12208 Impact Of Transition From The IDS-iSYS To The Roche Elecsys® Immunoassays On A Clinical Study Assessing Strict IGF-1 Control (I-Con) In Patients With Acromegaly
Notice bibliographique
Résumé
Abstract Disclosure: C.L. Chik: Advisory Board Member; Self; Ipsen, Novo Nordisk, Novartis Pharmaceuticals. Grant Recipient; Self; Pfizer, Inc.. C. Gandhi: None. J.A. Rivera: None. M. Denis: None. S. Van Uum: Advisory Board Member; Self; Ipsen, Pfizer, Inc., Novo Nordisk, Spruce. S.Z. Ezzat: Advisory Board Member; Self; Bayer, Inc., Eli Lilly & Company, Ipsen, Novartis Pharmaceuticals, Merck, Eisai. D.T. Holmes: Other; Self; Roche Diagnostics. Objective: IGF-1 measurements were transitioned from the IDS-iSYS to the Roche Elecsys® immunoassays by the central laboratory during our clinical study that assessed strict IGF-1 control (I-Con) and quality-of-life scores in patients with acromegaly. Given the known variabilities of the IGF-1 measurements and the critical nature of IGF-1 results to the validity of the study, a retrospective analysis of the stored samples was completed using both methods. Methods: IGF-1 was measured in available stored samples (n=38) using IDS-iSYS at one of the hospital laboratories and the Roche Elecsys® at the central laboratory. In addition, the end-of-study (EOS) IGF-1 results were compared with IGF-1 measurements during the study (DTS) at the central and the local laboratory of the two sites with more than 10 stored samples, with one site using IDS-iSYS and the second site using IGF-1-RIACT. Bland-Altman plot, regression analysis and intra-class correlation were used to assess the reliability of the IGF-1 measurements. Results: Ten acromegaly patients from four sites in Canada participated in the clinical study. After six months of addition of pegvisomant to a somatostatin analog (n=6) or dose escalation of pegvisomant (n=4), IGF-1 decreased from 258.5 ± 59.2 µg/L [121.8 ± 14.4 % upper limit of normal (%ULN)] to 184.1 ± 41.1 µg/L (86.7 ± 20.0 %ULN) (p=0.001). Two to five stored samples were available from the 10 patients (n=38) and the mean difference of IGF-1 between the IDS-iSYS and Roche Elecsys® was 10.8 µg/L or 4.6% when expressed as %ULN, with a trend to a higher value at the central laboratory. Linear regression of the difference between IGF-1 measurements against their average showed a slope of 0.1 (p<0.001) or 0.15 (p=0.01) when expressed as %ULN. Intra-class correlations between the central laboratory DTS and EOS measurements were compared with those by the local laboratory. In the site that used IDS-iSYS for IGF-1 measurements, the intra-class correlations with the Roche Elecsys® was 0.99 (n=11) for DTS measurements and 0.98 (n=13) for EOS measurements. In the second site that used IGF-1-RIACT, the intra-class correlations with the IDS-iSYS was 0.38 (n=13) for DTS results, and with the Roche Elecsys® was 0.64 (n=15) for EOS results. Conclusion: Although there were variabilities between the IDS-iSYS and the Roche Elecsys® IGF-1 measurements, the small difference between the two IGF-1 assays confirmed that the transition from the IDS-iSYS to the Roche Elecsys® by the central laboratory had little impact on the IGF-1 results of our study. Using intra-class correlations to assess reliability of the IGF-1 measurements, the reliability of the IGF-1 results appeared dependent on the IGF-1 method used in the individual site. Presentation: 6/2/2024
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 machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,005 | 0,010 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
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.
score_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 découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».