Methods and Design: “Simplicity, the rule of One”

A) One nation: How?. In a big country like Saudi Arabia (30 Million population: 20 Million nationals, 10 Million expats), it is unrealistic to enroll all hospitals in the country over a short period of time. The study design will assure fair and representative distribution of all health care sectors in our country according to the health care service coverage they provide. It has to take into account as well the involvement of all geographical regions and the balance between tertiary care and non-tertiary care hospitals. Most of the hospitals are non-tertiary care; and likely, most of the knowledge-care gaps exist in them. Tertiary care is defined in this proposal as hospitals that have all of the following: CCU/ICU, Cath Labs, AND cardiac surgery services.

Three general rules will allow consistent and reliable reports and comparisons over the years:

1. Health Care Sectors: MOH: 60%, Private: 20%, Others: 20%.

2. Geographic regions: central, east, west, north, and south.

3. Tertiary care versus not: non-tertiary care: 50%, tertiary care 50%.

A) CRF: A standard on-line Case Report Form (CRF) of the major clinical features, presentation, Key Performance Indicators (KPIs), and in-hospital mortality.

B) Data collection: data will be collected by One trained team that will visit each hospital and will be hired by the SHA, except in hospitals that are able to hire their own particular staff.

C) A One-month snap shot of all consecutive hospital admissions of AMI patients (STEMI or NSTEMI) is required per each hospital. Only hospitals with 50-beds or more will be eligible for the study.

D) A minimum of 20 AMI patients is required per each hospital within that 1 month. However, recruitment will be allowed to exceed 1 month (but only up to 3 months) if that target is not achieved. If the target is achieved in less than 1 month then recruitment should continue till a full 1 month is reached (i.e: there is no maximum limit for the number of recruited patients within the 1-month period).

E) Each hospital will be randomly chosen for a particular month over the overall 1-year registry period. The months assigned to non-tertiary care hospitals will be different from tertiary care hospitals to avoid double-counting of transferred patients among those two hospital systems. This will also avoid bias of a focused recruitment in 1 month only of all hospitals at once which might be potentially affected by seasonal variations.

F) Each survey will be administered in the country in waves every One year, i.e: wave 1, wave 2,..etc. The registry will start at the beginning of every Gregorian year, and will extend over a 1 year period.

G) Follow-up: mortality and re-admission rates after 1 month and 1 year of hospital discharge. Data will be collected by clinic visits and/or phone calls and registered in a form separately from website which will be sent by email to STARS coordinator.

H) One Annual Report to be released by the SHA for the overall and individual hospital results (without revealing their specific identity), and also to be presented at the SHA Annual Conference. Participating hospitals will be mentioned by name in the local newspapers (without mentioning the specific details of each hospital).

Inclusion Criteria:

1- Age ≥ 18.

2- All consecutive STEMI/NSTEMI (defined according to the latest ACC/ESC Guidelines).

3- Enrolled hospital should be at least 50 beds or more.

Exclusion Criteria:

1- Age ˂ 18.

2- Unstable angina.

Primary Objectives:

1- Increase the rates of primary PCI and/or pharmaco-invasive approaches as the main modes of acute revascularization for STEMI patients, and subsequently reduction in the rates of acute no-reperfusion.

2- Improvement of the quality of the acute revascularization management (Door to Needle time (DNT) and Door to Balloon time (DBT) for STEMI patients.

3- Improvement of rates of evidence-based medicine use (Anti-platelet therapies, statins, Beta-blockers, ACE-I/ARB, and statins).

Primary Endpoint:

1. DNT ˂30 minutes for ˃ 50% of STEMI patients.

2. DBT˂90 minutes for ˃ 50% of STEMI patients.

3. Rate of acute no re-perfusion (no thrombolytic therapy and no primary PCI) < 5% in eligible STEMI patients (< 12 hours of symptoms onset and no absolute contraindications).

4. Use of EBM at hospital discharge ˃ 90% in all comers of AMI patients

Secondary Objective:

Reduction of mortality and in-hospital cardiovascular complications

Secondary Endpoints:

1- In-hospital recurrent ischemia

2- In-hospital recurrent MI

3- In-hospital congestive heart failure

4- In-hospital cardiogenic shock

5- In-hospital, 1 month, and 1 year crude and risk-standardized mortality rates.

Statistical analysis:

Data will be summarized as means ±SD if they were normally distributed; otherwise, they will be summarized as the median and interquartile range (IQR). Differences between groups will be assessed using chi square or Fisher’s exact test for categorical variables, student t-test for continuous variables for normally distributed variables, and the Mann–Whitney U test for skewed variables. All analyses will be considered significant at P < 0.05. The analysis will be performed using SPSS software.

Since this is a nation-wide registry with no plan for comparison between the efficacies of different medications, there is no need for a sample size calculation. However, the estimated number of enrolled AMI patients is 3000.

Consent:

No written consent will be obtained because of the following reasons: STARS is an observational registry that will include collection of routine clinical data on patients presenting with AMI who will be managed by their own physicians according to the standard usual care and will require no extra testing or interventions. This will be an on-line database, and patients’ confidentiality will be secured by encrypting their exact names and the national identification numbers. This is similar to all our previous national (SPACE, CARES, HEARTS) and regional (GulfRACE-2) registries that were approved by the ethics committee and no written consent was mandated.

Roles and Rules:

1. STARS is a partnership project between the SHA and the health care sectors.

2. Individual hospital results are NOT to be released publically or to be used as an opportunity to “punish” hospitals, but rather to improve their CVS care.

3. Each hospital will access its own results on-line and compare itself to other hospitals without uncovering their identity in order to improve its own performance.

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