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Anxiety in Children Comparative Effectiveness Review Number 192 Anxiety in Children e Comparative Effectiveness Review Number 192 Anxiety in Children Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract No. 290-2015-00013-I Prepared by: Mayo Clinic Evidence-based Practice Center Rochester, MN Investigators: Zhen Wang, Ph.D. Stephen Whiteside, Ph.D., L.P. Leslie Sim, Ph.D., L.P. Wigdan Farah, M.B.B.S. Allison Morrow, B.A. Mouaz Alsawas, M.D., M.Sc. Patricia Barrionuevo Moreno, M.D. Mouaffaa Tello, M.D. Noor Asi, M.D. Bradley Beuschel, B.S.P.H. Lubna Daraz, Ph.D. Jehad Almasri, M.D. Feras Zaiem, M.D. Shalak Gunjal, M.S. Laura Larrea Mantilla, M.D. Oscar Ponce Ponte, M.D. Annie LeBlanc, Ph.D. Larry J. Prokop, M.L.S. M. Hassan Murad, M.D., M.P.H. AHRQ Publication No. 17-EHC023-EF August 2017 Erratum July 2018 Erratum The following corrections were made to this report. The sentence in the Structured Abstract, CBT “was more likely to increase remission than sertraline,” was deleted. On page 16, under Results, Drugs Versus CBT, Key Points and Discussion, “CBT was more likely to increase remission than sertraline (moderate SOE),” was deleted. In Table 8, Sertraline (class: SSRI) vs. CBT, relative risk (RR) for response was changed to 0.92 (95% CI: 0.75 to 1.13). RR for remission was changed to 1.00 (95% CI: 0.77 to 1.29). Overall evidence strength was changed to low (no difference). Here is Table 8 with the changes highlighted in yellow and also indicated with an asterisk in the cell. Table 8. Strength of evidence for drugs versus CBT Comparison Outcome Conclusion Study Design and Factors That Overall Sample Sizea Affect the Evidence Strength of Strength Evidenceb (Direction of Effect) Fluoxetine Primary SMD:-0.16; 1 RCT (102 Patients)51 Severe Low (class: SSRI) anxiety, child 95% CI: -0.55 imprecision (wide (no difference) vs. CBT report to 0.24; CIs and small I2=N/A sample size) Primary SMD:0.78; 1 RCT (102 Patients)51 Imprecision Moderate anxiety, 95% CI: 0.37 (small sample (increased clinician to 1.18; size) anxiety) report I2=N/A Function SMD: 0.54; 1 RCT (102 Patients)51 Imprecision Moderate 95% CI: 0.14 (small sample (reduced to 0.94; size) function) I2=N/A Secondary SMD: 0.51; 1 RCT (102 Patients)51 Imprecision Moderate measure 95% CI: 0.11 (small sample (increased to 0.90; size) anxiety) I2=N/A Social SMD: -0.19; 1 RCT (102 Patients)51 Severe Low function 95% CI: -0.58 imprecision (wide (no difference) to 0.21; CIs and small I2=N/A sample size) Sertraline Primary SMD: -0.15; 1 RCT (272 Patients)7, Severe Low (class: SSRI) anxiety, 95% CI: -0.31 67, 69-73 imprecision (wide (no difference) vs. clinician to 0.02; I2= CIs and small CBT report N/A sample size) Function SMD: -0.12; 1 RCT (272 Patients)7, Severe Low 95% CI: -0.35 67, 69-73 imprecision (wide (no difference) to 0.12; I2= CIs and small N/A sample size) Remission RR: 1.00; 1 RCT (272 Patients)7, Severe Low 95% CI: 67, 69-73 imprecision (wide (no difference)* 0.77 to 1.29;* CIs and small I2=N/A sample size)* Response RR: 0.92; 1 RCT (272 Patients)7, Severe Low 95% CI: 0.75 67, 69-73 imprecision (wide (no difference) to 1.13;* CIs and small I2=N/A sample size) On page 21, under Results, CBT Combined with Drugs, Discussion, the sentence, “One RCT of 272 patients compared the combination of CBT and sertraline to CBT, or to sertraline” was changed to “One RCT compared the combination of CBT and sertraline to CBT (279 patients), or to sertraline (273 patients).” In Table 10, CBT + sertraline (class: SSRI) vs CBT, the number of patients was changed to 279. Relative risk (RR) of remission was changed to 1.51 (95% CI: 1.22-1.86). Overall evidence strength was changed to moderate (improved remission). RR for response was changed to 1.35 (95% CI: 1.15-1.58). CBT+ Sertraline (class: SSRI) vs. Sertraline (class: SSRI), RR of remission was changed to 1.51 (95% CI: 1.22- 1.87). Overall evidence strength was changed to moderate (improved remission). RR for response was changed to 1.47 (95% CI: 1.24-1.75). Here is Table 10 with the changes highlighted in yellow. Table 10. Strength of evidence for CBT combined with drugs Comparison Outcome Conclusion Study Design and Factors That Overall Sample Sizea Affect the Evidence Strength of Strength Evidenceb (Direction of Effect) Imipramine Primary SMD: -0.74; 1 RCT (63 Patients)159 Imprecision (small Moderate (class: TCA) + anxiety, child 95% CI: -1.26 sample size) (reduced anxiety) CBT vs. CBT report to -0.23; I2=N/A Primary SMD: -0.61; 1 RCT (63 Patients)159 Severe Low anxiety. 95% CI: -1.11 imprecision (small (no difference) clinician report to 0.10; sample size and I2=N/A wide CI) Function SMD: -1.27; 1 RCT (63 Patients)159 Imprecision (small Moderate 95% CI: -1.81 sample size) (improved to -0.73; function) I2=N/A Fluoxetine Function SMD: -0.13; 1 RCT (41 Patients)160 Severe Low (class: SSRI) + 95% CI: -0.74 imprecision (small (no difference) CBT vs. CBT to 0.48; sample size and I2=N/A wide CI) Secondary SMD: -0.03; 1 RCT (41 Patients)160 Severe Low measure 95% CI: -0.59 imprecision (small (no difference) to 0.64; sample size and I2=N/A wide CI) Response RR: 1.71; 1 RCT (41 Patients)160 Severe Low 96% CI: 0.69 imprecision (small (no difference) to 4.24; sample size and I2=N/A wide CI) Remission RR: 0.24; 1 RCT (41 Patients)160 Severe Low 95% CI: 0.06 imprecision (small (reduced to 0.99; sample size and remission) I2=N/A wide CI) CBT + Primary SMD: -0.69; 1 RCT (279 Patients)7, Imprecision (small Moderate Sertraline anxiety, 95% CI: -0.93 67, 69-73 sample size) (reduced anxiety) (class: SSRI) clinician report to -0.45; vs. CBT I2=N/A Function SMD: -0.47; 1 RCT (279 Patients)7, Imprecision (small Moderate 95% CI: -0.70 67, 69-73 sample size) (improved to -0.23; function) I2=N/A Comparison Outcome Conclusion Study Design and Factors That Overall Sample Sizea Affect the Evidence Strength of Strength Evidenceb (Direction of Effect) Remission RR: 1.51; 1 RCT (279 Patients)7, Imprecision (small Moderate 95% CI: 1.22 67, 69-73 sample size) (improved to 1.86; remission) I2=N/A Response RR: 1.35; 1 RCT (279 Patients)7, Imprecision (small Moderate 95% CI: 1.15 67, 69-73 sample size) (improved to 1.58; response) I2=N/A CBT+ Primary SMD: -0.46; 1 RCT (273 Patients)7, Imprecision (small Moderate Sertraline anxiety, 95% CI: -0.70 67, 69-73 sample size) (reduced anxiety) (class: SSRI) clinician report to -0.22; vs. Sertraline I2=N/A (class: SSRI) Function SMD: -0.34; 1 RCT (273 Patients)7, Imprecision (small Moderate 95% CI: -0.58 67, 69-73 sample size) (improved to -0.10; function) I2=N/A Remission RR: 1.51; 1 RCT (273 Patients)7, Severe Moderate 95% CI: 1.22, 67, 69-73 imprecision (wide (improved 1.87; I2=N/A CIs and small remission) sample size) Response RR: 1.47; 1 RCT (273 Patients)7, Imprecision (small Moderate 95% CI: 1.24 67, 69-73 sample size) (improved to 1.75; response) I2=N/A This report is based on research conducted by the Mayo Clinic Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2015-00013-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report. The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients. This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders. AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.
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