The purpose of this study was to compare the incidence of neonatal abstinence syndrome (NAS) among infants of opiate-addicted women randomized to receive either buprenorphine

The purpose of this study was to compare the incidence of neonatal abstinence syndrome (NAS) among infants of opiate-addicted women randomized to receive either buprenorphine

Complete the required practice first then read the research article. All assigned questions are based on the article, but require you to apply concepts from lecture and practice. Focus on the overarching purpose, results, and discussion; not the more technical aspects of the study design or analysis. All answers need be in your own words. Don’t copy/paste from the article, and be as succinct as possible. Unless otherwise noted, answers should not exceed 2-3 sentences and text beyond this limit will not be graded. Required Practice: Epiville randomized trials study design http://epiville.ccnmtl.columbia.edu/randomized_trials/ Required Reading: Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O’Grady KE, Selby P, Martin PR, Fischer G. Neonatal abstinence syndrome after methadone or buprenorphine exposure. NEJM 2010:363(24);2320-31. Questions:
1. The purpose of this study was to compare the incidence of neonatal abstinence syndrome (NAS) among infants of opiate-addicted women randomized to receive either buprenorphine or methadone during pregnancy. a. True b. False c. Cannot determine
2. Copy and paste the sentence from the Abstract that indicates the study design used.
3. What was the rationale for comparing the two drugs (1-2
sentences max)?
4. Explain whether or not this study achieved clinical equipoise (1-2 sentences max).
5. Methadone was the standard of care for opiate-addicted pregnant women at the time of this study. Discuss why the researchers didn’t compare buprenorphine to no treatment (2-3 sentences max).
6. The authors discuss acquiring informed consent from participants. Briefly discuss the specific elements that were likely included on the consent form in this study (4-5 sentences max).
7. In this study: a. Participants, study staff, and data analysts knew to which treatment group participants were assigned b. Participants did not know which treatment group they were assigned to, but study staff and data analysts did c. Neither participants nor study staff knew which treatment group they were assigned to, but data analysts did d. No one related to the study except the PI knew which participants were in what treatment group 8. Explain the concept of intention-to-treat (1-2 sentences max).
9. How many TOTAL women did not complete treatment (methadone plus buprenorphine)? Hint: You can find this information in Table 1 or the in the first paragraph of the Results section. Table 1 shows you differences in key characteristics between women who did and did not stay in the study. These differences inform us about potential selection bias, which we will discuss after the midterm. a. 16 b. 28 c. 44 d. 131
10. The main findings from the study are reported in Table 2. Look at the odds-ratio (OR) for the “treated for NAS” group. Consider buprenorphine as the “exposed” group and methadone as the “unexposed” group. Choose the correct interpretation of the OR. Note: The OR is approximating the RR in this study. a. Women given buprenorphine were more likely to have an infant treated for NAS than women given methadone. b. Women given buprenorphine were less likely to have an infant treated for NAS than women given methadone. c. Women given buprenorphine were equally as likely to have an infant treated for NAS than women given methadone. d. Cannot determine from the information provided.

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By | 2018-10-10T00:10:18+00:00 October 10th, 2018|Uncategorized|