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Research Design, Biostatistics & Literature Evaluation

Julie E. Farrar ~3 min read Module 2 of 20

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Research Design, Biostatistics, and Literature Evaluation

I.INTRODUCTION

A.Epidemiology of Critical Care in the United States – Why continued research is essential to improving the

delivery of care to patients

10.1%–28.5% of all hospital inpatients receive care in an intensive care unit (ICU), approximating 5.7

million adults. Estimated mortality for ICU care is 20%–40% for common critical care syndromes (Crit

Care Med 2012;40:1072-9).

216.9%–38.4% of total hospital costs are spent on critical care services, approximating $121–$263 billion.

5.2%–11.2% of national health care expenditures

1% of gross domestic product

B.Why Pharmacists Need to Understand the Fundamentals of Research Practice, Trial Design, and Literature

Evaluation – High rates of morbidity and mortality necessitate efficient and efficacious decision-making on

the part of caregivers.

C.Necessity of Clinical Research in Critical Care – To optimize patient outcomes and minimize potential

patient harm while providing efficient stewardship of finite resources

D.Synthesizing Medical Knowledge with Experiential Knowledge and Pathophysiologic Reasoning – Essential

to creating patient-specific therapy care plans

II.BIOETHICS

A.The Belmont Report – Originally created as a result of the National Research Act of 1974; outlines the

fundamental ethical principles for the conduct of clinical research

Respect for individuals dictates that each research participant be treated with respect for his or her

dignity and autonomy. As such, informed consent shall be obtained from research participants or their

surrogates.

2The principle of justice requires that investigators recruit research subjects in a manner that allows equal

access to participation for all populations that may potentially benefit from the research endeavor.

Beneficence requires research investigators to ensure that risks are minimized and benefits maximized

for research participants.

B.A framework for the ethical conduct of clinical research includes seven requirements: (1) social value, (2)

scientific validity, (3) fair selection of research participants, (4) favorable risk-benefit ratio, (5) independent

review, (6) informed consent, and (7) respect for enrolled participants (JAMA 2000;283:2701-11).

C.Equipoise – Must be present for the conduct of a clinical trial. Equipoise is defined as the state of uncertainty

between treatments A and B for a given population of subjects with a predefined disease and/or syndrome.

Once the balance of uncertainty between treatments A and B is disturbed such that one treatment is believed

to be superior, the risk-benefit ratio is altered such that treatment may not be beneficial to the individual

research subject. Example: a proposal for clinical research ethics in critically ill patients during pandemics

(Front Public Health. 2024;12:1359654.)

HD Video Explanation — Synchronized with PDF

Starts at: minute 6 Open on YouTube