December 12, 2020
A meta-analysis of clinical reports cannot replace the evidence provided by clinical trials. Recruiting subjects in the field of rare diseases and personalized medicine is a critical task in clinical research [2, 43, 44]. In a therapeutic context where most studies become clinical reports, excluding systematic verification increases the risk of distortion and reduces efficacy because not all available evidence is taken into account . There is some evidence that case reports reflect useful data collection in rare cases and contribute to the progress and dissemination of new scientific discoveries three years or earlier than clinical trials . During this period, daily clinical practice or the design of confirmed clinical trials requires evidence from published clinical reports . We assessed the consistency between the results in the acceptable data group based on the main result and results classified as high to moderate SOE in Bradley`s meta-analysis . The reported validity indices were sensitivity, specificity and predictive values, estimated at 95% confidence intervals (CCI). Alegra T, Eizerik DP, de Cerqueira CC, Pereira TV, Dornelles AD, Schwartz IV. Efficacy and safety of idursulfase treatment in patients with type II mucopolysaccharidosis with or without comparison with placebo: systematic review and meta-analysis. Cad Saude Publica. 2013;29 (Suppl 1): S45-58. Some authors have pointed out the usefulness of N-of-1 studies in comparing the effects of different treatments in a single patient .
These designs can randomize repeated cycles of treatment defiants (. B for example, A-B-A-B-B) in a single participant whose A is the test drug and B the comparator. These studies obtain the usual methodological guarantees of conventional clinical trials (controlled, randomized and blinded). However, these constructs are not applicable in situations where the disease is not clinically stable or where the effects of transmission of treatment cannot be prevented . Therefore, for some diseases, most of the available evidence comes from case reports . Methods of aggregating the results of different N-of-1 studies in a meta-analysis were used for a randomized distribution of treatment exposure during study periods [36, 37]. They cannot be applied to aggregated results of case reports or rare disease registries. All chapters should have a signed agreement with the Wikimedia Foundation that confirms its right to use Wikimedia trademarks and the terms of renewal of their chapter status.
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