PRESENTation
Effect on bone density after Depo Medroxyprogesterone contraception use
Background of DMPA IM injection (aka. Depo shot)"
How does DMPA work to achieve contraception? Inhibits ovulation, thickening of cervcial mucus, and changes in endometrium
Journal club agenda
Appraising/Discussing Shared information
Background
Debrief/Open discussion
Question Development
Managing information
Feed back
Reminder for creating a best practice
How does osteopathic paradigm fit into this topic?
Review Literature Search Summary
The information pyramid
Why is this important?
- Depo medroxyprogesterone acetate (DMPA) is an injectable progesterone that has been used worldwide for now 60 years. - DMPA is especially useful for teens/womens who do not wish to pill everday and/or who do not wish to have foreign body injected into the body (ex. IUD) - Patients who had good results with DMPA most of times prefer go back on DMPA. - Some patients do not exactly remember how long they were on DMPA treatment for their contraception. - However, it has been known that - it may delay return to fertility - it may affect bone density/increase risk of osteoporosis-
Question Development
PICO Model
Patient population - Women aged 25-35 years old who wants contraception Intervention - Treatment of DMPA injection for contraception Comparison - Comparison of Bone mineal density in Women on Depo vs. Nonhormonal contraception Outcome - significant increase/recovery in BMD post treatment
Is it safe to restart Patient on DPMA injection if they have been on the contraception previously?
Information Management
01
How do we create a best practice?
02
How can we emphasize our practice paradigm?
03
How were the articles selected?
04
Where do the articles fit on the information pyramid
What does this mean?
Creating a Best Practice
Subtitle
Defining the Osteopathic Paradigm
Holistic & patient centered
Services/training
Philopsophy/ Eduation
Manipulative treatment/ Primary care core
Focus/Emphasis
The Osteopathic paradigm
Structure/function relationships & Psychosocial needs
NCBI search of articles pertaining to the topic: - Key words: Bone mineral Density, Depo injection, contraception - Utilizied Libriarin at Kettering Health - Large amount of studies looking at populations who inject drugs vs. who doesn't - But unable to find research that looks at BMD after reinitation of Depo shot
Literature Search
- Large study with over 500 participants -Compared outcomes of BMD who are receiving Depo contraception vs. non users - Monitored participants for 7 years - Multiple study sites - Cohorts matched at each study stide on basis of race and current smoking status.
Literature Search
The Pyramid!
Subtitle
Prospective cohort study
Limitations of Prospective Cohort Design
- Long duration and Large Sample size
- Not suitable for rare disease
- Follow up bias : Possibility of loss to follow up, which can introduce bias
- Cost and time: can be expensive and is time consuming
Advantage of Prospective Cohort Design
- Can provide clarity of the temporal sequesnce
- Allows for a calculation of incidence
- Can facilitate study of rare exposure
- It allows for the examination of multiple effects
- Works to prevent selection bias
- Provides a significant recall structure to reduce error states
Purpose
"Purpose was to "assess BMD changes associated with use of DMPA - IM during up to 4.6 years of treatment and up to 1.8 years of posttreatment follow up" given several studies have found "no significant differences in BMD between past users of DMPA and those who had never used DMPA" (Petitt et al)
Purpose!
Methods
- Phase 4, open label, prospective, matched cohort study
- Total of 608 patients where included in the study
- Women in 25-35 years of age who had regular menses or who were postpartum were selected in the study
- Out of 608 patients, treatment group received 150 mg DMPA IM every 12 weeks for up to 4.6 weeks. Control group were on nonhormal contraception (including barrier protection, IUD, tube ligation or patient with partner with vasectomy)
- Changes in BMD, lipid profiles, body weight, and biochemcial markers of bone metabolism were compared.
- (Women were excluded from study if they had suspected pregnancy, undiagnosed vaginal bleeding, current/past Hx of thromboembolic disorders, cardiovascular disease, history of cancer, known/suspected breast cancer, or abnormal cervical cytology, liver/renal disease, moderate HTN, abnormal glucose leve/hyperthyrodisim, present or past Hx of substance abuse)
Methods
- Statistical Methods
- Obtained modified intent to treat population given there were many who withdrawed from study during duration of study due to subject request, loss to follow up , protocol noncompliance
- Assess using Observed case analysis, where only observed data were evaluated without making adjustment for missing values
- Statistical test that was used were two sided, with a p value of <0.05 which was considered statiscally signficant.
- Within treatment differences, paired t tests and x^2 test was used for categorical variables.
Patient Demographic and baseline characteristics
Results
Results
Results
Conclusion: "Results showed BMD decline during DMPA-IM use, following discontinuation, significant incrased in BMD occur through 96 weeks posttreatment".
Results
Summary: This study observed that there was significant decline in BMD in total hip and lumbar spine of DMPA-IM users compared with nonhormonal subjects after 5 years of treatment, followed by a substantial degree of BMD recovery after discontinuation of DMPA-IM. After 96 weeks of discontinuation, total hip BMP had returned to almost to baseline whereas BMD for lumbar spine showed partial recoverty.
'Number Needed to treat'
Absolute Risk = Number of Events in Group / Total number in Group ARR = (AR Control) - (AR Treatment ) NNT = 1/ARR
Stregths vs. Limitations
Strengths: - No recall bias - No selection bias -subjects are enrolled in prospective cohort studies before they have experienced the outcome of interest (BMD) - Long duration of study/monitoring - Were able to assess multiple affects from DMPA
Limitations: - Many people withdrew from the study - Limited age group (25-35 year old participants) - Limited variables in race (majority of participants were white) - Limited control on exact eating habit/exercise (lifestyle factors) -Study was supported by Pfizer (Depo is manufactured by Pfizer)
Overall Article Appraisal
Question of safety of continuing /restarting Depo shot was well defined. However, question of safety of restarting Depo shot (after period of nontreatment) was not answered. -Significant nubmer of patients were not accounted for final outcome which could alter final data - It was unclear where each group of each participants were selected from. - it is unclear whether lifestyle variables such as food, physical activity was well controlled
How can we improve?
- PCP should have more in depth conversation of possibility of BMD changes with longer duration of Depo injection - Also, may need to discuss patient's plan for pregnancy/pregnancies
Was a Best Practice Created?
PICO MODEL
PICO Model
Patient population - Women aged 25-35 years old who wants contraception Intervention - Treatment of DMPA injection for contraception vs nonhormonal contraception Comparison - Comparison of Bone mineal density in Women on Depo vs. Nonhormonal contraception Outcome - significant recovery in BMD post treatment. However, compared to control group, had more BMD with significant number of patients who lost to follow up.
What are the Osteopathic Implication?
- Osteopathic care centeres on Mind, Body, and Spirit - Primary care providers are able to have long term relationship with patients, allowing providers to know about the patient better. - In these circumstances, we may be able to discuss or recommend better option of contraception if patient wants to be on Depo injection longer than 2 years or want to restart Depo injection after gap of nonuse. - May be able to influence more on healthier lifestyle habits that could maximize BMD recovery post Depo injection
Discussion Points
- How can we strengthen this study design? - what additional questions could be asked? - what limitation could we see in implementing this in residency setting or in our patient population? - Do you feel this will change how your visit goes when encountering Depo injection patients?
Additional articles were looked at:
Additional articles were looked at:
Additional articles were looked at:
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Depo shot
Hochong Bang
Created on September 28, 2024
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Transcript
PRESENTation
Effect on bone density after Depo Medroxyprogesterone contraception use
Background of DMPA IM injection (aka. Depo shot)"
How does DMPA work to achieve contraception? Inhibits ovulation, thickening of cervcial mucus, and changes in endometrium
Journal club agenda
Appraising/Discussing Shared information
Background
Debrief/Open discussion
Question Development
Managing information
Feed back
Reminder for creating a best practice
How does osteopathic paradigm fit into this topic?
Review Literature Search Summary
The information pyramid
Why is this important?
- Depo medroxyprogesterone acetate (DMPA) is an injectable progesterone that has been used worldwide for now 60 years. - DMPA is especially useful for teens/womens who do not wish to pill everday and/or who do not wish to have foreign body injected into the body (ex. IUD) - Patients who had good results with DMPA most of times prefer go back on DMPA. - Some patients do not exactly remember how long they were on DMPA treatment for their contraception. - However, it has been known that - it may delay return to fertility - it may affect bone density/increase risk of osteoporosis-
Question Development
PICO Model
Patient population - Women aged 25-35 years old who wants contraception Intervention - Treatment of DMPA injection for contraception Comparison - Comparison of Bone mineal density in Women on Depo vs. Nonhormonal contraception Outcome - significant increase/recovery in BMD post treatment
Is it safe to restart Patient on DPMA injection if they have been on the contraception previously?
Information Management
01
How do we create a best practice?
02
How can we emphasize our practice paradigm?
03
How were the articles selected?
04
Where do the articles fit on the information pyramid
What does this mean?
Creating a Best Practice
Subtitle
Defining the Osteopathic Paradigm
Holistic & patient centered
Services/training
Philopsophy/ Eduation
Manipulative treatment/ Primary care core
Focus/Emphasis
The Osteopathic paradigm
Structure/function relationships & Psychosocial needs
NCBI search of articles pertaining to the topic: - Key words: Bone mineral Density, Depo injection, contraception - Utilizied Libriarin at Kettering Health - Large amount of studies looking at populations who inject drugs vs. who doesn't - But unable to find research that looks at BMD after reinitation of Depo shot
Literature Search
- Large study with over 500 participants -Compared outcomes of BMD who are receiving Depo contraception vs. non users - Monitored participants for 7 years - Multiple study sites - Cohorts matched at each study stide on basis of race and current smoking status.
Literature Search
The Pyramid!
Subtitle
Prospective cohort study
Limitations of Prospective Cohort Design
Advantage of Prospective Cohort Design
Purpose
"Purpose was to "assess BMD changes associated with use of DMPA - IM during up to 4.6 years of treatment and up to 1.8 years of posttreatment follow up" given several studies have found "no significant differences in BMD between past users of DMPA and those who had never used DMPA" (Petitt et al)
Purpose!
Methods
Methods
Patient Demographic and baseline characteristics
Results
Results
Results
Conclusion: "Results showed BMD decline during DMPA-IM use, following discontinuation, significant incrased in BMD occur through 96 weeks posttreatment".
Results
Summary: This study observed that there was significant decline in BMD in total hip and lumbar spine of DMPA-IM users compared with nonhormonal subjects after 5 years of treatment, followed by a substantial degree of BMD recovery after discontinuation of DMPA-IM. After 96 weeks of discontinuation, total hip BMP had returned to almost to baseline whereas BMD for lumbar spine showed partial recoverty.
'Number Needed to treat'
Absolute Risk = Number of Events in Group / Total number in Group ARR = (AR Control) - (AR Treatment ) NNT = 1/ARR
Stregths vs. Limitations
Strengths: - No recall bias - No selection bias -subjects are enrolled in prospective cohort studies before they have experienced the outcome of interest (BMD) - Long duration of study/monitoring - Were able to assess multiple affects from DMPA
Limitations: - Many people withdrew from the study - Limited age group (25-35 year old participants) - Limited variables in race (majority of participants were white) - Limited control on exact eating habit/exercise (lifestyle factors) -Study was supported by Pfizer (Depo is manufactured by Pfizer)
Overall Article Appraisal
Question of safety of continuing /restarting Depo shot was well defined. However, question of safety of restarting Depo shot (after period of nontreatment) was not answered. -Significant nubmer of patients were not accounted for final outcome which could alter final data - It was unclear where each group of each participants were selected from. - it is unclear whether lifestyle variables such as food, physical activity was well controlled
How can we improve?
- PCP should have more in depth conversation of possibility of BMD changes with longer duration of Depo injection - Also, may need to discuss patient's plan for pregnancy/pregnancies
Was a Best Practice Created?
PICO MODEL
PICO Model
Patient population - Women aged 25-35 years old who wants contraception Intervention - Treatment of DMPA injection for contraception vs nonhormonal contraception Comparison - Comparison of Bone mineal density in Women on Depo vs. Nonhormonal contraception Outcome - significant recovery in BMD post treatment. However, compared to control group, had more BMD with significant number of patients who lost to follow up.
What are the Osteopathic Implication?
- Osteopathic care centeres on Mind, Body, and Spirit - Primary care providers are able to have long term relationship with patients, allowing providers to know about the patient better. - In these circumstances, we may be able to discuss or recommend better option of contraception if patient wants to be on Depo injection longer than 2 years or want to restart Depo injection after gap of nonuse. - May be able to influence more on healthier lifestyle habits that could maximize BMD recovery post Depo injection
Discussion Points
- How can we strengthen this study design? - what additional questions could be asked? - what limitation could we see in implementing this in residency setting or in our patient population? - Do you feel this will change how your visit goes when encountering Depo injection patients?
Additional articles were looked at:
Additional articles were looked at:
Additional articles were looked at:
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