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    Research designs are used to answer research questions

    "gold Standard" Outcome Observational Research PICO Research Design Research Question

    Research designs are chosen based on research questions

    Feasibility of research designs also depends upon research questions

    The methodology or research design used in a study is employed to answer the research question. Without a research question, there is no reason to have a methodological approach. Observational research designs like cases series, case-control, cross-sectional, retrospective cohort, and prospective cohort are research questions related to associations between variables.  Experimental research designs are used to answer research questions related to causal effects.

    When choosing a research methodology, one word should always come to mind, feasible.  The feasibility of what you can and cannot do given time, money, resources, and collaborators must be taken into consideration before conducting a study.  Researchers that have limited amounts of the aforementioned may be better served by retrospective observational designs where data on predictors and outcomes already exists.  Prospective and experimental designs require much more time and effort to conduct.  A significantly larger amount of empirical complexity and experience is needed to conduct these types of designs.  There must also have to be sufficient time to follow-up on the outcomes of interest.

    The PICO (population, intervention, comparator, and outcome) mnemonic is an excellent tool for defining important parts of a research methodology.  The population should be defined in regards to inclusion and exclusion criteria.  In order for studies and experiments to be replicated, the intervention or treatment must be explicitly described.  If the goal of a research study is to show evidence of a treatment effect, then a comparison, control, or comparator group is necessary. Comparator participants should possess similar demographic and clinical characteristics to treatment participants to truly understand any associations or effects.  Finally, the primary outcome should be measured at the current "gold standard" level to increase the precision and accuracy of research findings.  The "gold standard" outcome is also more generalizable and understood by clinicians because it is part of their lexicon and cognitive schema.
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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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    Evidence-based medicine and its applications

    Acquiring Clinical Evidence Applying Clinical Evidence Appraisal Of The Literature Appraising Clinical Evidence Asking Clinical Questions Assessing Clinical Practice Bloom's Taxonomy Cognitive Dissonance EBM Evidence-based Medicine PICO

    Critical appraisal of the clinical evidence

    The cart before the horse

    I'm getting ready to add an Education section to the website, I decided to go back to first principles.  Bloom's Taxonomy had a pervasive impact on my philosophy of learning, teaching, and cognitive complexity.  I used it back in February of this year for an evidence-based medicine (EBM) presentation at work.  Bloom's Taxonomy* stipulated six levels of "knowing" or cognitive complexity.  The six levels in increasing order were knowledge, comprehension, application, analysis, synthesis, and evaluation.  

    Here is the conundrum that Bloom's Taxonomy exacts upon applied EBM practice:

    There are five steps to EBM:  Asking, acquiring, appraising, applying, and assessing.  

    With asking, the EBM literature posits that clinicians experience "cognitive dissonance" when they have a knowledge gap in their clinical practice.  In order to deter the dissonance, the clinician decides to ask a clinical question to fill that gap.

    With acquiring, the clinician uses the PICO (population, intervention, comparator, outcome) mnemonic to acquire the best clinical evidence, given the resources and time available.

    Now we get to critical appraisal of the literature.  When looking at the nomenclature of the word "appraisal," it is reflective of the highest level of "knowing" or cognitive complexity in Bloom's Taxonomy, evaluation.  EBM stipulates that clinicians must be able to critically appraise the methods and statistical analyses of published studies.  This means that clinicians have to have functioning at a very high cognitive level to do this correctly.

    However, past literature has shown that researchers feel anxious and intimidated by statistics due to a lack of experience and competency.**  Also, undergraduate and graduate medical training rarely equips clinicians with the necessary competencies to conduct and effectively interpret clinical research evidence.***

    So, how can your everyday clinician with limited empirical/statistical training who feels "cognitive dissonance" a second time in the five steps of EBM critically appraise the literature?  Therein lies the conundrum, in my opinion.  

    I'm positing that we need to refocus our efforts on the lower echelons of Bloom's Taxonomy by educating physicians, residents, fellows, faculty, pharmacists, nurses, and staff to better understand (knowledge), recognize (comprehension), choose (application), examine (analysis), and design (synthesis) research studies before we can expect them to critically appraise (evaluation) the literature.  
    *Bloom, B. S.; Engelhart, M. D.; Furst, E. J.; Hill, W. H.;Krathwohl, D. R. (1956). Taxonomy of educational objectives: The classification of educational goals. Handbook I: Cognitive domain. New York: David McKay Company.
    **Marquardt, DW.  Criteria for evaluating the performance of statistical consultants in industry.  The American Statistician 1981; 35; 216-219.
    ***Wegwarth O.  Statistical illiteracy in residents:  What they do not learn today will hurt their patients tomorrow.  Journal of Graduate Medical Education 2013; 5; 340-341.
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    The research question is the foundation of everything empirical

    FINER PICO Research Question

    Foundation for measurement, design, power, and statistics

    80% of preliminary study planning should be given to the research question

    As a biostatistical consultant at an academic regional medical campus, I am supposed to spend 80% of my time working with residents, fellows, faculty, clinicians, researchers, nurses, pharmacists, and hospital staff to formulate and refine their research question. THAT is how important it is to any research study. 

    A research question is cultivated through researchers' efforts to know the existing literature, their clinical expertise and interests, their collaboration with peers, and their intrinsic motivation towards scientific discovery and innovation. Answerable, appropriate, meaningful, and purposeful research questions make valid and needed contributions to the literature.

    Deductive reasoning should be used when formulating a research question. Oftentimes, researchers will want to answer EVERY possible question and collect data on EVERY single variable that they can in hopes of finding SOMETHING SIGNIFICANT. This is not the way that REAL science works. A focused and refined research question is the basis for constructing and executing research. This does not mean that researchers cannot ask secondary, tertiary, and ancillary research questions as demographic, clinical, and confounding variables are yielded from literature reviews! Of course, these are important questions to ask and often lead to great discoveries! (Example:  Viagra) However, having ONE research question that serves as the foundation for a study is extremely important and should not be overlooked!

    Many novice researchers will plan an entire study around a type of research design or a statistic that they read in an article. REMEMBER, research designs and statistical tests are chosen to answer researcher questions, NOT the inverse.

    All of this being said, there are two existing frameworks that greatly assist in formulating (FINER) and refining (PICO) research questions. FINER stands for feasible, interesting, novel, interesting, and relevant. PICO stands for population, intervention, comparator, and outcome.