Assignment Paper

Major differences from last semester’s journal clubs are noted in bold.

In PHRM 531 you will be expected to, as an individual, lead one journal club discussion and participate in three additional journal club discussions. The student leading journal club will be responsible for preparing a handout, presenting the article, and involving the audience in a discussion. Each article will be accompanied by a patient case; the journal club leader is responsible for discussing how they would use the evaluated article in addressing the case. The students participating in journal club will be responsible for paying attention, responding to questions posed by the leader and faculty, and asking questions. All students (leaders and participants) must review the assigned article and patient case prior to class.

Students leading journal club will be allotted 30 minutes to provide an overview of the study, their interpretation of results, and their critique of the study. It is suggested to allow up to 10 minutes for the study overview, up to 10 minutes for the critique, and up to 5 minutes for application to the patient, and 5 to 10 minutes for additional questions. In order to increase student participation in journal club, the journal club leader is required to phrase at least three critique points as questions for the audience (e.g., “Do you all think the investigators’ use of per protocol analysis was appropriate?” “What additional endpoints do you think the investigators should have assessed?”). The journal club leader will be responsible for assigning participation points to group members based on their engagement in the activity and response to questions (see separately attached rubric).

Each student leading journal club will be evaluated by a course instructor (see separately attached rubric). Students who do not earn 75% of the content points will repeat the activity. Students who do not prepare an acceptable handout (considering both content and professional presentation) will re-do that portion of the assignment at the discretion of the course instructor and course coordinator. Additionally, all students, as participants, are required to ask at least three questions relating to interpretation, evaluation, or application of the article throughout the three other journal club presentations. Questions should not be basic (e.g., “Was the result for the primary endpoint statistically significant?”) but should be good questions demonstrating critical thinking (e.g., “Did you think the observed effect size would be considered clinically significant for the patient in our case?” “What were the pros and cons of the inclusion and exclusion criteria for this study?”). Course faculty will keep track of questions asked and have final say on whether to count or not count questions based on quality.

Assessment

Points will be earned for the following activities (see separately attached rubrics):

1. Leading journal club 40 points
2. Participation in other group members’ journal club discussions
• Engagement in group discussion
• Questions posed to journal club leader
4 points
6 points
Total: 50 points
 
Assigned Dates

Students will attend either journal club day 1 (Feb 17, 2020) or journal club day 2 (Mar 30, 2020). Students will not need to attend lab on the other journal club day.

During the assigned journal club day, students will lead one journal club presentation and participate in three additional journal club presentations. Students will choose one of ten provided articles to lead. Once articles have been chosen, students will find out which journal club day they must attend. Students will then be notified of the three other articles they will participate in for that day. Students must prepare their individual journal club review AND read the other three articles in preparation for participation during the session.

Article abstracts and a sign-up genius link will be provided for students to review and choose their preferred article to review.

Template

Instructions for using the attached template:

1. The journal club handout should provide an OVERVIEW of key information from the article – it should not rewrite the entire paper. For PHRM 531, the length limit for journal club handouts is 4 pages (or, 2 pages front and back).
2. All requested information should be included; however, do not feel like you need to discuss every point in the handout during your discussion. For example, you may choose not to address the location of the study in detail unless an audience participant asks about it.
3. The journal club critique is organized using the approach from PHRM 420; however, you may feel free to reorganize the critique section as necessary.
4. The prompts listed in the critique section are not exhaustive; similarly, each issue may not apply to each study. 
OVERVIEW
Citation  Provide the complete article citation using AMA format.
Location  Provide information regarding study sites including institution, state, and country, if applicable.
Funding  Describe the funding source and the role they played in the study (e.g., provided medication, developed study, developed manuscript, approved manuscript).
INTRODUCTION
Background  Provide a concise overview of the pertinent drug(s), disease state(s), etc. that have bearing on the discussion. This should include information besides just what is provided in the article intro.
Previous Trials  Cite and briefly discuss two to three previous trials that have bearing on the primary article. Summarize key details of the results and indicate how these studies led to the one being reviewed in the current presentation. This should include information besides just what is provided in the article intro.
Potential Impact  Based on the authors’ objectives, background information, and previous trials, describe the potential impact the results of this study could have on practice.
Objectives  Paraphrase the authors’ stated objective for the study.
METHODS
Study Design  Provide an overview of the following: Study type (e.g., case-control, clinical trial), phase of drug development (i.e., I, II, III, IV), randomization, control, blinding, etc. as applicable.
Inclusion Criteria  List and discuss stated inclusion criteria; highlight key information.  List and discuss stated inclusion criteria; highlight key information.
Exclusion Criteria  List and discuss stated exclusion criteria; highlight key information.  List and discuss stated exclusion criteria; highlight key information.
Interventions  Provide dosing, schedule, etc. for intervention, comparator, and monitoring. NOTE: This section does not apply to observational studies.
Primary Endpoint  List and discuss the primary endpoint. NOTE: For clinical trials, the primary endpoint is the endpoint used in the power calculation. If there is a discrepancy between the actual primary endpoint and the authors’ described primary endpoint, this should be addressed.
Secondary Endpoints  List the secondary endpoints; highlight key secondary endpoints.
Safety Endpoints  Describe the authors’ adverse drug event monitoring plan and any other related safety endpoints.
Statistical Analyses  List and describe the statistical tests used; describe the power calculation; note the populations analyzed (e.g., intention to treat, per protocol, as treated).
RESULTS
Enrollment  Describe issues such as number of patients screened, number/percentage of patients randomized, number/percentage of patients who received the intervention vs. control; include an overview of adherence, attrition, and other related considerations.
Baseline Characteristics  List and describe the results for baseline characteristics that are key to understanding and applying the study; this section should provide the audience with a clear picture of who was enrolled in the study. Differences between groups should be made clear.
Primary Endpoint  Provide results for the primary endpoint including measures of statistical significance (e.g., 95% confidence intervals, p-values).
Secondary Endpoints  Provide results for the primary endpoint including measures of statistical significance (e.g., 95% confidence intervals, p-values); highlight key results. NOTE: All statistically significant results are not necessarily key results and vice versa.
Safety Endpoints  Provide results for the primary endpoint including measures of statistical significance (e.g., 95% confidence intervals, p-values) when applicable; highlight key results. NOTE: All statistically significant results are not necessarily key results and vice versa.
AUTHORS’ CONCLUSIONS
Paraphrase the authors’ conclusion as well as key information from the discussion section.
GENERALIZABILITY/CRITIQUE/DISCUSSION
Journal/Authors  Is the journal directly related to the topic? Is it well-respected? What is the impact factor? Does the impact factor matter when interpreting the study results?
 Do the authors have sufficient expertise the subject area? Are the authors well-published? Are the contents of the article objective? Is there evidence of bias on the part of the authors?
Patient Population  Are the inclusion/exclusion criteria reflective of the study objective? Are the inclusion/exclusion criteria appropriate considering the phase of drug development? Were a reasonable portion of screened patients randomized into the study? Do the baseline characteristics reflect the population in which the intervention would be used in practice? Was the randomization scheme successful? Were there differences between groups that could influence the results of the study? What additional information would help describe the patient population?
Design/Intervention  Was the appropriate study type used considering previous work that has been done on the topic, ethical considerations, and study objective? Were appropriate safeguards (e.g., blinding, control, multiple sites) used to protect from bias? Were appropriate safeguards (e.g., randomization, ratio of patients in active group to control group) used to protect from confounding variables?
 Was the dosing, frequency, administration, etc. of the study and control intervention(s) appropriate? Was the control method (e.g., placebo, active) ethical considering available options? Did the control strategy accurately represent standard clinical practice? Did the monitoring plan protect patient safety? Are the intervention and monitoring plan reasonable to implement clinically?
Statistics  Were the statistical tests appropriate for the data being analyzed? Did the power calculation make sense? Was rationale provided for the effect size? Was the study adequately powered? Did it matter if the study was adequately powered? Was the appropriate population (e.g., per protocol, intention to treat) analyzed? Were the results presented appropriately? Was there evidence of bias in the statistical analysis?
Endpoints/Results  Were results provided for all stated endpoints? Was the primary endpoint appropriate considering the disease state and drug class? Was the primary endpoint/secondary endpoints appropriate considering the phase of drug development (i.e., consider whether it was surrogate or clinical). What additional endpoints would have been beneficial for evaluating the intervention? Were the endpoints objectively evaluable? Was the safety analysis comprehensive, considering the phase of drug development?
 Were the results statistically significant? Were the results clinically significant considering the intended patient population? What was the number needed to treat? What was the number needed to harm? Do these values affect our interpretation of the study? Were the safety results complete? Do the safety results suggest important considerations? Did the benefits in terms of efficacy outweigh the risks in terms of safety?
OVERALL STUDY EVALUATION
Strengths  List key overall strengths that you identified; these most likely have already been addressed in the handout; during the presentation, if you find that your opinion changes during discussion or that the group discussion goes in an unanticipated direction, incorporate that information.
Limitations  List key overall limitations that you identified; these most likely have already been addressed in the handout; during the presentation, if you find that your opinion changes during discussion or that the group discussion goes in an unanticipated direction, incorporate that information.
Clinical Impact  Considering your interpretation of the study, discuss 1) how you would apply study results to your case and 2) your ultimate recommendation for the patient. If you find that your opinion changes during discussion or that the group discussion goes in an unanticipated direction, incorporate that information.
LEADERS’ CONCLUSION
Describe your overall conclusion after reading the article; this should be in your own words and distinct from the authors’ conclusion. Provide your conclusion to the group, potentially modified based on the discussion. If there were divergent opinions, be sure to address both the majority and minority views.
REFERENCES
1. Cite the handout in MUCOP style as you would a written paper. 2. Provide a list of all cited sources.
AUTHORSHIP
Name, PharmD Student