Development and Validation of a Patient-Reported Outcome Measure for Fingernail and Toenail Conditions: The NAIL-Q.

Background: Patient-reported outcome measures (PROMs) are needed to measure outcomes that matter to people with nail conditions, from their perspective. Objective: To design a comprehensive new PROM (NAIL-Q) to measure outcomes important in toenail and fingernail conditions. Methods: A mixed methods iterative approach was used. Phase 1 involved concept elicitation interviews that were audio-recorded, transcribed, and coded line-by-line. Concepts were developed into scales and refined through cognitive debriefing interviews with patients and expert input. Data was then collected from an international sample using a crowdsource platform. Eligible participants were aged ≥18 years with a nail condition for at least 3 months. Rasch Measurement Theory (RMT) analysis was used to examine item and scale performance. Other psychometric tests included test-retest reliability, and convergent and construct validity. Results: Phase 1 interviews involved 23 patients with 10 nail conditions and input from 11 dermatologists. The analysis led to the development of 84 items for field-testing. In Phase 2, 555 participants completed the survey. Toenail conditions (n = 441) were more common than fingernail conditions (n = 186). The RMT analysis reduced the number of items tested to 45 in 7 scales measuring nail appearance, health-related quality of life concerns, and treatment outcomes. All items had ordered thresholds and nonsignificant chi-square p values. Reliability statistics with and without extremes for the Person Separation Index were ≥0.79 and Cronbach's alpha were ≥0.83, and for intraclass correlation coefficients were ≥0.81. Construct validity was further supported in that most participants agreed that the NAIL-Q was easy to understand, asked relevant and important questions in a respectful way, and that it should be used to inform clinical care. Conclusion: The NAIL-Q is a rigorously designed and tested PROM that measures nail appearance, health-related quality of life and treatment outcomes. This PROM can be used in clinical practice to inform patient care and to include the patient perspective in research.

Patient-reported outcome measures for patients with nail conditions: a systematic review of the psychometric evidence.

Nail conditions have an impact on appearance, function, and quality of life of patients. Patient reported outcome measures (PROMs) are important tools for evaluating treatment success from the patient perspective. It is important to understand the quality of PROMs to help guide selection of appropriate tools. The aim of this study was to critically appraise the psychometric properties of nail-specific PROMs using COSMIN guidelines. A systematic review was conducted in May 2019 to identify development and validation articles for nail-specific PROMs. Abstracts and subsequent full-texts were screened by two reviewers for eligibility. Data were extracted for study characteristics and psychometric properties. The risk of bias checklist was completed, and ratings applied to psychometric properties as per COSMIN guidelines. Modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria were applied based on the risk of bias checklist to assess methodological quality. The review identified 3289 articles of which 430 full-text articles were screened, nine of which met eligibility criteria. Included papers were for seven PROMs and in total reported on 31of 49 possible measurement properties. Of the 31 measurement properties reported, nine (29%) were rated as insufficient or indeterminate. The modified GRADE methodological quality rating was low or very low for 16 (32.7%) measurement properties, and 18 (36.7%) measurement properties were not described by any PROM. Currently there are no nail-specific PROMS available that demonstrate adequate validity, reliability, or responsiveness, according to COSMIN guidelines. Further research is required to assess missing or insufficiently tested measurement properties in all the PROMs identified.

The Impact of Nail Psoriasis and Treatment on Quality of Life: A Systematic Review.

At least 80% of patients with psoriasis will have nail involvement during their lifetimes. Understanding quality of life (QoL) impact of this condition and associated treatments is of utmost importance. Study objectives were to review the available literature describing patient-reported QoL outcomes in nail psoriasis and relationship with disease severity and treatment. A literature search was performed for English-language articles published prior to August 1, 2020. Articles were included in the review if primary data and validated patient-reported outcome measures assessing QoL were presented, and nail involvement was specifically examined. Fifteen studies were included in the final analysis. Patients with nail psoriasis had higher Psoriasis Area Severity Index and Dermatology Life Quality Index scores than those with psoriasis without nail involvement. The largest percent improvement in QoL score was associated with adalimumab. Studies investigating topicals, intralesionals, and systemic treatments were excluded since only biologic studies utilized validated patient-reported outcome measures. This review affirms that nail psoriasis is physically and emotionally distressing, warranting prompt treatment. Increased efforts are needed to address the impact of treatment on patient QoL using validated outcome measures that assess cosmetic, physical, and social problems.

Effect of onychomycosis and treatment on patient-reported quality-of-life outcomes: A systematic review.

BACKGROUND: Onychomycosis is the most common nail disorder, often causing physical, emotional, and aesthetic consequences. The effect of both the condition itself and treatment on quality of life has not been well studied. OBJECTIVE: The objectives of this study were to systematically review the available literature describing the effect of onychomycosis and treatment on quality of life. METHODS: We performed a search of the onychomycosis literature published before April 13, 2020. Articles were included in the review if primary data were presented, patient-reported outcome measures were used, and onychomycosis was specifically examined. RESULTS: Thirty studies were included in the final analysis. Poorest quality-of-life scores were associated with women and fingernail involvement. Quality-of-life scores improved from baseline with all treatment types; there were greater improvements reported with oral treatments compared with topical ones. CONCLUSIONS: This review affirms that onychomycosis significantly influences quality of life, warranting effective treatment. All treatments resulted in quality-of-life improvements; however, studies on oral and topical therapies were of higher quality than those evaluating devices. Increased efforts are needed to understand the effect of the disease and therapy as assessed by validated, nail-specific outcome measures that accurately assess patients' cosmetic, physical, and social difficulties.

Patient Satisfaction with Treatment for Onychocryptosis: A Systematic Review.

Onychocryptosis, or ingrown nail, is a common condition in which the nail plate penetrates the nail fold, often resulting in inflammation and pain. Nonsurgical and surgical treatments are utilized, but patient satisfaction with these therapies has not been well studied. The purpose of this study was to systematically review the available literature describing patient-reported outcomes of onychocryptosis treatments. We performed a search of the literature published prior to May 22, 2019. Articles were included in the review if primary data were presented, patient-reported outcome measures (PROMs) were used, and nail involvement was specifically examined. From the initial search, 18 studies were included in the final analysis. Patients receiving both nonsurgical and surgical interventions reported high levels of overall satisfaction; however, most studies used ad hoc measures rather than validated PROMs, providing little granular information on the impact of treatment on quality of life (QoL). This review affirms that treatment for onychocryptosis results in satisfactory outcomes for patients; however, increased efforts are needed to understand the impact of therapy on patient QoL as assessed by validated outcome measure that accurately assess patients' cosmetic, physical, and social difficulties.