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WGA subcommittee on Screening for OAG
The advanced stage of symptomatic open-angle glaucoma (OAG) and high
rates of undiagnosed disease raise the question of whether we can
improve the health of our communities by screening for OAG. This
question was first addressed by government in North America almost
twenty years ago and has been reviewed several times since. This issue
has also been discussed in a number of national and regional practice
guidelines for glaucoma.1,2 With a new US statement on OAG screening
published in March 2005,3 the WGA subcommittee for Screening for OAG
decided to review the important issues in OAG screening and ask what we
have done and what we still have to do to answer the question of whether
screening for OAG is worthwhile.
The Committee recognized that it would be very unwieldy to consider all
of the different possible screening activities in completing its task.
The Committee also recognized that screening for open-angle glaucoma has
been controversial, but that much of the controversy centered on the
value of mass or community screening for open-angle glaucoma. Mass or
community screenings are typically performed on unselected populations
such as community centers, shopping centers, churches, or on partially
selected populations, such as all volunteer employees working in a large
corporate building. The Committee decided to narrow its task to a
consideration of mass or community screenings in the context of an
economically developed country.
While there are many important considerations in determining whether
some form of screening for a disease is worthwhile, there are six
critical questions, published by Wilson and Junger,4 that must be
answered first.
Wilson and Junger's criteria for a screenable disease
- The condition sought should be an important health problem.
- There must be an accepted and effective treatment for patients with
the disease, that must be more effective at preventing morbidity when
initiated in the early, asymptomatic stage than when begun in the later,
symptomatic stages.
- Facilities for diagnosis and treatment should be available.
- There must be an appropriate, acceptable, and reasonably accurate
screening test.
- The natural history of the condition, including development from
latent to manifest disease, should be adequately understood.
- The cost of case-finding (including diagnosis and treatment of
patients diagnosed) should be economically balanced in relation to
possible expenditure on medical care as a whole.
Governmental Reports on Screening for OAG
In the 1980s, the United States government requested its Office of
Technology Assessment (OTA) to assess the effectiveness and costs of
providing a number of preventive health services to the elderly under
the government-funded Medicare program. A document, 'Screening for
Open-Angle Glaucoma in the Elderly,' was published in October of 1988.5
Below is a summary of the main conclusions of the OTA document.
- Open-Angle Glaucoma screening programs were expensive.
- There was little data on whether treatment of people with ocular
hypertension or open-angle glaucoma altered the course of the disease.
- The natural history of the disease was 'perplexing' and the natural
history of untreated open-angle glaucoma was unknown.
- There existed scarce data on screening test accuracy (sensitivity,
specificity, predictive value of positive test).
Based on the above, OTA concluded that both the benefits of screening
-
i.e., visual impairment prevented - and the costs of screening and
resultant treatment were highly uncertain. It should be emphasized that
the OTA task was specifically to assess the potential benefits and costs
if glaucoma screening were offered as a covered service by Medicare.
However, the influence of this document was far reaching and subsequent
opinions related to the value of general screening for open-angle
glaucoma were based, in large part, on issues raised by the OTA
document. Many of these issues were also considered by the Canadian Task
Force on Preventative Services, which took no definitive position on the
advisability of performing glaucoma screening on a general population
basis.6
Recently, the United States Preventive Services Task Force (UPSTF)
provided a new Recommendation Statement for OAG screening. A previous
1996 statement7 found insufficient evidence to recommend for or against
glaucoma screening in primary care practice. The USPSTF noted that
although glaucoma treatment with medication or surgery to lower
intraocular pressure had been the standard of care for years, definitive
evidence supporting the benefit of treating persons with early glaucoma
and minimal visual impairment was not available.
For its latest recommendation (released March 2005),3 the USPSTF
critically reviewed the literature for new evidence on the effectiveness
of screening and treatment for early POAG. It found good evidence that
early treatment of adults with increased IOP detected by screening
reduces the number of persons who develop small, visual field defects,
and that early treatment of those with early, asymptomatic POAG
decreases the number of those whose visual field progress. However, the
USPSTF concluded that the evidence is insufficient to determine the
extent to which screening - leading to earlier detection and treatment
of people with elevated IOP or OAG - would reduce impairment in
vision-related function or quality or life. Given the uncertainty of the
magnitude of benefit from early treatment and given the known harms of
early treatment (i.e., local eye irritation and an increased risk for
cataracts), the USPSTF could not determine the balance between the
benefits and harms of screening for glaucoma. It concluded that the
evidence is insufficient to recommend for or against routine screening.
The new statement thus represents no change from the Task Force's 1996
recommendation. In formulating its new recommendation, the USPSTF
focused its review only on studies of glaucoma treatment. Other criteria
on the screenability of a disease were not considered.
WGA Review
The WGA subcommittee on Screening for OAG decided to re-evaluate
the evidence upon which the OTA recommendation was based. Specifically,
it sought to apply updated data to Wilson and Junger's criteria for a
screenable disease and to determine whether this new evidence changes
the rationale for open-angle glaucoma screening.
- The condition sought should be an important health
problem.
-
OTA used data from the Framingham study8 to estimate prevalence and
incidence of open-angle glaucoma. Total prevalence in people over age 52
estimated at 1.2% and prevalence in people over age 65 estimated at
between 2 to 3%.
- More recent studies suggest that the overall prevalence is higher,
probably between 1.5 and 2.0% in persons over 40 years of age and the
prevalence among the elderly is markedly higher.9-20
- Quality of life data, though not extensive, is only recently
available.
- OTA did appreciate the burden of blindness from glaucoma and racial
difference in prevalence and blindness from glaucoma.
- Overall conclusion is that glaucoma is an important health problem,
particularly in Americans of African descent, though perhaps not as
important as diseases with equally high prevalence that results in
mortality.
- Overall summary: not much change from the 1980s.
- There must be an accepted and effective treatment for
patients with the disease that must be more effective at
preventing morbidity when initiated in the early, asymptomatic stage than when begun in the later, symptomatic
stages.
- Newer topical medications that are more effective, easier to use, and
better tolerated are now available.
- The Ocular Hypertension Treatment Study (OHTS) showed that treatment
of elevated IOP is effective in delaying onset of POAG.21
- The Early Manifest Glaucoma Treatment Trial (EMGT) showed that
treatment of early glaucoma is effective in slowing progression.22
- The Collaborative Initial Glaucoma Treatment Study (CIGTS) showed
health-related quality of life is comparable between medically and
surgically treated patients.23
- We still do not know whether delaying treatment of elevated IOP
affects the rate of progression to POAG (currently being investigated in
OHTS II) and whether delaying treatment of POAG affects rate of visual
field progression
- We still do not know whether health-related quality of life differs
between treated and untreated glaucoma patients.24
- Overall summary: much stronger support for this criterion since 1980s
- Facilities for diagnosis and treatment should be available.
- Almost all developed countries have appropriate facilities for
diagnosis and treatment
- However, access can be a major issue, particularly in countries where
there is no national health insurance, such as the U.S.A.
- Some programs, such as EyeCare America, Glaucoma Project, were not
available previously.
- Overall summary: not much change from the 1980s.
- There must be an appropriate, acceptable, and reasonably
accurate screening test.
- Glaucoma screening technologies assessed by OTA were tonometry, direct
ophthalmoscopy, and manual and early automated perimetry. The best
results found were sensitivity of 93% and specificity of 88% for automated perimetry (Humphrey
perimeter).
- A major advance in automated perimetry over the past decade has been
development of shorter testing algorithms, such as SITA as well as
frequency doubling perimetry.25-27
- There have been major advancements in testing for structural damage
with optic disc and nerve fiber layer photography and imaging
technologies.28
- However, the sensitivity and specificity of all these tools for
population-based screening is uncertain, as some have been tested only
on selected groups, not populations.
- The question of how to set optimum criteria for
sensitivity/specificity is another unresolved issue, which has major
implications for cost.
- Overall summary: major improvements have been made in perimetry,
particularly with regard to portability, speed, and perhaps also
accuracy as well as major improvements in assessment of structural
damage. However, their utility in population-based screening has not yet
been fully defined.
- The natural history of the condition,
including development from latent to manifest disease, should be adequately
understood.
- More data on risk factors for development and progression of OAG are
now available.
- We are better able to predict who, with ocular hypertension, is more
likely to develop glaucoma, but still very imprecise (OHTS).21,29
- We are better able to predict who, with early glaucoma, is more likely
to progress, but still very imprecise (EMGT).22
- We now have longitudinal data on likelihood of progressing to
blindness (Olmsted study).30
- We now have longitudinal data on what happens with untreated glaucoma,
long-term in the St. Lucia Study, 31 and short-term with determination
of rates of progression in EMGT22 and CNTGS.32
- Overall Summary: Since the 1980s, knowledge of natural history of
open-angle glaucoma better understood, particularly of untreated
glaucoma. However, still considerable imprecision in identifying (1) who
will develop glaucoma and who will not, and (2) among those with
glaucoma, who will progress and at what rate.
- The cost of case-finding (including
diagnosis and treatment of patients
diagnosed) should be economically balanced in relation to possible expenditure on medical care
as a whole.
- A limited number of cost-effectiveness and value-based analyses are
now available.
- We need to better understand: benefits of early detection (in terms of
decreased morbidity) weighed against the toll
on available resources, the risks, and the inconvenience of screening;
impact of false positives subjected to wasteful diagnostic work-ups;
impact of false negatives not seeking further care and presenting later
at more advanced symptomatic stage.
- Overall summary: We are in the early stages of acquiring new data on
this topic.
Summary
In summary, an updated review of the evidence shows improvement in some
of the screening criteria and no improvement in others. A summary is
provided below. A score of 1 denotes no evidence for meeting criteria
and a score of 5 denotes fully meeting criteria.
Criteria
1980s
Current
1. Important health problem
4
4
2. Effective treatment
1
4
3. Available facilities
3
3.5
4. Accurate screening
test
2
4
5. Natural History
Understood
1
3
6. Cost-effective
1
1.5
Mean
2.33
3.33
The WGA subcommittee on Screening for OAG felt that there are at
least two other rationales for glaucoma screening, and both of these
have received relatively little attention. One of these is that of
promoting public awareness of the disease. In this regard, screening has
been particularly effective when directed at legislators and physicians.
Another rationale is that in many medically underserved communities,
ophthalmologic services are not readily available and glaucoma screening
may offer an avenue for detecting vision disorders and getting those who
require attention into appropriate evaluation and treatment. This is
particularly true in many rural areas.
Additional screening issues
Because the prevalence of primary open-angle glaucoma in the general
population is not high, screening (even with a highly valid test)
results in a low predictive value of a positive test. Thus among
individuals who test positive based on the screening, only a small
percentage will actually have the disease, and most will have undergone
costly, unproductive diagnostic work-ups. This has led to the suggestion
by several organizations and individuals that screening may only be
justified in certain 'high-risk' groups (i.e., elderly, specific races,
persons with glaucoma family history) in which the yield per positive
test would be expected to be higher.
From an economic standpoint, such a recommendation is reasonable since
the costs per case decrease as the predictive value increases. The
Committee felt this to be a very important consideration, and one that
was applicable to most developed societies. However, the Committee felt
that the direct and indirect costs for glaucoma case-finding as well as
the direct and indirect costs for glaucoma treatment needed to be
considered before making a definitive recommendation on what constituted
an acceptable predictive value. The currently available literature does
not permit a sufficiently detailed assessment in this regard.
Even among developed economy countries, considerable differences exist
in the health care delivery system and, specifically, in the provision
of ophthalmic care. One such example is in the role provided by
opticians, optometrists, ophthalmologists, and primary care doctors in
different countries. The Committee felt that a general recommendation on
the desirability of population screening for glaucoma may not be equally
applicable to all countries, regardless of similarities in state of
economic development.
Committee consensus
- Evidence to justify glaucoma screening is considerably stronger than
it was a couple of decades ago.
- Other rationale, besides the traditional guidelines advocated by
Wilson and Junger exists and further strengthens the justification for
glaucoma screening.
- Justification for glaucoma screening is most strongly supported in
high-risk groups. However, the cut-off level of glaucoma prevalence
needed to make screening desirable is not known.
- Other types of glaucoma screening
- besides mass or community
screening - are feasible in different societies and should be considered
within the constraints of the societal health care delivery system.
- Evidence weakly supports justification for community glaucoma
screening on a limited scale and for specific purposes.
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