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WikiDoc Landmark trials
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]Associate Editor(s)-in-Chief: Maria Fernanda Villarreal, M.D. [2]
The following is a guide to creating your WikiDoc Journal Landmark Trial page. A trial page is a collection of all the the information on the article and a detailed breakdown of the study. For instance, each study is composed of different CONSORT checklist items, such as trial design, interventions, outcomes, randomization, statistical methods, limitations, etc. These pages will allow users to access the content they are looking for more efficiently, allows ease in navigating their study of interest, and maintains completeness and consistency of WikiDoc pages. The templates listed below contain standardized language that will assist you in creating and editing your pages. Before getting started, it is important to get acclimated, and to learn some of the basics about formatting. Here is a checklist of things to do before creating your page:
Complete Title of Study
- This section is the general title for the study. It should include the complete name of the study in the first sentence.
- This section should not include the study acronym.
Study Acronym
- This section should include the study acronym. It may be not necessarily be the initials letters on the heading name.
- For example, RALES- "Randomized ALdactone Evaluation Study for congestive heart failure"
- The complete title for this study was "The effect of spironolactone on morbidity and mortality in patients with severe heart failure"
Principal Investigator, Co-investigators, and Collaborating Institutions
- This section should include principal investigator, co-investigators, and collaborating institutions.
- This section should not include funding sources.
- To view a template and examples of the principal Investigator, co-investigators, and collaborating institutions statement, click here.
Overview
- This section is the general overview statement for the trial. It should include the study acronym name in the first sentence.
- This section will be an overview statement of all the overview statements below it.
- To view a template and examples of trial page overview statement, click here.
Disease State(s) Studied
- This section should include all the major diseases studied in the trial. It should include primary outcome diseases.
- To view a template and example of Disease State(s) Studied statement, click here.
Study Design
- Setting: Multicenter/Single center (if available, include # of sites and countries)
- Type of blinding: Single-blind, Double-blind, Open-label (or unblinded)
- Design: Parallel arms (2,3, or 4), cross-over, factorial, delayed-start, or other.
- Sample size: Include the total number of randomized patients. You can find this information in the CONSORT flow-chart, abstract or study methods section in the study.
- To view a template and example of study design statement, click here.
Study Duration and Time-points
This section should contain the total study duration in the first sentence.
- Participant enrollment: Description of the total of years used for participant enrollment. You can find this information with the "NCT" number (normally localized in the abstract of the study).
- Study Start Date: Study start date, usually located with "NCT" number (normally localized in the abstract of the study).
- Follow-up: Total years accumulated for follow up. In this section it is also important to include the stoppage criteria (and the reasons why?), if available.
- Study visits: Study visits represent the time-points where the primary outcome is assessed.
- To view a template and example of study design statement, click here.
Interventions
- This section should include all the treatment arms studied in the trial. It should include both active comparator and experimental arms.
- Number of arms: [Insert number of treatment arms]
- Experimental: [Insert number of experimental arms]
- Active Comparator/ Standard treatment: [Insert number of active control/standard treatment arms]
- To view a template and example of interventions statement, click here.
Study Measures
- This section should include study measures used in the trial. Measures are the items in a research study to which the participant responds. For example, if the outcome measurement is cholesterol levels - Total cholesterol. This will be measured in milligrams per deciliter of blood (mg/dL).
- The next question should be; how often we check for the cholesterol levels? This will correspond to outcome assessment visits (COA's)
- To view a template and example of study measures, click here.
Primary Endpoint
- This section describes the primary endpoint of a clinical trial. The primary endpoint is the reason of which subjects are randomized and for which the trial is powered.
- The primary endpoint can be more than 2 or 3, also called "composite endpoint"
- This section should not include any statistical report.
- To view a template and example of the primary endpoint, click here.
Secondary Endpoints
- This section describes the secondary endpoint of a clinical trial. Secondary endpoints are endpoints that are analyzed posthoc, for which the trial may not be powered nor randomized.
- The secondary endpoint can be more than 5 different outcomes, it is important to include them all.
- This section should not include any statistical report.
- To view a template and example of the secondary endpoint, click here.
Inclusion Criteria
- This section describes the inclusion criteria, which are characteristics that the prospective subjects must have if they are to be included in the study.
- To view a template and example of the inclusion criteria, click here.
Exclusion Criteria
- This section describes the exclusion criteria, which are characteristics that disqualify subjects to be included in the study.
- To view a template and example of the exclusion criteria, click here.
Outcome: Primary Endpoint
- This section should describe the primary endpoint outcome results, which are a comparison between experimental and control arms in the study. This section should include the statistical report (accordingly to the statistical test used)
- You can find this information under the primary and secondary outcome report.
- Report format: XX% vs. XX% (RR,HR,OR,SMD ; P value; NNT)
- To view a template and example of the outcome: primary endpoint, click here.
Outcome: Secondary Endpoint
- This section should describe the secondary endpoint endpoint outcome results, which are a comparison between experimental and control arms in the study. This section should include the statistical report(accordingly to the statistical test used)
- You can find this information under the primary and secondary outcome report.
- Report format: XX% vs. XX% (RR,HR,OR,SMD ; P value; NNT)
- To view a template and example of the outcome: secondary endpoint, click here.
Outcome: Exploratory Endpoints
- This section should describe the exploratory endpoints outcome results, which are a comparison between experimental and control arms in the study. This section should include the statistical report (accordingly to the statistical test used)
- You can find this information under the primary and secondary outcome report.
- To view a template and example of the outcome: exploratory endpoint, click here.
Subgroup analysis
- This section should describe the subgroup analysis, which are a comparison between experimental and control arms in the study. This section should include the statistical report (accordingly to the statistical test used)
- You can find this information under the primary and secondary outcome report.
- To view a template and example of the subgroup analysis, click here.
Outcome: Safety endpoints
- This section should describe the safety endpoint outcome results, which are a comparison between experimental and control arms in the study. This section should include the statistical report (accordingly to the statistical test used)
- You can find this information under the primary and secondary outcome report.
- Report format: XX% vs. XX% (RR,HR,OR,SMD; P value; NNH)
- To view a template and example of the outcome: safety endpoints, click here.
Statistical Methods
- This section describes the statistical methods of a clinical trial. Statistical models are usable for assessing the effect of interventions on one or more dependent variables. This section should include; sample size calculation (if available), statistical test used, descriptive statistics, power and effect size.
- XX% power to detect a XX% effect with respect to the primary outcome
- Statistical test (T-test, MANCOVA, ANOVA, linear regression,chi squared, correlation, etc)
- X% level of significance
- Analysis: Intention-to-treat/Per-protocol
- To view a template and example of statistical methods, click here.
Conclusions
- This section describes the conclusion of a clinical trial. Secondary endpoints are endpoints that are analyzed posthoc, for which the trial may not be powered nor randomized.
- In conclusion, Intervention 1 (active) is superior/lower/no difference than Intervention 2(control) to reduce/increase/no difference primary outcome.
- Positive/Negative for primary endpoint
- To view a template and example of the conclusions, click here.
Discussion and Limitations of the Trial
- This section describes discussion, limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses.
- To view a template and example of the discussion and limitations of the trial, click here.
Commentary
Associate Editor(s)-in-Chief: [Your initials here]
- This section should be your personal comments about the study.
- To view a template and example of the commentary, click here.
Slides
Click [Insert WikiDoc Link with images here] to download slides from the WikiDoc journal club on the [Acronym/name] trial.
Video Commentary
External sites for further information
References
BREAKDOWN
Complete Title of Study
A randomized trial of intensive versus standard blood-pressure control
Study Acronym
SPRINT
Principal Investigator, Co-investigators, and Collaborating Institutions
Principal Investigator: The SPRINT Research Group
Overview
In patients at high risk for CVD but who do not have a history of stroke or diabetes, intensive BP control (target SBP <120 mm Hg) improved CV outcomes and overall survival compared to standard therapy (target SBP 135-139 mm Hg), while modestly increasing the risk of some serious adverse events.
Disease State(s) Studied
- Cardiovascular diseases
- Hypertension
- Acute coronary disease
- Heart failure
- Stroke
- Chronic kidney disease
Study Design
- Setting: Multicenter (102 sites in the US and Puerto Rico)
- Design: Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study.
- N=9,361 patients without diabetes or stroke at elevated CV risk
Study Duration and Time-points
- Participant enrollment: 2010-2013
- Study Start Date: October 2010
- Median follow-up: 3.26 years (stopped prematurely; goal 5 years)
- Study visits: Participants were seen monthly for the first 3 months and every 3 months
Interventions
- Experimental: Intensive, target SBP <120 mm Hg (n=4,678)
- Active Comparator: Standard, target SBP 135-139 mm Hg (n=4,683)
Study Measures
- Blood pressure measurement(mmHg)
- Office visit while the patient was seated and after 5 minutes of quiet rest
- The measurements were made with the use of an automated measurement system (Model 907, Omron Healthcare)
Primary Endpoint
- First occurrence of MI, ACS, stroke, HF, or CV mortality
Secondary Endpoints
- MI
- ACS without MI
- Stroke
- HF
- CV mortality
- All-cause mortality
- Composite of primary outcome or all-cause mortality
- Of those with CKD at baseline
- ≥50% reduction in GFR, long-term HD, or renal transplant
- ≥50% reduction in GFR
- Long-term HD
- New albuminuria
- Of those without CKD at baseline
- ≥30% reduction in GFR to <60 mL/min/1.73 m2
- New albuminuria
Inclusion Criteria
Exclusion Criteria
Outcome: Primary Endpoint
XX% vs. XX% (RR,HR,OR,SMD ; P value; NNT)
Outcome: Secondary Endpoint
XX% vs. XX% (RR,HR,OR,SMD ; P value; NNT)
Outcome: Exploratory Endpoints
XX% vs. XX% (RR,HR,OR,SMD ; P value; NNH)
Subgroup Analysis
There was no significant/sinificant interaction for the primary outcome by variable1,variable2,variable3,variable4, and variable 5,
Outcome: Safety endpoints
- Serious adverse event (SAE)
XX% vs. XX% (RR,HR,OR,SMD ; P value; NNH)
Statistical Analysis
- XX power to detect a XX% effect with respect to the primary outcome. Sample size calculation add here.
- Statistical test used
- XX level of significance
- Analysis: Intention-to-treat/Per-protocol
Conclusions
- In conclusion, intervention 1 is superior/lower/no difference than intervention 2 to increase/reduce the primary outcome.
- Positive/Negative for primary endpoint
Discussion and Limitations of the Trial
Commentary
Associate Editor(s)-in-Chief: Template:Your Initials
Slides
Click [Add Link here] to download slides from the WikiDoc journal club on the [Trial acronym]