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Article: Eyes or subjects: Are ophthalmic randomized controlled trials properly designed and analyzed?

TitleEyes or subjects: Are ophthalmic randomized controlled trials properly designed and analyzed?
Authors
Issue Date2012
PublisherElsevier Inc. The Journal's web site is located at http://www.elsevier.com/locate/ophtha
Citation
Ophthalmology, 2012, v. 119 n. 4, p. 869-872 How to Cite?
AbstractObjective: In ophthalmic randomized controlled trials (RCTs), each subject may have 2 potential data points (i.e., eyes) contributing to the clinical trial. Hence, various study designs may arise requiring different statistical tools. This study aimed to assess the appropriateness of study design, statistical tools used, and reporting of results in ophthalmic RCTs. Design: A systematic review of 69 ophthalmic RCTs. Methods: The study design, sample size calculation, statistical analysis, and reporting methodology of all RCTs published in 4 major general clinical ophthalmology journals in 2009 were assessed. Main Outcome Measures: The study design of each article under review is evaluated. Results: The most common study design was a one-eye design (48%). Within this group, only half described the method of selecting the study eye, among which 5 chose the study eye by random selection. In the remaining trials, there were paired-eye design (13%), subject design (19%), and two-eye design (19%). Among the 13 two-eye design studies, 4 allocated both eyes of the subject to the same group, 4 allocated the eyes to different groups, and 4 did not restrict the allocation. None of these studies adjusted for the clustering effect in sample size calculation. Only 5 studies used statistical methods adjusting for nonindependence. Conclusions: There is currently substantial heterogeneity in the quality among published ophthalmic RCTs in terms of proper use of study design, sample size calculation, randomization method, and statistical tools. Future ophthalmic researchers are suggested to consult a statistician and to follow some guidelines such as the CONSORT statement when performing an RCT to improve further the quality of clinical trial. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. © 2012 American Academy of Ophthalmology.
Persistent Identifierhttp://hdl.handle.net/10722/178312
ISSN
2015 Impact Factor: 6.75
2015 SCImago Journal Rankings: 4.745
References

 

DC FieldValueLanguage
dc.contributor.authorLee, CFen_US
dc.contributor.authorCheng, ACOen_US
dc.contributor.authorFong, DYTen_US
dc.date.accessioned2012-12-19T09:45:12Z-
dc.date.available2012-12-19T09:45:12Z-
dc.date.issued2012en_US
dc.identifier.citationOphthalmology, 2012, v. 119 n. 4, p. 869-872en_US
dc.identifier.issn0161-6420en_US
dc.identifier.urihttp://hdl.handle.net/10722/178312-
dc.description.abstractObjective: In ophthalmic randomized controlled trials (RCTs), each subject may have 2 potential data points (i.e., eyes) contributing to the clinical trial. Hence, various study designs may arise requiring different statistical tools. This study aimed to assess the appropriateness of study design, statistical tools used, and reporting of results in ophthalmic RCTs. Design: A systematic review of 69 ophthalmic RCTs. Methods: The study design, sample size calculation, statistical analysis, and reporting methodology of all RCTs published in 4 major general clinical ophthalmology journals in 2009 were assessed. Main Outcome Measures: The study design of each article under review is evaluated. Results: The most common study design was a one-eye design (48%). Within this group, only half described the method of selecting the study eye, among which 5 chose the study eye by random selection. In the remaining trials, there were paired-eye design (13%), subject design (19%), and two-eye design (19%). Among the 13 two-eye design studies, 4 allocated both eyes of the subject to the same group, 4 allocated the eyes to different groups, and 4 did not restrict the allocation. None of these studies adjusted for the clustering effect in sample size calculation. Only 5 studies used statistical methods adjusting for nonindependence. Conclusions: There is currently substantial heterogeneity in the quality among published ophthalmic RCTs in terms of proper use of study design, sample size calculation, randomization method, and statistical tools. Future ophthalmic researchers are suggested to consult a statistician and to follow some guidelines such as the CONSORT statement when performing an RCT to improve further the quality of clinical trial. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. © 2012 American Academy of Ophthalmology.en_US
dc.languageengen_US
dc.publisherElsevier Inc. The Journal's web site is located at http://www.elsevier.com/locate/ophthaen_US
dc.relation.ispartofOphthalmologyen_US
dc.subject.meshEyeen_US
dc.subject.meshGuideline Adherenceen_US
dc.subject.meshHumansen_US
dc.subject.meshOphthalmology - Standardsen_US
dc.subject.meshPublishing - Standardsen_US
dc.subject.meshQuality Controlen_US
dc.subject.meshRandomized Controlled Trials As Topic - Standardsen_US
dc.subject.meshResearch Design - Standardsen_US
dc.subject.meshResearch Subjectsen_US
dc.subject.meshSerial Publicationsen_US
dc.titleEyes or subjects: Are ophthalmic randomized controlled trials properly designed and analyzed?en_US
dc.typeArticleen_US
dc.identifier.emailFong, DYT: dytfong@hku.hken_US
dc.identifier.authorityFong, DYT=rp00253en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1016/j.ophtha.2011.09.025en_US
dc.identifier.pmid22226885-
dc.identifier.scopuseid_2-s2.0-84859267635en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-84859267635&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume119en_US
dc.identifier.issue4en_US
dc.identifier.spage869en_US
dc.identifier.epage872en_US
dc.publisher.placeUnited Statesen_US
dc.identifier.scopusauthoridLee, CF=49661724900en_US
dc.identifier.scopusauthoridCheng, ACO=14827706400en_US
dc.identifier.scopusauthoridFong, DYT=35261710300en_US
dc.identifier.citeulike10235262-

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