In a breakthrough for atopic dermatitis (AD) treatment, researchers have validated a new Sleep-Loss Scale designed to measure how itch impacts sleep in AD patients. This scale promises to be a valuable tool in clinical trials, facilitating a more precise evaluation of treatment efficacy. The study’s findings underscore its reliability and validity, offering a promising new avenue for improving patient outcomes in moderate-to-severe cases of AD.
Study Methodology and Participants
To validate the Sleep-Loss Scale, researchers conducted concept elicitation and cognitive debriefing interviews with 21 individuals, including both adults and adolescents aged 12-17, who suffered from moderate-to-severe AD. These interviews aimed to develop a comprehensive conceptual model of the patient experience and explore the scale’s content validity. Additionally, data from a phase 2b clinical trial (NCT03443024) were analyzed to assess the scale’s psychometric properties, including reliability, construct validity, and sensitivity to change.
Key Findings and Implications
The qualitative data gathered emphasized the serious impact of sleep loss due to itching in patients with AD. The cognitive debriefing analysis showed that participants found the Sleep-Loss Scale to be relevant, appropriate, and easy to understand. The clinical trial data further demonstrated the scale’s good reliability, construct validity, and ability to detect improvements in sleep quality. Researchers established a meaningful within-patient change (MWPC) threshold of a 1-point improvement, validated by both qualitative and quantitative findings.
From a market access perspective, the Sleep-Loss Scale’s ability to provide reliable and valid patient-reported outcomes is crucial. This tool can potentially streamline the approval process for new AD treatments by offering unequivocal evidence of efficacy, thus making it easier for pharmaceutical companies to demonstrate the value of their products to regulatory bodies and healthcare providers.
The Practical Value of the Sleep-Loss Scale
Inferences:
– The Sleep-Loss Scale could become a standard measure in AD clinical trials, facilitating the approval of new treatments.
– Its acceptance by the patient population indicates a high degree of content validity, which is essential for regulatory approval.
– The defined MWPC threshold provides a clear benchmark for evaluating treatment efficacy, making it easier for healthcare providers to assess the benefit of new therapies.
Overall, the Sleep-Loss Scale is a significant advancement in the treatment of atopic dermatitis. Its ability to measure the impact of itch on sleep reliably and validly means it can be a critical tool in clinical trials. This development can lead to more targeted and effective treatments, ultimately improving quality of life for patients suffering from moderate-to-severe AD.
Original Article:
J Patient Rep Outcomes. 2024 Jul 22;8(1):77. doi: 10.1186/s41687-024-00764-2.
ABSTRACT
BACKGROUND: Sleep loss is a key factor contributing to disease burden in people with atopic dermatitis (AD). Mitigating itch to improve sleep is an important outcome of AD treatment. This study explored the content validity and measurement properties of the Sleep-Loss Scale, a single-item rating scale for assessing itch interference with sleep in clinical trials of AD treatments.
METHODS: Concept elicitation and cognitive debriefing interviews were conducted with 21 adults and adolescents (12-17 years of age) with moderate-to-severe AD to develop a conceptual model of patient experience in AD and explore the content validity of the scale. Data collected from adults with moderate-to-severe AD enrolled in a phase 2b study (NCT03443024) were used to assess Sleep-Loss Scale’s psychometric performance, including reliability, construct validity, and ability to detect change. Meaningful within-patient change (MWPC) thresholds were also determined using anchor-based methods.
RESULTS: Qualitative findings from concept elicitation highlighted the importance of sleep-loss related to itch in AD. Debriefing analysis of the Sleep-Loss Scale indicated that the scale was relevant, appropriate, and interpreted as intended. Trial data supported good reliability, construct validity and ability to detect improvement. MWPC was defined as a 1-point improvement using trial data, a finding supported by qualitative data.
CONCLUSIONS: The Sleep-Loss Scale provides a valid and reliable patient-reported measure of the impact of itch on sleep in patients with AD, and can detect change, indicating it is fit-for-purpose to evaluate the efficacy of AD treatments in moderate-to-severe patients.
PMID:39039395 | DOI:10.1186/s41687-024-00764-2
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