Université de Lorraine, APEMAC, Nancy, France.
Département des sciences cliniques et biomédicales «Luigi Sacco», Université de Milan, Milan, Italy.
BMJ Open. 2019 Feb 22;8(11):e025810. doi: 10.1136/bmjopen-2018-025810.
Antibiotic resistance is a serious and increasing worldwide threat to global public health. One of antibiotic stewardship programmes' objectives are to reduce inappropriate broad-spectrum antibiotics' prescription. Selective reporting of antibiotic susceptibility test (AST) results, which consists of reporting to prescribers only few (n=5-6) antibiotics, preferring first-line and narrow-spectrum agents, is one possible strategy advised in recommendations. However, selective reporting of AST has never been evaluated using an experimental design.
This study is a pragmatic, prospective, multicentre, controlled (selective reporting vs usual complete reporting of AST), before-after (year 2019 vs 2017) study. Selective reporting of AST is scheduled to be implemented from September 2018 in the ATOUTBIO group of 21 laboratories for all identified in urine cultures in adult outpatients, and to be compared with the usual complete AST performed in the EVOLAB group of 20 laboratories. The main objective is to assess the impact of selective reporting of AST for positive urine cultures in the outpatient setting on the prescription of broad-spectrum antibiotics frequently used for urinary tract infections (amoxicillin-clavulanate, third-generation cephalosporins and fluoroquinolones). The primary end point is the after (2019)-before (2017) difference in prescription rates for the previously mentioned antibiotics/classes that will be compared between the two laboratory groups, using linear regression models. Secondary objectives are to evaluate the feasibility of selective reporting of AST implementation by French laboratories and their acceptability by organising focus groups and individual semi-structured interviews with general practitioners and laboratory professionals.
This protocol was approved by French national ethics committees ( and ). Findings of this study will be widely disseminated through conference presentations, reports, factsheets and academic publications and generalisation will be further discussed.
NTC03612297.
抗生素耐药性是对全球公共健康构成的严重且日益严重的全球性威胁。抗生素管理计划的目标之一是减少不适当的广谱抗生素处方。建议的策略之一是选择性报告抗生素药敏试验（AST）结果，即仅向开处方者报告少数（n=5-6）抗生素，优先使用一线和窄谱药物。然而，AST 的选择性报告从未使用实验设计进行过评估。
这是一项实用的、前瞻性的、多中心的、对照（选择性报告与 AST 的常规完整报告）、前后（2019 年与 2017 年）研究。从 2018 年 9 月开始，ATOUTBIO 组的 21 个实验室计划对成人门诊尿液培养中所有鉴定的细菌进行 AST 的选择性报告，与 EVOLAB 组的 20 个实验室进行的常规完整 AST 进行比较。主要目标是评估选择性报告门诊尿液培养阳性 AST 对常用于尿路感染的广谱抗生素（阿莫西林-克拉维酸、第三代头孢菌素和氟喹诺酮类）处方的影响。主要终点是两个实验室组之间比较的前后（2019 年）-前（2017 年）差异，使用线性回归模型。次要目标是通过组织普通科医生和实验室专业人员的焦点小组和个别半结构化访谈，评估法国实验室实施 AST 选择性报告的可行性及其可接受性。
本方案已获得法国国家伦理委员会（ 和 ）的批准。本研究的结果将通过会议演讲、报告、情况说明书和学术出版物广泛传播，并将进一步讨论推广问题。
NTC03612297。
