Analysis of a Biostatistical Article “A Pilot Study of the Nutritional States of Opiate-using Pregnant Women on Methadone Maintenance Therapy” PHE 5020 Priscilla Tolin MSN, RN Intro Article studied the nutritional intake of pregnant women in a methadone maintenance program This study is significant due to the importance of healthy prenatal habits for the pregnant woman and her fetus This article used reputable resources such as the Institute of Medicine, the National Institute of Health and the National Institute of Child Health and Human Development to provide important information needed for the background and rationale for this study. 2 Data National estimates of opiate use in pregnancy are low due to a limited number of women self reporting opiate use Screening studies have identified that 1.0-2.6% of pregnant women misuse opiates Data Opiate use during pregnancy puts the fetus at risk i.e. Preterm birth Low birth weight Neonatal withdrawal symptoms Methadone programs are encouraged as effective treatment Maintenance therapy with methadone has been the standard of treatment in opioid addiction in pregnancy to prevent complications of opioid use and narcotic withdrawal, encourage prenatal care and drug treatment and avoid risks to the patient associated with a drug culture ("Opioid Abuse," 2012). 4 Data Poor nutrition negatively impacts pregnancy Micronutrient deficiencies are detrimental to pregnancy Women who are underweight and have inadequate energy are at risk for adverse pregnancy outcomes Data collected for this study identified that maternal micronutrient deficiencies are detrimental to pregnancy and women who are underweight before pregnancy or those that do not have adequate energy intake are at risk for adverse pregnancy outcomes (Tomedi et al, 2012). Women should try to conceive at a normal weight for better obstetrical outcomes and improved preconception care is necessary in helping women to reach this goal (Rasmussen, Catalano, & Yaktine, 2009). 5 Hypothesis Opiate using pregnant patients on methadone therapy will have more nutritional deficiencies compared to non-drug using pregnant patients This pilot study is to describe the nutritional status of a cohort of opiate dependent pregnant women treated with methadone compared to a cohort od non-drug using pregnant women (Tomedi et al, 2012). 6 Study Design Methods Located at Magee Women’s Hospital in Pittsburgh, Pennsylvania 2006-08 Eligibility 20-35 weeks’ gestation Compliant with methadone treatment Participants N=22 opiate users eligible In order to be eligible, pregnant women that were 20-35 weeks’ gestation that were attending a methadone treatment program had to be compliant with the treatment, be HIV negative, intend on maintaining the pregnancy, not placing the baby up for adoption, and delivering their baby at Magee Women’s Hospital (Tomedi et al, 2012). The participants in this study were given information about the detai.

1. Analysis of a Biostatistical Article
“A Pilot Study of the Nutritional States of Opiate-using
Pregnant Women on Methadone Maintenance Therapy”
PHE 5020
Priscilla Tolin MSN, RN
Intro
Article studied the nutritional intake of pregnant women in a
methadone maintenance program
This study is significant due to the importance of healthy
prenatal habits for the pregnant woman and her fetus
This article used reputable resources such as the Institute of
Medicine, the National Institute of Health and the National
Institute of Child Health and Human Development to provide
important information needed for the background and rationale
for this study.
2

2. Data
National estimates of opiate use in pregnancy are low due to a
limited number of women self reporting opiate use
Screening studies have identified that 1.0-2.6% of pregnant
women misuse opiates
Data
Opiate use during pregnancy puts the fetus at risk i.e.
Preterm birth
Low birth weight
Neonatal withdrawal symptoms
Methadone programs are encouraged as effective treatment
Maintenance therapy with methadone has been the standard of
treatment in opioid addiction in pregnancy to prevent
complications of opioid use and narcotic withdrawal, encourage
prenatal care and drug treatment and avoid risks to the patient
associated with a drug culture ("Opioid Abuse," 2012).
4
Data
Poor nutrition negatively impacts pregnancy
Micronutrient deficiencies are detrimental to pregnancy
Women who are underweight and have inadequate energy are at
risk for adverse pregnancy outcomes
Data collected for this study identified that maternal
micronutrient deficiencies are detrimental to pregnancy and
women who are underweight before pregnancy or those that do
not have adequate energy intake are at risk for adverse
pregnancy outcomes (Tomedi et al, 2012). Women should try to

3. conceive at a normal weight for better obstetrical outcomes and
improved preconception care is necessary in helping women to
reach this goal (Rasmussen, Catalano, & Yaktine, 2009).
5
Hypothesis
Opiate using pregnant patients on methadone therapy will have
more nutritional deficiencies compared to non-drug using
pregnant patients
This pilot study is to describe the nutritional status of a cohort
of opiate dependent pregnant women treated with methadone
compared to a cohort od non-drug using pregnant women
(Tomedi et al, 2012).
6
Study Design Methods
Located at Magee Women’s Hospital in Pittsburgh,
Pennsylvania 2006-08
Eligibility
20-35 weeks’ gestation
Compliant with methadone treatment
Participants N=22 opiate users eligible
In order to be eligible, pregnant women that were 20-35 weeks’
gestation that were attending a methadone treatment program
had to be compliant with the treatment, be HIV negative, intend
on maintaining the pregnancy, not placing the baby up for
adoption, and delivering their baby at Magee Women’s Hospital

4. (Tomedi et al, 2012). The participants in this study were given
information about the details of this study and signed informed
written consent before participating. Initial information that was
gathered during their third trimester included their height and
pre-pregnant weight (Tomedi et al, 2012). The participants were
also given a Food Frequency Questionnaire (FFQ) to report
their usual dietary intake in the past 3 months and they were
required to give blood samples to assess for biomarkers of
nutrition (Tomedi et al, 2012).
7
Study Design Methods
Control Group
Eligibility
20-35 weeks’ gestation
Non-drug users
Participating in antidepressant study
Participants N= 119 non-drug users eligible
Study Design Methods
Data gathered from three methods
Food Frequency Questionnaire
Tracked food intake over 3 months
Biological markers in blood sample
Measures micronutrients
Self reported demographic details
Statistical Analysis
Pearson Chi-Square test
Student’s t-test
Multivariable linear regression models assessed independent
associations between variables

5. The FFQ was semi quantitative and provided a projection of the
amount of nutrients consumed by the participants (Tomedi et al,
2012). In order to analyze the level of micronutrients and
essential fatty acids consumed by participants, blood samples
were drawn to measure biological markers. The blood samples
were analyzed in a duplicate, blinded fashion measuring plasma
folate, maternal vitamin D, plasma ascorbic acid, serum
carotenoids, and serum ferritin and essential fatty acids (Tomedi
et al, 2012).
10
Statistical Findings
Methadone participants
Lower BMI
Mean 22.9 vs 26.4 in control group, p=.02
Higher energy intake from sweets
Mean 23% vs 12.9% in control group, p< .01
Lower concentrations of micronutrients
Ex. Vitamin C 70.5 mg/day vs 90.6 mg/day in control group
Discussion
“Our pilot study found that methadone maintained pregnant
women may be at an increased risk of entering pregnancy
underweight and with nutritional deficiencies”
(Tomedi et al, 2012, p. 192)
The findings in this study are important because it identifies
problems with the nutritional status of methadone treated

6. pregnant patients. Despite having similar intake as the control
group, the methadone maintained pregnant women had
significantly poorer status for several of the micronutrients
(Tomedi et al, 2012). Identifying problems such as this can lead
to further research for interventions to prevent these nutritional
deficiencies in this patient population.
12
Limitations
Small sample size of methadone treated patients
Strict methadone program compared to general population
Food Frequency questionnaire results based on memory of
participants
Gaps in research were identified by the authors regarding
research that analyzes the nutritional needs of opiate users
entering treatment and the examination of the nutritional status
of pregnant women prescribed methadone. It would be
interesting to compare which stage of recovery the patient is in
compared to their nutritional status. The research could identify
if there is an improvement in the nutritional status the longer
they are participating in the methadone maintenance therapy and
the further along that they are in their recovery. This study
could also be could also be conducted with a larger group in
multiple geographical settings in the United States to compare
the nutritional status among a wide variety of methadone treated
pregnant patients. Comparing the differences can identify if
there are outside influences that are helping or hindering the
adequate nutritional status for their pregnancy.
13
References
Opioid abuse, dependence and addiction in pregnancy. (2012).
Retrieved from http://www.acog.org/Resources-And-

7. Publications/Committee-Opinions/Committee-on-Health-Care-
for-Underserved-Women/Opioid-Abuse-Dependence-and-
Addiction-in-Pregnancy
Rasmussen, K., Catalano, P., & Yaktine, A. (2009). New
guidelines for weight gain during pregnancy: what
obstetrician/gynecologists should know. Current Opinion in
Obstetrics and Gynecology, 21(6), 521-526.
http://dx.doi.org/http://doi.org/10.1097/GCO.0b013e328332d24
e
Tomedi, L., Bogen, D., Hanusa, B., Wisner, K., & Bodnar, L.
(2012). A pilot study of the nutritional status of opiate using
pregnant women on methadone maintenance therapy. Substance
Use & Misuse , 47(3), 286-295.
QI Plan Part 3
Write 1,400- to 1,750-word paper with the following sections:
· Criteria and Tasks
· · Authority, structure, and organization
· Describe the authority structure of the plan's implementation.
This must describe who is responsible for implementing the
plan. Include a description of each role involved in the plan:
· Board of directors
· Executive leadership
· Quality improvement committee
· Medical staff
· Middle management
· Department staff
· Communication
· Identify who the performance activity outcomes are
communicated to and who does the communicating. This
describes who is responsible for overseeing data collection and
preparing data reports.
· Education

8. · Describe how staff will be educated regarding the plan. This
covers how each staff member will be initially oriented to the
plan and how each employee fits into the plan based on job
responsibilities.
· Monitoring and Revising
· Annual evaluation
· Analyze what elements of the plan are annually evaluated for
improvement.
· Analyze how to monitor the effect of changes implemented
from the decision-making process.
· Regulatory and Accreditation
· External entities
· Analyze the effect of external entities, such as governmental
agencies, accrediting bodies, and professional interest groups,
on the quality and performance measure of an organization's
decision-making processes.
Cite at least 3 sources according to APA guidelines to support
your information.