Competency A: What is the scientific and clinical context of the study?

Subcompetency

Justification

Data Requirement

1. What is the disease or problem being studied?

Requires definition of the disease or problem under study

a. definition of disease or problem

2. What is the importance of the disease or problem being studied?

What are the clinical implications of this disease or problem?

a. i. mortality and ii. morbidity of this disease 

A disease or problem that affects many new people each year is more important

b. incidence in different racial, gender, socioeconomic groups

The prevelance of a disease or problem speaks to its ongoing burden, and consequently its importance

c. prevalence in different racial, gender, socioeconomic groups

The socioeconomic impact of the disease under study is important for policy decisions

d. monetary cost of treating this disease

3. What is the postulated pathophysiology or etiology of the problem?

Pathophysiologic context for interpretation of mechanism and efficacy

a. disease hypotheses

Is the hypothesized effect biologically plausible?

b. postulated mechanism behind each hypothesis 

Supporting evidence, especially from humans, helps to evaluate the truth of the hypotheses

c. i. animal and ii. human study evidence behind each hypothesis

4. What was the authors' statement of clinical application?

The authors' clinical recommendation is the one that many readers key in on

a. authors' statement of clinical application

5. Is there post-trial follow-up (e.g. post-marketing studies) available?

Long-term follow-up data after official trial close-out is important for detecting rare events

a. post-marketing studies

Competency B: What is the scientific discourse on the study question?

Subcompetency

Justification

Data Requirement

1. In what venues was this trial information disseminated?

Different publishing sources espouse different peer review standards and may promote particular biases (e.g. commercial or specialty biases)

a.trial publications i. title, ii. journal, iii. volume, iv. no, v. pages, vi. year, vii. peer-review status

Reflects upcoming trends, research questions, etc.

Trials that are ongoing may resolve outstanding questions

b. ongoing related trials

Other relevant completed studies are part of the scientific context

c. other primary and secondary research in the literature

General commentary on the study question provides additional context.

d. editorials, other commentary on study question

3. How have the results of this study been synthesized with other evidence?

Best approach to finding the scientific context of the trial

a. systematic reviews that include this trial

Formal frameworks for incorporating costs, societal tradeoffs, and patient preferences into interpretation of trial results

b. decision analyses/cost-effectiveness analyses that include this trial

Synthesizes information from trial into action for clinicians

c. practice guidelines that include this trial

Reflects non-systematic, and therefore possibly biased, commentary on related subjects

d. non-systematic reviews that cite this trial

4. What is the commentary on this trial?

Reflects opinions of peers

a. letters to the editor

Reflects opinions of anointed, usually expert, commentator

Reflects opinions of others in addition to above

c. consumer articles, press releases, bulletin boards, discussion groups that cite this trial

Competency C: What is the social, economic, and ethical context of this study?

Subcompetency

Justification

Data Requirement

1. Was the trial conducted ethically?

Human Subjects Committees (i.e., Institutional Review Boards) are a committee of peers charged with ensuring human rights compliance of study design

a. whether Human Subjects Committee approval i. sought, and ii. granted

By Geneva human-rights convention, subjects must be informed of risks of study, and must give informed consent

b. whether informed consent obtained from all subjects

Method may reveal undue pressuring of subjects to give informed consent

c. method for obtaining informed consent

Patient data collected in course of trial should be kept confidential and non-identifiable

d. method for protecting patient confidentiality

The presence of subject representatives on a study monitoring committee increases likelihood of the trial conduct being sensitive to patient concerns

e. whether subject representatives participated in study monitoring committee

2. Is this trial a pivotal trial for product approval?

Pivotal trials provide critical support for bringing intervention to market

a. FDA filings including this trial

3. Was the publication of the study influenced by outside events?

Outside motives for releasing data, e.g. stock price, may introduce bias

a. why study published when it was

Events around time of publication may have influenced reporting

b. submission and publication date