Methylene blue for intractable pain from oral mucositis related to cancer treatment: a randomized phase 2 clinical trial.

BACKGROUND: Oral mucositis (OM) in patients receiving cancer therapy is thus far not well managed with standard approaches. We aimed to assess the safety and effectiveness of methylene blue (MB) oral rinse for OM pain in patients receiving cancer therapy. METHODS: In this randomized, single-blind phase 2 clinical trial, patients were randomized to one of four arms: MB 0.025%+conventional therapy (CTx) (n = 15), MB 0.05%+CTx (n = 14), MB 0.1%+CTx (n = 15), or CTx alone (n = 16). Intervention groups received MB oral rinse every 6 h for 2 days with outcomes measured at days 1-2; safety was evaluated up to 30 days. The primary outcome measured change in the pain numeric rating scale (0-10) from baseline to day 2. Secondary outcome measured change in oral function burden scores from baseline to day 2, World Health Organization OM grades, morphine equivalent daily doses, and adverse events. The trial was registered with ClinicalTrials.gov ID: NCT03469284. RESULTS: Sixty patients (mean age 43, range 22-62 years) completed the study. Compared with those who received CTx alone, those who received MB had a significant reduction of pain scores at day 2 of treatment (mean ± SD); 0.025%: 5.2 ± 2.9, 0.05%: 4.5 ± 2.9, 0.1%: 5.15 ± 2.6) and reduction of oral function burden scores (0.025%: 2.5 ± 1.55, 0.05%: 2.8 ± 1.7, 0.1%: 2.9 ± 1.60). No serious adverse events were noted, but eight patients reported burning sensation of the oral cavity with the first dose, and this caused one patient to discontinue therapy. CONCLUSIONS: MB oral rinse showed significant pain reduction and improved oral functioning with minimal adverse effects. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03469284.

Experiences of mothers with preterm babies at a Mother and Baby Unit of a tertiary hospital: A descriptive phenomenological study.

Aim: To describe the lived experiences of mothers with preterm babies at a Mother and Baby Unit (MBU) of a tertiary hospital. Design: A descriptive phenomenological approach. Method: Ten mothers were purposively sampled during the month of May, 2017 to describe their experiences of having preterm babies. Recorded in-depth individual interviews were transcribed verbatim; codes were generated and inductively organised into themes. Results: Four themes were actively generated: 'Emotional experiences of mothers', 'Mother-baby interaction', 'Perception on care and support' and 'Challenges within Mother and Baby Unit environment'. Mothers were anxious about the premature delivery and were afraid of possible infant's death. They cherished interactions with their babies during kangaroo mother care and breastfeeding. Mothers applauded the nurses for their professional competence. They expressed concerns about inadequate accommodation, high cost of care, the frequency and duration of mother-baby interactions.

Childhood alopecia areata-Data from the National Alopecia Areata Registry.

BACKGROUND/OBJECTIVES: Alopecia areata may occur at any age and is the third-most-common dermatosis in children. The objective of this study was to investigate the clinical and epidemiologic features of children and adolescents with alopecia areata based on the data of the National Alopecia Areata registry on children and adolescents. METHODS: Two thousand two hundred eighteen children and adolescents with alopecia areata self-enrolled in the National Alopecia Areata Registry and completed a web-based, self-administered, short-intake screening questionnaire (first tier). In the second tier, 643 patients participated in a clinical examination and completed a long-form questionnaire. RESULTS: Mean age of onset was 5.9 ± 4.1 years. With a female to male ratio of 1.5:1, alopecia areata was more prevalent in girls, but boys were significantly more likely to have a severe type (P = .009). One-fourth of all children had a positive family history, with 8% having more than three affected relatives. The disease most commonly associated with alopecia areata was atopic dermatitis (32.7%). CONCLUSION: Childhood alopecia areata is more prevalent in girls than in boys, but boys have more extensive alopecia areata. Despite the low prevalence, congenital alopecia areata is an important differential diagnosis for neonatal hair loss. Alopecia areata runs in families, suggesting an underlying genetic background. One-quarter of the children reported at least one affected first-degree relative; 8% had more than three affected relatives.

The Utility and Validity of the Alopecia Areata Symptom Impact Scale in Measuring Disease-Related Symptoms and their Effect on Functioning.

Alopecia areata (AA) is an autoimmune disease that causes hair loss. Although persons with the disease can be physically described as having varying degrees of hair loss, the condition has significant ramifications on an individual's well-being. We previously reported the preliminary psychometric properties of the Alopecia Areata Symptom Impact Scale (AASIS), a disease-specific measure that asks participants about their AA symptoms and how these symptoms interfere with their daily functioning. The goals of this article are to provide a detailed description of the development of the AASIS items and to offer a psychometric update for the measure. Preliminary items for the AASIS were developed on the basis of responses from 1,649 participants to 125 health-related quality-of-life questions/items from the National Alopecia Areata Registry. Clinicians affiliated with the registry were asked to rate the relevance of these items for content validity. Cluster analysis and clinician ratings were used to reduce the number of items. The resulting 13-item AASIS was administered to 452 participants, who were also cognitively debriefed. Results showed that the AASIS is a valid and reliable measure of AA symptoms and their impact on functioning.

Health-Related Quality of Life (HRQoL) in alopecia areata patients-a secondary analysis of the National Alopecia Areata Registry Data.

Alopecia areata (AA) is a nonscarring and recurrent disease characterized by hair loss that may significantly affect patient health-related quality of life (HRQoL). Given the lack of reliable and accurate reporting of HRQoL status in patients with AA, we analyzed data from 532 AA patients from the National Alopecia Areata Registry whose registry record included HRQoL assessments using three validated instruments: Skindex-16, brief version of the Fear of Negative Evaluation Scale, and Dermatology Life Quality Index. The mean HRQoL scores were compared with previously reported HRQoL levels from healthy controls and patients with other skin diseases. Two-step cluster analysis of Skindex-16 scales divided patients into two groups: 481 (57%) with good HRQoL and 361 (43%) with poor HRQoL. Multivariate logistic regression modeling revealed a set of risk factors for poor HRQoL: age <50 years (odds ratio (OR) 3.99, 95% confidence interval (CI) 1.66-9.58), female gender (OR 2.74, 95% CI 1.73-4.34), hair loss 25-99% (OR 2.47, 95% CI 1.12-5.45), family stress (OR 1.8, 95% CI 1.13-2.86), and job change (OR 2.01, 95% CI 1.02-3.94). The current analysis provides an overview of the HRQoL status of AA patients and may guide patient care in the future.

Development of the alopecia areata symptom impact scale.

The existing literature on alopecia areata (AA) clearly demonstrates patients' concerns related to physical symptoms, emotional well-being, mental health, social functioning, and other dimensions of daily functioning. Although questionnaires such as the Skindex-16 and the Dermatology Life Quality Index have been used, these questionnaires were validated for skin conditions other than AA as a chronic condition. The goals of this study are to develop a measure of quality of life, symptoms, and their impact for patients with AA called the Alopecia Areata Symptom Impact Scale (AASIS) and to provide psychometric evidence for its use. We used data from 1,400 patients from the National Alopecia Areata Registry together with clinical experts' reviews and quantitative approaches. The preliminary version of the AASIS with 13 items was administered to about 210 patients with AA. Results indicated that the AASIS measures three underlying constructs related to AA. These dimensions were impact of AA, hair loss, and physical skin symptoms. The internal consistency reliabilities of these subscales are 0.93, 0.86, and 0.81, respectively. Cognitive debriefing results showed that patients find the AASIS items easy to understand, clear, and concise. Preliminary evidence suggests that the AASIS is a reliable and valid measure of the symptoms and their impact in patients with AA.