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Pooling Data from S...
Pooling Data from Similar Randomized Clinical Trials Comparing Latanoprost with Timolol; Medical Results and Statistical Aspects
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- Hedman, Katarina (författare)
- Uppsala universitet,Institutionen för neurovetenskap
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Alm, Albert (preses)
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Taube, Adam (preses)
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- Sheehan, T Joseph, Professor (opponent)
- Epidemiology and Biostatistics, Connecticut
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(creator_code:org_t)
- ISBN 9155455700
- Uppsala : Acta Universitatis Upsaliensis, 2003
- Engelska 54 s.
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Serie: Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, 0282-7476 ; 1235
- Relaterad länk:
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Oftalmologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Ophthalmology (hsv//eng)
Nyckelord
- Ophtalmology
- mean intraocular pressure
- target intraocular pressure
- latanoprost
- timolol
- open-angle glaucoma
- ocular hypertension
- trial design
- Oftalmiatrik
- Ophtalmology
- Oftalmologi
- Ophtalmology
- oftalmiatrik
Publikations- och innehållstyp
- vet (ämneskategori)
- dok (ämneskategori)
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