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FPIN Journal Club

SYSTEMATIC REVIEW WORKSHEET


SPEAKER NOTES
Title: Is this pregnancy viable?
Journal Club Author: Kate Rowland, MD The University of Chicago
PURL Citation: Slattendgren A, Prasad S, Oyola, S. Is this pregnancy viable? J
Fam Pract. 2013; 62 (6).
Original Article: Verhaegen J, Gallos ID, van Mello NM, et al. Accuracy of a
single progesterone
test to predict early pregnancy outcome in women with pain or bleeding:
meta-analysis of cohort studies. BMJ. 2012;345:e6077.
Journal Club Editor: Corey Lyon, DO University of Colorado
Definitions
Systematic review:
A review in which evidence on a topic or research question has been
systematically identified, appraised and summarized according to
predetermined criteria.
Meta-analysis:
A statistical technique. Summarizes the results of several studies into a
single estimate, giving more weight to larger studies.
1. What question did the study attempt to answer?
Patients Pregnant women <14 weeks gestational age with pain or
bleeding and an inconclusive ultrasound or no ultrasound
Intervention a single serum progesterone measurement
Comparison no progesterone measurement
Outcome viable pregnancy (no miscarriage, no ectopic)
Did the study address an appropriate and clearly focused question
Yes
No
2. Determining relevance:
a. Did the authors study a clinically meaningful
and/or a patient oriented outcome?
Yes
b. The patients covered by the review similar to your population
No
3. Determining validity:
a. What type of studies are included in the review?
Diagnostic cohorts or clinical prediction rule generating cohorts
b. The literature search is sufficiently rigorous to identify all the
relevant studies?
Look for
Yes
No
Which bibliographic databases were used
Follow up from reference lists
Personal contact with experts

No
Yes

Search for unpublished as well as published studies


Search for non-English language studies
c. Did the reviews authors do enough to assess the
quality of the included studies?
Yes
The authors need to consider the rigor of the studies
they have identified.
d. If the results of the review have been combined, was it
reasonable to do so?
Consider whether
The results were similar from study to study
The results of all the included studies are clearly
displayed
The results of the different studies are similar
The reasons for any variations are discussed

Yes

No

No

4. What are the results?


a. What is the overall result of the review?
In the five studies that included women with pain or bleeding and an
inconclusive ultrasound, the progesterone test predicted a nonviable
(miscarraiage or ectopic) pregnancy with a pooled sensitivity of 74.6% (95%
CI, 50.6%-89.4%) and specificity of 98.4% (95% CI, 90.9%-99.7%), a positive
likelihood ratio of 45 (7.1- 289) and a negative likelihood ratio of 0.26 (0.120.57). In these five studies, the cutoff for progesterone was between 3.2 and
6 ng/mL. Below the cutoff (3.2-6 ng/mL), 99.2% of pregnancies were not
viable; above the cutoff, 44.8% were not viable.
Nineteen studies included women with pain or bleeding and no ultrasound.
Nine of these studies used a cutoff of 10ng/dL. In these studies, the
progesterone test had a pooled sensitivity of 66.5% (53.6% to 77.4%),
specificity of 96.3% (91.1% to 98.5%), positive likelihood ratio of 18 (7.2 to
45), and negative likelihood ratio of 0.35 (0.24 to 0.50). 96.8% of
pregnancies with a progesterone lower than 10ng/dL were not viable; 37.2%
of pregnancies with a progesterone high were not viable.
Definitions;
Sensitivity - SnOut (Sensitivity rules Out dz) so a high sensitivity tells us if
the test is negative, we can believe that the patient doesnt have the disease
(or in this case does not have a non-viable pregnancy is still pregnant)
Specificity - SpIn (Specificity rules In disease) so a high specific test tells
us that if the test is positive, we can believe the patient has the disease (or in
this case, has a non-viable pregnancy)
Positive likelihood ratio -The Likelihood Ratio (LR) is the likelihood that a
given test result would be expected in a patient with the target disorder (nonviable pregnancy).
- You can calculate it out from the sens/spec; LR+ = sens / (1-spec)
- Should be greater than 1, the higher the better!

- LR+ > 10 indicates a large change in likelihood, < 2 indicates no


change in likelihood
Negative likelihood ratio -determine the likelihood that a patient with a
negative result actually does not have the disease (does not have a nonviable pregnancy so is still pregnant)
- LR = (1-sens) / spec
- Should be between 0 and 1, the lower the better!
b. Consider;
Are we clear about the reviews bottom line results
No
Are the results presented with confidence intervals,
NNT, odds ratio, etc
5. Applying the evidence:
a. If the findings are valid and relevant, will this change
your current practice?
b. Is the change in practice something that can be done in
a medical care setting of a family physician?
c. Can the results be implemented?
d. Are there any barrier to immediate implementation?
No
e. How was this study funded? No funding!

Yes
Yes

No

Yes

No

Yes
Yes

No
No
Yes

6. Teaching Points
1. Generalizability to practice: only apply these findings to women
who are similar to the women who were studied
2. Cutoff points change what you tell a patient
This systematic review and meta-analysis demonstrate the need to identify
the population that is being studied when reading a research article. In this
case, applying the results wrong could lead you to draw an incorrect
conclusion or assumption, causing more worry and anxiety to a patient.
This article is very specific about the women who are included in the studies
that are combined in this meta-analysis. The women had to be less than 14
weeks pregnant, and all of them were experiencing some kind of symptom,
pain or bleeding or both. Since only these women were included, the results
can only be applied to similar women in practice.
This article asked two different questions:
1. what are the diagnostic characteristics of a single progesterone
measurement in women who have symptoms and have an inconclusive
ultrasound
2. what are the diagnostic characteristics of a single progesterone
measurement in women who have symptoms but no ultrasound?

The systematic review of the literature turned up 26 studies that the authors
planned to include. In the end, they were able to work with fourteen of them
(5 of 7 for the with-ultrasound group and 9 of 19 in the no-ultrasound group).
The 12 that were omitted were excluded because they did not use a cutoff
that was similar enough to the included studies cutoffs to allow them to be
combined in the meta-analysis.
Its important to note, when applying this to practice, that these two
questions were answered using different cutoff measurements for normal
progesterone. The authors chose the most common cutoffs from the included
studies to highlight in the text and to produce sensitivity and specificity
numbers and likelihood ratios. (For the interested or advanced crowds, figure
6 on page 10 shows the sensitivities and specificities generated by three
different cutoff points for normal and not normal progesterone levels in
women with symptoms but no ultrasound. The graphs neatly show that as
you increase the cutoff point, the sensitivity rises but the specificity falls.
More true negatives are identified, but at the cost of more false positives.