PROGNOSIS Evidence Based Medicine

Dewi Masyithah Darlan Medical Faculty of USU

Introduction - Prognosis
Important phase of a disease - progression of a disease Prognosis : the prediction of the future course of events following the onset of disease. can include death, complications, remission/ recurrence, morbidity, disability, and social or occupational function

Introduction Prognosis
Natural History Studies Natural history studies permit the

development of rational strategies for: early detection of disease e.g. Invasive cervical CA treatment of disease e.g. Ptyriasis versicolor

Prognosis
Patients at risk of target event Prognostic factor Time

Suffer target outcome

Do not suffer target outcome

? ?

Introduction Prognosis
Natural History Studies Natural history studies permit the

development of rational strategies for: early detection of disease e.g. Invasive cervical CA treatment of disease e.g. Ptyriasis versicolor

A. Are the results of this prognosis study valid?

A.1. Was a defined, representative sample of patients assembled at a common (usually early) point in the course of their disease? How well define the individuals in the study criteria representative of the underlying population: inclusion, exclusion sampling method Similar: well-defined point in the course of their disease -- cohort

A1. Was a defined, representative sample of patients assembled at a common (usually early) point in the course of their disease? A prognostic study is biased if it yields a
systematic overestimate or underestimate of the likelihood of adverse outcomes in the patients under study When a sample is systematically different from the population of interest and is therefore likely biased because patients will have a better or worse prognosis than those in the population of interest - unrepresentative

A2. Was follow-up sufficiently long and complete? Ideal follow-up period until every patient recovers or has one the other outcomes of interest until the elapsed time of observation is of clinical interest to clinicians or patients
Short follow up time: Too few study patients with outcome of interest - little information of use to a patient

A2. Was follow-up sufficiently long and complete? Loss to follow up - influence the estimate of the risk of the outcome - validity??
patients are too ill (or too well) Die change address etc. Most evidence journals require at least 80% follow-up for a prognosis study to be considered valid

Bias in Follow-up Studies

Assembly or susceptibility bias: when exposed and non-exposed groups differ other than by the prognostics factors under study, and the extraneous factors affects the outcome of the study. examples: o differences in starting point of disease (survival cohort) o differences in stage or extent of disease, prior treatment, age, gender, or race

Bias in Follow-up Studies

Migration bias: o patients in one cohort leave their original cohort, either moving to one of the other cohorts under study or dropping out of the study altogether Generalizability bias o related to the selective referral of patients to tertiary (academic) medical centers

A3.Were objective outcome criteria applied a blind fashion?

investigators making judgments about clinical outcomes are kept blind to subjects clinical characteristics and prognostic factors. Minimize measurement bias!

A3.Were objective outcome criteria applied a blind fashion?

Measurement bias can be minimized by:

ensuring observers are blinded to the exposure status of the patients using careful criteria (definitions) for all outcome events apply equally rigorous efforts to ascertain all events in both exposure groups

A4. If subgroups with different prognoses are identified, was there adjustment for important prognostic factors?
Prognostic factors: factors associated with a particular outcome among disease subjects. Can predict good or bad outcome. prognostic factors need not be causal, and in fact they are often, but they must be strongly associated with development of an outcome to predict its occurrence. Examples: age, tumor stage

A4. If subgroups with different prognoses are identified, was there adjustment for important prognostic factors?

Risk factors: o distinct from prognostic factors o include lifestyle behaviors and environmental exposures that area assoc. with the development of a target disorder o Ex: smoking: important risk factors for developing lung cancer, but tumor stage is the most important prognostic in individuals who have lung cancer.

A5. Was there validation in an independent group ("test-set") of patients?

Too see if this was done, wed look for a statement in the studys methods section describing a prestudy intention to examine this specific group of prognostic factors, based on their appearance in a training set or previous study.

B. Are the results of this study important?

B1. How likely are the outcomes over time?

typically, results from prognosis studies

are reported in one of three ways:
as a percentage of survival at a particular point in time (such as 1 year or 5 year survival rates) median survival (the length of follow up by which) survival curves that depict, at each point in time The result presentation: Kaplan-Meier curves

Survival Rate
1 year survival A. Good B. 20% C. 20% D. 20% Median survival A. ? B. 3 months C. 9 months D. 7.5 months

B2. How precise are the prognostic estimates?

Precision - 95% confidence interval The narrower the confidence interval, the more precise is the estimate. If survival over time is the outcome of interest - earlier follow-up periods usually include results from more patients than in later periods, so that survival curves are more precise in the earlier periods

C. Can we apply this valid, important evidence about prognosis to our patient?

C1. Are the study patients so different from ours that we should not use the results at all in making predictions for our patients?
for more differences, the answer to

this questions is no and thus we can use the study results to inform our prognostic conclusions

C2. Will this evidence make a clinically important impact on our conclusions about what to offer or tell our patient?

Useful for:
initiating or not therapy monitoring therapy that has been initiated deciding which diagnostic tests to order providing patients and families with the information they want about what the future is likely to hold for them and their illness. Communicating to patients their likely fate Guiding treatments decisions Comparing outcomes to make inferences about quality of care

THE END

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