Qualitative and Outcomes Research
The Alopecia Areata Investigator Global Assessment scale: a measure for evaluating clinically meaningful success in clinical trials
K.W. Wyrwich; H. Kitchen; S. Knight; N.V.J. Aldhouse; J. Macey; F.P. Nunes; Y. Dutronc; N. Mesinkovska; J.M. Ko; and B.A. King
What: Noninterventional, cross-sectional, qualitative interview study.
Why: To develop a new assessment tool, the AA-IGA, which uses both patient and clinician perspectives for the evaluation of treatment outcomes in AA.
Methods: Qualitive interviews with 10 US Dermatologists and 30 patients with AA and >=50% hair loss.
Demographic: Thirty patients participated (57% female, mean age 35.2 years. Range 15–72). All US adults.
Spectrum: Mean SALT scores 57.9 (range 0–100).
Results: For 23/30 (77%) patients, scalp hair loss was the most bothersome symptom. This was due to cosmetic and also functional issues, such as concern over wigs being dislodged during activities. This was also the main outcome focus for clinicians. Of note, the study deliberately over-enrolled those with eyebrow/eyelash involvement (24/30=80%), presumably to reduce the chance of participants purely stating scalp hair loss as the most troublesome symptoms, by virtue of them only having scalp hair loss. Re treatment outcomes, short of 100%, patients considered a 70-90% (median 80%) re-growth a success and 75-90% (median 80%) was regarded a success by clinicians. One clinician felt a dynamic measure of >=50% regrowth defined success.
Clinicians reviewed and proposed percentage ranges for ﬁve response categories: ‘None’ = 0, ‘Limited’ = 1, ‘Moderate’ = 2, ‘Severe’ = 3, and ‘Complete’ = 4. This resulted in the following categories for the AA-IGA: None (0%); Limited (1-20%); Moderate (21-49%); Severe (50-94%; and Very Severe (95-100%). Therefore, of nearly all those interviewed, for patients with >=50% hair loss, an improvement to ‘Limited’ (<=20%) hair loss was agreed as treatment success.
Author Conclusions: The AA-IGA can be used to determine clinically meaningful treatment success for AA, with success deﬁned by patients and clinicians as reaching ≤ 20% scalp-hair loss
They recommend using SALT to assess extent and then AA-IGA to assess clinically meaningful response to treatment
Thoughts: is the ‘complete’ category somewhat redundant if the ‘severe’ category includes up to 99% hair loss? One clinician interviewed also made this suggestion.
The study shows strong concordance between main areas of concern (scalp hair loss) and treatment success between patients and clinicians interviewed.
Partner bereavement and risk of chronic urticaria, alopecia areata and vitiligo: cohort studies in the UK and Denmark
A.Y.S. Wong; A. Kjærsgaard; T. Frøslev; H.J. Forbes; K.E. Mansfield; R.J. Silverwood; H.T. Sørensen; L. Smeeth; S.A.J. Schmidt; and S.M. Langan
What: population- based cohort study using data from UK and Denmark.
Why: To determine if epidemiological evidence supports link between partner bereavement and developing chronic urticaria/AA/vitiligo
Methods: partners identified in UK with a Clinical Practice Research Data-link and the Civil Registration system for Denmark. Bereaved defined as partner having died. Bereaved matched with 10 nonbereaved with age, sex and county in Denmark and registered GP in UK. Partners followed from bereavement to first diagnosis of urticaria/AA/vitiligo. Median follow-up = 4 years in UK and 6 years in Denmark
Exposure: bereaved vs nonbereaved
Outcome: development of urticaria/AA/vitiligo
Results: Overall pooled HRs from UK and Denmark for association between partner bereavement and chronic urticaria/AA/vitiligo were0.95 (95% CI 0.85 –1.07), 0.90 (95% CI 0.73–1.12) and 0.90 (95% CI 0.74–1.10), respectively.
Author Conclusions: no evidence of partner bereavement increasing HR of AA (or urticaria/vitiligo).
Thoughts: good on them for publishing negative data.
Event rate for AA quite low. Only 49 cases from 901811 person years followed up in UK.
Total number of people followed up not stated. Person years described instead.
Hard to be sure date of diagnosis matched date of disease onset
Unclear how the outcome was discovered
Partner bereavement is a sensible, easily definable, and binary measure of stress. However, as this is such a specific measure and does not include any other of the plethora of stressors which those with AA may be exposed to, it is unsurprising that an association has not been found with such a low event rate. The event rate may be comparable in the nonbereaved population due to this population being subject to every other possible stressful event, not included in this study.
Intraoperative onychoscopy and histopathological correlation of red lunula in nail lichen planus: a case series.
I. Kaur and D. Jakha
What: Case series of 6 as part of a prospective study
Why: Red lunula can be found in Lichen planus but the pathogenesis of this nail finding is unclear. Use of intraoperative onychoscopy and histopathology to help determine pathogenesis.
Methods: patient with clinical/onychoscopic evidence of red lunula and nail LP were selected. The most representative nail was selected for 3mm punch biopsy of matrix and intraoperative onychoscopy
Demographic: F:M = 4:2. Age range 28-40. Mean age 33.8. Study took place in New Delhi, India
Spectrum: All patients had LP involvement of ﬁngernails and/or toenails. None had cutaneous or mucosal features of LP. Number of nails affected not stated.
Results: Clinically, all had red spots in the lunula of finger nails. These correlated with parallel linear red bands (aka linear lunular bands/LLB) on onychoscopy and with linear, dilated and tortuous vessels in the proximal nail bed and nail matrix just below the lunula (but not elsewhere in the nail) on intraoperative onychoscopy. Histology revealed features of LP + dilated dermal vessels. Histology and onychoscopic findings were the same in all patients.
Other common onychoscopic findings included: longitudinal ridging; pitting; chromonychia; and trachyonychia
Author conclusions: Linear lunular bands in LP are a variant of red lunula
Red lunula are due to dilated and tortuous vascular in nail matrix
Thoughts: Red lunula were more common on thumbnail and less so on the nail of the 5th finger. They were reported as absent on toenails. Was this because patients had less severe LP on their toenails or is the red lunla a site-specific finding of fingernails? The extent/severity of LP on participants toenails was not explicitly stated. Perhaps red lunula is a marker of disease severity/activity