Ackermann Deonna M, Bracken Karen, Janda Monika, Turner Robin M, Hersch Jolyn K, Drabarek Dorothy, Bell Katy J L
Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia.
JAMA Dermatol. 2023 Apr 1;159(4):432-440. doi: 10.1001/jamadermatol.2022.6478.
Adherence, both in research trials and in clinical practice, is crucial to the success of interventions. There is limited guidance on strategies to increase adherence and the measurement and reporting of adherence in trials of melanoma self-management practices.
This scoping review aimed to describe (1) strategies to improve adherence to self-management practices in randomized clinical trials of people at high risk of melanoma and (2) measurement and reporting of adherence data in these trials.
Four databases, including MEDLINE, Embase, CENTRAL, and CINAHL, were searched from inception to July 2022. Eligible studies were randomized clinical trials of self-monitoring interventions for early detection of melanoma in people at increased risk due to personal history (eg, melanoma, transplant, dysplastic naevus syndrome), family history of melanoma, or as determined by a risk assessment tool or clinical judgment.
From 939 records screened, 18 eligible randomized clinical trials were identified, ranging in size from 40 to 724 participants, using a range of adherence strategies but with sparse evidence on effectiveness of the strategies. Strategies were classified as trial design (n = 15); social and economic support (n = 5); intervention design (n = 18); intervention and condition support (n = 10); and participant support (n = 18). No strategies were reported for supporting underserved groups (eg, people who are socioeconomically disadvantaged, have low health literacy, non-English speakers, or older adults) to adhere to self-monitoring practices, and few trials targeted provider (referring to both clinicians and researchers) adherence (n = 5). Behavioral support tools included reminders (n = 8), priority-setting guidance (n = 5), and clinician feedback (n = 5). Measurement of adherence was usually by participant report of skin self-examination practice with some recent trials of digital interventions also directly measuring adherence to the intervention through website or application analytic data. Reporting of adherence data was limited, and fewer than half of all reports mentioned adherence in their discussion.
Using an adaptation of the World Health Organization framework for clinical adherence, this scoping review of randomized clinical trials identified key concepts as well as gaps in the way adherence is approached in design, conduct, and reporting of trials for skin self-examination and other self-management practices in people at high risk of melanoma. These findings may usefully guide future trials and clinical practice; evaluation of adherence strategies may be possible using a Study Within A Trial (SWAT) framework within host trials.
在研究试验和临床实践中，依从性对于干预措施的成功至关重要。在黑色素瘤自我管理实践试验中，关于提高依从性的策略以及依从性的测量和报告的指导有限。
本范围综述旨在描述（1）在黑色素瘤高风险人群的随机临床试验中提高自我管理实践依从性的策略，以及（2）这些试验中依从性数据的测量和报告。
检索了四个数据库，包括MEDLINE、Embase、CENTRAL和CINAHL，检索时间从建库至2022年7月。符合条件的研究是针对因个人病史（如黑色素瘤、移植、发育异常痣综合征）、黑色素瘤家族史或通过风险评估工具或临床判断确定为风险增加的人群进行的自我监测干预的随机临床试验，以早期发现黑色素瘤。
在筛选的939条记录中，确定了18项符合条件的随机临床试验，参与者人数从40人到724人不等，采用了一系列依从性策略，但关于这些策略有效性的证据稀少。策略分为试验设计（n = 15）；社会和经济支持（n = 5）；干预设计（n = 18）；干预和条件支持（n = 10）；以及参与者支持（n = 18）。没有报告支持服务不足群体（如社会经济地位不利、健康素养低、非英语使用者或老年人）坚持自我监测实践的策略，很少有试验针对提供者（指临床医生和研究人员）的依从性（n = 5）。行为支持工具包括提醒（n = 8）、优先事项设定指导（n = 5）和临床医生反馈（n = 5）。依从性的测量通常是通过参与者报告皮肤自我检查实践，最近一些数字干预试验也通过网站或应用分析数据直接测量对干预的依从性。依从性数据的报告有限，所有报告中不到一半在讨论中提及依从性。
通过改编世界卫生组织临床依从性框架，本对随机临床试验的范围综述确定了关键概念以及在黑色素瘤高风险人群的皮肤自我检查和其他自我管理实践试验的设计、实施和报告中处理依从性的方式上的差距。这些发现可能对指导未来的试验和临床实践有用；可以在宿主试验中使用试验中的研究（SWAT）框架对依从性策略进行评估。
