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 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
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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 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 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 suicide adjusted 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; 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 XXXXXXX participants 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 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 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)

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