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Landmark Trials > Gynaecology > Flashcards

Gynaecology Flashcards

1
Q

What was the aim of the JAMA Ovarian Ca Screening study 2011?

A

To evaluate the effect of screening for ovarian cancer mortality in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO)

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2
Q

What type of study was the JAMA 2011 Ovarian Ca Screening study?

A

Multicentre (USA), unblinded, RCT

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3
Q

What was the inclusion criteria of the JAMA 2011 Ovarian Ca Screening study?

A

Women aged 55y to 74y with no prior lung/ovarian/colorectal cancer

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4
Q

What was the intervention and comparision in the JAMA 2011 Ovarian Ca Screening study?

A

Intervention - Annual screening with Ca125 for 6y (abnormal >35) and TVUSS for 4y

Comparison - usual care

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5
Q

What were the primary and secondary outcomes the in the 2011 JAMA Ovarian Ca Screening study?

A

Primary - Mortality from ovarian, primary peritoneal and fallopian tube cancers

Secondary - ovarian Ca incidence, cancer stage, survival, potential harms of screening, all cause mortality

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6
Q

What were the main findings of the 2011 JAMA Ovarian Ca Screening study?

A

No difference in ovarian cancer mortality, all cause mortality, diagnosis or stage

Increase in harm from screening
- 5% of women had false positives and of those that went on to have surgeries, 15% had complications

  • PPV of Ca125 + TVUSS is only 23% and only 60% of cancers detected on screening
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7
Q

JAMA 2011 Ovarian Ca Screening Study conclusion?

A

In women in the general USA population, screening with Ca125 + TVUSS for ovarian cancer did not reduce overall cancer mortality and diagnostic evaluation of false-positive screening tests were associated with complications

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8
Q

JAMA 2011 Ovarian Ca Screening Study - strengths

A

Very large numbers (68000)
RCT
Clear screening protocol

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9
Q

JAMA 2011 Ovarian Ca Screening Study - weaknesses

A

Unblinded
Screening used an invasive test (TVUSS)
Minimal contamination

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10
Q

What was the aim of the Scottish pregnancy intervention study: a multicentre RCT of LMWH and low dose aspirin in recurrent miscarriage (SPIN 2010 Blood Journal)?

A

To assess whether aspirin + LMWH + intensive pregnancy surveillance reduces rates of pregnancy loss compared with intensive pregnancy surveillance alone in women with 2+ consecutive pregnancy losses.

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11
Q

What sort of study was the SPIN study?

A

Multi-centre (11), multi-country (2) unblinded RCT

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12
Q

What was the inclusion criteria in the SPIN study?

A

2+ consecutive pregnancy loss <24/40 and presented for antenatal care <7/40

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13
Q

What was the intervention and comparison in the SPIN study?

A

Intervention - LMWH 40mg SC + aspirin 75mg PO OD until 36/40 with intense pregnancy surveillance

Comparison - intensive pregnancy surveillance

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14
Q

What was the primary outcome in the SPIN trial?

A

Primary - pregnancy loss

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15
Q

What was the main the main result of the SPIN trial?

A

No significant difference in rates of pregnancy loss in both groups (~20%)

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16
Q

What was the conclusion of the SPIN trial?

A

LMWH + aspirin does not reduce the rate of pregnancy loss in women with 2+ prior consecutive miscarriages

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17
Q

SPIN trial - strengths

A

RCT

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18
Q

SPIN trial - weaknesses

A

Small numbers (300)
Studied just 2+ previous consecutive miscarriage - did not publish effects on of 3+ previous pregnancy loss
Does not provide use of these medications from pre-conception

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19
Q

What was the aim of the Effect of TLH vs TAH on disease-free survival among women with stage I endometrial cancer (LACE) study?

A

To investigate whether TLH is equivalent to TAH in women with treatment naive endometrial cancer

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20
Q

What type of study is the LACE study?

A

Multi-country (3), multi-centre (20), RCT

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21
Q

What was the inclusion criteria of the LACE study?

A

Women with endometrioid adenocarcinoma without extrauterine disease (stage I) and uterus <8/40 size

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22
Q

What were the interventions in the LACE trial?

A

TLH vs TAH

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23
Q

What were the primary and secondary outcomes in the LACE trial?

A

Primary - disease-free survival

Secondary - disease recurrence, patterns of recurrence and overall survival

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24
Q

What were the main findings of the LACE trial?

A

No statistically significant difference in disease-free survival at 4.5y, overall survival and recurrence rates of endometrial cancer after TLH vs TAH for stage I endometrioid adenocarcinoma

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25
Q

LACE - strengths

A

RCT
Included Australia and NZ centres - generalisable
Reasonably large numbers (760)

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26
Q

LACE - weaknesses

A

Unblinded (although unlikely to affect outcomes).
11% loss to follow-up

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27
Q

What was the aim of the Aspirin + Heparin or Aspirin Alone in Women with Recurrent Miscarriage NEJM 2010 study?

A

To determine whether aspirin + LMWH vs aspirin alone vs placebo improved live birth rates in women with unexplained recurrent miscarriage

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28
Q

What type of study was the NEJM 2010 LMWH/aspirin recurrent miscarriage study?

A

Multicentre (8 - Netherlands), blinded, RCT

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29
Q

What was the inclusion criteria in the NEJM 2010 LMWH/aspirin recurrent miscarriage study?

A

Women 18-42y with unexplained recurrent miscarriage (2+ <20/40), attempting to conceive or pregnant <6/40

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30
Q

What were the interventions and comparison in the NEJM 2010 LMWH/aspirin for recurrent miscarriage study?

A

Interventions:
- Aspirin 80mg/day + LMWH
- Aspirin 80mg/day alone

Comparison:
- Placebo

All from 6/40 until labour.

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31
Q

What were the primary and secondary outcomes int eh NEJM 2010 LMWH/aspirin recurrent miscarriage study?

A

Primary - rate of live births

Secondary - rates of miscarriage, IUFD (>20/40) and obstetric complications e.g. PET, HELLP, SGA, abruption, PTB

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32
Q

What were the main findings of the NEJM 2010 LMWH/aspirin recurrent miscarriage study?

A

No significant difference in live birth rates in all 3 groups.

Those receiving combination therapy delivered 1 week earlier than placebo.

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33
Q

What was the conclusion of the NEJM 2010 LMWH/aspirin recurrent miscarriage study?

A

Neither aspirin nor combined aspirin/LMWH improved live birth rates in women with unexplained miscarriage

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34
Q

NEJM 2010 LMWH/aspirin recurrent miscarriage study - strengths

A

RCT

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35
Q

NEJM 2010 LMWH/aspirin recurrent miscarriage study - weaknesses

A

Netherlands only centres - ?generalisable
Not blinded to clexane use
Small numbers (360)
Looked at 2+ miscarriage and did not publish data for 3+
Trial discontinued with 22 still in follow-up

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36
Q

What was the aim of the Breast cancer and HRT in the Million Women study? (Lancet 2003)

A

To investigate the effects of specific types of HRT on incident and fetal breast cancer

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37
Q

What type of study was the Million Women study?

A

Prospective cohort study of 1 million women

38
Q

What was the inclusion criteria of the Million Women study?

A

Women 50-64y recruited at the time of triennial breast screening

39
Q

What were the exposures in the Million Women study?

A
  • MHT use and type
  • Menopausal status
  • Baseline demographic factors
40
Q

What were the main findings in the Million Women study?

A

Statistically significant increase in breast cancer incidence (RR 1.66) and deaths (RR 1.22) in current MHT users

Statistically significant increase in breast cancer incidence in
- Combined MHT - RR 2.0
- Oestrogen only MHT - RR 1.3
- Tibolone - RR 1.45

Breast cancer deaths increased in risk with duration of use.

Increase in breast cancer incidence and deaths not seen in past users.

Endometrial cancers reduced in combined MHT users.

41
Q

Million Women study conclusion?

A

Current MHT use associated with increased risk if incident and fatal breast cancer, with the effect substantially greater in combined MHT

42
Q

Million Women study - strengths

A

Very large numbers
Long follow-up

43
Q

Million Women study - weaknesses

A

Poor design
Previous estradiol use included in never used group
Average age 55.9y - higher than the average age of women taking HRT
Selection bias (only women that present for screening)
- More likely to use MHT and higher SES

44
Q

What was the aim of the Ovarian Conservation at the Time of Hysterectomy for Benign Disease study? O&G 2005

A

To establish the optimum age at which prophylactic oophorectomy should be recommended for women at average risk of ovarian cancer

45
Q

What sort of study was the O&G 2005 Ovarian Conservation study?

A

Prospective observation trial using a Markov decision analytic model to estimate optimal survival strategy per 9 years

46
Q

What were the exposures in the O&G 2005 Ovarian Conservation study?

A
  • Ovarian conservation +/- oestrogen therapy
  • Oophorectomy +/- oestrogen therapy
47
Q

What was the inclusion criteria in the O&G 2005 Ovarian Conservation study?

A

Healthy women 40-80y who had hysterectomy for benign disease with published data from 1990

48
Q

What were the primary outcomes studied in the O&G 2005 Ovarian Conservation study?

A

Survival to 80 years
Ovarian cancer
Coronary heart disease
Hip fracture
Breast cancer
Stroke

49
Q

What were the main findings from the 2005 Ovarian Conservation study?

A

Ovarian conservation until age 65y benefits overall survival
- BSO <55y - 8.6% excess mortality by 80y
- BSO <59y - 4% excess mortality

Oestrogen replacement reduces the risk of mortality from CHD and hip fracture in women with oophorectomy

50
Q

What was the conclusion of the 2005 Ovarian Conservation study?

A

Ovarian conservation until at least 65y benefits long term survival for women at average risk of ovarian cancer when undergoing hysterectomy for benign disease

51
Q

2005 O&G Ovarian Conservation study - strengths

A

Large numbers

52
Q

2005 O&G Ovarian Conservation study - weaknesses

A

Probability estimates are derived mostly from case-controls studies - inherent possibility of selection bias, chance and reporting bias
Most women in studies caucasian 0 limited generalisability
Insufficient date on QoL
Definition of “average risk” of ovarian cancer was not provided

53
Q

What was the aim of the WHI combined MHT RCT? (JAMA 2002)

A

To assess the major health benefits and risks of oestrogen and progesterone in healthy post-menopausal women

54
Q

What type of study was the Risks and Benefits of Estrogen + Progestin in Healthy Postmenopausal Women (WHI) study? (JAMA 2002)

A

Multicentre (40, USA), placebo-controlled, RCT

55
Q

What was the inclusion criteria or the WHI combined MHT RCT?

A

Healthy postmenopausal women aged 50-79y with intact uterus

56
Q

What was the intervention and comparison in the WHI combined MHT RCT?

A

Intervention - Combined MHT in 1 daily tablet with 0.625mg conjugated equine estrogen and 2.5mg MPA

Comparison - matching placebo

57
Q

What were the primary outcomes in the WHI combined MHT RCT?

A

Coronary heart disease (MI or CHD death)

Invasive breast cancer

58
Q

What were the secondary outcomes of the WHI combined MHT RCT?

A

Global index of risks and benefits
- 2 primary outcomes plus stroke, PE, endometrial Ca, CRC, hip #, death due to other causes

59
Q

What were the main findings of the WHI combined MHT RCT?

A

Overall significant increase in primary outcomes
- CHD +7/10,000 women years
- Breast cancer +8/10,000 women years (significant after 5y use)

Overall extra 19 risk events/10,000 women years
- Increase in stroke and PE
- Reduction in CRC and hip #

60
Q

What was the conclusion of the WHI combined MHT study?

A

Overall risks exceeded benefits from use of combined oral MHT for an average of 5.2y follow-up

61
Q

WHI combined MHT RCT - strengths

A

Large numbers (16000)
6y follow-up

62
Q

WHI combined MHT RCT - weaknesses

A

Majority of study population age 60-69y - not reflective of population most likely to use MHT (50s)
Only tests 1x drug regimen (oral combined)
- data may not apply to transdermal/intrauterine formulations
42% discontinuation in active treatment arm and 10% cross over from placebo to active arm
No appropriate screening for co-morbidities

63
Q

What was the aim of the NEJM 2014 LARC teenage pregnancy study?

A

To assess whether removal of barriers to LARC (information lack, limited access, cost) reduces unintended pregnancy and birth rates among high-risk, sexually active teens.

64
Q

What type of study was the Provision of No-cost LARC and Teenage Pregnancy Study? (NEJM 2014)

A

Prospective cohort study

65
Q

What was the inclusion criteria in the LARC teen pregnancy NEJM 2014 study?

A

Adolescents 14-19y enrolled in the Contraceptive CHOICE project (counselling and free LARC or other contraceptive)

66
Q

LARC teen pregnancy NEJM 2014 study primary outcomes?

A

Rates of pregnancy, live birth and abortion at age 15-19y

67
Q

What were the main findings of the NEJM 2014 LARC teen pregnancy study?

A

Significant reduction in pregnancy, live birth and abortion rates in teens enrolled in CHOICE

  • Pregnancy 34 vs 158 per 1000
  • Live birth 19 vs 94 per 1000
  • Abortion 10 vs 41 per 1000
68
Q

NEJM 2014 LARC teen pregnancy study conclusion?

A

Teenage girls/women who were provided contraception at no cost and educated about reversible contraception and the benefits of LARC had much lower rates of pregnancy, birth and abortion

69
Q

NEJM LARC teen pregnancy study - strengths

A

Large numbers (1400)
Baseline characteristics of study population similar to source population

70
Q

NEJM LARC teen pregnancy study - weaknesses

A

USA - ?generalisability
Outcomes were self reported - possible bias
Teens surveyed regularly about contraceptive use - ?affected compliance

71
Q

What was the aim of the 2004 JAMA WHI oestrogen for PM women with hysterectomy study?

A

To assess the effects of oestrogen MHT after hysterectomy on major disease incidence in healthy postmenopausal women

72
Q

What sort of study was the WHI: Effects of Conjugated Equine Estrogen in Postmenopausal Women with Hysterectomy?

A

Double-blinded placebo-controlled RCT

73
Q

What was the inclusion criteria of the WHI oestrogen hysterectomy trial?

A

Healthy postmenopausal 50-79 who had undergone hysterectomy

74
Q

What was the intervention and comparison in the WHI oestrogen hysterectomy trial?

A

Intervention - 0.625mg/day conjugated equine oestrogen

Comparison - matching placebo

75
Q

What were the primary outcomes of the WHI oestrogen hysterectomy trial?

A

Coronary heart disease (MI or CHD death)

Invasive breast cancer

76
Q

What were the secondary outcomes of the WHI oestrogen hysterectomy trial?

A

Global index of risks and benefits
- 2 primary outcomes plus stroke, PE, endometrial Ca, CRC, hip #, death due to other causes

77
Q

What were the main findings of the WHI oestrogen hysterectomy trial?

A

No significant difference in the primary outcomes (breast cancer, CHD)

No significant difference in overall global index

Significant increase in stroke (+12 per 10,000 women years and DVT

Significant decrease in hip fracture (-6 per 10,000 women years)

78
Q

What was the conclusion of the WHI oestrogen hysterectomy study?

A

Conjugated equine estrogen did not change the risk of CHD or breast cancer or mortality, but did reduce fracture risk and increase stroke/DVT risk

79
Q

WHI oestrogen hysterectomy study - strengths

A

RCT
Large numbers (10,000)

80
Q

WHI oestrogen hysterectomy study - weaknesses

A

Tested only oral conjugated equine estrogen, did not test other types/preparations e.g. transdermal
High rates of discontinuation of study medications and crossover (Only 53% adherence to study protocol)
- can dilute effects
Study terminated early due to breast and CHD risk with combined MHT
Average age was 63y - higher than usual age of MHT use

81
Q

What was the aim of the NEJM 2005 medical vs surgical management for early pregnancy failure study?

A

To evaluate the safety, efficacy and acceptability of medical management of early pregnancy failure with misoprostol vs surgical management

82
Q

What type of study was A Comparison of Medical Management with Misoprostol and Surgical Management for Early Pregnancy Failure NEJM 2005?

A

Multi-centre (6), unblinded RCT

83
Q

What was the inclusion criteria of the 2005 NEJM medical vs surgical miscarriage study?

A

Early pregnancy loss
- Anembryonic gestation MSD 16-45mm
- Missed miscarriage CRL 5-40mm no FHR
- GS growth <2mm over 5d, <3mm over 7d
- Rise of HCG <15% of 2d with yolk sac seen
- Incomplete miscarriage >30mm RPOC
- Inevitable miscarriage <45mm GS, <40mm CRL

84
Q

What were the intervention and comparison in the 2005 NEJM medical vs surgical miscarriage study?

A

Intervention - 800mcg PV misoprostol, second dose if no POC passed by day 3
Comparison - MVAC

85
Q

What was the primary outcome of the 2005 NEJM medical vs surgical miscarriage study?

A

Treatment failure = MVAC within 30 days for unsuccessful firstline treatment

86
Q

What were the secondary outcomes in the 2005 NEJM medical vs surgical miscarriage study?

A

Adverse outcomes (e.g. fever, ED visit, haemorrhage, Hb drop, endometritis, N or V, diarrhoea, abdo pain, pain score) and acceptability

87
Q

What were the main findings of the 2005 NEJM medical vs surgical miscarriage study?

A

Statistically significant higher rates of treatment failure in misoprostol group 16% vs 3%

Miso
- 70% expulsion by day 3
- 84% expulsion by day 8
- more pain, nausea, vomiting, diarrhoea
- Lower success in anembryonic pregnancy

No difference in:
- pelvic infection
- haemorrhage
- ED visits <24h

88
Q

What was the conclusion of the 2005 NEJM medical vs surgical miscarriage study?

A

Treatment of early miscarriage with 800mcg PV misoprostol and safe and acceptable with 84% success rate

89
Q

2005 NEJM medical vs surgical miscarriage study -strengths

A

RCT, high powered
Strict inclusion criteria and well defined end points
Low loss to follow-up

90
Q

2005 NEJM medical vs surgical miscarriage study - weaknesses

A

Small numbers (600)
Unblinded
Heterogenous group of miscarriage type
4 centres in one country ?generalisable

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