Development of Recommendations for a Core Outcome Set for Clinical Trials of Physical Rehabilitation in Adults Across the Continuum of Solid Organ Transplantation
Notice bibliographique
Résumé
Introduction Clinical trials of physical rehabilitation (PR) in solid organ transplant (SOT) use varied outcome measures, which creates difficulties comparing and combining findings across studies. A core outcome set (COS), defined as “the minimum agreed set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population”, can address this issue. The purpose of this study was to develop consensus-based recommendations on standard COS for clinical trials of PR in adult SOT patients for three phases: pre-transplant, early post-transplant, late post-transplant. Material and Methods A Delphi procedure was used to reach consensus on the most important outcome domains for clinical trials of PR and SOT. The protocol was registered with COMET initiative (www.comet-initiative.org/). Panellists consisted of patients (SOT recipients); clinicians and researchers involved in the field of SOT rehabilitation in Canada. Panellists were provided with a list of 27 outcome domains based on a systematic review of exercise trials in SOT. Panellists were asked to rate the importance of outcome domains using a 9-point Likert scale ranging from “not important” to “very important-critical”. Three rounds of online questionnaires were performed to obtain consensus. In round 1, consensus for including an outcome was defined by 70% or more participants scoring “very important” and less than 15% scoring “not important”. In rounds 2 and 3, consensus was reached when 60% or more participants scored an outcome as “very important” and less than 15% scored it “not important”, within at least one subgroup of patients or clinicians/researchers. Results and Discussion Forty panellists were included in the study (25 clinicians and researchers and 15 patients); 33 completed all 3 rounds (response rates of 95% for rounds 1 and 2, and 92% for round 3). Five outcomes reached consensus in the pre-transplant phase; 10 in the early post-transplant phase and 8 in the late post-transplant phase (see Figure). Exercise capacity, mobility, quality of life, and frailty reached consensus across the 3 phases of transplant. 20% of the outcomes were related to body function and structure in the pre-transplant phase, 40% in the early- and 13% in the late- post-transplant phases. Differences were noted in the ratings between patients and clinicians/researchers, especially in the early post-transplant phase, where patients rated outcomes related to body function and structure (such as organ rejection and infections) as having greater importance than clinicians/researchers. Conclusion This study provides recommendations on COS domains that should be assessed in clinical trials of PR programs in adults across the continuum of SOT. Future steps include the selection of outcome measure instruments that match the domains identified in this study, and to expand the panel to an international group of experts.
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 | 0,632 | 0,740 |
| Méta-épidémiologie (sens strict) | 0,004 | 0,006 |
| Méta-épidémiologie (sens large) | 0,009 | 0,021 |
| Bibliométrie | 0,016 | 0,012 |
| Études des sciences et des technologies | 0,005 | 0,008 |
| Communication savante | 0,013 | 0,014 |
| Science ouverte | 0,018 | 0,016 |
| Intégrité de la recherche | 0,025 | 0,028 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,007 | 0,006 |
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; l’étiquette directe de Gemma et le classifieur distillé Codex s’accordent sur ce qui est montré ici.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».