Step 1. Critical:  all else depends on your finding a Randomized Controlled (Clinical) Trial Peer-Reviewed Journal Article (Level II Evidence)  Review Figure 1.1,~ p. 13 of your textbook for the Level of Evidence Pyramid, which shows an RCT is at Level II. When you communicate with physicians about an article, they respect the article more when it is at least on the Level II evidence pyramid, which suggests more credibility and possibly better input regarding outcomes of care.  Find your peer-reviewed Randomized Controlled Trial (RCT) article related to your area of interest.  

Step 2.  Once you have your article, read it, and then look at the CONSORT Checklist, and write the page number in the article that has the information the checklist requires. (FYI, researchers who publish their research use this checklist to be sure they have everything in their article, or it is often not accepted by premier scholarly publishers). The checklist is worth 25 points, as it takes time and discernment to do it correctly.


Step 3:  Once your fill out the CONSORT CHECKLIST (25 points), you must then write a formal summary of the Analysis of Strengths and Weaknesses (worth 8 points) that you will notice is on the CONSORT checklist. The following steps are to assist you in distilling the specifics for what is required in the Analysis of Strengths and Weaknesses for the CONSORT checklist. .

Step 4  Specifics of the ANALYSIS OF STRENGTHS AND WEAKNESSES.  Review ~p. 9 of your research textbook, and then note how to write

  1. Introduction  (1 point)

                   + Purpose of the RCT (discuss)

  1. Overall Strengths and Weaknesses  (1 point) 

                  +  Research Design (Discuss)

                  +  Important Findings

  1. Reliability and Validity  (2 points) (Check the

     methods, instruments, measurements or

     procedures sections of article); statistics; Level of Evidence and

     implications; cause-effect measurement; any threats to internal

     or external validity

  1. Ethics (1 point)

                  +  IRB? +Conflict of Interest +Informed Consent Signed

  1. Topic/Summary  (2 points)

                 + Implications

                 + Limitations

                 + Recommendation(s)

Step 5  Proofread, check for accuracy of information, grammar, and proper use of APA guidelines (worth 1 point)

Step 6:  Now look at the exemplar for the CHECKLIST and Analysis of Strengths of Weaknesses. 

Step 7: Calculate your grade: 25 possible points for CONSORT CHECKLIST being accurate and 8 points for Analysis of Strengths and

Weaknesses = 33 possibles

CONSORT 2010 checklist of information to include when reporting a randomised trial*

Section/TopicItem NoChecklist itemReported on page No
Title and abstract
 1aIdentification as a randomised trial in the title 
1bStructured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 
Background and objectives2aScientific background and explanation of rationale 
2bSpecific objectives or hypotheses 
Trial design3aDescription of trial design (such as parallel, factorial) including allocation ratio 
3bImportant changes to methods after trial commencement (such as eligibility criteria), with reasons 
Participants4aEligibility criteria for participants 
4bSettings and locations where the data were collected 
Interventions5The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 
Outcomes6aCompletely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 
6bAny changes to trial outcomes after the trial commenced, with reasons 
Sample size7aHow sample size was determined 
7bWhen applicable, explanation of any interim analyses and stopping guidelines 
 Sequence generation8aMethod used to generate the random allocation sequence 
8bType of randomisation; details of any restriction (such as blocking and block size) 
 Allocation concealment mechanism9Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 
 Implementation10Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 
Blinding11aIf done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 
11bIf relevant, description of the similarity of interventions 
Statistical methods12aStatistical methods used to compare groups for primary and secondary outcomes 
12bMethods for additional analyses, such as subgroup analyses and adjusted analyses 
Participant flow (a diagram is strongly recommended)13aFor each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome 
13bFor each group, losses and exclusions after randomisation, together with reasons 
Recruitment14a follow-up 
14bWhy the trial ended or was stopped 
Baseline data15A table showing baseline demographic and clinical characteristics for each group 
Numbers analysed16For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 
Outcomes and estimation17aFor each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 
17bFor binary outcomes, presentation of both absolute and relative effect sizes is recommended 
Ancillary analyses18Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 
Harms19All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) 
Limitations20Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses 
Generalisability21Generalisability (external validity, applicability) of the trial findings 
Interpretation22Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 
Other information 
Registration23Registration number and name of trial registry 
Protocol24Where the full trial protocol can be accessed, if available 
Funding25Sources of funding and other support (such as supply of drugs), role of funders 


*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see

Application of the CONSORT Statement to a Randomized Trial of Low-Dose Aspirin in Preventing Cardiovascular Disease in Women



Exemplar of CONSORT Assignment

Analysis of Strengths and Weaknesses


     The following analysis relates to the article by Ridker, Cook, Lee, Gordon, Gaziano, Manson, Hennekens, Buring (2005). The purpose of this Randomized Clinical Trial (RCT) was to determine if low-dose aspirin should be recommended as a strategy for prevention of cardiovascular disease for women age 45 or greater.

 Overall Strengths and Weaknesses

     There was a decrease in Cardiovascular events for women who received the aspirin as compared to women who received the placebo.  In addition, the ischemic stroke risk decreased by 30%.  The method of randomization was unclear, as well as the method for blinding (Author, 2016).

Reliability and Validity

     The statistics used compared aspirin and placebo groups using the Relative Risk, P values, cumulative incidence rates, and 95% confidence intervals. There was no explanation of how the authors selected these methods in terms of time, e.g. pre-specified or commencement after the initiation of the trial (Author, 2018). This is a Level II trial, which is at a higher level of evidence if the researchers follow the protocols for a Level II trial, and overall these researchers did.  The RCT had randomization, intervention and control groups, as well as manipulation of the independent variable, which provides strength in studying the cause-effect relationship.  Following these Level II design requirements reduces the threats to internal and external validity LoBiondo-Wood & Haber, 2018).


      The Institutional Review Board did monitor the study, and informed consent was signed by those participating as subjects in this study   .

Topic, Summary

     This is an important topic and the need to determine whether low-dose aspirin should be utilized needs to be analyzed.  Since this study was completed in 2005, much new information is available that renders the findings of this study lacking for generalization of the clinical applications to women in this age group.


American Psychological Association. (2009). Publication manual of the American

       Psychological Association (6th ed.). Washington, DC: Author.

Author, (n.d.) Application of CONSORT statement for a randomized trial of low-dose aspirin in

preventing cardiovascular disease in women. (Unpublished Doctoral Assignment). School

LoBiondo-Wood, G. & Haber, J. (2018). Nursing research:  Methods and critical appraisal for

       evidence-based practice. St. Louis, MO:  Elsevier.

Ridker, P.M., Cook, N.R., Lee, I., Gordon, D., Gazianao, J.M., Manson, J.E.,. . . Buring, J.E. 

       (2005).  A randomized trial of low-dose aspirin in the primary prevention of cardiovascular

       disease in women.  New England Journal of Medicine, 352(13), 1293-1304. Doi:


Note: CONSORT Checklist was completed for this Exemplar