Validity of Newly Developed Appropriateness Criteria for Cataract Surgery
Received 15 February 2008; received in revised form 2 July 2008; accepted 31 July 2008. published online 30 October 2008.
Objective
The introduction of phacoemulsification in the early 1990s significantly changed the treatment of cataract. It is possible that appropriateness criteria for cataract extraction developed before the widespread adoption of phacoemulsification no longer is as accurate or valid as possible. The objective of this study was to validate newly developed explicit appropriateness criteria.
Design
Prospective, observational cohort study.
Participants
Consecutive patients with a diagnosis of cataract who were on waiting lists to undergo cataract extraction by phacoemulsification were recruited.
Methods
Newly developed explicit appropriateness criteria for cataract extraction, following Research and Development methodology, were applied in this study conducted in 17 public teaching hospitals. Data necessary to classify the appropriateness of the intervention, including demographic and clinical data and that related to the surgery and complications, were recorded by previously trained ophthalmologists in all centers before the intervention and at the 6-week visit afterward.
Main Outcome Measures
Subjects completed 2 questionnaires that measure health-related quality of life—the Short Form 36 and the Visual Function Index 14 (VF-14)—before the procedure and 3 months afterward. Also, visual acuity was recorded by ophthalmologists previous to the intervention and at 6 weeks after.
Results
Five thousand two hundred fifty-seven cases were included in the study. At 3 months after cataract extraction, 4335 (82.5%) patients had responded to the questionnaires. Patients whose procedures were classified as necessary or appropriate by the new appropriateness criteria had greater improvements in visual acuity and VF-14 scores than those undergoing procedures classified as inappropriate. These differences seemed to be clinically relevant by measures such as the minimal clinically important difference and minimal detectable change. Complications rates were similar among all appropriateness categories, except for complications occurring in the peri-intervention period.
Conclusions
These results suggest a direct relationship between the newly developed explicit appropriateness criteria for cataract extraction and outcomes, as measured by clinical evaluation and health-related quality-of-life instruments. The results support the use of these criteria for clinical evaluation or the development of clinical guidelines.
Financial Disclosure(s)
The author(s) have no proprietary or commercial interest in any materials discussed in this article.
Available online: October 30, 2008.
1Unidad de Investigación, Hospital Galdakao-Usansolo-CIBER Epidemiología y Salud Pública (CIBERESP), Galdakao, Vizcaya, Spain
2Unidad de Investigación, Hospital de Basurto-CIBER Epidemiología y Salud Pública (CIBERESP), Bilbao, Vizcaya, Spain
3Fundación Vasca de Innovacioń e Investigación Sanitarias-(BIOEF)-CIBER Epidemiología y Salud Pública (CIBERESP), Sondika, Vizcaya, Spain
5Facultad de Medicina, Universidad de Sevilla, Spain
6Unidad de Epidemiologia Clinica, Corporacio Parc Tauli, Barcelona, Spain
7Direccion Territorial de Sanidad, San Sebastián-Donostia, Guipúzcoa, Spain
Correspondence: José M. Quintana, MD, Unidad de Investigación, Hospital Galdakao-Usansolo, Barrio Labeaga s/n, 48960 Galdakao, Vizcaya, Spain
Manuscript no. 2008-218.
A complete listing of the members of the IRYSS-Cataract Group is available at http://aaojournal.org.
Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
Supported in part by the Fondo de Investigación Sanitaria - Instituto de Salud Carlos III, Madrid, Spain (grant nos.: PI03/0550, PI03/0724, PI03/0471, PI03/0828, PI04/1577); the Department of Health of the Basque Country, Vitoria, Spain; and the thematic networks (Red IRYSS) of the Instituto de Salud Carlos III, Madrid, Spain (G03/220).
ABSTRACT