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Enregistrement W795371411 · doi:10.1177/070674371506000104

The STAR*D Trial: It is Time to Reexamine the Clinical Beliefs That Guide the Treatment of Major Depression

2015· article· en· W795371411 sur OpenAlexvenueno aff
H. Edmund Pigott

Notice bibliographique

RevueThe Canadian Journal of Psychiatry · 2015
Typearticle
Langueen
DomaineMedicine
ThématiqueTreatment of Major Depression
Établissements canadiensnon disponible
Organismes subventionnairesNational Institute of Mental Health
Mots-clésDepression (economics)PsychologyPsychiatryClinical trialStar (game theory)MedicineInternal medicine

Résumé

récupéré en direct d'OpenAlex

The STAR*D trial is the largest and most consequential antidepressant study ever conducted, with over 120 journal articles published by study investigators, innumerable citations of STAR*D's findings by other researchers, and extensive coverage in the media, thereby giving it an oversized impact on the of depression, worldwide. Funded at a cost of 35-million US dollars, STAR*D enrolled 4041 patients who screened positive for major depression while seeking routine medical or psychiatric care. In contrast most industry-funded trials, STAR*D included depressed patients with comorbid conditions, thereby increasing the generalizability of its findings and further, provided 12 months of free continuing care monitor the durability of effects.STAR*D provided up 4 steps per patient and was designed give guidance in selecting the best next-step for the many patients who fail get sufficient relief from their initial AD. Each step consisted of a 12-week, open-label trial, with an additional 2 weeks for patients deemed close remission. ADs were administered using a system of measurement-based care that involved assessing symptoms and side effects at each visit guide aggressive medication dosing ensure that the likelihood of achieving remission was maximized and that those who did not reach remission were truly resistant the medication.1, 30STAR*D allowed patients select options for randomization in steps 2 4 to empower patients, strengthen the therapeutic alliance, optimize adherence, and improve outcome2, 483 and evaluated the relative effectiveness of 11 pharmacologically distinct drug-drug combination treatments in 5 head-to-head comparisons. CT was also available as a switch or drug augmentation option in step 2, but too few patients included it as an acceptable treatment, resulting in only 101 contributing data after randomization. Therefore, CT was excluded from the step 2 switch and augmentation analyses.3,4 4Patients who achieved remission during step were encouraged enter the 12 months of free follow-up care, as were responder patients who failed attain remission but did not want continue the next step as would involve a change in medication. Remission was defined as a score of less than 8 on the HRSD, the study's prespecified primary outcome measure, and response as a 50% or greater reduction in depressive symptoms on it. The follow-up protocol strongly recommended that participants continue the previously effective acute medication(s) at the doses used in acute treatment but treating physicians were allowed make any psychotherapy, medication, or medication dose change5, 1908 they deemed necessary sustain a positive outcome during follow-up, including scheduling additional visits if depressive symptoms returned and (or) intolerable side effects emerged.6Prior Criticisms of Apparent Bias in the Reporting of STAR*D FindingsPigott and colleagues7,8 have previously criticized the investigators for the following:1) not reporting in their summary article5 remission and response rates using the prespecified HRSD but instead using the QIDS-SR, a nonblinded, clinic-administered assessment that was excluded from use as a research measure in the Research Protocol9;2) excluding from analysis patients who started on citalopram in their baseline visit and then dropped out without taking the exit HRSD despite the investigators' statement that our primary analyses classified patients with missing exit HRSD scores as nonremitters a priori1, 43 and these early dropout patients therefore should have been counted as failures as prespecified;3) asserting in their summary article a theoretical cumulative remission rate of 67% with the unrealistic provisos that this estimate assumes no dropouts, and it assumes that those who exited the study would have had the same remission rates as those who stayed in the protocol5, and4) other indicators of bias (see eTable 1). …

Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.

Comment cette classification a été obtenuedéplier

Prédiction distillée sur la base complète

Imitation des enseignants

Ni prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.

score de la tête « metaresearch » (Codex)0,003
score de la tête « metaresearch » (Gemma)0,000
Version: codex-gemma-dda1882f352aStatut de validation: machine_predicted_unvalidated
Catégories candidatesaucune
Catégories consensuellesaucune
DomaineSignal candidat: aucune · Signal consensuel: aucune
Devis d'étudeSignal candidat: Sans objet · Signal consensuel: Sans objet
GenreSignal candidat: Empirique · Signal consensuel: aucune
Score de désaccord entre enseignants0,578
Score d'incertitude au seuil0,944

Scores Codex et Gemma par catégorie

CatégorieCodexGemma
Métarecherche0,0030,000
Méta-épidémiologie (sens strict)0,0000,000
Méta-épidémiologie (sens large)0,0000,000
Bibliométrie0,0000,000
Études des sciences et des technologies0,0010,000
Communication savante0,0000,000
Science ouverte0,0010,000
Intégrité de la recherche0,0000,000
Charge utile insuffisante (le modèle a refusé de juger)0,0000,000

Scores machine (provisoires)

Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.

Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.

Tête enseignante Opus0,077
Tête enseignante GPT0,359
Écart entre enseignants0,282 · la distance entre les deux têtes enseignantes sur ce seul travail
Statut de validationscore_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découle

Classification

machine, non validée

Prédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.

Les modèles n’ont appliqué aucune catégorie : rien dans la taxonomie ne correspondait à ce travail.
Devis d'étudeSans objet
Domainenon disponible
GenreEmpirique

Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».

En bref

Citations92
Publié2015
Routes d'admission1
Résumé présentoui

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Même revueThe Canadian Journal of PsychiatryMême sujetTreatment of Major DepressionTravaux en français237 207