GN O O+I WC- MR
GN O O+I WC-
MR GN O O+I WC (I) WC
(C)
GN O O+I WC (I) WC
(C) POST GN GN-
OO POST GN GN- OO The patient goes to
a clinic with pain when urinating.
Patient is
diagnosed with a UTI and is given a prescription for antibiotic.
The clinic is participating in a medical records study evaluating the effectiveness of antibiotics.
The patient goes to a clinic with pain in their leg.
Patient is diagnosed with a blood clot and is given a prescription for a blood thinner.
The clinic is participating in a medical records study evaluating the
effectiveness of blood thinners.
The patient goes to a clinic with pain in their leg.
Patient is diagnosed with a blood clot.
The patient is
randomized to receive a prescription for one of two blood thinners:
Hemcorrect or Thrombofix.
The patient goes to a clinic with pain when urinating.
Patient is diagnosed with a UTI.
The patient is
randomized to receive a prescription for one of two antibiotics:
Urostat or Sanitist.
The patient goes to the emergency room after injuring their leg.
The patient needs surgery to place a metal rod to fix their broken leg.
The hospital is participating in a cluster-randomized study to compare two types of rods.
The patient receives the rod assign to the hospital.
The patient goes to a clinic for a
checkup.
The doctor orders routine laboratory tests.
The hospital is participating in a cluster-randomized study to compare two types of needles.
The patient’s blood is drawn using the needle assigned to the clinic.
MEDICAL RECORDS INDIVIDUAL RANDOMIZATION
CLUSTER RANDOMIZATIONAbbreviation Full Name Description
POST Post-study notification The patient learns about the study after the study is completed via a hospital newsletter.
GN General notification The patient learns about the study through signs in the waiting room.
GN-OO General notification with the option to exclude their medical records from the study
Patient learns about the study through signs in the waiting room. The sign explains that patients can opt-out of having their medical records included in the study.
O Oral consent After talking with the doctor, the patient needs to give oral consent to be included in the study O+I Oral consent and a one-
page study information sheet
After talking with the doctor, the patient needs to give oral consent to be included in the study. The doctor gives the patient a one-page information sheet with details about the study.
WC (MR) Written consent for
medical record review After talking with the doctor, the patient needs to sign a written consent document to be included in the study.
WC (I) Written consent detailing
the incremental risks After talking with the doctor, the patient needs to sign a written consent document to be included in the study. Only the incremental risks due to the research are described.
WC (C) Written consent detailing incremental and clinical risks
After talking with the doctor, the patient must sign a written consent document to be included in the study. The clinical risks associated with each intervention are described along with the incremental risks of participating in the research.
