1. Assignment 3 Worth a total of 50 points. Read each abstract or excerpt
carefully. These are all from published reports/papers. Please type your
answers for your final submitted version and use compl
QUESTIONAssignment 3 Worth a total of 50 points. Read each abstract or excerpt carefully.
These are all from published reports/papers. Please type your answers for your final
submitted version and use complAssignment 3 These are all from published
reports/papers. Please type your answers for your final submitted version and use
complete and clear sentences. No bullets and no one word answers except for the “1 pt.”
questions, where appropriate. In some cases the selections have been edited to remove
obvious answers J.1. Since marijuana legalization, pediatric exposures to cannabis have
increased.1 To date, pediatric deaths from cannabis exposure have not been reported. The
authors report an 11-month-old male who, following cannabis exposure, presented with
central nervous system depression after seizure, and progressed to cardiac arrest and died.
Myocarditis was diagnosed post-mortem and cannabis exposure was confirmed. Given the
temporal relationship of these two rare occurrences – cannabis exposure and sudden death
secondary to myocarditis in an 11-month-old – as well as histological consistency with
drug-induced myocarditis without confirmed alternate causes, and prior reported cases of
cannabis-associated myocarditis, a possible relationship exists between cannabis exposure
in this child and myocarditis leading to death. In areas where marijuana is commercially
available or decriminalized, the authors urge clinicians to preventively counsel parents and
to include cannabis exposure in the differential diagnosis of patients presenting with
myocarditis.A. What kind of study is this and why is it used here? (2pts)B. What is the
comparison group? (2pts)C. What is the measure of effect (if any)?
(1pt)2. Background: The aim was to study whether number of visits to emergency
department (ED) is associated with suicide, taking into consideration known risk factors.
Methods: This is a population-based study nested in a cohort. Computerized database on
attendees to ED (during 2002-2008) was record linked to nation-wide death registry to
identify 152 [suicides], and randomly selected 1520 [non-suicides]. The study was confined
to patients attending the ED, who were subsequently discharged, and not admitted to
hospital ward. Odds ratio (OR) and 95% confidence intervals (CI) of suicide risk according
to number of visits (logistic regression) adjusted for age, gender, mental and behavioral
disorders, non-causative diagnosis, and drug poisonings. Results: Suicides had on average
attended the ED four times, while [non-suicides] attended twice. The OR for attendance due

2. to mental and behavioral disorders was 3.08 (95% CI 1.61-5.88), 1.60 (95% CI 1.06-2.43)
for non-causative diagnosis, and 5.08 (95% CI 1.69-15.25) for poisoning. The ORs increased
gradually with increasing number of visits. Adjusted for age, gender, and the above
mentioned diagnoses, the OR for three attendances was 2.17, for five attendances 2.60, for
seven attendances 5.97, and for nine attendances 12.18 compared with those who had one
visit. Conclusions: Number of visits to the ED is an independent risk factor
for suicideadjusted for other known and important risk factors. The prevalence of four or
more visits was 40% among [suicides] compared with 10% among [non-suicides] . This
new risk factor may open new venues for suicide prevention. [ABSTRACT FROM
AUTHOR]A. What type of study is this and why might they have used this design?
(2pts)B. Describe the comparison groups. (2pts)C. Summarize and describe the results
in “lay” terms – but still quantitatively. (4pts)3. There has been no worldwide
XXXXXXXXXXXXX study on suicide as a global major public health problem. This study
aimed to identify the variations in suicide specific rates using the Human Development
Index (HDI) and some health related variables among countries around the world. In this
XXXXXXXXXX study, we obtained the data from the World Bank Report 2013. The analysis
was restricted to 91 countries for which both the epidemiologic data from the suicide rates
and HDI were available. Overall, the global prevalence of suicide rate was 10.5 (95%
confidence intervals: 8.8, 12.2) per 100,000 individuals, which significantly varied
according to gender (16.3 in males vs. 4.6 in females, p < 0.001) and different levels of
human development (11.64/100,000 individuals in very high development countries,
7.93/100,000 individuals in medium development countries, and 13.94/100,000
individuals in high development countries, p = 0.004). In conclusion, the suicide rate varies
greatly between countries with different development levels. Our findings also suggest that
male gender and HDI components are associated with an increased risk of suicide
behaviors. Hence, detecting population subgroups with a high suicide risk and reducing the
inequality of socioeconomic determinants are necessary to prevent this disorder around the
world.A. What type of study is this and why might they have used this design?
(2pts)B. Describe the study population. (2pts)C. Should suicide rates have been
standardized and why or why not? (2pts)D. What is the best interpretation of these
results and why? (2pts)4. Background and Aims Although they often co-occur, the
longitudinal relationship between depression and substance use disorders during
adolescence remains unclear. This study estimated the effects of
cumulative depression during early adolescence (ages 13-15 years) on the likelihood of
cannabis use disorder (CUD) and alcohol use disorder (AUD) at age 18. Design XXXXXXXXXX
study of youth assessed at least annually between 6th and 9th grades (~ age 12-15) and
again at age 18. Marginal structural models based on a counterfactual framework that
accounted for both potential fixed and time-varying confounders were used to estimate
cumulative effects of depressive symptoms over early adolescence. Setting The sample
originated from four public middle schools in Seattle, Washington, USA. Participants The
sample consisted of 521 youth (48.4% female; 44.5% were non-Hispanic White).
Measurements Structured in-person interviews with youth and their parents were
conducted to assess diagnostic symptom counts of depression during early adolescence;

3. diagnoses of CUD and AUD at age 18 was based the Voice-Diagnostic Interview Schedule for
Children. Cumulative depression was defined as the sum of depression symptom counts
from grades 7-9. Findings The past-year prevalence of cannabis and alcohol use disorder at
the age 18 study wave was 20.9 and 19.8%, respectively. A 1 standard deviation increase in
cumulative depression during early adolescence was associated with a 50% higher
likelihood of CUD [prevalence ratio (PR) = 1.50; 95% confidence interval (CI) = 1.07, 2.10].
Although similar in direction, there was no statistically significant association
between depression and AUD (PR = 1.41; 95% CI = 0.94, 2.11). Further, there were no
differences in associations according to gender. Conclusions Youth with more chronic or
severe forms of depression during early adolescence may be at elevated risk for developing
cannabis use disorder compared with otherwise similar youth who experience fewer
depressive symptoms during early adolescence.A. What type of study is this and how can
you tell? (2pts)B. What was the exposure? (2pts)C. How does the prevalence ratio
reported here differ from the risk or prevalence ratios we have seen thus far in this class?
(2pts)D. What is the best interpretation of these results and why? (2pts)5. Study
Description: Tapentadol has already been studied in adults. This study is needed to find out
if tapentadol works and is safe to use in children and adolescents with long-term pain.
During the first 2 weeks of the study (Part 1), participants will be given either tapentadol or
morphine prolonged-release tablets. Assignment will be done randomly (like tossing a
coin). The participant and the caregiver will know which medication they are taking. The
primary endpoint is based on data collected in Part 1 of this XXXXXXXXX. If eligible and
willing, participants from Part 1 can enter a 12 month follow-up period (Part 2). In Part 2 of
this XXXXXXXparticipants will be treated with tapentadol prolonged release tablets or with
the standard of care (observation arm).Outcomes: Binary variable “responder”. [ Time
frame: up to Day 14 (End of Part 1) ] A participant is defined as responder if both of the
following criteria are met: Completion of the 14-day TreatmentPeriod (Part 1). One of the
following calculated from the scheduled pain assessments (“pain right now”) documented
during the last 3 days of the Treatment Period: Average pain less than 50 on a visual analog
scale (VAS) for subjects aged 12 years to less than 18 years; or less than 5 on the Faces Pain
Scale-revised (FPS-R) for subjects aged 6 years to less than 12 years. Average reduction
from baseline of pain greater than and equal to 20 on a VAS for subjects aged 12 years to
less than 18 years; or greater and equal to 2 on the FPS-R for subjects aged 6 years to less
than 12 years. The proportion of participants classified as responders will be assessed and
compared between the treatment groups NOTE this is an ongoing study so no results are
reported yet.A. What type of study is this and why might they have used this design?
(2pts)B. Why is the comparison group given morphine instead of a placebo?.
(2pts)C. What is the outcome of this study and who will be counted? (1pt)D. What
effect measure will most likely be used and why? (1pt)E. If (for example) patients on
tapentadol are found to be 16% more likely to be “responders” than those on the standard
morphine treatment what would the value of the effect measure be?
(2pts)6. Background: Supervised injection facilities (SIFs) are legally sanctioned
environments for people to inject drugs under medical supervision. SIFs currently operate
in ten countries, but to date, no SIF has been opened in the USA. In light of increasing

4. overdose mortality in the USA, this study evaluated willingness to use a SIF among youth
who report non-medical prescription opioid (NMPO) use. Methods: Between January 2015
and February 2016, youth with recent NMPO use were recruited to participate in the Rhode
Island Young Adult Prescription Drug Study (RAPiDS). We explored factors associated with
willingness to use a SIF among participants who had injected drugs or were at risk of
initiating injection drug use (defined as having a sex partner who injects drugs or having a
close friend who injects). Results: Among 54 eligible participants, the median age was 26
(IQR = 24-28), 70.4% were male, and 74.1% were white. Among all participants, when
asked if they would use a SIF, 63.0% answered “Yes”, 31.5% answered “No”, and 5. 6% were
unsure. Among the 31 participants reporting injection drug use in the last six months, 27
(87.1%) reported willingness to use a SIF; 15 of the 19 (78.9%) who injected less than daily
reported willingness, while all 12 (100.0%) of the participants who injected daily reported
willingness. Compared to participants who were unwilling or were unsure, participants
willing to use a SIF were also more likely to have been homeless in the last six months, have
accidentally overdosed, have used heroin, have used fentanyl non-medically, and typically
use prescription opioids alone. Conclusions: Among young adults who use
prescription opioids non-medically and inject drugs or are at risk of initiating injection drug
use, more than six in ten reported willingness to use a SIF. Established risk factors for
overdose, including homelessness, history of overdose, daily injection drug use, heroin use,
and fentanyl misuse, were associated with higher SIF acceptability, indicating that young
people at the highest risk of overdose might ultimately be the same individuals to use the
facility. Supervised injection facilities merit consideration to reduce overdose mortality in
the USA.A. What type of study is this and why might they have used this design?
(2pts)B. Describe the study population and the comparison group. (2pts)C. Should any
of these results be standardized and why or why not? (2pts)D. What are some concerns
(as an epidemiologist) you might have about these results and why? (2pts)7. Objective.
To evaluate the time of onset, overall efficacy, and safety of fentanyl buccal tablet (FBT) for
noncancer-related breakthrough pain (BTP) in opioid-tolerant adults over 12 weeks.
Design. A novel 12-week study that mimicked clinical practice with dose titration to
effective dose, open-label treatment, and three randomized, double–blind, placebo-
controlled, multiple-crossover periods at weeks 4, 8, and 12. For each double–blind period,
study patients received nine doses (FBT = 6, placebo = 3) in a randomized sequence. Setting.
Twenty-one study centers in the United States. Population. Opioid-tolerant adults with
noncancer-related chronic pain and BTP. Outcome Measures. The primary outcome was the
sum of the pain intensity differences (PID) 5–60 minutes post dose (SPID60) during the
final double–blind period. Secondary outcomes included pain relief (PR), meaningful PR,
and proportion of episodes with a PID of ≥33% and ≥50%. Results. Of 148 patients who
entered the titration phase, 105 (71%) achieved a successful dose and 81 (55%)
participated in all three assessment periods in the study. The final RCT assessment period
results demonstrated continued efficacy of FBT vs placebo ( P < 0.05) for SPID60 (mean
[SD]: 7.7 [6.2] vs 4.6 [4.7]). The average onset of PR began at 5 minutes, with meaningful PR
by ≤10 minutes. The proportion of episodes with ≥33% improvement in PI was 7% with
FBT vs 3% with placebo at 5 minutes and with ≥50% was 17% vs 10% at 15 minutes. All

5. periods showed similar results. Adverse events and patient discontinuations were generally
typical of clinical opioid use. Conclusions. FBT showed continued clinically important
analgesic effects and was generally well tolerated over 12 weeks of treatment.A. Why is a
placebo being used?(2pts)B. Who is being treated and who is being given a placebo?
(2pts)C. What is the RR of an episode ending with pain relief of ≥33% comparing one
treated with FBT to a placebo? (1pt)D. By 10 minutes how many episodes of
breakthrough pain result in ≥50% improvement in pain intensity and how does that
compare to those who are treated? (1pt)E. Overall what is your impression of this as a
solution to break through pain and why? (2pts)