9. Epidemiologist; What are some concerns (as an epidemiologist) you might have about these results and why?

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 depressionduring 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)

Epidemiologist

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.

Epidemiologist

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.

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 depressionduring 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)

Epidemiologist

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.

Epidemiologist

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. 

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 depressionduring 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)

Epidemiologist

7. Epidemiologist

epidemiologist

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