ABP's+Content+Outline+for+PEM+(Research+Methods+Section)

=XIII. Research Methods =

1. Informed consent
Know the required components of an [|informed consent] document

Know the ethical issues that complicate obtaining [|informed consent] in young children

Know the ethical issues affecting [|informed consent] in [|older children and adolescents] (also see [|here]) and how these may be addressed

Know the issues raised by the Health Insurance Portability and Accountability Act ([|HIPAA]) in the [|informed consent] process

2. Waiver of consent
Know the requirements for waiver of consent in [|emergency research]

3. Institutional review board
Know the role of the [|institutional review board] in approving research projects involving [|human subjects]`

1. Human rights
Know the basic rights of humans participating in research

Know the role of the investigator in monitoring of human subjects during a clinical trial

2. Animal rights
Know the rights of animals used in research

1. Study design
Know study designs commonly used in [|epidemiologic] research

Know the differences in the implications of a [|case control], [|cohort], and [|randomized controlled study]

Know the rationale behind [|randomized trials]

Know the implications of prospective versus retrospective data collection in clinical research

Know the importance of [|sample size] determinations in research

Know the concept of [|meta-analysis] and its limitations

Know the definition and purpose of "[|intention to treat]" analysis

Know the issues raised by [|HIPAA] in clinical research

Know the role of [|power calculations] in research planning

Know the definition and methods of calculation of [|absolute reduction in risk] (ARR) and [|number needed to treat] (NNT)

2. Definitions
Know the definition of the "[|null hypothesis]"

Know the definition and method of calculation of [|sensitivity]

Know the definition and method of calculation of [|specificity]

Know the definition and method of calculation of [|positive predictive value]

Know the definition and method of calculation of [|negative predictive value]

Know the definition of categorical, ordinal, and continuous variables

Know the limitations of [|positive] and [|negative] predictive values in relationship to disease [|prevalence] when comparing diagnostic tests

Know the meaning of the clinical "[|likelihood ratio]" (LR) and its effect on post-test odds of disease 

3. Analysis and interpretation of results
Know the assumptions necessary to use parametric statistics (eg, t test)

Know the advantages and disadvantages of [|nonparametric tests] (eg, Wilcoxon test)

Understand the [|normal distribution] and the use of normal approximation in statistical analysis

Know the advantages of [|confidence interval] in the interpretation of results

Know the difference between [|standard deviation] (SD) and [|standard error of the mean] (SEM)

Know the use of [|odds ratios] in the interpretation of results

Know the difference between "[|statistically significant]" and "biologically meaningful"

Know the concept of "[|confounding]" as it applies to statistical analysis

Know the assumptions in choosing the proper statistical test for data analysis

Know methods to correct for the limitations of multiple comparisons

Understand the use of the [|central limit theorem] in justifying the use of the normal approximation in choosing a statistical test

Know the factors that contribute to [|type I and type II errors]

Know the interpretation and application of [|receiver-operating characteristic curves] (ROC)

4. Conduct of research
Know the common forms of [|scientific misconduct]

Know what constitutes an investigator [|conflict of interest] during the course of a study

Know the responsibilities of an investigator or co-investigator in the proper conduct of research

Know the responsibilities required of a [|valid author] in scientific publications

Know some common sources of bias in research (eg, [|ascertainment bias], recruitment bias, [|recall bias])

Know the techniques of [|evidence-based medicine] used to extract information from published research that is applicable to one's own patients

Know the advantages and disadvantages of paired or matched research designs

Know when a matched-pairs statistical test is appropriate

Know the strengths and limitations of [|regression analysis] (eg, what hypothesis is tested by regression analysis, the limitations of the R and R-squared statistics, and the use of "fit" versus "prediction" confidence intervals