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1. Mission
What is to be
achieved? What is the purpose of the caring process?
1.1 Mission
Statement
1.2 Periodic
Review of Mission
2. Records
Who are we dealing
with? How is the target population described? Who is in charge of
the subpopulations?
2.1 Group Care
of Active Members: Children and Youth, Adults, Seniors
2.2 Group Care
of New Members: Children and Youth, Adults, Seniors
2.3 Group Care
of Non-active Members: Children and Youth, Adults, Seniors
2.4 Group Care
of Potential Members: Children and Youth, Adults, Seniors
2.5 Specialized
Services
2.6 Electronic
Records of vital data, birth, death, major illness, moving,
job-change, group-attendance, service.
3. Diagnosis
What is the problem?
Into what category does the problem fit?
3.1 Social
Problems: Conflict, Crisis, Divorce, Mental Health,
Dishonesty, Drug Use, Others.
3.2 Spiritual
Problems: Loss of Faith, Loss of Life-meaning, Non-attendance,
Grief, Spiritual Distress, Others.
www.learnwell.org/care.htm
www.learnwell.org/spirit.htm
4. Treatment
What is to be done
about the problem? What evidence is there that the proposed
treatment is effective?
4.1 Group
Treatment: Teaching, Reading, Providing Services.
4.2 Individual
Treatment: Interviewing, Counseling, Connecting, Working, Studying,
Praying.
5. Results
What is the result of
the treatment? How effective was the treatment?
5.1 Measuring
Results
5.2 Achieving or
not Achieving a Level of Health
6. Continuous Quality
Improvement
6.1 Quality
Improvement
6.2
Team-building, Administration and Finance
6.3 Periodic
Updating and Analysis of Electronic Records
7. Guidelines for
Evidence-based Care
Evidence-based care is closely related to the other fields of
evidence-based services. The literature of evidence-based medicine,
social work, and education provides a rich background for those
engaged in evidence-based care. Following are a number of passages
from that field of literature.
7.1 Methodology
To help users assess the validity of the studies presented in
each volume of the series, the Evidence-based Practice Center (EPC) researchers restricted their
review of quality improvement strategies to those studies most
likely to produce scientifically valid results.
These include randomized controlled trials—considered the gold
standard of experiment designs—as well as other high quality
studies. They did so with the knowledge that the relatively strict
study criteria may have excluded some possibly relevant results.
Findings from the most valid studies were analyzed using accepted
statistical tools; further analyses of combined data also were
performed when studies were found to be consistent in their design
and population, and had comparable outcomes.
Nine quality improvement strategies were evaluated for their
effectiveness in the priority condition reports. The researchers
defined a "quality improvement (QI) strategy" as any tool or process
aimed at reducing the quality gap for a group of patients typical of
those seen in routine practice.
The following QI strategies were used in the priority condition
studies as a measure of potential gains of best practice adherence:
- Physician reminder systems (such as prompts in paper charts
or computer-based reminders).
- Facilitated relay of clinical data to providers (patient
data transmitted by telephone call or fax, from outpatient
specialty clinics to primary care physicians).
- Audit and feedback (physician performance tracking and
reviews, using quality indicators and reports, comparisons with
national/State quality report cards, publicly released
performance data, and benchmark outcomes data).
- Physician education (workshops and professional conferences,
educational outreach visits, distribution of educational
materials).
- Patient education (classes, parent and family education,
pamphlets and other media, etc.).
- Promotion of self-management (workshops, materials such as
blood pressure or glucose monitoring devices).
- Patient reminder systems (telephone calls or postcards from
physicians to their patients).
- Organizational changes (Total Quality Management or
Continuous Quality Improvement programs, multidisciplinary
teams, shifting from paper-based to computer-based
recordkeeping, long-distance case discussion between
professional peers).
- Financial incentives, regulation, and policy
(performance-based bonuses and alternative reimbursement systems
for physicians, positive or negative financial incentives for
patients, and changes in professional licensure requirements).
7.2 Overview
In 1997 the Agency for Health Care Policy and Research (AHCPR),
now known as the Agency for Healthcare Research and Quality (AHRQ),
launched its initiative to promote evidence-based practice in
everyday care through establishment of 12 Evidence-based Practice
Centers (EPCs). The EPCs develop evidence reports and technology
assessments on topics relevant to clinical, social
science/behavioral, economic, and other health care organization and
delivery issues—specifically those that are common, expensive,
and/or significant for the Medicare and Medicaid populations. With
this program, AHRQ became a "science partner" with private and
public organizations in their efforts to improve the quality,
effectiveness, and appropriateness of health care by synthesizing
the evidence and facilitating the translation of evidence-based
research findings. Topics are nominated by non-federal partners such
as professional societies, health plans, insurers, employers, and
patient groups. Go to
www.ahrq.gov/clinic/epc/epctopicn.htm for topic nomination
procedures. Federal partners often request evidence reports and
should contact the EPC Program Director for more information.
Source:
http://www.ahrq.gov/clinic/epc/
7.3 What is outcomes research?
Outcomes research seeks to understand the end results of
particular health care practices and interventions. End results
include effects that people experience and care about, such as
change in the ability to function. In particular, for individuals
with chronic conditions—where cure is not always possible—end
results include quality of life as well as mortality. By linking the
care people get to the outcomes they experience, outcomes research
has become the key to developing better ways to monitor and improve
the quality of care. Supporting improvements in health outcomes is a
strategic goal of the Agency for Healthcare Research and Quality (AHRQ,
formerly the Agency for Health Care Policy and Research).
The urgent need for outcomes research was highlighted in the
early 1980s, when researchers discovered that "geography is
destiny." Time and again, studies documented that medical practices
as commonplace as hysterectomy and hernia repair were performed much
more frequently in some areas than in others, even when there were
no differences in the underlying rates of disease. Furthermore,
there was often no information about the end results for the
patients who received a particular procedure, and few comparative
studies to show which interventions were most effective. These
findings challenged researchers, clinicians, and health systems
leaders to develop new tools to assess the impact of health care
services.
7.4 Outcomes information for decision making
For clinicians and patients, outcomes research provides evidence
about benefits, risks, and results of treatments so they can make
more informed decisions. One group of researchers, for example,
studied the outcomes of patients with pneumonia, a common cause of
hospitalization in elderly people. They developed a way for
clinicians to determine which patients with pneumonia can be treated
safely at home, an option that not only reduces Medicare costs but
is preferred by many patients. In areas such as cancer, where
outright cure is often not the only goal, outcomes research has
provided the information to help patients make choices that will
improve their quality of life.
For health care managers and purchasers, outcomes research can
identify potentially effective strategies they can implement to
improve the quality and value of care. AHRQ-sponsored outcomes
studies, for example, have shown that even when treatments are known
to be effective, many people who could benefit from them are not
getting them. Beta blocker medication, given after heart attacks,
can reduce mortality; blood-thinning medication can prevent strokes;
and thrombolytic ("clot-buster") therapy given immediately after a
heart attack can reduce the damage from the attack. Yet in each
case, many eligible patients are not getting these treatments. By
identifying and addressing the barriers to better care—for example,
through development of a tool to help doctors know which patients
with suspected heart attacks will benefit from thrombolytic
treatment—AHRQ researchers have helped translate these findings into
practical strategies to improve care.
7.5 Measuring outcomes
Historically, clinicians have relied primarily on traditional
biomedical measures, such as the results of laboratory tests, to
determine whether a health intervention is necessary and whether it
is successful. Researchers have discovered, however, that when they
use only these measures, they miss many of the outcomes that matter
most to patients. Hence, outcomes research also measures how people
function and their experiences with care. Source:
http://www.ahrq.gov/clinic/outfact.htm
- What is an Evidence-based Rating System?
An
evidence-based rating system is a science-based
systematic evaluation of the strength of the evidence
behind a statement. In the case of health claims, it
would rate the strength of the evidence behind a
proposed substance/disease relationship. A large number
of evidence-based rating systems are currently in use
today by physicians, dietitians and other health
professionals. FDA has tentatively chosen to model its
evidence-based rating system on that of the Institute
for Clinical Systems Improvement (ICSI) as adapted by
the American Dietetic Association with modifications
specific to FDA. In making this tentative decision, FDA
relied on criteria for evaluating evidence-based rating
systems as reviewed and critiqued by the Agency for
Healthcare Research and Quality (AHRQ). FDA also found
the modifications from the American Dietetic Association
to be particularly useful as they considered diet and
health relationships, whereas other groups focused on
drug and treatment applications.
- How are "Rate" and "Rank" Used in this System?
The terms "rate" and "rank" are not used
interchangeably to describe this system. The evaluation
process involves three separate rating systems:
(1) a rating for study design; (2) a rating for study
quality; and (3) a rating for the strength of the entire
body of evidence. Considering all classifications from
the three rating systems, a final rank of the
scientific evidence in support of a health claim would
be assigned.
- What are the Parts of an Evidence-based Rating
System?
In order to evaluate the level of scientific support
for a proposed substance/disease relationship, the
agency intends to follow a six-part procedure.
Each part of the evidence-based rating system is
described below:
- Define the substance /disease relationship
A proposed relationship between a substance and a
disease or health-related condition is identified.
If relevant, the subgroups within the general
population, for which the relationship is targeted
are identified. The relationship forms the basis for
selecting relevant studies and for evaluating the
quality of the selected studies.
- Collect and submit all relevant studies
All relevant studies (both favorable and
unfavorable) to the relationship to be tested (as
defined above in C.1.) are collected and submitted.
The evaluation of the proposed relationship relies
primarily on human studies.
- Classify, and therefore rate, each study as
to type of study
Each study would be characterized as a study
design type. By categorizing the study, it
automatically receives an initial study "rating"
based on the type of experimental design, which is
independent of the quality of the study. The rating
of study design is based on the principle of
minimizing bias. Only primary reports of data
collection are rated. Reports that synthesize or
reflect collections of primary reports are not
considered part of the rating system although they
may provide useful background information.
- Study Design Type One
- Randomized, controlled intervention
trials
- Study Design Type Two
- Prospective observational cohort studies
- Study Design Type Three
- Nonrandomized intervention trials with
concurrent or historical controls
- Case-control studies
- Study Design Type Four
- Cross-sectional studies
- Analyses of secondary disease endpoints
in intervention trials
- Case series
- Rate each study for quality
Each study
would be reviewed independently and assigned a
quality factor of +, Ø, - or N/A. The basis for the
assignment of the quality factor is discussed below.
- (+) means the report has adequately
addressed issues of scientific quality such as
inclusion/exclusion, bias, generalizability, and
data collection and analysis.
- (Ø) means some uncertainties exist as to
whether the report has adequately addressed
issues of scientific quality such as
inclusion/exclusion, bias, generalizability, and
data collection and analysis.
- (-) means the report has not adequately
addressed issues of scientific quality such as
inclusion/exclusion, bias, generalizability, and
data collection and analysis.
- N/A means the report is not a primary
reference, therefore the quality has not been
assessed, and such a reference is not considered
as part of the body of evidence on which the
final ranking is based. Examples of non-primary
references are review articles and meta
analyses.
- Rate the strength of the total body of
evidence
The studies are considered collectively across
the evidence base in order to rate the strength of
the body of evidence. The rating system is based on
three factors: quantity, consistency, and relevance
to disease risk reduction in the general population
or target subgroup. These three factors and the
final "rank" for the strength of the evidence for
the "relationship" are described below.
- Rating the body of evidence for quantity,
consistency, and relevance to disease risk
reduction in the general population or target
subgroup.
- Quantity. Considers the number of
studies, the total number of individuals
studied and the generalizability of the
findings to the target population.
- (***) means the number of studies
and the number of individuals tested
(from all studies of design types one
and two that are of high quality (+)
combined) are sufficiently large to
comfortably generalize to the target
population.
- (**) means there are a sufficient
number of studies and individuals tested
from study design type three and higher
(i.e., study design types one and two)
of at least moderate quality (Ø) but
uncertainties remain as to
generalizability to the target
population.
- (*) means that the number of studies
and the number of individuals tested is
insufficient to generalize to the target
population.
- Consistency. Considers whether
studies with both similar and different
designs report similar findings.
- (***) means a sufficient number of
studies of design types one and two that
are of high quality (+) have consistent
results. Any inconsistencies should be
explained satisfactorily.
- (**) means there is a moderate
consistency across all study levels.
- (*) means that the results of
studies are inconsistent.
- Relevance to Disease Risk Reduction
in the General Population or Target
Subgroup. Considers whether or not the
magnitude of the risk-reduction effect in
the target population is physiologically
meaningful and achievable in the general US
population or a subgroup of the US general
population under intake and use conditions
that are appropriate for such conventional
human food and human dietary supplements
that would be the subject of the claim.
- (***) means that the magnitude of
the effect observed in studies of design
types one and two that are of high
quality (+) is physiologically
meaningful and achievable under intake
and use conditions that are appropriate
for such conventional human food and
human dietary supplements that would be
the subject of the claim.
- (**) means there is some suggestion
from studies of design type three and
higher (i.e., study design types one and
two) and of moderate (Ø) to high (+)
quality that the effect will be
physiologically meaningful, and
achievable under intake and use
conditions that are appropriate for such
conventional human food and human
dietary supplements that would be the
subject of the claim but uncertainties
remain.
- (*) means that the magnitude of the
effect in the studies is not likely to
be physiologically meaningful or
achievable under intake and use
conditions that are appropriate for such
conventional human food and human
dietary supplements that would be the
subject of the claim.
- Ranking the Strength of the Evidence for a
Health Claim
- The first level, or highest rank of
scientific evidence to support the
substance/disease relationship meets the
"Significant Scientific Agreement among
qualified experts" standard. (For the
purpose of this guidance, the first level
rank is only used as a reference point. In
all other respects it is outside the scope
of this guidance.)
This level reflects a high level of
comfort among qualified scientists that
the claimed substance/disease relationship
is scientifically valid. In general, the
first level ranked relationship would be
considered to have a very low probability of
significant new data overturning the
conclusion that the relationship is valid or
significantly changing the nature of the
relationship. It would have high consistency
with conclusions of authoritative bodies.
The relationship would be based on relevant,
high quality studies of mostly study design
types one and two, and sufficient numbers of
individuals would be tested to result in a
high degree of confidence that results are
relevant to the target population. Studies
of different design would almost always
result in similar findings, and the benefit
would be physiologically meaningful and
achievable under intake and use conditions
that are appropriate for such conventional
human food and human dietary supplements
that would be the subject of the claim.
- The second level rank of scientific
evidence to support the substance/disease
relationship is the highest level for a
qualified health claim, and represents a
moderate/good level of comfort among
qualified scientists that the claimed
relationship is scientifically valid.
Qualified experts would rank the
relationship as "promising," but not
definitive. The claim would be based on
relevant, high to moderate quality studies
of study design type three and higher (i.e.,
design types one and two) and sufficient
numbers of individuals would be tested to
result in a moderate degree of confidence
that results could be extrapolated to the
target population. Studies of similar or
different design would generally result in
similar findings and the benefit would
reasonably be considered to be
physiologically meaningful and achievable
under intake and use conditions that are
appropriate for such conventional human food
and dietary supplements that would be the
subject of the claim. (Note: The term
"moderate/good" for the second level rank
may seem ungenerous. This terminology
derives from historical data evaluated by
the National Academy of Sciences that
indicated that over time many diet/disease
relationships that met this level of
evidence were not necessarily sustained.)
- The third level rank of scientific
evidence to support the substance/disease
relationship is the middle level for a
qualified health claim and represents a
low level of comfort among qualified
scientists that the claimed relationship is
scientifically valid. It would have low
consistency with statements from
authoritative bodies or be ranked as "low"
in terms of scientific support by qualified
scientists. The relationship would be based
mostly on moderate to low quality studies of
study design type three, and insufficient
numbers of individuals would be tested,
resulting in a low degree of confidence that
results could be extrapolated to the target
population. Studies of different design
would generally result in similar findings
but uncertainties would exist. Uncertainties
would also exist as to whether the benefit
would be considered physiologically
meaningful and achievable under intake and
use conditions that are appropriate for such
conventional human food and human dietary
supplements that would be the subject of the
claim.
- The fourth level, or the lowest rank of
scientific evidence to support the claimed
substance/disease relationship, is the
lowest level for a qualified health claim
and represents an extremely low level of
comfort among qualified scientists that
the claimed relationship is scientifically
valid. It would have very low consistency
with conclusions of authoritative bodies or
be ranked very low by qualified scientists.
The relationship would be based mostly on
moderate to low quality studies of study
design type three and insufficient numbers
of individuals would be tested, resulting in
a very low degree of confidence that results
could be extrapolated to the target
population. Studies of different design
would generally result in similar findings
but uncertainties would exist. There could
be considerable uncertainty as to whether or
not the benefit would be considered
physiologically meaningful or achievable
under intake and use conditions that are
appropriate for such conventional human food
and human dietary supplements that would be
the subject of the claim. This level
requires at least some credible evidence to
support the relationship. There cannot be a
strong body of evidence against the claim
(e.g., a study or studies of high
persuasiveness, quality and relevance that
do not detect an effect). If that is the
case, such evidence provides a sound basis
for concluding that the claim is not valid.
- If the scientific evidence to support
the substance/disease relationship is below
that described as the fourth level (see
above) no claim will be appropriate.
- Report the "rank"
The result of the evidence-based rating system
will be a statement describing the nature of the
evidence and the rationale for linking a substance
to a disease/health-related condition with a ranking
as to the strength of the scientific evidence in
support of that relationship. The process for
arriving at the rank of the evidence to support the
substance/disease relationship is illustrated in
Table 1. The rank will be supported by:
- A clear and transparent demonstration of
which research studies were evaluated to provide
the rank.
- Evidence tables showing the rigor of the
evaluation. Source:
http://www.cfsan.fda.gov/~dms/hclmgui4.html
7.6
Office of National Drug Control Policy
Evidence-Based Principles
for Substance Abuse Prevention
En español
The National Drug Control Strategy's Performance
Measures of Effectiveness require the Office of
National Drug Control Policy to "develop and
implement a set of research-based principles upon
which prevention programming can be based." The
following principles and guidelines were drawn from
literature reviews and guidance supported by the
federal departments of Education, Justice, and
Health and Human Services as well as the White House
Office of National Drug Control Policy. Some
prevention interventions covered by these reviews
have been tested in laboratory, clinical, and
community settings using the most rigorous research
methods. Additional interventions have been studied
with techniques that meet other recognized
standards. The principles and guidelines presented
here are broadly supported by a growing body of
research.
ADDRESS APPROPRIATE RISK AND PROTECTIVE
FACTORS FOR SUBSTANCE ABUSE IN A DEFINED
POPULATION
- Define a population A population can be
defined by age, sex, race, geography
(neighborhood, town, or region), and institution
(school or workplace).
- Assess levels of risk, protection, and
substance abuse for that population. Risk
factors increase the risk of substance abuse,
and protective factors inhibit substance abuse
in the presence of risk. Risk and protective
factors can be grouped in domains for research
purposes (genetic, biological, social,
psychological, contextual, economic, and
cultural) and characterized as to their
relevance to individuals, the family, peer,
school, workplace, and community. Substance
abuse can involve marijuana, cocaine, heroin,
inhalants, methamphetamine, alcohol, and tobacco
(especially among youth) as well as sequences,
substitutions, and combinations of those and
other psycho-active substances.
- Focus on all levels of risk, with special
attention to those exposed to high risk and low
protection Prevention programs and policies
should focus on all levels of risk, but special
attention must be given to the most important
risk factors, protective factors, psychoactive
substances, individuals, and groups exposed to
high risk and low protection in a defined
population. Population assessment can help
sharpen the focus of prevention.
USE APPROACHES THAT HAVE BEEN SHOWN TO BE
EFFECTIVE
- Reduce the availability of illicit drugs,
and of alcohol and tobacco for the under-aged
Community-wide laws, policies, and programs can
reduce the availability and marketing of illicit
drugs. They can also reduce the availability and
appeal of alcohol and tobacco to the under-aged.
- Strengthen anti-drug-use attitudes and norms
Strengthen environmental support for
anti-drug-use attitudes by sharing accurate
information about substance-abuse, encouraging
drug-free activities, and enforcing laws, and
policies related to illicit substances.
- Strengthen life skills and drug refusal
techniques Teach life skills and drug refusal
skills, using interactive techniques that focus
on critical thinking, communication, and social
competency.
- Reduce risk and enhance protection in
families Strengthen family skills by setting
rules, clarifying expectations, monitoring
behavior, communicating regularly, providing
social support, and modeling positive behaviors.
- Strengthen social bonding Strengthen social
bonding and caring relationships with people
holding strong standards against substance abuse
in families, schools, peer groups, mentoring
programs, religious and spiritual contexts, and
structured recreational activities.
- Ensure that interventions are appropriate
for the populations being addressed Make sure
that prevention interventions, including
programs and policies, are acceptable to and
appropriate for the needs and motivations of the
populations and cultures being addressed.
INTERVENE EARLY AT IMPORTANT STAGES AND
TRANSITIONS
- Intervene early and at developmental stages
and life transitions that predict later
substance abuse. Such developmental stages and
life transitions can involve biological,
psychological, or social circumstances that can
increase the risk of substance abuse. Whether
the stages or transitions are expected (such as
puberty, adolescence, or graduation from school)
or unexpected (for example the sudden death of a
loved one), they should be addressed by
preventive interventions as soon as
possible—even before each stage or transition,
whenever feasible.
- Reinforce interventions over time Repeated
exposure to scientifically accurate and
age-appropriate anti-drug-use messages and other
interventions—especially in later developmental
stages and life transitions that may increase
the risk of substance abuse—can ensure that
skills, norms, expectations, and behaviors
learned earlier are reinforced over time.
INTERVENE IN APPROPRIATE SETTINGS AND DOMAINS
- Intervene in appropriate settings and
domains Intervene in settings and domains that
most affect risk and protection for substance
abuse, including homes, social services,
schools, peer groups, workplaces, recreational
settings, religious and spiritual settings, and
communities.
MANAGE PROGRAMS EFFECTIVELY
- Ensure consistency and coverage of programs
and policies Implementation of prevention
programs, policies, and messages for different
parts of the community should be consistent,
compatible, and appropriate.
- Train staff and volunteers To ensure that
prevention programs and messages are continually
delivered as intended, training should be
provided regularly to staff and volunteers.
- Monitor and evaluate programs To verify that
goals and objectives are being achieved program
monitoring and evaluation should be a regular
part of program implementation. When goals are
not reached, adjustments should be made to
increase effectiveness.
Source:
http://www.ncjrs.gov/ondcppubs/publications/prevent/evidence_based_eng.html
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