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Research Design, Biostatistics & Literature Evaluation
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Content 1 min
Research Design, Biostatistics, and Literature Evaluation Julie E. Farrar, Pharm.D., BCCCP University of Tennessee Health Science Center Memphis, Tennessee David M. Hill, Pharm.D., MS, FCCP, FCCM, B…
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Research Design, Biostatistics, and Literature Evaluation Research Design, Biostatistics, and Literature Evaluation Julie E. Farrar, Pharm.D., BCCCP University of Tennessee Health Science Center Mem…
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Learning Objectives 3 min
Research Design, Biostatistics, and Literature Evaluation Learning Objectives 1. Identify factors influencing the conduct of essential critical care research. 2. Evaluate the appropriateness of var…
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Research Design, Biostatistics, and Literature Evaluation 4. An epidemiologic study seeks to determine the impact of adverse drug events in the intensive care unit (ICU) on patient outcomes, which…
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Research Design, Biostatistics, and Literature Evaluation 8. In a study of ARDS, patients are treated with a neu- romuscular blocking agent (NMBA) or placebo to determine whether administering a NMB…
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Exam Content Outline 1 min
Research Design, Biostatistics, and Literature Evaluation BPS Critical Care Pharmacy Examination Content Outline This chapter covers the following sections of the Critical Care Pharmacy Examination Co…
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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 ca…
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Research Design, Biostatistics, and Literature Evaluation D. The Common Rule – Created in 1991 as uniform ethical standards for research after a series of exposures of unethical research misconduct,…
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Research Design, Biostatistics, and Literature Evaluation C. Informed Consent 1. Necessity depends on many factors (e.g., IRB or trial design) 2. 6th–8th grade literacy level 3. Because of the acu…
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Research Design, Biostatistics, and Literature Evaluation i. Study was classified as exempt from IRB review and informed consent because of the study’s QI nature. ii. After a complaint, the Office…
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Research Design, Biostatistics, and Literature Evaluation Practice Case 1. You are working with a multicenter group to develop a cluster-crossover randomized trial. Patients will be recruited at 12…
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Research Design, Biostatistics, and Literature Evaluation 3. Preliminary research should exist to suggest that the intervention is based on pathophysiology and repeated outcomes consistent with the…
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Research Design, Biostatistics, and Literature Evaluation b. Typically novel or rare patient population or intervention 6. Challenges with observational studies a. Missing data are frequently a pro…
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Research Design, Biostatistics, and Literature Evaluation F. Pharmacokinetic and Pharmacodynamic trials 1. Studies designed to evaluate effects of unique disease states on clinically relevant pharma…
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Research Design, Biostatistics, and Literature Evaluation b. Observation bias: Observers (research team) are aware of the research purpose and allow this knowledge to influence interpretation of res…
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Research Design, Biostatistics, and Literature Evaluation Practice Case Questions 2 and 3 pertain to the following case. You are a critical care pharmacist in the medical ICU and wish to retrospective…
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Data Tables 3 min
Research Design, Biostatistics, and Literature Evaluation i. Two-tailed tests distribute half of the α value at the far left hand and far right hand ends of the distribution ii. One-tailed tests di…
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Research Design, Biostatistics, and Literature Evaluation 3. Descriptive statistics a. Measures of central tendency b. Mean: Used for continuous and normally distributed data (parametric), sensitiv…
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Research Design, Biostatistics, and Literature Evaluation c. A 95% CI describes the interval that would contain the true population point estimate in 95 of 100 random samples. I. Correlation: Descr…
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Data Tables 2 min
Research Design, Biostatistics, and Literature Evaluation Table 2. Statistical Regression Model According to Type of Data Dependent Variables Independent Variables Test(s) Continuous Continuous Linear…
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Research Design, Biostatistics, and Literature Evaluation 2. Kaplan-Meier method a. Describes the impact of a single predictor variable on the time-to-event between cohorts b. Compares the survival…
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Research Design, Biostatistics, and Literature Evaluation Practice Case Questions 4–6 pertain to the following case. The neurosurgery physician group at your institution would like your input in evalu…
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Data Tables 3 min
Research Design, Biostatistics, and Literature Evaluation VI.  APPLICATION OF KNOWLEDGE TO PATIENT CARE A. Integration of Various Types of Knowledge (Table 3) Table 3. Assessment of Primary Literatur…
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Research Design, Biostatistics, and Literature Evaluation b. Can aid in determining short-term goals. Example: Selecting an initial dose of loop diuretic according to the home medication dose and cu…
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Research Design, Biostatistics, and Literature Evaluation REFERENCES Introduction Angus DC, Barnato AE, Linde-Zwirble WT, et al. Use of intensive care at the end of life in the United States: an epi…
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Research Design, Biostatistics, and Literature Evaluation oversight, and patient safety research. Jt Comm J Qual Patient Saf. 2008;34(6):349-353. https://doi.org/10.1016/ s1553-7250(08)34044-6 Luce J…
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Research Design, Biostatistics, and Literature Evaluation effects. Pharmacoepidemiol Drug Saf. 2003;12(7):551- 558. https://doi.org/10.1002/pds.883 Moodie EE, Stephens DA. Using directed acyclic graph…
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Research Design, Biostatistics, and Literature Evaluation studies. Guidance for authors from editors of respi- ratory, sleep, and critical care journals. Ann Am Thorac Soc. 2019;16(1):22-28. https://…
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Answers & Explanations 5 min
Research Design, Biostatistics, and Literature Evaluation ANSWERS AND EXPLANATIONS TO PRACTICE CASE QUESTIONS 1. Answer: D This study requires consideration of options A, B, and C. Informed consent…
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Research Design, Biostatistics, and Literature Evaluation is around 89% (Answers A, B, and C are incorrect). The PPV is calculated by dividing 189/289, and the NPV is calculated by dividing 100/112.…
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Self-Assessment 5 min
Research Design, Biostatistics, and Literature Evaluation ANSWERS AND EXPLANATIONS TO SELF-ASSESSMENT QUESTIONS 1. Answer: C This study seeks to compare two viable treatments of hypovolemic shock i…
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Research Design, Biostatistics, and Literature Evaluation hypovolemic shock are both less than 1, mortality was decreased with albumin use (Answers A, C, and D are incorrect). 7. Answer: A This pat…