PHA 335 - Journal Club L4

What is the purpose of literature evaluation?

To critically evaluate clinical research for patient care

From what perspective is literature evaluation conducted?

From a clinician’s perspective

Why is literature evaluation important?

To evaluate study design, methods, statistical analysis, interpret results, and identify bias

What are the three main goals of literature evaluation?

Evaluate study design and methods; Interpret results for patient care; Identify bias

What are the nine questions for critical appraisal?

Clinical relevance; Study design; Recruitment/selection; Methods; Endpoints; Statistics; Results; Limitations; Application to practice

What should be assessed to determine clinical relevance?

Disease state overview, standard of care, and prior literature

What should you look at for standard of care?

Clinical practice guidelines

What details should you know about interventions?

Mechanism of action; dosing; safety; pharmacokinetics

Why is the research question important?

It identifies the gap in literature and relevance to patient care

What information is evaluated in study design?

Study name; authors; journal; date; population; design; interventions; endpoints; statistical analysis

What types of study designs should you recognize?

RCT; cohort; case-control; cross-sectional; meta-analysis

What additional study design details are important?

Study duration and follow-up intervals

What is evaluated in recruitment and selection?

Inclusion and exclusion criteria

What are inclusion criteria?

Who is allowed in the study

What are exclusion criteria?

Who is NOT allowed in the study

What is evaluated in study methods?

Randomization; patient flow; dropouts; baseline demographics; intervention details

Why are baseline demographics important?

To ensure no significant differences between groups

What is the goal of proper methods?

To eliminate bias and confounders

What intervention details should be included?

Drug; dose; route; frequency OR program length and content

What are endpoints?

Outcomes measured in a study

What are primary endpoints?

Outcomes the study is powered to detect differences in

What are secondary endpoints?

Additional outcomes not primarily powered

What are efficacy endpoints?

Benefits of the intervention

What are safety endpoints?

Adverse effects of the intervention

What is evaluated in statistical analysis?

Sample size; study design; statistical tests; ITT vs PP

What is a superiority study?

Shows one treatment is better than another

What is a non-inferiority study?

Shows a treatment is not worse than another

What is intent-to-treat (ITT)?

Includes all enrolled patients who received at least one dose

What does ITT reflect?

Real-world conditions

What is per-protocol (PP)?

Includes only patients who followed the study protocol

What does PP reflect?

Ideal conditions of treatment

What are key research findings?

Primary results; secondary results; subgroup analysis; author conclusions

Which results are most important?

Primary results

Why are primary results most important?

The study is powered to detect these differences

What should you always assess in results?

Both efficacy and safety

What should be evaluated in study limitations?

Strengths and limitations of methods

What should limitations focus on?

Methods, NOT results

What is evaluated in application to practice?

How findings can be used in patient care

What is a journal club?

An activity to evaluate medical literature for clinical applicability

What is the goal of a journal club?

Determine if research applies to clinical practice

What should be included in the introduction section of a research evaluation?

Article title; citation; study purpose; background; funding source

What should NOT be done in the background section?

Do not summarize the article; do your own research

Where can funding source be found?

Beginning or end of the article

What should be included in the methods section?

Study design; patients; intervention; outcomes; statistical analysis

What should be included for study patients?

Inclusion and exclusion criteria

What should be included for interventions?

Dose; route; frequency OR program details

What should be included for outcomes?

Dependent variables

What should be included for statistics?

Statistical tests; sample size; power; alpha/beta

What should be included in the results section?

Patient characteristics; outcomes; safety data

What characteristics should be reported?

Age; gender; race; medications; disease history

What should be included in outcome summary?

What researchers found

What should be included in safety?

Adverse effects (if reported)

What should be included in conclusions?

Author conclusions; student conclusions; strengths; limitations

What should student conclusions include?

Your thoughts and interpretation

What should strengths and limitations focus on?

Study design and methods

What are limitations not mentioned?

Additional weaknesses not identified by authors

What is the goal of the evaluation template?

To tell the full story of the research without needing the article

What should be minimized in the template?

Copy and paste

What should be considered when writing?

Your audience and their knowledge level