Clinical trial center, INSERM CICEC 1408, University Hospital of Saint-Etienne, Saint-Etienne, France.
Groupe Immunité Muqueuse et Agents Pathogènes (GIMAP), EA3064 - Medical School of Saint-Etienne, University of Lyon, Saint-Etienne, France.
Hum Vaccin Immunother. 2019;15(12):2969-2979. doi: 10.1080/21645515.2019.1625646. Epub 2019 Jun 26.
A trustworthy relationship between primary physicians (PPs) and their patients is crucial for vaccine acceptance. Little is known about attitudes of PPs toward participation of their patients in a preventive vaccine trial (PVT) proposed by investigation sites.A cross-sectional study was conducted in Auvergne-Rhône-Alpes region (France) including an anonymous questionnaire for general practitioners (GPs) and other specialists as well as face-to-face interviews. A scenario of a patient, with chronic medical conditions, invited to participate in a PVT and reporting this situation to his/her PP was drawn up. PPs' attitudes were assessed in quantitative approach by a 5-point Likert scale and in qualitative approach by semi-directed individual interviews.Among the 521 respondents to the questionnaire, 429 (82.3%) were GPs and 92 (17.7%) were other specialists. Only 7.5% (39/521) of respondents regularly practice clinical research. Confronted with the scenario, 312 respondents (59.8%) declared they would give their opinion spontaneously. Before giving their opinion, PPs would like more information about the trial (91.4%, n = 476). Whatever their attitude, 488 (93.7%) would be influenced by available safety data. Face-to-face interviews confirmed that PPs lack of knowledge about clinical research, and would like to obtain information from investigators, particularly about safety.PPs seem to be concerned by the decision of their patients to participate or not in a PVT but would like more information about the trial and clinical research before giving their opinion. Getting PPs to be more involved in the enrollment of patients in PVT may improve recruitment.
初级保健医生（PPs）与其患者之间建立信任关系对于疫苗接种至关重要。人们对 PPs 对调查点提出的参与预防性疫苗试验（PVT）的态度知之甚少。本研究在奥弗涅-罗讷-阿尔卑斯地区（法国）进行了一项横断面研究，包括为全科医生（GP）和其他专家提供匿名问卷以及面对面访谈。设计了一个有慢性疾病的患者被邀请参加 PVT 并向其 PPs 报告这种情况的情景。通过 5 点李克特量表对 PPs 的态度进行定量评估，并通过半结构化个人访谈进行定性评估。在回答问卷的 521 名受访者中，429 名（82.3%）是全科医生，92 名（17.7%）是其他专家。只有 7.5%（39/521）的受访者定期进行临床研究。在面对这种情况时，312 名受访者（59.8%）表示他们会自发发表意见。在发表意见之前，PPs 希望获得更多有关试验的信息（91.4%，n=476）。无论他们的态度如何，488 名（93.7%）都会受到可用安全数据的影响。面对面访谈证实，PPs 对临床研究的了解不足，希望从研究者那里获得信息，特别是有关安全性的信息。PPs 似乎对患者是否参与 PVT 的决定感到担忧，但在发表意见之前，他们希望获得更多有关试验和临床研究的信息。让 PPs 更多地参与 PVT 患者的入组可能会改善招募情况。
