Primary outcome reporting in adolescent depression clinical trials needs standardization

[1]  A Laupacis,et al.  How well is the clinical importance of study results reported? An assessment of randomized controlled trials. , 2001, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[2]  D. Moher,et al.  A scoping review of outcome-reporting recommendations for clinical trial protocols and reports , 2019 .

[3]  M. Hellmich,et al.  Whole body vibration added to treatment as usual is effective in adolescents with depression: a partly randomized, three-armed clinical trial in inpatients , 2018, European Child & Adolescent Psychiatry.

[4]  B. Harrison,et al.  The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): a randomised, double-blind, placebo-controlled, multicentre clinical trial. , 2019, The lancet. Psychiatry.

[5]  D. Moher,et al.  CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials , 2010, Journal of clinical epidemiology.

[6]  S. Merry,et al.  Cognitive behavioural therapy (CBT), third-wave CBT and interpersonal therapy (IPT) based interventions for preventing depression in children and adolescents. , 2016, The Cochrane database of systematic reviews.

[7]  J. A. Martin,et al.  Childhood depression and risk of suicide: a preliminary report of a longitudinal study. , 1993, Journal of the American Academy of Child and Adolescent Psychiatry.

[8]  P. Glasziou,et al.  Avoidable waste in the production and reporting of research evidence. , 2009, Obstetrics and gynecology.

[9]  D. Moher,et al.  Outcome reporting recommendations for clinical trial protocols and reports: a scoping review , 2020, Trials.

[10]  S. Assmann,et al.  Subgroup analysis and other (mis)uses of baseline data in clinical trials , 2000, The Lancet.

[11]  P. Hazell,et al.  Tricyclic drugs for depression in children and adolescents. , 2013, The Cochrane database of systematic reviews.

[12]  W. Katon,et al.  Collaborative care for adolescents with depression in primary care: a randomized clinical trial. , 2014, JAMA.

[13]  C. Gamble,et al.  Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias — An Updated Review , 2013, PloS one.

[14]  S. Tonev,et al.  Remission and recovery in the Treatment for Adolescents with Depression Study (TADS): acute and long-term outcomes. , 2009, Journal of the American Academy of Child and Adolescent Psychiatry.

[15]  James C. Mundt,et al.  Integrating technology into cognitive behavior therapy for adolescent depression: a pilot study , 2015, Annals of General Psychiatry.

[16]  S. Eaton,et al.  Outcome reporting in randomised controlled trials and meta-analyses of appendicitis treatments in children: a systematic review , 2015, Trials.

[17]  D. Pine,et al.  Depression in adolescence , 2012, The Lancet.

[18]  Angus G K McNair,et al.  The COMET Handbook: version 1.0 , 2017, Trials.

[19]  I. Goodyer,et al.  A randomised controlled trial of cognitive behaviour therapy in adolescents with major depression treated by selective serotonin reuptake inhibitors. The ADAPT trial. , 2008, Health technology assessment.

[20]  D. Kupfer,et al.  Randomized efficacy trial of two psychotherapies for depression in youth with inflammatory bowel disease. , 2014, Journal of the American Academy of Child and Adolescent Psychiatry.

[21]  A. Kiss,et al.  Maintenance study for adolescent depression. , 2008, Journal of child and adolescent psychopharmacology.

[22]  A Kohn,et al.  [Data torturing]. , 1994, Harefuah.

[23]  Benedetto Vitiello,et al.  Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. , 2004, JAMA.

[24]  P. Williamson,et al.  Industry funding was associated with increased use of core outcome sets. , 2019, Journal of clinical epidemiology.

[25]  M M Weissman,et al.  Depressed adolescents grown up. , 1999, JAMA.

[26]  J. March,et al.  A double-blind efficacy and safety study of duloxetine flexible dosing in children and adolescents with major depressive disorder. , 2014, Journal of child and adolescent psychopharmacology.

[27]  P. Szatmari,et al.  Outcomes reported in randomised clinical trials of major depressive disorder treatments in adolescents: a systematic scoping review protocol , 2019, BMJ Open.

[28]  P. Williamson,et al.  A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery , 2017, Journal of clinical epidemiology.

[29]  J. March,et al.  A double-blind efficacy and safety study of duloxetine fixed doses in children and adolescents with major depressive disorder. , 2014, Journal of child and adolescent psychopharmacology.

[30]  P. Harris,et al.  Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support , 2009, J. Biomed. Informatics.

[31]  Nazmus Saquib,et al.  Practices and impact of primary outcome adjustment in randomized controlled trials: meta-epidemiologic study , 2013, BMJ.

[32]  C. Gullion,et al.  Cognitive Behavioral Therapy in Primary Care for Youth Declining Antidepressants: A Randomized Trial , 2016, Pediatrics.

[33]  U. Chung.  7.3 ADAPTING AND IMPLEMENTING SUPPORT FOR STUDENTS EXPOSED TO TRAUMA IN SOUTH KOREA: A PILOT STUDY , 2016 .

[34]  J. Mills.  Data torturing. , 1993, The New England journal of medicine.

[35]  M. Wolpert,et al.  Review: What Outcomes Count? A Review of Outcomes Measured for Adolescent Depression Between 2007 and 2017. , 2019, Journal of the American Academy of Child and Adolescent Psychiatry.

[36]  J. March,et al.  Social problem-solving among adolescents treated for depression. , 2010, Behaviour research and therapy.

[37]  L. Shamseer,et al.  Measurement Issues in Trials of Pediatric Acute Diarrheal Diseases: A Systematic Review , 2010, Pediatrics.

[38]  P. Szatmari,et al.  Counting What Counts: The Case for Harmonized Outcomes in Child and Youth Mental Health Research. , 2019, Journal of the American Academy of Child and Adolescent Psychiatry.

[39]  A. Kiss,et al.  A Pilot Study of Citalopram Treatment in Preventing Relapse of Depressive Episode after Acute Treatment. , 2016, Journal of the Canadian Academy of Child and Adolescent Psychiatry = Journal de l'Academie canadienne de psychiatrie de l'enfant et de l'adolescent.

[40]  Paula R Williamson,et al.  A Systematic Review of Studies That Aim to Determine Which Outcomes to Measure in Clinical Trials in Children , 2008, PLoS medicine.

[41]  Tianjing Li,et al.  Outcomes in Cochrane Systematic Reviews Addressing Four Common Eye Conditions: An Evaluation of Completeness and Comparability , 2014, PloS one.

[42]  Tianjing Li,et al.  Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis. , 2017, Journal of clinical epidemiology.

[43]  Rachel Churchill,et al.  Psychological therapies versus antidepressant medication, alone and in combination for depression in children and adolescents. , 2014, The Cochrane database of systematic reviews.

[44]  Wayne M Glines,et al.  Epidemiology of mental disorders in children and adolescents , 2009, Dialogues in clinical neuroscience.

[45]  B. Thombs,et al.  Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology , 2015, PloS one.

[46]  P. Szatmari,et al.  Systematic scoping review identifies heterogeneity in outcomes measured in adolescent depression clinical trials. , 2020, Journal of clinical epidemiology.

[47]  S. Normand,et al.  The use and abuse of multiple outcomes in randomized controlled depression trials. , 2011, Contemporary clinical trials.

[48]  N. Butcher,et al.  Neurodevelopmental outcome descriptions in cohorts of extremely preterm children , 2020, Archives of Disease in Childhood.

[49]  Douglas G Altman,et al.  Epidemiology and reporting of randomised trials published in PubMed journals , 2005, The Lancet.

[50]  G. Emslie,et al.  Escitalopram in the treatment of adolescent depression: a randomized placebo-controlled multisite trial. , 2009, Journal of the American Academy of Child and Adolescent Psychiatry.

[51]  David Moher,et al.  Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study , 2017, British Medical Journal.

[52]  D. Altman,et al.  Reporting on covariate adjustment in randomised controlled trials before and after revision of the 2001 CONSORT statement: a literature review , 2010, Trials.

[53]  David Moher,et al.  Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. , 2012, The Cochrane database of systematic reviews.

[54]  P. Lee.  Covariate adjustments in randomized controlled trials increased study power and reduced biasedness of effect size estimation. , 2016, Journal of clinical epidemiology.

[55]  Mansor Abu Talib,et al.  The clinical effectiveness of cognitive behavior therapy and an alternative medicine approach in reducing symptoms of depression in adolescents , 2016, Psychiatry Research.

[56]  G. Antes,et al.  CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials , 2011 .

[57]  N. Demartines,et al.  Poor outcome reporting in medical research; building practice on spoilt grounds. , 2017, Annals of translational medicine.

[58]  Kaleab Z. Abebe,et al.  Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial. , 2008, JAMA.

[59]  C. Martell,et al.  The Adolescent Behavioral Activation Program: Adapting Behavioral Activation as a Treatment for Depression in Adolescence , 2016, Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53.

[60]  B. Widmer,et al.  Cognitive-behavioural therapy and short-term psychoanalytic psychotherapy versus brief psychosocial intervention in adolescents with unipolar major depression (IMPACT): a multicentre, pragmatic, observer-blind, randomised controlled trial. , 2017, Health technology assessment.

[61]  D. Beaton,et al.  Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research. , 2002, Current opinion in rheumatology.

[62]  M. DelBello,et al.  A double-blind, placebo-controlled study of selegiline transdermal system in depressed adolescents. , 2014, Journal of child and adolescent psychopharmacology.

[63]  Lisa M. Schwartz,et al.  Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review , 2010, BMJ : British Medical Journal.

[64]  Harlan M Krumholz,et al.  Increasing value and reducing waste: addressing inaccessible research , 2014, The Lancet.

[65]  P. Cuijpers.  Targets and outcomes of psychotherapies for mental disorders: an overview , 2019, World psychiatry : official journal of the World Psychiatric Association.

[66]  Femke L. Truijens,et al.  What "good outcome" means to patients: Understanding recovery and improvement in psychotherapy for major depression from a mixed-methods perspective. , 2019, Journal of counseling psychology.

[67]  L. Hartling,et al.  Primary Outcomes Reporting in Trials (PORTal): a systematic review of inadequate reporting in pediatric randomized controlled trials. , 2017, Journal of clinical epidemiology.

[68]  David Moher,et al.  Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) , 2019, Trials.

[69]  S. Kutcher,et al.  Diagnosis and measurement of adolescent depression: a review of commonly utilized instruments. , 2001, Journal of child and adolescent psychopharmacology.

[70]  D. Altman,et al.  Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors , 2005, BMJ : British Medical Journal.

[71]  P. Szatmari,et al.  From Research to Practice: The Importance of Appropriate Outcome Selection, Measurement, and Reporting in Pediatric Mental Health Research. , 2020, Journal of the American Academy of Child and Adolescent Psychiatry.

[72]  Sally Hopewell,et al.  The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed , 2010, BMJ : British Medical Journal.

[73]  Creatine target engagement with brain bioenergetics: a dose-ranging phosphorus-31 magnetic resonance spectroscopy study of adolescent females with SSRI-resistant depression , 2016, Amino Acids.

[74]  R. Findling,et al.  The short-term safety and efficacy of fluoxetine in depressed adolescents with alcohol and cannabis use disorders: a pilot randomized placebo-controlled trial , 2009 .

[75]  P. Szatmari,et al.  Core set of outcomes for adolescents with major depressive disorder: A tool of standardized outcomes for clinical research , 2020 .

[76]  E. Costello,et al.  Adult Functional Outcomes of Common Childhood Psychiatric Problems: A Prospective, Longitudinal Study. , 2015, JAMA psychiatry.

[77]  D. Moher,et al.  CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials , 2010, BMC medicine.

[78]  S. Mullen.  Major depressive disorder in children and adolescents , 2018, The mental health clinician.

[79]  J. Henzen.  Publisher's note , 1979, Brain Research.