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Appendix C1Quality Assessment of Randomized, Controlled Trials

Author, Year
Trial
Randomization adequate?Allocation concealment adequate?Groups similar at baseline?Maintain comparable groups?Eligibility criteria specified?Outcome assessors masked?Care provider masked?Patient masked?Reporting of attrition, crossovers, adherence, and contamination?Loss to followup differential/high?Intention-to-treat analysis?Post-randomization exclusions?Outcomes prespecified?Funding sourceExternal validityQuality rating
Anderson, 200442
WHI
YesYesYesYesYesYesYesYesYesNoYesNoYesNational Heart, Lung, and Blood Institute, U.S. Department of Health and Human ServicesGoodFair
Anderson, 200323
WHI
YesYesYesCompliance rates similarYesYesYesYesYesNoYesNRYesNational Heart, Lung, and Blood Institute, U.S. Department of Health and Human ServicesGoodFair
Cherry, 200267
ESPRIT
YesYesYesGreater noncompliance in treatment groupYesYesYesYesUnclearUnclearYesNRYesSchering AGFairFair
Ettinger, 200469
ULTRA
YesYesMostly: 2% lower lumbar spine BMD in treatment group compared with placebo groupUnclearYesYesYesYesYes: attrition and adherence
No: crossovers and contamination
NoYesNoYesBerlex Laboratories, IncFairFair
Heiss, 200833
WHI extension
YesYesYesYesYesYesYesYesYesNoYesNoYesNational Heart, Lung, and Blood Institute, U.S. Department of Health and Human ServicesGoodFair
Hulley, 200261
HERS II
YesYesYesYesYesYesYesYesYesNoYesYesYesWyeth-Ayerst ResearchGood/FairFair
LaCroix, 201149
WHI extension
YesYesYesYesYesYesYesYesYesNoYesNoYesNational Heart, Lung, and Blood Institute, U.S. Department of Health and Human ServicesGoodFair
Resnick, 200658
WHISCA
YesYesYesYesYesYesYesYesYesCompletion rates at year 3: 42.2% E+P vs. 44.1% placeboYesNoYesNational Heart, Lung, and Blood Institute, U.S. Department of Health and Human ServicesGoodFair
Resnick, 200957
WHISCA
YesYesMostly, except for smoking statusYesYesYesYesYesYesCompletion rates at year 4: 75.1% estrogen vs. 71.9% placeboYesNoYesNational Heart, Lung, and Blood Institute, U.S. Department of Health and Human ServicesGoodFair
Rossouw, 200212
WHI
YesYesYesYesYesYesYesYesYesNoYesNoYesNational Heart, Lung, and Blood Institute, U.S. Department of Health and Human ServicesGoodFair
Shumaker, 200355
WHIMS
YesYesMostly, except for history of stroke and prior statins useNRYesYesYesYesYes: attrition and adherence
No: crossovers and contamination
Year 6 3MSE scores obtained for 31 (1.45%) E+P and 44 (1.98%) placebo participantsYesNoYesNational Heart, Lung, and Blood Institute, U.S. Department of Health and Human ServicesGoodFair
Shumaker, 200454
WHIMS
YesYesMostly, except for hypertensionNRYesYesYesYesYes: attrition and adherence
No: crossovers and contamination
Drop out rate for year 7: 59.4% for estrogen vs. 54.2% for placeboYesNoYesNational Heart, Lung, and Blood Institute, U.S. Department of Health and Human ServicesGoodFair
Tierney, 200968
EMS
YesYesYesUnclearYesYesYesYesYes: attrition and adherence
No: crossovers and contamination
NoYesNoYesNot reportedFairFair
Vickers, 200766
WISDOM
YesYesYesUnclearYesYesYesYesYesUnclear; prematurely closed trialYesUnclearUnclear: primary outcome changedNot reportedFairFair

Abbreviations: BMD=bone mineral density; E+P=estrogen and progestin; EMS=Estrogen Memory Study; ESPRIT=Oestrogen in the Prevention of Reinfarction Trial; HERS/HERS II=Heart and Estrogen/Progestin Replacement Study; ULTRA= Ultra-Low-Dose Transdermal Estrogen Assessment; WHI=Women’s Health Initiative; WHIMS=Women's Health Initiative Memory Study; WHISCA=Women's Health Initiative Study of Cognitive Aging; WISDOM=Women's International Study of Long Duration Oestrogen After Menopause.

From: Appendix C, Evidence and Quality Tables

Cover of Menopausal Hormone Therapy for the Primary Prevention of Chronic Conditions
Menopausal Hormone Therapy for the Primary Prevention of Chronic Conditions: Systematic Review to Update the 2002 and 2005 U.S. Preventive Services Task Force Recommendations.
Evidence Syntheses, No. 93.
Nelson HD, Walker M, Zakher B, et al.

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