Table 3 |
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|
Characteristics of cohort-controlled echocardiographic studies included in analysis |
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|
Author |
Year |
Patient selection |
Ascertainment of drug exposure |
Mean duration (days) |
Blinding of outcome assessment |
|
|
|||||
|
Gardin [10] |
2000 |
Recruited by physicians known to be frequent prescribers – 25 centres. Controls from same centres |
Medical records and interview – dexfenfluramine, or combination of fenfluramine-phentermine |
252 |
Performed blind, tapes read blind at central laboratory |
|
Hensrud [11] |
1999 |
Patients from double-blind randomized controlled trial |
In trial of fenfluramine-phentermine |
284 |
Blinded reviewer |
|
Jollis [12] |
2000 |
Prescription registry data for 33 practices, controls from same centres |
Prescription registry – fenfluramine-phentermine together |
337 |
Blinded reviewer |
|
Khan [13] |
1998 |
Participated in drug study at medical centre, controls from media advert |
Medical records and self-reports – dexfenfluramine, fenfluramine or phentermine. |
615 |
67 unblinded; others performed blind |
|
Shively [14] |
1999 |
Recruited by prescribers at 26 centres; controls were obese patients at same centres with no drugs for 5 years |
Medical records – dexfenfluramine |
207 |
Blinded and told not to discuss medication history |
|
Wee [15] |
1998 |
46/76 patients with previous echo from two academic centres; patients acted as their own controls |
Medical records – dexfenfluramine or fenfluramine |
Median 160 |
Performed unblinded; reread in blinded manner by one of two readers |
|
Weissman [16] |
1998 |
1072/1212 patients from double-blind randomized controlled trial |
In a trial of dexfenfluramine |
71 |
Double blinding of trial maintained |
|
|
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|
Loke et al. BMC Clinical Pharmacology 2002 2:6 doi:10.1186/1472-6904-2-6 |
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