Note: Descriptions are shown in the official language in which they were submitted.
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Non-Provisional International Patent Application under the Patent Cooperation
Treaty
for
VIABLE PATIENT HEALTH SYSTEMS
by
Inventor: Laura Johanne Tremblay
Copyright 2012-2020 Laura Johanne Tremblay. All rights reserved.
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 SYS __
1EMS, 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
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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 Biochemistry 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
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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
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1.2 Long Term Strategy 61
VII. Meta-Analysis (MA) and Network Meta-Analysis (NMA) 62
VIII. Concluding Remarks 65
Claims 69
Abstract 87
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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
Al c 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.
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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.
(CD Tremblay U. 2020)
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.
(CD Tremblay U. 2020)
Upstream Health System Operations - functional upstream health system
components: primary (10)
disease prevention and health promotion strategies, activities, patient
services, interventions, patient
outcomes, and infrastructure, including digital infrastructure.
(CD Tremblay U. 2020)
Downstream Health System Components - secondary (2 ) disease prevention and
tertiary (30)
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.
(CD Tremblay U. 2020)
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Downstream Health System Operations - functional downstream health system
components:
secondary (2 ) disease prevention and tertiary (30) disease prevention
strategies, activities, patient
services, interventions, patient outcomes, and infrastructure, including
digital infrastructure.
(CD Tremblay U. 2020)
Primary Health Care (PHC) Continuum ¨ the totality of all upstream and
downstream health system
components and operations.
(CD Tremblay U. 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.
(CD Tremblay U. 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.
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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 (30) 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.
(CD Tremblay U. 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.
(CD Tremblay U. 2020)
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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.
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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.
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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.
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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.
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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 (10) 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. (CD Tremblay U.
2020)
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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).
(CD Tremblay U. 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
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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 10
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.
(0 Tremblay U. 2020)
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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.
(0 Tremblay U. 2020)
Related Application Data
Tremblay U. 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 U. 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 U. 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;
September19:1-
260.
Tremblay U. 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.
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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. (CD
Tremblay U. 2012-2020)
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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 30 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 (30) 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).
(0 Tremblay U. 2012-2020)
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Methodology of Systematic Review Science
Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for systematic
review and meta-
analysis protocols (PRISMA-P) 2015 statement. Systematic reviews. 2015;4(1):1-
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 3Ø 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.
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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 (30) 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.
(CD Tremblay U. 2020)
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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.
(CD Tremblay U. 2020)
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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. (CD
Tremblay U. 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 10 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. (CD Tremblay U.
2020)
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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. (0 Tremblay U. 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
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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. (CD Tremblay U.
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
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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),
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:
directly by the
patient, or indirectly by the patient's private insurance company. (CD
Tremblay U. 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)
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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. (0 Tremblay U. 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
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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.
(CD Tremblay U. 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.
(CD Tremblay U. 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
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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 10 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.
(CD Tremblay U. 2020)
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:
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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.
(CD Tremblay U. 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,
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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. (CD Tremblay U.
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.
(CD Tremblay U. 2020)
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1.1 Immunology Perspectives
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.
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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),
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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 de-
repression (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
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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. (CD Tremblay U.
2020)
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3. Upstream Attention Relative to Regulation of Cell Metabolism
Attention upstream creates balance between itself and its overweight
counterpart of illness-
treatment 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. (CD
Tremblay U. 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.
(CD Tremblay U. 2020)
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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.
(CD Tremblay U. 2020)
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5. Upstream Attention Balanced with Downstream Demands
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 (10) 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. (CD Tremblay U.
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
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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:
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. (CD Tremblay U.
2020)
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.
(CD Tremblay U. 2020)
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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 10 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. (CD Tremblay U.
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:
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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 self-
sustain, 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]. (CD Tremblay U.
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.
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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).
(CD Tremblay U. 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].
(CD Tremblay U. 2020)
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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). (CD Tremblay U.
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
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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. (CD Tremblay U.
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 self-
sustain, derived from increased patient wellness levels in strengthened SDOH.
(CD Tremblay U. 2020)
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.
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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.
(CD Tremblay U. 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.
(CD Tremblay U. 2020)
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10.1 Positive Return
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.
(CD Tremblay U. 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 (10) 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.
(CD Tremblay U. 2020)
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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.
(CD Tremblay U. 2020)
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.
(CD Tremblay U. 2020)
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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
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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 capacity-
building 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. (CD Tremblay U. 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,
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communities, and populations, advance translation of wellness strategies in
proactive patient-
focused care, for increased access to service at reduced cost. (0 Tremblay
U. 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
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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 cost-
effectiveness, 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.
(CD Tremblay U. 2020)
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
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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
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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 (10) 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
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even counterbalance between upstream and downstream components and operations,
facilitating
growth in viability itself. (CD Tremblay U.
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
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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,
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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. (CD Tremblay U.
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 time-
horizon that accounts for inflation, interest rates, varying cash flows, and
the value of money.
(CD Tremblay U. 2020)
V. International Systems
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
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gauges of wellness and SDOH improvement, that protect against the self-
defeating instance of
narrow economic considerations absent health. (CD Tremblay U.
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.
(CD Tremblay U. 2020)
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 (FIL7) 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,
1-1L7 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 1-1L7 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 5Ø
3. Developed Countries
At present, over 50 countries support 1-1L7, and this support includes
hundreds of corporate
members that represent healthcare providers, government stakeholders, payers,
pharmaceutical
companies, suppliers, and consulting firms. Purposes of 1-1L7's information
and communications
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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.
(CD Tremblay U. 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
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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
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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:
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. 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
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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 time-
frames utilized to create equilibrium within a new patient health system, for
wellness-
amplification, and expansion of non-health sectors (such as natural resources,
legal system).
(CD Tremblay U. 2020)
VI. Global Systems
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 non-
health 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
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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.
(0 Tremblay U. 2020)
1.1 Indonesia and Canada: Integrated Development of Improved SDOH
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.
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.
(CD Tremblay U. 2020)
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
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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.
(CD Tremblay U. 2020)
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
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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
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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.
(CD Tremblay U. 2020)
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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 (30) 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)
(CD Tremblay U. 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:
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i) immediate, related to intrinsic benefits inherent to primary (10) 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;
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= 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;
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= 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.
(CD Tremblay U. 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 change-
agent 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.
(CD Tremblay U. 2020)
