That Itch to Write: 10 Literary Responses
Itch NRS v2. Itching and skin pain are the most important and relevant AD symptoms.
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The Itch NRS v2. Predominant symptoms reported by patients include itch and skin pain [ 4 ]. Patients with moderate to severe AD experience a heavy disease burden including physical and psychosocial abnormalities, and a decrease in health-related quality of life HRQoL , especially in children [ 5 ]. Traditional measures are primarily based on visual assessment of clinical signs and symptoms by physicians. To better understand the burden of AD from the patient perspective, patient-reported outcome PRO measures are recommended as an important additional assessment tool [ 10 ].
A literature review was conducted which indicated limited evidence of pre-existing PRO tools suitable for use in a clinical trial setting to assess symptoms such as itch and skin pain severity as the main concepts of interest. The EIQ is likely unsuitable for clinical trial purposes because it includes items, representing a considerable burden on trial participants. A less burdensome measure, which also has precedence in clinical trial work is the POEM. In relation to the measurement of pain in AD, the literature shows that a pain visual analogue scale [ 14 , 15 ] and the McGill Pain Questionnaire [ 16 ], have both previously been used as outcome measures of AD.
The measures used in these studies were neither AD specific, nor focused on dermatological-related pain. The existing tools for the assessment of AD-related itch and skin pain in a clinical trial setting are limited in their ability to accurately assess the impact of new therapies on the patient-reported symptom severity in AD.
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Given the high daily symptom variability present in AD, h recall is preferred to allow for the reliable assessment of symptoms [ 10 ]. As such, we sought to develop a simple, symptom-specific measures as part of a tool to be administered in a daily diary. This study documents the generation of two patient-reported symptom specific measures of AD severity that can be used as clinical trial endpoint measures. Specifically, this study aimed to identify the concepts most relevant to participants through concept elicitation, validate the psychometric capabilities of the arising measures and confirm their content through cognitive debriefing with patients.
The study was conducted in two components Fig. In stage two of component one, an eDiary study was conducted for 2-weeks involving all 43 participants who had taken part in the CE interviews, as well as another 31 US English speaking participants 22 adults and 9 adolescents who were newly recruited for this stage. Thus, stage two of component one had a total of 74 participants. Additional patient-reported demographic and clinician-reported health data were collected for each participant enrolled by the study recruiter at each site.
The CE interviews were conducted in-person by a trained interviewer using a semi-structured discussion guide. The interviewer initially asked open-ended questions designed to elicit spontaneous discussion, which were then followed by in-depth probing around the concepts of interest. Interviews were conducted at a convenient location for the participant and lasted approximately 1 h. Following the concept elicitation, two point NRS items were developed, each with a h recall period.
For the daily eDiary stage, all participants received training on how to use the daily eDiary. The 7-day recall questionnaires were programmed for completion on Days 0, 7, and 14 of the 2-week period. The daily eDiary was programmed so that all questions had to be answered; participants could not submit partial daily eDiary data.
Brain hardwired to respond to others’ itching
After the 2-week daily eDiary stage, CD interviews were conducted to explore the relevance, appropriateness, and interpretability of the daily eDiary. Per the CE interviews, the CD interviews were conducted in-person by a trained interviewer using a semi-structured discussion guide and lasted approximately 1 h. In addition, a second version of the Skin Pain NRS was developed that included descriptors of skin pain in the item anchors to help define the target symptom. Per the in-person CD interviews, the telephone CD interviews focused on the relevance, appropriateness, and interpretability of version 2.
Participants and their referring clinicians received remuneration for their participation. Demographic and health information data were summarized descriptively using data collected at Day 0 for all 74 participants. Data were coded using a mixed deductive-inductive approach using a pre-specified codebook along with the creation of new codes derived from the data as needed.
While describing their experiences of AD, participants were first asked an open-ended general interview question about their experiences, concepts reported in response to this question were coded as spontaneous. The interviewer then asked probing questions around the concepts of interest, responses to this question were coded as probed. Measurement properties of the NRS measures were then evaluated using data collected from the eDiary study. The study population included Conditions such as attention deficit hyperactivity disorder, anxiety, and obesity were present in only a few participants.
However, all locations were noted at least once in both groups. Seven participants also reported feeling annoyed, frustrated, and sad due to the frequency with which they experience itch. Some skin pain descriptors were used to refer to milder sensations; for example, one adult participant rated skin soreness as a 1—4 on a point scale, whereas skin pain she rated as a 5— Like itch, the triggers for skin pain included the climate and seasons, contact with the skin, as well as perfumes, scented lotions, and sweat.
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Overall, the responses were well distributed, with participants using the majority of the response options at all time points. Floor and ceiling responses were low and ranged from 4. Similar response distributions were observed in the adolescent and adult subgroups. In addition, the Itch NRS had moderate 0. The correlations within the adolescent and adult subgroups fluctuated across time points, but generally yielded similar values to the total study population. Participants who showed a decline had a large effect size change 1.
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Analysis of the response distribution on Days 1, 7, and 14 for the Skin Pain NRS revealed that the most severe response option did not receive endorsement from any participant at any time point Fig. Floor responses ranged from ICCs between Day 7 and Day 14 0.
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This is supported by a large effect size of 1. Overall, there were no differences between adolescent and adult participants in their understanding of the content, relevance, response scale and options, or recall period for the two NRS measures. Participant: Like, how bad … the intensity. I was just guessing as far as choosing a number. A six is not as high of a number but higher than average. The Skin Pain NRS was also well-understood by the majority of participants in the in-person CD interviews, noting it as a relevant symptom.
Indeed, four participants suggested describing the type of skin pain in the item wording to clarify its meaning. In terms of the level of change participants considered meaningful using the Skin Pain NRS, there was no clear preference, but a 1- or 2-point change appeared beneficial to the majority of participants. The findings from Stage 2 indicated that the Itch NRS and Skin Pain NRS were psychometrically valid measures of the target concepts and were responsive to changes in condition across the age categories.
Therefore, we made modifications to address these concerns and subsequently tested the revised versions of the NRS measures in telephone CD interviews. To maintain consistency between the two measures, the wording of the Skin Pain NRS was modified in line with these revisions. The recall period and response scale and options were retained per the original versions of the measures.
Consistent with the in-person CD interviews, there were no issues raised in terms of the response scale or recall period. For example, two participants were unsure if v2.
In contrast, just one participant mentioned that he thought about itching as well as skin pain when answering v2. Participants also gave feedback on the descriptors used in v2. These terms were similar to those spontaneously used by participants in the CE interviews to describe their skin pain experiences. When asked what score change would be meaningful on each of the two revised versions of the Skin Pain NRS, there was no clear pattern or discernable best score change among participants.
The objective of this research was to incorporate the patient voice in the development of valid and reliable patient outcomes in AD. This study incorporated mixed research methods to ensure that the measurement properties of the two generated measures captured daily symptoms. The first stage of this study was undertaken to gather insights from adults and adolescents regarding the symptoms and impacts of AD from the patient perspective.
Adults and adolescents with AD described very similar disease experiences that negatively affected their quality of life including their ability to do physical tasks, as well as feeling embarrassed or ashamed in front of others. In component one, the Itch NRS performed well both qualitatively and quantitatively and was shown to be a valid, reliable, and sensitive measure of AD-related itch.
Similarly, the Skin Pain NRS was shown to be both valid and reliable based on the in-person CD interviews and daily eDiary study, but revisions were also made to maintain consistency with the updated format of the Itch NRS as well as to test the utility of including skin pain descriptors within the item stem itself.
However, participants preferred the version with the descriptors as it was better understood and better represented their overall skin pain experiences. Findings from the quantitative analysis support that original versions of both the Itch NRS and Skin Pain NRS are reliable at both the group and individual patient level [ 25 ]. The modifications to the tools were made to improve comprehension rather than to address psychometric weaknesses.