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RANZCOG written Exam > Gynae Landmark Trials > Flashcards

Gynae Landmark Trials Flashcards

1
Q

What is the PLCO trial and aim

A

The effect of screening on ovarian cancer mortality - the prostate, lung, colorectal and ovarian cancer screening randomised control trial, 2011

RCT - 78,000 women

Aim: to assess effect of ovarian cancer screening on mortality

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2
Q

PLCO trial

PICO

A

The effect of screening on ovarian cancer mortality - the prostate, lung, colorectal and ovarian cancer screening randomised control trial

Population: 55-74 yr olds, nil previous lung/ovarian/CRC cancer

Intervention: Annual Ca-125 screening, abnormal >35 + TVUSS
Comparison: usual care

Outcomes: mortality from ovarian cancer

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3
Q

PLCO trial results

A

The effect of screening on ovarian cancer mortality - the prostate, lung, colorectal and ovarian cancer screening randomised control trial 2011

  • No difference in ovarian cancer mortality, diagnosis or stage
  • Increased harm from screening, 5% false + each –> OT –> 15% serious complication rate
  • PPV of ca-125 + TVUSS only 23%, only 60% of cancer screen detected
  • All cause mortality unchanged
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4
Q

Strengths/limitations of PLCO trial

A

The effect of screening on ovarian cancer mortality - the prostate, lung, colorectal and ovarian cancer screening randomised control trial 2011
Strengths
- large numbers
minimal screening outside protocol
limits
- not blinded
- no information re. which systemic therapy or surgeon both affect survival
- screening usually invasive test (TVUSS)

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5
Q

Summary of PLCO trial

A

The effect of screening on ovarian cancer mortality - the prostate, lung, colorectal and ovarian cancer screening randomised control trial 2011

screening intervention is not effective at reducing mortality from ovarian cancer in average risk women AND increases harm from intervention

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6
Q

What is the SPIN trial and aim

A

SPIN (Scottish Pregnancy Intervention) study: a multi centre, RCT of LMWH and LDA for recurrent miscarriage. Blood 2010

RCT - multi-country - 294 women

Aim: to assess whether aspirin + LMWH + monitoring is better than monitoring alone in those with unexplained recurrent miscarriage

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7
Q

SPIN
PICO

A

SPIN (Scottish Pregnancy Intervention) study: a multi centre, RCT of LMWH and LDA for recurrent miscarriage. Blood 2010

Population: at ANC <7/40 with history of 2+ consecutive pregnancy loss <24/40, no cause identified for recurrent MC

Intervention: aspirin 75 mg + LMWH 40 mg SC + monitoring

Comparison: monitoring alone

Outcome: loss of index pregnancy

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8
Q

SPIN trial results

A

SPIN (Scottish Pregnancy Intervention) study: a multi centre, RCT of LMWH and LDA for recurrent miscarriage. Blood 2010

  • No difference in outcomes
  • loss of about 20% in both groups
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9
Q

Strengths and limitations of SPIN trial

A

SPIN (Scottish Pregnancy Intervention) study: a multi centre, RCT of LMWH and LDA for recurrent miscarriage. Blood 2010

Strengths
- RCT
Limitations
- Design not robust enough to examine subgroups
- Small Numbers
- Looked at 2 rather than 3 consecutive miscarriages
- already 7 weeks along - further research into starting preconception

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10
Q

SPIN trial summary

A

SPIN (Scottish Pregnancy Intervention) study: a multi centre, RCT of LMWH and LDA for recurrent miscarriage. Blood 2010

LMWH + Aspirin DOES NOT reduce unexplained recurrent pregnancy loss

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11
Q

What is the LACE trial and aim

A

Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free survival among women with stage I endometrial Cancer. Janda et al 2017

Multinational randomised trial - 760 women

Aim: to investigate whether TLH is equivalent to TAH in women with treatment naive endometrial Ca

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12
Q

LACE
PICO

A

Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free survival among women with stage I endometrial Cancer. Janda et al 2017

Population: 760 women with stage 1 endometrioid endometrial Ca

Intervention: TLH
Comparison: TAH

Outcomes: disease-free survival assessed at 4.5 years after randomisation, secondary outcomes: recurrence of endometrial Ca and overall survival

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13
Q

LACE trial results

A

Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free survival among women with stage I endometrial Cancer. Janda et al 2017

no statistically significant difference in recurrence of endometrial Ca or overall survival between TLH or TAH

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14
Q

LACE trial strengths and limitations

A

Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free survival among women with stage I endometrial Cancer. Janda et al 2017

Strengths
- Randomised equivalence trial
- Nz population - generalisable
- Surgeons were accredited to perform in the study
Limitations
- Not blinded
- Randomisation was performed prior to the patient being scheduled for surgery
- Funding constraints - 2 phase design first focusing on QoL
- Inconsistency of pelvic and aortic retroperitoneal lymph node dissection

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15
Q

LACE trial Summary

A

Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free survival among women with stage I endometrial Cancer. Janda et al 2017

Women with early stage endometrial Ca - TLH is appropriate approach for treatment of stage 1 endometrial Ca

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16
Q

What is ALIFE trial and aim

A

Aspirin + Heparin or Aspirin alone in women with recurrent miscarriage. Kaandorp (NEJM2010)

RCT 364 women

Aim: does aspirin + heparin vs. aspirin alone improve live births rates vs. placebo

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17
Q

ALIFE trial
PICO

A

Aspirin + Heparin or Aspirin alone in women with recurrent miscarriage. Kaandorp (NEJM2010)

Population: 18-42y, 2 or more unexplained MC <20/40 attempting conception or <6/40

Intervention/comparison
- 80 mg aspirin to 36/40 + LMWH from 6/40 till labour
- 80 mg aspirin alone
- Placebo

Outcomes: rate of live birth

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18
Q

ALIFE trial results

A

Aspirin + Heparin or Aspirin alone in women with recurrent miscarriage. Kaandorp (NEJM2010)

no difference in live birth rates between groups ~ 55%
Those receiving combo therapy delivered 1 weeks earlier than placebo

No difference in the subgroup analysis of women with thrombophilia

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19
Q

ALIFE trial strengths/limitations

A

Aspirin + Heparin or Aspirin alone in women with recurrent miscarriage. Kaandorp (NEJM2010)

Strengths
- RCT
Limitations
- 2 or more MC rather than 3
- only 85% adherence to treatment
- Use of LMWH not blinded
- Not powered to assess effect of treatment on thrombophilia (prevalence was 16%)

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20
Q

ALIFE trial summary

A

Aspirin + Heparin or Aspirin alone in women with recurrent miscarriage. Kaandorp (NEJM2010)

LDA +/- heparin does not improve life birth rate for unexplained recurrent MC

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21
Q

Million women study and aim

A

Breast Cancer and hormone replacement therapy in the Million women study, Million woman study group, Lancet 2003

Aim: Effects of HRT on breast cancer incidence and mortality

22
Q

Million women study
PICO

A

Aspirin + Heparin or Aspirin alone in women with recurrent miscarriage. Kaandorp (NEJM2010)

Population: cohort study on million UK women 50-65 y gave info on HRT use and personal details, FU for cancer incidence and death
- 9364 Br Ca, 637 deaths
Inclusion: women recruited at time of triennial breast screening

Intervention: split according to use and type of HRT, menopausal status and baseline factors

23
Q

Million women study results

A

Aspirin + Heparin or Aspirin alone in women with recurrent miscarriage. Kaandorp (NEJM2010)

HRT - half had used at some time
Breast Ca
- current users at recruitment more likely to develop than never uses RR 1.66 (ss)
– E only RR 1.3 (ss)
– E+P RR 2 (ss)
also more likely to die from Br Ca RR 1.22
- Past users of HRT were not at increased risk of Br Ca/death RR 1.01 and 1.05
- Tibolone increased risk of Br Ca incidence 1.45 (ss) - less effect than E/P
- In current users, Br Ca increased with total duration of use
- Little variation in the RR between specific Es and Ps and their doses or between continuous or sequential regimens
- After 10 years of HRT = 5 additional breast Ca per 1000 users E only and 19 for E+P
- Effect of HRT or tibolone for increased Br Ca risk wears off by about 5 years

24
Q

Million Women Study strengths and limitations

A

Aspirin + Heparin or Aspirin alone in women with recurrent miscarriage. Kaandorp (NEJM2010)

Strengths
- Large numbers and long f/up
Limits
- Poor design
- Previous estradiol use - used then stopped had been included in never used group
- Endometrial Ca risk persists after stopping HRT
- Average age women 55.9 so higher risk group that women taking HRT in 40s and early 50s
- Only assessed the 75% of women who show up for screening

25
Q

Million women study summary

A

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

26
Q

Ovarian Conservation at the time of hysterectomy for benign disease

A

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

27
Q

Ovarian Conservation at the time of hysterectomy for benign disease
PICO

A

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

28
Q

Ovarian Conservation at the time of hysterectomy for benign disease. Parker

Results

A

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

29
Q

Ovarian Conservation at the time of hysterectomy for benign disease. Parker limitations and strengths

A

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

30
Q

Ovarian Conservation at the time of hysterectomy for benign disease. Parker (obstetrics and Gynaecology 2005)
Summary

A

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

31
Q

WHI RCT aim

A

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

32
Q

WHI E+P
PICO

A

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

33
Q

WHI E+P
Results

A

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

34
Q

WHI E+P
Strengths and limitations

A

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

35
Q

WHI E+P
summary

A

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

36
Q

The CHOICE contraceptive project and aim

A

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

37
Q

CHOICE
PICO

A

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

38
Q

CHOICE results

A

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

39
Q

CHOICE strengths and limitations

A

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

40
Q

CHOICE summary

A

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

41
Q

WHI E alone
Aim

A

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

42
Q

WHI E alone
PICO

A

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

43
Q

WHI E alone
Reulsts

A

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

44
Q

WHI E alone
strengths and limitations

A

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

45
Q

WHI E alone
summary

A

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

46
Q

Medical vs surgical for EP failure

A

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

47
Q

Medical vs surgical for EP failure
PICO

A

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

48
Q

medical vx surgical for EP failure
Results

A

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
49
Q

Medical vs surgical for EP failure
Strength/limitations

A

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

50
Q

Medical vs surgical for EP failure
summary

A

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

RANZCOG written Exam (3 decks)

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