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    FINER and PICO

    Comparator FINER Hypothesis Testing Intervention Outcome PICO Population Post-positivism Research Design Research Question Sampling Method Statistical Power Analysis Statistics

    An amalgamation of philosophy and objectivity

    The research question is the foundation of everything empirical

    Research questions (and answering them) are always the primary focus of anything and everything empirical, methodological, epidemiological, and statistical. Without a research question, there is no reason to conduct a study or run statistics.

    The following are DIRECTLY derived from research questions:

    1. Null and alternative hypotheses (hypothesis testing and inferential statistics)
    2. Research design (observation or experimental)
    3. Population of interest (inclusion and exclusion criteria) 
    4. Sampling method (non-probability or probability)
    5. Intervention or independent variable (categorical, ordinal, or continuous)
    6. Confounding or control variables (secondary, tertiary, and ancillary research questions)
    7. Comparator or control treatment (categorical, ordinal, or continuous)
    8. Outcome or dependent variable (categorical, ordinal, or continuous)
    9. Outcome and design for an a priori power analysis to calculate sample size
    10. Structure of the database (between-subjects, within-subjects, or multivariate) and code book
    11. Statistical tests used (descriptive, between-subjects, within-subjects, correlations, survival, or multivariate)

    Researchers must take the appropriate amount of time to fully formulate and refine research questions. SO MUCH is dependent upon it for their study. Luckily, this task is made easier with the use of two prevalent mnemonics: FINER (feasible, interesting, novel, ethical, relevant) and PICO (population, intervention, comparator, outcome).

    FINER is a more of a philosophy for writing research questions. The arguments for the "F," "I," "N," "E," and "R" are all and informed upon by the empirical literature in the area of empirical or clinical interest. Researchers especially have to be well vested in the most current literature in order to make sound arguments for interesting, novel, and relevant questions.

    PICO is employed to explicitly and operationally define the population of interest, the intervention, the comparator, and the outcome in a research question. It is also more readily applicable in busy clinical and empirical environments and when writing literature search queries.  

    These two mnemonics compliment each other very well in applied empirical and clinical environments. The post-positivist philosophy of social and medical sciences lends itself well to FINER. Measurement of observable constructs and the application of experimental designs through the PICO mnemonic is also strongly reflective of a post-positivist philosophical orientation. Together, the "why" and "what" questions associated with conducting research can be argued in an evidence-based, objective, and logically sound fashion.
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    Mastery of the literature

    Effect Size "gold Standard" Outcome Novel Research Question Relevant Research Question Research Design Statistical Power Analysis

    Mastery of the literature leads to relevant research questions

    Become an expert in the empirical field of endeavor

    There is nothing more important when designing and conducting research than being heavily vested in the associated knowledge base. Research questions are born and formulated out of the literature. One cannot argue for a "gap" in the literature unless he or she has put forth the time and effort to know all of the literature. The literature also makes it very easy to make hard decisions in the preliminary phases of study planning.

    Here is what the literature can do for you:

    1. Give you an evidence-based measure of effect to use in an a priori power analysis. It will show more empirical rigor on your part if you use the values from the most current and highest-quality evidence available.

    2. Help you choose the "gold standard" outcome that is most generalizable and applicable to your audience and peers. Using the best outcome measure available increases the internal validity of your study as well. If the same outcome is used in many studies, then it has more validity evidence to back it up. This, again, shows stronger empirical reasoning on your part.

    3. Allow you to ask a question that is relevant and that will generate new knowledge. You will be able to pass the "So what?" question with ease when you know the literature. You will know what new knowledge needs to be generated and how it is relevant in the context of the existing literature.

    4. Help you choose the correct research design to answer your research question. If you find that the literature only has observational evidence related to your area of interest, then you can make the informed decision to employ a more complex design to yield causal effects.   
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    Feasible research questions are answerable

    Effect Size Feasible Research Questions Research Design Research Question Sample Size Statistical Power Analysis Statistical-power-test

    Feasible research in terms of scope, time, resources, and expertise

    Changing the face of medicine versus completing a research study

    I have conducted thousands of statistical consultations over the years and have worked with many novice resident researchers over that time. One cannot help but admire the spirit, energy, and motivation of young people wanting to make an impact on medicine through research. I enjoy the zeal and drive of bright people wanting to be physicians and researchers. This is a good thing!

    That being said, I spend a lot of my time with novice researchers using deductive reasoning to hone down their research questions into something tangible and feasible. They come into the office with an idea that will change medicine forever and we will be cruising around the Caribbean in a year! This has never been researched before!  No one has ever done this before! Trust me, I want all of these proclamations to be true and I also want to change the face of medicine. Yet, most times it just not feasible to do so given the time, resources, participants, competencies and environment associated with the study.

    I focus on a few primary areas when it comes to feasible research questions with my consultees:

    1. Participant pool - Are there enough participants available in the immediate clinical or empirical environment to achieve adequate statistical power for inferential analyses? How will you recruit the participants? What are your inclusion and exclusion criteria? Inclusion and exclusion criteria may need to be modified to increase sample size.

    2. Effect size - Small effect sizes require large sample sizes.    

    3. Research design - Retrospective designs are always more feasible because the data already exists.

    4. Communication - Research never occurs in isolation. Researchers should communicate and collaborate with their peers regarding their research projects. Attendings and academic physicians can give you ideas on how to feasibly conduct your research.

    5. Time - What is the time frame for the study from inception to publication? How much time do you have to set aside for the research study? Does the completion of your research coincide with abstract deadlines of interest?

    6. Power analysis - Conduct an a priori power anlaysis based on an evidence-based measure of effect to see if the study is feasible in regards to sample size needed to achieve power.
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    Effect size, sample size, and statistical power

    Effect Size Measurement Research Design Sample Size Statistical Power Analysis

    Effect size, sample size, and statistical power

    Choose an effect size to maximize statistical power and decrease sample size

    Effect size, sample size, and statistical power are nebulous empirical constructs that require a strong working knowledge of each in a conceptual fashion.  Also, there are basic interdependent relationships that exist amongst the three constructs. A change in one will ALWAYS exact a predictable and static change in the other two.

    An effect size is the hypothesized difference expected by researchers in an a priori fashion between independent groups (between-subjects analysis), across time or observations (within-subjects analysis), or the magnitude and direction of association between constructs (correlations and multivariate analyses).

    Effect size planning is perhaps the HARDEST part of designing a research study. Oftentimes, researchers have NO IDEA of what type of effect size they are trying to detect.

    First and foremost, when researchers cannot state the hypothesized differences in their outcomes, an evidence-based measure of effect yielded from a published study that is theoretically or conceptually similar to the phenomenon of interest should be used. Using an evidence-based measure of effect in an a priori power analysis shows more empirical rigor on the part of the researchers and increases the internal validity of the study with the use of published values.

    Sample size is the absolute number of participants that are sampled from a given population for purposes of running inferential statistics. The nomenclature of the word, inferential, denotes the basic empirical reasoning that we are drawing a representative sample from a population and then conducting statistics in order to make inferences back to said population. An important part of preliminary study planning is to specify the inclusion and exclusion criteria for participation in your study and then getting an idea of how large a participant pool you have available to you from which to draw a sample for purposes of running inferential statistics.

    Due to the underlying algebra associated with mathematical science, large sample sizes will drastically increase your chances of detecting a statistically significant finding, or in other terms, drastically increase your statistical power. Large sample sizes will also allow you to detect both large and small effect sizes, regardless of scale of measurement of the outcome, research design, and/or magnitude, variance, and direction of the effect. Small sample sizes will decrease your chances of detecting statistically significant differences (statistical power), especially with categorical and ordinal outcomes, between-subjects and multivariate designs, and small effect sizes.

    Statistical power is the chance you have as a researcher to reject the null hypothesis, given that the treatment effect actually exists in the population. Basically, statistical power is the chance you have of finding a significant difference or main effect when running statistical analyses.  Statistical power is what you are interested in when you ask, "How many people do I need to find significance?"

    In the applied empirical sense, measuring for large effect sizes increases statistical power. Trying to detect small effect sizes will decrease your statistical power. Continuous outcomes increase statistical power because of increased precision and accuracy in measurement. Categorical and ordinal outcomes decrease statistical power because of decreased variance and objectivity of measurement. Within-subjects designs generate more statistical power due to participants serving as their own controls. Between-subjects and multivariate designs require more observations to detect differences and therefore decrease statistical power.