Malhi GS, Mann JJ. Depression. Lancet. 2018;392(10161):2299–312. https://doi.org/10.1016/s0140-6736(18)31948-2.

Article  PubMed  Google Scholar 

Prescribed medicines review: summary. Gov.uk. Available from: https://www.gov.uk/government/publications/prescribed-medicines-review-report/prescribed-medicines-review-summary. Cited 2023 Nov 12.

Cipriani A, Furukawa TA, Salanti G, Chaimani A, Atkinson LZ, Ogawa Y, et al. Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis. Lancet. 2018;391(10128):1357–66. https://doi.org/10.1016/s0140-6736(17)32802-7.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Ho SC, Jacob SA, Tangiisuran B. Barriers and facilitators of adherence to antidepressants among outpatients with major depressive disorder: a qualitative study. PLoS One. 2017;12(6):e0179290. https://doi.org/10.1371/journal.pone.0179290.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Braund TA, Tillman G, Palmer DM, Gordon E, Rush AJ, Harris AWF. Antidepressant side effects and their impact on treatment outcome in people with major depressive disorder: an iSPOT-D report. Transl Psychiatry. 2021;11(1):417. https://doi.org/10.1038/s41398-021-01533-1.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Chevance A, Tomlinson A, Ravaud P, Touboul S, Henshall C, Tran V-T, et al. Important adverse events to be evaluated in antidepressant trials and meta-analyses in depression: a large international preference study including patients and healthcare professionals. Evid Based Ment Health. 2022;25(e1):e41-8. https://doi.org/10.1136/ebmental-2021-300418.

Article  PubMed  PubMed Central  Google Scholar 

MedDRA. Meddra.org. Available from: https://www.meddra.org/. Cited 2023 Nov 12.

Harrison J, Mozzicato P. MedDRA®: the tale of a terminology: side effects of drugs essay. Side Effects Drugs Ann. (2009) 31: xxxiii–xli. https://doi.org/10.1016/S0378-6080(09)03160-2.

Goldman SA. Adverse event reporting and standardized medical terminologies: strengths and limitations. Drug Inf J. 2002;36(2):439–44. https://doi.org/10.1177/009286150203600224.

Article  Google Scholar 

Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, et al. Development of the national cancer institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 2014;106(9):dju244–dju244. https://doi.org/10.1093/jnci/dju244. Cited 2024 Jan 9.

Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010;362(10):865–9. https://doi.org/10.1056/nejmp0911494.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Kluetz PG, Chingos DT, Basch EM, Mitchell SA. Patient-reported outcomes in cancer clinical trials: measuring symptomatic adverse events with the national cancer institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). Am Soc Clin Oncol Educ Book. 2016;36:67–73. https://doi.org/10.1200/edbk_159514.

Article  Google Scholar 

Dueck AC, Mendoza TR, Mitchell SA, Reeve BB, Castro KM, Rogak LJ, et al. Validity and reliability of the US national cancer institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). JAMA Oncol. 2015;1(8):1051. Available from: https://jamanetwork.com/journals/jamaoncology/fullarticle/2425835. Cited 2023 Nov 29.

McIntyre RS, Ismail Z, Watling CP, Weiss C, Meehan SR, Musingarimi P, et al. Patient-reported outcome measures for life engagement in mental health: a systematic review. J Patient Rep Outcomes. 2022;6(1). https://doi.org/10.1186/s41687-022-00468-5.

de Bienassis K, Kristensen S, Hewlett E, Roe D, Mainz J, Klazinga N. Measuring patient voice matters: setting the scene for patient-reported indicators. Int J Qual Health Care. 2021;34(Suppl 1):ii3-6. https://doi.org/10.1093/intqhc/mzab002.

Article  PubMed  Google Scholar 

Black N. Patient reported outcome measures could help transform healthcare. BMJ. 2013;346:f167. Available from: https://doi.org/10.1136/bmj.f167. 

Article  PubMed  Google Scholar 

Side effects - antidepressants. nhs.uk. Available from: https://www.nhs.uk/mental-health/talking-therapies-medicine-treatments/medicines-and-psychiatry/antidepressants/side-effects/. Cited 2023 Nov 12.

Selective serotonin reuptake inhibitors (SSRIs). NHS inform. 2023. Available from: https://www.nhsinform.scot/tests-and-treatments/medicines-and-medical-aids/types-of-medicine/selective-serotonin-reuptake-inhibitors-ssris/. Cited 2023 Nov 12.

Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13(1):117. https://doi.org/10.1186/1471-2288-13-117.

Article  PubMed  PubMed Central  Google Scholar 

Ioannidis JPA, Lau J. Improving safety reporting from randomised trials. Drug Saf. 2002;25(2):77–84. https://doi.org/10.2165/00002018-200225020-00002.

Article  PubMed  Google Scholar 

Mayo-Wilson E, Fusco N, Li T, Hong H, Canner JK, Dickersin K, et al. Harms are assessed inconsistently and reported inadequately part 1: systematic adverse events. J Clin Epidemiol. 2019;113:20–7. https://doi.org/10.1016/j.jclinepi.2019.04.022.

Article  PubMed  Google Scholar 

Mayo-Wilson E, Fusco N, Li T, Hong H, Canner JK, Dickersin K, et al. Harms are assessed inconsistently and reported inadequately Part 2: nonsystematic adverse events. J Clin Epidemiol. 2019;113:11–9. https://doi.org/10.1016/j.jclinepi.2019.04.020.

Article  PubMed  Google Scholar 

Benizri N, Hallot S, Burns K, Goldfarb M. Patient and family representation in randomized clinical trials published in 3 medical and surgical journals: a systematic review: a systematic review. JAMA Netw Open. 2022;5(9):e2230858. https://doi.org/10.1001/jamanetworkopen.2022.30858.

Article  PubMed  PubMed Central  Google Scholar 

Liu X, Agerbo E, Ingstrup KG, Musliner K, Meltzer-Brody S, Bergink V, et al. Antidepressant use during pregnancy and psychiatric disorders in offspring: Danish nationwide register based cohort study. BMJ. 2017;358:j3668. https://doi.org/10.1136/bmj.j3668.

Article  PubMed  PubMed Central  Google Scholar 

Wisner KL, Zarin DA, Holmboe ES, Appelbaum PS, Gelenberg AJ, Leonard HL, et al. Risk-benefit decision making for treatment of depression during pregnancy. Am J Psychiatry. 2000;157(12):1933–40. https://doi.org/10.1176/appi.ajp.157.12.1933.

Article  CAS  PubMed  Google Scholar 

Spanhel K, Balci S, Baumeister H, Bengel J, Sander LB. Cultural adaptation of Internet- and mobile-based interventions for mental disorders: a systematic review protocol. Syst Rev. 2020;9(1):207. https://doi.org/10.1186/s13643-020-01438-y.

Article  PubMed  PubMed Central  Google Scholar 

Wisniewski SR, Rush AJ, Balasubramani GK, Trivedi MH, Nierenberg AA. Self-rated global measure of the frequency, intensity, and burden of side effects. J Psychiatr Pract. 2006;12(2):71–9. Available from: https://pubmed.ncbi.nlm.nih.gov/16728903/. Cited 2024 Jan 9.

Article  PubMed  Google Scholar 

Pearce FJ, Cruz Rivera S, Liu X, Manna E, Denniston AK, Calvert MJ. The role of patient-reported outcome measures in trials of artificial intelligence health technologies: a systematic evaluation of clinicaltrials.gov records (1997–2022). Lancet Digit Health. 2023;5(3):e160-7. https://doi.org/10.1016/S2589-7500(22)00249-7.

Article  CAS  PubMed  Google Scholar 

Wiering B, de Boer D, Delnoij D. Patient involvement in the development of patient-reported outcome measures: a scoping review. Health Expect. 2017;20(1):11–23. Available from: https://pubmed.ncbi.nlm.nih.gov/26889874/. Cited 2024 Jan 9.

Basch E, Yap C. Patient-reported outcomes for tolerability assessment in phase I cancer clinical trials. J Natl Cancer Inst. 2021;113(8):943–4. https://doi.org/10.1093/jnci/djab017.

Article  PubMed  PubMed Central  Google Scholar 

Gelkopf M, Mazor Y, Roe D. A systematic review of patient-reported outcome measurement (PROM) and provider assessment in mental health: goals, implementation, setting, measurement characteristics and barriers. Int J Qual Health Care. 2021;34(Suppl 1):ii13-27. https://doi.org/10.1093/intqhc/mzz133.

Article  PubMed  Google Scholar 

Achtyes E, Simmons A, Skabeev A, Levy N, Jiang Y, Marcy P, et al. Patient preferences concerning the efficacy and side-effect profile of schizophrenia medications: a survey of patients living with schizophrenia. BMC Psychiatry. 2018;18(1):292. https://doi.org/10.1186/s12888-018-1856-y.

Article  PubMed  PubMed Central  Google Scholar 

Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, et al. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012;27(10):1361–7. https://doi.org/10.1007/s11606-012-2077-6.

Article  PubMed  PubMed Central  Google Scholar 

Páez G, Forte DN, Gabeiras MDPL. Exploring the relationship between shared decision-making, patient-centered medicine, and evidence-based medicine. Linacre Q. 2021;88(3):272–80. https://doi.org/10.1177/00243639211018355.

Article  PubMed  PubMed Central