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9  Discussion  195




                  9  Discussion

                  Here we highlight several main points and give some further thoughts or references
                  to statistics in ophthalmology and vision research.
                     The design of study and data collection are crucial to any clinical study. This de-
                  termines the data quality. Sophisticated statistical methods will not make up for a bad
                  quality data. This is true also of machine learning and computational methods. There
                  is a term that is familiar to many statisticians but needs to be more widely used in big
                  data—the term being garbage in garbage out. Statisticians and computer scientists
                  are not alchemists. They cannot turn base metal into gold. So to avoid this problem the
                  clinical study should be carefully designed with a thoughtful consideration of the unit
                  of analysis, sample size, randomization, methods of measurement, consideration of
                  confounders and missing data possibilities. It is highly recommended, for the success
                  of the study, to have a statistician on board as a partner to contribute to the decision
                  about the study design, database construction, and coding of categorical variables.
                     The appropriate analytical strategies to data analysis depend crucially on the pur-
                  pose of the study as well as on the way the data are collected. We have seen that a
                  wrong choice of a data analysis method may lead to biased estimates of the studied
                  associations. Another crucial point is that the decision of the data analysis method
                  should ideally be done at the point of designing the study. Indeed, in randomized
                  clinical trials, which are near the top of the pyramid of the evidence, the standard is
                  to write a statistical analysis plan before the data is locked for the analysis [39].
                     The reporting of the results of the ophthalmic study is critical. Some funders and
                  journals impose that authors follow relevant reporting guidelines; in some journals, the
                  use of guidelines is not mandatory. Each report should lead to a reproducible work. We
                  listed some of the guidelines in the Section 5. A full up-to-date list of all the guidelines
                  is being created by the EQUATOR team (https://www.equator-network.org/).
                     There is a steady rise of advanced complex analytical methods for imaging data:
                  statistical, machine learning and data science. While statistical modeling methods
                  may be simpler in the number of parameters (than machine leaning methods) and
                  they are inherently interpretable; the drawback is that they commonly require a
                  thoughtful process to build the model and may be less accurate due the lower num-
                  ber of parameters (though depending on research question they may be sufficiently
                  accurate). On the other hand computationally complex machine learning methods
                  require less time and less clinical expertise to be built and may be more accurate
                  in e.g. diagnosis or prognosis, but they involve a very large number of parameters
                  (hundreds of thousand or millions) and larger number of patients data such as large
                  number of annotated images for training. These are the pros and cons to be weighted
                  for each study separately.
                     Alongside major investments in strengthening the measurements via imaging,
                  genotyping, and biomarker assessments, there is clearly a need for methodological
                  advances in statistics, machine learning and data science; and especially a need for
                  these disciplines to collaborate. Only then the great promise to accelerate progress
                  toward successful prevention and treatment of ophthalmic diseases will be delivered.
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