Background Despite increasing interest in patient involvement in health care research, researchers may be uncertain about the benefits of involving patients in the design and conduction of clinical studies. We aimed to evaluate the impact of patient involvement on patient recruitment and retention in a clinical study of PET/CT in women with advanced breast cancer. Further, we report our experience regarding the researchers' attitudes towards involving patients as partners in the research process. Methods Two patient representatives from the Danish Breast Cancer Organization were invited as partners in the research team. These patient partners were asked to contribute in particular to participator information material and evaluation of ethical aspects of the study. The impact of patient involvement on patient recruitment was evaluated by comparing expected versus actual number of patients recruited, and then relating it to patient recruitment in a similar study at the same institution that did not involve patients as research partners. Results Having patients as partners in the research team led to a major revision of the participator information material and improved patient recruitment. The expected number of patients was 260, but 380 were actually enrolled within the planned study period, thus 146% of the expected patient recruitment. In the previous study, only 100 of the expected 150 patients were enrolled during a 10-month extended study period, i.e. 67% of the expected number. Patient retention in the current study was high, with 86% of eligible patients attending follow-up scans. We observed initial resistance amongst researchers against inviting patients as team partners. This resistance gradually lessened during the study, and the most reluctant researchers at the beginning of the study later applauded the collaboration and the ideas generated by the patient representatives. Conclusion Involving patients as partners in the research team resulted in major changes to the participator information material and contributed to higher than expected patient recruitment and retention. Furthermore, we observed a positive change of attitude amongst the researchers towards patient involvement in the research process. Trial registration Ongoing study: ClinicalTrials.gov (NCT03358589).Previous study: ClinicalTrials.gov (NCT01552655).

中文翻译：

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从患者参与分析晚期乳腺癌女性 PET/CT 的临床研究中学习。

背景 尽管对患者参与医疗保健研究的兴趣日益增加，但研究人员可能不确定让患者参与临床研究的设计和实施的好处。我们旨在评估患者参与对晚期乳腺癌女性 PET/CT 临床研究中患者招募和保留的影响。此外，我们报告了我们在研究人员对让患者作为合作伙伴参与研究过程的态度方面的经验。方法邀请丹麦乳腺癌组织的两名患者代表作为研究团队的合作伙伴。这些患者合作伙伴被要求特别为参与者信息材料和研究伦理方面的评估做出贡献。通过比较预期和实际招募的患者数量，评估患者参与对患者招募的影响，然后将其与同一机构的类似研究中的患者招募相关联，该研究不涉及患者作为研究伙伴。结果 让患者作为研究团队的合作伙伴导致对参与者信息材料的重大修订并改进了患者招募。预期患者人数为 260 人，但在计划的研究期内实际招募了 380 名患者，因此是预期患者招募的 146%。在之前的研究中，预期的 150 名患者中只有 100 名在 10 个月的延长研究期间入组，即预期人数的 67%。当前研究中的患者保留率很高，86% 的合格患者参加了后续扫描。我们观察到研究人员最初反对邀请患者作为团队合作伙伴。这种阻力在研究过程中逐渐减弱，研究开始时最不情愿的研究人员后来对患者代表的合作和提出的想法表示赞赏。结论 让患者作为研究团队的合作伙伴导致参与者信息材料发生重大变化，并导致患者招募和保留率高于预期。此外，我们观察到研究人员对患者参与研究过程的态度发生了积极变化。试验注册 正在进行的研究：ClinicalTrials.gov (NCT03358589)。先前的研究：ClinicalTrials.gov (NCT01552655)。这种阻力在研究过程中逐渐减弱，研究开始时最不情愿的研究人员后来对患者代表的合作和提出的想法表示赞赏。结论 让患者作为研究团队的合作伙伴导致参与者信息材料发生重大变化，并导致患者招募和保留率高于预期。此外，我们观察到研究人员对患者参与研究过程的态度发生了积极变化。试验注册 正在进行的研究：ClinicalTrials.gov (NCT03358589)。先前的研究：ClinicalTrials.gov (NCT01552655)。这种阻力在研究过程中逐渐减弱，研究开始时最不情愿的研究人员后来对患者代表的合作和提出的想法表示赞赏。结论 让患者作为研究团队的合作伙伴导致参与者信息材料发生重大变化，并导致患者招募和保留率高于预期。此外，我们观察到研究人员对患者参与研究过程的态度发生了积极变化。试验注册 正在进行的研究：ClinicalTrials.gov (NCT03358589)。先前的研究：ClinicalTrials.gov (NCT01552655)。结论 让患者作为研究团队的合作伙伴导致参与者信息材料发生重大变化，并导致患者招募和保留率高于预期。此外，我们观察到研究人员对患者参与研究过程的态度发生了积极变化。试验注册 正在进行的研究：ClinicalTrials.gov (NCT03358589)。先前的研究：ClinicalTrials.gov (NCT01552655)。结论 让患者作为研究团队的合作伙伴导致参与者信息材料发生重大变化，并导致患者招募和保留率高于预期。此外，我们观察到研究人员对患者参与研究过程的态度发生了积极变化。试验注册 正在进行的研究：ClinicalTrials.gov (NCT03358589)。先前的研究：ClinicalTrials.gov (NCT01552655)。