Evaluating the Impact of Incentives on Clinical Trial Participation: Protocol for a Mixed Methods, Community-Engaged Study
Notice bibliographique
Résumé
BACKGROUND: Monetary incentives in research are frequently used to support participant recruitment and retention. However, there are scant empirical data regarding how researchers decide upon the type and amount of incentives offered. Likewise, there is little guidance to assist study investigators and institutional review boards (IRBs) in their decision-making on incentives. Monetary incentives, in addition to other factors such as the risk of harm or other intangible benefits, guide individuals' decisions to enroll in research studies. These factors emphasize the need for evidence-informed guidance for study investigators and IRBs when determining the type and amount of incentives to provide to research participants. OBJECTIVE: The specific aims of our research project are to (1) characterize key stakeholders' views on and assessments of incentives in biomedical HIV research; (2) reach consensus among stakeholders on the factors that are considered when choosing research incentives, including consensus on the relative importance of such factors; and (3) pilot-test the use of the guidance developed via aims 1 and 2 by presenting stakeholders with vignettes of hypothetical research studies for which they will choose corresponding incentive types. METHODS: Our 2-year study will involve monthly, active engagement with a stakeholder advisory board of people living with HIV, researchers, and IRB members. For aim 1, we will conduct a nationwide survey (N=300) among people living with HIV to understand their views regarding the incentives used in HIV research. For aim 2, we will collect qualitative data by conducting focus groups with people living with HIV (n=60) and key informant interviews with stakeholders involved in HIV research (people living with HIV, IRB members, and biomedical HIV researchers: n=36) to extend and deepen our understanding of how incentives in HIV research are perceived. These participants will also complete a conjoint analysis experiment to gain an understanding of the relative importance of key HIV research study attributes and the impact that these attributes have on study participation. The data from the nationwide survey (aim 1) will be triangulated with the qualitative and conjoint analysis data (aim 2) to create 25 vignettes that describe hypothetical HIV research studies. Finally, individuals from each stakeholder group will select the most appropriate incentive that they feel should be used in each of the 25 vignettes (aim 3). RESULTS: The stakeholder advisory board began monthly meetings in March 2021. All study aims are expected to be completed by December 2022. CONCLUSIONS: By studying the role of incentives in HIV clinical trial participation, we will establish a decision-making paradigm to guide the choice of incentives for HIV research and, eventually, other types of similar research and facilitate the ethical recruitment of clinical research participants. TRIAL REGISTRATION: ClinicalTrials.gov NCT04809636; https://clinicaltrials.gov/ct2/show/NCT04809636. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33608.
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 | 0,174 | 0,177 |
| Méta-épidémiologie (sens strict) | 0,007 | 0,006 |
| Méta-épidémiologie (sens large) | 0,008 | 0,007 |
| Bibliométrie | 0,007 | 0,009 |
| Études des sciences et des technologies | 0,007 | 0,006 |
| Communication savante | 0,008 | 0,007 |
| Science ouverte | 0,005 | 0,005 |
| Intégrité de la recherche | 0,009 | 0,013 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,080 | 0,021 |
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 ».