Critical Appraisal of Prognostic Studies
*Corresponding Author:
Leonardo Roever, Department of Clinical Research, Av Pará, 1720 - Bairro Umuarama, Uberlândia-MG-CEP 38400-902, Brazil, Tel: +553488039878, Email: leonardoroever@hotmail.com
Received: 08-Dec-2015 / Accepted Date: 15-Dec-2015 / Published Date: 22-Dec-2015 DOI: 10.4172/2471-9919.1000e105
Introduction
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].
| Appraisal questions |
|---|
| 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.
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.
Use this checklist can improve the evaluation of prognostic studies.
References
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Citation: Roever L (2015) Critical Appraisal of Prognostic Studies. Evidence Based Medicine and Practice 1: e105. 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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