Background Content valid and clinically meaningful instruments are required to evaluate outcomes of therapeutic interventions in alopecia areata (AA). Objective To develop an investigator global assessment (IGA) to interpret treatment response in AA treatment studies. Methods Qualitative interviews were conducted in the US with expert dermatologists and AA patients who had experienced ≥50% scalp hair loss. Thematic data analysis identified critical outcomes and evaluated the content validity of the new IGA. Results Expert clinicians (n=10) judged AA treatment success by the amount of scalp hair growth (median 80% scalp hair). Adult (n=25) and adolescent (n=5) patients participated. Scalp hair loss was the most bothersome AA sign/symptom to most patients. Perceived treatment success ‐‐ short of 100% scalp hair ‐‐ was the presence of ~70‐90% scalp hair (median 80%). Using additional clinician and patient insights, the AA‐IGA™ was developed as an ordinal, static measure comprising five severity categories of the Severity of Alopecia Tool (SALT) 0‐100% scores. Nearly all queried clinicians and patients in this study agreed that for patients with ≥ 50% scalp hair loss, successful treatment would be hair regrowth resulting in ≤ 20% scalp hair loss, and supported the AA‐IGA™ as a meaningful clinician‐reported measure for this patient population. Conclusions We recommend the use of the SALT to assess the extent (0‐100%) of scalp hair loss. Using the SALT assessment, the AA‐IGA™ is a robust ordinal measure providing distinct and clinically meaningful gradations of scalp hair loss that reflects patients’ and expert clinicians’ perspectives and treatment expectations.

Background: Alopecia areata (AA) is characterized by hair loss that can affect the scalp and body. This study describes the psychosocial burden of AA. Methods: Participants diagnosed with AA who had experienced ≥50% scalp hair loss according to the Severity of Alopecia Tool (SALT) were identified by clinicians. A semi-structured interview guide, developed with expert clinician input, included open-ended questions to explore patients’ experiences of living with AA. Data were thematically analyzed to identify concepts and relationships. Results: Participants (n = 45, 58% female, mean age 33.3 years [range 15–72], mean SALT 67.2 [range 0–100]) described the AA diagnosis as “devastating”. Both males and females reported emotional and psychological impacts of AA including feeling sad/depressed (n = 21), embarrassed/ashamed (n = 10) and angry/frustrated (n = 3). Patients felt helpless (n = 5) due to the unpredictability of disease recurrence, and anxious (n = 19) about judgement from others. Many patients avoided social situations (n = 18), which impaired relationships and increased isolation. Coping strategies included concealment of hair loss through wigs or make-up, although fear of the displacement of these coverings also caused anxiety and the avoidance of activities that could result in scalp exposure (n = 22). Some patients became more accepting of AA over time, which lessened the emotional impact, though efficacious treatment was still desired. A conceptual framework was developed, and a conceptual model was created to depict the relationship between the physical signs/symptoms and the associated psychosocial effects of AA. Conclusion: AA impairs patients’ emotional and psychological wellbeing, relationships and lifestyles. Greater disease awareness and effective treatments are needed.

Background Eyebrow and eyelash hair loss and nail damage—in addition to scalp hair loss—are important signs/symptoms of alopecia areata (AA) to patients and deserve assessment in AA clinical trials. Objectives Our objective was to develop clinician-reported outcome (ClinRO) and patient-reported outcome (PRO) measures and accompanying photoguides to aid in the assessment of AA-related eyebrow, eyelash and nail signs/symptoms. Methods Iterative rounds of qualitative, semi-structured interviews were conducted with US expert dermatologists and North American patients with AA. Patients with eyebrow, eyelash and nail involvement were purposefully sampled. Interview transcripts were qualitatively analyzed. Results Dermatologists (n = 10) described eyebrow and eyelash loss as concerning for affected patients and, along with nail appearance, as deserving assessment. Dermatologist data informed the development of single item, 4-point Likert-type ClinRO and PRO measures of current eyebrow loss, eyelash loss and nail appearance and a PRO measure of eye irritation. Patients (n = 45, age 15–72 years) confirmed the importance and relevance of these signs/symptoms. Interim revision resulted in measures that were understood by and relevant to patients. Dermatologists (n = 5) and patients (n = 10, age 21–54 years) participated in the development of the eyebrow, eyelash and nail photoguides and confirmed that they included photos that appropriately represented different severity levels and were helpful to derive and standardize ratings across raters. Conclusions The ClinRO and PRO measures for eyebrow, eyelash and nail appearance, with their accompanying photoguides and the PRO Measure for Eye Irritation provide clear and meaningful assessments of outcomes important to patients with AA.

Psychiatric illness and sleeping disorders are important co-morbidities of human immunodeficiency virus (HIV) infection, which impact both the individual and antiretroviral therapy (ART) selection. This systematic review aimed to assess the prevalence of psychiatric illness and sleep disturbance in people living with HIV (PLHIV) in the UK. Systematic searches for publications reporting epidemiological data for psychiatric co-morbidities and sleep disturbance with HIV were conducted in Embase, MEDLINE, Cochrane Library, eight key conferences (2013–2015), and by hand-searching references of included publications. Data were extracted from publications (2000 onwards) reporting the UK prevalence of depression, anxiety, suicide ideation, or sleep disturbance as a co-morbidity of HIV infection. Comparative UK general population data were obtained from the 2007 Adult Psychiatric Morbidity in England household survey, the 2012 Health Survey for England, and ‘PatientBase’ (epidemiological database). Sixteen publications met the inclusion criteria. Amongst PLHIV in the UK, the prevalence of depression varied from 17–47%, compared with a reported 2–5% prevalence for the UK general population. A similar disparity was observed in the prevalence of anxiety (22–49% PLHIV versus 4–5% general population), depression or anxiety (50–58% PLHIV versus 27% general population), difficulty sleeping (61% PLHIV versus 10% population), and suicide ideation (31% PLHIV versus 1% general population). This systematic review of UK data demonstrates that rates of psychiatric illness and sleep disturbance are substantially higher amongst PLHIV than in the general population. These data underline the importance of fully considering sleep and psychiatric issues prior to selection and prescription of antiretroviral drugs, as well as the need for ongoing psychiatric and psychological support for PLHIV on ART.

Infertility has a negative impact on quality of life (QoL) and well-being of affected individuals and couples. A variety of patient-reported outcome (PRO) measures to assess infertility-related QoL are available; however, there is a concern regarding potential issues with their development methodology, validation and use. This review aimed to i) identify PRO measures used in infertility interventional studies ii) assess validation evidence to identify a reliable, valid PRO measure to assess changes in QoL or treatment satisfaction in clinical studies with female patients following treatment with novel therapies iii) identify potential gaps in evidence for validity. A structured literature search of Medline, Embase, and the Cochrane Library (accessed in September 2015) was conducted using pre-defined search terms. The identified publications were reviewed applying eligibility criteria to select interventional female infertility studies using PROs. Infertility-specific PRO measures assessing QoL, treatment satisfaction or psychiatric health, and included in studies by ≥2 research groups were selected and critically reviewed in light of scientific and regulatory guidance (e.g. FDA PRO Guidance for Industry) for evidence of content validity, psychometric strength, and patient acceptability. The literature search and hand-searching yielded 122 publications; 78 unique PRO measures assessing QoL, treatment satisfaction or psychiatric health were identified. Five PRO measures met the selection criteria for detailed review: Fertility Quality of Life (FertiQoL); Fertility Problem Inventory (FPI); Fertility Problem Stress (FPS); Infertility Questionnaire (IFQ); Illness Cognitions Questionnaire adapted for Infertility (ICQ-I). None of the PRO measures met all validation criteria. The FertiQoL was the most widely used infertility-specific PRO measure to assess QoL in interventional studies, with reasonable evidence for adequate content validity, psychometric strength, and linguistic validation. However, gaps in evidence remain including test-retest reliability and thresholds for interpreting clinically important changes. While the FPI demonstrated reasonable evidence for content and psychometric validity, its utility as an outcome measure is limited by a lack of recall period. The FertiQoL and the FPI are potentially useful measures of infertility-related QoL in interventional studies. Further research is recommended to address gaps in evidence and confirm both PRO measures as reliable assessments of patient outcomes.

Background Valid patient‐reported outcome (PRO) measures are required to evaluate alopecia areata (AA) treatments. Objectives To develop a content‐valid and clinically meaningful PRO measure to assess AA scalp hair loss with scores comparable to the 5‐response level AA Investigator Global Assessment (AA‐IGA™). Methods A draft PRO measure was developed based on input from 10 AA clinical experts. The PRO measure was cognitively debriefed, modified, and finalized through two rounds of qualitative semi‐structured interviews with patients with AA who had experienced ≥50% scalp hair loss. Data were thematically analysed. Results Adults (Round 1: n=25; Round 2: n=15) and adolescents aged 15–17 (Round 1: n=5) in North America participated. All patients named scalp hair loss as a key AA sign/symptom. Patients demonstrated the ability to self‐report their current amount of scalp hair using percentages. In Round 1 not all patients interpreted the measurement concept consistently; therefore, the PRO was modified to clarify the measurement concept to improve usability. Following modifications, Round 2 patients responded without difficulty to the PRO measure. Patients confirmed that they could use the 5‐level response scale to rate their scalp hair loss (No missing hair, 0%; Limited, 1–20%; Moderate, 21–49%; Large, 50–94%; Nearly all or all, 95–100%). Almost all patients deemed hair regrowth resulting in ≤20% scalp hair loss a treatment success. Conclusions The Scalp Hair Assessment PRO™ is a content‐valid, clinically meaningful assessment of distinct gradations of scalp hair loss for evaluating AA treatment for patients with ≥50% hair loss at baseline.