Hospital Pharmacy - July/August 2017 - 493
Thornby
relative risk) as applicable. In terms of study design, readers
should take into consideration elements included to reduce
the potential risk of bias such as randomization, blinding, use
of an appropriate control (including dose and interval), intention-to-treat or per protocol analysis, sample size, and
accounting for potential confounders and number of study
centers. The study design elements used in a trial should be
analyzed in an effort to confidently determine whether any
differences detected are due to the intervention alone and not
bias. As seen in Figure 1, a table enables the reader to denote
the study design and number of groups and classify the type
of data for baseline characteristics, outcomes, and adverse
drug events to assist with determining the appropriate use of
statistical tests. With this information, readers can rule in or
out the possibility of a type I error. Power should also be
reviewed if no statistically significant difference was
observed in the primary outcome. It is recommended to calculate risk estimates, particularly the absolute risk reduction
which is the actual difference in event rates between treatments. Relative risk estimates such as relative risk and relative risk reduction are often reported in studies as the results
may appear better. Thus, calculating both provides greater
insight to the study's results and clinical importance. The
absolute risk reduction will also lead to calculating number
needed-to-treat if a statistically significant difference was
observed between an intervention and control for a nominal
outcome in a superiority trial.
Obtain Clinically Significant Results
In the ROOTs journal club format, this section is typically
the lengthiest due to a detailed analysis of study results, factors that may impact the clinical application of the study
findings, and major potential limitations of the trial. To
begin, readers should clearly state the results of key safety
and efficacy outcome measures with the numerical results
and accompanying P values and confidence intervals.
Restating this information in a clear, concise manner allows
the reader to showcase the magnitude of treatment effect
which carries considerable weight in determining the clinical
relevance of the findings. However, try to provide summative statements of numerical results, or highlight trends and
deviations from trends, rather than presenting all the results.
A comparison of the treatment effect demonstrated by the
standard of care is integral to investigating the value, if any,
of the intervention under exploration. Likewise, the potential
clinical significance of an intervention is influenced by considerations of cost, convenience, and clinical practice guideline recommendations. Cost and convenience might not
factor into the interpretation of the study but might be of benefit when translating results to clinical practice. By researching and providing information on these factors, readers
provide needed information to appropriately interpret the
potential value of the intervention. It should be noted that
often a critical assessment of a study requires the reader to
493
consult numerous resources such as clinical practice guidelines, prescribing information, other published literature, and
related commentaries. In the pursuit of providing succinct
and thorough decision-making information, readers should
be cautious to furnish a well-rounded perspective. Although
clinical practice recommendations can be extensive, the presenter should tailor the information to focus on the specific
clinical issue in the patient population under investigation
with the respective grading of evidence supporting the recommendation. In doing so, readers may be alerted to deficiencies in the study design or potential inconsistencies in
the recommended care of patients. Examples of potential
study limitations that may hinder clinical relevance of study
findings could include inadequate study duration, use of surrogate outcome measures or inappropriate primary outcomes, failure to investigate adherence, comparison with
suboptimally dosed control or not the standard of care, lack
of assessment of ancillary medications which may alter the
efficacy of the intervention, and inclusion or exclusion of a
restricted patient population that is not representative of the
majority of patients. Interpreting the limitations of a trial and
how to translate their implications and then apply to clinical
practice is often the biggest "limitation" of a good journal
club. An example might help to place the importance of limitations into perspective. A clinical trial published in 2006 and
an extension of that same trial in 2007 was the sole study
used for aripiprazole to receive Food and Drug Administration
(FDA) approval for adjunctive treatment in bipolar
disorder.27,28 In 2011, this trial, and the use of aripiprazole in
bipolar disorder, was called into question. Tsai and colleagues determined
four issues that limit the interpretation of that trial as supporting
the use of aripiprazole for bipolar maintenance: (1) insufficient
duration to demonstrate maintenance efficacy; (2) limited
generalizability due to its enriched sample; (3) possible
conflation of iatrogenic adverse effects of abrupt medication
discontinuation with beneficial effects of treatment; and (4) a
low overall completion rate.29
A journal club would have revealed these flaws and institutions might have questioned the validity of the results much
sooner. The importance of this step in the process cannot be
overstated, as interpreting the limitations is often the "missing link" in journal clubs, as limitations are often easy to
identify, but translating what they mean for the overall conclusion is important, because some critical flaws, as seen in
the aripiprazole example, may make it more difficult to find
benefit with a drug, but it is shown in the study to be beneficial anyway. And as with this example, sometimes it may be
prudent to further examine the evidence in clinical practice
guidelines or evidence used to support recommendations
from an authoritative body such as the FDA rather than
assume that the drug is safe and effective because it was
approved.
Table of Contents for the Digital Edition of Hospital Pharmacy - July/August 2017
The Evolution of Drug Information Centers and Specialists
Letter: Sodium Phosphates Injection—Osmolarity Labeling Correction
ISMP Adverse Drug Reactions
Drug Monographs: Avelumab and Ribociclib
Formulary Drug Review: Naldemedine
Chimeric Antigen Receptor T-Cell Therapy for Lymphomas: A Review of a Drug Class or Therapeutic Class in a Late Stage of Clinical Development
International Mentoring Programs: Leadership Opportunities to Enhance Worldwide Pharmacy Practice
Compounded Apixaban Suspensions for Enteral Feeding Tubes
Impact of Developing Adult Ketamine Order Panels for the Emergency Department
Critical Appraisal of Biomedical Literature With a Succinct Journal Club Template: The ROOTs Format
Effect of a Rivaroxaban Patient Assistance Kit (R-PAK) for Patients Discharged With Rivaroxaban: A Randomized Controlled Trial
Examining the Use of Sodium Nitroprusside in Coronary Artery Bypass Grafting: Is the Benefit Worth the Cost?
Successful Implementation of an Antimicrobial Stewardship Program at an Academic Medical Center
Hospital Pharmacy - July/August 2017 - 445
Hospital Pharmacy - July/August 2017 - 446
Hospital Pharmacy - July/August 2017 - 447
Hospital Pharmacy - July/August 2017 - 448
Hospital Pharmacy - July/August 2017 - 449
Hospital Pharmacy - July/August 2017 - 450
Hospital Pharmacy - July/August 2017 - 451
Hospital Pharmacy - July/August 2017 - The Evolution of Drug Information Centers and Specialists
Hospital Pharmacy - July/August 2017 - 453
Hospital Pharmacy - July/August 2017 - Letter: Sodium Phosphates Injection—Osmolarity Labeling Correction
Hospital Pharmacy - July/August 2017 - ISMP Adverse Drug Reactions
Hospital Pharmacy - July/August 2017 - 456
Hospital Pharmacy - July/August 2017 - 457
Hospital Pharmacy - July/August 2017 - 458
Hospital Pharmacy - July/August 2017 - Drug Monographs: Avelumab and Ribociclib
Hospital Pharmacy - July/August 2017 - 460
Hospital Pharmacy - July/August 2017 - 461
Hospital Pharmacy - July/August 2017 - 462
Hospital Pharmacy - July/August 2017 - 463
Hospital Pharmacy - July/August 2017 - Formulary Drug Review: Naldemedine
Hospital Pharmacy - July/August 2017 - 465
Hospital Pharmacy - July/August 2017 - 466
Hospital Pharmacy - July/August 2017 - 467
Hospital Pharmacy - July/August 2017 - 468
Hospital Pharmacy - July/August 2017 - Chimeric Antigen Receptor T-Cell Therapy for Lymphomas: A Review of a Drug Class or Therapeutic Class in a Late Stage of Clinical Development
Hospital Pharmacy - July/August 2017 - 470
Hospital Pharmacy - July/August 2017 - International Mentoring Programs: Leadership Opportunities to Enhance Worldwide Pharmacy Practice
Hospital Pharmacy - July/August 2017 - 472
Hospital Pharmacy - July/August 2017 - 473
Hospital Pharmacy - July/August 2017 - 474
Hospital Pharmacy - July/August 2017 - 475
Hospital Pharmacy - July/August 2017 - 476
Hospital Pharmacy - July/August 2017 - 477
Hospital Pharmacy - July/August 2017 - Compounded Apixaban Suspensions for Enteral Feeding Tubes
Hospital Pharmacy - July/August 2017 - 479
Hospital Pharmacy - July/August 2017 - 480
Hospital Pharmacy - July/August 2017 - 481
Hospital Pharmacy - July/August 2017 - 482
Hospital Pharmacy - July/August 2017 - Impact of Developing Adult Ketamine Order Panels for the Emergency Department
Hospital Pharmacy - July/August 2017 - 484
Hospital Pharmacy - July/August 2017 - 485
Hospital Pharmacy - July/August 2017 - 486
Hospital Pharmacy - July/August 2017 - 487
Hospital Pharmacy - July/August 2017 - Critical Appraisal of Biomedical Literature With a Succinct Journal Club Template: The ROOTs Format
Hospital Pharmacy - July/August 2017 - 489
Hospital Pharmacy - July/August 2017 - 490
Hospital Pharmacy - July/August 2017 - 491
Hospital Pharmacy - July/August 2017 - 492
Hospital Pharmacy - July/August 2017 - 493
Hospital Pharmacy - July/August 2017 - 494
Hospital Pharmacy - July/August 2017 - 495
Hospital Pharmacy - July/August 2017 - Effect of a Rivaroxaban Patient Assistance Kit (R-PAK) for Patients Discharged With Rivaroxaban: A Randomized Controlled Trial
Hospital Pharmacy - July/August 2017 - 497
Hospital Pharmacy - July/August 2017 - 498
Hospital Pharmacy - July/August 2017 - 499
Hospital Pharmacy - July/August 2017 - 500
Hospital Pharmacy - July/August 2017 - 501
Hospital Pharmacy - July/August 2017 - Examining the Use of Sodium Nitroprusside in Coronary Artery Bypass Grafting: Is the Benefit Worth the Cost?
Hospital Pharmacy - July/August 2017 - 503
Hospital Pharmacy - July/August 2017 - 504
Hospital Pharmacy - July/August 2017 - 505
Hospital Pharmacy - July/August 2017 - 506
Hospital Pharmacy - July/August 2017 - 507
Hospital Pharmacy - July/August 2017 - Successful Implementation of an Antimicrobial Stewardship Program at an Academic Medical Center
Hospital Pharmacy - July/August 2017 - 509
Hospital Pharmacy - July/August 2017 - 510
Hospital Pharmacy - July/August 2017 - 511
Hospital Pharmacy - July/August 2017 - 512
Hospital Pharmacy - July/August 2017 - 513
Hospital Pharmacy - July/August 2017 - 514
Hospital Pharmacy - July/August 2017 - 515
Hospital Pharmacy - July/August 2017 - 516
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