Critical Analysis Flashcards
Type I error
False positive, ie, falsely rejecting N0.
It is linked to the p-value, which arises from α, which is usually set at 0.05 and is the probability of committing a type I error.
Type II error
False negative, ie, falsely accepting N0.
It is linked to β, which is the probability of committing a type II error, and is usually equal to 20%.
Case Reports/Case Series - advantages & disadvantages
Case report = a report on a single patient with an outcome of interest.
Case series = a collection of reports on the treatment of individual patients.
Advantages: inexpensive, quick, generates hypotheses, good for rare diseases as longitudinal studies difficult to perform.
Disadvantages: cannot establish causality as no control group, little statistical validity.
Cross Sectional Study - advantages & disadvantages
= study of a sample of the population at a single instance in time.
Advantages: cheap, easy, quick, can demonstrate an association between two variables, can establish prevalence of disease in population being studied.
Disadvantages: cannot establish causality, subject to incidence-prevalence bias (where risk factor appears to cause the disease, when in reality, it actually affects the duration or prognosis of disease).
What is a Case Control Study?
= Involves identifying patients with the outcome of interest (cases) and then selecting controls (patients without the same outcome), and then looking back to see if they have the exposure of interest. Thus sample selection is always defined by the disease or the outcome being studied. The question being asked is if the cases have a greater exposure to the risk factor in question than the controls.
Case Control Study - advantages & disadvantages
Advantages: inexpensive, good for rare outcomes, not time consuming.
Disadvantages: not useful for rare exposures, recall bias, temporality cannot be established, good controls can be difficult to identify.
What is a Cohort Study?
A cohort study always begins from exposure, ie, it is defined by the exposure (in contrast to a case control study). A longitudinal study, which begins with identification of a cohort.
Can be divided into prospective and retrospective cohort studies depending on the type of follow-up.
Prospective Cohort Studies - advantages & disadvantages
Prospective = the direction of study is into the future.
Advantages: good for rare exposures, temporality can be established, multiple outcomes can be studied, control selection not a major issue, no recall bias.
Disadvantages: time consuming, cannot be used for rare outcomes, dropout rates can be an issue due to length of study (attrition bias).
Retrospective Cohort Studies - advantages & disadvantages
Retrospective = the follow-up period occurred prior to the study being started, and the cohort is assembled from historical records.
Advantages: similar as for prospective cohort studies (good for rare exposures, multiple outcomes can be studied, control selection not a major issue, no recall bias), although in some cases, it may be difficult to establish temporality.
Disadvantages: recall bias (of confounders).
What is an RCT?
A prospective interventional cohort study, with randomisation.
Randomisation is used to ensure equal distribution of factors that may affect the outcome in each group (ie, confounders). This creates groups that only differ in terms of the exposure/intervention.
N-of-1 RCT
Randomised double blind multiple crossover in same patient involving active patient and placebo.
Crossover Design RCT
Administration of 2 or more experimental therapies one after the other, to the same group of patients. Can be affected by order of treatments. There is also a carryover effect, which may be mitigated by a washout period between treatments.
Factorial Design RCT
Multiple treatments are compared separately or combined in a single trial.
Pragmatic RCT
Broad inclusion criteria to best represent real world practice. This increases external validity, but at the expensive of internal validity.
Systematic Review & Meta-analysis
Systematic review = a review of RCTs based on strict quality control.
Meta-analysis = mathematical analysis and visual interpretation of the systematic review.
Advantages: increases power of study to find a true effect, allows for more objective appraisal of evidence, heterogeneity can be investigated.
Disadvantages: only as good as the studies that are included.
Network Meta-analysis
Allows indirect comparison of two treatments that have not been directly compared in studies. This requires as assumption of homogeneity, similarity, consistency.
Types of Qualitative Studies
- Ethnographic - immerses subjects in an unfamiliar culture
- Case control (differs from quantitative case control studies)
- Phenomenological - description of how participant(s) experience as certain event
- Grounded theory - to explain why a course of action occurred as it did, eg, patient satisfaction study
- Historical - describes past events to better understand present and future
- Narrative model - over extended period of time
Hierarchy of Evidence
From bottom to top:
Expert opinion, editorials
Case series, case reports
Case control studies
Cohort studies
RCTs
Systematic reviews, meta-analysis
MOOSE
A reporting guideline from Meta-Analysis of Observational Studies in Epidemiology, which improves reporting.
START
Short term assessment of risk and treatability, a risk assessment tool.
QUOROM
Quality of reporting of meta-analysis.
A statement developed to help improve the quality of reporting of systematic reviews.
CONSORT
Consolidated standards of reporting trials - intended to improve the reporting of RCTs.
PRISMA
Preferred reporting items for systematic reviews and meta-analysis.
An evidence-based minimum set of items for reporting in systematic reviews and meta-analyses.
Interval Data
Type of ordinal categorical data in which the interval between each number is also a meaningful real number, but zero point is arbitrary.
For example, patient satisfaction on a 1-10 scale.
Dichotomous Data
Type of categorical data.
Variable that has only two possible outcomes.
For example, alive vs dead, smoker or non-smoker.
Ratio Data
Type of interval categorical data in which the zero-value is of meaning. For example, age.
Nominal Data
Type of categorical data.
Nominal categories.
For example, blood group, marital status.
Ordinal Data
Type of nominal categorical data data for which the order of the variables has meaning, but there is no mathematical relationship between data points.
For example; grading of tumours, ranking of depression as mild/moderate/severe.
Types of Function Data
- Dependent = is the result of the action of the independent variable. For example, the outcome of interest.
- Independent = under control of the investigator, such as the drug or treatment. For example, the exposure variable.
Types of Numerical Data
- Continuous = data that may take any value within a defined range. For example, height, BMI. Note this can be converted to categorical data by separating the data into groups, such as short, medium, tall.
- Discrete = value can only be whole numbers. For example, number of people.
Mean
Average value.
Used on normally distributed data. If the data is skewed, the mean will not be an accurate representation of the average.
Median
Represents the average when the data is skewed (not normally distributed). It is the middle value of the data points when they are listed in ascending order. If there are an even number of data points, then average the two midpoints.
Mode
The most frequently occurring observation.