database resources final project database demonstrations 2/7/2012
TRANSCRIPT
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 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