TY - JOUR
T1 - Methodologic rigor of clinical trials on surgical management of eyes with coexisting cataract and glaucoma
AU - Jampel, Henry D.
AU - Friedman, David S.
AU - Lubomski, Lisa H.
AU - Kempen, John H.
AU - Quigley, Harry
AU - Congdon, Nathan
AU - Levkovitch-Verbin, Hani
AU - Robinson, Karen A.
AU - Bass, Eric B.
N1 - Funding Information:
This article is based on research conducted by the Johns Hopkins University Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (formerly the Agency for Health Care Policy and Research; contract no. 290-97-0006), Rockville, Maryland. The authors of this article are responsible for its contents, including any clinical or treatment recommendations. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
Funding Information:
We recently completed a comprehensive systematic review of the literature on the surgical management of coexisting cataract and glaucoma, sponsored by the American Academy of Ophthalmology and funded by the Agency for Healthcare Research and Quality. 4 The review addressed several controversial issues, including the following questions among others. Are patients better served by combined glaucoma and cataract surgery, or is cataract surgery sufficient? Are staged procedures more effective than combined procedures? Are antifibrosis agents beneficial? We report on the content of the literature on short- and long-term intraocular pressure (IOP) control in a companion article (Friedman et al, Surgical Strategies for Coexisting Glaucoma and Cataract: An Evidence-based Update, Ophthalmology 109:1902–15). The following is a description of our findings regarding the quality of the controlled trials and cohort studies on the surgical management of coexisting cataract and glaucoma. We also evaluated whether study quality varied by year of publication, study question, and journal of publication.
PY - 2002/10/1
Y1 - 2002/10/1
N2 - Objective: To assess the methodologic quality of published studies of the surgical management of coexisting cataract and glaucoma. Design: Literature review and analysis. Method: We performed a systematic search of the literature to identify all English language articles pertaining to the surgical management of coexisting cataract and glaucoma in adults. Quality assessment was performed on all randomized controlled trials, nonrandomized controlled trials, and cohort studies. Overall quality scores and scores for individual methodologic domains were based on the evaluations of two experienced investigators who independently reviewed articles using an objective quality assessment form. Main Outcome Measures: Quality in each of five domains (representativeness, bias and confounding, intervention description, outcomes and follow-up, and statistical quality and interpretation) measured as the percentage of methodologic criteria met by each study. Results: Thirty-six randomized controlled trials and 45 other studies were evaluated. The mean quality score for the randomized, controlled clinical trials was 63% (range, 11%-88%), and for the other studies the score was 45% (range, 3%-83%). The mean domain scores were 65% for description of therapy (range, 0%-100%), 62% for statistical analysis (range, 0%-100%), 58% for representativeness (range, 0%-94%), 49% for outcomes assessment (range, 0%-83%), and 30% for bias and confounding (range, 0%-83%). Twenty-five of the studies (31%) received a score of 0% in the bias and confounding domain for not randomizing patients, not masking the observers to treatment group, and not having equivalent groups at baseline. Conclusions: Greater methodologic rigor and more detailed reporting of study results, particularly in the area of bias and confounding, could improve the quality of published clinical studies assessing the surgical management of coexisting cataract and glaucoma.
AB - Objective: To assess the methodologic quality of published studies of the surgical management of coexisting cataract and glaucoma. Design: Literature review and analysis. Method: We performed a systematic search of the literature to identify all English language articles pertaining to the surgical management of coexisting cataract and glaucoma in adults. Quality assessment was performed on all randomized controlled trials, nonrandomized controlled trials, and cohort studies. Overall quality scores and scores for individual methodologic domains were based on the evaluations of two experienced investigators who independently reviewed articles using an objective quality assessment form. Main Outcome Measures: Quality in each of five domains (representativeness, bias and confounding, intervention description, outcomes and follow-up, and statistical quality and interpretation) measured as the percentage of methodologic criteria met by each study. Results: Thirty-six randomized controlled trials and 45 other studies were evaluated. The mean quality score for the randomized, controlled clinical trials was 63% (range, 11%-88%), and for the other studies the score was 45% (range, 3%-83%). The mean domain scores were 65% for description of therapy (range, 0%-100%), 62% for statistical analysis (range, 0%-100%), 58% for representativeness (range, 0%-94%), 49% for outcomes assessment (range, 0%-83%), and 30% for bias and confounding (range, 0%-83%). Twenty-five of the studies (31%) received a score of 0% in the bias and confounding domain for not randomizing patients, not masking the observers to treatment group, and not having equivalent groups at baseline. Conclusions: Greater methodologic rigor and more detailed reporting of study results, particularly in the area of bias and confounding, could improve the quality of published clinical studies assessing the surgical management of coexisting cataract and glaucoma.
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U2 - 10.1016/S0161-6420(02)01084-9
DO - 10.1016/S0161-6420(02)01084-9
M3 - Article
C2 - 12359611
AN - SCOPUS:0036789287
SN - 0161-6420
VL - 109
SP - 1892
EP - 1901
JO - Ophthalmology
JF - Ophthalmology
IS - 10
ER -