Moore Courtney M, Wiehe Sarah E, Lynch Dustin O, Claxton Gina Em, Landman Matthew P, Carroll Aaron E, Musey Paul I
Research Jam, The Indiana Clinical and Translational Sciences Institute, Indianapolis, IN, United States.
Children's Health Services Research, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, United States.
J Particip Med. 2020 May 20;12(2):e14973. doi: 10.2196/14973.
Skin and soft tissue infections (SSTIs) due to community-acquired methicillin-resistant Staphylococcus aureus (MRSA) can lead to a number of significant known medical outcomes including hospitalization, surgical procedures such as incision and drainage (I&D), and the need for decolonization procedures to remove the bacteria from the skin and nose and prevent recurrent infection. Little research has been done to understand patient and caregiver-centered outcomes associated with the successful treatment of MRSA infection.
This study aimed to uncover MRSA decolonization outcomes that are important to patients and their parents in order to create a set of prototype measures for use in the MRSA Eradication and Decolonization in Children (MEDiC) study.
A 4-hour, human-centered design (HCD) workshop was held with 5 adolescents (aged 10-18 years) who had experienced an I&D procedure and 11 parents of children who had experienced an I&D procedure. The workshop explored the patient and family experience with skin infection to uncover patient-centered outcomes of MRSA treatment. The research team analyzed the audio and artifacts created during the workshop and coded for thematic similarity. The final themes represent patient-centered outcome domains to be measured in the MEDiC comparative effectiveness trial.
The workshop identified 9 outcomes of importance to patients and their parents: fewer MRSA outbreaks, improved emotional health, improved self-perception, decreased social stigma, increased amount of free time, increased control over free time, fewer days of school or work missed, decreased physical pain and discomfort, and decreased financial burden.
This study represents an innovative HCD approach to engaging patients and families with lived experience with MRSA SSTIs in the study design and trial development to determine meaningful patient-centered outcomes. We were able to identify 9 major recurrent themes. These themes were used to develop the primary and secondary outcome measures for MEDiC, a prospectively enrolling comparative effectiveness trial.
ClinicalTrials.gov NCT02127658; https://clinicaltrials.gov/ct2/show/NCT02127658.
社区获得性耐甲氧西林金黄色葡萄球菌(MRSA)引起的皮肤和软组织感染(SSTIs)可导致许多重大的已知医疗后果,包括住院、手术操作如切开引流(I&D),以及需要进行去定植程序以从皮肤和鼻腔清除细菌并预防反复感染。关于与MRSA感染成功治疗相关的以患者和护理人员为中心的结果,目前研究较少。
本研究旨在揭示对患者及其父母重要的MRSA去定植结果,以便创建一套用于儿童MRSA根除和去定植(MEDiC)研究的原型测量指标。
与5名经历过切开引流手术的青少年(10 - 18岁)和11名经历过切开引流手术的儿童的父母举办了一场为期4小时的以人为本设计(HCD)研讨会。该研讨会探讨了患者和家庭的皮肤感染经历,以揭示以患者为中心的MRSA治疗结果。研究团队分析了研讨会期间产生的音频和工件,并对主题相似性进行编码。最终主题代表了将在MEDiC比较有效性试验中测量的以患者为中心的结果领域。
研讨会确定了9个对患者及其父母重要的结果:MRSA爆发减少、情绪健康改善、自我认知改善、社会耻辱感降低、自由时间增加、对自由时间的控制增加、错过上学或工作的天数减少、身体疼痛和不适减轻以及经济负担减轻。
本研究代表了一种创新的以人为本设计方法,让有MRSA SSTIs实际经历的患者和家庭参与研究设计和试验开发,以确定有意义的以患者为中心的结果。我们能够识别出9个主要的反复出现的主题。这些主题被用于制定MEDiC的主要和次要结果测量指标,MEDiC是一项前瞻性招募的比较有效性试验。
ClinicalTrials.gov NCT02127658;https://clinicaltrials.gov/ct2/show/NCT02127658 。