(032) Development of a Core Outcome Set for Provoked Vestibulodynia
Notice bibliographique
Résumé
Abstract Introduction The literature on vulvodynia treatment is heterogeneous in terms of intervention type, study quality, and outcome measures. A systematic review (SR) of vulvodynia treatments was recently published focusing on randomized controlled trials (RCTs) and non-RCTs for provoked vestibulodynia (PVD, a vulvodynia subtype). The authors of the SR concluded that most studies had very low certainty of evidence, which limited the ability to draw conclusions about intervention efficacy. In addition, the authors noted a large degree of heterogeneity in outcome measures, which limited the ability to conduct a meta-analysis, and they recommended that future studies incorporate a core outcome set (COS, an agreed-upon standardized set of outcomes that should be assessed and reported, as a minimum, in all clinical trials in specific areas of health or healthcare) so that results from future clinical trials of PVD can be combined and evaluated. Objective To establish a COS for PVD. Methods The Project Management Team of the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) consists of vulvodynia researchers/clinicians, a patient partner, and health technology methodologists. Since March 2022, the team has conducted a literature review and extracted all outcomes from the PVD treatment literature (as of 1990 for published studies, and no date limit for the clinical trials database). Sixty-six outcomes (e.g., pain during intercourse, sexual function) have been identified. To conduct a two round Delphi survey with multiple stakeholders, registration for participation in the study (ongoing) has been open to a variety of stakeholders: people with current or past lived experience of PVD, relatives of those with lived experience of PVD, healthcare practitioners, researchers, and others (e.g., leaders of patient or funding organizations). Participants who register will provide background information to ensure representativeness of stakeholder identification and sociodemographic status (e.g., country of residence, gender), after which they will be asked to participate in the first survey. The first survey asks participants to rate each of the outcomes on a 9-point scale (from outcome is not important to outcome is critical to include and should always be measured in treatment studies) and to list any outcomes that should be included but were missed. In the second survey, the outcomes with the highest ranks from the first survey and all new outcomes will be presented to the participants, and they will be asked to rate them. Then, a virtual consensus meeting will be held with some members from all stakeholder groups to discuss the highest ranked outcomes and to decide which ones to include in the core outcome set. Results We will report on interim progress of the COS for PVD. Conclusions The results of this study will contribute critical information to standardize outcome reporting across PVD treatment studies so that stakeholders can directly compare the effectiveness of different interventions, identify clinically relevant outcomes, and reduce the risk of reporting bias. In addition, they will allow for the generation of consistent data for meta-analyses. Disclosure No
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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 | 0,002 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 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 tête enseignante, 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 ».