Relative effectiveness assessment of listed drugs (REAL): A new method for an early comparison of the effectiveness of approved health technologies

2011

PLoS ONE

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BackgroundTo compare response to antidepressants between randomized controlled trials (RCTs) and observational trials.Methods and FindingsPublished and unpublished studies (from 1989 to 2009) were searched for by 2 reviewers on Medline, the Cochrane library, Embase, clinicaltrials.gov, Current Controlled Trial, bibliographies and by mailing key organisations and researchers. RCTs and observational studies on fluoxetine or venlafaxine in first-line treatment for major depressive disorder reported in English, French or Spanish language were included in the main analysis. Studies including patients from a wider spectrum of depressive disorders (anxious depression, minor depressive episode, dysthymia) were added in a second analysis. The main outcome was the pre-/post-treatment difference on depression scales standardised to 100 (17-item or 21-item Hamilton Rating Scale for Depression or Montgomery and Åsberg Rating Scale) in each study arm. A meta-regression was conducted to adjust the comparison between observational studies and RCTs on treatment type, study characteristics and average patient characteristics. 12 observational studies and 109 RCTs involving 6757 and 11035 patients in 12 and 149 arms were included in the main analysis. Meta-regression showed that the standardised treatment response in RCTs is greater by a magnitude of 4.59 (2.61 to 6.56). Study characteristics were related to standardised treatment response, positively (study duration, number of follow-up assessments, outpatients versus inpatients, per protocol analysis versus intention to treat analysis) or negatively (blinded design, placebo design). At patient level, response increased with baseline severity and decreased with age. Results of the second analysis were consistent with this.ConclusionsResponse to antidepressants is greater in RCTs than in observational studies. Observational studies should be considered as a necessary complement to RCTs.

Section: Discussionmentioning

confidence: 99%

Antidepressant Response in Major Depressive Disorder: A Meta-Regression Comparison of Randomized Controlled Trials and Observational Studies

Naudet

Maria²,

2011

PLoS ONE

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“…To deal with this problem, the HAS has recently proposed a specific methodology referred to as REAL (Relative Effectiveness Assessment of pharmaceuticals). [7] REAL consists in a three-phase procedure:…”

Section: Generalisation Of Mtc Findings To Real-life Practicesmentioning

confidence: 99%

Real Medical Benefit Assessed by Indirect Comparison

Zylberman²,

Cucherat³

et al. 2009

Therapies

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-Frequently, in data packages submitted for Marketing Approval to the CHMP, there is a lack of relevant head-tohead comparisons of medicinal products that could enable national authorities responsible for the approval of reimbursement to assess the Added Therapeutic Value (ASMR) of new clinical entities or line extensions of existing therapies. Indirect or mixed treatment comparisons (MTC) are methods stemming from the field of meta-analysis that have been designed to tackle this problem. Adjusted indirect comparisons, meta-regressions, mixed models, Bayesian network analyses pool results of randomised controlled trials (RCTs), enabling a quantitative synthesis. The REAL procedure, recently developed by the HAS (French National Authority for Health), is a mixture of an MTC and effect model based on expert opinions. It is intended to translate the efficacy observed in the trials into effectiveness expected in day-to-day clinical practice in France.

“…Pour traiter ce problème, la HAS a proposé récemment une méthodologie spécifique d'éva-luation de l'efficacité réelle relative des produits pharmaceutiques dite méthode REAL (Relative Effectiveness Assessment of Listed drugs). [7] La méthode REAL est une procédure qui se déroule en trois étapes :…”

Section: Généralisation Des Résultats De Comparaisons Mixtes Aux Pratunclassified

Bénéfice médical réel estimé par comparaisons indirectes

Zylberman²,

Cucherat³

et al. 2009

Therapies

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