【作者】 王婷；

【导师】 孙强； 阴佳；

【作者基本信息】 山东大学 ， 社会医学与卫生事业管理， 2024， 硕士

【副题名】基于RE-AIM框架

【摘要】 研究背景抗微生物药物耐药性(Antimicrobial resistance,AMR)是全球最严重的公共卫生问题之一。中国基层医疗卫生机构抗生素不合理使用现象尤为突出,上呼吸道感染(Upper Respiratory Tract Infection,URTIs)是抗生素不合理使用的常见疾病。国内已开展多项干预研究以期改善基层地区抗生素不合理使用现况,但至今尚未发现在基层长期有效的促进抗生素合理使用的干预措施。课题组开发了临床辅助决策支持系统(Clinical Decision Support System,CDSS)并开展了为期6个月的试点干预,评估证实了短期效果与在农村地区推广的潜在可能,但仍有必要对其长期应用有效性及推广性进行全面评估。覆盖效力适应实施维持框架(Reach,effectiveness,adoption,implementation,maintenance,RE-AIM)具备从内部有效性与外部有效性维度评价干预项目的优势。因此,本研究采用RE-AIM 框架进行以 CDSS 为核心的促进基层医疗卫生机构抗生素合理使用的干预项目(后文简记:干预项目)的实施效果评价研究。研究目的运用RE-AIM框架对干预项目的实施效果进行评价,探讨干预项目在基层医疗卫生机构的长期有效性及其在实施过程中的促进与障碍因素,为今后卫生决策部门调整促进基层URTIs抗生素合理使用干预策略及卫生资源配置提供参考。研究方法1.干预项目的长期有效性评价采用混合研究方法评价干预项目的长期有效性,一方面,基于课题组前期开展的为期6个月的试点干预评价,继续进行为期1年的干预后长期随访研究,探讨干预项目的长期有效性。量性评价指标包括URTIs抗生素处方率(Antibiotic Prescription Rate,APR)和 URTIs 抗生素联用处方率(Multiple Antibiotic Prescription Rate,MAPR),同时,于长期随访研究结束后对干预组村医展开质性访谈,探讨CDSS的临床支持作用。2.干预项目的实施过程评价采用混合研究方法评价干预项目的可及性、采纳性、实施性与持续性。量性评价指标包括村医全程参与率、参与者的人口学代表性、村卫生室持续参与率、村卫生室下村医持续参与率、培训参与率、活动内容实施率、数据上报达标率、村医继续参与率与乡镇卫生院继续支持开展率以探讨干预项目的具体实施过程,同时通过质性访谈探讨实施过程中的促进与障碍因素。研究结果1.干预项目的长期有效性评价量性研究结果显示,在正式干预结束后12个月(长期随访结束),运用双重差分模型(Differences-in-Differences,DID)评估了干预措施的长期有效性,在控制了混杂因素的情况下,干预组村医的URTIs抗生素处方率下降10.8个百分点(p<0.001);同时,干预组村医的URTIs抗生素联用处方率下降4.5个百分点(p=0.001),且患者在首诊后未来30天内的住院率仅为0.23。质性研究结果显示,干预组村医普遍表示通过长期使用CDSS,不仅提升了自身URTIs诊疗知识,规范了问诊行为,也改变了自身长期以来形成的不正确的用药态度,增强了处方信心,从而改善了既往不合理处方行为,降低了抗生素处方率。2.干预项目的实施过程评价量性研究结果显示,在Reach维度,村卫生室和村医的全程参与率均为92.85%且全程参与干预项目的村医的人口学代表性为0.979;在Adoption维度,村卫生室持续参与率为92.85%,村卫生室下村医持续参与率为86.7%;在Implementation维度,集体培训总体参与率为92.85%,干预活动内容总体实施率为92.85%,数据上报总体达标率为85.18%;在Maintenance维度,CDSS整体使用质量得分为9.54±0.88,整体临床支持水平得分为9.23±1.01,100%的村医愿意在未来继续使用CDSS,同时,100%的参与研究的乡镇卫生院继续支持干预项目在辖区内开展与推广。质性研究结果表明,干预项目在实施过程中的促进因素主要为利益相关方认可项目理念、CDSS预测准确且使用便捷、项目经济激励措施完善以及行政力量助推作用;阻碍因素主要为村医基本公共卫生服务工作负担重、CDSS登录操作步骤繁琐且未与医院信息系统联网、农村地区村卫生室因生存压力出现裁撤,不利于项目推广。结论与建议一方面,以CDSS为核心的促进村医URTIs抗生素合理使用的干预项目在长期促进抗生素合理使用方面具有重要价值。通过干预组村医长期坚持使用CDSS,其URTIs抗生素处方率和抗生素联用处方率较干预前均下降较为明显;同时,CDSS为村医提供了规范问诊流程指导,增强了其个人知识与技能,促进了其抗生素合理使用行为。另一方面,以CDSS为核心的促进村医URTIs抗生素合理使用干预项目的可及性、采纳性、实施性和可持续性均较好,绝大多数干预组村医较为认可CDSS的临床应用价值并愿意未来继续使用或推荐给同行。同时,CDSS在干预组村卫生室应用情况较好,具备推广应用价值,但仍存在CDSS操作登录步骤繁琐、功能有待升级、未与医院系统并网、项目监督考核机制不健全、项目宣传不到位等阻碍因素,应进一步调整与改进。立足于干预项目的进一步推广需要,建议升级系统功能、简化登录操作步骤,探索与医院信息系统并网、并进行大规模推广宣传,建立项目监督考核机制、形成螺旋式闭环管理模式,从而推动CDSS在农村地区的大规模推广应用。更多还原

【Abstract】 BackgroundAntimicrobial resistance(AMR)is one of the most serious public health problems worldwide.The irrational use of antibiotics in primary healthcare organizations in China is particularly prominent,with Upper Respiratory Tract Infection(URTIs)being the main source of irrational antibiotic use.Many intervention studies have been conducted in China to improve the irrational use of antibiotics at the primary level,but no long-term effective interventions have been found to promote the rational use of antibiotics at the primary level.The Clinical Decision Support System(CDSS)previously developed by the research group has shown good results and the potential to be promoted in rural areas after a 6-month pilot intervention evaluation,and it is necessary to conduct a comprehensive evaluation of its long-term effectiveness and promotion.Meanwhile,the Reach,effectiveness,adoption,implementation,maintenance(RE-AIM)framework has the advantage of evaluating intervention programs from the dimensions of internal and external effectiveness.Therefore,in this study,the RE-AIM framework was adopted to conduct an evaluation study of the effectiveness of the CDSScentered intervention program to promote the rational use of antibiotics in primary care(hereinafter referred to as the intervention program).ObjectivesThe RE-AIM framework was used to evaluate the effectiveness of the implementation of the intervention program,to explore the long-term effectiveness of the intervention program in primary care and its facilitators and barriers during its implementation,and to provide a reference for future health decision-making authorities to adjust the intervention strategy for promoting the rational use of antibiotics in primary URTIs and the allocation of health resources.Methods1.Evaluation of the long-term effectiveness of intervention projectsA mixed research approach was used to evaluate the long-term effectiveness of the intervention program,on the one hand,based on the 6-month pilot intervention evaluation conducted by the group in the previous period,and continued with a 1-year post-intervention long-term follow-up study to explore the long-term effectiveness of the intervention program.The quantitative evaluation indicators included URTIs Antibiotic Prescription Rate(APR)and URTIs Multiple Antibiotic Prescription Rate(MAPR),while qualitative interviews were conducted with village doctors in the intervention group at the end of the long-term follow-up study to explore the clinical effectiveness of CDSS.interviews were conducted to explore the clinical supportive role of CDSS.2.Evaluation of the implementation process of intervention projectsA mixed research approach was used to evaluate the accessibility,adoption,implementation and sustainability of the intervention program.Quantitative evaluation indicators included the rate of full participation of village doctors,demographic representativeness of participants,sustained participation of village health units,sustained participation of village doctors under the village health units,participation in training,implementation of activities,compliance with data reporting,continued participation of village doctors and continued support from township health centers in order to explore the process of program implementation,and facilitating and hindering factors were explored through qualitative interviews.Results1.Evaluation of the long-term effectiveness of intervention projectsThe results of the quantitative study showed that at 12 months after the end of the formal intervention(end of long-term follow-up),the long-term effectiveness of the intervention was assessed using a double-difference model(Differences-in-Differences(DID)),and controlling for confounders,the rate of antibiotic prescribing for URTIs among village doctors in the intervention group decreased by 10.8 percentage points(p<0.001);at the same time,the URTIs antibiotic co-prescription rate of village doctors in the intervention group decreased by 4.5 percentage points(p=0.001),and the hospitalization rate of patients in the next 30 days after the first consultation was only 0.23.The qualitative findings showed that the village doctors in the intervention group generally reported that through the use of CDSS in the long term,they not only improved their own knowledge of diagnosis and treatment of URTIs and standardized their consulting behaviors,but also changed their own incorrect attitudes toward medication that had developed over time,and increased their prescribing confidence,thus improving previous irrational prescribing behaviors and reducing the antibiotic prescribing rate.2.Evaluation of the implementation process of intervention projectsThe results of the quantitative study showed that,in the Reach dimension,the full participation rate of both VHUs and village doctors was 92.85%and the demographic representativeness of the village doctors who participated in the intervention program was 0.979;in the Adoption dimension,the sustained participation rate of VHUs was 92.85%,and the sustained participation rate of village doctors under the VHUs was 86.7%;in the Implementation dimension,the overall participation rate of group training was 92.85%,the overall implementation rate of intervention activity content was 92.85%,and the overall compliance rate of data reporting was 85.18%;in the Maintenance dimension,the overall quality of use of CDSS was scored as 9.54±0.88,and the overall level of clinical support was scored as 9.23±1.01,and 100%of the village doctors were willing to continue to use the CDSS,while 100%of the township health centers participating in the study continued to support the development and dissemination of the intervention program in their jurisdictions.The results of the qualitative study showed that the facilitating factors in the implementation of the intervention project were the recognition of the project concept by stakeholders,the accuracy of the CDSS predictions and the ease of use,the improvement of the project’s economic incentives,and the role of the administrative force;the hindering factors were the heavy workload of village doctors in the provision of basic public health services,the cumbersome CDSS log-in procedure and the lack of networking with the hospital’s information system,the abolition of the village health office in the rural area due to the pressure of survival,and the unfavorable impact on the village health office.The obstacles were the heavy workload of village doctors,the cumbersome operation of CDSS login and the lack of connection with the hospital information system,and the abolition of village health offices in rural areas due to the pressure of survival,which was not conducive to the promotion of the project.Conclusion and RecommendationOn the one hand,the CDSS-centred intervention programme to promote the rational use of antibiotics by village doctors’ URTIs has an important value in promoting the rational use of antibiotics in the long term.Through the long-term persistent use of CDSS by village doctors in the intervention group,the prescription rate of antibiotics for URTIs and the prescription rate of antibiotic combinations decreased significantly compared with the pre-intervention rate;at the same time,the CDSS provided guidance on the standardised consultation process for the village doctors,enhanced their personal knowledge and skills,and promoted the rational use of their antibiotic behaviours.On the other hand,the Reach,Adoption,Implementation and Maintenance of the CDSS-centred Intervention Project to Promote the Rational Use of Antibiotics in URTIs among Village Doctors is relatively good,and the vast majority of the village doctors in the intervention group recognised the value of the clinical application of the CDSS and were willing to continue to use it in the future,or to recommend it to their peers.Meanwhile,the CDSS was well applied in the village health offices of the intervention group,and has the value of promotion and application.However,there are still obstacles such as the cumbersome steps of CDSS operation and logging in,the functions to be upgraded,the absence of a parallel network with the hospital system,the lack of a sound mechanism for monitoring and evaluation of the project,and the lack of project publicity,etc.,which should be further adjusted and improved.Based on the need for further promotion of the intervention programme,it is recommended that the system functions be upgraded,the log-in operation steps be simplified,a parallel network with the hospital information system be explored,large-scale promotion and publicity be carried out,and a monitoring and evaluation mechanism be established for the programme to form a closed-loop spiral management model,so as to promote large-scale popularisation of the CDSS in the rural areas.更多还原