Critical Appraisal of Prognostic Studies
Department of Clinical Research, Federal University of Uberlândia, Uberlândia, Brazil
Received date: December 08, 2015; Accepted date: December 15, 2015 Published date: December 22, 2015
Citation: Roever L (2015) Critical Appraisal of Prognostic Studies. Evidence Based Medicine and Practice 1:1000e105. doi:10.4172/2471-9919.1000e105
Copyright: © 2015 Roever L. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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Prognosis can be defined as the prediction of the future course of a disease after its installation. Patient groups are listed accompanied in time to measure their clinical outcomes. The Table 1 shows the checklists needed to make a critical analysis of prognostic studies [1-14].
Use this checklist can improve the evaluation of prognostic studies.
|The variables included in the rule are clearly defined?|
|Was a defined, representative sample of patients assembled at a common (usually early) point in the course of their disease?|
|Were objective and unbiased outcome criteria used?|
|Did the individual assessing the outcome criteria know whether or not the patient had a potential prognostic factor, i.e., were they blinded?|
|Were objective outcome criteria applied in a “blind” fashion?|
|Was there validation in an independent group (“test set”) of patients?|
|Was patient follow-up sufficiently long and complete?|
|Was the initial sample of patient’s representative?|
|People evaluating the outcome know the predictor variables?|
|People evaluating the predictor variables know the outcome?|
|Was the follow-up of these patients sufficiently long and complete?|
|Were the outcome criteria objective and applied in a blinded fashion?|
|Were outcome criteria either objective or applied in a ‘blind’ fashion?|
|If subgroups with different prognoses are identified, did adjustment for important prognostic factors take place?|
|If different subgroups of patients were identified, was there an adjustment for the different prognostic factors, as well as prospective validation in an independent “test group” of patients?|
|Was there adjustment for important prognostic factors?|
|Was there standardization for potentially important prognostic factors, e.g., age?|
|Were different sub-groups compared?|
|Was there validation in an independent group of patients?|
|Are the results of the study valid?|
|What are the results?|
|How likely are the outcomes over time?|
|How likely are the outcome event(s) over a specified period of time?|
|Were all important variables included and the positivity criteria explained?|
|The statistical method is adequately described?|
|How precise are the estimates of this likelihood?|
|Are the results presented with confidence intervals?|
|How precise are the prognostic estimates?|
|Were the study patients similar to this patient?|
|Can I apply this valid, important evidence about prognosis to my patient?|
|Is my patient so different to those in the study that the results cannot apply?|
|Will this evidence make a clinically important impact on my conclusions about what to offer to tell my patients|
|How do the outcomes behave over time?|
|Are the patients in the study similar to mine?|
|Will the results lead directly to selecting or avoiding a treatment?|
|Can the results be used in my clinical practice?|
|Are the results useful for reassuring or counselling my patient?|
|Will the evidence make a clinically important impact on your conclusions about what to offer or tell this patient?|
|Are exclusions and drop outs well described and do the authors discuss the reasons for them?|
|Sometimes the outcome cannot be measured in the same way in all patients.|
|In addition to your opinion, might there be studies analyzing the impact (in monetary terms or health results) of the rule?|
|If nothing will change, the rule is at best useless in terms of benefit to the patients.|
|How the initial estimation has changed after applying the rule, and the effect it has had on the action threshold.|
|Conflicts of interest are declared.|
|Rate the overall methodological quality of the study, using the following as a guide:
High quality (++): Majority of criteria met. Little or no risk of bias.
Acceptable (+): Most criteria met. Some flaws in the study with an associated risk of bias.
Low quality (-): Either most criteria not met, or significant flaws relating to key aspects of study design.
Reject (0): Poor quality study with significant flaws. Wrong study type. Not relevant to guideline.
Table 1: Critical appraisal of prognostic studies.