Interpreting Statistical Output for Data Analysis PowerPoint Presentation
Data analysis
Anna Yi Purdue Global University MN 504 Scientific and Analytic Approaches to Advanced Evidenced-Based Practice Dr. Diggins
picot
What is it?
Population
Intervention
Comparison
Outcome
Time Frame
“Formulation of a well-constructed PICOT question yields a pathway for seeking and applying the body of existing knowledge and provides a mechanism for determining whether the question, as posed, can be answered” (Elias et al., 2015, p. 594).
intro
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My Picot question
In women with history of recurrent miscarriages(P), does taking progesterone compared to low molecular weight heparin(I/C) decrease the risks of recurring pregnancy loss(O)?
Clinical questions
Background questions provide general knowledge (Melnyk and Fineout-Overholt, 2019)
What is considered a miscarriage?
What is the first step after recurring miscarriage?
What are the causes of pregnancy loss?
Foreground questions can be answered with studied evidence and using journal articles (Eldredge, 2008).
Does progesterone supplements lower chances of another miscarriage?
Can taking low doses of aspirin prevent miscarriage?
Defined key clinical question with reference to evidence-based databank (for example, Pubmed, Medline, CINAHL, etc).
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Key clinical questions
Are there any maternal risks or complications in hormone or anticoagulant therapy?
What are potential complications or associated negative fetal outcomes in hormone or anticoagulant therapy?
What are other usual methods of treatment for recurrent miscarriages?
Level I
“Evidence from a systematic review or meta-analysis of all relevant randomized controlled trials (RCT)” ((Melnyk & Fineout-Overholt, 2019, p. 18)
Level II
“Evidence obtained from well-designed RCTs” (Melnyk & Fineout-Overholt, 2019, p. 18).
Levels of evidence
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Cochrane Database
Cochrane offers a smaller, manageable amount of studies including randomized controlled trial (RCTs) and systematic Cochrane reviews (Melnyk & Fineout-Overholt, 2019).
Keywords searches: “recurrent miscarriages” AND “progesterone” AND “low molecular weight heparin” AND ”aspirin”
Time adjustment to search publications within 6 years
Results: 5 Cochrane reviews, 27 trials
Level one: evidence from a systematic review or meta-analysis of all RCTs that are relevant highest level of evidence
Level two: evidence obtained from a well-designed RCT
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Level 1 evidence
Article 1: ”Progesterone for Preventing Miscarriages in Women with Recurrent Miscarriage of Unclear Etiology”
Objective: to determine the effectiveness and safety of using progesterone therapy to prevent reoccurring pregnancy loss
Method: A randomized controlled trial searching Cochranes Pregnancy and Childbirth’s Trails Register, MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCO)
Participants: 1684 women were a part of the 12 trials (8 trials compared with placebo and remaining 4 trials compared progesterone administration with no treatment)
Main Results: The meta-analysis shows that women who have experienced three or more miscarriages versus two showed reduction in miscarriage rates while taking progesterone. Also, probable reduction in miscarrying again for women taking progesterone versus placebo/control (Haas, et al., 2019).
Level one: evidence from a systematic review or meta-analysis of all RCTs that are relevant highest level of evidence
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Pubmed database
PubMed is a free database with access to citations from life science journals maintained by the National Center for Biotechnology Information (NCBI) at the NLM at the National Library of Medicine (Melnyk & Fineout-Overholt, 2019).
Keyword searches: “recurrent miscarriages” AND “low molecular weight heparin”
Time adjustment to search publications within 10 years
Results: 32 results, 10 RCTs
Level 2 Evidence
Article 2: "Low-Molecular-Weight-Heparin for the Treatment of Unexplained Recurrent Miscarriage With Negative Antiphospholipid Antibodies: A Randomized Controlled Trial”
Objective: Assessing the efficacy of low-molecular-weigh-heparin (LMWH) as a treatment for women who have experienced recurrent miscarriages (RM) and tested negative for antiphospholipid antibodies. The primary outcome is the continuation of pregnancy beyond 20 weeks (Shaaban, et al., 2017)
Method: An RCT of 300 women randomly assigned into 2 groups: study and control.
Participants: 300 women who are patients of Assiut Women Health Hospital and Nag-Hamady Central Hospital with 3 or more RM. (150 women receiving LMWH with daily folic acid as a study group and 150 women in the control group receiving just folic acid)
Main Results: A significant number of women who were in the study group taking LMWH (4500 IU subcutaneous) were able to continue their pregnancy over 20 weeks in comparison to the control group receiving just folic acid (500 mcg) (Shaaban, et al., 2017)
Referenced randomized control study research and systematic review of randomized control studies (Level 1 and 2 Evidence).
Level two: evidence obtained from a well-designed RCT
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Analysis of both levels of evidence
Article 1
Women with 3 or more miscarriages show reduction in miscarriage compared to women with two miscarriages.
95% CI 0.34 to 1.01
Reduction of miscarriage for women taking progesterone supplement compared to placebo/control group.
95% CI 1.00 to 1.13
P < 0.10
Moderate‐quality evidence
(Haas, et al., 2019).
Article 2
Women taking LMWH on top of folic acid in early pregnancy decreased chances of miscarriage before 20 weeks of gestation
Study group (4500 IU Tinzaparin sodium & 500 mc folic acid)
P= .002
Birth baby and discharged in women taking LMWH
P= .001
(Shaaban, et al., 2017)
Provides an overview of the evidence using descriptive statistics, inlcuding the sample size, p-factor and strength of evidence.
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conclusion
Negative maternal outcomes show little to no difference in using progesterone (Haas, et al., 2019). With a safe dose, LMWH shows to be safe however, a small percentage developed ecchymosis at injection site (Shaaban, et al., 2017).
Use of LMWH showed no cases of fetal congenital anomalies (Shaaban, et al., 2017). However, the evidence is considered low quality showing the effect in using progesterone and preterm birth (Haas, et al., 2019). Furthermore, there were no reports of neonatal death, congenital abnormalities, low birthweight (Haas, et al., 2019).
There is moderate quality of evidence that shows hormone therapy can reduce the risk of miscarriage for partners who have experience three or more miscarriages (Haas, et al., 2019). Also provided is a level two evidence (RCT) showing that starting LMWH early in pregnancy can decreases the chances of miscarriage before 20 weeks of gestation (Shaaban, et al., 2017).
conclusion
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references
Elias, B. L., Polancich, S., Jones, C., & Colvin, S. (2015). Evolving the PICOT method for the digital age: The PICOT-D. Journal of Nursing Education, 54(10), 594-599. doi:http://dx.doi.org.libauth.purdueglobal.edu/10.3928/01484834-20150916-09
Haas, D. M., Hathaway, T. J., & Ramsey P. S., (2019). Progestogen for preventing miscarriage in women with recurrent miscarriage of unclear etiology. Cochrane Database of Systematic Reviews, Issue 11. Art. No.: CD003511. DOI: 10.1002/14651858.CD003511.pub5.
Melnyk, B. M., & Fineout-Overholt, E. (2019). Evidence-based practice in nursing & healthcare: A guide to best practice (4th ed.). Philadelphia: Wolters Kluwer.
Shaaban, O. M., Abbas, A. M., Zahran, K. M., Fathalla, M. M., Anan, M. A., & Salman, S. A. (2017). Low-molecular-weight-heparin for the treatment of unexplained recurrent miscarriage with negative antiphospholipid antibodies: A randomized controlled trial. Clinical and Applied Thrombosis/Hemostasis : Official Journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis, 23(6), 567–572. https://doi.org/10.1177/1076029616665167
references
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