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Segundo Examen Parcial de Etica y Metodologia de la Investigación.pdf
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Print Edition Inquiries
E qib.. I EE3. Ee Hi E. Within the study aims, an estimate of the diagnostic accuracy of a test should be included, or the comparison of that accuracy among the tests or participating groups 1.
The inclusion and exclusion criteria of the participants in the study should appear 2 and the place where the data or samples were gathered, as well as specification of the reason for their choice 3. In the case of it not being a consecutive sample of patients then how they were assembled should be explained 4 , as well as the directionality of the study 5. On the test being evaluated, the reference standard used should be defined 6 and technical specifications given, which include how and when the measurements were made, for both the diagnostic test and the reference standard 7.
Additionally, the number, training and experience of the people who have carried out and interpreted the tests and the reference standard should be specified 9 , and if the results have undergone blind reviewing The statistical methods used to calculate and compare measurements of diagnostic accuracy and to quantify the standard error should be described 11 , as too should the methods for calculating the reproducibility of the tests Also included is the time interval between the application of the diagnostic test, the reference standard and any other treatment administered between these 16 , the distribution of the severity of the disease among the patients 17 , a table with the results of the diagnostic tests in comparison with those obtained from the reference standard 18 and the communication of any adverse effect produced during the study Lastly, the diagnostic accuracy and the statistical precision should be estimated 20 , how indeterminate results have been treated 21 , the estimation of the variability of the diagnostic accuracy for each subgroup of participants, researchers or centres 22 , and the calculation of the reproducibility of the technique In this section it is important to comment on the clinical applicability of the study findings Observer variability In order to calculate the inter-observer variability in the application of the criteria, 4 of the 44 works were selected at random and reviewed independently by the two observers.
The creation and management of the data base and the statistical analyses of the results were performed with the SPSS statistical package version 12 for Windows Inc. All of the articles reviewed evaluated tests centred on the study of cancer, with prostate cancer, 10 Mean fulfilment of the 24 methodological standards applied was 9.
No statistically significant differences were observed in the fulfilment of the criteria before and after the year publication of the STARD guide Analysing the criteria individually, the greatest deficiencies were found in the material and methods section table 2. If we compare the fulfilment of the criteria among the clinical journals and those dedicated to cancer research tables 2 and 3 , it can be seen that statistically significant differences exist in certain standards.
Discussion The articles on genetic-molecular diagnostic tests published recently in the best international journals of clinical medicine and in two important publications of cancer research, fail to satisfy most of the quality requirements assembled in the STARD14 proposal. This shortcoming could be a reflection of severe limitations in the research methodology, or carelessness in the preparation of the articles and their editorial process, or both.
If we compare with other diagnostic fields, it can be seen that genetic, proteomic and molecular studies show inferior methodological quality, while for example in the laboratory field, and due fundamentally to the efforts of different authors and editorial groups, there has been a gradual improvement in their quality The methodological quality found in both the clinical journals as well as those dedicated to cancer research is similar, although with some specificity.
The most analytical aspects, like the specification of the technical characteristics, are given more attention to in the cancer journals; while others more related to the way in which to carry out the study, as for example the blind reviewing of the results obtained, are better fulfilled in the clinical journals. The only antecedent in the field of genetic-molecular diagnosis of this kind of investigation was a review carried out in on the same four clinical journals as those analysed in this work Although the same methodological criteria were not used, those employed at that time are included in the STARD guide, and are therefore comparable.
As in this review, no work fulfilled an acceptable number of methodological standards, the calculation of the genetic test's reproducibility was unusual and there was a general lack of blind reviewing in the interpretation of the results. Hence it would appear that genetic-molecular diagnostic studies are more impermeable to clinical-epidemiological advances.
Our intention of facilitating comparison with previous works led us to the application of the same restrictive selection criteria as employed previously7,, and as a result to a reduced sample of articles, a fact which limits the reach of the results. Nevertheless, by including all the original articles which have been published on the field of genetic and molecular diagnosis in the best international journals of clinical medicine and in the two publications of the American Association of Cancer Research for containing an important part of the works published on the same matter , an adequate perspective of the quality of research and publication of this kind of study is offered.
The guide employed for the evaluation of the articles STARD is very recent but has been rapidly disseminated among most journals which publish diagnostic evaluations; in fact, two of them JAMA and Lancet have included it among the rules for authors17,18, although not so New England Journal of Medicine or the two cancer journals.
It could be argued that there is little experience in its application, and it is true that there may be doubts about the applicability of some of its criteria due to the lack of precise indications. However, available experience shows that concordance on its application is high among observers11,12, as it has been too in the sample carried out in the present study.
Moreover, many of the STARD criteria have already been applied in previous methodological guides, which has facilitated its use. Studies on diagnosis in genomics, proteomics and related fields have some specificities in their validation19 which the STARD guide does not include, and although various initiatives have originated for the elaboration of a set of guidelines suitable for the validation of these tests15, no definitive one has been drawn up yet. This fact represents a limitation in that some intrinsic problems have not been evaluated, although they are not exclusive to this field of research.
This problem is controlled by determining the reproducibility of the discriminatory pattern observed in samples independent of the original. Another limitation to bear in mind is the study period, since the STARD criteria were first published early in the year , and this study recompiles articles from to Certainly it is early for the initiative to have had effect, at least in the journals which have included it in the instructions for their authors; and our study does not have the statistical capacity to establish comparisons.
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However, the fact that it was not published does not explain the low quality observed, as many of its criteria are essential requirements in most observational studies already partially compiled --the most relevant ones-- in other guides and previous publications.
Not all the requirements have the same importance in terms of their effects on the validity of the evaluated studies. Bearing in mind the main characteristics that a genetic test should possess for its correct use21, it is important to underline the key aspects of validity which have shown themselves to be the most deficient. In first place are the analytical characteristics of the test evaluated, as due to the current rapid development of genetic tests for the same test there may be different techniques and one should know which of them shows the most acceptable values of diagnostic accuracy.
Hence, the scanty calculation of the technique's reproducibility in the investigations evaluated is notable. In previous reviews this concept was already considered essential, and yet in the field of genetics or proteomics, where the value of the determinations will also depend on the capacity to give the same result when applied to the same patients under the same conditions19, it has been neglected all too often.
Secondly, another key methodological deficiency, and one which limits the applicability of the results, is the inadequate description of the inclusion and exclusion criteria of the subjects participating in the study, these barely appearing in less than half of the works evaluated.
This lack of information impedes detailed consideration of the clinical applicability of the test evaluated, which is an indispensable element in this kind of investigation To summarize, the future projection of the new genetic-molecular technologies in the field of diagnosis and precocious detection is very limited by the lack of rigour in the research on these tests. These problems are at the root of the reiterated false expectations which are created around these diagnostic tests. If an effective interdisciplinary relationship basic, clinical, epidemiological which facilitated the rigorous development of these genetic-molecular diagnostic tests existed then a lot of unnecessary research would be avoided.
Furthermore, adherence to the methodological standards would allow the genetic-molecular and proteomic tests to become very useful tools in clinical and health service research, especially in the field of cancer References 1.
Schwartz MK. Genetic testing and the clinical laboratory improvement amendments of present and future. Clin Chem. Managed care in the genomics era: assessing the cost effectiveness of genetic tests. Am J Manag Care. Milunsky A.SJi z! Thus, financial accounting is closer to practioners while management accounting is closer to organizations and other external agencies.
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