[Current Status of Onychomycosis Topical Therapy Conducted at Home].

　Patients usually consult a dermatologist for the treatment of onychomycosis. However, in the case of home care, visiting nurses may assist with bathing, which offers the opportunity to observe patients' feet for possible signs of onychomycosis without causing anxiety. It is estimated that more than 30% of patients receiving home care have onychomycosis. Before the approval of efinaconazole, healthcare personnel hesitated to treat onychomycosis because of: 1) possible side effects, especially liver dysfunction and pain due to repeated blood collection, as a major goal of home care is to minimize pain; and 2) the questionable efficacy of previously available antifungal medications. In addition, many patients report fear of "transmitting athlete's foot to others" and "do not want to show my dirty toenails". On the other hand, caregivers reportedly worry about "athlete's foot being transmitted to them".

Patient-reported outcomes from two randomised studies comparing once-weekly application of amorolfine 5% nail lacquer to other methods of topical treatment in distal and lateral subungual onychomycosis.

Patient adherence is a key consideration in the choice of a topical regimen for the treatment of onychomycosis. The objective of this study was to investigate patient-reported outcomes (treatment utilisation, adherence and satisfaction) in onychomycosis treated with once-weekly amorolfine 5% nail lacquer versus once-daily ciclopirox 8% nail lacquer (Study A) or once-daily urea 40% ointment/bifonazole 1% cream combination regimen (Study B). Study A: Subjects received amorolfine and ciclopirox on opposite feet for 12 weeks. Study B: Subjects received amorolfine and urea/bifonazole on opposite feet for 6-7 weeks. Assessments included subject adherence as per label, treatment preference and questionnaire. Study A: More subjects adhered to amorolfine (85%) than to ciclopirox (60%) (P = .025). Overall, subjects were satisfied (95% vs 100%, respectively) and the treatments were balanced in terms of preference (50% vs 45%) at week 12. Study B: More subjects adhered to amorolfine dosage (81.8%) than to the dosage of the urea/bifonazole combination regimen (59.1%) (P = .096). At the end of study, 85.7% of subjects preferred amorolfine versus 14.3% for urea/bifonazole. Fewer subjects experienced local side effects with amorolfine (4.5%) compared to urea (27.3%) and bifonazole (15%). Amorolfine 5% nail lacquer offers a simple and convenient treatment option, which may result in improved patient adherence and consequently lead to improved efficacy and patient satisfaction.

Onychomycosis: A study of self-recognition by patients and quality of life.

BACKGROUND: Onychomycosis accounts for approximately half of all nail disorders and is usually asymptomatic. OBJECTIVES: To evaluate patients' recognition of fungal nail disease, concomitant fungal skin diseases, complications, and quality of life. METHODS: Patients from the fungal nail clinic were enrolled between May 2011 and April 2012. Patients' awareness of diseased nails was evaluated and the Dermatology Life Quality Index (DLQI) questionnaire was used to evaluate the impact of dermatologic disease on quality of life. RESULTS: A total of 110 patients with onychomycosis were enrolled in the study, of which 64 (58.2%) were female and the mean age was  60.8 years. The number of patients who were able to recognize the presence of onychomycosis was 71 (64.5%), while 32 (29.1%) and 7 (6.4%) were diagnosed by a dermatologist and other physicians, respectively. Multivariate analysis showed that patient recognition of the disease was significantly associated with female sex and young age. The mean DLQI score was  3.6. LIMITATION: Patient recall bias including the duration of fungal nail infection, long-term past history and previous treatment was a limitation of this study that affected DLQI scores. CONCLUSION: About half of onychomycosis patients, especially elderly males, could not recognize the disease by themselves. It is important for physicians to educate patients with risk factors for onychomycosis to recognize this condition early to prevent concomitant infection and complications, and to improve patients' well-being.

Psychosocial impact of onychomycosis: a review.

Onychomycosis (tinea unguium) is the most common nail disorder. Nonetheless, it requires lengthy, often ineffective treatments, and recurrence is frequent. Predominantly a disease of the elderly, onychomycosis is becoming more and more common. Besides interfering with normal nail function, fungal nail infections are relatively painful, unsightly in appearance, disrupt daily activities, and have a negative psychosocial connotation. Commonly reported psychosocial factors are embarrassment, low self-esteem, and social withdrawal. Yet advances in therapy have been achieved since these reports were made, and many of these treatment options have proven to be more effective. Thus, the impact of these advances on psychosocial well-being of patients with onychomycosis is worth analyzing. The objective of this paper is to review studies that investigated the psychosocial impact of onychomycosis on a variety of patient populations. An alternative, total patient approach that dermatologists and general practitioners alike could use to incorporate patients' psychosocial well-being into the holistic management of onychomycosis will also be discussed.

Quality of life in patients with toenail onychomycosis.

Onychomycosis is a common, chronic fungal nail infection that can have a significant negative impact on patients' physical and social functioning and emotional well-being. This study was undertaken to assess health-related quality of life (HRQoL) in patients with toenail onychomycosis. The Onychomycosis QoL questionnaire (ONYCHO), as a disease-specific instrument, and the Short Form 36 Health Survey (SF-36) as a generic instrument, were applied in 140 consecutive patients affected by onychomycosis. Women and patients who were experiencing toenail onychomycosis for more than 2 years were reporting worse disease-specific HRQoL. The patients working in blue-collar occupations and patients with greater involvement of individual nails were more affected by onychomycosis regarding symptoms. The results of this study confirm that although onychomycosis is not a life-threatening disease, it can significantly reduce patients' QoL.

[Compliance of the patients and related influential factors on the topical antifungal treatment of onychomycosis].

OBJECTIVE: To explore the compliance rate of patients and its influential factors on topical antifungal treatment of onychomycosis. METHODS: Dermatology life quality index (DLQI) and self-administered questionnaires were employed in this study. RESULTS: The overall compliance rate of the topical antifungal treatment was 23.9% (92/385). The cure rates on onychomycosis in patients with good compliance was 63.04% (58/92), but only 2.05% (6/293) in those noncompliant patients, respectively. Regarding the influencing factors as age, sex, level of awareness, occupation, course of disease, personal income, inconvenience in access to the treatment, keep forgetting in taking the medicine, being impatient, lack of confidence, misunderstanding on topical as 'dirty' and the process of drug taking was troublesome, together with the quality of life were identified. There were significant differences between those compliant or noncompliant patients. For some factors as adverse effects of drug, number of affected nails, site of the disease, too busy in daily life, lack of related knowledge etc., no significant differences were found between the compliant or noncompliant patients. CONCLUSION: Our results showed that onychomycosis patients had poor compliance in topical antifungal treatment which significantly influencing the therapeutic effects. Age, sex, level of awareness on the disease, occupation, course of disease, personal income, inconvenience in receiving the treatment, forgetting to take the medicine, lack of patience, lack of confidence, different kinds of misunderstanding about the disease and quality of life etc. might affect the compliance rate of the disease.

Health-related quality of life in patients with nail disorders.

Fingernails and toenails are important organs of our body, serving as protection for the tips of fingers and toes. Fingernails also enhance fine touching and tactile sensitivity, as well as aid in the picking up of small objects. Healthy-looking nails are an important part of an individual's body image, and any nail abnormalities may be considered by patients as a significant cosmetic problem, markedly influencing their self-esteem. However, recent data have indicated that nail lesions are not only important because of cosmetic disfigurement, but may be a symptom of significant morbidity. Severe nail involvement was also shown to negatively impair social functioning and to interfere with work ability, thus markedly influencing a patient's well-being. Based on literature data and our own experience we conclude that nail diseases cause a marked decrease in health-related quality of life in a substantial percentage of patients. Nail changes are an important medical concern for patients and, therefore, nail diseases should raise attention and receive proper care from both physicians and other healthcare providers.

Stigmatisation in onychomycosis patients: a population-based study.

Patients with onychomycosis may experience significant psychosocial problems, similarly to other skin diseases. The objectives of this study were to analyse the level of stigmatisation among subjects with onychomycosis and the effect of anti-mycotic therapy on this feeling. This prospective study was carried out among 1684 patients (1050 women and 634 men, mean age 52.2 ± 15.5 years) with onychomycosis. All subjects were asked to fulfil the stigmatisation questionnaire at the baseline visit and after the completion of the anti-mycotic therapy. Stigmatisation level was assessed with reference to gender, age, education, type and duration of onychomycosis and the number of involved nails. Patients with onychomycosis reported markedly increased feeling of stigmatisation. Fingernail involvement was the major variable negatively influencing the stigmatisation level. Female patients and younger ones appeared to be more stigmatised. No significant relationships were found between stigmatisation level and education, number of involved fingernails or toenails, as well as the duration of onychomycosis. The anti-mycotic therapy resulted in significant reduction of all analysed aspects of stigmatisation to about 40% of the baseline level. Onychomycosis should be considered as an important problem for patients, significantly reducing their physical, mental and social well-being, also leading to marked stigmatisation of patients.

Naildex: pilot evaluation of an onychodystrophy severity instrument.

A valid and reliable measure that captures onychodystrophy disease severity is important for both clinical and research applications. Three hundred and twenty-two patients at two Veterans Affairs Medical Centers with clinical evidence of onychodystrophy suggesting onychomycosis (at least 25% in a distal subungual pattern) were examined using Naildex parameters. Naildex scores were calculated by a combination of: per cent of each nail infected, area of each nail and number of infected nails. Patients also completed a nail-specific quality of life questionnaire (NailQoL) and nail samples were collected and examined mycologically. Data was analysed for all enrolled patients (n = 322) and patients with mycologically-confirmed onychomycosis (n = 243). Inter-rater reliability was calculated from two examiners who each evaluated 17 patients with mycologically-confirmed onychomycosis. Significant correlations (P < 0.01) between Naildex and NailQoL as well as proxy measures (duration of infection) indicated construct validity of the instrument for all patients as well as mycologically-confirmed cases. Strong correlation (r = 0.754, P < 0.01, n = 17) indicated high inter-rate reliability. This pilot evaluation suggests that Naildex is a valid and reliable measure of onychomycosis severity.

Evaluation of quality of life in patients with toenail onychomycosis by Polish version of an international onychomycosis-specific questionnaire.

BACKGROUND: Onychomycosis is the most frequent nail disease, which could impair the patient's quality of life. OBJECTIVE: The present study was undertaken to evaluate the impact of toenail onychomycosis on quality of life among Polish population. PATIENTS AND METHODS: Three thousand nine-hundred and four (3904: 2269 females and 1635 males) individuals fulfilled an international onychomycosis-specific quality-of-life questionnaire consisting of statements regarding social, emotional and symptoms problems. All patients had toenail onychomycosis confirmed by the positive direct microscopic examination and/or by the positive mycologic culture. Seven hundred and sixty-seven patients simultaneously had fingernail onychomycosis. All patients were divided into subgroups according to sex, age, education level, place of living, type of onychomycosis, number of involved toenails, fingernails involvement, duration of illness and previously used antimycotic therapy. RESULTS: Most of the patients demonstrated significantly reduced quality of life. The degree of life impairment varied between analysed subgroups. Patients with more advanced toenail onychomycosis and with fingernail involvement were more seriously affected. Both social and emotional impairments were more pronounced in female than in male patients, although there were no differences according to symptoms. Moreover, patients with better educational level and people living in towns or cities were more emotionally and socially affected by onychomycosis, although people living in the country or with poorer education level presented with significantly more severe symptoms. CONCLUSIONS: Toenail onychomycosis is still a serious medical problem, which can significantly reduce the patient's quality of life.

NailQoL: a quality-of-life instrument for onychomycosis.

BACKGROUND: The disease burden onychomycosis is not trivial. The aim is to develop a quality of life instrument to measure the onychomycosis burden. METHODS: 402 patients with mycologically-confirmed onychomycosis completed a baseline questionnaire of 39 quality of life items (modified Skindex-29 questions and 10 additional nail-specific questions). Internal consistency, reproducibility and responsiveness of the final instrument, NailQoL were measured. RESULTS: 15 items consisting of symptom (3), emotion (10), and functional (2) domains were retained in NailQoL. Symptom and emotion subscales = 0.80-0.92. Administration alpha demonstrated good internal consistency (Cronbach's of the instrument to 46 patients at one month after baseline revealed good reproducibility (ICC 0.88-0.91). Responsiveness was measured in 292 patients at 18 months; statistically significant better NailQoL scores were found in individuals with complete cure (mycological and clinical) (P < 0.01). CONCLUSION: NailQoL represents a new concise, valid, reliable, and responsive instrument for measuring burden of skin disease for patients with onychomycosis.

The OnyCOE-t questionnaire: responsiveness and clinical meaningfulness of a patient-reported outcomes questionnaire for toenail onychomycosis.

BACKGROUND: This research was conducted to confirm the validity and reliability and to assess the responsiveness and clinical meaningfulness of the OnyCOE-t, a questionnaire specifically designed to measure patient-reported outcomes (PRO) associated with toenail onychomycosis. METHODS: 504 patients with toenail onychomycosis randomized to receive 12 weeks of terbinafine 250 mg/day with or without target toenail debridement in the IRON-CLAD trial completed the OnyCOE-t at baseline, weeks 6, 12, 24, and 48. The OnyCOE-t is composed of 6 multi-item scales and 1 single-item scale. These include a 7-item Toenail Symptom assessment, which comprises both Symptom Frequency and Symptom Bothersomeness scales; an 8-item Appearance Problems scale; a 7-item Physical Activities Problems scale; a 1-item Overall Problem scale; a 7-item Stigma scale; and a 3-item Treatment Satisfaction scale. In total, 33 toenail onychomycosis-specific items are included in the OnyCOE-t. Clinical data, in particular the percent clearing of mycotic involvement in the target toenail, and OnyCOE-t responses were used to evaluate the questionnaire's reliability, validity, responsiveness, and the minimally clinical important difference (MCID). RESULTS: The OnyCOE-t was shown to be reliable and valid. Construct validity and known groups validity were acceptable. Internal consistency reliability of multi-item scales was demonstrated by Cronbach's alpha > .84. Responsiveness was good, with the Treatment Satisfaction, Symptom Frequency, Overall Problem, and Appearance Problem scales demonstrating the most responsiveness (Guyatt's statistic of 1.72, 1.31, 1.13, and 1.11, respectively). MCID was evaluated for three different clinical measures, and indicated that approximately an 8.5-point change (on a 0 to 100 scale) was clinically meaningful based on a 25% improvement in target nail clearing. CONCLUSION: The OnyCOE-t questionnaire is a unique, toenail-specific PRO questionnaire that can be used with confidence in future studies of toenail onychomycosis. MCID was evaluated for three different clinical measures, and indicated that approximately a 7-point change (on a 0 to 100 scale) was clinically meaningful based on a 12.5% improvement in target nail clearing.

Itraconazole pulse therapy improves the quality of life of patients with toenail onychomycosis.

BACKGROUND: Toenail onychomycosis is a common disease that can have serious adverse effects on the quality of life (QOL) of patients. AIM: To evaluate the impact of itraconazole pulse therapy on the QOL of patients with toenail onychomycosis. METHODS: A total of 20 patients with disto-lateral subungual toenail onychomycosis were treated with itraconazole 200 mg twice daily for 1 week every 4 weeks for 12 weeks. The patients were asked to complete a QOL questionnaire before treatment and on the last follow-up visit (week 48). A score of 0-4 was given according to the five possible responses to each question and these were summed to give the final score of the patient. The mean of the final scores of the patients before and after treatment were compared using the Wilcoxon matched-pairs test. RESULTS: At 48 weeks after commencing treatment, 14 patients (70%) responded to treatment (nine patients were cured with almost totally clear toenails and five patients improved), and 16 patients (80%) were mycologically cured (negative KOH smear and culture). The mean of the QOL scores of the patients before treatment was 18.0+/-7.8, which reduced to 13.1+/-11.3 after treatment (two-tailed, p=0.009). CONCLUSION: Itraconazole pulse therapy is an effective treatment and can improve the QOL of patients with toenail onychomycosis.

[Quality of life in dermatology: Tunisian version of the Skindex-29]. / Etude de la qualité de vie en dermatologie: élaboration d'une version Tunisienne du Skindex-29.

The skin situated in the interface between the body and the outside world, is a zone privileged by the interactions between the individual and the society. The objective of our work was to study the quality of life in dermatology, while elaborating a Tunisian version of the Skindex-29 scale. For that we questioned 60 patients, among them 20 are affected by psoriasis, 20 are affected by vitiligo and 20 are affected by onychomycosis. The evaluation of the psychometric properties of the questionnaire was satisfactory. The chronic dermatosis altered the quality of life of the patients. This deterioration touches by order descending the patients affected by psoriasis, vitiligo, and onychomycosis. The patients were particularly sensitive when uncovered zones were reached, particularly the face. These results are in conformity with the data of the literature relating to the subject. The validation of this version is necessary.

[Onychomycosis and quality of life]. / Onychomycoses et qualité de vie.

The study of the quality of life in onychomycosis is recent. Since 10 years, the evolution of methods has allowed to have more precision about the patient's feelings, especially in physical, functional, psychical and social criteria. In the future, we can hope than such studies could help to manage therapies decisions to get a best efficacy and lower costs.

Onychomycosis: health-related quality of life considerations.

The symptoms of onychomycosis and their impact on personal appearance are important determinants of patients' perceptions of their own health. The effect of onychomycosis is greater on psychosocial than physical functioning and is directly related to the extent of nail involvement. This review identified a number of disease-targeted questionnaires that have been developed to assess the impact of onychomycosis and its treatment on health-related quality of life (HR-QOL). The instruments differ considerably in the extent to which they have been psychometrically tested. Most have been shown to provide both valid and reliable measurement of HR-QOL in patients with onychomycosis of the toes. However, not all have been tested in patients with fingernail disease. The generic and disease-targeted scales of most of the available questionnaires exhibit poor variability, which may limit their responsiveness to clinically important change. Only one instrument, the Onychomycosis Disease-Specific Questionnaire, has been incorporated into a clinical trial. Thus, information relating to the impact of onychomycosis treatment on HR-QOL is limited. Future efforts should focus on the systematic evaluation of existing questionnaires in all populations for which they were developed. In addition, it is important that disease-targeted measures be included in future clinical trials so that a better understanding of the impact of onychomycosis treatment on patient HR-QOL may be gained.

Epidemiology and prevalence of onychomycosis in HIV-positive individuals.

BACKGROUND: Patients who are human immunodeficiency virus (HIV) positive are predisposed to the development of infections including tinea pedis and onychomycosis. While smaller studies have been reported, there has been no large study evaluating the prevalence of onychomycosis in HIV-positive individuals, or comparing the development of onychomycosis in a typical temperate area with that in a typical tropical area. METHODS: HIV-positive individuals were evaluated at five clinics: four in Ontario, Canada and one in Sao Paulo, Brazil. The subjects were asked questions to determine the epidemiology of onychomycosis in HIV-positive individuals. The feet were examined and nail material was obtained for mycologic examination to determine the causative organism of onychomycosis. RESULTS: A total of 500 subjects were examined (415 men and 85 women; age (mean +/- SE), 39 +/- 0.4 years; 400 Canadian, 100 Brazilian). The racial origins of the Canadian patients were: Caucasian, 83.8%; Asian, 4.3%; African-American, 8.1%; Hispanic, 3.3%; American Indian, 0.3%. The Brazilian origins were: Caucasian, 68.7%; African, 18.1%; mixed race, 13.3%. Abnormal appearing nails and mycologic evidence of onychomycosis were present in 200 (40.0%) and 116 (23.2%), respectively, of 500 subjects. The prevalence of onychomycosis in the Canadian and Brazilian samples was 24.0% (96 of 400) and 20.0% (20 of 100), respectively. The projected prevalence of onychomycosis in HIV-positive individuals in Canada was 19.9% (95% CI: 16.0-23.9%) after taking into account the age and sex distribution of HIV-positive individuals in the population. When nails appeared clinically abnormal, the prevalence of onychomycosis was 50.5% (Canada, 51.3%; Brazil, 45.5%). For comparison, published data indicate that the prevalence of onychomycosis in immunocompetent individuals living in Canada is 6.9%. The clinical presentation of onychomycosis for the whole sample (n=500) was: distal and lateral subungual onychomycosis (DLSO), 20.0%; white superficial onychomycosis (WSO), 3.6%; proximal subungual onychomycosis (PSO), 1.8% (Canadian and Brazilian samples: DLSO 21.2% vs. 15.0%, WSO 3.3% vs. 5.0%, and PSO 1.5% vs. 3.0%). The distribution of the causative fungal organisms was: dermatophytes: Candida species: nondermatophyte molds, 73:2:2 (Canadian and Brazilian samples: dermatophytes 95.5% vs. 90.9%, Candida species 3.0% vs. 0%, and nondermatophyte molds 1.5% vs. 9.0%). The use of protease inhibitors, reverse transcriptase inhibitors, or oral antifungal agents did not make a significant difference in the prevalence of onychomycosis for both the Canadian and Brazilian groups. Patients with onychomycosis were aware of their abnormal appearing nails (chi2(1)=69.7, P<0.001), embarrassed by the appearance of their nails (chi2(1)=29.7, P<0.001), and took measures to hide their nails from other individuals. A higher proportion of individuals with onychomycosis experienced discomfort compared with those without the disease (chi2(1)=9.0, P=0.003). Also, individuals who experienced pain in the nail unit were more likely to have onychomycosis (risk odds ratio (ROR), 2.2; 95% CI: 1.0-4.7, P=0.05). CONCLUSIONS: The prevalence of onychomycosis in HIV-positive individuals in the sample of 500 patients was 23.2%. In the Canadian (n=400) and Brazilian (n=100) samples, the corresponding figures were 24% and 20%, respectively, with the predominant causative organisms being dermatophytes. The projected prevalence of onychomycosis in HIV-positive Canadians is 19.9%. Predisposing factors include a CD4 count of approximately 370, a positive family history of onychomycosis, a history of tinea pedis, and walking barefoot around pools. Onychomycosis can be symptomatic, a source of embarrassment, and a potential cause of morbidity.

Measuring the impact of onychomycosis on patient quality of life.

According to survey research, onychomycosis, a fungal infection of the toenail or fingernail, affects quality of life including physical and social functioning and emotional health. We developed an onychomycosis disease-specific questionnaire (ODSQ) that sensitively assessed symptom distress, functional impact, and social stigma associated with the disease. Samples of patients enrolled in a randomized controlled clinical trial were used for the psychometric evaluations. The multi-item scales were internally consistent (alpha > or = 0.80) and reproducible (ICC > 0.85). Interscale correlations between the ODSQ and generic scales were moderate and consistent with the hypothesized magnitude and directions. Construct validation, employing known groups analysis, supported the hypothesized impact of onychomycosis on three domains of quality of life: physical functioning, emotional health, and social functioning. Significant differences were found between clinically "cured", "improved", or "failed" patients, and between mycologically "eradicated" and "persistent" patients. The ODSQ was responsive to clinical change and more sensitive than derived Medical Outcomes Study Short Form-36 scales. The ODSQ provides reliable, validated and responsive information about the consequences of onychomycosis and its treatment.