Gynae Landmark Trials Flashcards

Question

Million women study summary

Answer 1

Aspirin + Heparin or Aspirin alone in women with recurrent miscarriage. Kaandorp (NEJM2010) Increased invasive Br Ca with HRT use - Combined use @5 yrs 6/1000 @10 years 19/1000, 2 less endometrial Ca - E alone @ 10 years 5/1000 + 4 extra endometrial Ca Current/recent HRT increases BCa, E+P significantly more than E only

Answer 2

Ovarian Conservation at the time of hysterectomy for benign disease. Parker (obstetrics and Gynaecology 2005) Aim: to establish an average age at which prophylactic oophorectomy could be recommended/beneficial for women at average risk of ovarian Ca

Answer 3

Ovarian Conservation at the time of hysterectomy for benign disease. Parker (obstetrics and Gynaecology 2005) Methods: Retrospective analysis of published data for absolute and relative risks after oophorectomy vs conservation. Using Markov decision analysis model to estimate optimal survival strategy per 5 years. Population: 40-80yo in published data from 1990 Intervention/comparison 4 strategies compared: Oophorectomy (with or without E) Conservation (with or without E) Outcomes: - Survival to 80 years - Ovarian ca, Coronary heart disease, Hip fracture, Breast ca, Stroke

Answer 4

Ovarian Conservation at the time of hysterectomy for benign disease. Parker (obstetrics and Gynaecology 2005) Conservation until age 65 benefits long term survival - oophorectomy < 55 - 8.5% excess mortality by 80 - oophorectomy <59 - 4% excess mortality by 80 - increased mortality mostly from extra CHD/Hip#, replacing E reduced this - At no age is there a clear benefit from oophorectomy

Answer 5

Ovarian Conservation at the time of hysterectomy for benign disease. Parker (obstetrics and Gynaecology 2005) Strengths - large numbers Limits - probability estimates mostly from case control studies - selection bias, reporting bias, chance - Predominantly white Caucasian not necessarily generalisable - Other morbidities not includes - A definition for average risk was not provided

Answer 6

ovarian conservation should be performed until 65yo for long term survival benefit in women at average risk for ovarian Ca

Answer 7

Women's health Initiative: Risks and benefits of estrogen + progesterone in healthy postmenopausal women - principal results from WHI RCT, WHI (JAMA 2002) Aim: to assess risk and benefits of E+P in healthy PM women. Aims to prevent CHD, breast and colon Ca and improve #/osteoporosis RCT - 16608 women (average age 63) recruited by mail or media

Answer 8

Women's health Initiative: Risks and benefits of estrogen + progesterone in healthy postmenopausal women - principal results from WHI RCT, WHI (JAMA 2002) Population: 50-79y post menopausal, intact uterus, likely to stay in same area for >3 years Intervention: CEE (conjugated equine estrogen) 0.625mg + MPA 2.5mg Comparison: placebo Outcomes: CHD, breast cancer Secondary outcomes: global index of risks and benefits, primary outcomes + stroke, PE, Colorectal Ca and other Ca, Hip fracture, death from other causes

Answer 9

Women's health Initiative: Risks and benefits of estrogen + progesterone in healthy postmenopausal women - principal results from WHI RCT, WHI (JAMA 2002) Primary: Increased! - CHD + 7 - Br Ca +8 (significant after 5 years) Secondary outcomes total of 19 extra risk events/10,000 woman years - More: stroke +8, PE +8 Less: colorectal Ca -6, Hip fracture -5 No significant effect on total mortality

Answer 10

Women's health Initiative: Risks and benefits of estrogen + progesterone in healthy postmenopausal women - principal results from WHI RCT, WHI (JAMA 2002) strengths - large numbers - 6y f/up Limits - Trial stopped when overall finding of harm for breast Ca and GIS (5.2 yrs) - only one dose and formulation tested (CEE and MPA) - results don't apply to lower dose MHT regimes or other forms of E or P e.g. transdermal - doesn't differentiate effect from E vs, P - results don't apply to E only - average age 63 - higher than those using HRT for sx (50% past/present smokers) - Nil appropriate screening for significant comorbidities and were included

Answer 11

Trial demonstrates increased risk of harm in older women using HRT (stoke, VTE, CHD, Breast Ca) Did not demonstrate increased CVD risk in younger women ie. <10 years after menopause Overall risks>benefits at 5 yrs. No effect on mortality, don't use E+P for primary prevention of CHD

Answer 12

Provision of no-cost, long acting contraception and teenage pregnancy. Secure et al 2014 Large prospective cohort study - 1404 teenage girls and women Aim: designed to promote the use of LARCs to reduce unintended pregnancy in the St. Louis region

Answer 13

Provision of no-cost, long acting contraception and teenage pregnancy. Secure et al 2014 Population: 9256 girls and women aged 14-45 Intervention: participants were educated about reversible contraception, with an emphasis on the benefits of LARC methods, were provided with their choice of contraception at no cost and followed for 2-3 years Comparison: National US data Outcomes - pregnancy, birth and induced abortion rates among teenage girls and women 15-19 of age in this cohort

Answer 14

Provision of no-cost, long acting contraception and teenage pregnancy. Secure et al 2014 -72% chose IUD or implant - remaining 28% chose another method - Lower rates of pregnancies, births and abortions in CHOICE participants (substantially lower) - Continued to use LARC methods for longer than shorter-acting methods

Answer 15

Provision of no-cost, long acting contraception and teenage pregnancy. Secure et al 2014 strengths - Large numbers Limitations - Information about pregnancy was self-reported could be underestimated in CHOICE cohort - Regular surveys may contribute to adherence to their contraception - Generalisability is uncertain

Answer 16

Provision of no-cost, long acting contraception and teenage pregnancy. Secure et al 2014 When barriers to contraception (lack of knowledge, limited access and cost) are removed and the use of the most effective contraceptive methods are encouraged a large percentage opted for a LARC Rates of pregnancy, birth and abortion in CHOICE cohort were below the most recent corresponding national rates and below the CDC 2015 goal

Answer 17

Effects of conjugated equine estrogen in postmenopausal women with hysterectomy - the women's health initiative RCT 2004 Double blind RCT - 10,739 women Aim: to assess effects of MHT on major disease incidence in healthy postmenopausal women

Answer 18

Effects of conjugated equine estrogen in postmenopausal women with hysterectomy - the women's health initiative RCT 2004 Population: 50-79y (avg 63) post menopausal, previous hysterectomy, likely to stay in same area >3y. No breast Ca Intervention: CEE 0.625 mg Comparison: placebo Outcomes: CHD, Breast Ca Secondary outcomes: globe index of risks and benefits, primary outcomes + stroke, PE, colorectal Ca, Hip fracture, death from other causes

Answer 19

Effects of conjugated equine estrogen in postmenopausal women with hysterectomy - the women's health initiative RCT 2004 Primary: no difference - No significant diff CHD RR 0.91 - No sig diff Breast Ca RR 0.77 (CI 0.59-1.01) Secondly outcomes: no difference in overall global index (+2 events, NS) + significant increase stroke +12/10,000 women years (39% increase) +sig increase DVT HR 1.47 - sig decrease hip fracture HR 0.6 lower (6 less) No sig difference on overall mortality, colorectal Ca, PE

Answer 20

Effects of conjugated equine estrogen in postmenopausal women with hysterectomy - the women's health initiative RCT 2004 strengths - large numbers Limitations -Terminated early - similar results with E+P- deemed unacceptable risk, a longer intervention may have provided stat sig evidence esp CHD and BCa - Lower than anticipated rates for CHD and hip# reduce the power -Adherence to protocol 53%- high discontinue of meds (dilute CEE effect) -Only one dose and formulation tested -Average age 63yo- higher than those using HRT for Sx -Nil appropriate screening for significant comorbidities and were included

Answer 21

Effects of conjugated equine estrogen in postmenopausal women with hysterectomy - the women's health initiative RCT 2004 CEE did not change risk of CHD or Br Ca or mortality but did reduce fracture and increase risk of stroke/DVT

Answer 22

A comparison of medical management with misoprostol and surgical management for early pregnancy failure, Zhang NEJM 2005 RCT - 652 women Aim: Evaluate safety, efficacy and acceptability of medical vs surgical management of miscarriage

Answer 23

A comparison of medical management with misoprostol and surgical management for early pregnancy failure, Zhang NEJM 2005 Population: - Anembyronic gesetation (35%) MSD 16-45mm - Embryonic death (60%) CRL 5-40mm no FH - Sac <2mm over 5d, <3mm over 7d - Rise in hcg <15% over 2 d with YS seen - Incomplete mc with >30mm RPOC - Inevitable mc <45mm sac, <40mm crl Intervention - Misoprostol 800 mag pv D1, repeated D3 if USS incomplete, ERPOC D8 if incomplete Comparison: surgical management Outcome: treatment failure: surgical treatment within 30 days

Answer 24

A comparison of medical management with misoprostol and surgical management for early pregnancy failure, Zhang NEJM 2005 - misoprostol = 16% treatment failure vs 3% surgical - 70% expulsion by D3, 84% success by D8 - 80% would use again and recommend to others - more pain/nausea/vomiting/diarrhoea - lower success in anembryonic gestation - Sig more Hb drop >30 surgical - 97% success No sig difference in complications: pelvic infection, haemorrhage same <1% no sig diff in frequency of ED visits <24 hours

Answer 25

A comparison of medical management with misoprostol and surgical management for early pregnancy failure, Zhang NEJM 2005 Strengths - strict inclusion criteria and well defined end points - minimal loss to FU Limitations - unblinded - small numbers incomplete miscarriages (as RPOC >3 cm) - Included varying different types of MC - heterogenous - One dose regime only

Answer 26

A comparison of medical management with misoprostol and surgical management for early pregnancy failure, Zhang NEJM 2005 treatment of early MC with 800 msg OV is safe and acceptable with 85% success at D8 with no difference in infection or haemorrhage

Gynae Landmark Trials Flashcards

(50 cards)