CONSORT 2010 checklist of information to include when reporting a randomised trial* Section/Topic Item No Checklist item Reported on page No Title and abstract 1a 1b Identification as a randomised trial in the title Structured summary of trial design, methods, results, and conclusions 2a 2b Scientific background and explanation of rationale Specific objectives or hypotheses Interventions 3a 3b 4a 4b 5 Outcomes 6a Sample size 6b 7a 7b Description of trial design (such as parallel, factorial) including allocation ratio Important changes to methods after trial commencement (such as eligibility criteria), with reasons Eligibility criteria for participants Settings and locations where the data were collected The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Any changes to trial outcomes after the trial commenced, with reasons How sample size was determined When applicable, explanation of any interim analyses and stopping guidelines Introduction Background and objectives Methods Trial design Participants Randomisation: Sequence generation Allocation concealment mechanism Implementation 8a 8b 9 Method used to generate the random allocation sequence Type of randomisation; details of any restriction (such as blocking and block size) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how If relevant, description of the similarity of interventions Statistical methods used to compare groups for primary and secondary outcomes Methods for additional analyses, such as subgroup analyses and adjusted analyses Blinding 11a Statistical methods 11b 12a 12b CONSORT 2010 checklist (for specific guidance see CONSORT for abstracts) Page 1 Results Participant flow (a diagram is strongly recommended) Recruitment Ancillary analyses 17b 18 Harms 19 For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome For each group, losses and exclusions after randomisation, together with reasons follow-up Why the trial ended or was stopped A table showing baseline demographic and clinical characteristics for each group For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) Discussion Limitations Generalisability Interpretation 20 21 22 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Generalisability (external validity, applicability) of the trial findings Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence Other information Registration Protocol Funding 23 24 25 Registration number and name of trial registry Where the full trial protocol can be accessed, if available Sources of funding and other support (such as supply of drugs), role of funders Baseline data Numbers analysed Outcomes and estimation 13a 13b 14a 14b 15 16 17a *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 www.consort-statement.org. CONSORT 2010 checklist Page 2 Running head: CONSORT OF RANDOMIZED CLINICAL TRIAL Application of the CONSORT Statement to a Randomized Trial of Low-Dose Aspirin in Preventing Cardiovascular Disease in Women Author School Exemplar of CONSORT Assignment 1 CONSORT STATEMENT AND ASPIRIN AS PRIMARY PREVENTION 2 Analysis of Strengths and Weaknesses Introduction 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). CONSORT STATEMENT AND ASPIRIN AS PRIMARY PREVENTION 3 Ethics 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. CONSORT STATEMENT AND ASPIRIN AS PRIMARY PREVENTION 4 References 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: 10.1956/nejmoa050613. Note: CONSORT Checklist was completed for this Exemplar NUR400 CONSORT ASSIGNMENT DETAILS Directions for your CONSORT assignment (follow along with the CONSORT rubric as you read the following steps): 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. If you are not sure of how to find articles using our DCN Databases,do the following: a. Go to the DCN Home Page b. Notice that there are 3 columns and 3 rows, each with a green heading category. Go to the second row, first column, and click on Databases. Once your see the top heading, Database Access, look below and see “For DCN Students: Database Use Tutorial (MP4 Recording). Study the tutorial, and it will assist you in finding a Randomized Controlled (Clinical) Trial article c. If you need further assistance with finding an article after you review the tutorial, email Mr. Madsen, Director of the LRC. He has a Masters of Library Services degree, and can assist you in finding articles that you may not be able to access. If you find an article that charges a fee, e-mail Mr. Madsen the article you need, and he can usually get the full text article for you at no charge. His email address is LMadsen@denvercollegeofnursing.edu. 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 a. Introduction (1 point) + Purpose of the RCT (discuss) b. Overall Strengths and Weaknesses (1 point) + Research Design (Discuss) + Important Findings c. 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 d. Ethics (1 point) + IRB? +Conflict of Interest +Informed Consent Signed e. 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 possible points FURTHER QUESTIONS: Please do not hesitate to contact me or arrange a ZOOM Office Hour time period to answer any questions regarding your CONSORT work. Dr. Bator 225-907-5147 NUR400 Rubric for Summary of Strengths and Weaknesses for CONSORT assignment (The checklist is worth 25 points + the rubric below equals a total of 33 points) Metrics: Schematic Criteria CONSORT Rubric Analysis (Checklist) Overall analysis of strengths and weaknesses of the study, e.g., reliability and validity, ethics (IRB), topic, etc. (7 points) APA Citation, grammar, spelling is either 1 or 0 points Total points: add columns 14=_/33 Excellent Needs some improvement Needs significant improvement Poor CONSORT checklist correct (18-25 points) CONSORT checklist with a few errors (12-17 points) CONSORT Checklist CONSORT checklist (6-11 points) Somewhat identifies the strengths and weaknesses of the study. (5 points) Identifies to a limited degree the study findings. (0-5 points) Slightly or does not identify the study findings. (3 points) (0-2 points) Correct Incorrect Incorrect Incorrect (1 point) (0 points) (0 points) (0 points) _________points _________points _________points _________points Clearly identifies the strengths and weaknesses of the study. (7 points) Level 1 Systematic review or meta-analysis of randomized controlled trials (RCTS) Level II Randomized controlled trials Level III Quasiexperimental studies Level IV Nonexperimental studies Level V Metasynthesis Level VI Qualitative studies Level VII Opinion of experts and authorities, expert committee reports or organizations, not based on research
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