Tags

  • Published on

    Non-inferiority trials and the Affordable Care Act

    Affordable Care Act Clinical Pathways Non-inferiority

    Non-inferiority trials will be popular with ACA

    Analysis of cost savings and quality care

    With the dissemination of the Affordable Care Act into the healthcare system, clinical pathways and efficiency in treatment will be mainstays within medicine.  Hospitals and institutions will have to find ways to provide quality care in an economically viable fashion both for patients and the "bottom line."

    Healthcare professionals are always looking at ways to cut costs.  One way that researchers will be able to assist in these endeavors is to promote the use of non-inferiority designs.  By providing a cheaper treatment that is JUST AS GOOD as the current "gold standard" treatment, costs can be reduced dramatically as it relates to clinical treatment regimens.  

    There must be an empirically and clinically validated margin of non-inferiority.  Sample sizes will increase as relevant margins decrease.  These trials are most relevant when 1) secondary endpoints are better, 2) treatments are cheaper or easier to administer, 3) randomized controlled trials are not feasible or ethical, and 4) when compliance to treatment will be higher in comparison to the "gold standard."*

    Better secondary endpoints, cheaper and more patient-friendly treatments, and higher rates of compliance will all be necessary as the Affordable Care Act promulgates into the healthcare marketplace.   
    *Lesaffre, E.  Superiority, equivalence, and non-inferiority trials.  Bull NYU Hosp Jt Dis.  2008;66(2): 150-154.
  • Published on

    Operationalization of constructs and behaviors

    Affordable Care Act Confirmatory Factor Analysis Construct Validity Cross-sectional Operationalization Prevalence Principal Components Analysis Social Science Standards Of Care Survey

    Operationalization leading to understanding

    Measurement of new phenomena

    The term operationalization is very near and dear to my heart since I conducted my dissertation on operationalizing and validating the construct of isomorphism in supervision. Operationalization essentially means defining observable and measurable components of a given construct or behavior.

    The term is used often in the social sciences because scientists in that field have to spend so much time creating and validating their constructs of interest, just to be able to measure for them. From an empirical standpoint, they have to operationalize the construct as it exists within the perception, context, experience, and environment of members of a population.

    Many social scientists use survey methodologies (cross-sectional) to operationalize an abstract, new, or unique construct or behavior. They master the content area related to the construct, create a survey, and then administer it to a sample from a targeted population to see what content areas or items account for the most variance. Principal components analysis and confirmatory factor analysis are used to establish the construct validity of survey instruments.

    Medical professionals use cross-sectional research designs to establish the prevalence of disease states. Operationalization within physiology deals more with using "gold standard" techniques and concrete measures such as lab values.  Treatment protocols are another form of operationalization within medicine.  Certain procedures like a central line insertion require 20+ sequential steps to be conducted by surgical team members, every time.  With the advent of the Affordable Care Act and upcoming clinical pathways, operationalization will play an even larger role in building economical, efficient, and effective standards of care.