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Which endpoint: mean intraocular pressure or proportion of successful patients?
Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för neurovetenskap, Oftalmiatrik.
Uppsala universitet, Humanistisk-samhällsvetenskapliga vetenskapsområdet, Samhällsvetenskapliga fakulteten, Institutionen för informationsvetenskap, Statistik.
2003 (Engelska)Ingår i: Journal of glaucoma, ISSN 1057-0829, E-ISSN 1536-481X, Vol. 12, nr 4, s. 321-332Artikel i tidskrift (Refereegranskat) Published
Abstract [en]

A reduction in intraocular pressure in clinical trials can be determined through the mean intraocular pressure, through the proportion of patients who have the intraocular pressure reduced to a specific target intraocular pressure, or both. Since both these possible endpoints measure the shift of 2 intraocular pressure distributions, we recommend that only one of them be tested. In general, testing the difference between mean-values is much more efficient than testing the difference between proportions. However, proportions of successful patients are valuable in showing the clinical implication of a reduction in mean intraocular pressure, particularly when evaluating a moderate pressure reduction. The effect of a small mean intraocular pressure reduction on the probability to reach the target intraocular pressure is pointed out, particularly the fact that it can be substantial even if the mean reduction is smaller than the measurement error.

Ort, förlag, år, upplaga, sidor
2003. Vol. 12, nr 4, s. 321-332
Nationell ämneskategori
Medicin och hälsovetenskap
Identifikatorer
URN: urn:nbn:se:uu:diva-90325PubMedID: 12897577OAI: oai:DiVA.org:uu-90325DiVA, id: diva2:162637
Tillgänglig från: 2003-04-07 Skapad: 2003-04-07 Senast uppdaterad: 2017-12-14Bibliografiskt granskad
Ingår i avhandling
1. Pooling Data from Similar Randomized Clinical Trials Comparing Latanoprost with Timolol; Medical Results and Statistical Aspects
Öppna denna publikation i ny flik eller fönster >>Pooling Data from Similar Randomized Clinical Trials Comparing Latanoprost with Timolol; Medical Results and Statistical Aspects
2003 (Engelska)Doktorsavhandling, sammanläggning (Övrigt vetenskapligt)
Abstract [en]

Two different principles were studied. 1st - statistical analysis techniques were used to obtain medical results from a patient population. 2nd - the patient population was used to study the statistical analysis techniques.

Medical conclusions: latanoprost and timolol treatment showed a statistically significant and clinically useful mean IOP-reduction in a typical worldwide clinical trial population. Latanoprost reduced the IOP 1.6 mm Hg more than timolol. The IOP-reduction was maintained with timolol and slightly enforced with latanoprost up to 6 months of treatment. The mean IOP-reduction was maintained during 2 years of latanoprost treatment. The overall risk of withdrawal due to insufficient IOP-reduction with latanoprost was 8%.

The statistical methodological issues are of a general and reoccurring character in trial design of the IOP-reduction: should the statistical hypothesis testing be based on the mean intraocular pressure (IOP) or the proportion of patients who reach a specific IOP level, should the estimate of the IOP or IOP-reduction be based on single eyes, mean of bilaterally eligible and identically treated eyes or the difference between an eye with active treatment and a placebo treated contralateral eye, and is mean of replicated recordings useful? Statistical methodological conclusions: the most effective response variable varies with the selected patient population. Therefore, the trial design process should include a comparison of the variability, test power and required sample size for the possible response variables in a sample of the target population. At minimum a statistical consideration should be done.

Ort, förlag, år, upplaga, sidor
Uppsala: Acta Universitatis Upsaliensis, 2003. s. 54
Serie
Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 0282-7476 ; 1235
Nyckelord
Ophtalmology, mean intraocular pressure, target intraocular pressure, latanoprost, timolol, open-angle glaucoma, ocular hypertension, trial design, Oftalmiatrik
Nationell ämneskategori
Oftalmologi
Forskningsämne
oftalmiatrik
Identifikatorer
urn:nbn:se:uu:diva-3392 (URN)91-554-5570-0 (ISBN)
Disputation
2003-05-03, Grönwallsalen, Uppsala University Hospital, entrance 70, Uppsala, 13:15
Opponent
Handledare
Tillgänglig från: 2003-04-07 Skapad: 2003-04-07Bibliografiskt granskad

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