A multiyear cross-sectional study of U.S. national prescribing patterns of first-generation sedating antihistamines in older adults with skin disease.

BACKGROUND: First-generation antihistamines (FGAs) are classified as 'potentially inappropriate' for use in older patients (patients aged ≥ 65 years). However, the prevalence of and factors associated with FGA prescription have not been studied. OBJECTIVES: To examine FGA prescription rates for older patients who visited dermatology offices, and compare them to those for younger patients (patients aged 18-65 years) who visited dermatology offices and those for older patients who visited primary-care physicians (PCPs). METHODS: This was a multiyear cross-sectional observational study using data from the U.S. National Ambulatory Medical Care Survey (2006-2015). Visits by patients aged 18 years or older were included in the study; the data comprised 15 243 dermatology office visits and 66 036 PCP office visits. The main outcome was FGA prescription. Other variables included physician specialty (dermatologist or PCP), patient's age, diagnosis of dermatological conditions and reason for visit. RESULTS: For dermatology visits, the overall FGA prescription rate for older patients was similar to that for younger patients (1·5% vs. 1·2%; P = 0·19), even when the diagnosis was dermatitis or pruritus (3·7% vs. 4·8%; P = 0·21) or when itch was a complaint (7·6% vs. 6·7%; P = 0·64). However, the rate of FGA prescription for dermatology visits was lower than that for PCP visits, in analyses matched for patient and visit characteristics (3·9% vs. 7·4%; P = 0·02). CONCLUSIONS: Our findings suggest that FGAs are overprescribed to older patients but that dermatologists are less likely to prescribe FGAs than PCPs. What's already known about this topic? First-generation antihistamines (FGAs) have been shown to pose substantial risks to older adults, including cognitive impairment, falls, confusion, dry mouth and constipation. Therefore, FGAs have been classified as 'potentially inappropriate' for use in older patients by the American Geriatrics Society. It has also been shown that dermatologists do not always take patient characteristics (e.g. age or life expectancy) into account when deciding on a treatment, instead following a 'one-size-fits-all' approach. What does this study add? FGAs are often prescribed during dermatology visits, and prescription rates do not differ between older and younger patients. There were no significant differences in prescription rates when comparing younger and older adults with the same diagnosis or symptom (e.g. dermatitis, pruritus or itch). FGAs are prescribed at higher rates in primary-care offices than in dermatology offices.

Assessing effectiveness in acne clinical trials: steps towards a core outcome measure set.

BACKGROUND: Acne ranks second to dermatitis in terms of global burden of skin disease. As such, it is essential that data on treatment efficacy are generated in a way that maximizes the opportunity for comparison among treatments. Interest in developing core outcome sets for use in clinical trials to standardize data collection in skin disease is surging. OBJECTIVES: The goal of this review is to provide an update on the efforts underway, challenges encountered and future directions in the development of an acne core outcome measure set for use in clinical trials. METHODS: The activities of the Acne Core Outcomes Research Network (ACORN) are presented in the context of currently acceptable methodologies for core outcome set development. CONCLUSIONS: Emphasis is placed on following a rigorous methodology, involving patients and recognizing a role for emerging technologies.

Systematic review of atopic dermatitis disease definition in studies using routinely collected health data.

BACKGROUND: Routinely collected electronic health data obtained for administrative and clinical purposes are increasingly used to study atopic dermatitis (AD). Methods for identifying AD patients in routinely collected electronic health data differ, and it is unknown how this might affect study results. OBJECTIVES: To evaluate how patients with AD have been identified in studies using routinely collected electronic health data, to determine whether these methods were validated and to estimate how the method for identifying patients with AD affected variability in prevalence estimates. METHODS: We systematically searched PubMed, Embase and Web of Science for studies using routinely collected electronic health data that reported on AD as a primary outcome. Studies of localized AD and other types of dermatitis were excluded. The protocol for this review was registered in PROSPERO (CRD42016037968). RESULTS: In total, 59 studies met eligibility criteria. Medical diagnosis codes for inclusion and exclusion, number of occasions of a code, type of provider associated with a code and prescription data were used to identify patients with AD. Only two studies described validation of their methods and no study reported on disease severity. Prevalence estimates ranged from 0·18% to 38·33% (median 4·91%) and up to threefold variation in prevalence was introduced by differences in the method for identifying patients with AD. CONCLUSIONS: This systematic review highlights the need for clear reporting of methods for identifying patients with AD in routinely collected electronic health data to allow for meaningful interpretation and comparison of results.

Validation and comparison of quality-of-life measures for topical 5-fluorouracil treatment: results from a randomized controlled trial.

BACKGROUND: Topical 5-fluorouracil (5-FU) is commonly used for high-risk patients with keratinocyte carcinoma (KC). Skindex and Skin Cancer Index (SCI) are validated instruments to measure quality of life (QoL) of patients with KC and those who have had surgical treatment of KCs. AIM: To validate Skindex and SCI for topical 5-fluorouracil (5-FU) application and to compare the two QoL instruments. METHODS: We randomized 932 veterans at high risk for developing a KC to either topical 5-FU or vehicle control cream applied to the face and ears for up to 1 month. We collected their Skindex-29 and SCI scores at baseline and follow-up visits. RESULTS: Compared with controls, 5-FU reduced QoL, measured by the Skindex symptom, Skindex function and SCI social subscales (P < 0.001, P < 0.01, P = 0.02, respectively). At 1 month, significant changes in QoL in the 5-FU group were observed in the Skindex symptom (10.1, 95% CI 0.36-12.6), Skindex function (6.0, 95% CI 4.0-8.0) and SCI social (-3.5, 95% CI -6.2 to -0.8) subscales, while the other subscales of Skindex and SCI did not show significant changes. All three Skindex subscales at 1 month correlated with patient-reported symptom score and photograph-based toxicity score, whereas social subscale was the only one of the SCI subscales that correlated with patient-reported symptom and photograph-based toxicity scores. CONCLUSIONS: Our study validated Skindex symptom, Skindex function and SCI social subscales for QoL measurement during treatment with topical 5-FU. The study could not provide evidence for construct validity of the other subscales. Skindex was more responsive than SCI in the context of 5-FU treatment.

Reliability and validity of the Advanced Basal Cell Carcinoma Index (aBCCdex).

BACKGROUND: Patient-reported outcome (PRO) questionnaires were recently developed specifically for use with patients with advanced basal cell carcinoma (aBCC) and basal cell carcinoma naevus syndrome (BCCNS). OBJECTIVES: To evaluate the measurement properties of PRO questionnaires for use in patients with aBCC or BCCNS. METHODS: In total 129 patients from 10 clinical sites in the U.S.A. and the BCCNS Support Network completed the two newly developed questionnaires multiple times over 3 months. Patients also completed the Skindex-16 and the 12-Item Short-Form Health Survey as collateral measures. Psychometric properties of the questionnaires were evaluated, including internal consistency and test-retest reliability, construct and known-groups validity, and responsiveness. RESULTS: Based on the results of exploratory factor analysis and clinical input, the two newly developed questionnaires were combined into a single questionnaire, called the aBCCdex, which is relevant for patients with both aBCC and BCCNS. The internal consistency reliability was acceptable, and all aBCCdex scale scores correlated significantly with conceptually similar scales. When divided into groups that differed based on scores from collateral measures, aBCCdex scale scores differentiated between groups (known-groups validity) and were responsive to change. CONCLUSIONS: The aBCCdex is a brief and comprehensive questionnaire appropriate for use with patients with aBCC and BCCNS. Its reliability and validity have been confirmed. Further research is necessary to estimate the minimally important difference in a larger patient population.

Factors affecting sunscreen use and sun avoidance in a U.S. national sample of organ transplant recipients.

BACKGROUND: Organ transplant recipients have an increased risk of nonmelanoma skin cancers due to immunosuppressive therapy following transplantation. Use of sunscreen has been shown to reduce this risk. OBJECTIVES: To identify patient and healthcare factors associated with sun-protective behaviours in organ transplant recipients after transplantation with the goal of increasing overall sunscreen use. METHODS: This study utilized a cross-sectional, retrospective survey from a national sample of 198 organ transplant recipients in the U.S.A. from 2004 to 2008 with no prior diagnosis of skin cancer. The main outcome measures were sunscreen use and sun avoidance before and after transplantation. Frequency of sunscreen use and sun exposure was obtained by self-report on Likert scales ranging from never to always, and these responses were converted to a numerical scale from 0 to 4. RESULTS: Overall sunscreen use increased after transplantation (from a score of 1·4 to 2·1, P < 0·001). Sex, Fitzpatrick skin type, receiving advice to avoid sun from a healthcare provider, and pretransplantation sunscreen use were significantly associated with frequency of post-transplantation sunscreen use in multivariate models. Pretransplantation sun exposure, advice to avoid sun and pretransplantation sunscreen use were significantly associated with sun avoidance post-transplantation. CONCLUSIONS: Both patient features and clinician advice are associated with sun-protective behaviours after organ transplantation. These results will help physicians target expanded sun-protection counselling to those patients most in need of such intervention.

A multicentre, cross-sectional study on quality of life in patients with cutaneous lupus erythematosus.

BACKGROUND: A study at the University of Pennsylvania (UPenn) Medical Center demonstrated that quality of life in patients with cutaneous lupus erythematosus (CLE) is negatively impacted. Whether patients with CLE in other geographic locations have similar quality of life is unknown. OBJECTIVES: We sought to compare quality of life indicators between patients with CLE at the University of Texas Southwestern (UTSW) Medical Center at Dallas and those at UPenn. METHODS: Patients with CLE (total n=248) at UTSW (n=91) and UPenn (n=157) completed the Skindex-29 +3 and Short Form-36 (SF-36) surveys related to quality of life. Additional information, including demographics, presence of systemic lupus erythematosus (SLE) and disease severity, was collected from UTSW patients with CLE. RESULTS: Most Skindex-29 + 3 and SF-36 subdomain scores between UTSW and UPenn patients with CLE were similar. However, UTSW patients with CLE were significantly more affected in the functioning and lupus-specific Skindex-29 + 3 domains, and physical functioning, role-physical and general health SF-36 subscales than UPenn patients with CLE (P<0·05). Factors related to poor quality of life in UTSW patients with CLE include sex, income, education, presence of SLE, and skin disease activity. CONCLUSIONS: Most quality of life indicators were similar between the two CLE populations. Differences in psychosocial behaviour, and a larger proportion of patients with SLE and females in the UTSW group likely attributed to differences in a minority of Skindex-29+3 and SF-36 subdomains. Capturing data from CLE populations in different locations provides a more thorough picture of the quality of life that patients with CLE experience on a daily basis with special attention to quality of life issues in select patients with CLE.

Quality of life in mild to moderate acne: relationship to clinical severity and factors influencing change with treatment.

BACKGROUND: Because of its effects on quality of life, acne vulgaris is more than a merely physiological or cosmetic entity. OBJECTIVES: To describe the influence of mild to moderate acne on patients' quality of life, measured using Skindex-29, and to correlate changes in Skindex-29 scores with changes in objective and subjective indices in clinical severity after treatment with topical 4% erythromycin 0.2% zinc. Also, to evaluate efficacy and side-effects of the treatment. METHODS: Observational, prospective study of 1878 patients cared for by 252 clinicians in Spain. Data included epidemiological information and responses to Skindex-29, a subjective change and objective severity index. RESULTS: Baseline Skindex scale scores were worse in women, older patients, and those with more severe clinical disease. Skindex was sensitive to changes in objective severity but changes in Skindex scale scores were also related to other factors. Patients who reported their skin condition to be 'the same' or 'worse' at the end of the study had significantly worse baseline scores on the 'symptoms' and 'emotions' scales but 'functioning' scores were not worse than for those who reported their condition had improved. CONCLUSION: The effects of acne vulgaris on quality of life and changes in quality of life after treatment are not only explainable by objective severity of acne. Patients' and clinicians' judgements about acne severity are different.

Age, gender, quality of life and psychological distress in patients hospitalized with psoriasis.

BACKGROUND: Psoriasis has a great impact on the quality of life of patients, and the ageing population is an important public health issue. OBJECTIVES: To investigate whether older patients with psoriasis have a different impairment in quality of life compared with younger patients, considering level of severity, duration of disease, gender and psychological distress. METHODS: The study was performed between February 2000 and February 2002 at the inpatient wards of the Dermatological Institute IDI-IRCCS, Rome, Italy, in the framework of a large project on clinical, epidemiological, emotional and quality of life aspects of psoriasis (IMPROVE study). This is a hospital-based cross-sectional study, with measures of quality of life (Skindex-29, Dermatology Life Quality Index and Psoriasis Disability Index) and of psychological distress, generic (12-item General Health Questionnaire) and psoriasis-related (Psoriasis Life Stress Inventory), all self-assessed by patients. We compared the mean scores of each quality of life instrument in patients aged < 65 years and >/= 65 years, in subsets of patients based on clinical and sociodemographic characteristics. RESULTS: We analysed 936 patients hospitalized at IDI-IRCCS with a diagnosis of psoriasis. Quality of life was significantly more impaired in the older group for all the Skindex-29 scales, and psychological distress was higher in older patients. In particular, older women suffering from anxiety or depression had the greatest impairment in quality of life. The results were somewhat different using the other quality of life instruments. CONCLUSIONS: These results should alert dermatologists that similar levels of clinical severity in psoriasis may be associated with different levels of quality of life and psychological distress of patients. Particular attention should be devoted to older patients, and especially to older women.

Development and validation of a health-related quality of life instrument for women with melasma.

BACKGROUND: Melasma can have significant emotional and psychological effects on those affected with the condition. In the past, the impact of melasma on health-related quality of life (HRQoL) has been assessed using general measures of skin disease that equally weigh both the physical and psychosocial distress arising from the presence of a dermatological condition. OBJECTIVES: Our purpose was to develop and validate a disease-specific HRQoL instrument to identify the areas of the patient's life most impaired by melasma as well as the effects of the condition on their level of functioning in correlation with disease severity: the Melasma Quality of Life scale (MELASQOL). PATIENTS AND METHODS: A random sample of 102 women identified by an investigator as having melasma were evaluated by the investigator using the Melasma Area and Severity Index (MASI). The patients were then anonymously surveyed with the SKINDEX-16, the Fear of Negative Evaluation scale, the Dermatology Life Quality Index (DLQI), a skin discoloration evaluation questionnaire, and a measure of perceived life quality difference without melasma. The 10-item MELASQOL scale was devised from the comprehensive HRQoL assessment battery. RESULTS: The psychometric properties of the MELASQOL were comparable with the properties of the DLQI and the SKINDEX-16. The MELASQOL scores were highly correlated with the other HRQoL measures. The discriminatory ability of the MELASQOL is superior to the SKINDEX-16 and the DLQI for melasma. The three life domains most adversely affected by melasma (social life, recreation/leisure and emotional well-being) were highlighted by this instrument. These were the same three areas of life that patients believed would improve the most if they no longer were affected by the disease. CONCLUSIONS: The MELASQOL can be used to evaluate objectively the effect of melasma on a patient's HRQoL. The high correlation with the DLQI, the SKINDEX-16 and the skin discoloration questionnaire suggests that the new scale is a valid instrument, which can be used to monitor the level of impairment individuals suffer due to their melasma. The MELASQOL scores can help guide treatment methods as well as track the improvement of patients' HRQoL.