Aims:
Adherence, both in research trials and in clinical practice, is crucial to the success of interventions. This scoping review aimed to describe (i) strategies to improve adherence to self-management practices in randomised clinical trials of people at high risk of melanoma and (ii) measurement and reporting of adherence data in these trials.
Methods:
We searched MEDLINE, EMBASE, CINAHL and CENTRAL to July 2022. Eligible studies were randomised trials of self-monitoring interventions for early detection of melanoma in people at increased risk due to personal history (e.g., melanoma, transplant, dysplastic naevus syndrome), family history of melanoma or as determined by a risk assessment tool or clinical judgement. Two reviewers screened titles and abstracts and full-text reports for inclusion. Data were extracted by one reviewer, with a convenience sample (n=5) checked by a second. We adapted the World Health Organization framework for clinical adherence to the clinical trial setting to guide data extraction.
Results:
From 939 records screened, we identified 18 eligible trials 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 to adhere, and few trials targeted provider adherence (n=5). Behavioural 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.
Discussion:
This review identified key concepts as well as gaps in the way adherence is approached in the design, conduct and reporting of trials for skin self-examination and other self-management practices in people at high risk of melanoma. Our findings may usefully guide future trials and clinical practice. Evaluation of adherence strategies may be possible using a Study Within A Trial (SWAT) within host trials.
Conclusion:
Clearer definition, measurement, reporting, and discussion of intervention adherence in trial settings is needed to successfully guide implementation into practice.