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.

Skindex, a quality-of-life measure for patients with skin disease: reliability, validity, and responsiveness.

To measure the effects of skin disease on patients' quality of life, we developed a 61-item self-administered survey instrument called Skindex. Skindex has eight scales, each of which addresses a construct, or an abstract component, in a comprehensive conceptual framework: cognitive effects, social effects, depression, fear, embarrassment, anger, physical discomfort, and physical limitations. Item responses are standardized from 0 (no effect) to 100 (maximal effect); a scale score is the average of responses to items addressing a construct. In 201 patients seen by dermatologists, mean scale scores (+/-SD) ranged from 14 (+/-17) for physical limitations to 31 (+/-22) for physical discomfort. Scale scores were reproducible after 72 h (r = 0.68-0.90) and were internally consistent (Cronbach's alpha = 0.76-0.86). Construct validity was assessed in two ways: (i) in a comparison of patients with inflammatory dermatoses and patients with isolated lesions, patients with inflammatory dermatoses had higher scale scores, and (ii) in an exploratory factor analysis, 78% of the common variance was explained by seven factors that correlated with the scale scores of Skindex. Most of the a priori scale scores changed in the expected direction in patients who reported that their skin conditions had improved or worsened after 6 mo. Finally, physicians' judgments of disease severity did not consistently correlate with Skindex scores. These preliminary data suggest that Skindex reliably and responsively measures the effects of skin disease on patients' quality of life and may supplement clinical judgments of disease severity.

Convergent and discriminant validity of a generic and a disease-specific instrument to measure quality of life in patients with skin disease.

Skindex is a quality-of-life instrument for skin diseases. To determine its convergent validity and its advantage relative to a generic measure, we compared responses of 132 dermatology patients to Skindex and the Medical Outcomes Study 36-item Short-Form Survey (SF-36). We hypothesized that (i) correlations between similar scales would be strong but not redundant (r = 0.5-0.6), and (ii) Skindex scores would correlate more highly with responses about skin disease-related aspects of health, and SF-36 scores would correlate more highly with responses concerning general health. As measured by the SF-36, patients reported general health status similar to the normal population, and SF-36 scores did not correlate with dermatologists' judgments about the severity of skin disease. Correlations between the same scales of the two instruments were as hypothesized (range of r, 0.44-0.56), and patients with low, medium, or high responses to Skindex differed similarly in SF-36 scores. On the other hand, some patients who reported on the SF-36 that they were free of physical symptoms (37% of patients) or social effects (54%) on Skindex, reported such effects from their skin disease. Also, responses about skin-related health aspects correlated more highly with Skindex than SF-36 (for skin condition, mean r = 0.42 vs 0.28; for disfigurement, 0.38 vs 0.24). Conversely, responses concerning general health correlated more highly with SF-36 than Skindex (for self-reported health status, mean r = 0.28 vs 0.16; for co-morbidity, 0.48 vs 0.37). This study further supports the validity of Skindex and also suggests that both generic and disease-specific health status measures can contribute to the assessment of patients with skin diseases.

Functional status before hospitalization in acutely ill older adults: validity and clinical importance of retrospective reports.

OBJECTIVES: Retrospective reports of patients' functional status before hospital admission are often used in longitudinal studies and by clinicians caring for hospitalized patients. However, the validity of these reports has not been established. Our aim was to examine the validity of retrospective reports by testing hypotheses about the relationships these measures would have with other clinical measures if they were valid. DESIGN: A prospective cohort study. PARTICIPANTS AND SETTING: A total of 2877 older patients (mean age 81, 36% women) hospitalized on the general medical service at two hospitals. For 1953 of the subjects, the patient was the primary respondent, whereas for 924 subjects, a surrogate was the primary respondent. MEASUREMENTS: Shortly after hospital admission, patients or surrogates reported whether the patient was independent in each of five activities of daily living (ADLs) on admission and at baseline 2 weeks before admission. Outcome measures included reported independence in each ADL 3 months after the hospitalization and survival to 1 year. RESULTS: Patients' retrospective reports of their ADL function 2 weeks before admission had a clinically plausible relationship with ADL function at the time of admission, in that patients independent in an ADL on admission rarely reported they were dependent in that ADL 2 weeks before admission (range 2-6%). Surrogates were somewhat more likely than patients to report that patients independent on admission were dependent 2 weeks before admission (range 5-14%). Retrospective reports of prehospitalization ADL function demonstrated strong evidence of predictive validity for both patients' and surrogates' reports. For example, among patients dependent in bathing on admission, patients who were reported as independent 2 weeks before admission were much more likely than those reported as dependent 2 weeks before admission to be independent 3 months after hospitalization (68% vs 20%, P < .001 for patient respondents; 30% vs 5%, P < .001 for surrogate respondents). Similarly, among patients dependent in bathing on hospital admission, survival 1 year after hospitalization was much higher in patients who were independent in bathing 2 weeks before admission than patients who were dependent 2 weeks before admission (76% vs 59%, P < .001 for patient respondents; 60% vs 45%, P < .001 for surrogate respondents). Results were similar for each of the other four ADLs. In a logistic regression model controlling for the number of ADLs reported as dependent on admission, the number of ADLs reported as dependent 2 weeks before admission was significantly associated with 1-year mortality among both patient (odds ratio (OR) = 1.39 per dependent ADL, 95% confidence interval (CI) - 1.26-1.54) and surrogate (OR = 1.14, 95% CI = 1.06-1.24) respondents. CONCLUSIONS: Hospitalized patients' assessments of their ability to perform ADLs before their hospitalization have evidence of face and predictive validity. These measures are strong predictors of important health outcomes such as functioning and survival. In particular, among patients dependent in ADL function on hospital admission, these results highlight the prognostic importance of inquiring about the patient's functional status before the onset of the acute illness.