ArticlePDF Available

Clinical guidelines for diabetic retinopathy in Kenya: an executive summary of the recommendations

Authors:

Abstract

All persons living with Diabetes Mellitus (DM) have a lifetime risk of developing Diabetic Retinopathy (DR), a potentially blinding microvascular complication of DM. The risk increases with the duration of diabetes. The onset and progression of DR can be delayed through optimization of control of blood glucose, blood pressure and lipids. The risk of blindness from DR can be reduced through cost-effective interventions such as screening for DR and treatment of sight-threatening DR with laser photocoagulation and anti-VEGF medications. Several factors make it important to provide guidance to clinicians who provide services for diabetes and diabetic retinopathy in Kenya. First, the magnitude of both DM and DR is expected to increase over the next decade. Secondly, as the retina is easily accessible for examination, the early signs of retinopathy may provide clinicians with the first evidence of microvascular damage from diabetes. This information can be used to guide subsequent management of both DM and DR. Thirdly, there are notable gaps in service delivery for the detection, treatment and follow-up of patients with DR, and the services are inequitable. Strengthening of service delivery will require close collaboration between diabetes services and eye care services. Following a systematic and collaborative process of guideline development, the first published national guidelines for the management of diabetic retinopathy have been developed. The purpose of this paper is to highlight the recommendations in the guidelines, and to facilitate their adoption and implementation.
33
Journal of Ophthalmology of Eastern Central and Southern AfricaDecember 2017
Clinical guidelines for diabetic retinopathy in Kenya: an executive summary of the
recommendations
Nyawira M1,9 , Muchai G2,4, Gichangi M3, Gichuhi S2, Githeko K4, Atieno J5, Karimurio J2, Kibachio J6, Ngugi N7,
Nyaga P7, Nyamori J2, Zindamoyen ANM8, Bascaran C9, Foster A9 for the Technical Working Group
1Kenya Medical Training College, Nairobi, Kenya
2Department of Ophthalmology, University of Nairobi, Kenya
3Ophthalmic Services Unit, Ministry of Health, Kenya
4Upper Hill Eye and Laser Center, Kenya
5Kabarak University, Nakuru, Kenya
6Division of Non-Communicable Diseases, Ministry of Health, Nairobi, Kenya
7Kenyatta National Hospital, Nairobi, Kenya
8PCEA Kikuyu Eye Hospital, Kikuyu, Kenya
9London School of Hygiene and Tropical Medicine, London, United Kingdom
Corresponding author: Dr Nyawira Mwangi, Kenya Medical Training College, Nairobi, Kenya. Email: Nyawira.
Mwangi@lshtm.ac.uk
ABSTRACT
All persons living with Diabetes Mellitus (DM) have a lifetime risk of developing Diabetic Retinopathy (DR), a
potentially blinding microvascular complication of DM. The risk increases with the duration of diabetes. The
onset and progression of DR can be delayed through optimization of control of blood glucose, blood pressure
and lipids. The risk of blindness from DR can be reduced through cost-eective interventions such as screening
for DR and treatment of sight-threatening DR with laser photocoagulation and anti-VEGF medications.
Several factors make it important to provide guidance to clinicians who provide services for diabetes and
diabetic retinopathy in Kenya. First, the magnitude of both DM and DR is expected to increase over the next
decade. Secondly, as the retina is easily accessible for examination, the early signs of retinopathy may provide
clinicians with the rst evidence of microvascular damage from diabetes. This information can be used to guide
subsequent management of both DM and DR. Thirdly, there are notable gaps in service delivery for the detection,
treatment and follow-up of patients with DR, and the services are inequitable. Strengthening of service delivery
will require close collaboration between diabetes services and eye care services.
Following a systematic and collaborative process of guideline development, the rst published national
guidelines for the management of diabetic retinopathy have been developed. The purpose of this paper is to
highlight the recommendations in the guidelines, and to facilitate their adoption and implementation.
Key words: Clinical practice guidelines, Diabetic retinopathy, Kenya
INTRODUCTION
Diabetes Mellitus (DM) is a priority non-communicable
disease that requires multidisciplinary care and continuity
of care. Its prevalence and incidence is increasing in
every country. According to the STEPwise survey1 for
risk factors of non-communicable diseases in 2015, DM
affects an estimated 2% of the Kenyan population aged
18-69 years with the highest proportion (5%) being in
the 45-59 years age group. Every patient with diabetes
is at risk of potentially blinding ocular complications,
particularly Diabetic Retinopathy (DR). In turn, visual
loss from diabetic retinopathy is associated with additional
morbidity, such as falls, fractures and difculties with
seeing and taking medications. Both DM and DR are
silent diseases that patients may be unaware of until they
cause complications. Clinicians attending to patients
with these conditions have a role to reduce the associated
morbidity, disability and mortality.
Diabetic Retinopathy (DR) is the leading cause of
blindness in diabetes, and for this reason it warrants
specic attention. It is estimated that a third of the
people with diabetes have diabetic retinopathy, and one
third of the latter (or 10% of those with diabetes) have
vision threatening DR2. Early signs of retinopathy
or maculopathy in a patient with diabetes, identied
on retinal examination, may be the rst evidence of
generalised microvascular damage from poor control
of diabetes. This information would be very useful in
planning subsequent holistic management of the patient.
There is therefore need to strengthen links between eye
care services and diabetes services.
34
Journal of Ophthalmology of Eastern Central and Southern Africa December 2017
The risk factors for DR include both modiable and
non-modiable factors. Epidemiologic studies have
identied the non-modiable risk factors to include
increasing duration of diabetes and genetic factors2,3.
The leading modiable risk factors include poor
control of blood sugar, poor control of blood pressure
and dyslipidaemia2,4-6. Service providers need to pay
attention to these factors, as well as to other lifestyle
factors associated with diabetes in order to delay onset or
progression of DR. These are interventions for primary
prevention of blindness from DR.
Stronger service delivery for DR is required within the
existing health system7-9. Currently there are notable gaps
in the screening, diagnosis, referral, treatment and follow-
up. Although screening for DR and laser treatment are
cost-effective interventions for prevention of blindness
from DR10, there are inequities in access to them. Some
of the services are underutilised and of insufcient
quality. DR guidelines and use of clinical guidelines is
an important step towards ensuring that all people with
diabetes have access to quality DR services.
The purpose of these clinical practice guidelines is
to give guidance regarding screening and diagnosis of
DR, management of diabetes as it pertains specically to
DR, and treatment of DR. These guidelines apply to all
patients with type 1 or type 2 diabetes who are at least 12
years old, who receive care at the primary, secondary or
tertiary level of the health system. They should be used by
health workers providing diabetes services and eye care
services, as well as by administrators and policy-makers
who plan for the resources for these services.
METHODOLOGY FOR GUIDELINES
DEVELOPMENT
The development of these guidelines was a systematic,
widely consultative process guided by an expert
technical group over a lengthy period and involving
many stakeholders. The process was guided by the use of
several toolkits and guidelines which include: ADAPTE
toolkit11, PGEAC framework12, AGREE 11 instrument13
and WHO handbook for guidelines development14.
The guidelines were adapted from existing relevant
standards and guidelines, particularly the American
Diabetes Association standards for medical care in
diabetes15 International Council of Ophthalmology
guidelines for diabetic eye care16 Canadian Diabetes
Association’s retinopathy guidelines17 and the Royal
College of Ophthalmologists’ diabetic retinopathy
guidelines18. The following guidelines were also
reviewed, and the recommendations are in line with their
provisions: Kenya national guidelines for management
of diabetes19, Kenya national strategy for the prevention
and control of non-communicable diseases20, and
International Diabetes Federation’s diabetes eye health
guide for health professionals21. The adaptation strategy
was chosen instead of de novo development in order to
avoid duplication of effort, to use the available resources
cost-effectively and to facilitate customization of the
guidelines to reect local context. These guidelines
were identied through a literature search followed by
application of the AGREE 11 instrument to evaluate the
quality of the guidelines. Previous drafts of local DR
guidelines were also reviewed. Care was taken to ensure
that the guidelines are evidence-based, locally applicable,
of high quality, and that the process of adaptation was
consultative. The guidelines were subjected to external
review by a multidisciplinary team as well as pilot-testing
in various health facilities.
The process of guideline development is discussed in
detail in a separate paper.
Key messages
1. Stronger service delivery is needed for People
Living with Diabetes (PLWD) in Kenya in relation
to DR. There is need to develop strong links between
diabetes services and eye care services within the
existing health system.
2. Blindness from DR is avoidable, but only if diabetes
care givers and eye health professionals perform
their roles in ensuring early detection and treatment
of DR.
3. Screening is important for early detection of treatable
diabetic retinopathy. It is also a cost-effective
intervention for reducing blindness from DR. All
patients with diabetes aged 12 years and above
should have a retinal examination (usually a dilated
eye examination or a retinal photograph) once a
year or more frequently if recommended by the eye
specialist.
4. Consistent and appropriate metabolic control reduces
the onset and progression of sight-threatening
diabetic retinopathy.
5. Laser photocoagulation therapy, local intraocular
pharmacological therapy and surgery reduce the risk
of signicant visual loss.
Recommendations
Domain: Strengthening links between diabetes services
and eye care services at primary, secondary and tertiary
level of care
1. All health workers providing diabetes services should
raise awareness of PLWD on diabetic retinopathy and
support them to access eye examination (Panel 1).
2. The health worker attending to a PLWD at any health
care level should use a checklist (Panel 2) to identify
whether the patient has had a retinal examination in
the preceding 12 months. Any patient who has not
should be referred to the nearest facility for screening
for DR.
35
Journal of Ophthalmology of Eastern Central and Southern AfricaDecember 2017
3. The screening examination for DR should be
performed by trained personnel (health care worker,
eye care workers or technicians) and should consist
of a minimum of:
a. A retinal examination appropriate for DR,
which would include dilated direct or indirect
ophthalmoscopy, slit lamp bio-microscopic
examination of the retina or retinal photography.
b. Visual acuity test using distant and near charts.
If the visual acuity is reduced, then pin hole test
is also performed.”
4. All PLWD require follow up, therefore service
providers in both eye clinics and diabetes clinics
should encourage compliance with follow-up.
5. A service charter for diabetes services and eye care
services should be available in all clinics offering
these services to inform PLWD of the minimum care
they should expect and to highlight the importance
of yearly comprehensive risk assessment including
dilated eye examination.
6. The ophthalmologist and the physician/diabetologist/
endocrinologist will provide clinical governance as
the team leads for diabetes services and eye care
services. The clinical governance team would also
include: (a) liaison diabetes nurse (from the diabetes
clinic), (b) liaison ophthalmic nurse (from the eye
clinic), (c) designated medical records ofcer and (d)
a biomedical / equipment maintenance technician.
7. The physician/diabetologist/endocrinologist and the
ophthalmologist would be responsible for oversight
on the screening for DR, training of health workers
and data management.
8. The Ophthalmic Services Unit would be responsible
for clinical governance for DR services at national
level.
9. Data would be systematically collected in both
diabetes clinics and eye clinics. The liaison nurse in
the diabetic clinic and eye clinic would forward the
captured data to the designated records ofcer for
reporting.
10. The Ophthalmic Services Unit would coordinate
the use of this data to inform decisions on service
improvement strategies.
Panel 1: Key messages for health workers attending to
PLWD
1 in 3 of patients with diabetes has diabetic retinopathy.
Act to save their vision today!
1Send all newly diagnosed patients with diabetes
for a baseline retinal examination.
2Ensure all patients with diabetes have an annual
retinal examination.
3Refer any patient with diabetes who has poor
vision to an eye specialist urgently.
4Do not wait for visual loss to refer patients with
diabetes to an eye specialist- ‘prevention is better
than cure.’
5Glycated hemoglobin (HbA1c) is a good indicator
for long-term sugar control and should be done
at least annually for all patients. Good glycemic
control prevents or delays diabetic retinopathy.
6Assess for other end organ damage- oral
examination, diabetic foot review, renal and
cardiac function, tests for neuropathy at least
annually
7Assess for hypertension, hyperlipidemia and other
co-morbidities as these may impact negatively on
diabetes and diabetic retinopathy.
8Send all pregnant patients with diabetes for a
retinal examination at least each trimester and
post-delivery, or more frequently if recommended
by the eye specialist.
Panel 2: Checklist for screening for DR
Patients name: …………………………………………
Date of birth: …………………………………………
Date of screening: ……………………………………
Duration of diabetes: …………………………………
Have you ever had an examination of the back of the eye
(either a photograph was taken or drops were instilled
into the eye before examination)?
a. YES b. NO
How long ago was the last examination of the back of the
eye?
a. < 12 months b. ≥ 12 months
Where was the eye examination done? ...........................
facility
Recommendation: ……………………………………
Have an eye check: as soon as possible / in the next
………………. months at………………. health facility
Domain: Eye examination for DR
Annual dilated and comprehensive eye examination is
recommended for all patients with diabetes, aged 12 years
and above, starting at the time of diagnosis of diabetes
mellitus, unless the eye specialist recommends a different
frequency. For type 1 diabetes, an eye exam should be
done at diagnosis, at 5 years of diagnosis and annually
thereafter.
36
Journal of Ophthalmology of Eastern Central and Southern Africa December 2017
Domain: Patient-centred care
1. Health workers should provide verbal and written
information on diabetes, diabetic retinopathy, and
on the health care that is needed, including self-
management.
2. All PLWD should receive regular and individualised
self-management support on healthy diet, appropriate
physical activity and weight reduction if they are
overweight. All smokers should be encouraged to
quit smoking.
3. Patient education materials such as posters, leaets,
booklets and yers on DR should be available (Panel
3) to patients and to peer support groups.
4. Diabetes support and structured self-management
education should also be provided to family members
of PLWD.
5. PLWD should be treated with dignity and involved
in decision-making for their care. The results of
their examination and the implications should be
explained to them, and they should be encouraged to
ask questions. The presence of co-morbidities should
be taken into consideration in the care of each patient.
Panel 3: Key messages for patients
DID YOU KNOW THAT DIABETES AFFECTS THE
EYES?
What can you do to prevent blindness?
1Diabetes mellitus is marked by high sugar levels
in blood. High blood sugar destroys small blood
vessels in the body including those at the back
of the eyes, leading to a condition called diabetic
retinopathy.
2Damage to the eyes is slow, painless, gets worse
with time and nally leads to blindness if not
treated in good time.
3The damage to the eyes needs to be detected early,
before permanent damage occurs.
4An eye check by an eye specialist can detect
damage to the eyes before symptoms develop.
During the examination, the eye specialist will
check vision, and instil an eye drop to assess the
damage in the eye. Both eyes need to be examined.
5For prevention and treatment of diabetic
retinopathy, the eye specialist may advise on sugar,
blood pressure, and lipid control.
6For treatment of diabetic retinopathy, the eye
specialist may perform laser or administer
injections in the eye or perform eye surgery.
7All persons with diabetes should have their eyes
checked once every year by an eye specialist, even
before any symptoms or poor vision develop or as
frequently as recommended by the eye specialist.
8A child with diabetes should have the eyes checked
annually from the age of 12 years, or more
frequently if recommended by the specialist.
9A pregnant mother with diabetes should undergo an
eye check by an eye specialist at least once every
trimester, and soon after delivery, or as frequently
as recommended by the eye specialist.
10 If the eyes are found to be normal at your eye
check by an eye specialist, please continue with an
eye check annually. If you notice any abnormality
with your eyes, visit the eye specialist as soon as
possible.
Domain: Metabolic control
1. All PLWD should be asked about the level of control
of glucose, blood pressure and lipids.
2. To prevent the onset and delay the progression of
diabetic retinopathy, people with diabetes should be
treated to achieve optimal control of blood glucose.
3. Regular monitoring of blood sugar at home should be
encouraged.
4. Regular monitoring of blood pressure in a health
care setting or at home should be encouraged. Target
blood pressure is 140/90 mmHg. Drugs blocking
the Renin-Angiotensin System (RAS) may have
benets, particularly for mild retinopathy, but should
be discontinued during pregnancy.
5. A comprehensive biochemical prole (risk
assessment) should be done at least annually,
and include fasting lipid prole, HbA1c, urine
microalbumin among other tests.
6. Aim for a target glycosylated haemoglobin (HbA1c)
of <7%.
7. Serum fasting lipid prole should be assessed at
diagnosis and annually. Consider statins in primary
and secondary prevention of DR but discontinue
statins in pregnancy.
Domain: Pregnancy
1. All female PLWD of reproductive age should be
asked if they are pregnant.
2. Patients should be assessed for diabetic retinopathy
before pregnancy, at least once every trimester of
pregnancy, as well as within 6 months after delivery
or more frequently if recommended by the eye
specialist.
3. Statins and angiotensin inhibitors should be
discontinued in patients who are planning for
pregnancy.
4. All women of child-bearing age who have diabetes
should be educated that pregnancies should be
planned.
37
Journal of Ophthalmology of Eastern Central and Southern AfricaDecember 2017
Domain: Screening programs for DR
1. All PLWD should be screened for DR at least once
a year, irrespective of whether they have ocular
symptoms or not.
2. Screening programs can utilise whatever screening
method is available (ophthalmoscopy, slit-lamp bio-
microscopy and retinal photography), and should be
conducted by a suitably trained person. Pupil dilation
is recommended. Visual acuity should be assessed
before pupil dilation.
3. Photography based screening
a. Where a fundus camera is available, ideally the
fundus camera should be located in the diabetes
clinic.
b. Fundus photographers should be trained to
identify cataract, other causes of media haziness
and glaucoma on the images. Patients who
have these pathologies should be referred to
an ophthalmologist. Ultrasonography may be
useful in assessing the posterior segment in the
presence of cataract or vitreous haemorrhage.
c. Regular retraining in form of short courses
(either online courses or standard contact
courses) should be provided for screeners.
4. The following patients should be referred to an
ophthalmologist:
a. Where the screening examination is unsuccessful,
or the results of the visual acuity test or retinal
examination are unclear
b. Where the retinal examination is unsuccessful,
for example due to additional pathologies
c. Any grade of retinopathy, except mild non-
proliferative retinopathy
d. Visual acuity worse than 6/12 and all patients
with ocular symptoms
5. Screening should identify true positives (patients
with DR). For this to be achieved, it is important to
use the correct equipment, adhere to the standards of
practice, make correct diagnosis and have a quality
assurance mechanism. The guidelines for quality
assurance are provided as an addendum to the
guidelines.
6. All health workers have a role in ensuring patients
undergo screening. All health workers should also
document and collect data on screening activities,
as the data is useful for planning and monitoring
services. Health workers at each health facility
will collect this data using standard monthly data
collection forms. The Ophthalmic Services Unit in
the Ministry of Health will coordinate the collection
of data.
Domain: Diagnostic evaluation of patients at the eye
clinic
Once the person with diabetes has been referred to
an eye specialist, he or she should undergo a complete
ophthalmic assessment. Ophthalmic evaluation by an
eye care worker is available at the secondary level of the
health system. This should include taking medical history,
assessing visual acuity, and identifying and grading DR
or Diabetic Macula Oedema (DME), using standard
procedures described in the guidelines.
Domain: Referral pathway
Once a decision for referral for evaluation or treatment has
been made, it should be carried out as soon as possible.
The nearest health facility offering DR services will be
identied (mapping of services has been conducted,
and this information is provided as an addendum to the
guidelines), and patients will be referred to reach the
facility on the designated days that the services can be
provided.
Domain: Treatment interventions
The ophthalmologist will make the nal diagnosis and
the decision on the treatment that the patient should
receive. There is evidence from Cochrane systematic
reviews included in Panel 4 to support the use of laser
photocoagulation in proliferative diabetic retinopathy22
anti-VEGF injections in diabetic macula oedema23 and
intravitreal steroids in refractory diabetic macula oedema24.
Laser or intravitreal injections can be administered by the
ophthalmologist at secondary level. Surgical interventions
for DR will be provided by the vitreo-retinal surgeon at
tertiary level. Practical information on these procedures is
provided in the guidelines.
Panel 4. Evidence from Cochrane systematic reviews for
Interventions used to treat diabetic retinopathy.
Laser photocoagulation is benecial in reducing the
risk of severe visual loss and the risk of progression
12 months after treatment in patients with proliferative
diabetic retinopathy compared to no treatment or deferred
treatment. However most trials here are old and the
quality of evidence is judged as low22.
There is very low or low quality evidence from randomized
controlled trials that anti-VEGF injections are effective in
patients with proliferative diabetic retinopathy but they
prevent intraocular bleeding25.
There is high quality evidence that anti-VEGF injections
are effective in preserving and improving vision in
patients with diabetic macula oedema compared to grid
laser23.
38
Journal of Ophthalmology of Eastern Central and Southern Africa December 2017
Intravitreal steroids delivered either by injection or
implants may improve visual outcomes in patients with
persistent or refractory diabetic macula oedema but it
is unclear whether they are benecial in other earlier
stages24.
Domain: Follow up
All PLWD screened for DR will require follow up. The
frequency of follow-up depends on the clinical ndings,
and the grading/severity of DR, as described in the
guidelines.
Domain: Patients with low vision
Refer the patient with low vision (best corrected visual
acuity of <6/18) for rehabilitation. PLWD who would
benet from counselling and social services should be
referred as appropriate.
Domain: Monitoring DR services
Specic process and outcome indicators will be used
to monitor services on a quarterly basis at each level of
service delivery, using the hospital health management
and information system. Health workers at each health
facility will therefore collect this data using standard
monthly data collection forms. The Ophthalmic Services
Unit will coordinate the collection of data. The indicators
of interest are listed in the guidelines.
CONCLUSIONS
Patients with diabetes require specic care relevant to
diabetic retinopathy, which includes patient education,
screening, referral, treatment and follow-up. These are
the rst published national clinical practice guidelines for
the screening and management of diabetic retinopathy.
Their goal is to ensure best practice throughout the
whole pathway from primary care to tertiary care.
Implementation of the guidelines has potential to reduce
blindness from DR.
The Working Group welcomes feedback from all users
of these guidelines. In particular, data on the enablers and
challenges experienced in the use of the guidelines would
be very useful in informing revisions on the guidelines.
Please email feedback to the Ophthalmic Services Unit,
Ministry of Health, through ophthalmicserviceske@
gmail.com.
ACKNOWLEDGEMENTS
We acknowledge The Fred Hollows Foundation for
funding the process of guidelines development.
Conict of interest: Nothing to declare.
REFERENCES
1. Ministry of Health, Kenya National Bureau of
Statistics, World Health Organization. Kenya
STEPwise survey for non-communicable diseases
risk factors 2015 report. Ministry of Health, Division
of Non-Communicable Diseases, 2015.
2. Yau JWY, Rogers SL, Kawasaki R, Lamoureux EL,
Kowalski JW, Bek T, et al. Global prevalence and
major risk factors of diabetic retinopathy. Diabetes
Care. 2012; 35:556-564.
3. University of Winsconsin. The Winsconsin
Epidemiologic Study of Diabetic Retinopathy
(WESDR) 2015 [cited 2015 151215]. Available
from: www.epi.ophth.wisc.edu.
4. The Diabetes Control and Complications Trial
Research Group. The effect of intensive treatment of
diabetes on the development and progression of long-
term complications on insulin-dependent diabetes
mellitus. New Engl J Med. 1993; 329(14):
5. King P, Peacock I, Donnelly R. The UK Prospective
Diabetes Study (UKPDS): clinical and therapeutic
implications for type 2 diabetes. Br J Clin Pharmacol.
1999; 48:643-648.
6. The ACCORD Study Group. Effects of intensive
blood-pressure control in type 2 diabetes mellitus.
New Engl J Med. 2010; 362:1575-585.
7. Poore S, Foster A, Zondervan M, Blanchet K.
Planning and developing services for diabetic
retinopathy in Sub-Saharan Africa. Int J Health
Policy Manag. 2015; 4(1):19-28.
8. Kupitz DG, Fenwick E, Kollmann KHM, Holz
FG, Finger RP. Diabetes and diabetic retinopathy
management in East Africa: Knowledge, Attitudes,
and Practices of hospital staff in Kenya. Asia-Pacic
Ophthalmol. 2014; 3(5):
9. Bastawrous A, Mathenge W, Wing K, Bastawrous M,
Rono H, Helen WA, et al. The incidence of diabetes
mellitus and diabetic retinopathy in a population-
based cohort study of people aged 50 years and over
in Nakuru , Kenya. 2017:1-14
10. Jones S, Edwards RT. Diabetic retinopathy screening:
a systematic review of the economic evidence.
Diabetic Med. 2010; 27(3):249-256.
11. The ADAPTE Collaboration. The ADAPTE process:
resource toolkit for guideline adaptation ver 2.0,
available at http://www.g-i-n.net. 2009.
12. Graham ID, Morrison MB. Evaluation and adaptation
of clinical practice guidelines. Evidence Based
Nursing (EBN). 2005; 8:68-72
13. The AGREE Research Trust. AGREE 11 instrument,
available at http://www.agreetrust.org. 2009.
14. World Health Organization. WHO Handbook for
guideline development, available at http://www.who.
int. 2012.
39
Journal of Ophthalmology of Eastern Central and Southern AfricaDecember 2017
15. American Diabetes Association. Standards of
Medical Care in Diabetes-2017. Diabetes Care.
2017; 40(Suppl 1):
16. International Council of Ophthalmology. ICO
Guidelines for Diabetic Eye Care-updated 2017.
San Francisco, California: International Council of
Ophthalmology, 2017 23 February 2017. Report No.
17. Canadian Diabetes Association Clinical Practice
Guideline Expert Committee, Boyd SR, Advani A,
Altomare F, Stockl F. Retinopathy. Can J Diabetes.
2013; 37 (Suppl 1):S137-41.
18. Royal College of Ophthalmologists. Diabetic
Retinopathy guidelines, available at www.rcophth.
ac.uk. 2012.
19. Ministry of Public Health and Sanitation. National
Clinical Guidelines for management of diabetes
mellitus. 2010.
20. Ministry of Health. Kenya National Strategy for
Prevention and Control of Non-communicable
Disease 2015-2020. 2015.
21. International Diabetes Federation, Foundation TFH.
Diabetes eye health: a guide for health professionals,
available at www.idf.org/eyecare. 2015.
22. Evans JR, Michelessi M, Virgili G. Laser
photocoagulation for proliferative diabetic
retinopathy. The Cochrane Database of Systematic
Reviews. 2014; 24(11):Cd011234.
23. Virgili G, Parravano M, Menchini F, Evans JR.
Anti-vascular endothelial growth factor for diabetic
macular oedema. Cochrane Database of Systematic
Reviews. 2014; (10)
24. Grover DA, Li T, Chong CCW. Intravitreal steroids
for macular edema in diabetes. Cochrane Database
of Systematic Reviews. 2008; (1)
25. Martinez-Zapata MJ, Martí-Carvajal AJ, Solà I,
Pijoán JI, Buil-Calvo JA, Cordero JA, et al. Anti-
vascular endothelial growth factor for proliferative
diabetic retinopathy. Cochrane Database of
Systematic Reviews. 2014; (11)
... Some of the services are underutilized for a variety of reasons, while some of the services delivered are of insufficient quality. This disparity is linked to multiple supply and demand factors, such as variation in referral practices of diabetes care providers, screening practices of eye care providers, integration of services, and level of awareness of patients [9,12,13]. ...
... They are in English, but they can be translated. An executive summary of the guidelines is published in a separate paper [12]. Feedback from pilot-testing indicated that the guideline is useful in various clinical and geographic settings in the country. ...
... Some of the services are underutilized for a variety of reasons, while some of the services delivered are of insufficient quality. This disparity is linked to multiple supply and demand factors, such as variation in referral practices of diabetes care providers, screening practices of eye care providers, integration of services, and level of awareness of patients [9,12,13]. ...
... They are in English, but they can be translated. An executive summary of the guidelines is published in a separate paper [12]. Feedback from pilot-testing indicated that the guideline is useful in various clinical and geographic settings in the country. ...
Article
Full-text available
Background: The use of clinical practice guidelines envisages augmenting quality and best practice in clinical outcomes. Generic guidelines that are not adapted for local use often fail to produce these outcomes. Adaptation is a systematic and rigorous process that should maintain the quality and validity of the guideline, while making it more usable by the targeted users. Diverse skills are required for the task of adaptation. Although adapting a guideline is not a guarantee that it will be implemented, adaptation may improve acceptance and adherence to its recommendations. Methods: We describe the process used to adapt clinical guidelines for diabetic retinopathy in Kenya, using validated tools and manuals. A technical working group consisting of volunteers provided leadership. Results: The process was intensive and required more time than anticipated. Flexibility in the process and concurrent health system activities contributed to the success of the adaptation. The outputs from the adaptation include the guidelines in different formats, point of care instruments, as well as tools for training, monitoring, quality assurance and patient education. Conclusion: Guideline adaptation is applicable and feasible at the national level in Kenya. However, it is labor- and time -intensive. It presents a valuable opportunity to develop several additional outputs that are useful at the point of care.
Article
Full-text available
Background Vision loss due to diabetic retinopathy can largely be prevented or delayed through treatment. Patients with vision-threatening diabetic retinopathy are typically offered laser or intravitreal injections which often require more than one treatment cycle. However, treatment is not always initiated, or it is not completed, resulting in poor visual outcomes. Interventions aimed at improving the uptake or completion of treatment for diabetic retinopathy can potentially help prevent or delay visual loss in people with diabetes. Methods We will search MEDLINE, Embase, Global Health and Cochrane Register of Studies for studies reporting interventions to improve the uptake of treatment for diabetic retinopathy (DR) and/or diabetic macular oedema (DMO), compared with usual care, in adults with diabetes. The review will include studies published in the last 20 years in the English language. We will include any study design that measured any of the following outcomes in relation to treatment uptake and completion for DR and/or DMO: (1) proportion of patients initiating treatment for DR and/or DMO among those to whom it is recommended, (2) proportion of patients completing treatment for DR and/or DMO among those to whom it is recommended, (3) proportion of patients completing treatment for DR and/or DMO among those initiating treatment and (4) number and proportion of DR and/or DMO rounds of treatment completed per patient, as dictated by the treatment protocol. For included studies, we will also report any measures of cost-effectiveness when available. Two reviewers will screen search results independently. Risk of bias assessment will be done by two reviewers, and data extraction will be done by one reviewer with verification of 10% of the papers by a second reviewer. The results will be synthesised narratively. Discussion This rapid review aims to identify and synthesise the peer-reviewed literature on the effectiveness of interventions to increase uptake and completion of treatment for DR and/or DMO in LMICs. The rapid review methodology was chosen in order to rapidly synthesise the available evidence to support programme implementers and policy-makers in designing evidence-based health programmes and public health policy and inform the allocation of resources. Systematic review registration OSF osf.io/h5wgr
Article
Full-text available
Background: The epidemic rise of diabetes carries major negative public health and economic consequences particularly for low and middle-income countries. The highest predicted percentage growth in diabetes is in the sub-Saharan Africa (SSA) region where to date there has been no data on the incidence of diabetic retinopathy from population-based cohort studies and minimal data on incident diabetes. The primary aims of this study were to estimate the cumulative six-year incidence of Diabetes Mellitus (DM) and DR (Diabetic Retinopathy), respectively, among people aged ≥50 years in Kenya. Methods: Random cluster sampling with probability proportionate to size were used to select a representative cross-sectional sample of adults aged ≥50 years in 2007-8 in Nakuru District, Kenya. A six-year follow-up was undertaken in 2013-14. On both occasions a comprehensive ophthalmic examination was performed including LogMAR visual acuity, digital retinal photography and independent grading of images. Data were collected on general health and risk factors. The primary outcomes were the incidence of diabetes mellitus and the incidence of diabetic retinopathy, which were calculated by dividing the number of events identified at 6-year follow-up by the number of people at risk at the beginning of follow-up. Age-adjusted risk ratios of the outcomes (DM and DR respectively) were estimated for each covariate using a Poisson regression model with robust error variance to allow for the clustered design and including inverse-probability weighting. Results: At baseline, 4414 participants aged ≥50 years underwent complete examination. Of the 4104 non-diabetic participants, 2059 were followed-up at six-years (50 · 2%). The cumulative incidence of DM was estimated at 61 · 0 per 1000 (95% CI: 50 · 3-73 · 7) in people aged ≥50 years. The cumulative incidence of DR in the sample population was estimated at 15 · 8 per 1000 (95% CI: 9 · 5-26 · 3) among those without DM at baseline, and 224 · 7 per 1000 (116.9-388.2) among participants with known DM at baseline. A multivariable risk factor analysis demonstrated increasing age and higher body mass index to be associated with incident DM. DR incidence was strongly associated with increasing age, and with higher BMI, urban dwelling and higher socioeconomic status. Conclusions: Diabetes Mellitus is a growing public health concern with a major complication of diabetic retinopathy. In a population of 1 · 6 million, of whom 150,000 are ≥50 years, we estimated that 1650 people aged ≥50 develop DM per year, and 450 develop DR. Strengthening of health systems is necessary to reduce incident diabetes and its complications in this and similar settings.
Article
Full-text available
Background: Over the past few decades diabetes has emerged as an important non-communicable disease in SubSaharan Africa (SSA). Sight loss from Diabetic Retinopathy (DR) can be prevented with screening and early treatment. The objective of this paper is to outline the required actions and considerations in the planning and development of DR screening services. Methods: A multiple-case study approach was used to analyse five DR screening services in Botswana, Ghana, Tanzania and Zambia. Cases included: two regional screening programmes, two hospital-based screening services and one nationwide screening service. Data was collected using qualitative methodologies including: document analysis, indepth interviews and observation. The World Health Organization (WHO) Health Systems Framework was adopted as the conceptual framework for analysis. Results: Planning for a sustainable and integrated DR screening programme demanded a health systems approach. Collaboration with representatives from a variety of ministerial departments and professional bodies was required. Evolution of DR screening services may occur in a variety of ways including: increasing geographical coverage, integration into the general healthcare system, and stepwise progression from a passive, opportunistic service to one that systematically and proactively seeks to prevent DR. Lessons learned from the implementation of cervical cancer prevention programmes in resource-poor settings may assist the development of DR programmes in similar settings. Conclusion: To promote good planning of DR screening services and ensure limited resources are used effectively, there is a need to learn from screening programmes in other medical specialities and a need to share experiences between newly-developing DR programmes in resource-poor countries. The WHO Health Systems Framework presents an invaluable tool to ensure a systematic approach to planning DR screening services
Article
Full-text available
Background: There is no evidence from randomized trials to support a strategy of lowering systolic blood pressure below 135 to 140 mm Hg in persons with type 2 diabetes mellitus. We investigated whether therapy targeting normal systolic pressure (i.e., <120 mm Hg) reduces major cardiovascular events in participants with type 2 diabetes at high risk for cardiovascular events. Methods: A total of 4733 participants with type 2 diabetes were randomly assigned to intensive therapy, targeting a systolic pressure of less than 120 mm Hg, or standard therapy, targeting a systolic pressure of less than 140 mm Hg. The primary composite outcome was nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The mean follow-up was 4.7 years. Results: After 1 year, the mean systolic blood pressure was 119.3 mm Hg in the intensive-therapy group and 133.5 mm Hg in the standard-therapy group. The annual rate of the primary outcome was 1.87% in the intensive-therapy group and 2.09% in the standard-therapy group (hazard ratio with intensive therapy, 0.88; 95% confidence interval [CI], 0.73 to 1.06; P=0.20). The annual rates of death from any cause were 1.28% and 1.19% in the two groups, respectively (hazard ratio, 1.07; 95% CI, 0.85 to 1.35; P=0.55). The annual rates of stroke, a prespecified secondary outcome, were 0.32% and 0.53% in the two groups, respectively (hazard ratio, 0.59; 95% CI, 0.39 to 0.89; P=0.01). Serious adverse events attributed to antihypertensive treatment occurred in 77 of the 2362 participants in the intensive-therapy group (3.3%) and 30 of the 2371 participants in the standard-therapy group (1.3%) (P<0.001). Conclusions: In patients with type 2 diabetes at high risk for cardiovascular events, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, did not reduce the rate of a composite outcome of fatal and nonfatal major cardiovascular events. (ClinicalTrials.gov number, NCT00000620.)
Article
Full-text available
To examine the global prevalence and major risk factors for diabetic retinopathy (DR) and vision-threatening diabetic retinopathy (VTDR) among people with diabetes. A pooled analysis using individual participant data from population-based studies around the world was performed. A systematic literature review was conducted to identify all population-based studies in general populations or individuals with diabetes who had ascertained DR from retinal photographs. Studies provided data for DR end points, including any DR, proliferative DR, diabetic macular edema, and VTDR, and also major systemic risk factors. Pooled prevalence estimates were directly age-standardized to the 2010 World Diabetes Population aged 20-79 years. A total of 35 studies (1980-2008) provided data from 22,896 individuals with diabetes. The overall prevalence was 34.6% (95% CI 34.5-34.8) for any DR, 6.96% (6.87-7.04) for proliferative DR, 6.81% (6.74-6.89) for diabetic macular edema, and 10.2% (10.1-10.3) for VTDR. All DR prevalence end points increased with diabetes duration, hemoglobin A(1c), and blood pressure levels and were higher in people with type 1 compared with type 2 diabetes. There are approximately 93 million people with DR, 17 million with proliferative DR, 21 million with diabetic macular edema, and 28 million with VTDR worldwide. Longer diabetes duration and poorer glycemic and blood pressure control are strongly associated with DR. These data highlight the substantial worldwide public health burden of DR and the importance of modifiable risk factors in its occurrence. This study is limited by data pooled from studies at different time points, with different methodologies and population characteristics.
Article
Full-text available
Clinical practice guidelines are “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”1 They are intended to offer concise instructions on how to provide healthcare services.2 The most important benefit of clinical practice guidelines is their potential to improve both the quality or process of care and patient outcomes.3 Increasingly, clinicians and clinical managers must choose from numerous, sometimes differing, and occasionally contradictory, guidelines.4 This situation is further complicated by concerns about the quality of available guidelines.5,6,7,8,9,10,11 Indeed, adoption of guidelines of questionable validity can lead to the use of ineffective interventions, inefficient use of scarce resources, and perhaps most importantly, harm to patients.12,13 Determining which guidelines are quality products worthy of adoption can be daunting. Every effort should be made to identify existing guidelines that have been rigorously developed and to adopt or adapt them for local use.12 However, organisations and clinicians should scrutinise the methods by which the guidelines were developed, as well as the content and utility of the recommendations. Even guidelines developed by prominent professional groups or government bodies should not be exempt from this scrutiny as it has been shown that these guidelines may be of substandard quality.10 The Practice Guidelines Evaluation and Adaptation Cycle14,15 is a framework for organising and making decisions about which high quality guidelines to adopt (figure). Although the cycle was originally intended for use by organisations and groups wanting to implement best practice, most steps of the process are also helpful in guiding evaluation of guidelines by individual clinicians. This Users’ guide will describe strategies for identifying, critically appraising, and adopting or adapting guidelines for local use. ![Graphic][1] Practice guidelines evaluation and adaptation cycle Adapted from … [1]: /embed/graphic-1.gif
Article
Background: Proliferative diabetic retinopathy (PDR) is a complication of diabetic retinopathy that can cause blindness. Although panretinal photocoagulation (PRP) is the treatment of choice for PDR, it has secondary effects that can affect vision. An alternative treatment such as anti-vascular endothelial growth factor (anti-VEGF), which produces an inhibition of vascular proliferation, could improve the vision of people with PDR. Objectives: To assess the effectiveness and safety of anti-VEGFs for PDR. Search methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 3), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to April 2014), EMBASE (January 1980 to April 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 28 April 2014. Selection criteria: We included randomised controlled trials (RCTs) comparing anti-VEGFs to another active treatment, sham treatment or no treatment for people with PDR. We also included studies that assessed the combination of anti-VEGFs with other treatments. Data collection and analysis: Two review authors independently selected studies for inclusion, extracted data and assessed risk of bias for all included trials. We calculated the risk ratio (RR) or the mean difference (MD), and 95% confidence intervals (CI). Main results: We included 18 RCTs with 1005 participants (1131 eyes) of whom 57% were men. The median number of participants per RCT was 40 (range 15 to 261). The studies took place in Asia (three studies), Europe (two studies), the Middle East (seven studies), North America (three studies) and South America (three studies). Eight RCTs recruited people eligible for PRP, nine RCTs enrolled people with diabetes requiring vitrectomy and one RCT recruited people undergoing cataract surgery. The median follow-up was six months (range one to 12 months). Seven studies were at high risk of bias and the remainder were unclear risk of bias in one or more domains.Very low quality evidence from one study of 61 people showed that people treated with bevacizumab and PRP were less likely to lose 3 or more lines of visual acuity at 12 months compared with people treated with PRP alone (RR 0.19, 95% CI 0.05 to 0.81). People treated with anti-VEGF had an increased chance of gaining 3 or more lines of visual acuity but the effect was imprecise and compatible with no effect or being less likely to gain vision (RR 6.78, 95% CI 0.37 to 125.95). No other study reported these two outcomes. On average, people treated with anti-VEGF (bevacizumab, pegaptanib or ranibizumab) had better visual acuity at 12 months compared with people not receiving anti-VEGF (MD -0.07 logMAR, 95% CI -0.12 to -0.02; 5 RCTs, 373 participants, low quality evidence). There was some evidence to suggest a regression of PDR with smaller leakage on fluorescein angiography but it was difficult to estimate a pooled result from the two trials reporting this outcome. People receiving anti-VEGF were less likely to have vitreous or pre-retinal haemorrhage at 12 months (RR 0.32, 95% CI 0.16 to 0.65; 3 RCTs, 342 participants, low quality evidence). No study reported on fluorescein leakage or quality of life.All of the nine trials of anti-VEGF before or during vitrectomy investigated bevacizumab; most studies investigated bevacizumab before vitrectomy, one study investigated bevacizumab during surgery.People treated with bevacizumab and vitrectomy were less likely to lose 3 or more lines of visual acuity at 12 months compared with people given vitrectomy alone but the effect was imprecise and compatible with no effect or being more likely to lose vision (RR 0.49, 95% CI 0.08 to 3.14; 3 RCTs, 94 participants, low quality evidence). People treated with bevacizumab were more likely to gain 3 or more lines of visual acuity (RR 1.62, 95% CI 1.20 to 2.17; 3 RCTs, 94 participants, low quality evidence). On average, people treated with bevacizumab had better visual acuity at 12 months compared with people not receiving bevacizumab but there was uncertainty in the estimate (the CIs included 0; i.e. were compatible with no effect, and there was considerable inconsistency between studies; MD -0.24 logMAR, 95% CI -0.50 to 0.01; 6 RCTs, 335 participants, I(2) = 67%; low quality evidence). People receiving bevacizumab were less likely to have vitreous or pre-retinal haemorrhage at 12 months (RR 0.30, 95% CI 0.18 to 0.52; 7 RCTs, 393 participants, low quality evidence). No study reported on quality of life.Reasons for downgrading the quality of the evidence included risk of bias in included studies, imprecision of the estimates, inconsistency of effect estimates and indirectness (few studies reported at 12 months).Adverse effects were rarely reported and there was no evidence for any increased risk with anti-VEGF but given the relatively few studies that reported these, and the low event rate, the power of the analysis to detect any differences was low. Authors' conclusions: There was very low or low quality evidence from RCTs for the efficacy and safety of anti-VEGF agents when used to treat PDR over and above current standard treatments. However, the results suggest that anti-VEGFs can reduce the risk of intraocular bleeding in people with PDR. Further carefully designed clinical trials should be able to improve this evidence.
Article
Background: Diabetic retinopathy is a complication of diabetes in which high blood sugar levels damage the blood vessels in the retina. Sometimes new blood vessels grow in the retina, and these can have harmful effects; this is known as proliferative diabetic retinopathy. Laser photocoagulation is an intervention that is commonly used to treat diabetic retinopathy, in which light energy is applied to the retina with the aim of stopping the growth and development of new blood vessels, and thereby preserving vision. Objectives: To assess the effects of laser photocoagulation for diabetic retinopathy compared to no treatment or deferred treatment. Search methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 5), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to June 2014), EMBASE (January 1980 to June 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 3 June 2014. Selection criteria: We included randomised controlled trials (RCTs) where people (or eyes) with diabetic retinopathy were randomly allocated to laser photocoagulation or no treatment or deferred treatment. We excluded trials of lasers that are no longer in routine use. Our primary outcome was the proportion of people who lost 15 or more letters (3 lines) of best-corrected visual acuity (BCVA) as measured on a logMAR chart at 12 months. We also looked at longer-term follow-up of the primary outcome at two to five years. Secondary outcomes included mean best corrected distance visual acuity, severe visual loss, mean near visual acuity, progression of diabetic retinopathy, quality of life, pain, loss of driving licence, vitreous haemorrhage and retinal detachment. Data collection and analysis: We used standard methods as expected by the Cochrane Collaboration. Two review authors selected studies and extracted data. Main results: We identified a large number of trials of laser photocoagulation of diabetic retinopathy (n = 83) but only five of these studies were eligible for inclusion in the review, i.e. they compared laser photocoagulation with currently available lasers to no (or deferred) treatment. Three studies were conducted in the USA, one study in the UK and one study in Japan. A total of 4786 people (9503 eyes) were included in these studies. The majority of participants in four of these trials were people with proliferative diabetic retinopathy; one trial recruited mainly people with non-proliferative retinopathy. Four of the studies evaluated panretinal photocoagulation with argon laser and one study investigated selective photocoagulation of non-perfusion areas. Three studies compared laser treatment to no treatment and two studies compared laser treatment to deferred laser treatment. All studies were at risk of performance bias because the treatment and control were different and no study attempted to produce a sham treatment. Three studies were considered to be at risk of attrition bias.At 12 months there was little difference between eyes that received laser photocoagulation and those allocated to no treatment (or deferred treatment), in terms of loss of 15 or more letters of visual acuity (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.89 to 1.11; 8926 eyes; 2 RCTs, low quality evidence). Longer term follow-up did not show a consistent pattern, but one study found a 20% reduction in risk of loss of 15 or more letters of visual acuity at five years with laser treatment. Treatment with laser reduced the risk of severe visual loss by over 50% at 12 months (RR 0.46, 95% CI 0.24 to 0.86; 9276 eyes; 4 RCTs, moderate quality evidence). There was a beneficial effect on progression of diabetic retinopathy with treated eyes experiencing a 50% reduction in risk of progression of diabetic retinopathy (RR 0.49, 95% CI 0.37 to 0.64; 8331 eyes; 4 RCTs, low quality evidence) and a similar reduction in risk of vitreous haemorrhage (RR 0.56, 95% CI 0.37 to 0.85; 224 eyes; 2 RCTs, low quality evidence).None of the studies reported near visual acuity or patient-relevant outcomes such as quality of life, pain, loss of driving licence or adverse effects such as retinal detachment.We did not plan any subgroup analyses, but there was a difference in baseline risk in participants with non-proliferative retinopathy compared to those with proliferative retinopathy. With the small number of included studies we could not do a formal subgroup analysis comparing effect in proliferative and non-proliferative retinopathy. Authors' conclusions: This review provides evidence that laser photocoagulation is beneficial in treating proliferative diabetic retinopathy. We judged the evidence to be moderate or low, depending on the outcome. This is partly related to reporting of trials conducted many years ago, after which panretinal photocoagulation has become the mainstay of treatment of proliferative diabetic retinopathy.Future Cochrane Reviews on variations in the laser treatment protocol are planned. Future research on laser photocoagulation should investigate the combination of laser photocoagulation with newer treatments such as anti-vascular endothelial growth factors (anti-VEGFs).
Article
Background: Diabetic macular oedema (DMO) is a common complication of diabetic retinopathy. Although grid or focal laser photocoagulation has been shown to reduce the risk of visual loss in DMO, or clinically significant macular oedema (CSMO), vision is rarely improved. Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) modalities is used to try to improve vision in people with DMO. Objectives: To investigate the effects in preserving and improving vision and acceptability, including the safety, compliance with therapy and quality of life, of antiangiogenic therapy with anti-VEGF modalities for the treatment of DMO. Search methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 3), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to April 2014), EMBASE (January 1980 to April 2014), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to April 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 28 April 2014. Selection criteria: We included randomised controlled trials (RCTs) comparing any antiangiogenic drugs with an anti-VEGF mechanism of action versus another treatment, sham treatment or no treatment in people with DMO. Data collection and analysis: We used standard methodological procedures expected by The Cochrane Collaboration. The risk ratios (RR) for visual loss and visual gain of three or more lines of logMAR visual acuity were estimated at one year of follow-up (plus or minus six months) after treatment initiation. Main results: Eighteen studies provided data on four comparisons of interest in this review. Participants in the trials had central DMO and moderate vision loss.Compared with grid laser photocoagulation, people treated with antiangiogenic therapy were more likely to gain 3 or more lines of vision at one year (RR 3.6, 95% confidence interval (CI) 2.7 to 4.8, 10 studies, 1333 cases, high quality evidence) and less likely to lose 3 or more lines of vision (RR 0.11, 95% CI 0.05 to 0.24, 7 studies, 1086 cases, high quality evidence). In meta-analyses, no significant subgroup difference was demonstrated between bevacizumab, ranibizumab and aflibercept for the two primary outcomes, but there was little power to detect a difference. The quality of the evidence was judged to be high, because the effect was large, precisely measured and did not vary across studies, although some studies were at high or unclear risk of bias for one or more domains. Regarding absolute benefit, we estimated that 8 out of 100 participants with DMO may gain 3 or more lines of visual acuity using photocoagulation whereas 28 would do so with antiangiogenic therapy, meaning that 100 participants need to be treated with antiangiogenic therapy to allow 20 more people (95% CI 13 to 29) to markedly improve their vision after one year. People treated with anti-VEGF on average had 1.6 lines better vision (95% CI 1.4 to 1.8) after one year compared to laser photocoagulation (9 studies, 1292 cases, high quality evidence). To achieve this result, seven to nine injections were delivered in the first year and three or four in the second, in larger studies adopting either as needed regimens with monthly monitoring or fixed regimens.In other analyses antiangiogenic therapy was more effective than sham (3 studies on 497 analysed participants, high quality evidence) and ranibizumab associated with laser was more effective than laser alone (4 studies on 919 participants, high quality evidence).Ocular severe adverse events, such as endophthalmitis, were rare in the included studies. Meta-analyses conducted for all antiangiogenic drugs compared with either sham or photocoagulation did not show a significant difference regarding serious systemic adverse events (15 studies, 441 events in 2985 participants, RR 0.98, 95% CI 0.83 to 1.17), arterial thromboembolic events (14 studies, 129 events in 3034 participants, RR 0.89, 95% CI 0.63 to 1.25) and overall mortality (63 events in 3562 participants, RR 0.88, 95% CI 0.52 to 1.47). We judged the quality of the evidence on adverse effects as moderate due to partial reporting of safety data and the exclusion of participants with previous cardiovascular events in some studies. Authors' conclusions: There is high quality evidence that antiangiogenic drugs provide a benefit compared to current therapeutic options for DMO, that is grid laser photocoagulation, in clinical trial populations at one or two years. Future research should investigate differences between drugs, effectiveness under real-world monitoring and treatment conditions, and safety in high-risk populations, particularly regarding cardiovascular risk.
Article
Diabet. Med. 27, 249–256 (2010) Abstract This paper systematically reviews the published literature on the economic evidence of diabetic retinopathy screening. Twenty‐nine electronic databases were searched for studies published between 1998 and 2008. Internet searches were carried out and reference lists of key studies were hand searched for relevant articles. The key search terms used were ‘diabetic retinopathy’, ‘screening’, ‘economic’ and ‘cost’. The search identified 416 papers of which 21 fulfilled the inclusion criteria, comprising nine cost‐effectiveness studies, one cost analysis, one cost‐minimization analysis, four cost–utility analyses and six reviews. Eleven of the included studies used economic modelling techniques and/or computer simulation to assess screening strategies. To date, the economic evaluation literature on diabetic retinopathy screening has focused on four key questions: the overall cost‐effectiveness of ophthalmic care; the cost‐effectiveness of systematic vs. opportunistic screening; how screening should be organized and delivered; and how often people should be screened. Systematic screening for diabetic retinopathy is cost‐effective in terms of sight years preserved compared with no screening. Digital photography with telemedicine links has the potential to deliver cost‐effective, accessible screening to rural, remote and hard‐to‐reach populations. Variation in compliance rates, age of onset of diabetes, glycaemic control and screening sensitivities influence the cost‐effectiveness of screening programmes and are important sources of uncertainty in relation to the issue of optimal screening intervals. There is controversy in relation to the economic evidence on optimal screening intervals. Further research is needed to address the issue of optimal screening interval, the opportunities for targeted screening to reflect relative risk and the effect of different screening intervals on attendance or compliance by patients.