What type of study is this and why might they have used this design?
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 depressionand 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)