Enhancing the effectiveness of health care for Ontarians through research Introduction to the...

Enhancing the effectiveness of health carefor Ontarians through research

Introduction to the Institute for Clinical Evaluative Sciences (ICES)

and ICES expansion site, ICES@Western

November 7, 2012

CPAH/RDC Statistics and Data Series at Western

Amit Garg, Director ICES@Western

Theresa Hands, Privacy Officer

Salimah Shariff, Lead Epidemiologist


Outline

• Who are we?

• What does ICES do?

• What does ICES@Western offer?

• Where is ICES@Western located?

• When will ICES@Western be operational?

• How does ICES do it?

2


Who are we? ICES

• Independent, non-profit organization

• Conducts research that contributes to: effectiveness, quality, equity and efficiency of

health care and health services in Ontario

3


Who are we?Network of Health Services Research Centres

4

Opened 2012


What does ICES do? ICES goals

• Carry out population-based health services research that is relevant to clinical practice and health policy development

• Document province-wide patterns and trends in health care delivery

• Develop and share evidence to inform decision-making by policy makers, managers, clinicians, planners and consumers

5


What does ICES do? ICES goals

• Promote linkages among health services researchers and decision-makers

• Train researchers and promote a wider understanding of epidemiology and health services research

6


What does ICES do?Examples of ICES studies

• Some of these you may have heard of…. Mortality among Patients Admitted to Hospitals on

Weekends as Compared with Weekdays (NEJM, 2001) Cyclo-oxygenase-2 inhibitors versus non-selective non-

steroidal anti-inflammatory drugs and congestive heart failure outcomes in elderly patients: a population-based cohort study (Lancet, 2004)

Unwalkable neighborhoods, poverty, and the risk of diabetes among recent immigrants to Canada compared with long-term residents (Diabetes Care, 2012)

7

ICES Ontario, Canada linked database characteristics

Cost: if had to collect data same data prospectively or through medical chart review very expensive.

Do kidney donors have a higher risk of

major cardiovascular events

non donor controls of

similar health

when followedfor years after

donation?

compared to

QuestionQuestion

Garg AX et al. BMJ 2012

We conducted a retrospective, population-based, matched cohort study that used large Ontario, Canada population-based healthcare databases

Ontario Residents

Living Kidney Donors1992-2009

Healthy Non-Donors

Restriction: Excluded any Ontario resident with a medical condition before their index date that could preclude donation: i.e. kidney disease, DM, HTN, Cancer, CVD, pulmonary dx, liver dx, SLE, chronic infections, HIV

Match each donor to 10 non-donors Age (±2 years), Sex Index Date (±6 months) Income and Residential Status

Non-Donors (controls)of similar health as donors

- Manual review of all chartsDate of nephrectomyreferred to as index date(start time of follow-up)

Randomly assigned an index date to entire Ontario population (using same distribution of index dates in donors)

This provided on average of 11 years of medical records for baseline assessment, with 99% of people having at least two years of baseline data for review

From 9.6 million Ontarians this resulted in exclusion of 85% of adults (15% remained)

Some Baseline Characteristics

Living Kidney Donors

(N = 2028)

Non-Donors

(N = 20,280)

Age at Index Date, Years (IQR) 43 (34-50) 43 (34-50)

Age Last Follow-Up, Years (IQR) 50 (42-58) 50 (42-58)

Women 60% 60%

Follow-Up, years (range) 6.8 (0.5 to 18) 6.5 (0.1 to 18)

Follow-up, total-person years 15,176 147,332

Validated codes were used

No difference between the groups

Donors: 1.3%; 1.7 events per 1000 person yearsNon-donors: 1.4%; 2.0 events per 1000 person years

Hazard ratio 0.85, 95% CI 0.57 to 1.27

Major cardiovascular event (death censored)

Good precision in the estimateGood precision in the estimate

Population database strengthsPopulation database strengths• Large population-based assessment

• Databases allow for rigorous selection of non-donor controls

• F/u up to 18 years, minimal loss to follow-up. (<6% emigrated)

• CV events based on accurate and reliable codes (no recall bias)

• Cost of this study $ vs. prospective study $$$$$$

• Association vs. causation. Unmeasured confounding

• Some data not available: body mass index, blood pressure values, creatinine,

cause of death

Population database limitationsPopulation database limitations

Statin Metabolism

100%

40%

40%

2%2% Systemic Availability

1) Enterocytes - Small Intestine

2) Hepatocytes

CYP3A4 Metabolized Statins

Atorvastatin, simvastatin, lovastatin

100%

80%

80%

40%

40% Systemic Availability

1) Enterocytes - Small Intestine

2) HepatocytesCYP3A4 Metabolized Statins

+

Clarithromycin or Erythromycin

Statin Metabolism + CYP3A4 inhibitor

Clarithromycin / erythromycininhibits CYP3A4

Azithromycin a macrolide antibiotic used for similar indications does not inhibit CYP3A4

Clarithro /Erythro

(n ~ 75,000)

30 days

Hospitalization with rhabdomyolysis

Hospitalization with AKI

All cause mortality

+ AKI based on serum creatinine

(data in subpopulation)Azithro(n ~ 68,000)

compared to

Question: Question:

Population Based Study of Older statin users with new outpatient co-prescriptions

Can’t ethically randomizea patient to a potentially severeadverse drug-drug interaction.

Would be required to interveneat time knew about worrisomeprescription.

Patel A et al. (under review) 2012

Baseline Characteristics by co-prescription

Clarithromycinn=72,591

Erythromycinn = 3,267

total n = 75,858

Azithromycinn = 68,478

Demographics

Age, years 74 (SD 6) 74 (SD 6)

Women 40,130 (53%) 36,323 (53%)

Co-morbidities

Cerebrovascular disease 3,189 (4%) 2,765 (4%)

Peripheral vascular disease 2,101 (3%) 1,844 (3%)

Coronary artery disease 39,908 (53%) 36,950 (54%)

Congestive heart failure 12,652 (17%) 11,776 (17%)

Systemic malignancy 21,875 (29%) 19,955 (29%)


Erythromycinn = 3,267

total n = 75,858


Statin Characteristics

Atorvastatin 55,027 (73%) 50,111 (73%)

Simvastatin 18,421 (24%) 16,369 (24%)

Lovastatin 2,410 (3%) 1,998 (3%)

High dose statin 30,296 (40%) 27,550 (40%)

Low dose statin 45,562 (60%) 40,928 (60%)

Medication use in preceding year

Oral hypoglycemic or insulin 20,367 (27%) 17,819 (26%)

Beta-blockers 29,318 (39%) 27,008 (39%)

Verapamil or diltiazem 7,941 (11%) 7,206 (11%)

Use of other calcium channel blockers 18,521 (24%) 16,982 (25%)

Potassium sparing diuretics 3,307 (4%) 2,992 (4%)

Non-potassium sparing diuretics 26,901 (36%) 24,720 (36%)

NSAIDs (excluding aspirin) 16,516 (22%) 14,797 (21%)

ACE inhibitor or ARB 49,017 (65%) 44,323 (65%)


Erythromycinn = 93

total n = 2,427


Renal Function

serum creatinine, µmol/L 90 (76-108) 90 (76-108)

eGFR mL/min/1.73 m2 66 (51-80) 65 (51-79)

eGFR category

≥ 90 mL/min/1.73m2 170 (7%) 109 (7%)

60-89 mL/min/1.73m2 1294 (53%) 782 (53%)

45-59 mL/min/1.73m2 564 (23%) 331 (22%)

30-44 mL/min/1.73m2 281 (11%) 199 (13%)

< 30 mL/min/1.73m2 118 (5%) 67 (5%)

ResultsNumber of Events (%)

AdjustedRelative Risk

(95% CI)

Clarithromycin/Erythromycin

n=75,858

Azithromycinn=68,478

Rhabdomyolysis 24 (0.03%) 10 (0.01%) 2.17 (1.03 to 4.52)

Acute kidney injury

347 (0.46%) 176 (0.26%) 1.78 (1.52 to 2.19)

Mortality 529 (0.70%) 306 (0.45%) 1.56 (1.37 to 1.82)

Number needed to harm (death) 1 in 400

Subpopulation with Lab Values

Number of Events (%)

Relative Risk (95% CI)

Clarithromycin/Erythromycin

Azithromycin

n=2,427 n=1,488

Acute kidney injury(AKIN stage 1)

47 (1.94%) 10 (0.67%) 2.92 (1.47 to 5.79)

Number needed to harm (AKI) 1 in 80

Patel A et al. (under review) 2012

Amit Garg

This is the results - why is it being presented first before codes.

Limitations First population based study

looking at outcomes of this drug-drug interaction.

Consistent with pharmacokinetic and case report data.

Large number of patients.

Near identical baseline characteristics table for both groups.

Associations, therefore not causal.

Unable to analyze by specific statin type.

Analysis restricted to older adults.

Strengths


How does ICES do it?Key to ICES research

• Ability to anonymously link population-based health information on an individual patient basis

• Linked data allows researchers to obtain a more comprehensive view of specific health care issues

25


Ms. Theresa Hands

Privacy Officer, ICES@Western

26


How does ICES do it?How health data is generated

• Patient enters hospital to receive care

• Person sees physician for a consult

• Elderly person lives in nursing home

CONSENT

• Given to the institution / caregiver only

• Can be explicit or implicit

• Use data for care, or for improving future care

27


How does ICES do it?How health data is generated

• Patient enters clinical study

• Person fills out survey

EXPLICIT CONSENT

• to use data for specified purpose

28


How does ICES do it?Ontario Privacy Law: PHIPA (2004)

• Personal Health Information Protection Act

• No use of Personal Health Information (PHI) without consent

29


How does ICES do it?So… how can we do our work?

EXCEPTION: “Prescribed Entities”

•4 of these in Ontario Pediatric Oncology Group of Ontario (POGO) Cancer Care Ontario (CCO) Canadian Institute for Health Information (CIHI) Institute for Clinical Evaluative Sciences (ICES)

30


How does ICES do it?Privacy

• ICES is a prescribed entity under PHIPA 2004 (s. 45[1] and O. Reg 329/04 section 18[1] ): Disclosure for planning and management of the health system

• Health information custodians may disclose personal health information (PHI) to ICES for the purposes of:

• Analysis and compiling statistical information related to managing the health system allocation of resources evaluation and monitoring planning for all or part of the health system

31


How does ICES do it?Prescribed Entities

• Have policies, practices and procedures in place to protect the privacy interests of the individuals and the capacity to make sure it is kept securely

• The Ontario Information and Privacy Commissioner (IPC) has reviewed and approved these policies, practices and procedures

• The review / approval is renewed every three years

• VERY big deal!

32


Dr. Salimah Shariff

Lead Epidemiologist, ICES@Western

33


How does ICES do it?Key to ICES research

• Ability to anonymously link population-based health information on an individual patient basis

34


How does ICES do it?Data sources – Patient-level data

• Health Services Databases“transactions” of health care utilizationOntario Health Insurance Plan Claims (OHIP)Discharge Abstracts for Inpatient Hospitalizations (CIHI DAD)Same Day Surgery (CIHI SDS)National Ambulatory Care Reporting System (NACRS)Ontario Drug Benefit Claims (ODB)

35



• Disease Cohorts/Registry DatabasesReceived from partner organizationOntario Cancer Registry (OCR)Canadian Organ Replacement Register (CORR)

ICES Derived DatabasesOntario Diabetes Database (ODD)Linkage of delivering mothers to their newborns (MOMBABY)

36



• Externally Linked Data Sources Chart reviews Electronic medical records (ex. Cerner) Surveys

• Statistics Canada (Canadian Community Health Survey - CCHS)

• Interviews, questionnaires Research datasets

37



• Patient-level data sources can be linked to each other using unique patient identifiers ICES Key Numbers (IKN)= Encrypted OHIP #

38


How does ICES do it?Data sources – Supporting data

• Population and Demographic Data Registered Persons Database files (RPDB) Population Estimates Canadian Census Profiles PCCF+ (StatsCan postal code conversion file) Citizenship and Immigration Canada

39


How does ICES do it?Data sources – Supporting data

• Other Supporting Data Sources Care providers (all physicians in Ontario) Facilities and Institutions Management Information System (MIS;

financial and statistical data for hospitals) Geographic conversion tables (LHIN, Census

Subdivisions, Counties, Residence codes, etc) Coding tables (ICD9, ICD10, CCP, CCI, OHIP)

40


How does ICES do it?Linking datasets

• All data sources can be linked at various levels

41

Patient-level

Care providers

Health care

facilities

Population &

Geography

PhysicianIdentifier

FacilityIdentifier

Postal Code, LHIN

RPDBIKN


What does ICES@Western offer?Process for intaking ICES studies

1. Develop a research question Do we have the data you need?

2. Identify ICES Scientist Only ICES Scientists can access ICES data for

research Principal investigator or co-principal investigator must

be an ICES scientist Must participate fully in the research project Responsible party within ICES

42



3. Submit 1-page research proposal & Privacy Impact Assessment (PIA)

Reviewed by a lead Scientist PIA used to ensure privacy requirements at ICES

mandated by the “Personal Health Information Protection Act” (PHIPA)

Ensures that project conforms to ICES policies and procedures

43



4. Submit Project Activation Worksheet (PAW) Required in order to activate the project Provide estimate of resources and time for project

(budget)

5. Request REB approval from Western Submit to Health Sciences REB, Delegated Review

44



6. Develop Dataset Creation Plan (DCP) Study design Data sources and data elements Time-frames Inclusion/Exclusion criteria Variable definitions

• Exposure• Outcomes• Other variables

Analytic plan Output tables

45



7. Submit project for execution at ICES@Western Reviewed by lead epidemiologist/analyst Entered into the queue Analyst assigned

• Only ICES staff and faculty have access to ICES data holdings

• Analysts are trained and have expertise in conducting health administrative database research

46



8. Project commences Continuous communication with analyst & study

team May require modifications to DCP

9. Results provided Aggregate level Results with fewer than 6 individuals are reported as

“<=5”

10.Publish!

47


What does ICES@Western offer?Things to consider

• Cost Cost recovery

• Project must have grant (or other) money• Staff time is billed to investigator

Grant support letter• Must be submitted at least 4 weeks prior to grant

submission deadline

• Time Projects vary in time depending on scope and

resources required

48


What does ICES@Western offer?Services we can provide

• Epidemiological Literature searches Study design/methodology, DCP advice

• Biostatistical Analytic design advice

• Administrative Grant support letters REB submission New data linkages

49



• Support for Graduate Student Training Work closely with an analyst Have limited access to data Can perform own analyses

50



• Faculty Scholars Program www.iceswestern.ca Open to all Western Faculty Training, mentorship, epidemiologic and analytic

support to help Scholars develop and complete a minimum of one ICES study

Guidance on grant writing and manuscript preparation

Applications accepted until February 2013 for

program commencement in September 2013

51


When & WhereICES@Western

• When will we be operational? January, 2013 Process for new projects can start NOW

• Where are we located? ELL-218 (within Pharmacy hallway) Victoria Hospital, E-Tower, Lower Level

52


Contact UsICES@Western

• Amit Garg, Director ICES@Western [email protected] 519-685-8502

• Theresa Hands, Privacy Officer [email protected] 519-685-8500 x56045

• Salimah Shariff, Lead Epidemiologist [email protected] 519-685-8500 x56555

53


54

Questions?

54 of XX

Enhancing the effectiveness of health care for Ontarians through research Introduction to the...

Documents

Transcript of Enhancing the effectiveness of health care for Ontarians through research Introduction to the...