The study, using an adaption of the World Health Organization framework for adherence, characterized strategies built into the design, conduct, and reporting of melanoma trials, offering insights into potential improvements for skin self-examination in research.
A new systematic review has identified common strategies for and gaps in ensuring adherence to self-monitoring for early detection of new or recurrent melanoma, a complex challenge affected by various interacting factors.
The study, using an adaption of the World Health Organization (WHO) framework for adherence, characterized strategies built into the design, conduct, and reporting of melanoma trials, offering insights into potential improvements for these strategies in research. Currently, few high-risk patients routinely perform skin self-examination (SSE) frequently or thoroughly.
“There is currently limited practical guidance for the best practices to maximize adherence to SSE in research or practice,” wrote the researchers in JAMA Dermatology. “Assessment of adherence to an intervention in a trial may provide valuable insights on the ease with which it can be translated into routine clinical practice. Trialists may consider developing a comprehensive adherence plan as part of the study protocol, including strategies for dealing with nonadherence, and may find our adaptation of the WHO adherence framework helpful for this. However, care is needed to ensure strategies are achievable in everyday routine care.”
The 18 randomized controlled trials included in the analysis ranged from 40 to over 700 patients. Various approaches to bolster adherence to SSE were leveraged in the trials, including trial design, social support, intervention design, intervention and condition support, and participant support.
Intervention design was used by all trials to increase adherence, 13 of which used theories of health behavior change, 2 of which reported on patient and public involvement in the study design and materials, and 1 of which reported codesign of the intervention with potential recipients.
The most common trial design strategy was eligibility criteria limits, used by 14 of the studies. These criteria typically limited eligibility to patients who spoke English and who were more likely to adhere to self-monitoring practices, assessed with pretests for adherence.
Social support was offered in 5 trials, all of which provided access to health care professionals and services. In some trials, research staff helped with urgent clinical appointments, while in others, information was provided on how to access care and calendar scheduling was enabled for scheduling doctor appointments. Some of these trials offered information on melanoma risk within families through an internet-based education tool.
The researchers noted that no trials used economic support to cover additional costs nor ensured materials were sensitive to health literacy. As a result, they wrote, diversity in the trials may have unintentionally been hindered, leading to underrepresentation of certain groups of patients.
“Research is needed to identify adherence interventions that are low cost and can be easily integrated into the workflow of routine clinical practice, including automated digital interventions,” explained the researchers. “Interventions that require the active participation of health care professionals or large administrative support may be difficult to implement in busy clinical contexts. Evaluation of individual components of a complex intervention may be undertaken using a SWAT [Studies Within A Trial] repository within the host randomized clinical trial: a ‘self-contained study that has been embedded within a host trial with the aim of evaluating or exploring alternative ways of delivering or organizing a particular trial process.’”
The researchers noted that SWAT may have direct effects on adherence in the host trial while offering generalizable results for other trials and guiding implementation post trial.
Ackermann D, Bracken K, Janda M, et al. Strategies to improve adherence to skin self-examination and other self-management practices in people at high risk of melanoma: a scoping review of randomized controlled trials. JAMA Dermatol. 2023;159(4):432-440. doi:10.1001/jamadermatol.2022.6478