, including the production of goods or services used up in the process of producing such goods or services;

• the own-account production of all goods that are retained by their producers for their own final consumption or gross capital formation;

• the own-account production of knowledge-capturing products that are retained by their producers for their own final consumption or gross capital formation but excluding (by convention) such products produced by households for their own use;

• the own-account production of housing services by owner occupiers;

• the production of domestic and personal services by employing paid domestic staff.

Tax Revenue - revenue collected from taxes on personal income, corporate profits, social security contributions, goods and services, payroll, property, and other taxes; total tax revenue as a percentage of GDP, indicates the share of a country's output collected by the government through taxes; one measure of the degree to which the government controls the economy's resources; tax burden equals total tax revenues received as a percentage of GDP.

Organization for Economic Co-operation and Development (OECD) Mission - promotion of policies that will improve the economic and social welfare of people in developed nations.

OECD’s Main Purpose - to improve the global economy and promote world trade; member countries’ democratic governments work together to find solutions to common problems, sharing a commitment to improving the economy and well-being of the general population.

OECD Objectives:

1. Improve confidence in markets and the institutions that help them function;

2. Obtain healthy public finances to achieve future sustainable economic growth;

3. Achieve growth through innovation, environmentally friendly strategies, and the sustainability of developing economies; and,

4. Provide resources for people to develop the skills they need to be productive.

Econometrics - a discipline that develops mathematical and statistical methods, applies them to the estimation of economic models, and conducts quantitative analysis of the behavior of economic data; the testing of the performance of economies and economic theories using mathematical methods. Econometric theory mainly deals with establishing the statistical properties of estimators and the development of tests, while applied econometrics uses statistical methods to test and evaluate economic theories, and to forecast future values of economic variables.

Cost-Effectiveness Analysis (CEA) - evaluates effectiveness of two or more treatments or interventions relative to their cost.

Cost-Effectiveness (CE) Thresholds - are often established by analysis of previous reimbursement decisions: they are not themselves outputs of cost-effectiveness analyses, but are guides to interpretation of these outputs for decision-making.

Incremental Cost-Effectiveness Ratio (ICER) - a summary measure that represents the economic value of an intervention being compared to an alternative intervention; commonly used when considering new interventions that generate improved health effects at greater cost; calculated by dividing the difference in total costs (incremental cost) by the difference in the chosen measure of health outcome or effect (incremental effect) providing a ratio of ‘extra cost per extra unit of health effect’ for the more expensive therapy versus the alternative; ICERs reported by economic evaluations are compared with a pre-determined cost-effectiveness (CE) threshold to decide whether choosing the new intervention is an efficient use of resources.

Dominant Strategy - interventions that are more effective at producing health benefits, and are associated with net cost savings.

Informatics - the science of how to use data, information and knowledge to improve human health and the delivery of health care services. Decision-analytic model - a model of how decisions are or should be made, aiming to provide decision-makers with the best available evidence; often used in assessment of new interventions; compares the expected costs and consequences of decision options by synthesizing information from multiple sources and applying mathematical techniques, usually with computer software; example: model for consideration of trade-off between costs, benefits and harms of diagnostic tests or interventions.

Systematic Review (SR) - attempts to identify, evaluate and summarize all available evidence addressing a specific research question(s), with key characteristics including: clearly stated set of objectives with pre-defined eligibility criteria for studies; an explicit, reproducible methodology to minimize bias, thus providing more reliable findings; a systematic search that attempts to identify all studies meeting eligibility criteria; an assessment of risk of bias of the included studies; and a transparent, systematic presentation and synthesis of the characteristics and findings of the included studies, according to pre-specified protocol.

Meta- Analysis (MA) - a statistical method often used in systematic reviews to combine results from several independent studies of the same test, treatment or other intervention, to estimate overall effect; can provide more precise estimates of the effects of health care interventions than those derived from individual studies; and can facilitate investigations across studies within a systematic review, regarding consistency of evidence and exploration of differences.

Network Meta- Analysis (NMA) or ‘Multiple Treatments Meta- Analysis’ or ‘Mixed Treatment Comparison’ - statistical synthesis of information over a network of comparisons, to assess the comparative effectiveness of more than two alternative treatment options for the same condition; relies on mixed comparison, synthesizing direct evidence (from studies that directly compare the interventions of interest) and indirect evidence (from studies that do not compare the interventions of interest directly) over the entire network to obtain:

1. the relative treatment effects for all comparisons, and

2. a ranking of the treatments. Background

Since the system-wide concept of primary health care was defined in 1978 by the World Health Organization (WHO) the development of its upstream nature has been severely neglected relative to the exorbitant cost expenditure of downstream outpatient and acute inpatient care. Healthcare expenditure comprised predominantly of prioritized illness treatment, increasingly depletes limited resources: intensifying pressure on the micro level of patient care, for evidence based, quality patient outcomes; and on the macro level, for health system function that is sustainable. Reflective of decades-long neglect to the upstream elements of primary (1°) disease prevention and health promotion, are crisis issues of sustainability that have become increasingly pronounced in recent years: crisis issues that will continue to escalate until a shift into upstream healthcare development takes hold through adaptive policy implementation and federal legislation, based on relevant research evidence. Attempts to maintain “system health” at even a baseline sustainability status have failed to provide results that sufficiently offset the continually rising fiscal pressure on healthcare budgets, let alone create renewal toward viability.

A health system that functions within a balanced Primary Health Care (PHC) continuum, where upstream and downstream components operate in even counterbalance, has never existed. Neither has the systemic significance of health’s social determinants and their necessary translation within balanced health systems ever been acknowledged in real health service provision. Marc Lalonde’s 1974 report was the first federal report to formally acknowledge the existence of determinants of health outside of the restricted illness-treatment context that formed basis for Medicare legislation of 1957 (Hospital Insurance and Diagnostic Services Act), 1966 (Medical Care Act) and 1984 (Canada Health Act). However, because these three federal Acts focus only on the restricted bio-medical approach to patient care, not only were all residents of all provinces and territories not provided ‘access to health care regardless of ability to pay,’ as the Canada Health Act purports to do (residents in Canada’s remote areas have never been provided reasonable access to health care regardless of ability to pay, nor have residents in Canada’s remote areas ever had this access reasonably facilitated); but all residents of Canada have not had access to a balanced health system that protects their health as a fundamental human right; and neither have any other individuals throughout the globe, ever had access to a balanced health system that protects their health as a fundamental human right. (© Tremblay LJ. 2020) Despite acknowledgment within the Toronto Charter of 2002 that socioeconomic status is the most significant social determinant of health (SDOH), an absence of research invested into activities that acknowledge health’s social determinants, particularly regarding low socioeconomic populations whose health is most at risk, indicates neglect that negatively interacts with the already problematic imbalance of sophisticated scientific research investment into acute care downstream. More specifically, low socioeconomic populations within Canada’s remote north, represent a pronounced manifestation of the relative paucity of scientific research investment into SDOH; where the positive correlation between low socioeconomic status and unhealthy behaviors, is compounded within remote Canada by northern environmental and geographical challenges.

Beyond Canada, all humans, elite and marginalized: global citizens of humanity that include stateless humans with no nationality (0.2% of the world population, at 12,000,000 stateless humans), nationals, permanent residents, and citizens; have not had access to a balanced health system that protects their health as a fundamental human right. Countries that share similar access challenges inherent to Canada’s northern expanse, coupled with escalating rates of poverty within aboriginal populations, share similar challenges in the creation of their balanced health systems. In turn, challenges shared, offer opportunity for development of partnerships on a global scale, where partnerships built, result in economic relationships that have potential to be highly correlated with improved health envisioned by the UN’s Sustainable Development Goals.

Consensus among health scientists holds that the goal of the healthcare system is to maximize years of healthy life gained for a population at any given level of resource investment; or in simpler terms, the goal of the healthcare system is to maximize health for given resources. However, the author and inventor of this patent application asserts that historically, health, in practical terms, has never been considered in its entirety as the sum total of its parts: inclusive of an individual’s health that is irrefutably anchored, and in fact, largely originated, within the upstream of the PHC continuum (most people begin their life without disease-diagnosis at birth). (© Tremblay LJ. 2020)

Consensus also holds that historically, health resources have been considered virtually entirely in terms of ‘resources assigned to the downstream of illness treatment;’ rather than ‘resources synchronously assigned to all components of the complete PHC continuum,’ to encompass the entire meaning of ‘health:’ state of complete physical, mental, and social wellbeing, and not merely absence of disease. Indeed, if the goal of the healthcare system is truly, to maximize health for given resources, then health must be considered for what it actually is in its entirety, in the sum total of its parts. Accurate consideration of health in its entirety, demands development of primary (1°) disease prevention and health promotion components that are inseparable from the goal of maximized health; through protection of health as a fundamental human right, protection that is inherent to 1° disease prevention and health promotion itself. Health resources within a patient health system that accurately considers health in its entirety, are ‘resources assigned to maintain balance between the upstream and the downstream components of the entire PHC continuum,’ reflective of the true entity of ‘health’ upon which the system is built. (© Tremblay LJ. 2020)

Prior Art

Where elements of health care have been quantified within indicators such as the Canadian Index of Wellbeing, that measures societal progress over time alongside the Gross Domestic Product (GDP), there is no prior art regarding the creation of balance between the upstream and downstream components of the Primary Health Care (PHC) continuum.

Further, there are no co-inventors to viable patient health systems:

I. defined by claims on pages 69 to 86 of this non-provisional, international patent application;

II. conceived entirely and solely by the author and inventor of viable patient health systems,

Laura Johanne Tremblay. (© Tremblay LJ. 2020)

Related Application Data

Tremblay LJ. Systematic review thesis proposal. College of Nursing, University of SK.2014;

August 20:1-50.

According to best practice recommendations for the conduct of systematic reviews, this author’s systematic review study protocol is registered with a Centre for Reviews and Dissemination (CRD) number of 42015023509:

Tremblay LJ. Nurse practitioner impact: a systematic review protocol, systematic review ongoing as living document. PROSPERO, Centre for Reviews and Dissemination, University of York, UK. 2015; June 28:1-14.

Tremblay LJ. Nurse practitioner impact on quantitative patient outcomes in four healthcare settings’ system context: a systematic review and meta-analysis. Embargoed until October 06, 2020 at Electronic Theses and Dissertations. University of Saskatchewan, Canada. 2017; September 19:1- 260.

Tremblay LJ. Nurse practitioner impact on quantitative patient outcomes in four healthcare settings’ system context: a systematic review and meta-analysis. Canadian Copyright Registration Number 1157699. Innovation, Science and Economic Development Canada, Canadian Intellectual Property Office (CIPO), Gatineau, QC. 2019; March 13. 2012 Origin of Research Thesis Authored by Laura Johanne Tremblay © February 2017

Unlike the Primary Health Care (PHC) principles of health promotion, public participation, accessibility and intersectoral cooperation, that all existed as subject headings in scientific databases, the author and inventor of this patent application, Laura Johanne Tremblay, found the PHC principle of ‘appropriate technology’ non-existent as subject heading in scientific databases of fall 2012. Subsequently, the PHC principle of appropriate technology was explored within nursing research by Laura Johanne Tremblay, through conduct of a systematic review (SR) of Randomized Controlled Trials (RCTs) that test Nurse Practitioner (NP) effectiveness (CRD number 42015023509), where functions of the NP role embody the principle of appropriate technology.

Given the 2017 research Thesis authored by Laura Johanne Tremblay, titled ‘Nurse practitioner impact on quantitative patient outcomes in four healthcare settings’ system context: a systematic review and meta-analysis,’ requires rectification and updates to its embargoed data set, and remains embargoed until October 06, 2020; only an excerpt of findings are disclosed below, to provide the reader with perspective regarding the data ultimately reported in this author’s forthcoming peer- reviewed science journal publication of systematic review CRD number 42015023509.

Healthcare Setting

This author’s systematic review (2017 report of CRD number 42015023509) reported an adverse imbalance between patient care provided in upstream settings relative to illness treatment in downstream settings. From a set of 29 included RCT studies: 28% of RCTs (8/29; 28%) were set in primary clinics, and less commonly, in patients’ homes or community; 62% of RCTs (18/29; 62%) were set in specialized referral / outpatient clinics; and 10% of RCTs (3/29; 10%) were set in either emergency departments or in acute inpatient hospitals. No included studies in this author’s SR (2017 report) were set exclusively in long term care. A proportion of 9/12 RCTs (75%) that were not set in acute care nonetheless reported acute care utilization, suggesting a significant reliance on acute care services by outpatients and patients from primary clinic care settings. (© Tremblay LJ. 2012-2020) Primary to Secondary to Tertiary Disease Prevention Spectrum

Only 7% of RCTs (2/29; 7%) in this author’s systematic review (2017 report of CRD number 42015023509) evaluated NP intervention effects upon the maintenance of good health, in the context of primary (1°) disease prevention and health promotion. Thirty-four percent (10/29; 34%) of included studies were secondary (2°) disease prevention trials, testing NP intervention effects on management that aims to reduce the impact of a disease or injury that has already occurred. Tertiary (3°) disease prevention trials comprised 59% (17/29; 59%) of this author’s SR (2017 report), testing NP intervention effects on management of long-term, often complex health problems and injuries.

Reinforcing this adverse imbalance in the 1° to 2° to 3° disease prevention spectrum, is the fact that the single RCT in this author’s SR (2017 report) that tested an intervention explicitly for preventive purposes (prevention of additional weight gain) was also the one and only RCT that focused on the issue of obesity, now considered a chronic disease in itself, known to be very significantly and directly linked with many other chronic diseases.

All Quantitative Patient Outcomes in All Settings

Systematic summary of ‘all quantitative patient outcomes in all settings’ provides insight into the design, function, and limitations of the health system as a larger whole. The largest category of endpoint-outcomes measured by trial authors of included studies in this author’s SR (2017 report) was ‘surrogate measures of disease,’ indicating an emphasis in NP intervention research on the ‘systems-threatening issues’ of long term tertiary (3°) prevention, manifest in permanent aspects of chronic disease. Approximately 50 years ago, an issue in question was how to meet demand for services in Canadian primary clinics. By now, the issue in question relates to health systems in their entirety: in terms of design, function, and limitations, for adequate service delivery to the public in all settings, with NP services found heavily imbalanced downstream within this author’s systematic review (2017 report of CRD number 42015023509). (© Tremblay LJ. 2012-2020) Methodology of Systematic Review Science

Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for systematic review and metaanalysis protocols (PRISMA-P) 2015 statement. Systematic reviews. 2015;4(l): l-9.

Higgins J, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions. 1st ed. Mississauga, ON: Wiley -Blackwell; 2008.

Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Journal of Clinical Epidemiology. 2009;62: 1006-1012.

Borenstein M, Hedges LV, Higgins JPT, Rothstein HR. Introduction to Meta-Analysis. West Sussex, UK: Wiley; 2009.

Comprehensive Meta-Analysis [computer program]. Version 3.0. Englewood, NJ: Biostat; 2014.

Cipriani A, Higgins JPT, Geddes JR, & Salanti G. Conceptual and technical challenges in network meta-analysis. Annals of Internal Medicine . 2013;159(July):130-137&W52-W54.

Hutton B, Salanti G, Caldwell DM et al. The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions: checklist and explanations. Annals of Internal Medicine . 2015;162:777-784.

Viable Patient Health Systems

Summary

There are no co-inventors to viable patient health systems, defined by claims on pages 69 to 86 of this non-provisional, international patent application, conceived entirely and solely by the author and inventor of viable patient health systems, Laura Johanne Tremblay. Claims are paraphrased below.

In a balanced Primary Health Care (PHC) continuum, upstream primary (1°) disease prevention and health promotion components operate in even counterbalance with downstream secondary (2°) and tertiary (3°) disease prevention components: attention upstream balances downstream demands, transforming patient health system sustainability into patient health system viability. Accordingly, several advantages of one or more aspects are as follows.

Evenly counterbalanced upstream-downstream operations facilitate development of increased patient wellness levels, where standardized quantification of patient wellness levels increases accuracy of actual health measurement within economic evaluations that pertain to the entire PHC continuum. Equal patient access to upstream and downstream health system components, enables equal access to wellness reserves in both upstream and downstream directions, supporting sustained maintenance of a balanced patient health system; where sustained maintenance of even counterbalance between the upstream and downstream components of the PHC continuum is a viable patient health system. Viable patient health systems protect patient health as a fundamental human right and enable growth in non health sectors (such as natural resources, legal system).

Optimal designs of coordinated, linked networks upstream and downstream, further facilitate improved social determinants of health, which are positively impacted throughout the entire PHC continuum by appropriate technology (AT) interventions: a dominant strategy that produces higher degrees of quality, positive patient outcomes, including improved patient wellness levels, with less expenditure; where improved patient wellness levels increase most dramatically in vulnerable, marginalized populations. Augmented cost-savings from strategic focus on vulnerable, marginalized populations, further constitute crucial commonality between countries that adopt viable patient health systems under harmonized international standards. (© Tremblay LJ. 2020) Novel meta-analytic methods distinguish between upstream and downstream patient care settings for additional insight toward enhanced cost-effectiveness (societal perspective) at both macro and micro levels of viable patient health systems. Constantly responsive to underlying conditions, patterns of economic growth in health and non health sectors, are regularly monitored: informing all systems, including international partnerships, allowing partnerships to expand into international partnership systems with potential to benefit the global economy. Other advantages of one or more aspects will be apparent from a consideration of this description’s development. (© Tremblay LJ. 2020)

Viable Patient Health Systems

This patent document contains material which is subject to copyright protection. The copyright owner, Laura Johanne Tremblay, has no objection to the reproduction of the patent document or the patent disclosure by respective Intellectual Property Offices, as it appears in respective Intellectual Property Offices’ files or records, but otherwise reserves all copyright rights whatsoever. Further, there are no co-inventors to viable patient health systems, defined by claims on pages 69 to 86 of this non-provisional, international patent application, conceived entirely and solely by the author and inventor of viable patient health systems, Laura Johanne Tremblay. (© Tremblay LJ. 2020)

I. Balance Between Upstream and Downstream in Primary Health Care (PHC) Continuum

1. Patient First in Upstream Development

‘Patient-first’ refers to:

1. proactive provision of primary (1°) disease prevention and health promotion services to the patient before the patient ever requires illness treatment downstream. Concrete 1° disease prevention and health promotion components upstream, largely require their original conception, and include built-in methods of assessing intervention efficacy and effectiveness, for development toward sustainability and viability. Good governance of patient health systems is only possible with good information on health challenges made accessible to all involved: individual patients, communities, civil society, government, health professionals, and business sectors.

2. patient at the center of interprofessional teams’ (IPTs’) long term commitment to patients’ best interests, at individual and group levels. Increased production of high quality, positive patient outcomes in the patients’ best interests, include improved wellness levels that incentivize patients and IPTs toward further increased productivity of positive patient outcomes. Long term commitment over generations, through methods such as Community Based Participatory Research (CBPR), facilitate community capacity-building for maintenance and development of positive change. (© Tremblay LJ. 2020) 3. equal patient access to upstream and downstream components in balanced patient health systems, where well-functioning Social Determinants of Health (SDOH) exist throughout an entire Primary Health Care (PHC) continuum.

4. cost savings associated with benefits gained from development of patients’ wellness strengths, enabling both the individual patient and the patient health system to capitalize on wellness before illness ever requires treatment. (© Tremblay LJ. 2020)

2. Health Economic Evaluations

Health resources within a patient health system that accurately considers health in its entirety, are ‘resources assigned to maintain balance between the upstream and downstream components of the entire PHC continuum,’ reflective of the true entity of ‘health’ upon which the patient health system is built.

2.1 Quality-adjusted life years (QALYs) and Disability-adjusted life years (DALYs) in Cost- Effectiveness Analyses (CEAs) of Interventions

Historically, resource allocation decisions that have been considered economically ‘optimal,’ meaning ‘greatest benefit from finite resources,’ have not been decisions based upon the entire concept of health that accurately, and most importantly, includes non-illness status. Even the value of ‘ 1’ used to represent ‘perfect health’ in a simulated perfect market used for QALY calculations, does not supply information on specific aspects of wellness that comprise ‘perfect health.’ The perfect endpoint concept of ‘no-illness’ on the simulated scale widely used for QALY calculations in economic evaluations throughout the world, for decades, at individual and societal levels, overlooks benefits inherent to wellness strengths. Wellness strengths are an integral factor of health in people’s real lives, yet historically, wellness levels have essentially been disregarded in scientists’ mathematical considerations of resource allocation devoted to people’s real health.

While scientists maintain caution in their use of the QALY given multiple assumptions that underlie the QALY approach, scientists and decision-makers nonetheless, continue to recognize the QALY as accepted convention in many resource allocation decisions. It is important to also note that use of other measures such as the DALY (disability-adjusted life year, a measure of healthy years lost to disease or injury) introduce additional assumptions to those for the QALY, adding basis for further caution in sound interpretation by policy makers of economic evaluations, based upon these conventional metrics. Convention agrees that dismissing cost criteria in resource allocation decisions may cause net harm to individuals and to society as a whole, yet economic optimization that dismisses the complete definition of health has also been convention; and this convention contains within it, an unavoidable constant-factor of net harm:

I. individually, by its dismissal of what it is that constitutes complete health within the individual patient;

II. societally, by an imbalanced, overweight component of illness treatment action, at expense to the system overall; and

III. globally, by overlooking health as a fundamental human right to be protected within balanced patient health systems, creating crisis in health systems throughout the world, upon balance issues left unattended ever since inception. (© Tremblay LJ. 2020)

2.2 Health Market in Traditional Healthcare Systems

Key parties related to resource allocation within a traditional healthcare system include the:

1. buyer-patient,

2. agent-provider who guides the patient through care strategies,

3. seller-producer-industry (such as: technology producers, drug companies, hospitals, clinics) that work in the seller’s best interests for maximal shareholder profit, and

4. health payer-government that often, largely pays the cost of the intervention and is typically, most focused on ‘balancing the budget.’ In Canada, approximately 30 percent of healthcare expenditure (dentistry, optometry, prescription drugs) is paid for privately: either directly by the patient, or indirectly by the patient’s private insurance company.

In traditional healthcare systems, both buyer-patient and agent-provider are utility maximizers, seeking greatest benefit from finite resources, yet generally, neither are exposed to price, so that neither is motivated to consider cost in decision-making that has historically, been predominantly associated with downstream illness treatment. In addition, the buyer-patient may often lack information on choices regarding the most appropriate services available; to a lesser degree, the agent-provider may also have limited awareness regarding available care strategies, while not uncommonly sales pressured by industry.

2.3 Health Market in Novel Patient Health Systems

Key parties in patient health systems mirror those in traditional healthcare systems. However, since all key parties are involved in resource allocation, all key parties in patient health systems are made aware of the: a. cost associated with various care strategies, including b. benefit (cost-savings) gained by building wellness levels within the patient.

Consequently, all key parties have reason to consider the lowest cost in decision-making that seeks greatest benefit from finite resources; including cost-saving alternative(s) toward achieving a particular health outcome, with key parties including the:

1. buyer-patient who ultimately bears cost in their taxation,

2. agent-provider who guides the patient through care strategies, holding profit-bearing elements of cost related to various treatments within their care provision business (example: fee for service clinics),

4. health payer-government that often, largely pays the cost of the intervention and is typically, most focused on ‘balancing the budget. In Canada, approximately 30 percent of healthcare expenditure (dentistry, optometry, prescription drugs) is paid for privately: directly by the patient, or indirectly by the patient’s private insurance company. (© Tremblay LJ. 2020)

2.4 Unique to the New Health Market

Exposure to cost motivates key parties to openly consider cost associated with various care strategies, including the benefit (cost-savings) gained by building wellness within the buyer-patient; while historically, cost has predominantly, been associated with downstream illness treatment, in degrees often unbeknown to the buyer-patient. Key parties’ awareness of benefit (cost-savings) gained by building wellness levels within the buyer-patient, includes awareness of benefit simultaneously gained by the system itself, throughout the entire PHC continuum.

Key parties’ decisions to fund or forgo funding particular interventions, involve evaluation of many factors, including but not limited to: i. intervention effectiveness ii. safety (potentially harmful side-effects of medication) iii. tolerability (symptomology) iv. duration of treatment relative to stage of illness (period of use) v. quality (valid/accurate and reliable/consistent) evidence base related to intervention vi. cost effectiveness vii. cost savings of wellness strategies related to intervention, on a micro level of individual patient care, and on a macro system level, throughout the entire PHC continuum.

In the past, within traditional healthcare systems, even when key parties agree there is sufficient information upon which to base a funding decision, these same key parties have overlooked ‘benefit to be gained by building wellness levels within the patient’ in their evaluation of value for money, failing to acknowledge the existence of insufficient information regarding both: a. patients’ measurable wellness levels, and b. cost-savings associated with integrating wellness into calculations at both individual and system levels. (© Tremblay LJ. 2020)

While the perfect endpoint of ‘no-illness’ has been conventionally accepted for decades on the simulated scale used for QALY calculations in economic evaluations, the concept of ‘no-illness’ overlooks benefits inherent to strengths within wellness, beyond ‘no-illness.’ Levels of wellness are an integral factor of health, not merely the absence of disease; yet historically, measurement of wellness levels has essentially, been disregarded in scientists’ mathematical considerations of resource allocation devoted to people’s health.

Further, decisions to publicly fund particular interventions or not, have traditionally involved avowedly independent bodies that consider a range of cases from exceptional individual cases to cases of interventions used (or overused) by larger patient populations. If ‘whether or not to publicly fund a particular intervention’ may be evaluated by independent bodies for management of net harm to an overall population, then evaluation of whether or not to integrate cost-savings of wellness strategies that protect an individual’s health (at micro and macro system levels) is also fundamental to accurate management of net harm to an overall population. In other words, independent bodies’ integration of ‘benefit gained from wellness development’ into evaluations of ‘net harm to an overall population,’ for all cases of interventions, is requisite in accurate consideration of individuals and overall populations whose net harm is being evaluated. (© Tremblay LJ. 2020)

Regarding the absence of conflict of interest (situation in which a person or organization is involved in multiple interests, financial or otherwise, and serving one interest could involve working against another) in unbiased independent bodies: while a clinician may truly act in their patients’ best interests, even a perception of conflict of interest (hypothetical example: clinical expert / clinician involved in guideline development for a new disease treatment, receives funds from the manufacturer of that same new treatment) has potential to interfere with that clinician’s entire guideline activity, in his / her ability to recommend a particular disease treatment. If only perception of conflict of interest compromises a clinician’s entire guideline activity, how much more then, is the very existence of imbalanced health systems in critically dangerous GDP consumption states a conflict of interest; far from a perception problem that in many cases, presents life-threatening issues while accepted through ongoing execution of the status quo. Management strategies with potential to be better than standard practice and cost less, necessitate open to the public and press consideration. Implementation of new market strategies can create renewal toward viability in the face of failing health systems, unable to provide results that sufficiently offset continually increasing fiscal pressure on healthcare budgets. (© Tremblay LJ. 2020)

2.5 Two Paradigms Used in Economic Evaluations

Two analytical paradigms in economic evaluations include: i) analysis of individual patient-level data (IPD) from single studies, usually randomized, and ii) decision-analytic modeling. Professor of Health Economics Dr. Michael Drummond clarifies these paradigms to be a false dichotomy (not mutually exclusive) where increasingly, more economic evaluations effectively use a combination of these methods. Particularly in cost-effectiveness analyses that take a lifetime perspective, mathematical modeling assembles evidence from a range of sources for estimations of patient-level cost and effect. Further, the second panel on cost-effectiveness in health and medicine, refers to multiple factors beyond clinical evidence and cost-effectiveness that are brought to bear on resource allocation decisions, including: patient’s expectations; equity concerns; and pragmatic issues of logistics and feasibility.

3. Value of Wellness: Intrinsic, Retrospective, and Prospective

3.1 Intrinsic and Retrospective

The simulated perfect market for health created within economic models, has historically, been applied to an incomplete consideration of what constitutes health, by inaccurate reference to the very definition of health that has been globally accepted by scientists who conduct economic evaluations. Critical non-sustainability issues presently experienced by healthcare systems on a global scale, reflect cumulative retrospective harm suffered by traditional illness-oriented systems, imbalanced since their inception. This crisis-context significantly increases value projections of primary (1°) disease prevention and health promotion components beyond immediately beneficial, intrinsic terms, inherent to that which is 1° disease prevention and health promotion: aiming to prevent disease or injury before it ever occurs. Increased resistance to disease or injury through strengths built, as an individual progresses to higher levels of wellness, further minimizes unhealthy, unsafe behaviors. The value of wellness is integral to value projections of primary (1°) disease prevention and health promotion components and their operations. Beyond immediately beneficial, intrinsic terms inherent to wellness, are retrospective terms derived from elimination of sunk cost sources: terms that increase value projections in relation to already sunk, retrospective costs that have accumulated through decades of generalized disregard for protection of health’s origins.

3.2 Prospective

For many years, economic models have been designed to predict future cost (20 years forward from present) of chronic disease management (CDM), using illness-oriented metrics, finding best evidence upon which to project future chronic health states, future clinical effects and future costs related to two treatment strategies: standard care versus new drug intervention. By now, QALY valuation of wellness management may also use a life-time horizon approach: projecting future upstream effects of standard care versus wellness-oriented intervention, analyzing all relevant factors and parameters over a long enough period of time for detection of all pertinent detail, including mitigation of any novelty effect due to heightened awareness (curiosity factor) of new wellness strategies, for prediction of long-term cost-savings: 1. for the patient, whose health is a fundamental human right, and

2. for the health system, that in most countries with well-functioning revenue systems, is largely funded by patients’ tax dollars.

However, economic models created for CDM’s lifetime horizon analyses, often include the problem of data deficient in direct quality of life (QoL) measures. That is, many studies deemed to contain sufficient data for inclusion within CDM’s lifetime horizon analyses, have been acknowledged to not contain any actual, direct QoL measurement for QALY calculations. In such cases where direct QoL data is non-existent, the QoL component of the QALY becomes derived from other sources, indirect to the primary research being considered, only adding to the uncertainty as to what the true impact of a new intervention for CDM actually is, in terms of the QALY. Though not yet common practice, economic models designed using wellness-oriented metrics, including QALY valuation of wellness management, can predict strengths 20 years from now, and advance upstream wellness development for protection of health as a fundamental human right; utilizing best evidence to project future sustained wellness states, future clinical benefits, and future cost-savings related to two treatment strategies: standard care versus wellness-oriented intervention. Challenges surrounding the conventional QALY metric warrant improvements that build beyond the cautionary assumptions associated with current conventions, through integration of wellness metrics that enable a more accurate consideration of health within economic evaluations. (© Tremblay LJ. 2020)

3.3 Wellness Metric within QALYs

Integral to health, wellness is represented as a percentage of the total QALY status assessed for a particular health state,

(Quantitative wellness measure / QALY) x 100% = percentage of wellness within QALY.

Wellness is measured quantitatively in adults using the psychometrically sound instrument ‘Five Factor Wellness Inventory’ (FFWEL or 5F-Wel) with versions of 5F-Wel for teenagers and elementary school children available alongside the RAND (Research ANd Development) Corporation’s Child and Adolescent Wellness Scale (CAWS), also psychometrically sound. QALYs that express wellness as a percentage of the total QALY status assessed for a particular health state, more accurately reflect the sum total of parts representing actual health; rather than previously skewed QALY quantifications deficient in measures of non-illness dimensions, while nonetheless, being scaled toward a ‘ 1 ’ representation of unattainable ‘perfect health. ’ Different utility scores are assigned to different wellness states just as different utility scores are assigned to different disease states. Integration of utility scores for specific wellness states into QALY calculations within economic evaluations, facilitates:

1. resource allocation decisions that authentically protect individual and societal health from net harm, through more accurate, complete consideration of health within economic evaluations; and,

2. improved measurement of health system components and operations, in the development of balance throughout the entire PHC continuum. (© Tremblay LJ. 2020)

4. Economic Evaluations Across Jurisdictions

Decision analytic models are widely used in economic evaluation of health interventions, providing a powerful framework within which to incorporate a full range of evidence. Randomized controlled trials (RCTs) provide key evidence for these models, not only regarding treatment effects, but also, regarding study parameters such as baseline risk, resource use and health-related quality of life. The use of meta-analysis based on individual patient level data (IPD) from homogenous RCTs, brings additional advantages to decision analytic models. However, jurisdictions lacking IPD, may overcome such barriers through collection of data derived from partnerships between countries with similar healthcare systems and clinical practice patterns; where strategic data collection may be able to facilitate the development of relevant regional databases and registries, in order to assess whether or not there are natural groupings of similar jurisdictions, that increase confidence in transferring cost-effectiveness results from one jurisdiction to another.

II. Maintenance of Even Counterbalance

1. Introduction: Immunology, Pharmacology, and Biochemistry Perspectives

We have learned how to genetically engineer new cellular systems, before learning how to balance the system in which we live.

Cell biologist Annabel Valledor’s research in molecular biology and immunology, focusses on immune responses in diseases with inflammatory origin. In Valledor’s study of cells that selectively distinguish between non-self and self (foreign microorganism that enters the human body) at inflammatory sites, Valledor noted in 2010, that although cardinal signs of inflammation have been known for a long time, the mechanisms and mediators involved, have largely been ignored and only recently, have begun to be elucidated. This reflection is telling not only in terms of scientific areas found neglected versus those in which strides forward have been made, but it is telling insofar as distinctions made between dynamics that underscore scientific initiatives for progress forward, from dynamics that envelope other scientific foci, inhibiting further development. As Valledor explained in 2010: under normal circumstances in which macrophages kill or inactivate microorganisms, phases of destruction and repair are well balanced. However, under persistence of the proinflammatory phase or when macrophages trigger an altered response, acute infection may result in chronic inflammation and potentially, fatal septic shock.

1.1.1 Context within Modern Research

The systems in which we live as a society change and adapt over time through influence of many factors. Whether or not change results in successful adaptation is also determined by many factors. Interesting context not only within the world of modern research but within the world at large, is the fact that only a few years prior to Valledor’s 2010 statement noted above, the well-known international research project that mapped the entire human genome, was completed in 2003. Through use of public funds and 20 institutions from six different countries: the USA, UK, Germany, France, Japan, and China, mapping of the entire human genome began in 1990 and was completed 13 years later in April 2003, at a cost of three billion dollars. Where the goal had originally been set for completion in 2005, the human genome was mapped two years ahead of schedule, only a few years prior to Valledor’s recognition that the biomolecular mechanisms and mediators involved in the extremely common experience of inflammation, have only recently, begun to be elucidated. 1.2 Pharmacology Perspectives

In 2017, within the world of pharmacology, Zucconi pointed to a new drug targeting strategy in epigenetic enzymes, where enzymes are specialized proteins that catalyze specific metabolic reactions. Histone-modifying enzymes comprise one category of epigenetic enzymes. Associated with the structure of chromosomal DNA (deoxyribonucleic acid) within the cell nucleus, DNA is tightly wound around histone protein [Definitions: 1) Chromosome - a single DNA molecule that contains many genes, for storage and transmission of genetic information; 2) One gene is a segment of chromosome that codes for a single polypeptide chain or RNA (ribonucleic acid) molecule; and 3) Epigenetic refers to external modifications to DNA that affect gene expression; that is, without changes to the actual gene sequence within DNA, gene expression is altered by physical modifications to the external structure of DNA (histone modification)].

In 2017, Zucconi wrote that epigenetic enzymes are key regulators of gene expression, and pivotal determinants of cell fate, by regulating chromatin (filamentous complex of DNA, histones and other proteins) modifications on both nucleosomal proteins and DNA. These modifications result in changes in the timing and volume of gene expression. Research on histone-modifying enzymes includes: 1) earlier drug development strategies that focused on ligands (a ligand is a molecule or ion bound to a protein macromolecule, where protein is comprised of one or more polypeptide chains of amino acids) binding to enzyme active-sites (sites that bind substrate molecules for metabolic reaction); and 2) more recent research that focusses less on enzyme active sites and more on enzyme allosteric-sites (sites that bind modulator molecules, which either activate or inhibit enzyme activity) described by researchers as “attractive opportunities” for therapeutic (drug) development. In this example, highly specialized drug research narrows its target to specific sites on enzyme molecules, seeking new avenues of more precise drug action on complex epigenetic enzymes involved in particular disease processes.

1.3 Biochemistry Perspectives

Biochemist Albert Lehninger’s research career focused on bioenergetics of the mitochondrion, a cell organelle (specialized membrane-bound structure within a living cell) that is the site of many of the cell’s most important energy reactions. Lehninger characterized and quantified many features of mitochondrial enzyme systems, including: the degradation of fatty acids (fatty acid oxidation), calcium transport, synthesis of the cell’s energy molecule ATP (adenosine triphosphate), and proton stoichiometries. Cellular energy conservation is maintained through auto-regulation of cell metabolism, its self-regulation of anabolic and catabolic processes. Regulated according to the cell’s energy needs, ATP formation is balanced with its consumption, doing the work of the cell, through many various cellular pathways that are naturally interconnected.

Within the cell, various enzyme systems self-adjust and self-regulate. For example, particular biosynthetic pathways (amino acid biosynthesis) are regulated through the concentration of repressible enzymes, and this concentration is controlled by repression (inactivation) and derepression (activation) of genes (segments of DNA molecule) that code for enzyme biosynthesis, based upon fluctuating concentrations of particular molecules within the cell. Dynamics of cellular metabolism include even more sophisticated allosteric enzyme-systems, whose pacemaker enzymes set the rate of metabolism (constantly increasing or decreasing the rate of metabolism) within particular biochemical pathways. Even when the external environment fluctuates, self-adjusting and self-regulating properties allow living cells to maintain themselves in a steady state.

1.3.1 Future Contexts

The Human Genome Project that involved many countries for over a decade, and sophisticated biomolecular research for drug development in treatment of illness, are examples of research that is both intensive and expensive. Consideration of societal needs that form basis for research in general, includes Valledor’s year 2010 recognition, of only recent advances in the scientific knowledge of inflammations’ biomolecular mechanisms and mediators, despite its cardinal signs long known since the early days of medicine, an example of select focus within the world of research itself. Similarly, the systemic undertow of dynamics foreign to patients’ best interests, apparently unseen to many even within health systems, but prolonged over many decades, has contributed to self-defeating, chronic health-system-illness that has become increasingly critical around the globe. Biochemist Dr. Albert Lehninger (1917-1986) anticipated future contexts confronting new generations in the preface to his 1982 text:

There will be ever-greater concern for the health and well-being of mankind. The extraordinary advances in biochemical genetics and genetic engineering, together with their social implications, are already matters of wide public interest. The growing world population, with its increasing demands for food, raw materials, and energy, can even now be seen to impinge on the delicate ecological balances within the biosphere. Increasingly, society must make important decisions involving conflicts between biological principles and political, industrial, or ethical concerns. It can therefore be argued that a knowledge of biochemistry is useful for all well-informed citizens, whatever their calling - quite apart from the special intellectual excitement it offers to those who wish to explore and understand the molecular interactions that take place in living organisms.

2. Patients’ Best Interests within Our Living Systems

Extraordinary advances in biochemical genetics and genetic engineering, together with their social implications, involve the intricacies of living organisms’ biochemical pathways: their precise interrelatedness and efficiently balanced regulation. Axioms prefaced to such specialized knowledge include Lehninger’s axiom in the molecular logic of the living state.

2.1 Axiom in the Molecular Logic of the Living State

Living cells are self-regulating chemical engines, tuned to operate on the principle of maximum economy.

Living organisms’ intricately interrelated and efficiently balanced systems can inform crucially required system change needed to create maximized health for given resources. Cellular energy conservation is maintained through self-regulation of anabolic and catabolic processes, and informs the system in which we live: on an agenda of optimal health using finite resources, where the health of each individual is regarded as a fundamental human right; and where health is irrefutably anchored, in fact largely originated, within the upstream of the PHC continuum (most people begin their life without disease-diagnosis at birth). The system in which we live, in each country and throughout the world, complex with competing agendas, contains a common factor of self as patient whose health itself, as a fundamental human right, creates the framework for viable patient health systems. Creation of even counterbalance between the up and downstream components of the PHC continuum can be achieved through attention paid to patients’ best-interests and to that which has been learned on the cellular level constituting life. (© Tremblay LJ. 2020) 3. Upstream Attention Relative to Regulation of Cell Metabolism

Attention upstream creates balance between itself and its overweight counterpart of illnesstreatment downstream, that through global consensus, is recognized to threaten traditional healthcare systems’ very existence. Even in the United States, one of the world’s biggest health care spenders, consuming almost 20% of their nation’s GDP through health care; initiatives such as ‘Haven Healthcare’ attempt to address the commonly recognized debilitating effect of healthcare industry on the larger economy, with its mission statement: “to transform health care to create better outcomes and overall experience, as well as lower costs for you and your family. We want you to get the right care, every time so that you can live your best life possible.” However, Haven Healthcare’s mission statement pertains to (and is limited to) employees of the three American companies that formed Haven Healthcare: Amazon, Berkshire Hathaway and JPMorgan Chase.

In terms of the precise regulatory function of living cells, including cell metabolism and immune cell function, cellular biologist Valledor noted that activity of macrophages in both the proinflammatory and the resolution phases is complex and must be tightly regulated, where phases of destruction and repair are well balanced. Metabolically, energy conservation is maintained through self-regulation of cellular anabolic and catabolic processes. Analogous to fluctuating concentrations of various molecules within living cells, viable patient health systems allows for well-defined and precise regulation of upstream and downstream health system components and operations, for baseline maintenance of even counterbalance between upstream attention and downstream demands that encompass patients’ fundamental right to health. (© Tremblay LJ. 2020)

The cell membrane is not only a semi-permeable boundary that encloses the cellular system of fluctuating, self-regulating intracellular biomolecular concentrations, it is a dynamic structure, with fluid properties and many complex functions, containing systems that transport nutrient molecules (such as glucose) into the cell and metabolic waste products out of the cell. Cell membranes’ preservation of highly complex, viably functional cellular systems can be considered figuratively, in nonliteral comparative terms, alongside the GDP’s production boundary and its macroeconomic containment of a country’s functioning economic activity. (© Tremblay LJ. 2020) 4. Gross Domestic Product (GDP) Production Boundary

Unique to each country, the GDP production boundary defines what activities are regarded as production and hence included in the compilation of the GDP. Within the System of National Accounts’ (SNAs’) international standard, the production boundary includes categories of economic activity ranging from: production of all goods or services that are supplied to units other than their producers, or intended to be so supplied, including the production of goods or services used up in the process of producing such goods or services; to own-account production of all goods that are retained by their producers for their own consumption or capital formation, own-account production of knowledge-capturing products that are retained by their producers, for their own consumption or capital formation, excluding (by convention) such products produced by households for their own use, own-account production of housing services by owner occupiers, and production of domestic and personal services by employing paid domestic staff.

However, the production boundary’s inattention to unpaid work comprises inaccurate measure of the total economy. Unlike the life-sustaining boundary of the living cell’s membrane, in its preservation of functioning cellular systems, the production boundary’s disconnect between market and the component of the unpaid work community from which the market is partially derived, mal- affects the market that economists strive to optimize. The total economy includes not only the traditional ‘commodity economy’ but the ‘unpaid care economy’ that produces services for families, communities, and society. Given the OECD’s stated purpose: ‘to improve the global economy and promote world trade, through member countries’ democratic governments, working together to find solutions to common problems, sharing a commitment to improving the economy and well-being of the general population;’ integrating the unpaid care economy into the production boundary’s activities has beneficial effects on health by definition, and in turn, on the economy. The quality and quantity of labor supplied to production, and the quality and quantity of goods demanded from production are derived from the community that the same production is in part, designed to serve, including its unpaid components. On consideration of a balanced PHC continuum, optimal use of society’s scarce resources to maximize health for given resources, involves consideration of each individual within the system. Whether paid or unpaid, each individual influences dynamics that contribute to balance within the entire PHC continuum of viable patient health systems.

Optimal function of upstream health system components (strategies, activities, patient services, interventions, patient outcomes, and infrastructure, including digital infrastructure) builds wellness that is vital to individual health, and to good health system design, naturally ameliorating dire problems faced downstream. Similar to the auto-regulation of balanced cell metabolism, development of upstream health system components where presently non-existent or under-utilized, enables optimal functioning for formation of even counterbalance with operation of downstream health system components (strategies, activities, patient services, interventions, patient outcomes, and infrastructure, including digital infrastructure) toward the establishment of patient health system sustainability. In other words, development of upstream infrastructure requires a systemic approach that coordinates with downstream components and operations.

6. Balance Maintained Creates Viability

The PHC principle of appropriate technology strategically matches essential needs to resources, including professional health human resources that are actually available. The dominant strategy of Appropriate Technology (AT) interventions produces higher degrees of quality, positive patient outcomes with less expenditure; where implementation of AT interventions via a dedicated change agent positively impacts social determinants of health (SDOH) throughout an entire PHC continuum. Transformed infrastructure that enables optimal operation of primary (1°) disease prevention and health promotion components, developmentally shifts health system landscape to the upstream, for proliferation of individual patient wellness and development of evenly counterbalanced, living societal systems. Precise auto-regulation of the living cell’s metabolism informs systemic balancing of comprehensive health services throughout the PHC continuum of viable patient health systems: well-defined coordination between upstream and downstream operations, simultaneously impacts both directions of healthcare’s continuum, enabling sustainability to be most efficiently achieved and maintained toward patient health system viability, for all populations of the public, marginalized and elite. (© Tremblay LJ. 2020)

7. Capacity to Self-Sustain

Proliferation of patient wellness within successful societal systems, supports patients’ capacity to self-sustain and the system’s capacity to take the long-term perspective required for system redesign. Multiple generations’ commitment to goals of balanced integration of all aspects of primary (1°), secondary (2°), and tertiary (3°) disease prevention, more easily and appropriately become the focus for change when goals are set within an interprofessional team framework that includes the patient at the center of both the team and the larger system frame. Where the axiom of molecular logic of the living state affirms that self-regulating cells operate on the principle of maximum economy; traditional healthcare systems, not yet self-regulating, use decision analytic models within economic evaluations, in an attempt to optimize benefit gained from finite resources. Decision analytic models synthesize evidence on clinical and economic outcomes from many different sources: data from clinical trials, observational studies, insurance claim databases, case registries, public health statistics, and preference surveys. Using the societal perspective, models logically structure research evidence to help inform decisions within health systems. For decisions on resource allocation in health services, mathematical models often estimate cost per quality- adjusted life year (QALY) gained as a measure of value for money. QALYs that express wellness as a percentage of the total QALY status assessed for a particular health state, more accurately reflect the sum total of parts representing actual health, where utility scores assigned to wellness states in QALY calculations within economic evaluations, facilitate:

7.1 Wellness Metric in Capacity to Self-Sustain

According to definitions of: a. Wellness: a dynamic process of progress toward maximizing an individual’s potential, and its strengths-focus in diagnosis (example of wellness diagnosis: health-seeking behavior regarding weight-loss diet); and, b. Viability: ability to continue to exist or to develop as a living being; the percentage of wellness measure within QALYs for different health states, equals the individual’s or group’s capacity to self-sustain.

Percentage of wellness within QALY = (Quantitative wellness measure / QALY) x 100%

= individual’s or group’s capacity to self-sustain.

(© Tremblay LJ. 2020) Expression of wellness as a percentage of the total QALY status assessed for a particular health state, quantifies an individual’s or group’s capacity to self-sustain for viable operation at both micro and macro levels. Integration of different utility scores for different wellness states into QALY calculations within decision analytic modeling, improves accuracy of quantified health in economic evaluations, for resource allocation decisions that authentically protect individual and societal health from net harm. Such resource allocation decisions enable development of factors that continue to build patient and societal wellness levels, including social determinants of health, well-known to offset fiscal issues that have essentially, been out of control for decades downstream.

Measurement and valuation of upstream health system components and operations, enables determination of equilibrium with health system components and operations downstream. Using a life-time horizon approach in QALY valuation of wellness management, economic models designed to project future upstream effects of standard care versus wellness-oriented intervention, predict future long-term cost-savings using wellness-oriented metrics. At both the micro individual and macro systems levels, wellness may be measured and summed:

I. intrinsically, inherent to 1° disease prevention and health promotion;

II. retrospectively, derived from elimination of sunk cost sources; and

III. prospectively, projecting forward utilizing wellness metrics, upon wellness’ essence of increased strength.

Conservation of health resources by protecting and building patient wellness levels, increases the capacity to self-sustain and facilitates long-term maintenance of even counterbalance between the upstream and downstream components of the PHC continuum. An increased capacity to self-sustain develops viability and a health system able to capitalize on its strengths within measured patient wellness. (© Tremblay LJ. 2020)

8. Viability within an Entire PHC Continuum

Development of an increased capacity to self-sustain (increased wellness) is analogous to power production of the cell’s major carrier of chemical energy, adenosine triphosphate, or ATP. Capture, storage, transport, and release of chemical energy via ATP within a living cell, comprise linked networks of processes, optimally designed in their constant responsiveness to underlying cellular conditions through two fundamental networks of enzyme-catalyzed reactions: A. Networked processes that conserve (store up) energy derived from the environment (solar energy and nutrients) in the chemical form of ATP, are analogous to the upstream end of the PHC continuum that conserves (develops, builds and stores) wellness and increases capacity to selfsustain, to capitalize on wellness reserves and progressively build improved health. Development of the upstream end of the PHC continuum is made using standardized measures of upstream operations, including: standardized measures of primary disease prevention and health promotion strategies, activities, patient services, and interventions; standardized patient outcome measures, including standardized wellness measures; and standardized measures of upstream infrastructure performance, including digital infrastructure performance. Regularly scheduled, periodic audits (external, internal, and government revenue audits) guide continuous improvement in upstream operations and facilitate accountability in performance and finances on all levels:

1. at the macro systems level, including management and administration, and

2. at the micro level of individual patient care.

Audits enable identification of upstream processes that i) are no longer working, or ii) are working, but could become more efficient: to drive better performance, provide more value and optimize future operations’ performance and finances. Economic growth toward specific goals is ideally, a continuous formulation and reformulation in response to changing conditions, with attention and resources allocated to the long-term course of the economy.

Given the standardized measure of functional upstream health system components (primary disease prevention and health promotion strategies, activities, patient services, interventions, patient outcomes, and infrastructure, including digital infrastructure) equals the standardized measure of upstream operations:

The standardized measure of upstream operations / x individual patients of community/city

= standardized concentration of upstream operations

= standardized [upstream operations], (© Tremblay LJ. 2020)

Examples of upstream operations include, but are not limited to: i. primary clinic care visits that accommodate client education/counseling/wellness strategy development, ii. home care visits, and iii. community events that encompass group education/social support sessions. Each example listed above contains functional components (or operations) of patient services, interventions and patient outcomes, that conserve (develop, build and store) wellness, to capitalize on wellness and build health. Associated with each example of upstream operation are corresponding components of primary disease prevention and health promotion strategies, activities, and infrastructure (including digital infrastructure). (© Tremblay LJ. 2020)

B. Networked processes that utilize ATP energy to biosynthesize a living cell’s components from simpler precursor molecules, doing the work of the cell, are analogous to the downstream end of the PHC continuum that uses wellness-resources during various stages of illness treatment. Development of the downstream end of the PHC continuum, toward even counterbalance with the upstream, is made using standardized measures of downstream operations, including: standardized measures of secondary and tertiary disease prevention strategies, activities, patient services, and interventions; standardized patient outcome measures, including standardized wellness measures; and standardized measures of downstream infrastructure performance, including digital infrastructure performance. Regularly scheduled, periodic audits (external, internal, and government revenue audits) guide continuous improvement in downstream operations and facilitate accountability in performance and finances on all levels:

1. at the macro systems level, including management and administration; and

2. at the micro level of individual patient care.

Audits enable identification of downstream processes that i) are no longer working, or ii) are working, but could become more efficient: to drive better performance, provide more value and optimize future operations’ performance and finances. Economic growth toward specific goals is ideally, a continuous formulation and reformulation in response to changing conditions, with attention and resources allocated to the long-term course of the economy.

Given the standardized measure of functional downstream health system components (secondary and tertiary disease prevention strategies, activities, patient services, interventions, patient outcomes, and infrastructure, including digital infrastructure) equals the standardized measure of downstream operations:

The standardized measure of downstream operations / x individual patients of community/city = standardized concentration of downstream operations

= standardized [downstream operations], (© Tremblay LJ. 2020) Examples of downstream operations include but are not limited to: i. specialized referral visits at outpatient care clinics, ii. emergency department visits, iii. inpatient admissions and discharges to and from acute care hospital, iv. participation in rehabilitation programs for permanent impairments, and v. chronic disease management.

Each example listed above contains functional components (or operations) of patient services, interventions and patient outcomes, that use wellness resources during various stages of illness treatment downstream. Associated with each example of downstream operation are corresponding components of secondary and/or tertiary disease prevention strategies, activities, and infrastructure (including digital infrastructure). (© Tremblay LJ. 2020)

Within the entire PHC continuum, regularly scheduled upstream audits, coordinated with regularly scheduled downstream audits, enable constant responsiveness to underlying conditions, for optimal design of linked networks: where certain processes may be eliminated, others streamlined, and still others capitalized upon, in a concerted effort between both upstream and downstream operations. In living cellular systems, ATP is a powerful link between fundamental networks of enzyme- catalyzed reactions. So too, in viable patient health systems, the strengths-building element of wellness is a powerful link between that built within the upstream end of the PHC continuum, and that which is sparingly used within expensive downstream environments that treat illness. When confronted with the downstream work of illness treatment, access to wellness reserves is more easily facilitated, and systemic balance throughout the entire PHC continuum is more easily maintained, through the optimal design of coordinated, linked networks. Regulation of evenly counterbalanced upstream-downstream operations facilitates increased reserves of patient wellness resources: vital to health and health systems, where standardized quantification of patient wellness levels increases accuracy of actual health measurement within economic evaluations.

Equal patient access to upstream and downstream health system components that are coordinated, linked and regulated, enables equal access to wellness reserves in both upstream and downstream directions, supporting sustained maintenance of an evenly counterbalanced patient health system. Moreover, optimal designs of coordinated, linked networks, further facilitate improved social determinants of health, creating a positive domino effect: where improved social determinants of health further facilitate development of increased wellness throughout the entire PHC continuum, increasing capacity for system redesign toward improved viability; wherein wellness strengths accrue at an estimated rate of growth projected from time-frames utilized to create equilibrium within a new patient health system. (© Tremblay LJ. 2020)

9. Social Determinants of Health (SDOH)

Upstream investment develops wellness resources, capitalized upon in building health: proactively strengthening social determinants of health (SDOH) throughout the entire PHC continuum, increasing system viability, and creating economic growth; since strengthening SDOH throughout the entire PHC continuum optimizes conditions within which populations are able to thrive. Beneficial positive correlations between a) standardized quantitative measures of SDOH and economic growth, for example: standardized quantitative measures of increased socioeconomic status (or SES, the most significant SDOH) and economic growth; and between b) macroeconomic indicators of consumer spending and GDP, contrast with harmful positive correlations found between low socioeconomic status and unhealthy behaviors, compounded in remote Canada by northern environmental and geographical challenges. Analyzed for society as a whole, the economic viability of viable patient health systems is achieved when economic benefits exceed economic costs; where economic benefits of viable patient health systems include increased capacity to selfsustain, derived from increased patient wellness levels in strengthened SDOH.

9.1 Economic Growth

Economic growth equals increased capacity to produce goods and services in the economy, compared from one period of time to another; occurs whenever people take resources and rearrange them in ways that are more valuable, generating more economic value per unit of raw material.

9.2 Economic Efficiency

Economic efficiency equals distribution or allocation of all goods and factors of production (land, labor, capital, and entrepreneurship) in an economy to their most valuable uses, with minimal or no waste; every scarce resource in an economy is used and distributed among producers and consumers respectively, producing the most economic output and benefit to consumers. 9.3 Structural Problems versus Structural Solutions

The late Dr. Simon Kuznets, American economist, statistician, and founder of the formal GDP formula, recognized that when consequences of long-term commitments become problematic, the cost of the extra effort that must then be made to counteract their negative cumulative impact, may not be negligible. Opposite to the negative potential of persistent problems within low growth economies to become structural problems: undermining people’s jobs, living standards and aspirations for years into the future; improved SDOH carry positive potential, in their provision of structural solutions for generations to come, where improved societal foundations create more predictable environments in which businesses can thrive and create jobs. Governments taking advantage of very low interest rates are able to invest in infrastructure for a future that harnesses SDOH solutions. Intentional integration of SDOH improvements throughout the entire PHC continuum of viable patient health systems, recognizes the direct contribution of societal SDOH factors to the wellness component of the QALY metric throughout:

1. an individual patient’s life cycle, and

2. a group or population’s generation turnover, where systemic SDOH improvements actualize optimized conditions within which, populations thrive. (© Tremblay LJ. 2020)

10. Vulnerable, Marginalized Individuals and Populations

Long-term, sustained maintenance of upstream-downstream-balance within the PHC continuum, creates patient health system viability, which inevitably increases focus on vulnerable, marginalized individuals and populations. Development of increased primary (1°) disease prevention and health promotion components within imbalanced PHC continua in all healthcare systems with overweight downstream components, necessarily increases focus on vulnerable individuals and populations, historically marginalized on the perimeter, or entirely outside of the system.

Best interests of all patients, elite or marginalized, may be most effectively explored within issues most pronounced in marginalized populations of our society. Change efforts strategically focused on vulnerable, marginalized populations most powerfully potentiate positive transformation for all members of society as an inclusive whole. Vulnerable, marginalized individuals and populations present common-ground between each society and country that uses viable patient health systems, offering mutual learning links for partnerships’ integration of wellness-based strategies.

Positive return on upstream investment is most evident in vulnerable and marginalized populations, where positive correlation between low socioeconomic status and unhealthy behaviors is commonly visible. Not only is increased upstream activity felt most dramatically by those who have historically, had least availability and access to upstream health services, or any health service; but benefit of new upstream activity is naturally expected to be most dramatic within vulnerable and marginalized populations. Resources in viable patient health systems are more valuable when rearranged in ways that generate more economic value per unit of raw material, through upstream investment. (© Tremblay LJ. 2020)

10.2 Improved Social Determinants of Health (SDOH)

Investment in new upstream services within viable patient health systems creates positive effects at macro and micro levels: connecting marginalized populations to mainstream society, and allowing individual integration for development of personal autonomy. At a macro level of mainstream society, that has to date, experienced a predominantly ‘sick-care’ system of traditional healthcare; encountering increased primary (1°) disease prevention and health promotion components that facilitate improved upstream operations, comprise largely new experiences which strengthen the system overall, through increased wellness levels that contribute to improved social environments, social support networks, and a positive domino effect of ongoing, continued growth in SDOH throughout the entire PHC continuum. Upstream investment improves the social and economic factors that influence people's health, and naturally manifests most dramatically within vulnerable, marginalized individuals and populations. Greatest gains made in increased wellness levels within vulnerable, marginalized populations, create greatest gains in wellness levels overall, at the macro level; and within all individuals throughout the entire PHC continuum, at the micro level. More specifically, generation of more economic value per unit of raw material, through upstream investment that strategically focusses on vulnerable, marginalized populations, most powerfully potentiates positive transformation for all members of society as an inclusive whole; since resources, including wellness resources, are more valuable when rearranged in ways that generate more economic value per unit of raw material. (© Tremblay LJ. 2020) 10.3 Capacity -Building and Positive Domino Effect

Dynamics that previously compounded negatively (negative domino effect in the positive correlation between low socioeconomic status and unhealthy behaviors) now build positively and facilitate further improvements within the SDOH. This process of capacity-building is naturally most pronounced within disadvantaged populations who have most to discover within expanded health realms, creating a positive domino effect that contributes most to increased wellness levels for sustained maintenance of balance throughout the entire PHC continuum, that encompasses all populations contained within it. Increased wellness that builds most dramatically in disadvantaged populations, thus benefits the larger set of all populations contained within the entire PHC continuum; populations that previously, lived human lives with lesser degrees of wellness themselves, by nature of imbalanced systems that caused net harm to the overall population. From those who have most to discover within positive health realms, the greatest contributions of increased wellness are made for sustained maintenance of balance throughout the entire PHC continuum, serving the larger population as a whole. On both micro and macro levels, integration of innovative, proactive patient-centered initiatives upstream, ameliorates lifelong chronic health challenges that drain both individual patients and the system itself in the long term.

Over the long term, balancing complex healthcare demands through strategic application of evolving knowledge, together with patients as partners in their own health management; restores resourcefulness needed to meet complex, systemic challenges throughout all components of the PHC continuum, both up and downstream. Recognizing health to be a fundamental human right, strategic focus on the most vulnerable and marginalized individuals, communities, populations, and countries, augments cost-savings within balanced, viable patient health systems, for all populations and individuals. Improved wellness levels mitigate the negative domino effect of reliance on expensive social safety nets (examples: rehabilitation programs for drug addiction, infection control programs that attempt to limit / halt infectious disease transmission). Instead of negative domino effects that health systems have tolerated for decades, benefits of wellness amplification accrue alongside associated economies outside of the health sector. Viable patient health systems allow individuals, societies, and countries who create them, to realize expansion of non-health sectors (such as natural resources, legal system) as the health sector not only gains control of its expenditure as percent GDP, but creates its own viability. (© Tremblay LJ. 2020) III. Appropriate Technology (AT) Embodied in the NP Role

Appropriate Technology - modes of care that are appropriately adapted to the community’s social, economic and cultural development; as alternatives to high technology, high cost services, through innovative models of health care that disseminate research results, for improved knowledge and ongoing capacity-building to the design and delivery of health care services.

1. Patients’ Best Interests for Dominant Strategy of AT Interventions

Neither tax revenue nor corporate profits, one of the most closely monitored economic indicators in the world, have been able to address the critical escalation of systemic sustainability issues within traditional, illness-oriented healthcare systems. Competitive advantages of low production cost and efficient process in provision of patient services, for high quality output with minimum waste, are secured through viable patient health systems. Increased productivity (that is, increased output per unit of input; where input that costs more per output gained, is not efficient) of high quality positive patient outcomes constitute patients’ best interests, which incentivizes further increased productivity of high quality positive patient outcomes within the system overall. Appropriate Technology (AT) interventions that are more effective at producing high quality positive patient outcomes, with net cost savings, comprise a dominant strategy. Increased production of high quality positive patient outcomes for less expenditure, including increased production of capacity to self-sustain derived from patients’ wellness levels, serves patients’ best interests; and is achieved through implementation of AT interventions.

1.1 NP Role Embodies Appropriate Technology (AT)

Aligned with the primary health care principle of appropriate technology, Nurse Practitioners (NPs) engage in care with all population sectors: including vulnerable, marginalized populations within local environments of struggle, facilitating quality patient and family centered care in the development of improved SDOH. Where NPs practice according to all principles of primary health care, it may be argued that the principle of appropriate technology most closely aligns with practice of the NP: as a mode of care that appropriately adapts to the community’s social, economic and cultural development; builds capacity in design and delivery of health care services, through advanced knowledge and competencies; with consideration of alternatives to high cost, high tech services; recognizing the importance of developing and testing innovative models of health care; and of disseminating results of healthcare research. Implementation of the principle of AT throughout the entire PHC continuum involves standardized quantitative measurement of:

1. cost-effective resource utilization, including resources traditionally underutilized;

2. patient health services appropriately adapted, designed and delivered according to a community’s social, economic and cultural development;

3. patient health services based upon innovative models of health care that disseminate research results, for improved knowledge and ongoing capacity-building within the patient-provider team and throughout the PHC continuum; and

4. cost-savings inherent to development of increased patient wellness levels, related to patient health services noted in 2. and 3. above.

While practical application of wellness strategies are evaluated over time by all health providers, NPs’ ubiquity within viable patient health systems, provides powerful potential for capacitybuilding within numerous settings, related to: i. improved efficiency (minimum wasted effort, minimum wasted resource-expense); ii. increased productivity, particularly within contexts of previous underutilization; and iii. reductions in overall costs. (© Tremblay LJ. 2020)

Within a team framework that centers the patient within the team, operations of viable patient health systems further strategize upon the question "how can the NP be utilized in a way that potentiates the productivity and expertise of the patient and complementary provider(s)?” where the versatile NP role contains the capacity to implement the principle of AT throughout the entire PHC continuum, at multiple levels of change:

1. Macro: systemically across all settings and vertically throughout the hierarchy of each setting’s own structure; and

2. Micro: where parameters of NP role-functions in either role of autonomous practitioner or interprofessional team member, closely align with the principle of AT.

As a dedicated change agent within viable patient health systems, the NP role serves as a reference-point for all other types of change agents that facilitate the development and sustained maintenance of upstream-downstream-balance throughout the entire PHC continuum. Nursing frameworks that emphasize holism, health promotion and partnership with individuals, families, communities, and populations, advance translation of wellness strategies in proactive patient- focused care, for increased access to service at reduced cost. (© Tremblay LJ. 2020)

1.2 Historical Research Context

From as long ago as 1973, whether or not RCT research reports benefit for both patients and practitioners by integration of NP services, replication of new modes of care may not benefit the public at large without regulatory change that is accepted by all professionals according to the primary interests of the public their professional services are intended to serve. Results of Dr. Walter Spitzer’s original non- inferiority trial of 1974 showed the NP to be clinically safe, effective and cost-effective from a societal perspective, based on quantitative patient outcomes and a 22% net increase in families accepted into primary care practice during the one-year trial period. At one year follow-up, families receiving primary clinic services continued to increase, plateauing at a 41% net increase in more families receiving care (2256 families receiving care by June 30, 1973) compared to the baseline value of 1598 families receiving care on July 01, 1971. However, this societal benefit was not realized economically by the physicians’ primary care practice, due to restricted reimbursement for NP services. At the time of the trial, Ontario regulations did not permit billing for unsupervised NP services previously provided by GPs, where GP services were reimbursed by government according to the Ontario medical association’s fee schedule. More recently, in 2004, Dr. David Chenoweth, an American econometrician, undertook a research study that assessed the initial impact of onsite NP services for six months, on 4,284 employees’ health care costs (including their dependents) at an industrial manufacturing company in North Carolina, U.S.

1.3 Data Management at Micro and Macro Levels

In viable patient health systems, indices of individual patient care and organizational change are consistently monitored over time, with data recorded accordingly, to facilitate analysis including characterization of data trends; where development of theoretically grounded and practically useful indices of effectiveness of upstream patient care services, facilitates increased operation of upstream health system components. At the micro level, data management may consider the set of indices outlined in Chenoweth’s follow-up study evaluating care provided by onsite NP services, for employees of a manufacturing company in North Carolina, U.S.:

1. Total number of visits per month 2. Total visits by location

3. Type of visits by location (walk-in, phone appointment, appointment)

4. Percentage of employees by location using NP services

5. Average visits per employee by location

6. Drug prescription tiers ($10, $30, $50, Over the Counter or OTC)

7. Top utilized diagnoses as percentage of total visits

8. Number of top utilized diagnoses by location

9. Most common prescriptions

10. Total referrals to primary care physician or specialist

11. Number of referrals by location

Data management at the macro level may consider the approach used in Chenoweth’s 2004 assessment of onsite NP service costs at a group, organizational level: based upon annualized actual values from insurance claims paid by the company’s health plan payer. The difference in costs between projected values (without NP service) and actual values (with NP service) equaled the reported benefit of the onsite NP service. In viable patient health systems, micro and macro level data consistently monitored over time, further includes factors beyond clinical evidence and costeffectiveness, namely: patients’ expectations, equity concerns, and issues of logistics and feasibility. Data may be derived from many different sources including clinical trials, observational studies, insurance claim databases, case registries, public health statistics, and preference surveys.

Benefit-cost analysis performed in Chenoweth’s 2004 study, assessed whether six months of the NP program was worth its cost; favorable impacts were reported in 2005, in terms of:

1. Onsite NP service costs within nine ‘Major Diagnostic Categories;’ versus costs that would have been incurred had off-site care been utilized, and

2. Actual health care costs of NP service at the group (organizational) level; versus projected health care costs at the group (organizational) level without NP service.

Moreover, substantial reductions in health care costs reported by Chenoweth in 2005, did not include measure of two additional endpoints: i. on-site injury and illness patterns, that may have been found reduced had these patterns been measured, and ii. employee productivity, that may have been found improved as a result of the on-site NP program, had this productivity endpoint been measured.

Furthermore, the difference between actual versus projected health care costs in Chenoweth’s study, only reflected the difference in direct costs of medical care payments incurred either onsite or offsite, without consideration of hidden costs such as: a. lost productivity associated with offsite healthcare visits, or b. the number of lost-time absences avoided by employees seeking onsite service.

Favorable benefit to cost ratios (savings) were reported by Chenoweth in both the initial impact analysis published in 2005, and in its three-year follow-up published in 2008, confirming initial findings that an onsite NP has a favorable benefit to cost function, with recommendations made for additional longer term analyses to confirm both sets of findings.

IV. Cost

1. Threefold Cost Savings Synergistically Alleviate Downstream Crisis

In 2005, econometrician Dr. D. Chenoweth recognized the importance of optimizing benefit-to- cost function in healthcare, particularly by those entrusted with the care of the community. Chenoweth reiterated this view in his 2008 follow-up study, emphasizing the importance of optimizing benefit to-cost function of health services in measurable ways, through rigorously accurate and transparent report of quantitative data by researchers, including report of the data’s limitations. Regarding limitations, analysis of quantitative results from well-conducted (valid and reliable) studies, informs design of future research, whereupon even more useful statistical analyses may be performed in patients’ best interests. Scientific best practice standards involve use of all relevant, high quality data regarding allocation of patients’ tax dollars in patient care provision; where evaluation of resource cost analyses, considers not only limitations of clinical evidence and cost-effectiveness data, but factors such as: patients’ expectations, equity concerns, and logistics and feasibility. Cost savings inherent to viable patient health systems over the long term are three-fold, related to:

1. increased health system components and operations in less expensive upstream setting,

2. decreased health system components and operations in more expensive downstream setting, and 3. sustainability gained toward viability.

Increased health system components and operations in upstream settings (examples: primary clinic care and community care settings) that are generally less expensive, result not only in cost savings but also in cost saving benefits of increased wellness-based patient outcomes (examples: maternal / infant health and knowledge), with potential to compound positively through practical benefits inherent to primary (1°) disease prevention and health promotion. Decreased health system components and operations in downstream settings (examples: specialized referral / outpatient clinic care, emergency department / acute inpatient care, and long term care settings) that are generally more expensive, are also associated with cost savings. However, if not at least in balance with upstream health system components and operations, downstream health system components and operations carry potential to negatively compound financial challenges to the system, threatening maintenance of even counterbalance; where sustained maintenance of even counterbalance between upstream and downstream health system components and operations, throughout the entire PHC continuum, is a viable patient health system.

Cost savings of viable patient health systems in present terms and over the long term, result from: i. decreasing patients’ high cost loss downstream, a. QALY loss inherent to illness diagnosis and illness treatment, and b. dollar loss in more expensive downstream setting(s), either by patients’ direct payment, or indirectly, via patients’ tax dollars; and ii. enabling development of wellness-resources to be capitalized upon in building health: intrinsically, retrospectively, and prospectively; throughout the entire PHC continuum.

Opposite to diagnosis of illness with treatment that occurs predominantly downstream, diagnosis of wellness and development of wellness strategies, occur throughout the entire PHC continuum, although predominantly upstream. In addition, diagnosis of wellness and development of wellness strategies, are generally more effective at producing health benefits associated with net cost savings. By definition, integration of wellness diagnoses into health provider assessment protocols is a dominant strategy, facilitating higher levels of patient wellness to be capitalized upon in building health: intrinsically, retrospectively, and prospectively, throughout the entire PHC continuum; while decreasing patients’ high-cost loss downstream, for net cost savings in present terms, and over the long term. Cost savings inherent to viable patient health systems, enable long term maintenance of even counterbalance between upstream and downstream components and operations, facilitating growth in viability itself. (© Tremblay LJ. 2020)

2. Development of Decision Analytical Models for Economic Evaluation

Since randomized controlled trial-based (RCT-based) economic evaluations may not provide sufficient information for regulatory and reimbursement decisions, models allow for synthesis of information from multiple sources, including a comprehensive comparison of expected costs and or cost-savings, with consequences of decision options. Aiming to provide decision-makers with the best available evidence regarding a specific question or decision-problem, all relevant and available options are defined within the model for a particular recipient population and setting. However, mathematical results of decision analytical models are subject to the influences of: i. variability: refers to data diversity inherent to a set of values, with its range quantitatively described using statistical metrics such as variance, standard deviation, and interquartile ranges; ii. uncertainty: refers to a lack of data or an incomplete understanding of the decision’s context

(versus provision of transparent, thorough data-reporting); and iii. heterogeneity: refers to variability in intervention effects being evaluated from multiple sources (different studies); also known as statistical heterogeneity, and is a consequence of clinical or methodological diversity or both, among the studies; manifesting itself in observed intervention effects being more different from each other than one would expect due to random error (chance) alone.

In light of the above three influences, mathematical results of decision analytical models must be managed appropriately.

2.1 Societal Perspective in Cost-Effectiveness Analyses (CEAs)

Broad societal perspectives are integral to decision makers’ objectives regarding transparent allocation of public resources in publicly-funded patient viable patient health systems. On examination of costs associated with health interventions, the first panel on cost-effectiveness in health and medicine from 1996, recognized the societal perspective within major resource / cost categories, including: costs of health care services; costs of patient time expended for an intervention; costs associated with caregiving (paid or unpaid); other costs associated with illness such as childcare and travel expense; economic costs borne by employers, other employees, and the rest of society, including ‘friction costs’ associated with absenteeism and employee turnover; and costs associated with non-health impacts of the intervention, for example, on the educational system, the criminal justice system, or the environment. Based on recommendations of the 1996 panel on cost-effectiveness in health and medicine, cost-effectiveness analyses (CEAs) that inform societal resource allocation must include:

1. costs from a long term, societal perspective: where the numerator of a cost-effectiveness (CE) ratio captures resource impact (costs or savings) associated with an intervention, and the denominator captures health impact (improvement or decline) associated with an intervention; and,

2. all important measures of impact on human health and resources, in either the denominator or numerator of a CE ratio, to avoid incomplete CEAs.

Time series data within major resource / cost categories, documented at specified periods of time, enables study of phenomena over time: through comparison of current trends with trends anticipated, and trends past. Repeated measurement of particular endpoints at specific times, tracked over regular intervals of time (endpoints such as: employee productivity; number of lost- time absences avoided by employees seeking onsite health service) creates a series of data that enables valid statistical analysis of patterns. Time series data and time series analysis may be utilized within CEAs that facilitate informed decisions in patients’ best interests.

Approximately twenty years past the first panel on cost-effectiveness in health and medicine, revised recommendations were provided in 2016 by a second panel, related to the reported inclination on the part of many individuals to minimize the reality of resource scarcity. The second panel clarified multiple factors beyond cost-effectiveness that are brought to bear on resource allocation decisions, and emphasized the crucial necessity of appropriate perspective being taken in analysis, for accurate information to be provided to decision-makers. If different decision makers have conflicting requirements, the analytic perspective and scope (boundaries of the analysis) should be broad enough to allow results to be dismantled into component parts for various analyses in the best interests of the patient public. While the second panel on cost-effectiveness in health and medicine maintains distinctions between two perspectives used in CEAs: i. the health care sector perspective (traditional downstream healthcare expenditure); and, ii. the societal perspective (incorporates all costs and health effects regardless of who incurs the costs and who obtains the effects); the societal perspective’s incorporation of all costs and health effects is most reflective of an entire PHC continuum. (© Tremblay LJ. 2020)

2.2 Decision Analytical Models Built for Viable Patient Health Systems

Decision analytical models that consider an entire PHC continuum, use the societal perspective to analyze:

I. Generation of even counterbalance between upstream and downstream ends of the entire PHC continuum, using calculations of discrepancies between standardized measure of functional upstream and downstream health system components; and

II. Costs and cost-savings in two phases:

Phase 1 - Generation of even counterbalance between upstream and downstream ends of the entire PHC continuum noted in I. above, and

Phase 2 - Sustained maintenance of even counterbalance between upstream and downstream ends of the entire PHC continuum; for viability in present terms, and over a long-term timehorizon that accounts for inflation, interest rates, varying cash flows, and the value of money.

1. Broad Gauges of Growth

In our digitized, globalized world, viable patient health systems inevitably connects to international systems and their economies. Dr. S. Kuznets, founder of the GDP formulation, noted that objectives regarding rate of economic growth should be explicit, where growth goals should specify more growth of what and for what, warning that institutional arrangements designed specifically for a broad continuous examination of the long-term future, are typically insufficient on the part of the private sector, government, and universities. Within international and global perspectives, broad gauges of growth are fundamental, to quantify development of viability over the long term. Broad metrics used to quantify development of viability over the long term include gauges of wellness and SDOH improvement, that protect against the self-defeating instance of narrow economic considerations absent health. (© Tremblay LJ. 2020)

2. Informatics

In viable patient health systems, informatics science that supports improved human health, guides the integration of wellness data into patient health system components and their operations: strategies, activities, patient services, interventions, patient outcomes, and infrastructure, including digital infrastructure; throughout an entire PHC continuum. With an understanding of organizational workflow, as well as the potential and limitations of information technology, informaticians facilitate technology-based improvements involving biomedical data management, including management of wellness data: wellness development strategies and activities; patient services that integrate wellness diagnoses within wellness-oriented health assessment protocols and interventions; wellness-based patient outcomes; all within an infrastructure, including digital infrastructure, that builds wellness levels in individuals and populations throughout the entire PHC continuum.

Informaticians’ facilitation of improvements in biomedical data management, includes management of SDOH data: particularly between potentially partnered countries with similar viable patient health systems, involving natural grouping of similar jurisdictions for natural grouping of data. International standards for electronic transfer of clinical and administrative data, known as Health Level Seven (HL7) were originally formed in the late 1980’s by a group of health care providers, to facilitate computer based management of clinical healthcare information between various levels of healthcare systems. Serving as a prototype for harmonizing disparate standards, HL7 became a primary standard for healthcare systems’ national health record projects in a number of countries, including England, Germany, the Netherlands, Canada, Japan, and Korea. Developments continue in the current HL7 Version 4.0, a ‘Fast Healthcare Interoperability Resources (FHIR) standard,’ with further improvements in health care interoperability expected by the third quarter of 2020, in the anticipated release of HL7 Version 5.0.

3. Developed Countries

At present, over 50 countries support HL7, and this support includes hundreds of corporate members that represent healthcare providers, government stakeholders, payers, pharmaceutical companies, suppliers, and consulting firms. Purposes of HL7’s information and communications technology range widely from health administration to patients’ eHealth. However, the impact of information and communications technology on patient health, most relevant to developed countries, is typically inferior within most underdeveloped countries; while underdeveloped countries are often thought to be benevolently and altruistically aided by developed countries.

Econometrician Dr. Chenoweth recognized in 2005, that despite it being counterintuitive to profit-seeking organizations within the world of health systems, fundamental obligations of those entrusted with providing care services to their communities include optimizing patient benefit to cost functions. Dr. Chenoweth reiterated this again in his 2008 follow-up study. Yet corporate economic impact that mal-affects patients’ health in both developed and underdeveloped countries, particularly in cases of lost corporate tax revenue from tax avoidance, has the opposite effect than that of optimizing patient benefit to cost functions, both at home and abroad, universally damaging the larger economy in which patients live.

In viable patient health systems, laws and regulations are adhered to by legitimate democratic government that is answerable to its citizens, in its straightforward public report of factors potentially detrimental to fundamental human rights (such as health) including economic impacts that are universally harmful to all involved societies. Tax transparency law in developed countries’ democracies, obliges business entities including government-owned businesses (Canadian Crown corporations) to explain their decisions and actions made on behalf of the citizens that elected their government, and to release specific documents to the public. Analogous to infectious disease control that attempts to manage transmission at various levels: 1) endemically within a population, 2) in outbreaks of above normal levels of disease within a local epidemic, or 3) within a global pandemic, where disease transmission is spread over several countries or continents; warnings are issued through measures of threshold values in public reports. Similarly, in viable patient health systems, economic impacts that are potentially detrimental to fundamental human rights (such as health) at various levels (populations, societies, countries, and continents) are disclosed to the public and reported in measures of threshold values, for warnings related to various levels of negative impact on health; including identification of factors that carry universally harmful societal impact, and create imbalance within PHC continua. (© Tremblay LJ. 2020)

However, corporate regulations created in the private interests of investors, remain unavailable to the public. Corporate disputes related to issues surrounding investor rights agreements are often heard outside of the public court in private trade-adjudication groups largely comprised of corporate representatives. While corporate investors are legitimately given rights to sue entities for even potentially, harming their future profits; the public has no clear avenue of action against corporate disputes that may be potentially detrimental to their human rights, including most importantly and fundamentally, the human right to health. An example of corporate economic impact that universally harms societies (harms all societies involved) and their Social Determinants of Health (SDOH), is the scenario of parent companies from first world, developed countries artificially shifting taxable profits into offshore tax havens, avoiding tax and damaging the larger economy.

Perhaps more obvious is the harm experienced by the underdeveloped host country, whose government may be interested in the new jobs and revenues associated with onset of international finance activity, for a relatively small local infrastructure investment in internet access. Yet the Social Determinant of Health (SDOH) of ‘employment and working conditions,’ when fixed in tax haven jurisdictions, suffers setback within the host country; where beneficial negative correlations between:

1. standardized quantitative measures of improved SDOH and reduced employment fixed in tax haven jurisdiction(s), and between,

2. standardized quantitative measures of economic growth and reduced employment fixed in tax haven jurisdiction(s), are both undermined. Law within the underdeveloped host country typically involves little or no tax liability with minimal reporting of information for foreign individuals and businesses, lack of transparency obligations, and lack of local presence requirements.

However, economist Dr. Michael Carnahan explains that well-functioning revenue systems are a necessary pre-requisite for strong, sustained and inclusive economic development in developing countries. Local tax revenue provides funds for public expenditure on infrastructure that enables local businesses to start or expand. A developing country that instead, offers tax haven opportunities, typically becomes increasingly oriented to the interests of privileged international business persons who do not even live there, causing the local economy, democracy and culture of its own society to deteriorate. Services organized by the host country to protect foreigners’ wealth, are disconnected from local producers’ businesses. Regional entrepreneurship and infrastructure development for advancement of local institutions, are undermined; in turn, undermining local capacity for self-governance.

Harm to societies involved in tax havens manifests similarly within developed, democratic host countries. For example, the country of Luxembourg in western Europe has one of the highest estimations of GDP per capita in the world, yet according to Dr. Gabriel Zucman, poverty has doubled in Luxembourg since 1980, and real wages (adjusted for inflation) for ordinary citizens of Luxembourg have been stagnant for decades. Again, the Social Determinant of Health (SDOH) of ‘employment and working conditions,’ when fixed in tax haven jurisdictions, suffers setback within the host country; where beneficial negative correlations between:

2. standardized quantitative measures of economic growth and reduced employment fixed in tax haven jurisdiction(s), are both undermined. Over 60 percent of Luxembourg’s workforce is comprised of expatriate individuals, who reap the majority of wealth benefits generated within Luxembourg. Benefit gained by foreigners at the expense of locals has created economic and political rifts reinforced by phenomena such as: tripled housing costs accompanying dramatically increased salaries of expatriate wealth managers, alongside inadequate development of local public institutions’ infrastructure, where Zucman notes an accelerated decline within Luxembourg’s public education system, mal-affecting local families within Luxembourg.

Organizations such as Global Financial Integrity (GFI) and the Financial Accountability and Corporate Transparency (FACT) Coalition interface with the OECD in work toward establishing requirements for financial disclosure on the part of parent companies of large multinational companies. GFI President Raymond Baker alerts business and government communities to the crucial need for true transparency, describing tax haven activity as one of the most economically damaging practices that multinational companies engage in, citing billions lost by the U.S. in corporate tax revenue, and confirming that developing countries lose even more through tax haven activity. Baker acknowledges recently proposed U.S. regulation is a start, but warns that government needs to make international commitment to tax transparency real, by publishing stronger rules that puts information into the hands of the people, or at least into the hands of the people they have elected.

4. Stateless Populations

Kuznets’ direction for broad continuous examination of the long-term future, by now, includes consideration of an estimated 12 million stateless people, relative to the current world population estimate of 7.7 billion. Attention paid to the long-term course of the economy does not allow for an oversight of issues associated with 12 million stateless people, particularly while statelessness significantly and straightforwardly mal-affects the SDOH and subsequent economy. Yet only within the OECD’s third objective: “achieve growth through innovation, environmentally friendly strategies, and the sustainability of developing economies;” do populations beyond developed democratic member countries appear to be acknowledged. Potentially overlooking stateless populations and underdeveloped nations who are not OECD members, contributes to a fragile and uncertain global economy.

Conversely, viable patient health systems' strategic focus on the most vulnerable and marginalized, has potential to: i. mitigate the negative domino effect of reliance on expensive social safety nets (examples: rehabilitation programs for drug addiction, infection control programs that attempt to limit / halt infectious disease transmission) through improved wellness levels, ii. create and augment cost-savings through improved wellness levels, iii. harbor wellness strengths that accrue at an estimated rate of growth projected from timeframes utilized to create equilibrium within a new patient health system, for wellnessamplification, and expansion of non-health sectors (such as natural resources, legal system).

1. Partnerships Built Upon Harmonized International Standards

Minimization of redundancies and conflicts in the harmonization of international standards for viable patient health systems, opens avenues for enhanced economic partnerships in health and nonhealth sectors (such as natural resources, legal system) over the long term. Harmonized international standards that phase out technical barriers to trade, and that facilitate partnerships between countries with relatively straightforward, transparent relations, advance partnership possibilities in more complex arenas. With flexibility for innovation, and provisions for easier market access, harmonized international standards for viable patient health systems contain potential to generate additional networks of global partnerships. (© Tremblay LJ. 2020)

1.1 Indonesia and Canada: Integrated Development of Improved SDOH

Integrated development of improved SDOH throughout entire PHC continua provides long term positive payback of more stable societies, constituting a crucial factor to be retained in harmonization of international standards for viable patient health systems. A hypothetical example involves consideration of enhanced relations between Indonesia and Canada. Bordered by the longest coastlines in the world, Indonesia and Canada share significant geographical access challenges to health service. In Canada, the ratio of low population to expansive area, particularly in northern regions, compounds this challenge. However, commonalities inherent to both countries also include newly forming patient health systems (in the case of Indonesia) and newly forming components of patient health systems (in the case of Canada’s underdeveloped upstream end of the PHC continuum) within similarly daunting geographical challenges. Yet using a harmonized framework that focuses on improved SDOH, both countries are able to inform each other of insights gained in the creation of their viable patient health systems. Formation of balance within Canada’s health system may inform early stage formation of an entire PHC continuum within Indonesia; while the latter early stage formation may inform the former in many respects.

1.2 Long Term Strategy

Mutual learning links serve long term strategy for partnered countries that manage viable patient health systems. Decades ago, in 1982, American biochemist Lehninger recognized that the science of nutrition is one of biochemistry’s greatest contributions to human welfare. Within the above example, specific issues mutually shared between Indonesia and Canada’s geographies, may serve as mutual learning links within a strategic long term partnership. For example, poverty within both countries may be addressed in part by food insecurity research. Translation of food insecurity research impacts many SDOH of individual patients, communities, and societies, in both countries. Regarding potential poverty reduction plans in both countries, translation of food insecurity research i) links directly with the SDOH ‘food security,’ and ii) links economically to both countries’ agricultural sectors. However, poverty issues shared by both countries, occur within very different contexts, in regions challenged to support agricultural development relative to high population density: Indonesia is approximately seven times Canada’s population, within approximately one fifth of Canada’s area; versus regions physically unable to support agricultural development: Canada’s pre-Cambrian shield, comprising over 50% of Canada’s area at eight million square kilometers of rock, largely situated in remote Canada. In each case, similarities and differences may link insights gained toward solutions, through the commonality of newly forming patient health systems that support long term SDOH development, at various stages of development per region.

Commonalities found between similar viable patient health systems of partnered countries, may enable development of mutually relevant databases, based upon natural groupings of similar jurisdictions within harmonized international standards. In the above example, organization of data in regional databases and registries, may include elements of poverty reduction plans that strategically support long term SDOH development of viable patient health systems. The commonality of newly forming patient health systems provide ample opportunity for mutually beneficial insights within shared geographical challenges, despite similar challenges manifesting very differently within Indonesia versus Canada. Learning links that support long term SDOH development within partnered countries may further generate additional international partnerships upon harmonized international standards. Networks of international partnerships built using viable patient health systems, result in economic relationships that have potential to be highly correlated with improved health envisioned by the UN’s Sustainable Development Goals.

VII. Meta- Analysis (MA) and Network Meta- Analysis (NMA)

Relatively common to downstream, illness-treatment research, are the mathematical and statistical techniques of meta-analysis (MA) and network meta-analysis (NMA); the latter NMA also known as ‘Multiple Treatments Meta- Analysis’ or ‘Mixed Treatment Comparison.’ Among many reasons noted in 2009 by Borenstein, Hedges, Higgins and Rothstein for conducting meta- analysis, one reason rests in the logic of trying to understand an entire body of evidence through meaningful synthesis of results that have been gathered systematically, as opposed to understanding studies individually in isolation, without consideration paid to the body of evidence as a whole. Reasons for conducting meta-analyses thus lie beyond the simple reporting of summary effect data, and include insight gained by the analysis in terms of designing future research, identifying where evidence is lacking. Meta-analysis that distinguishes between four patient care settings throughout an entire PHC continuum, may provide further insight toward maximization of intervention effectiveness, including cost-effectiveness, at both micro (patient) and macro (systems) levels within viable patient health systems,' where each setting represents the common ground / constant variable for each set of calculations comparing the ‘effect of intervention’ to ‘standard practice without intervention. ’

An expansion of classical pair-wise meta-analysis, NMA assesses the comparative effectiveness of more than two alternative treatment options for the same condition within a single analysis. NMA synthesizes direct evidence (from studies that directly compare interventions) and indirect evidence (derived from studies that do not compare the interventions directly but contain a common comparator) over the entire network to estimate:

1. the relative treatment effects for all comparisons; and

2. a ranking of the treatments.

However, treatments compared indirectly using a common comparator have not been randomized, resulting in comparative effectiveness data that within the hierarchy of scientific evidence, is only at the observational level of evidence, beneath high quality (low risk of bias) randomized trial evidence. Nonetheless, ranking of treatments from NMA is utilized by organizations such as the UK’s National Institute for Health and Care Excellence (NICE) and Germany’s federal agency Institut fur Qualitat und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) (English translation: Institute for Quality and Efficiency in Health Care) in their creation of evidence-based guidelines for consideration by government-payers of public health services. NMA displays a single coherent ranking of treatments (example: a preferential order of treatments prescribed from the same drug class to an average patient) in a Table or Rankogram.

Regarding analysis of intervention effectiveness data through either: a. classical pair-wise meta-analysis (MA), b. network meta-analysis (NMA), or c. neither MA nor NMA, should intervention effectiveness data under investigation not be homogenous for pooling; it is important to recognize that no health intervention is non-complex. Whether within the micro level of individual patient care provided to the complexity of the human body and person, of different gender, age, culture and geography (example: prescribing and managing drug treatment for an individual patient, over time and through transitions); or within the complexity of macro service systems (local / organizational, national, international / global) guideline development teams are trained to assess wide spectra of evidence based upon its methodological merit and thorough, transparent report. (© Tremblay LJ. 2020)

VIII. Concluding Remarks

Accordingly, the reader will see that viable patient health systems can be used:

I. firstly, to balance upstream health system components and operations: primary (1°) disease prevention and health promotion strategies, activities, patient services, interventions, patient outcomes, and infrastructure, including digital infrastructure; with downstream health system components and operations: secondary (2°) and tertiary (3°) disease prevention strategies, activities, patient services, interventions, patient outcomes, and infrastructure, including digital infrastructure; throughout Primary Health Care (PHC) continua; and

II. secondly, to maintain evenly counterbalanced patient health systems over the long term, whereby viability in patient health systems protects patient health as a fundamental human right and enables growth in non health sectors (such as natural resources, legal system)

(© Tremblay LJ. 2020) Furthermore, viable patient health systems has advantages in that it: provides three-fold cost-savings through synergistic alleviation of traditional healthcare systems’ fiscal crises, by: i) increasing less expensive upstream health system components and operations, ii) decreasing more expensive downstream health system components and operations, and iii) strengthening sustainability toward greater viability; proliferates patient wellness, increasing individual patients’ capacity to self-sustain and the system’s capacity to take the long-term perspective required for system redesign; optimizes resources within new health markets by exposing all key parties to cost alternatives, including the benefits (cost-savings) gained by building wellness levels within patients and populations; decreases patients’ high cost loss downstream (costs of QALY-loss inherent to illness diagnosis and illness treatment; and dollar-loss, either by patients’ direct payment, or indirectly via patients’ tax dollars) enabling further development of wellness-resources to be capitalized upon in building health; provides benefits that are: i) immediate, related to intrinsic benefits inherent to primary (1°) disease prevention and health promotion; ii) dramatic, juxtaposed against decades of sunk, retrospective costs; and iii) long term, using a lifetime horizon approach in prospective projections that utilize wellness metrics in viable patient health systems' mathematical models; integrates a psychometrically sound wellness score into QALY metrics used in economic evaluations: i) allowing for increased accuracy in numeric representation of actual health that includes non-illness dimensions, and ii) facilitating resource allocation decisions for different health states, within evenly counterbalanced patient health systems, where:

(Quantitative wellness measure / QALY) x 100% = percentage of wellness within QALY

= an individual’s or group’s capacity to self-sustain; allows for well-defined, precise regulation of coordinated upstream and downstream health system operations, linked for maintenance of even counterbalance between upstream attention and downstream demands; enables equal patient access to wellness reserves in upstream and downstream directions, supporting sustained maintenance of an evenly counterbalanced patient health system; enables sustainability to be most efficiently achieved and maintained toward patient health system viability, through simultaneously coordinated impact, in both upstream and downstream directions of PHC’s continuum; implements the dominant strategy of Appropriate Technology (AT) interventions: for production of higher degrees of quality positive patient outcomes, including production of capacity to self-sustain, for less expenditure; improves implementation of the principle of AT via a dedicated change-agent role, that functions as a reference-point for all other types of change agents, facilitating: i) increased upstream components and operations, ii) development of wellness levels within the patient at the center of patient-provider teams, throughout the entire PHC continuum, iii) maintenance of even counterbalance between upstream and downstream ends of the PHC continuum, and iv) improved SDOH throughout the entire PHC continuum; significantly builds production of patient wellness, related to improved efficiency, increased productivity, and overall cost reductions associated with the ubiquity of Nurse Practitioners’ (NPs) throughout the entire PHC continuum; proactively strengthens social determinants of health (SDOH) throughout the entire PHC continuum: i) creating structural solutions for generations, with long-term positive payback of more stable societies, ii) increasing viability, since translation of improved SDOH equals optimized conditions within which populations thrive, iii) resulting in economic growth, where economic viability of viable patient health systems is achieved when economic benefits exceed economic costs, through production of capacity to self-sustain, derived from patients’ wellness levels; strategically focuses on vulnerable, marginalized populations, wherein positive return is most evident on upstream investment: i) creating a positive domino effect that contributes most to increased wellness for maintenance of even counterbalance within viable patient health systems, ii) augmenting cost savings by mitigating the negative domino effect of reliance on expensive social safety nets, and iii) constituting crucial commonality between countries that adopt viable patient health systems,' develops theoretically grounded and practically useful indices of effectiveness of primary health care services, to facilitate increased operation of upstream health system components; consistently monitors indices of individual patient care and organizational change, to facilitate analysis of health service data over time, in a continuous formulation and reformulation that responds to changing conditions; optimizes benefit-to-cost function in patient care, through rigorous, systematic report of quantitative data, including report of all the data’s limitations; assumes a broad societal perspective in strategic planning and decision-making for transparent allocation of public resources in viable patient health systems,' distinguishes between four patient care settings for additional analyses toward enhanced cost-effectiveness at macro and micro levels within viable patient health systems,' monitors unique patterns of economic growth in health and non health sectors within viable patient health systems, including partnered countries that adopt viable patient health systems under harmonized international standards. (© Tremblay LJ. 2020)

Although the description above contains many specificities, these should not be construed as limiting the scope of the embodiments, but as merely providing instances of some of several embodiments. For example,

1. the strengths-building element of ‘wellness,’ is a powerful link between that built upstream and that which is sparingly used in downstream environments, but other links can be identified in viable patient health systems,'

2. strategic focus on the most vulnerable, marginalized individuals, populations, and countries, mitigates the negative domino effect of reliance on expensive social safety nets and augments cost-savings through improved wellness levels, yet other populations will yield positive return on upstream investment within viable patient health systems,' and

3. the dominant strategy of Appropriate Technology (AT) interventions produces higher degrees of quality, positive patient outcomes with less expenditure: the NP role contains the capacity to address an entire Primary Health Care (PHC) continuum and represents a dedicated changeagent at both the micro and macro levels of change, for improved implementation of AT interventions; yet other change agents within viable patient health systems are able to implement the principle of AT.

Thus, the scope of the embodiments should be determined by the appended claims and their legal equivalents. (© Tremblay LJ. 2020)

Claims

69 Claims What is claimed is:

1. A viable patient health system, comprising: a. first means for auditing standardized quantitative measures of upstream health system components and operations: primary disease prevention and health promotion strategies, activities, patient services, interventions, patient outcomes, and infrastructure, including digital infrastructure; over set periods of time relative to baseline quantitative measures at outset, to develop an upstream end of an entire primary health care continuum toward balance with a downstream end of said entire primary health care continuum, by independent body in computer system for health payer ’s record; b. second means for auditing balance generated between standardized quantitative measures of upstream health system components and operations of claim l.a., and standardized quantitative measures of downstream health system components and operations: secondary disease prevention and tertiary disease prevention strategies, activities, patient services, interventions, patient outcomes, and infrastructure, including digital infrastructure; over same set periods of time of claim l.a. relative to baseline quantitative measures at outset, throughout the entire primary health care continuum, by independent body in computer system for health payer ’s record; c. third means for auditing viability in sustained maintenance of substantially even counterbalance retained between standardized quantitative measures of upstream health system components and operations of claim l.a., and standardized quantitative measures of downstream health system components and operations of claim 1. b. ; over further set periods of time relative to baseline quantitative measures at outset, throughout the entire primary health care continuum, by independent body in computer system for health payer ’s record; d. fourth means for auditing viability of patient health system of claim l.c., including an extent of viability thereof, over further set periods of time of claim l.c. relative to baseline quantitative measures at outset, throughout the entire primary health care continuum, by independent body in computer system for health payer ’s record; 70 e. fifth means for auditing standardized quantitative measures of continuous improvement of a viable patient health system of claim l.c. and claim l.d., including fluctuations in viability thereof throughout the entire primary health care continuum, over same further set periods of time of claim l.c. and claim l.d. and ongoing, thereby advancing increments of time of claim l.c. and claim l.d., relative to baseline quantitative measures at outset, enabling an ongoing responsiveness to underlying conditions, by independent body in computer system for health payer ’s record; whereby viability of said viable patient health system protects patient health as a fundamental human right and enables growth in non health sectors. (© Tremblay LJ. 2020)

2. A viable patient health system of claim 1., wherein standardized quantitative measures of upstream health system components and operations throughout an entire primary health care continuum are developed and computed over set periods of time of claim La., claim Lb., and claim l.c., relative to baseline quantitative measures at outset; through means for categorizing, monitoring, computing, and charting standardized quantitative measures of upstream health system components and operations, including standardized quantitative measures of patient wellness, by independent body in computer system, for health payer’s record; whereby viability of said viable patient health system protects patient health as a fundamental human right and enables growth in non health sectors. (© Tremblay LJ. 2020)

3. A viable patient health system of claim 1., wherein standardized quantitative measures of downstream health system components and operations throughout an entire primary health care continuum are monitored and computed over set periods of time of claim l.a., claim l.b., and claim l.c., relative to baseline quantitative measures at outset; through means for categorizing, monitoring, computing, and charting standardized quantitative measures of downstream health system components and operations, including standardized quantitative measures of patient wellness, by independent body in computer system, for health payer’s record; whereby viability of said viable patient health system protects patient health as a fundamental human right and enables growth in non health sectors. (© Tremblay LJ. 2020)

4. A viable patient health system of claim L, wherein categorizing, monitoring, computing, and charting standardized quantitative measures over set periods of time of claim La., claim Lb., and claim l.c., relative to baseline quantitative measures at outset, from an entire primary health care 71 continuum, includes balancing standardized quantitative measures of downstream health system components and operations of claim 3. to a substantially even counterbalance with standardized quantitative measures of upstream health system components and operations of claim 2., by independent body in computer system, for health payer’s record; whereby viability of said viable patient health system protects patient health as a fundamental human right and enables growth in non health sectors. (© Tremblay LJ. 2020)

5. A viable patient health system of claim 1., wherein standardized quantitative measures of upstream health system components and operations of claim 2. balance with standardized quantitative measures of downstream health system components and operations of claim 3. to an enduring equilibrium derived from the substantially even counterbalance of claim 4., for viability in sustained maintenance of substantially even counterbalance over set periods of time of claim l.c., relative to baseline quantitative measures at outset, between the upstream end and the downstream end of an entire primary health care continuum; through means for categorizing, monitoring, computing, and charting said standardized quantitative measures of upstream health system components and operations of claim 2., and through means for categorizing, monitoring, computing, and charting said standardized quantitative measures of downstream health system components and operations of claim 3., by independent body in computer system, for health payer’s record; whereby viability of said viable patient health system protects patient health as a fundamental human right and enables growth in non health sectors. (© Tremblay LJ. 2020)

6. A viable patient health system of claim 1., wherein sustained maintenance of substantially even counterbalance for viability of an entire primary health care continuum of claim 5., is achieved over set periods of time of claim 5., relative to baseline quantitative measures at outset, by self regulating ‘off / on’ development of standardized quantitative measures of upstream health system components and operations of claim 2. in combination with monitoring of standardized quantitative measures of downstream health system components and operations of claim 3., by independent body in computer system, for health payer’s record; through means for categorizing, monitoring, computing, and charting said standardized quantitative measures of downstream health system components and operations of claim 3., and through means for categorizing, monitoring, computing, and charting said standardized quantitative measures of upstream health 72 system components and operations of claim 2., by independent body in computer system, for health payer’s record; whereby viability of said viable patient health system protects patient health as a fundamental human right and enables growth in non health sectors. (© Tremblay LJ. 2020)

7. A viable patient health system of claim 1., wherein self regulating of claim 6. is based upon a discrepancy between computed and charted standardized quantitative measures of downstream health system components and operations of claim 3.; and computed and charted standardized quantitative measures of upstream health system components and operations of claim 2., over same set periods of time of claim 5. and claim 6., relative to baseline quantitative measures at outset, throughout an entire primary health care continuum, by independent body in computer system, for health payer’s record; whereby viability of said viable patient health system protects patient health as a fundamental human right and enables growth in non health sectors. (© Tremblay LJ. 2020)

8. A viable patient health system of claim 1., wherein viability in sustained maintenance of substantially even counterbalance between the upstream end and the downstream end of an entire primary health care continuum of claim 5. and claim 6., further described in claim 7., is scored and charted, through means for calculating and charting accrued growth in standardized quantitative measures of patient wellness, throughout said entire primary health care continuum, over set periods of time of claim 5., claim 6., and claim 7., relative to baseline quantitative measures at outset, and relative to timeframe utilized for creation of enduring equilibrium of claim 5.; by independent body in computer system, for health payer’s record; wherein said accrued growth in standardized quantitative measures of patient wellness over set periods of time of claim 5., claim 6., and claim 7., is evaluated by independent body in computer system, for health payer’s record, in economic evaluation of growth rate of patient wellness within viability; wherein said growth rate of patient wellness within viability, determines economic benefits in excess of economic costs within viability, including calculation of economic benefit associated with an increased capacity to self sustain, by independent body in computer system, for health payer’s record; wherein calculation and charting of said increased capacity to self sustain, by independent body in computer system, for health payer’s record, is derived from a proportion of wellness score per quality adjusted life year; 73 whereby viability of said viable patient health system protects patient health as a fundamental human right and enables growth in non health sectors. (© Tremblay LJ. 2020)

9. A viable patient health system of claim 1., further including a system for equal patient access to upstream and downstream health system components and operations, comprising: a. means for legally enforcing equal patient access throughout an entire primary health care continuum by independent body in computer system for health payer’s record, according to section 3 of Canada’s 1984 Health Act, in its primary objective to protect, promote and restore the physical and mental well-being of residents of Canada, and to facilitate reasonable access to health services throughout said entire primary health care continuum, without financial or other barriers; according to common, central factor of an individual’s fundamental human right to health, in all governing societies that adopt viable patient health systems,' b. means for providing all patients access to upstream health system components and operations throughout the entire primary health care continuum, including upstream patient services, interventions and patient outcomes: categorized, monitored, computed and charted, over set periods of time of claim l.a., claim l.b., and claim l.c., by independent body in computer system, for health payer’s record, either: i. within community’s upstream operations, or ii. in communities without upstream operations, through access to upstream operations in closest proximity: potentially within coordinated networks of upstream and downstream patient services; where patient access is categorized, monitored, computed and charted by independent body in computer system, for health payer’s record; c. means for providing all patients access to downstream health system components and operations throughout the entire primary health care continuum, including downstream patient services, interventions, and patient outcomes: categorized, monitored, computed and charted over set periods of time of claim 9.b., by independent body in computer system, for health payer’s record, either: i. within community’s downstream operations, or 74 ii. in communities without downstream operations, through access to downstream operations in closest proximity: potentially within coordinated networks of upstream and downstream patient services; where patient access is categorized, monitored, computed and charted by independent body in computer system, for health payer’s record; d. means for all downstream operations throughout the entire primary health care continuum to utilize a bidirectional feedback loop to a coordinating access point within upstream operations, monitored in computer system by independent body, for health payer’s record; where all downstream operations must be linked to pre requisite record of previous attendance at said coordinating access point within upstream operations, with exception of life threatening emergency; e. means for all upstream operations throughout the entire primary health care continuum that are coordinated with subsequent downstream patient illness treatment, to utilize the bidirectional feedback loop of claim 9.d. to a coordinating access point within downstream operations, monitored in computer system by independent body, for health payer’s record; where all upstream operations coordinated with subsequent downstream patient illness treatment must be linked to pre requisite record of previous attendance at the coordinating access point within upstream operations of claim 9.d., and must be linked to record of corresponding subsequent downstream patient illness treatment, at said coordinating access point within downstream operations of claim 9.e.; f. means for all upstream operations throughout the entire primary health care continuum that develop patient wellness strategy separate from downstream patient illness treatment, to be linked to pre requisite record of previous attendance at a coordinating access point within upstream operations, with exception of initial upstream patient appointment; g. means for calculating in computer system by independent body, for health payer’s record, a standardized concentration of downstream health system operations per ‘x’ individual patients of community / city over set periods of time of claim 9.c., throughout the entire primary health care continuum; wherein ‘x’ equals a whole number value consistently used in claim 9.e. and claim 9.f; and the standardized quantitative measure of downstream health system operations of claim 3. / ‘x’ individual patients of community / city, equals the standardized concentration of downstream health system operations over said set periods of time of claim 9.c.; h. means for calculating in computer system by independent body, for health payer’s record, a standardized concentration of upstream health system operations per ‘x’ individual patients of community / city over set periods of time of claim 9.b., throughout the entire primary health care continuum; wherein ‘x’ equals a whole number value consistently used in claim 9.e. and claim 9.f; and the standardized quantitative measure of upstream health system operations of claim 2. / ‘x’ individual patients of community / city, equals the standardized concentration of upstream health system operations over said set periods of time of claim 9.b.; i. means for standardized concentration of downstream health system operations of claim 9.g., to never exceed the standardized concentration of upstream health system operations of claim 9.h. throughout the entire primary health care continuum, without penalty issued by independent body to an associated downstream structure, documented by independent body in computer system, for health payer’s record; j. means for calculating by independent body in computer system, for health payer’s record, a discrepancy between standardized concentration of upstream health system operations of claim 9.h. and standardized concentration of downstream health system operations of claim 9.g. throughout the entire primary health care continuum, for determination of penalty proportionate to a degree of excessive standardized concentration of downstream health system operations, throughout said entire primary health care continuum over set periods of time of claim 9.g. and claim 9.h., imposed by patient health system's payer to the associated downstream structure; k. means for maintaining patient health system’s balance between upstream and downstream operations, throughout the entire primary health care continuum, by payment of penalty issued in claim 9.i. and penalty imposed in claim 9.j., paid by the associated downstream structure to the patient health system’s payer, documented by independent body in computer system for health payer’s record; and documented by patient health system's payer in computer system for health payer’s record; l. means for standardized concentration of upstream health system operations of claim 9.h., to never exceed the standardized concentration of downstream health system operations of claim 9.g. throughout the entire primary health care continuum, without reward issued by independent body to an associated upstream structure, documented by independent body in computer system, for health payer’s record; m. means for calculating by independent body in computer system, for health payer’s record, a discrepancy between standardized concentration of upstream health system operations of claim 9.h. and standardized concentration of downstream health system operations of claim 9.g. throughout the entire primary health care continuum, for determination of reward proportionate to a degree of excessive standardized concentration of upstream health system operations, throughout said entire primary health care continuum, over set periods of time of claim 9.g. and claim 9.h., granted by patient health system’s payer to the associated upstream structure; n. means for building patient health system’s strength between upstream and downstream operations throughout the entire primary health care continuum, by receipt of reward issued in claim 9.1. and reward granted in claim 9.m., received by the associated upstream structure from patient health system’s payer, documented by independent body in computer system for health payer’s record; and documented by patient health system’s payer in computer system for health payer’s record; where any degree of excessive standardized concentration of upstream health system operations of claim 9.m., represents increased wellness reserves for said entire primary health care continuum, creating further incentive for patients with equal access to upstream and downstream health system components and operations to build further wellness reserves; o. means for calculating an extent of viability of claim l.d., proportionate to increased wellness reserves of claim 9.n., over set periods of time of claims 5., 6., 7., 8., and claim 9., throughout the entire primary health care continuum, by independent body in computer system, for health payer’s record; whereby viability of said viable patient health system protects patient health as a fundamental human right and enables growth in non health sectors. (© Tremblay LJ. 2020)

77 A viable patient health system of claim 1., further including a system of new use via a dedicated change agent, comprising: a. means for facilitating improved operations over set periods of time of claims l.a., l.b., l.c., l.d., and claim l.e., relative to baseline quantitative measures at outset, including: i. first means for evaluating standardized quantitative measures of patient wellness, wherein evaluating includes categorizing, monitoring, computing, and charting said standardized quantitative measures of patient wellness, by a dedicated change agent throughout an entire primary health care continuum; wherein new use of a dedicated change agent in operations of claim 10. a. i. is quantitatively evaluated, through categorizing, monitoring, computing, and charting said operations of said new use of claim 10. a. i., over set periods of time of claims l.a., l.b., l.c., l.d., and claim l.e., by independent body in computer system, for health payer’s record; ii. second means for adapting modes of care to a community’s social, economic and cultural development, throughout the entire primary health care continuum, by a dedicated change agent; wherein new use of a dedicated change agent in operations of claim 10. a. ii. is quantitatively evaluated, through categorizing, monitoring, computing, and charting said operations of said new use of claim 10. a. ii., over set periods of time of claims l.a., l.b., l.c., l.d., and claim l.e., by independent body in computer system, for health payer’s record; iii. third means for evaluating standardized quantitative measures of social determinants of health, wherein evaluating includes categorizing, monitoring, computing, and charting said standardized quantitative measures of social determinants of health, by a dedicated change agent throughout the entire primary health care continuum; wherein new use of a dedicated change agent in operations of claim 10. a. iii. is quantitatively evaluated, through categorizing, monitoring, computing, and charting said operations of said new use of claim 10. a. iii., over set periods of time of claims l.a., l.b., l.c., l.d., and claim l.e., by independent body in computer system, for health payer’s record; b. means for facilitating increased implementation of the dominant strategy of appropriate technology interventions, and for evaluating standardized quantitative measures of said increased implementation; wherein evaluating includes categorizing, monitoring, computing, and charting said standardized quantitative measures by a dedicated change agent, throughout 78 the entire primary health care continuum, over set periods of time of claims l.a., l.b., l.c., l.d., and claim l.e., relative to baseline quantitative measures at outset; wherein new use of a dedicated change agent in operations of claim 10. b. is quantitatively evaluated, through categorizing, monitoring, computing, and charting said operations of said new use of claim 10. b. over set periods of time of claims l.a., l.b., l.c., l.d., and claim l.e., by independent body in computer system, for health payer’s record; wherein improved operations of claim 10.a., and increased implementation of appropriate technology interventions of claim 10.b., further positively impact social determinants of health throughout the entire primary health care continuum, producing cost savings associated with said improved operations and said increased implementation of appropriate technology interventions, related to economic evaluation of growth rate within viability of claim 8.; whereby viability of said viable patient health system protects patient health as a fundamental human right and enables growth in non health sectors. (© Tremblay LJ. 2020) 1. A viable patient health system of claim 1. , further including a system that systemically evaluates improvement in social determinants of health, comprising: a. means for auditing standardized quantitative measures of social determinants of health of claim 10., throughout an entire primary health care continuum over set periods of time of claims l.a., l.b., l.c., l.d., and claim l.e., relative to baseline quantitative measures at outset; including baseline quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, by independent body in computer system for health payer’s record; b. means for evaluating improvement in standardized quantitative measures of social determinants of health of claim l l.a, through categorizing, monitoring, computing, and charting said improvement in standardized quantitative measures of social determinants of health; and means for categorizing, monitoring, computing, and charting reduction in standardized quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, relative to baseline quantitative measures of claim 11. a.; throughout the entire primary health care continuum over set periods of time of claim 11.a., by independent body in computer system for health payer’s record; 79 c. means for auditing standardized quantitative measures of economic growth in economic evaluation of growth rate of patient wellness within viability of claim 8., throughout the entire primary health care continuum, over said set periods of time of claim 11. a., by independent body in computer system for health payer’s record; d. means for evaluating and charting positive correlation between quantified improvement in social determinants of health of claim l l.b. and quantified economic growth of claim l l.c. throughout the entire primary health care continuum, over set periods of time of claim 11. a., by independent body in computer system for health payer’s record; e. means for evaluating and charting negative correlation between improvement in standardized quantitative measures of social determinants of health of claim l l.b. and reduction in standardized quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values of claim l l.b.; and means for evaluating and charting negative correlation between quantified economic growth of claim l l.c. and reduction in standardized quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values of claim 1 l.b., throughout the entire primary health care continuum over set periods of time of claim 11.a., by independent body in computer system for health payer’s record; f. means for evaluating and charting relationship between positive correlation of claim 1 l.d., and extent of viability of claim l.d. and claim 9.o., where economic benefits exist in excess of economic costs within viability of claim 8., throughout the entire primary health care continuum, over set periods of time of claim 1 l.a., by independent body in computer system for health payer’s record; whereby viability of said viable patient health system protects patient health as a fundamental human right and enables growth in non health sectors. (© Tremblay LJ. 2020)

12. A viable patient health system of claim 1., further including a system that systemically evaluates positive impact on mutually exclusive groups of vulnerable, marginalized populations, and non vulnerable, non marginalized populations, comprising: 80 a. means for auditing standardized quantitative measures of wellness levels within vulnerable, marginalized populations and non vulnerable, non marginalized populations of claims 8., 9., 10., and claim 11., throughout an entire primary health care continuum over set periods of time of claims l.a., l.b., l.c., l.d., and claim l.e., relative to baseline quantitative measures at outset, including baseline quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, by independent body in computer system for health payer’s record; b. means for evaluating improvement in standardized quantitative measures of wellness levels within vulnerable, marginalized populations and non vulnerable, non marginalized populations of claim 12. a, through categorizing, monitoring, computing, and charting said improvement in standardized quantitative measures of wellness levels; and means for categorizing, monitoring, computing, and charting reduction in standardized quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, relative to baseline quantitative measures of claim 12. a.; throughout the entire primary health care continuum over set periods of time of claim 12. a., by independent body in computer system for health payer’s record; c. means for auditing standardized quantitative measures of economic growth in economic evaluation of growth rate of patient wellness within viability of claim 8., throughout the entire primary health care continuum, over set periods of time of claim 12. a., by independent body in computer system for health payer’s record; d. means for evaluating and charting positive correlation between quantified improvement in wellness levels of claim 12.b. and quantified economic growth of claim 12.c., throughout the entire primary health care continuum, over set periods of time of claim 12. a.; by independent body in computer system for health payer’s record; e. means for evaluating and charting positive return associated with improvement in standardized quantitative measures of wellness levels within vulnerable, marginalized populations of claim 12. b., relative to positive return associated with improvement in standardized quantitative measures of wellness levels within non vulnerable, non marginalized populations of claim 12.b., throughout the entire primary health care continuum 81 over set periods of time of claim 12. a., by independent body in computer system for health payer’s record; f. means for evaluating and charting negative correlation between improvement in standardized quantitative measures of wellness levels within vulnerable, marginalized populations and non vulnerable, non marginalized populations of claim 12.b., and reduction in standardized quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values of claim 12.b.; and means for evaluating and charting negative correlation between quantified economic growth of claim

12.c. and reduction in standardized quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values of claim 12.b.; throughout the entire primary health care continuum over set periods of time of claim 12. a., by independent body in computer system for health payer’s record; g. means for evaluating and charting relationship between positive correlation of claim 12.d. and extent of viability of claim l.d and claim 9.o., where economic benefits exist in excess of economic costs within viability of claim 8., throughout the entire primary health care continuum, over set periods of time of claim 12. a., by independent body in computer system for health payer’s record; whereby viability of said viable patient health system protects patient health as a fundamental human right and enables growth in non health sectors. (© Tremblay LJ. 2020)

13. A viable patient health system of claim 1., further including a system that systemically responds to underlying conditions within distinct patient care settings, comprising: a. means for estimating cost effectiveness of interventions per setting, at a micro patient provider level, throughout an entire primary health care continuum, according to set time series over set periods of time, relative to baseline quantitative measures at outset; including baseline quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, by independent body in computer system for health payer’s record; b. means for estimating cost effectiveness of interventions per setting, at a macro systems level, throughout the entire primary health care continuum, according to set time series over set 82 periods of time, relative to baseline quantitative measures at outset; including baseline quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, by independent body in computer system for health payer’s record; c. means for estimating relative intervention effects for comparisons per setting of claim 13. a. and claim 13.b., throughout the entire primary health care continuum, according to set time series over set periods of time of claim 13. a. and claim 13.b., relative to baseline quantitative measures at outset; including baseline quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, by independent body in computer system for health payer’s record; d. means for estimating a ranking of interventions per setting, of claims 13. a., claim 13.b., and claim 13.c., throughout the entire primary health care continuum, according to set time series over set periods of time of claim 13. a., claim 13.b., and claim 13.c., relative to baseline quantitative measures at outset; including baseline quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, by independent body in computer system for health payer’s record; e. means for estimating intervention cost effectiveness in upstream end relative to downstream end of the entire primary health care continuum, according to set time series over set periods of time of claims 13. a., 13. b., 13. c., and claim 13. d., relative to baseline quantitative measures at outset; including baseline quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, by independent body in computer system for health payer’s record; f. means for facilitating constant responsiveness to underlying conditions in sustained maintenance of substantially even counterbalance, through linked upstream and downstream networks, including bidirectional feedback loops of claim 9.d. and claim 9.e., and linked operations of claim 9.f, coordinated throughout the entire primary health care continuum; based upon ranking of interventions of claim 13.d. and cost effectiveness analyses of claim 13. e., according to set time series over set periods of time of claims 13. a., 13. b., 13. c., 13. d., and claim 13.e., relative to baseline quantitative measures at outset; including baseline 83 quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, by independent body in computer system for health payer’s record; whereby viability of said viable patient health system protects patient health as a fundamental human right and enables growth in non health sectors. (© Tremblay LJ. 2020) 4. A viable patient health system of claim 1., further including a system that systemically evaluates economic improvement in mutually exclusive categories of health sectors and non-health sectors, within international partnerships built upon similar viable patient health systems, comprising: a. means for auditing standardized quantitative measures of economic improvement in health sectors using economic evaluation of claim 8., further including systems of claims 9., 10., 11., 12., and claim 13.; throughout an entire primary health care continuum within each country of international partnership, harmonized to common standard, over set periods of time of claims l.a., l.b., l.c., l.d., and claim l.e., relative to baseline quantitative measures at outset; including baseline quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, by independent body in computer system, for each country’s respective health payer’s record; b. means for evaluating increase in standardized quantitative measures of economic improvement in health sectors of claim 14. a. through categorizing, monitoring, computing, and charting said increase in standardized quantitative measures of economic improvement, and means for categorizing, monitoring, computing, and charting reduction in standardized quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, relative to baseline quantitative measures of claim 14. a.; throughout the entire primary health care continuum within each country of international partnership, harmonized to common standard, over set periods of time of claim 14.a., by independent body in computer system, for each country’s respective health payer’s record; c. means for evaluating and charting negative correlation between increase in standardized quantitative measures of economic improvement in health sectors of claim 14. b. and reduction 84 in standardized quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values of claim 14. b.; d. means for evaluating and charting relationship between economic improvement in health sectors of claim 14.b. and extent of viability of claim l.d. and claim 9.o., where economic benefits exist in excess of economic costs within viability of claim 8., throughout each country’s respective entire primary health care continuum; over set periods of time of claim 14. a., for each country of international partnership, by independent body in computer system for each country’s respective health payer’s record; e. means for evaluating and charting economic improvement in non health sectors, relative to economic improvement in health sectors of claim 14.b., where health sectors and non health sectors are mutually exclusive within a production boundary of a system of national accounts; within each country of international partnership, harmonized to common standard, over set periods of time of claims l.a., l.b., l.c., l.d., and claim l.e., relative to baseline quantitative measures at outset, including baseline quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, by independent body in computer system for each country’s respective health payer’s record; f. means for evaluating and charting negative correlation between economic improvement in non health sectors of claim 14.e., and reduction in standardized quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values of claim 14. b.; g. means for evaluating and charting relationship between economic improvement in health sectors of claim 14. b. and economic improvement in non health sectors of claim 14.e., in analysis of greatest benefit from finite resources; over set periods of time of claim 14. a., for each country of international partnership, by independent body in computer system for each country’s respective health payer’s record; whereby viability of said viable patient health system protects patient health as a fundamental human right and enables growth in non health sectors. (© Tremblay LJ. 2020) 85 A viable patient health system of claim 1., further including a system that systemically evaluates economic improvement in mutually exclusive categories of health sectors and non-health sectors, within systems of international partnerships built upon similar viable patient health systems, comprising: a. means for auditing standardized quantitative measures of economic improvement in health sectors using economic evaluation of claim 8., further including systems of claims 9., 10., 11., 12., 13. and claim 14.; throughout entire primary health care continua within each international partnership system; harmonized to common standard, over set periods of time of claims l.a., l.b., l.c., l.d., and claim l.e., relative to baseline quantitative measures at outset; including baseline quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, by independent body in computer system, for each country’s respective health payer’s record; b. means for evaluating increase in standardized quantitative measures of economic improvement in health sectors of claim 15. a., through categorizing, monitoring, computing, and charting said increase in standardized quantitative measures of economic improvement, and means for categorizing, monitoring, computing, and charting reduction in standardized quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, relative to baseline quantitative measures of claim 15.a.; throughout entire primary health care continua within each international partnership system, harmonized to common standard, over set periods of time of claim 15. a., by independent body in computer system, for each country’s respective health payer’s record; c. means for evaluating and charting negative correlation between increase in standardized quantitative measures of economic improvement in health sectors of claim 15.b. and reduction in standardized quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values of claim 15.b. ; d. means for evaluating and charting relationship between economic improvement in health sectors of claim 15.b. and extent of viability of claim l.d. and claim 9.o., where economic benefits exist in excess of economic costs within viability of claim 8., throughout each country’s respective entire primary health care continuum within each international 86 partnership system; over set periods of time of claim 15. a., by independent body in computer system for each country’s respective health payer’s record; e. means for evaluating and charting economic improvement in non health sectors, relative to economic improvement in health sectors of claim 15.b., where health sectors and non health sectors are mutually exclusive within a production boundary of a system of national accounts; within each international partnership system, harmonized to common standard, over set periods of time of claims l.a., l.b., l.c., l.d., and claim l.e., relative to baseline quantitative measures at outset, including baseline quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values, by independent body in computer system for each country’s respective health payer’s record; f. means for evaluating and charting negative correlation between economic improvement in non health sectors of claim 15.e., and reduction in standardized quantitative measures of factors that carry universally harmful societal impact, publicly disclosed in standardized quantitative measures of threshold values of claim 15.b. ; g. means for evaluating and charting relationship between economic improvement in health sectors of claim 15.b. and economic improvement in non health sectors of claim 15.e., in analysis of greatest benefit from finite resources; over set periods of time of claim 15. a., for each country of international partnership system, by independent body in computer system for each country’s respective health payer’s record; whereby viability of said viable patient health system protects patient health as a fundamental human right and enables growth in non health sectors. (© Tremblay LJ. 2020)