- Gaebel W.
- Riesbeck M.
- Wolwer W.
- et al.
- Curson D.A.
- Barnes T.R.
- Bamber R.W.
- et al.
Communication of Evidence-Based Medicine
Communication of Efficacy
Conventional Efficacy Measures
- Gao K.
- Kemp D.E.
- Calabrese J.R.
Number Needed to Treat
Number Needed to Treat to Benefit
|Diagnosis/Study/Treatment Arms||Response Rate||NNTB, Mean (95% CI)||DAE Rate||NNTH, Mean (95% CI)|
| Kahn et al (2007)|
|QTP-XR 400 mg/d||49/111||7 (4–90)||6/113||N/A|
|QTP-XR 600 mg/d||67/111||3 (2–6)||3/113||N/A|
|QTP-XR 800 mg/d||66/117||4 (3–8)||3/121||N/A|
| Cutler et al (2009)|
28and Weisler et al (2009)
|QTP-XR 50 mg/d||76/178||10 (5–112)||15/181||N/A|
|QTP-XR 150 mg/d||178/334||5 (4–8)||55/328||9 (19–19)|
|QTP-XR 300 mg/d||172/337||6 (4–9)||57/331||9 (6–15)|
|Duloxetine 60 mg/d||67/141||7 (4–21)||20/149||13 (7–50)|
| Vieta et al (2010)|
|QTP-XR 400–800 mg/d||82/149||5 (3–9)||4/155||N/A|
| Suppes et al (2010)|
|QTP-XR 300 mg/d||87/133||4 (3–10)||17/139||9 (6–20)|
| Bauer et al (2009)|
|QTP-XR 150 mg/d||92/166||N/A||27/315||15 (10–21)|
|QTP-XR 300 mg/d||179/307||8 (5–24)||46/311||8 (6–11)|
Number Needed to Treat to Harm
- Gao K.
- Kemp D.E.
- Calabrese J.R.
Likelihood of Being Helped or Harmed
Communication Based on Phase of Illness
- Gao K.
- Kemp D.E.
- Calabrese J.R.
- Gao K.
- Kemp D.E.
- Calabrese J.R.
Communication Based on Duration of Treatment
Communication Based on Disorders
Communication Based on Cost
Generic Versus Branded Drugs
|Efficacy/tolerability||Studies in healthy volunteers (sample size, 18–36 subjects), crossover design, generic vs branded, and single dose to assess bioequivalence and tolerability. Bioequivalence generally defined as the 90% CI of a generic's Cmax and AUC within the range of 80%–125% of that of the branded drug.||Vigorous studies in animals and humans, including large, well-powered randomized, double-blind, placebo-controlled studies in patients to show its efficacy. Adverse events are carefully tracked. Bioavailability testing is also required.|
|Application||Abbreviated New Drug Application||New Drug Application|
Direct Versus Indirect Costs
Short-Term Versus Long-Term Costs
Communication Based on Effectiveness
Efficacy Versus Effectiveness
Comorbidity and Effectiveness
Communication Based on Cost-Effectiveness
- First vs multiple episode schizophrenia: two-year outcome of intermittent and maintenance medication strategies.Schizophr Res. 2002; 53: 145-159
- Relapse prevention in first-episode schizophrenia—maintenance vs intermittent drug treatment with prodrome-based early intervention: results of a randomized controlled trial within the German Research Network on Schizophrenia.J Clin Psychiatry. 2011; 72: 205-218
- Long-term depot maintenance of chronic schizophrenic out-patients: the seven year follow-up of the Medical Research Council fluphenazine/placebo trial.Br J Psychiatry. 1985; 146: 474-480
- Bouncing back: is the bipolar rebound phenomenon peculiar to lithium?.J Psychopharmacol. 2008; 22: 452-456
- Risk of recurrence in women with bipolar disorder during pregnancy: prospective study of mood stabilizer discontinuation.Am J Psychiatry. 2007; 164: 1817-1824
- Continuation versus discontinuation of lithium in recurrent bipolar illness: a naturalistic study.Bipolar Disord. 2007; 9: 435-442
- Evidence that patients with single versus recurrent depressive episodes are differentially sensitive to treatment discontinuation: a meta-analysis of placebo-controlled randomized trials.J Clin Psychiatry. 2008; 69: 1423-1436
- Illness risk following rapid versus gradual discontinuation of antidepressants.Am J Psychiatry. 2010; 167: 934-941
- Relationship of pharmacologic compliance to long-term prophylaxis in recurrent depression.Psychopharmacol Bull. 1992; 28: 231-235
- The cost of relapse and the predictors of relapse in the treatment of schizophrenia.BMC Psychiatry. 2010; 10: 2
- Indirect costs associated with nonadherence to treatment for bipolar disorder.J Occup Environ Med. 2010; 52: 478-485
- The cost of relapse in patients with schizophrenia in the European SOHO (Schizophrenia Outpatient Health Outcomes) study.Prog Neuropsychopharmacol Biol Psychiatry. 2009; 33: 835-841
- Effects of prior authorization on medication discontinuation among Medicaid beneficiaries with bipolar disorder.Psychiatr Serv. 2009; 60: 520-527
- Cost-sharing effects on adherence and persistence for second-generation antipsychotics in commercially insured patients.Manag Care. 2010; 19: 40-47
- Evidence based medicine: what it is and what it isn't.Clin Orthop Relat Res. 2007; 455: 3-5
- What is “quality of evidence” and why is it important to clinicians?.BMJ. 2008; 336: 995-998
- GRADE guidelines: 3.J Clin Epidemiol. 2011; 64: 401-406
- Evidence-based medicine, part 1.J Am Osteopath Assoc. 2007; 107: 295-297
- Pharmacological treatment of the maintenance phase of bipolar depression: focus on relapse prevention studies and the impact of design on generalizability.in: Zarate Jr, C.A. Manji H.K. Bipolar Depression: Molecular Neurobiology, Clinical Diagnosis and Pharmacotherapy. Birhauser Verlag AG, Basel, Switzerland2009: 159-178
- Using numerical results from systematic reviews in clinical practice.Ann Intern Med. 1997; 126: 712-720
- Reviewing CATIE for clinicians: balancing benefit and risk using evidence-based medicine tools.Curr Med Res Opin. 2007; 23: 2551-2557
- Comparisons of the tolerability and sensitivity of quetiapine-XR in the acute treatment of schizophrenia, bipolar mania, bipolar depression, major depressive disorder, and generalized anxiety disorder.Int J Neuropsychopharmacol. 2011; 14: 131-142
- A review of sensitivity and tolerability of antipsychotics in patients with bipolar disorder or schizophrenia: focus on somnolence.J Clin Psychiatry. 2008; 69: 302-309
- Number needed to treat to harm for discontinuation due to adverse events in the treatment of bipolar depression, major depressive disorder, and generalized anxiety disorder with atypical antipsychotics.J Clin Psychiatry. 2011; 72: 1063-1071
- Number needed to treat: what it is and what it isn't, and why every clinician should know how to calculate it.J Clin Psychiatry. 2011; 72: 412-413
- Confidence intervals for the number needed to treat.BMJ. 1998; 317: 1309-1312
- Efficacy and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: a randomized, double-blind, placebo-controlled study.J Clin Psychiatry. 2007; 68: 832-842
- Extended release quetiapine fumarate monotherapy in major depressive disorder: a placebo- and duloxetine-controlled study.J Clin Psychiatry. 2009; 70: 526-539
- Extended release quetiapine fumarate monotherapy for major depressive disorder: results of a double-blind, randomized, placebo-controlled study.CNS Spectr. 2009; 14: 299-313
- Extended-Release Quetiapine as Monotherapy for the Treatment of Adults With Acute Mania: A Randomized, Double-Blind, 3-Week Trial.Clin Ther. 2011; 33: 1643-1658
- Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression.J Affect Disord. 2010; 121: 106-115
- Extended-release quetiapine as adjunct to an antidepressant in patients with major depressive disorder: results of a randomized, placebo-controlled, double-blind study.J Clin Psychiatry. 2009; 70: 540-549
- Effectiveness of antipsychotic drugs in patients with chronic schizophrenia.N Engl J Med. 2005; 353: 1209-1223
- Predictors of non-stabilization during the combination therapy of lithium and Divalproex in rapid cycling bipolar disorder: a post-hoc analysis of two studies.Psychopharmacol Bull. 2010; 43: 23-38
- Recent substance use disorder, not generalized anxiety disorder, intensifies lithium-induced THS increase in rapid-cycling bipolar disorder.in: New Resarch Abstracts of the American Psychiatric Association 161st Annual Meeting. American Psychiatric Press, Washington, DC2008: NR1-NR051
- Users' guides to the medical literature.JAMA. 2000; 283: 2829-2836
- Antipsychotics for the treatment of schizophrenia: likelihood to be helped or harmed, understanding proximal and distal benefits and risks.Expert Rev Neurother. 2008; 8: 1079-1091
- A 28-week comparison of ziprasidone and haloperidol in outpatients with stable schizophrenia.J Clin Psychiatry. 2002; 63: 516-523
- A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression.Am J Psychiatry. 2005; 162: 1351-1360
- Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression.Arch Gen Psychiatry. 2003; 60: 1079-1088
- Randomized, placebo-controlled trial of olanzapine as maintenance therapy in patients with bipolar I disorder responding to acute treatment with olanzapine.Am J Psychiatry. 2006; 163: 247-256
- Lifestyle intervention and metformin for treatment of antipsychotic-induced weight gain: a randomized controlled trial.JAMA. 2008; 299: 185-193
- Reasons and outcomes of olanzapine dose adjustments in the outpatient treatment of schizophrenia.Pharmacopsychiatry. 2009; 42: 135-140
- Impact of side-effects of atypical antipsychotics on non-compliance, relapse and cost.J Int Med Res. 2003; 31: 188-196
- Age comparison of treatment adherence with antipsychotic medications among individuals with bipolar disorder.Int J Geriatr Psychiatry. 2007; 22: 992-998
- Factors associated with prospective long-term treatment adherence among individuals with bipolar disorder.Psychiatr Serv. 2008; 59: 753-759
- Predictors of nonadherence among individuals with bipolar disorder receiving treatment in a community mental health clinic.Compr Psychiatry. 2009; 50: 100-107
- Strategies for addressing adherence problems in patients with serious and persistent mental illness: recommendations from the expert consensus guidelines.J Psychiatr Pract. 2010; 16: 306-324
- Why do persons with bipolar disorder stop their medication?.Psychopharmacol Bull. 2010; 43: 5-14
- Cognitive, physiological, and personality correlates of recurrence of depression.J Affect Disord. 2005; 87: 221-229
- Cognitive functions among euthymic bipolar I patients after a single manic episode versus recurrent episodes.J Affect Disord. 2011; 130: 180-191
- Does stage of illness impact treatment response in bipolar disorder?.Bipolar Disord. 2011; 13: 87-98
- Predictors of mood response to acute tryptophan depletion.Neuropsychopharmacology. 2002; 27: 852-861
- Cost-effectiveness model comparing olanzapine and other oral atypical antipsychotics in the treatment of schizophrenia in the United States.Cost Eff Resour Alloc. 2009; 7: 4
- Facts and Myths About Generic Drugs.http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm(Accessed November 16, 2011)
- Generic drugs: the benefits and risks of making the switch.J Fam Pract. 2010; 59: 634-640
- Patients' attitudes towards generic substitution of oral atypical antipsychotics: a questionnaire-based survey in a hypothetical pharmacy setting.CNS Drugs. 2009; 23: 693-701
- Physician perceptions about generic drugs.Ann Pharmacother. 2011; 45: 31-38
- Generic substitution in the treatment of epilepsy: case evidence of breakthrough seizures.Neurology. 2008; 71: 525-530
- Current approaches to the use of generic antiepileptic drugs.Epilepsy Behav. 2007; 11: 46-52
- Switching from brand-name to generic psychotropic medications: a literature review.CNS Neurosci Ther. 2010;
- Are generic medications safe and effective?.J Psychosoc Nurs Ment Health Serv. 2010; 48: 13-16
- Loss of response after switching from brand name to generic formulations: three cases and a discussion of key clinical considerations when switching.Int Clin Psychopharmacol. 2010; 25: 180-182
- Did a switch to a generic antidepressant cause relapse?.J Fam Pract. 2008; 57: 109-114
- Clinical effects of a randomized switch of patients from clozaril to generic clozapine.J Clin Psychiatry. 2001; 62: 14-17
- Lack of bioequivalence between generic risperidone oral solution and originator risperidone tablets.Int J Clin Pharmacol Ther. 2007; 45: 293-299
- Comparison of pharmacokinetic profiles of brand-name and generic formulations of citalopram and venlafaxine: a crossover study.J Clin Psychiatry. 2009; 70: 958-966
- Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: a systematic review and meta-analysis.Drugs. 2010; 70: 605-621
- Discontinuation rates and health care costs in adult patients starting generic versus brand SSRI or SNRI antidepressants in commercial health plans.J Manag Care Pharm. 2011; 17: 123-132
- Clinical trial-based cost-effectiveness analyses of antipsychotic use.Am J Psychiatry. 2006; 163: 2047-2056
- The costs of schizophrenia.J Clin Psychiatry. 2007; 68: 4-7
- Direct and indirect costs of employees with treatment-resistant and non-treatment-resistant major depressive disorder.Curr Med Res Opin. 2010; 26: 2475-2484
- Cost of depression in Europe.J Ment Health Policy Econ. 2006; 9: 87-98
- A review of the costs associated with depression and treatment noncompliance: the potential benefits of online support.Int Clin Psychopharmacol. 2010; 25: 288-296
- A systematic review of the evidence of the burden of bipolar disorder in Europe.Clin Pract Epidemiol Ment Health. 2009; 5: 3
- The economic burden of insomnia: direct and indirect costs for individuals with insomnia syndrome, insomnia symptoms, and good sleepers.Sleep. 2009; 32: 55-64
- Societal costs and quality of life of children suffering from attention deficient hyperactivity disorder (ADHD).Eur Child Adolesc Psychiatry. 2007; 16: 316-326
- Use of mental health and primary care services by caregivers of patients with bipolar disorder: a preliminary study.Bipolar Disord. 2005; 7: 126-135
- Drug prices, out-of-pocket payments, and insurer costs: how do payers vary?.Adv Health Econ Health Serv Res. 2010; 22: 221-231
- Clinically unintended medication switches and inability to prescribe preferred medications under Medicare Part D.J Psychopharmacol. 2011;
- Prescription drug co-payments and cost-related medication underuse.Health Econ Policy Law. 2008; 3: 51-67
- Pharmaceutical policies: effects of cap and co-payment on rational drug use.Cochrane Database Syst Rev. 2008; (CD007017)
- The impact of co-payment increases on dispensings of government-subsidised medicines in Australia.Pharmacoepidemiol Drug Saf. 2008; 17: 1091-1099
- The impact of cost sharing of prescription drug expenditures on health care utilization by the elderly: own- and cross-price elasticities.Health Policy. 2007; 82: 340-347
- When patients have to pay a share of drug costs: effects on frequency of physician visits, hospital admissions and filling of prescriptions.CMAJ. 2005; 173: 1335-1340
- Clinical trials design lessons from the CATIE study.Am J Psychiatry. 2009; 166: 1222-1228
- Long-term mental health resource utilization and cost of care following group psychoeducation or unstructured group support for bipolar disorders: a cost-benefit analysis.J Clin Psychiatry. 2009; 70: 378-386
- Long-term effectiveness and cost of a systematic care program for bipolar disorder.Arch Gen Psychiatry. 2006; 63: 500-508
- Criteria for Distinguishing Effectiveness From Efficacy Trials in Systematic Reviews. 2007; 356: 1711-1722
- Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication.Arch Gen Psychiatry. 2005; 62: 617-627
- The impact of comorbidity of mental and physical conditions on role disability in the US adult household population.Arch Gen Psychiatry. 2007; 64: 1180-1188
- Medical comorbidity in bipolar disorder: relationship between illnesses of the endocrine/metabolic system and treatment outcome.Bipolar Disord. 2010; 12: 404-413
- The effects of undertreated chronic medical illnesses in patients with severe mental disorders.J Clin Psychiatry. 2009; 70: 22-29
- Star-D: lessons learned and future implications.Depress Anxiety. 2011; 28: 521-524
- Comparison of mania patients suitable for treatment trials versus clinical treatment.Hum Psychopharmacol. 2008; 23: 447-454
- Prospective 12-month course of bipolar disorder in out-patients with and without comorbid anxiety disorders.Br J Psychiatry. 2006; 189: 20-25
- Difference in treatment outcome in outpatients with anxious versus nonanxious depression: a STAR*D report.Am J Psychiatry. 2008; 165: 342-351
- Concurrent anxiety and substance use disorders among outpatients with major depression: clinical features and effect on treatment outcome.Drug Alcohol Depend. 2009; 99: 248-260
- Depressive illness burden associated with complex polypharmacy in patients with bipolar disorder: findings from the STEP-BD.J Clin Psychiatry. 2009; 70: 155-162
- Polypharmacy in children and adolescents treated for major depressive disorder: a claims database study.J Clin Psychiatry. 2009; 70: 240-246
- Safety and tolerability associated with second-generation antipsychotic polytherapy in bipolar disorder: findings from the Systematic Treatment Enhancement Program for Bipolar Disorder.J Clin Psychiatry. 2011; 72: 240-247
- Acute bipolar mania: a systematic review and meta-analysis of co-therapy vs. monotherapy.Acta Psychiatr Scand. 2007; 115: 12-20
- Choosing cost-effective interventions in psychiatry: results from the CHOICE programme of the World Health Organization.World Psychiatry. 2005; 4: 37-44
- Individualized cost-effectiveness analysis.PLoS Med. 2011; 8: e1001058
- Cost-effectiveness of second-generation antipsychotics and perphenazine in a randomized trial of treatment for chronic schizophrenia.Am J Psychiatry. 2006; 163: 2080-2089
- Cost-effectiveness of pharmacological and psychosocial interventions for schizophrenia.Cost Eff Resour Alloc. 2011; 9: 6