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Landmark Trials > Gynaecology landmark > Flashcards

Gynaecology landmark Flashcards

1
Q

Effectiveness of Long-Acting Reversible Contraception (CHOICE project).
Author, journal, year.
Aim

A

New England Journal of Medicine, 2012.
Winner et al.
To assess the failure rate of common contraceptive methods vs LARCs in women at increased risk of unintended pregnancy

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2
Q

Effectiveness of Long-Acting Reversible Contraception (CHOICE project). Methodology

A

Large prospective cohort study.
Women (14-45y) selected their contraception (pill, patch, ring, depo, IUD, implant), given for free. Telephone f/u 3/12, 6/12, then every 6/12 after.

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3
Q

Effectiveness of Long-Acting Reversible Contraception (CHOICE project).
Results

A

7486 women. 156 pregnancies attributed to contraceptive failure.
At 1 yr, short acting failure rate 4.8%, LARC 0.3%, depo 0.1%
* (perfect use).
If <21y and used pill, patch, ring, risk of pregnancy double that of older group. LARC not a/w variable failure rate with age.

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4
Q

Effectiveness of Long-Acting Reversible Contraception (CHOICE project).
Conclusions

A

LARCs show lower failure rates than shorter acting alternatives, particularly among younger women

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5
Q

Effectiveness of Long-Acting Reversible Contraception (CHOICE project).
Strengths.

A

Large sample, prospective study, low loss to f/u, objective data gathering (e.g. pharmacy records)
Apart from depo / DMPA assessed typical use efficacy which is more clinically relevant

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6
Q

Effectiveness of Long-Acting Reversible Contraception (CHOICE project). Weaknesses

A

Not randomised (pt more likely to comply with pill if choose to take it). ? not generalisable to all populations - these women seeking contraception. No data on BMI.
No data on patient satisfaction.
Only counted perfect use for DMPA / depo, and typical use for other methods

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7
Q

Effect of screening on ovarian cancer mortality (PLCO).
Journal, author, year.
Aim

A

JAMA (Journal of the American Medical Association)
2011
Buys et al.
To evaluate the effect of screening on ovarian cancer mortality

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8
Q

Effect of screening on ovarian cancer mortality (PLCO).

Methodology

A

RCT. PLCO = prostate, lung, colorectal and ovarian cancer screening trial.
78,216 (excluded those with oophorectomy pre trial).
Randomised to yearly screening (6y with Ca125, 4y with TV USS) vs. usual care, followed up for max 13y.

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9
Q

Effect of screening on ovarian cancer mortality (PLCO).

Results

A

Mortality from ovarian cancer (primary outcome) not statistically significant between the two groups.
Ovarian Ca incidence not statistically significant b/w 2 groups. 77-78% of cancers high grade (3 or 4) in both groups (no observed stage shift with screening).
3285 false positive results, with 1080 women undergoing surgery - major complication rate of 15%.

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10
Q

Effect of screening on ovarian cancer mortality (PLCO).

Strengths

A

Randomised
Controlled
Good compliance with assigned groups.
Large sample - boundary for futility had been researched

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11
Q

Effect of screening on ovarian cancer mortality (PLCO).

Weaknesses

A

Unblinded (invasive tests - TV USS). Self-administered questionnaire - source of bias.
Were the Ca125 and TV USS cut offs appropriate? If changed then high risk of false positives

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12
Q

Effect of screening on ovarian cancer mortality (PLCO).

Conclusions

A

Simultaneous screening with CA-125 and TV USS compared with usual care did not reduce ovarian cancer mortality.
False positive screening test results associated with complications

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13
Q

Scottish pregnancy intervention (SPIN) study. A multicentre RCT of LMWH and low dose Aspirin in women with recurrent miscarriage.
Journal, year, author.
Aim

A

Blood, 2010.
Clark et al.
Does enoxaparin, aspirin, and intensive pregnancy surveillance reduce rates of pregnancy loss c.f. intensive pregnancy surveillance alone in women with >/=2 prev consecutive miscarriages.

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14
Q

Scottish pregnancy intervention (SPIN) study. A multicentre RCT of LMWH and Aspirin in women with recurrent miscarriage.
Methodology

A

Multi-centre RCT
UK and NZ.
Women <7/40 with 2+ prev consecutive misc <24/40 randomised to clexane, aspirin, intense surveillance vs. intense surveillance alone (2/52 USS to 12/40 then 4/52 USS to 28/40).

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15
Q

Scottish pregnancy intervention (SPIN) study. A multicentre RCT of LMWH and Aspirin in women with
recurrent miscarriage.
Results

A

22% pregnancy loss in pharmacological group, 20% in surveillance alone. No significant difference b/w the groups. No significant safety issues with clexane.
Thrombophilia prevalence similar in general population

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16
Q

Scottish pregnancy intervention (SPIN) study. A multicentre RCT of LMWH and Aspirin in women with
recurrent miscarriage.
Conclusion

A

LMWH and low dose aspirin for women with 2 or more
consecutive pregnancy losses has no measurable benefit in preventing further loss
compared with intensive fetal surveillance.

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17
Q

Scottish pregnancy intervention (SPIN) study. A multicentre RCT of LMWH and Aspirin in women with
recurrent miscarriage.
Strengths.

A

Well matched controls, RCT, multicentre.

Central collection and testing blood samples to ensure uniform detection of thrombophilia

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18
Q

Scottish pregnancy intervention (SPIN) study. A multicentre RCT of LMWH and Aspirin in women with
recurrent miscarriage.
Weaknesses

A

Is intensive surveillance practical and feasible?
Small sample size, unable to examine subgroups.
2 prev miscarriages, rather than 3
Does not test implantation theory as Rx started after pregnancy confirmed

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19
Q

The eVALuate study: Two parallel randomised trials, TLH vs. TAH, TLH vs. TVH.
Journal, year, author, aim

A

BMJ, 2004
Garry et al.
To compare the effects of lap hyst and abdo hyst in the abdominal trial and lap hyst and vag hyst in the vaginal trial

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20
Q

The eVALuate study: Two parallel randomised trials, TLH vs. TAH, TLH vs. TVH.
Methodology

A 
Two parallel, multicentre, randomised trials. UK and SA. 
Benign hyst patients. 
Abdo trial (876): TAH 292 vs. TLH 584
Vag trial (504): TVH 168 vs. TLH 336
F/u at 6/52, 4/12 and 1y
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21
Q

The eVALuate study: Two parallel randomised trials, TLH vs. TAH, TLH vs. TVH.
Results

A

Abdo trial - TLH a/w higher rate of major complications (11.1% vs. 6.2%), TLH longer operating time, TLH less pain and shorter hospital stay, 6/52 better quality of life
Vag trial - underpowered, TLH took longer and higher rate of detecting unexpected pathology

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22
Q

The eVALuate study: Two parallel randomised trials, TLH vs. TAH, TLH vs. TVH.
Conclusions

A

Laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy, longer operating time.
TLH less pain, quicker recovery and better short term quality of life.

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23
Q

The eVALuate study: Two parallel randomised trials, TLH vs. TAH, TLH vs. TVH.
Strengths

A

Randomised

Intention to treat analysis

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24
Q

The eVALuate study: Two parallel randomised trials, TLH vs. TAH, TLH vs. TVH.
Weaknesses

A

Trial underpowered for vag group. Ended before recruitment target reached.
Conversion to laparotomy major complication.
Surgeons less experienced than are now?
Significant 1y loss to f/u

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25
Q

Aspirin plus heparin or aspirin alone in women with recurrent miscarriage (ALIFE trial)
Journal, year, author, aim

A

NEJM, 2010
Kaandorp et al
To determine if aspirin and heparin or aspirin alone improve pregnancy rate in woman with unexplained recurrent miscarriage

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26
Q

Aspirin plus heparin or aspirin alone in women with recurrent miscarriage (ALIFE trial)
Methodology

A

Multi-centre randomized control trial in the Netherlands
364 women, 18-42y, 2+ miscarriages
Aspirin + LMWH vs. aspirin alone vs. placebo
Primary outcome: rate of live birth
Intention to treat analysis

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27
Q

Aspirin plus heparin or aspirin alone in women with recurrent miscarriage (ALIFE trial)
Results

A

No difference in the live birth rates between three groups – 54.5%, 50.8%, 57%
Those receiving combination therapy delivered 1 week earlier than placebo

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28
Q

Aspirin plus heparin or aspirin alone in women with recurrent miscarriage (ALIFE trial)
Conclusions

A

No difference in live birth rates for recurrent miscarriage with use of aspirin, LMWH or both.

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29
Q

Aspirin plus heparin or aspirin alone in women with recurrent miscarriage (ALIFE trial)
Strengths

A

Randomised control trial
Intention to treat analysis
Blinded aspirin

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30
Q

Aspirin plus heparin or aspirin alone in women with recurrent miscarriage (ALIFE trial)
Weaknesses

A

Broad definition of recurrent miscarriage. 40% of woman had previous live birth ?diluted results of the study.
Small numbers in trial ? underpowered.
LMWH not blinded.
Trial discontinued with 22 still in follow up.
Sponsored by GSK who manufacture LMWH

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31
Q

Breast cancer and HRT in the Million Women Study.

Journal, year, author, aim

A

The Lancet, 2003, Million Women Study Collaborators.

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

32
Q

Breast cancer and HRT in the Million Women Study.

Methodology

A

Prospective cohort study. 1,084,110 UK women age 50-64y (1/4). May 1996-March 2001. NHS breast cancer screening centres sent invitation for screening + questionnaire - ever users (current, past), never users, menopausal status.
Cancer registrations and deaths from NHS Central Registers

33
Q

Breast cancer and HRT in the Million Women Study.

Results

A

Average age 55.9y. 9364 invasive breast Ca, 637 deaths. Risk of BC higher in ever users than never users. Among ever users, risk increased among current but not past users. Greater risk of BC with E+P HRT. RR in current users increased with increasing total duration of use.

34
Q

Breast cancer and HRT in the Million Women Study.

Conclusions

A

Current use of HRT is associated with an increased risk of incident and fatal breast cancer. The effect is substantially greater for oestrogen-progestagen combinations than for other types of HRT.

35
Q

Breast cancer and HRT in the Million Women Study.

Strengths

A

Large size of cohort. Prospective collection of exposure information. All study participants had routine mammography soon after completing baseline questionnaires (reporting bias virtually eliminated). Main analysis restricted to post-menopausal women to limit confounding

36
Q

Breast cancer and HRT in the Million Women Study.

Weaknesses

A

Small numbers and short follow up for mortality data. Observational. Time order, information and detection bias (women on HRT more likely to participate), confounding. Biological plausibility - BMI known to be a RF, opposite in this study. Majority white 96%

37
Q

LACE

Journal, year, author, aim

A

Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free Survival Among Women with Stage I endometrial cancer. A randomised clinical trial

LACE = Laparoscopic Approach to Cancer of the Endometrium

Janda et al
JAMA, 2017

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

38
Q

LACE method

A

Multinational, randomised equivalence trial
760 women
Randomised to TLH or TAH
Intention to treat analysis

Stage 1 endometrioid adenocarcinoma on histology (any grade) + CT or MRI

Excluded uterine size >10/40

Pelvic LN dissection performed unless

  • Morbidly obese
  • Grade 1 or grade 2 + stage IA
  • Patient medically unfit for LN dissection
39
Q

LACE

results

A

Median follow up 4.5y

Disease free survival similar in both groups (~81%)
- favours TLH

No statistically significant difference in:

  • Recurrence of endometrial cancer
  • Overall survival

Intra-op adverse events similar

Post-op adverse events less frequent in TLH group
Costs lower in TLH group

TLH group - 6% converted to laparotomy

40
Q

LACE

conclusion

A

Among women with stage 1 endometrial cancer, the use of TAH c.f. TLH resulted in equivalent disease-free survival at 4.5y and no difference in overall survival. These findings support the use of TLH for women with stage 1 endometrial cancer

41
Q

LACE

Strengths

A 
Randomised
Prospective
Large, multicentred
Appropriately powered
Australia / NZ
Credentialing system to ensure surgeons proficient in both surgical techniques
42
Q

LACE weaknesses

A

Unable to blind surgeons or patients
- Unlikely to affect disease-free or overall survival - collected by clinical trial staff

LN dissection left to discretion of surgeon
- ? Impact on survival

Surgeons all screened to ensure competent / proficient at both approaches
- Can’t generalise to all surgeons

43
Q

Ovarian conservation at the time of hysterectomy for benign disease.

journal, year, author, aim

A

Parker et al

Obstetrics and Gynecology, 2005

Prophylactic oophorectomy is often recommended concurrent with hysterectomy for benign disease. The optimal age for this recommendation in women at average risk for ovarian cancer has not been determined

44
Q

Ovarian conservation at the time of hysterectomy for benign disease.

method

A

Retrospective analysis of published data for absolute and relative risk with oophorectomy or conservation

40-80y

4 strategies compared:
• Ovarian conservation +/- estrogen use
• Oophrectomy +/- estrogen use

45
Q

Ovarian conservation at the time of hysterectomy for benign disease.

results

A

Ovarian conservation without oestrogen therapy

  • Reduced CHD
  • Reduced hip fracture
  • Reductions outweigh the increase in mortality from ovarian cancer

> 64y - no statistical difference

46
Q

Ovarian conservation at the time of hysterectomy for benign disease.

conclusions

A

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

47
Q

Ovarian conservation at the time of hysterectomy for benign disease.

strengths

A

Large numbers

48
Q

Ovarian conservation at the time of hysterectomy for benign disease.

weaknesses

A

Probability estimates derived from case control studies

- Selection bias
- Reporting bias
- Chance

Predominantly white Caucasian populations, therefore not necessarily generalisable to all populations

49
Q

WHI E+P

journal, aim, author, year

A

Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principle results from the WHI randomised controlled trial

Women’s Health Initiative

JAMA, 2002

To assess the major health benefits and risks of the most commonly used combined hormone preparation in the US

50
Q

WHI E+P

method

A

Randomised controlled primary prevention trial
16,600 women

Follow up:

  • 6 week phone call
  • 6 monthly phone call
  • Annual clinic review + mammogram
  • ECG at baseline, 3y, 6y

All primary analyses use time-to-event methods and are based on the intention-to-treat principle

Age 50-79 years at initial screening
Intact uterus
Post-menopausal

Combined estrogen and progesterone
Vs. placebo

51
Q

WHI E+P

results

A

Mean age 63y

Over 1 year, 10 000 women taking E+P compared with placebo might experience:
\+7 CHD events
\+8 strokes
\+8 PEs
\+8 invasive breast cancers
  • 6 colorectal cancers
  • 5 hip fractures
52
Q

WHI E+P

conclusion

A

The results indicate that this regime should not be initiated or continued for primary prevention of CHD

53
Q

WHI E+P

weaknesses

A

Average age 63y - higher than those using HRT for symptoms

Only tested 1 drug regimen

High rates of discontinuation in the active treatment arm (42%)
High rate of crossover to active treatment in the placebo arm (10.7%)

Used women who had previous used HRT after “3 month washout period”

Unblinding rate high

54
Q

WHI E+P

strengths

A

Large numbers

Randomised

55
Q

WHI E

journal, aim, author, year

A

Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: The WHI randomised controlled trial.

The Women’s Health Initiative

JAMA, 2004

To investigate the effects of conjugated equine oestrogen on major disease events in healthy post menopausal women

56
Q

WHI E

methods

A

Randomised, double-blind, placebo controlled disease prevention trial

10,700 women randomised

Follow up

  • 6 week phone call
  • 6 monthly phone and annual clinic visit
  • ECGs at baseline 3, 6 and 9 years
  • Annual mammograms and breast exams

Age 50-79 years at initial screening
Previous hysterectomy

Oral oestrogen vs. placebo

57
Q

WHI E

results

A

Average follow up 6.8y

No difference between two groups for CHD

Incidence of stroke, VTE - in E group

Reduction in fractures in CEE group

Non significant lower rate of invasive breast cancer in E group

58
Q

WHI E

strengths

A

Large, randomised
Double blinded
- Low rate of unblinding

59
Q

WHI E

weaknesses

A

Higher than expected crossover from placebo to active hormone use

Trial terminated early
At time of study termination, 54% had already stopped taking study medication (similar between groups)

Average age 63 - higher than those using HRT for symptoms

Only one dose and formulation tested

60
Q

WHI E

conclusion

A

CEE did not change the risk of CHD, but did increase the risk of stroke and VTE.
Non-statistically significant reduction in risk of breast cancer with CEE.

61
Q

Provision of no-cost, long-acting contraception and teenage pregnancy

journal, aim, author, year

A

Secura et al

NEJM, 2014

To determine if promotion and access to no-cost LARCs would reduce unintended teenage pregnancy

62
Q

Provision of no-cost, long-acting contraception and teenage pregnancy

method

A

Contraceptive CHOICE Project
Prospective cohort study
St Louis
1404 females 14-19y

Followed for 2 or 3y
Telephone interviews every 6 months

Compared with nationally published data of teenage pregnancy rates in 2010

63
Q

Provision of no-cost, long-acting contraception and teenage pregnancy

results

A

72% chose IUD or implant

Teen pregnancy and abortion rates, were approx 4x lower than national average

Implant most common contraceptive choice for 14-17y
IUD most common for 18-19y

64
Q

Provision of no-cost, long-acting contraception and teenage pregnancy

strengths

A

Good follow up rates

Findings in keeping with data that LARC is more effective contraception (well established)

65
Q

Provision of no-cost, long-acting contraception and teenage pregnancy

weaknesses

A

Information on primary outcomes self reported

Regular survey of teens may have influenced adherence to their contraceptive method

National average in 2010 higher than in 2012 which was when data collection finished
- but still significant reduction

66
Q

Provision of no-cost, long-acting contraception and teenage pregnancy

conclusions

A

Teenage girls and women who were provided contraception at no cost and educated about LARC had rates of pregnancy, birth and abortion that were much lower than the national rates for sexually experienced teens

67
Q

A comparison of medical management with misoprostol and surgical management for early pregnancy failure.

journal, year, author, aim

A

Zhang et al

NEJM, 2005

To assess the efficacy, safety and acceptability of misoprostol for management of first trimester miscarriage

68
Q

A comparison of medical management with misoprostol and surgical management for early pregnancy failure.

method

A

RCT in the US
625 women
3:1
Miso vs. ERPOC

First trimester pregnancy failure
- Missed or incomplete miscarriage

Day 1: 800mcg PV
Day 3: repeat if RPOC on USS
Day 8: offered ERPOC if RPOC

69
Q

A comparison of medical management with misoprostol and surgical management for early pregnancy failure.

results

A

Average gestation at pregnancy failure – 7.6 weeks

Success rates at 30 days:

  • 84% for medical management
  • 97% for surgical management

Misoprostol had a lower rate of success for anembryonic pregnancies

No difference in rate of:

  • infection
  • bleeding requiring transfusion

similar to acceptability

70
Q

A comparison of medical management with misoprostol and surgical management for early pregnancy failure.

strengths

A

RCT
Relatively low rates of loss to follow-up
Well defined primary outcome

71
Q

A comparison of medical management with misoprostol and surgical management for early pregnancy failure.

weaknesses

A

Only tested one regime and had a resource intensive follow-up scheme for RPOC (i.e. a mandatory further USS)

May have been underpowered to detect adverse outcomes, particularly with surgical management

72
Q

A comparison of medical management with misoprostol and surgical management for early pregnancy failure.

conclusion

A

Treatment of early pregnancy failure with 800mcg pv misoprostol is a safe and acceptable approach, with a success rate of ~84%

73
Q

Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial)

Aim

A

BMJ, 2006
Trinder et al

Determine whether a clinically important difference exists in the incidence of gynae infection between surgical management and expectant or medical management of miscarriage

74
Q

MIST

Method

A

3 groups

Expectant management
- At home with no intervention

Medical management - pv misoprostol 800mcg - po mifepristone 200mg 24-48h prior

  • Admitted to hospital for misoprostol
  • Surgical evacuation offered if not successful within 8hr of miso

Surgical evacuation
- ERPOC under GA

75
Q

MIST

results

A

No difference in confirmed infection within 14 days

Expectant vs. surgical

  • Higher unplanned hospital admissions
  • High rate of unplanned surgical curettage

Medical - 398 vs. surgical (403)

  • Higher unplanned hospital admissions
  • High rate of unplanned surgical curettage

Cessation of bleeding after randomisation was significantly earlier in the surgical group

Incomplete miscarriage

  • Expectant management success rates of 75%
  • Medical management does not seem to offer greater success

Expectant management
- Used significantly more analgesia

Landmark Trials (2 decks)

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