Cohort
R Hoey and K AllanDoes speculum examination have a role in assessing bleeding in early pregnancy?
Emergency Medicine Journal
2004;21:461-463
- Submitted by:Janda Stevens - MD
- Institution:Grand Rapids Medical Education and Research Center
- Date submitted:2nd May 2007
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes. To assess to what extent a speculum examination after a bimanual examination influences the accuracy of diagnosis and subsequent management of women with bleeding in early pregnancy in an
accident and emergency (A&E) department.
accident and emergency (A&E) department.
2
Design
2.1
Is the study design suitable for the objectives?
Yes. A prospective study was suitable for the objective.
2.2
Who / what was studied?
236 women less than 20 weeks gestation who present to the emergency department with the complaint of vaginal bleedingall pregnant women. Patients had to meet all criteria listed in box 2 for inclusion
in the study.
in the study.
2.3
Was a control group used if appropriate?
No control group.
2.4
Were outcomes defined at the start of the study?
Yes. Outcome was defined as change in diagnosis and/or management following speculum exam vs. no change in diagnosis and/or managment after speculum exam.
2.5
Was this the right sample to answer the objectives?
Yes
2.6
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
There was no statistical analysis to show the power of the results.
2.7
Were all subjects accounted for?
Yes.
2.8
Were all appropriate outcomes considered?
Yes - change in magement as a result of the speculum exam
2.9
Has ethical approval been obtained if appropriate?
Not stated in paper.
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
Yes. Using a standard questionaire diagnosis and management were recorded before and after a speculum exam.
3.2
Was the assessment of outcomes blinded?
No. Results were obtained by a standard questionnaire.
3.3
Was follow up sufficiently long and complete?
Yes. Diagnosis and management was an immediate decision and no further follow-up was necessary.
3.4
Are the measurements valid?
Yes
3.5
Are the measurements reliable?
Yes
3.6
Are the measurements reproducible?
Yes, Figure 1
4
Presentation of results
4.1
Are the basic data adequately described?
Yes
4.2
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
Yes
4.3
How large are the effects within a specified time?
Descriptive statistics only, confidence intervals were not used
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
Yes
5
Analysis
5.1
Are the data suitable for analysis?
Yes, for descriptive analysis
5.2
Are the methods appropriate to the data?
Yes
5.3
Are any statistics correctly performed and interpreted?
No statistical analysis was performed.
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
Yes
6.2
Is the discussion biased?
No
7
Interpretation
7.1
Are the author's conclusions justified by the data?
Yes. It concludes that a speculum exam following a bimanual exam rarely changes the diagnosis or managment of bleeding in early pregnancy.
7.2
What level of evidence has this paper presented? (using CEBM levels)
2b
7.3
Does this paper help me to answer my problem?
Yes, it shows that speculum exams may be unnecessary in assessing bleeding in early pregnancy.
8
Implementation
8.1
Can any necessary change be implemented in practice?
Yes. Speculum exams may be unnecessary in the patient with bleeding in early pregnancy.
8.2
What aids to implementation exist?
A speculum examination arguably takes additional time, equipment, and expertise. It may be uncomfortable and stressful for the patient, especially when performed by an A&E SHO who is unlikely to have postgraduate training in gynaecology. Patients may also worry about the safety of
the fetus.
the fetus.
8.3
What barriers to implementation exist?
Some hospitals have standard guidelines for managing these patients that includes a speculum examination. In the initial assessment of the
pregnant patient many authors recommend both bimanual and speculum examinations to assess the cause of the bleeding and the state of the os
pregnant patient many authors recommend both bimanual and speculum examinations to assess the cause of the bleeding and the state of the os
8.4
Are the study patients similar to your own?
Yes.
8.5
Does the paper give any conclusions that will affect what you will offer or tell your patient?
In the minority of cases the speculum examination led to a change in diagnosis and in management plan. The authors feel the need for speculum should be assessed on a case by case basis depending on whether the findings on bimanual are conclusive. If the clinician is confident with bimanual there is little to be gained from a speculum examination. Each patient should be treated independently and the examination tailored accordingly.