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==WikiDoc Landmark trials ==
{{CMG}}{{AE}}{{MV}}
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'''- "'''R'''andomized '''AL'''dactone '''E'''valuation '''S'''tudy 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==
{{AE}} [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 {{fontcolor|#FF0000|here}}] to download slides from the WikiDoc journal club on the [Acronym/name] trial.
==Video Commentary==
==External sites for further information==
* [http://wikijournalclub.org/wiki/SPRINT  Wiki Journal Club]
==References==
{{Reflist|2}}
[[Category:Clinical trials]]
{{WH}}
==BREAKDOWN==
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==Overview==
==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.  
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 ==
==Disease State(s) Studied ==


*Cardiovascular Diseases
*[[Cardiovascular diseases]]
*Hypertension
*[[Hypertension]]
*Coronary Disease
* Acute coronary disease
*Heart failure
*[[Heart failure]]
 
*[[Stroke]]
==Study Phase==
*[[Chronic kidney disease]]


==Study Design==
==Study Design==


Multicenter, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study.  
*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==
==Study Duration and Time-points==
2010-2013
 
*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==
==Interventions==
*Experimental: Intensive, target SBP <120 mm Hg (n=4,678)
*Experimental: Intensive, target SBP <120 mm Hg (n=4,678)
*Active Comparator: Standard, target SBP 135-139 mm Hg (n=4,683)
*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 ==
==Primary Endpoint ==
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==Inclusion Criteria==
==Inclusion Criteria==
* Age ≥50 years
 
* SBP (mmHg) in a range:
** 130-180 on ≤1 medication
** 130-170 on ≤2 medications
** 130-160 on ≤3 medications
** 130-150 on ≤4 medications
* ≥1 of the following CVD risk criteria:
** Clinical CVD (non-stroke):
*** Prior MI, PCI, CABG, CEA, or carotid stenting
*** Revascularized PAD
*** ACS ± EKG changes, EKG changes on a stress test, or ischemic findings on other cardiac imaging
*** ≥50% stenosis of coronary, carotid, or LE artery, or
*** AAA ≥5 cm
** Subclinical CVD:
*** Carotid artery calcium score ≥400 in prior 2 years
*** ABI ≤0.90 in prior 2 years, or
*** LVH on EKG, echocardiogram, or other imaging in prior 2 years
** CKD: eGFR 20-59 mL/min/1.73 m<sup>2</sup> on MDRD in prior 6 months
** Framingham estimated 10-year CVD risk ≥15% in prior 12 months
** Age ≥75 years


==Exclusion Criteria==
==Exclusion Criteria==
* DM
 
* Stroke
* Not on disease-appropriate antihypertensives (eg, beta blocker and recent MI)
* Secondary cause of hypertension
* If able to stand, 1 min standing SBP <110
* Proteinuria in any of the following ranges:
** ≥1g/day urine protein
** ≥600 mg/day urine albumin
** Spot protein:creatinine ≥1g protein/g creatinine
** Spot albumin:creatinine ≥600 mg/g creatinine
** Urine dipstick ≥2+ protein if none of the above are available
* Polycystic kidney disease
* Glomerulonephritis
* eGFR < 20 mL/min/1.73 m<sup>2</sup>
* CV event, procedure, or UA hospitalization in prior 3 months
* Symptomatic HF in prior 6 mo
* LVEF <35%
* Life-limiting illness
* Poor adherence
* Organ transplant
* Unintentional weight loss >10% in prior 6 months
* Pregnancy


==Outcome: Primary Endpoint==
==Outcome: Primary Endpoint==
; First ACS, stroke, HF, or CV death
XX% vs. XX% (RR,HR,OR,SMD ; P value; NNT)
: 5.2% vs. 6.8% (HR 0.75; 95% CI 0.64-0.89; P<0.001; NNT 63)
 


==Outcome: Secondary Endpoint==
==Outcome: Secondary Endpoint==
; MI
XX% vs. XX% (RR,HR,OR,SMD ; P value; NNT)
: 2.1% vs. 2.5% (HR 0.83; 95% CI 0.64-1.09; P=0.19)


; ACS without MI
==Outcome: Exploratory Endpoints==
: 0.9% vs. 0.9% (HR 1.00; 95% CI 0.64-1.55; P=0.99)
XX% vs. XX% (RR,HR,OR,SMD ; P value; NNH)
 
; Stroke
: 1.3% vs. 1.5% (HR 0.89; 95% CI 0.62-1.25; P=0.50)


; HF
: 1.3% vs. 2.1% (HR 0.62; 95% CI 0.45-0.84; P=0.002; NNT 125)
; CV mortality
: 0.8% vs. 1.4% (HR 0.57; 95% CI 0.38-0.85; P=0.005; NNT 167)
; All-cause mortality
: 3.3% vs. 4.5% (HR 0.73; 95% CI 0.60-0.90; P=0.003; NNT 83)
; Composite of primary outcome or all-cause mortality
: 7.1% vs. 9.0% (HR 0.78; 95% CI 0.67-0.90; P<0.001; NNT 53)
; Of those with CKD at baseline
: '''≥50% reduction in GFR, long-term HD, or renal transplant''': 1.1% vs. 1.1% (HR 0.89; 95% CI 0.42-1.87; P=0.76)
: '''≥50% reduction in GFR''': 0.8% vs. 0.8% (HR 0.87; 95% CI 0.36-2.07; P=0.75)
: '''Long-term HD''': 0.5% vs. 0.8% (HR 0.57; 95% CI 0.19-2.54; P=0.27)
: '''Renal transplant''': none
: '''New albuminuria''': 9.3% vs. 11.8% (HR 0.72; 95% CI 0.48-1.07; P=0.11)
:: ''Above defined as doubling of albumin:creatinine ratio from <10 to >10 mg albumin/g creatinine.''
; Of those without CKD at baseline
: '''≥30% reduction in GFR to <60 mL/min/1.73 m<sup>2</sup>''': 3.8% vs. 1.1% (HR 3.49; 95% CI 2.44-5.10; P<0.001; NNH 37)
: '''New albuminuria''': 6.2% vs. 7.4% (HR 0.81; 95% CI 0.63-1.04; P=0.10)
==Outcome: Exploratory Endpoints==
; BP at year 1
: '''SBP''': 121.4 vs. 136.2 mmHg
: '''DBP''': 68.7 vs. 76.3 mmHg


; Number of antihypertensives
: 2.8 vs. 1.8
: '''None''': 2.7% vs. 11.3%
: '''1''': 10.5% vs. 31.1%
: '''2''': 30.5% vs. 33.3%
: '''3''': 31.8% vs. 17.2%
: '''≥4''': 24.3% vs. 6.9%
:: ''Breakdown of medication utilization is presented on page 30 of the supplementary appendix.''


===Subgroup Analysis===
===Subgroup Analysis===
There was no significant interaction for the primary outcome by CKD at baseline, age, sex, race, prior CVD, or SBP.
There was no significant/sinificant interaction for the primary outcome by variable1,variable2,variable3,variable4, and variable 5,


==Outcome: Safety endpoints==
==Outcome: Safety endpoints==
; Serious adverse event (SAE)
; Serious adverse event (SAE)
: 38.3% vs. 37.1% (HR 1.04; P=0.25)
XX% vs. XX% (RR,HR,OR,SMD ; P value; NNH)
: '''Hypotension''': 2.4% vs. 1.4% (HR 1.67; P=0.001; NNH 100)
: '''Syncope''': 2.3% vs. 1.7% (HR 1.33; P=0.05; NNH 167)
: '''Bradycardia''': 1.9% vs. 1.6% (HR 1.19; P=0.28)
: '''Electrolyte abnormality''': 3.1% vs. 2.3% (HR 1.35; P=0.02; NNH 125)
: '''Fall with injury''': 2.2% vs. 2.3% (HR 0.95; P=0.71)
: '''AKI/ARF''': 4.1% vs. 2.5% (HR 1.66; P<0.001; NNH 63)
:: '''SAE possibly or definitely associated with the intervention''' 4.7% vs. 2.5% (HR 1.88; P<0.001; NNH 45)
::: ''Above is from page 33 of supplemental appendix.''<ref name="suppapp">[http://www.nejm.org/doi/suppl/10.1056/NEJMoa1511939/suppl_file/nejmoa1511939_appendix.pdf Supplemental Appendix]</ref>
 
; SAE or ED visit
: '''Hypotension''': 3.4% vs. 2.0% (HR 1.70; P<0.001; NNH 71)
: '''Syncope''': 3.5% vs. 2.4% (HR 1.44; P=0.003; NNH 91)
: '''Bradycardia''': 2.2% vs. 1.8% (HR 1.25; P=0.13)
: '''Electrolyte abnormality''': 3.8% vs. 2.8% (HR 1.38; P=0.006; NNH 100)
: '''Fall with injury''': 7.1% vs. 7.1% (HR 1.00; P=0.97)
: '''AKI/ARF''': 4.4% vs. 2.6% (HR 1.71; P<0.001; NNH 56)
 
; Laboratory abnormality
: '''Na <130 mmol/L''': 3.8% vs. 2.1% (HR 1.76; P<0.001; NNH 59)
: '''Na >150 mmol/L''': 0.1% vs. 0% (HR not given; P=0.02; NNH 1,000)
: '''K <3 mmol/L''': 2.4% vs. 1.6% (HR 1.50; P=0.006; NNH 125)
: '''K >5.5 mmol/L''': 3.8% vs. 3.7% (HR 1.00; P=0.97)
 
; Orthostatic hypotension
: 16.6% vs. 18.3% (HR 0.88; P=0.01; NNT 59)
: '''With dizziness''': 1.3% vs. 1.5% (HR 0.85; P=0.35)


==Statistical Analysis==
==Statistical Analysis==
*88.7% power to detect a 20% effect with respect to the primary outcome
*XX power to detect a XX% effect with respect to the primary outcome. Sample size calculation add here.
*Cox proportional-hazards regression with two-sided tests (HR)
*Statistical test used
**5% level of significance
**XX level of significance
*Analysis: Intention-to-treat
*Analysis: Intention-to-treat/Per-protocol


==Conclusions==
==Conclusions==
In conclusion, lower systolic blood pressure targets of less than 120 mm Hg, as compared with < 140 mm Hg, in patients at high risk for cardiovascular events but without diabetes resulted in lower rates of major cardiovascular events and death from any cause.
*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==
==Discussion and Limitations of the Trial==


*Lack of generalizability to patients with diabetes, those with prior stroke, and those younger than 50 years of age.
==Commentary==
*Recruitment limitations, lack of enrollment to older adults residing in nursing homes or assisted-living facilities.
{{AE}}{{Your Initials}}
*Safety surveillance and effects of lower blood pressure on the central nervous system and kidney cannot be reasonably interpreted until the analysis of these endpoints is completed.


==Commentary==
{{AE}}{{MV}}
*Assess kidney injury related to lower systolic blood pressure. Long term adverse renal outcome.
*Meta-analysis on existing trials evaluating identical systolic-blood pressure targets.
*Can we know more characteristics on patients lost in follow-up?
*Intracranial hypoperfusion has been linked to cognitive decline in the elderly, which may be worsened by lower BP targets, although SPRINT was likely too short to detect a meaningful change in cognitive status.


==Slides==
==Slides==
 
Click [Add Link {{fontcolor|#FF0000|here}}] to download slides from the WikiDoc journal club on the [Trial acronym]


==Video Commentary==
==Video Commentary==
==References==




==External sites for further information==
==External sites for further information==
* [http://wikijournalclub.org/wiki/SPRINT|Wiki Journal Club]




==References==
{{Reflist|2}}




Latest revision as of 16:39, 19 January 2016

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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

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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

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]

Video Commentary

External sites for further information

References

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