Database ResourcesFinal ProjectDatabase Demonstrations

2/7/2012

Outline Assignment 4/Final Project

HCG and Ectopic Pregnancy Wound Study* POINT Trial*

Obtaining and paying for data management help

CTSI DMU – Jennifer Creasman Genentech – Susanne Prokscha Course Evaluation

*Only if time permits

Final Project

Due 2/21/12, send to

ucsfdbclass@yahoo.com

Final Project Part A

Send in a copy of your research study database.

Populate your database, preferably with real, de-identified data, but test data are acceptable.

We will work with you to arrange a way for us to review your database.

Final ProjectPart B

Write a one-page data management section for your research study protocol or a one-page description of your current research study database.

Example: β-hCG and the Likelihood of Ectopic Pregnancy

Study Description

Cross-sectional study and record review comparing the β-hCG distributions in women with ectopic pregnancies, abnormal intrauterine pregnancies, and normal intrauterine pregnancies presenting to the SFGH emergency department with abdominal pain or vaginal bleeding and a positive urine pregnancy test.

Study Database Simple Access database Single dynamic table with one row per patient. Principal fields:

complaint (pain, bleeding, or both)β-hCG level, final determination as to the pregnancy

type.

Demo: PreVUEFinalDEIdentified.mdb

Data Collection and Entry Imported baseline data, HCG levels,

and dictations from the LCR (THREDS) Chart review by 2 faculty members, 1

resident, 1 medical student, and 1 research nurse.

Some entered onto paper and then transcribed.

Others entered directly using screen form.

Error Checking and Validation Standard field validation (e.g., for

dates) and coding (No = 0, Yes = 1, Unknown = -9)

On entry of outcome classification (e.g. ruptured ectopic), prompted to specify criterion (SubjectID = 222)

Error: inadequate monitoring and interim analysis

Analysis

Queries in Access Excel for figures Stata for confidence intervals

Confidentiality/Back-ups

Pre-HIPAA Even after de-identifying, Access

database still problematic

Stored on secure departmental server

Back-ups checked periodically

Budget

Typical unfunded research project. No $ budget. Took advantage of departmental

resources (e.g., the computers and the research nurse).

Database set up and all data management by investigator.

β-hCG and the Likelihood of Ectopic Pregnancy

Why does this first primary data collection project qualify as a success?

Because it was completed (culminating in the publication of valid and useful results).

Where to get data management help

CTSI Data Management Unit Outside consultants

-- Typically $100-$150/hour Outsource data management to

QuesGen SFCC Others (? SOM IT)

Before seeking help with data management

Search the internet and ask other researchers for already developed data collection forms.

Draft your data collection form.Test your data collection form with dummy subjects and,

even better, with real (de-identified) study subjects.Enter your test data into a data table with rows

corresponding to subjects and columns corresponding to data elements. (Use Excel, Access, Stata, or even Word.)

Create or at least think about a data dictionary.Decide who will collect the data, and when/how the data

will be collected.

CTSI DMU – Jennifer Creasman

Genentech – Susanne Prokscha

Example: Wound Study

Study Description

Prospective cohort study of the association between various predictors (diabetes, time since injury, anatomical location, etc.) and 30-day complications (infection or dehiscence) in emergency department patients presenting to one of three SF peninsula emergency departments* with a laceration.

*Moffitt, Mills-Peninsula, Stanford

Study Database QuesGen 3 dynamic tables

SubjectWound (one record per study subject)

FollowUp (2* records per study subject) CallLog (many records per study subject)

9 static lookup lists

Demo: Studydata.net

Data Collection and Entry

Physician entered data on paper form

RA transcribed from paper form into database via on-screen lac form

RA made 30-day follow-up call and filled out on-screen follow-up form

Error Checking and Validation Standard field validation (e.g., for

dates) and coding (see follow-up form)

Reporting/Analysis

Monitoring/reporting done within QuesGen

For analysis, exported to AccessStata for P values and confidence

intervalsSee Excel spreadsheet

(WoundAnalysisForJQ.xls)

Confidentiality/Security

QuesGen is HIPAA compliant (so is REDCap)

Budget

$10k to QuesGen for programming, hosting, combining datasets.

Example: POINT Trial

Platelet-Oriented Inhibition in New TIA

and minor ischemic stroke (POINT) Trial

POINT is a randomized, double-blind, multicenter clinical trial to determine whether clopidogrel 75mg/day (after a loading dose of 600mg) is effective in improving survival free from major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when initiated within 12 hours of TIA or minor ischemic stroke onset in patients receiving aspirin 50-325mg/day.

Inclusion Criteria

Neurologic deficit (based on history or  exam) attributed to focal brain ischemia and EITHER:

High risk TIA: Complete resolution of the deficit at the time of  randomization AND ABCD2 score >4 OR

Minor ischemic stroke:  residual deficit with NIHSS< 3 at the time of randomization.

• Ability to randomize within 12 hours of symptom onset. • Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy. • Subject will be prescribed aspirin at a dose of 50-325 mg/day.

Exclusion Criteria (Selected)

• Clear indication for anticoagulation (e.g., warfarin, heparin) anticipated during the study period (e.g., atrial fibrillation, mechanical heart valve)

• Severe renal (serum creatinine >2 mg/dL) or hepatic insufficiency

• TIA symptoms limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo.

• Planned thrombolysis or endovascular intervention for the index event.

Enrollment1) Patient presents to Mills-Peninsula ED within 12* hours of

acute neurologic event.2) ED MD determines no bleed on CT. Not getting thrombolysis.

Not on warfarin. No afib on ECG. Seems to meet inclusion criteria.

3) ED MD pages member of study team (Anke Hebig or Michael Kohn)

4) Study team member comes to ED, completes screening, and if eligible obtains consent.

5) Study team member randomizes patient using WEBDCU computer program. Orders study drug from Mills-Peninsula pharmacy.

6) Patient takes 600 mg (8 pills) of study drug with first dose of aspirin (dosage determined by treating physician 50-325 mg/day)

7) Study drug kit with 89 pills remaining goes with patient into hospital or home if patient is discharged from ED.

8) Patient takes 1 tablet/day plus prescribed dose of aspirin*Probably needs to be more like 10-11 hours to allow time for CT and initial workup

Aspirin Dose

Protocol page 16:

“An initial dose of 162 mg/day for 5 days (per the CAST trial) followed by 81 mg/day will be strongly recommended.”

50-325 mg/day

Follow-up

1) Study team member will contact patient at 7 days.

1) Follow-up appointment at 90 days with a participating Mills-Peninsula neurologist to determine neurologic status and occurrence of ischemic stroke, myocardial infarction, ischemic vascular death, hemorrhage, or other adverse event. (All events to be adjudicated by the POINT adjudication team.)

Risk FactorPoint

s

Age

  ≥ 60 years 1

Blood Pressure

  SBP ≥ 140 or DBP ≥ 90 1

Clincal features of TIA

Unilateral weakness (with or without speech impairment) 2

 Speech impairment without unilateral

weakness 1

Duration

TIA duration ≥ 60 minutes 2

  TIA duration 10-59 minutes 1

Diabetes

  Diabetes diagnosed by a physician 1

Total ABCD2 Score 0 – 7

ABCD2

Johnston SC, et al. Lancet. 2007 Jan 27;369(9558):283-92.

ABCD2

Johnston SC, et al. Lancet. 2007 Jan 27;369(9558):283-92.

Score% of TIA Patients

90-Day Stroke Risk

0-3 34% 3.1%

4-5 45% 9.8%

6-7 21% 17.8%

POINT Study Control Group

Johnston SC, et al. Lancet. 2007 Jan 27;369(9558):283-92.

Score% of TIA Patients

90-Day Stroke Risk

0-3 NA NA

4-5 ? ?

6-7 ? ?

POINT Study Control Group

Johnston SC, et al. Lancet. 2007 Jan 27;369(9558):283-92.

Score% of TIA Patients

90-Day Stroke Risk

0-3 NA NA

4-5 45% 9.8%

6-7 21% 17.8%

Expected 90-Day Stroke Rate = 12%

POINT Study

Expected 90-Day Stroke Rate in Control Group = 12%

If clopidogrel decreases stroke risk by one-third (RRR = 33%), what is the ARR and NNT?

Demonstration: WebDCU

www.pointtrial.org

Course Evaluation