Sandbox: landmarktrial template

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WikiDoc Landmark Trials

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]Associate Editor(s)-in-Chief: Yazan Daaboul, M.D.; Maria Fernanda Villarreal, M.D. [2]; Haytham Allaham, M.D. [3]

The following is a guide to create your WikiDoc landmark trial page. A landmark 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.

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.
  • Report format:
    • [Insert header title of the study]

Study Acronym

  • This section should include the study acronym. It may be not necessarily be the initials letters of 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".
  • To view a template and example of study acronym, click here.
  • Report format:
    • [Insert trial acronym/if there is no acronym, go to next section]

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 example of the principal Investigator, co-investigators, and collaborating institutions statement, click here.
  • Report format:
    • [Insert sub-header: Insert first author(s)/ study group]

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.
  • Report format:
    • In [population of study], [intervention 1] improved/declined/remain equal [primary outcome] compared to [intervention 2] in [period of time] and [follow-up].
    • The [year] [insert acronym] study was a [multi-center/single-center], randomized trial designed to investigate whether [intervention 1] was associated with a difference in the rate of [outcome/adverse effects]. The primary outcome was defined as [insert definition here] and were adjudicated by a committee [aware/unaware] of randomization. A total of [# total randomized] patients were studied. Major complications related to the intervention were [insert complication1], [insert complication2]. The investigators conclude that a [intervention 1] reduces/increases the risk/presence of [outcome 1].
    • [Insert methods and conclusion from abstract here].

Disease State(s) Studied

  • This section should include all the major diseases studied in the trial. It should include primary and secondary outcome diseases.
  • To view a template and example of disease state(s) studied statement, click here.
  • Report format: (list format)
    • [Insert disease studied 1(primary outcome)]
    • [Insert disease studied 2(primary outcome)]
    • [Insert disease studied 3(secondary outcome)]
    • [Insert disease studied 4(secondary outcome)]

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 (# of arms), 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.
  • Report format:
    • Setting: [Insert Multi-center/Single-center]
    • Type of blinding: [Insert single-blind, double-blind, open-label or unblinded]
    • Design: [Insert Multi-center/Single-center] # parallel arms, cross-over, factorial, delayed-start, or not mentioned]
    • Sample size: [Insert total number of randomized patients]

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, also known as "COA's" (clinical outcome visits)
  • To view a template and example of study duration and time-points, click here.
  • Report format:
    • Participant enrollment: [# of years, months, days]
    • Study Start Date: [Insert the year]
    • Follow-up:[Insert follow-up time]
    • Study visits: [Insert # visits, outcome assessment, time-points]

Interventions

  • This section should include all the treatment arms studied in the trial. It should include both active comparator and experimental arms.
  • To view a template and example of interventions statement, click here.
  • Report format:
    • Number of arms: [Insert number of arms]
    • Experimental: [Insert number of experimental arms]
    • Active Comparator/ Standard treatment: [Insert number of active control/standard treatment arms]

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 (for eg. 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.
  • Report Format:
    • [Insert measurement unit(s) used]
    • [Setting and measurement method]
    • [Type of measurement(automated)(manual)]

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 outcomes, also called "composite endpoint".
  • This section should not include any statistical report.
  • To view a template and example of the primary endpoint, click here.
  • Report Format:
    • [Insert primary endpoint/primary outcome scale]

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.
  • Report Format:
    • [Insert secondary endpoint/secondary outcome scale]

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.
  • Report Format:
    • [Inclusion criterion 1 ]
    • [Inclusion criterion 2 ]
    • [Inclusion criterion 3 ]
    • [Inclusion criterion +4 ]

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.
  • Report Format:
    • [Exclusion criterion 1 ]
    • [Exclusion criterion 2 ]
    • [Exclusion criterion 3 ]
    • [Exclusion criterion +4 ]

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 (in accordance 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 (in accordance 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: secondary endpoint, click here.
  • Report format:
    • [XX% vs. XX% (RR,HR,OR,SMD ; P value; NNT)]

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 (in accordance 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.
  • Report format:
    • [XX% vs. XX% (RR,HR,OR,SMD ; P value; NNT)]

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 (in accordance 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 (in accordance 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: safety endpoints, click here.
  • Report format:
    • [XX% vs. XX% (RR,HR,OR,SMD ; P value; NNT)]

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.
  • Report format:
    • XX% power to detect a XX% effect with respect to the primary outcome
    • Statistical test (T-test, MANCOVA, ANOVA, linear regression, chi-square test, Pearson's correlation, etc)
    • X% level of significance
    • Analysis: [intention-to-treat/Per-protocol]

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.
  • To view a template and example of the conclusions, click here.
  • Report format:
    • In conclusion, intervention 1 (active) is superior/inferior/no difference than intervention 2(control) to reduce/increase/no difference primary outcome.
    • Positive/Negative for primary endpoint

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.
  • Report format:
    • The limitations in the [insert acronym name here] trial were the following: [limitation1], [limitation2], [limitation3], and [limitation4]

Commentary

Associate Editor(s)-in-Chief: [Your initials here]

  • In this section, you should add your personal comments about the study.
  • To view a template and example of the commentary, click here.

Slides

  • In this section, attach the powerpoint slides corresponding to the trial.
  • Click [Insert WikiDoc Link with images here] to download slides from the WikiDoc journal club on the [Acronym/name] trial.

Video Commentary

  • Attach YouTube video (if available) with the study commentary and discussion.

External sites for further information

References

Template:WH

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