PUBLICATION BIAS AND PROTOCOL DEVIATIONS IN REGISTERED ORTHOPAEDIC TRIALS
Notice bibliographique
Résumé
The number randomized controlled trials (RCTs) published in orthopaedic has increased substantially since the early 20th century, though these studies still comprise a small proportion of the overall orthopaedic literature. Not all RCTs are conducted according to the original methodology (i.e. protocol deviation), and not all completed trials are eventually published (i.e. publication bias). At the macro level, publication bias and protocol deviations can greatly impact the overall quality and trustworthiness of the literature available to orthopaedic surgeons and their patients. Thus, the aim of this study was to evaluate publicly registered orthopaedic clinical trials to determine: 1) the rate of uncompleted/unpublished studies, and 2) the frequency and types of protocol deviations in these studies. Using the ClinicalTrials.gov (CTG) database, all orthopaedic RCTs were included if they met the following criteria: 1) interventional RCTs, 2) registered on the CTG registry, 3) the trial was completed between January 1, 2010 and December 31, 2020, and 4) the trial has status “completed.” Ongoing randomized control trials were excluded from the inquiry. Data on trial characteristics was extracted. The proportion of completed studies was calculated and tracked over time. Among published studies, the frequency and types of protocol deviations were recorded. A total of 105 completed RCTs were included. Industry and non-industry funded trials were present in similar proportions (48.6% and 49.5%, respectively). Overall, 35% of trials marked as ‘complete’ were not published, at a minimum of two years following the end of the inclusion period. The proportion of unpublished trials in a given year ranged from 0% (0/3, 2011) to 62.5% (5/8, 2016), with no clear temporal trend. Of the published trials, 63.2% (43/68) did not have a major protocol deviation. Industry and non-industry funded studies had similar rates of protocol deviations, at 37.9% and 36.8%, respectively. The most common type of protocol deviation was the use of a different primary outcome than originally planned, including some studies which did not report on the originally planned primary outcome at all. The most important finding of this study is that despite rising numbers of registered orthopaedic RCTs, publication bias and protocol deviations remain common, with no discernible trend towards improvement over time. Publication bias should be addressed at both the researcher and journal levels, with a commitment to the ongoing application of the scientific method, including thoughtful and intentional replication of previously published RCTs. Protocol deviations must always be tracked and reported with a clear rationale, and a priori outcome selection is an important step towards minimizing risk of bias in RCTs. Ongoing tracking and auditing of protocol adherence and publication efforts are an important part of the research process which should be carefully monitored after RCTs are funded and approved.
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 enseignantsNi 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.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,227 | 0,316 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,001 |
| Bibliométrie | 0,002 | 0,006 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,002 | 0,001 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| 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; les deux têtes enseignantes 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 ».