Can we reassure women with post-menopausal bleeding by negative blind endometrial sampling?

We will discuss “Diagnostic workup for postmenopausal bleeding: a randomised controlled trial.” by van Hanegem and co-workers from 27 July 2016 for 7 days.

*This paper will be made free-to-view  approximately 10 days before the start of #BlueJC. The linked mini-commentary on this paper can be found via this study.

We are now on LinkedIn too: http://linkd.in/1BVrpad (simply ask to join)!

Start date: 27 July the discussion will open for 7 days between 27 July to 3 August 2016)

First hosted discussion session(s) on Twitter starts at: GMT+1 (British Summer Time) 8pm (using hashtag #BlueJC)

Host: @BlueJCHost

Platforms: Twitter, Facebook and LinkedIn 

BJOG_BlueJC_160x600WebBanner_Mar15_(reoriented)_3The Blue Journal Club is an international journal club on women’s health research based on Twitter (as @BlueJCHost). We start our conversation on the last Wednesday of every month and use the hashtag #BlueJC for our tweets. Simply add this hashtag (“#BlueJC”) to each tweet and we will capture it. Each #BlueJC opens for 7 days with an advertised start time. All BJOG #BlueJC papers also have complementary slide sets suitable for face-to-face journal clubs with your local colleagues. You can access the slide set of this paper here (click on the “supporting information” tab).

The discussion points are attached below (quoted from the published Journal Club guide)

Scenario

A post-menopausal woman was referred by her primary care physician with post-menopausal bleeding. Her transvaginal ultrasound showed an endometrial thickness of 9mm, but no other abnormality. She has a BMI of 26kg/m2, but no other medical history. You performed an endometrial sampling using Pipelle, which showed no malignancy. During the investigations, she had no further post-menopausal bleeding. Could you reassure this woman?

Description of research

Participants Women with post-menopausal bleeding (PMB), endometrial thickness > 4mm and benign endometrial sampling results
Intervention Operative hysteroscopy after saline infusion sonography (SIS)
Comparison Expectant management
Outcomes Primary outcome: recurrence of PMB within a year after randomisation

Secondary outcomes: time to recurrent bleeding and recurrent bleeding after > 1 year

Study design Multicentre randomised controlled trial (Dutch trial register number NTR2130)
Authors’ conclusion Operative hysteroscopy did not reduce recurrent PMB, but 6% of women with benign Pipelle biopsies were found to have high-risk endometrial pathologies.

Discussion Points

  • What advice would you give to the woman in the scenario?
  • Is outpatient operative hysteroscopy acceptable to post-menopausal women in your practice?
  • Can you describe the differences between a diagnostic randomised controlled trial and diagnostic accuracy study?
  • What are the strengths and weaknesses of this RCT?
  • Could you suggest an alternative primary outcome to answer the clinical question?
  • How would this alternative primary outcome impact on the design and conduct of this trial?
  • Base on the results of this RCT, does SIS enhance the current diagnostic work-up?
  • How does this RCT enhance your practice, in view of the existing evidence (see suggested reading)?

Suggested reading

  • Critical Appraisal Skill Programme (CASP). CASP checklist for Randomised Controlled Trials (http://www.casp-uk.net/).
  • Rodger M, Ramsay T, Fergusson D. Diagnostic randomised controlled trials: the final frontier. Trials. 2012 Aug 16;13:137. doi: 10.1186/1745-6215-13-137. PubMed PMID: 22897974
  • Cooper NAM, Barton PM, Breijer M, Caffrey O, Opmeer BC, Timmermans A, et al. Cost-effectiveness of diagnostic strategies for the management of abnormal uterine bleeding (heavy menstrual bleeding and post-menopausal bleeding): a decision analysis. Health Technol Assess 2014;18(24).

For those who want to understand hashtags, this may be a useful guide. For an introduction to #BlueJC, please refer to BJOG 2013;120:657–60. Follow @BlueJCHostthis blog and our Facebook page to receive news about #BlueJC.

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