Maccabi Healthcare Services (MHS) Warfarin Treatment Registry (Israel)

Field Names
Records
Coordinating Country
Israel
Region

All regions of Israel

(The clinical database has a country-wide distribution)

Brief Database Description

Maccabi Healthcare Services (MHS) is the second largest public health plan in Israel and is responsible for the healthcare of approximately 25% of the total population. The clinical database has a country-wide distribution. Maccabi is both the insurer and provider of medical services for 2 million members, with only 1-2% yearly turnover (mostly follow-up from cradle to grave).* All members’ health-related interactions are automatically documented in a central computerized database.

Maccabi Healthcare has created and maintains several chronic disease registries, which are updated automatically in real time from the central medical record. These include the following registries: Cardiovascular Disease (CVD), Diabetes, Chronic disease, Weight , Hypertension (HTN), Home care, Cancer, Schizophrenia/bipolar, Warfarin treatment, Chronic kidney disease (CKD), Chronic obstructive pulmonary disease (Weight ), Osteoporosis, and weight disorders registries.

MHS has established an automated registry of patients treated with Warfarin. The MHS Warfarin Treatment Registry was initiated just before 2010, but data are available since 1998. As of January 2017, a total of 42,515 members have been identified, out of which 26,114 are currently active in MHS. Patients' inclusion in the MHS Warfarin Treatment Registry is continuous, based on Coumadin (i.e., Warfarin) purchases for at least 30 days.

The following patients are included in the Warfarin Treatment Registry:
• All warfarin users (at least 1 purchase)

The following entry criteria are used for including people in the Warfarin Treatment Registry:
• INR
• Hospitalizations
• Duration of use
• Inclusion (or date of inclusion) in the MHS Cardiovascular Diseases (CVD) Registry [namely for atrial fibrillation, heart valve disorders, or deep vein thrombosis (DVT)].

Data for each patient in the MHS Warfarin Treatment Registry include:
• Demographics
• Lab results (e.g. INR)
• Co-morbidities
• Medications & compliance
• Physician visits

This registry was initiated primarily for operational purposes, e.g., managing patients at risk, monitoring, quality measures (health value indicators) and alerts for unbalanced patients. This registry has not been used for specific epidemiology research.

*Other health plans include Clalit (2 million members), Mehudet (1 million members), and Leumit (0.7 million members). In Israel, all citizens must be insured by one of the 4 public health plans, and payment is done by taxation relative to income. Health services coverage is defined by a general national health "basket" governmental law. However, some additional coverage may be chosen to be included in the basic health "basket" by each health plan.

Database Type
Longitudinal Population Database
- Drug and Diagnosis Data
- - Electronic Medical Records

- - - Outpatient and inpatient

Registry
Specific drug exposure registry
(Warfarin Treatment Registry)

Database Source
EHR/EMR

(Personal electronic medical records)

Frequency of Data Collection
Ongoing

(The database compiles information from various sources which are automatically feeding the central EMR, mostly in real time)

Frequency of Data Update
Ongoing

(The database is updated on a daily basis - All data are collected daily from clinical and operational systems and integrated through central synchronized tables. The national identity number allows patient centered updates of all relevant files and registries automatically and simultaneously.)

Years Covered
1998 - Present

(The MHS Warfarin Treatment Registry was initiated just before 2010, but uses retroactive data since 1998 as well as ongoing data. The registry is automatically updated on a daily basis.)

Population Type
Insured

(Members insured in a Israeli public HMO - Maccabi Health Services)

Patient Type
Inpatient and Outpatient
Date of Last Update
Ongoing

(The MHS Warfarin Treatment Registry is updated on a daily basis;
This profile was developed for the B.R.I.D.G.E. TO DATA site on July 26, 2017.)

Field Names
Records
Database Population Size
<200,000

[The MHS Warfarin Treatment Registry is a computer-based system and has been continuously updated since 2010. As of January 2017, a total of 42,515 members have been identified, out of which 26,114 are currently active in MHS. Patients' inclusion in the MHS Warfarin Treatment Registry is continuous, based on Coumadin (i.e., Warfarin) purchases for at least 30 days.]

Active Population Size
<200,000

(As of January 2017, a total of 42,515 members have been identified, out of which 26,114 are currently active in MHS.)

Annual Change in Population
2,300 new patients each year

[Approximately 2,300 new patients were entered into the registry each year between 2000 and 2015. In 2016, the number of registrants decreased to 1,300, probably due to the introduction of a novel oral anticoagulant. However, the database includes all patient histories, including patients who left the Maccabi database (<2% turnover) as well as patients who are deceased, exit the system, or have a clinical status change relevant to the registry. For example, 4 months following the last purchase of warfarin and 1.5 months following the last INR test, the patient transitions to an inactive status in the registry. However their full data is always stored, if they are ever active in the registry at any point in time. Any changes to the inclusion/exclusion criteria for the disease registry are retroactive. Maccabi is both the insurer and provider of medical services for 2 million members, with only 1-2% yearly turnover (mostly follow-up from cradle to grave).]

Sample Weights - Extrapolation Factors
No
Final Population Size
N/A

(Not applicable, as data collection is ongoing)

Field Names
Records
Age of Patients at Data Collection
Yes

DOB is recorded

Approximate Percentage of Participants <18 years and those >65 years

<18 years = 0.5%
>65 years = 65%

(Based on active patients as of January 2017)

Gender Data
Yes
Percentage of Males/Females

Males = 54%
Females = 46%

(Based on active patients as of January 2017)

Ethnicity / Race Data
No

There are no data on race or ethnicity; however, data on the country of immigration are available.

Geographic Location

The patient's exact home address in Israel is recorded

Date of Birth Recorded
Yes

Date of birth can be provided in any desired format, including YYYMMDD

Death Recorded
Yes

Date of death can be provided in any desired format, including YYYMMDD

Availability of death certificate / autopsy information
No

While death certificates are not available through this database, a copy of the death certificate can be identified at the Israel Ministry of Health using the unique ID number. Additionally, case ascertainment is possible through direct contact with the treating physician.

Other Demographic Data
Yes

Sociodemographic information in the database includes those captured by the Israeli Central Bureau of Statistics: Marital status, Socioeconomic status (i.e., regional poverty index), and Duration of residence in Israel.

Field Names
Records
Physician ID
Yes

The treating physician's name and clinic address are recorded in each patient's EMR

Physician Specialty
Yes
Pharmacy ID
Yes

Data are available on pharmacy dispensing the medication(s)

Field Names
Records
Diagnosis Data
Yes

All medical conditions are recorded, including chronic diseases, co-morbidities, and primary reason for physician/clinic/specialist visit

Diagnoses Coded
ICD-9

ICD-O-2
(Diagnoses of medical conditions are connected to ICD-9 codes, and diagnoses of cancer are connected to the Cancer Registry with all ICD-O-2 codes)

Diagnoses: Date Parameters
1998 - Present

(The MHS Warfarin Treatment Registry was initiated just before 2010, but uses retroactive data since 1998 as well as ongoing data. The registry is automatically updated on a daily basis.)

Diagnoses: Maximum Number of Codes Allowed
Unlimited
Physical Examination Findings
Yes

The registry includes physical exam findings such as blood pressure, height, weight, and BMI. Inquiries regarding other specific data can be made by getting in touch with the Registry contacts.

Birth Defect Data
No

However, specific diagnoses may be linked to the main MHS EMR database via unique personal ID number

Cancer Data
No

However, diagnoses of cancer are connected to the Cancer Registry with all ICD-O-2 codes

Infectious Disease Data
N/A

(Not applicable)

Environmental Exposures
N/A

(Not applicable)

Behavioral Data Elements
Yes

Behavioral data include smoking status and medication compliance

Field Names
Records
Procedure Data
Yes

Information is available on all dispensed medications, lab results, and hospitalizations in general hospitals, treatments, imaging tests, outpatient care, nursing care, and physiotherapy.

Procedures Coded
CPT

(Procedures are connected to CPT codes)

Number of Procedures Coded
Unlimited
Procedure Date Parameters
1998 - Present

(The MHS Warfarin Treatment Registry was initiated just before 2010, but uses retroactive data since 1998 as well as ongoing data. The registry is automatically updated on a daily basis.)

Laboratory Information
Yes

The Warfarin Treatment Registry includes laboratory data such as INR, eGFR, cholesterol, HDL, LDL, non-HDL, triglycerides, creatinine, HBA1c, CRP, microalbumin (urine), albumin/creatinine ratio, microalbumin (urine, 24 hour excretion), homocysteine, potassium (K), sodium (Na), protein (urine, 24 hour excretion), and creatine kinase. All lab data can be cross-linked across registries and to the full MHS EMR database via a unique personal ID. Additionally, some imaging data or summary reports may also be accessed based on specific needs.

Field Names
Records
Drug Data
Yes: Prescription & OTC

All prescriptions are captured, but OTC drug data are only recorded if the medication was purchased in contracted pharmacies

Drug Date Parameters
1998 - Present

(The MHS Warfarin Treatment Registry was initiated just before 2010, but uses retroactive data since 1998 as well as ongoing data. The registry is automatically updated on a daily basis.)

Drug Regimen & Route
Yes

Information is recorded on prescribed regimen and route

Drug Manufacturer
Yes
Drug Dosage
Yes
Drug Days Supply
Yes
Drug Coding System: Maximum Number
Unlimited

(There is no limit on the number of drugs recorded for a given date. All drugs dispensed are recorded.)

Drug Coding System: Primary
Other

[PSI - Maccabi Healthcare Services uses a coding system for drugs that was originally developed by the Pharmaceutical Society of Israel (PSI). These codes can be converted to ATC-like codes. The PSI Drug Database is an online drug formulary for health and veterinary medications. The searches are conducted by active ingredient, and information on all generic and trade name drugs containing that active ingredient are listed, including approved indication(s), formulation, route of administration, manufacturer, drug registration number (numerical format, e.g., Oxytocin 10 IU/ML 131-23-30924-00), dosage, ATC description, and prescribing information.]

Drug Coding System: Other
N/A

(Not applicable)

Drug Generic Name
Yes
Drug Additional Information
Yes

Additional drug information present in the database includes: Date of medication purchase, cost of medication, and medication compliance

Field Names
Records
Cost Data
Yes

Information is available on costs of all services provided

Cost Denomination
New Israeli Shekel (NIS)
Type of Cost Data
Yes

Actual cost for all services are available, including hospital charges

Description of Surrogate Link
N/A

(Not applicable)

Field Names
Records
Data Validation Against Original Source
Yes

The EMRs are a centralized source of all medical information for patients in the Maccabi Healthcare system. Automated QA processes are applied to automatic data collection. However, when required, case ascertainment can be verified through direct contact with a treating physician for validation purposes.

Access to Medical Records
No

Only database staff have access to the medical records

Linkage to Other Databases
Yes

Linkage does exist

Brief Description of Linkage Capabilities

All patients have a single national identity number which enables contact with other national databases and sources of information, e.g., Israeli National Cancer Register, Maccabi Chronic Disease Registries, and vital statistics databases. Some of the Maccabi Healthcare Services' disease registries are based upon linkage to national registries such as the Israeli National Cancer Register.

Field Names
Records
Database Contact Data

Adi Rennert
Business Development
Database Research Services
27 Hamered St., 4th floor
Tel Aviv 68125
ISRAEL
Phone: +972-3-514-3755
Fax: +972-3-795-2612
Email: Rennert_a@mac.org.il

Alternate Contact

Gabriel Chodick, PhD
Head, Epidemiology & Database Research Unit
27 Hamered St.
Tel Aviv 68125
ISRAEL
Phone: +972-3-795-2430
Email: hodik_g@mac.org.il

Source of Database Funding
Government

(Maccabi Healthcare Services is a non-profit HMO that receives funding from the government. Maccabi Healthcare Services provides the data for the Maccabi Healthcare Services Clinical Database. The database and the patient registries are managed by MaccabiTech.)

Sponsoring Government Agency
N/A

(Not applicable)

Sponsoring Pharmaceutical Manufacturer

N/A

(Not applicable)

Database Usage Restrictions
Private Access

NOTE: If interested, the database manager may be contacted regarding accessing the dataset

Charge for Database Usage
Yes

The database manager can be contacted regarding costs for accessing the dataset

Data Media Format
DVD
CD
Diskette
PDF Files

(De-identified data can be provided in a variety of formats)

Number of Publications Using Database
0
References of Studies Using/Describing Database

N/A

[Not applicable; this registry was initiated primarily for operational purposes, e.g., managing patients at risk, monitoring, quality measures (health value indicators) and alerts for unbalanced patients. This registry has not been used for specific epidemiology research and includes sensitive patient information, and therefore currently there are no publications associated with this registry.]

Database Contact
Database Contact Data

Adi Rennert
Business Development
Database Research Services
27 Hamered St., 4th floor
Tel Aviv 68125
ISRAEL
Phone: +972-3-514-3755
Fax: +972-3-795-2612
Email: Rennert_a@mac.org.il

Alternate Contact

Gabriel Chodick, PhD
Head, Epidemiology & Database Research Unit
27 Hamered St.
Tel Aviv 68125
ISRAEL
Phone: +972-3-795-2430
Email: hodik_g@mac.org.il

References of Studies Using/Describing Database

N/A

Comment: Drug Date Parameters
(The MHS Warfarin Treatment Registry was initiated just before 2010, but uses retroactive data since 1998 as well as ongoing data. The registry is automatically updated on a daily basis.)