EBO technical review of the validity of Recommendation #14 of the Clinical Practice Guidelines for the Management of Cataract among Adults

PRACTICE variations and the emerging changes in our health-care system have engendered the need for clinical guidelines in medical practice. In response to these changes, the Philippine Academy of Ophthalmology
developed and released its first Evidence-Based Clinical Practice Guidelines for the Management of Cataract in
March 2001.1 In the same year, the guidelines became the first in Asia to be included in the National Guideline Clearinghouse,2 an on-line database of evidence-based clinical practice guidelines put up by the Agency for
Healthcare Research and Quality of the United States Department of Health and Human Services. It has been 4 years since the cataract guidelines were developed. In a rapidly evolving field like ophthalmology, some of the recommendations formulated then may no longer represent the most appropriate in local clinical practice. The process of updating the entire set of guidelines can be very costly and time-consuming. Thus, the committee on Evidence Based Ophthalmology plans to approach this task by evaluating the document in sections, prioritizing recommendations that are deemed outdated in reference to changes in the evidence, available resources, and values placed on outcomes. In recent years, a growing number of local ophthalmologists have shifted from extracapsular cataract extraction to phacoemulsification because of the immediate visual rehabilitation and superior visual outcomes seen in the latter. However, in a country burdened with a huge cataract backlog and limited resources, cost-effective methods of delivering eye care may have to be employed.3 It is against this background that the committee gave priority to the review of Recommendation #14, which states that both phacoemulsification and extracapsular cataract extraction (ECCE) are acceptable techniques among patients undergoing cataract surgery.

OBJECTIVE
To assess the current validity of Recommendation #14, which states that both phacoemulsification and extracapsular cataract extraction (ECCE) are acceptable techniques among patients undergoing cataract surgery.

METHODOLOGY
Using the conceptual model developed by the US Agency for Healthcare Research and Quality,4, 5 the group evaluated Recommendation #14 to determine whether it  should be updated or withdrawn. Accordingly, an update was warranted under any of the following circumstances:
1. New preventive, diagnostic, or treatment interventions may have emerged to complement or supersede
other interventions.
2. New evidence may require updating of the estimates of benefits and harm for existing interventions.
3. New evidence may identify as important outcomes that were previously unappreciated or wholly unrecognized.
4. Evidence that current practice is optimal may change.
5. The values that individuals or society place on different outcomes may change over time.
6. The resources available for health care may change significantly. Updating the guideline recommendation was done in 2 stages: (1) identifying significant new evidence by conducting a systematic review of the literature, and (2) assessing whether the new evidence warrants updating or withdrawal by using the delphi method in soliciting the opinion of experts from the original panel that developed the guidelines.

Search strategy
We reran the search for primary studies comparing ECCE to phacoemulsification from January 2001 to May
2005. Trials were identified from the Cochrane Controlled Trials Register–CENTRAL/CCTR (which contains the
Cochrane Eyes and Vision Group trials register) on the Cochrane Library and MEDLINE.

The following strategy was used to search CENTRAL
Issue 2 2004:
#1 CATARACT-EXTRACTION*1:ME
#2 LENS-IMPLANTATION-INTRAOCULAR*1:ME
#3 #1 or #2
#4 CATARACT near EXTRACT*
#5 ((LENS next OPACIT*) and EXTRACT*)
#6 EXTRACAPSULAR or PHACO or PHAKO
#7 EXTRACAPSULAR or MANUAL-SMALLINCISION
#8 ((INTRAOCULAR next LENS*) near IMPLANT*)
#9 SUTURELESS near CATARACT
#10 #4 or #5 or #6 or #8 or #9
#11 #3 or #10
The following strategy was used to search MEDLINE to August 2005:
#1 EXPLODE “CATARACT-EXTRACTION”/all subheadings
#2 “LENS-IMPLANTATION,-INTRAOCULAR”/all subheadings
#3 #1 or #2
#4 LENS near OPACIT*
#5 (CATARACT or #4) near EXTRACT*
#6 EXTRA?CAPSULAR or PHA?O or
#7 EXTRA?CAPSULAR or MANUAL- SMALL – INCISION
#8 INTRA?OCULAR next LENS*
#9 #7 near IMPLANT*

#10 SUTURELESS near CATARACT
#11 (#5 or #6 or #9 or #10) in TI,AB
#12 #3 or #11
To identify randomized controlled trials, this search was combined with the following:
#1 “RANDOMIZED-CONTROLLED-TRIAL”/all subheadings
#2 “RANDOMIZATION”/all subheadings
#3 “CONTROLLED-STUDY”/all subheadings
#4 “MULTICENTER-STUDY”/all subheadings
#5 “PHASE-3-CLINICAL-TRIAL”/all subheadings
#6 “PHASE-4-CLINICAL-TRIAL”/all subheadings
#7 “DOUBLE-BLIND-PROCEDURE”/all subheadings
#8 “SINGLE-BLIND-PROCEDURE”/all subheadings
#9 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8
#10 RANDOM* or CROSS?OVER* or FACTORIAL*
or PLACEBO* or VOLUNTEER* in TI,AB
#11 (SINGL* or DOUBL* or TREBL* or TRIPL*) near
(BLIND* or MASK*) in TI,AB
#12 #9 or #10 or #11
#13 HUMAN in DER
#14 #12 and #13
#15 #13 not #14
#16 #11 not #15
Data Collection and Analysis
Identified evidence was used to assess the current validity of Recommendation #14. These results were used
to classify the recommendation into one of the following categories:
1. Withdraw. New evidence called into question 1 or more key therapeutic recommendations, or new evidence
suggested the need for new key therapeutic guideline recommendations.
2. Retain, append new evidence. Key therapeutic recommendations were still valid, but new evidence supported changes to other recommendations, or supported greater refinement of existing recommendations.
3. Retain. The guideline continued to represent good
clinical care. Based on the results of the identified evidence, Recommendation #14 was thus classified as Retain, append new evidence. The proposed revision was sent to all members of the original guideline developer group for approval.

RESULTS
Two new metaanalyses6, 7 and 1 prospective randomized controlled trial8 were identified, retrieved, and appraised. Two trials comparing the cost and benefits of ECCE with those of manual small-incision cataract surgery 9, 10 were included to introduce the latter technique as an additional
option in addressing the cataract backlog in the Philippines. (See Appendix for details.) Among the 21 members of the original panel that developed the guidelines, 15 (71%) responded. All 15 agreed to retain and update Recommendation #14 by appending new evidence. However, 3 out of the 15 (20%) did not accept all the proposed changes. One remarked that the outcomes should have been expressed in odds ratio or relative risk for the strength of the recommendation to be better appraised. The other 2 suggested that phacoemulsification be singled out as the preferred procedure. The remaining 6 (29%) of the 21 members of the panel were not able to review and submit their responses in time for this update. Based on the review, 2 studies11, 12 previously cited were also excluded from the Summary of Evidence.

CONCLUSION
Based on these data, Recommendation #14 of the Clinical Practice Guidelines for the Management of Cataract among adults should be retained but relevant new information for clinicians needs to be appended.

References
1. Philippine Academy of Ophthalmology, Family Medicine Research Group. Clinical practice guidelines for the management of cataract among adults. Philipp J Ophthalmol 2001; 26: 180-195.
2. Philippine Academy of Ophthalmology, Family Medicine Research Group, UP-PGH. Clinical practice guidelines for the management of cataract among adults. National Guideline Clearinghouse, Agency for Healthcare Research and Quality of the United States Department of Health and Human Services. April 2002. http:// www.guideline.gov/summary/summary.aspx?doc_id=2963&nbr=2189& string=Philippines.
3. Department of Health, Republic of the Philippines and Institute of Ophthalmology, National Institutes of Health. Philippine National Survey on Blindness. Manila: University of the Philippines, 2004; 268 pp.
4. Agency for Healthcare Research and Quality. http://www.ahrq.gov.
5. Shekelle PG, Ortiz E, Rhodes S, et al. Validity of the Agency for Healthcare Research and Quality Clinical Practice Guidelines. JAMA 2001; 282; 1461-1467.
6. Snellingen T, Evans JR, Ravilla T, Foster A. Surgical interventions for age-related cataract (Cochrane Review). In: The Cochrane Library, Issue 2, 2004. Chichester, UK: John Wiley & Sons, Ltd.
7. Wei Li You. Effect of phacoemulsification versus extracapsular extraction on visual acuity: a metaanalysis. Chinese Journal of Ophthalmology 2004: 40: 474-477.
8. Taban M, Behrens A, et al. Acute endophthalmitis following cataract surgery: a systematic review of the literature. Arch Ophthalmol 2005; 123: 613-620.
9. Gogate PM, Deshpande M, Wormald RP, et al. Extracapsular cataract surgery compared with manual small-incision cataract surgery in community eye care setting in Western India: a randomized controlled trial. Br J Ophthalmol 2003; 87: 667-672.
10. Gogate PM, Deshpande M, Wormald RP. Is manual small incision cataract surgery affordable in the developing countries? A cost comparison with extracapsular cataract extraction. Br J Ophthalmol 2003; 87: 843-846.
11. Halpern BL, Pavilack MA, Gallagher SP. The incidence of atonic pupil following cataract surgery. Arch Ophthalmol 1995; 113: 448-450.
12. Castells X, Comas M, Castilla M., et al. Clinical outcomes and costs of cataract surgery performed by planned ECCE and phacoemulsification. Int Ophthalmol 1998; 22: 363-367.