Patient-Reported Outcome Measures and Their Clinical Applications in Dermatology.

With more disease- and symptom-specific measures available and research pointing to increased usefulness, patient-reported outcome measures (PROMs) can be routinely used in clinical care. PROMs increase efficiency in healthcare, improve the clinician-patient relationship, and increase patient satisfaction with their care. PROMs can be administered before, during, and after clinic visits using paper-and-pencil, mobile phones, tablets, and computers. Herein, we combine available literature with expert views to discuss overcoming barriers and helping dermatologists incorporate PROMs into routine patient-centered care. We believe dermatology patients will benefit from broader PROM implementation and routine clinical use. However, a few major barriers exist: (1) cost to implement the technology, (2) selecting the right PROMs for each disease, and (3) helping both patients and clinicians understand how PROMs add to and complement their current clinical experience. We provide recommendations to assist dermatologists when considering whether to implement PROMs in their practices.

Differences in Skin Cancer Rates by Transplanted Organ Type and Patient Age After Organ Transplant in White Patients.

Importance: Although it is known that patients with thoracic organ transplants develop skin cancer more frequently than those who receive nonthoracic organ transplants, patterns of risk for subsequent skin cancers are unknown. Objective: To further characterize organ transplant recipients who develop multiple skin cancers and assess for patterns of development of additional skin cancers beyond the first skin cancer diagnosis by patient age and transplanted organ type. Design, Setting, and Participants: This cohort study used validated electronic health record-based data from a single tertiary care academic medical center to identify 5129 solid organ transplant recipients who underwent transplant surgery between 1992 and 2017 and were older than 18 years at the time of transplant. The cohort was limited to White patients because they have the highest skin cancer risk based on phenotype. The mean follow-up was 6.6 years. Data were analyzed June 9, 2021, to May 31, 2022. Main Outcomes and Measures: Differences in rates of skin cancer development for first and subsequent skin cancers were measured using t test or analysis of variance and χ2 tests for continuous and categorical variables. Rates of skin cancer development were compared based on organ type and patient age at transplant using Fine-Gray tests and cumulative incidence plots. Results: A total of 5129 organ transplant recipients (mean [SD] age, 51.3 [12.9] years; 3287 men [64.1%]) were included. Of these, 695 patients (13.6%) had development of at least 1 skin cancer, with 6842 skin cancers identified in the cohort overall. Compared with liver transplant recipients, heart, lung, or kidney recipients were more likely to develop at least 1 skin cancer (χ2 test, 25.6; df, 4; P < .001). There was no significant difference by transplanted organ type in the rate of developing a second or third skin cancer; however, the age at transplant was associated with the time to developing a second (χ2 test, 20.4; df, 4; P < .001) or third (χ2 test, 10.9; df, 4; P < .02) skin cancer. Conclusions and Relevance: This cohort study found that there was no difference by organ type for development of subsequent skin cancers in organ transplant recipients, and recipients of all organ types developed additional skin cancers at high rates after the initial skin cancer.

Expanding Personalized, Data-Driven Dermatology: Leveraging Digital Health Technology and Machine Learning to Improve Patient Outcomes.

The current revolution of digital health technology and machine learning offers enormous potential to improve patient care. Nevertheless, it is essential to recognize that dermatology requires an approach different from those of other specialties. For many dermatological conditions, there is a lack of standardized methodology for quantitatively tracking disease progression and treatment response (clinimetrics). Furthermore, dermatological diseases impact patients in complex ways, some of which can be measured only through patient reports (psychometrics). New tools using digital health technology (e.g., smartphone applications, wearable devices) can aid in capturing both clinimetric and psychometric variables over time. With these data, machine learning can inform efforts to improve health care by, for example, the identification of high-risk patient groups, optimization of treatment strategies, and prediction of disease outcomes. We use the term personalized, data-driven dermatology to refer to the use of comprehensive data to inform individual patient care and improve patient outcomes. In this paper, we provide a framework that includes data from multiple sources, leverages digital health technology, and uses machine learning. Although this framework is applicable broadly to dermatological conditions, we use the example of a serious inflammatory skin condition, chronic cutaneous graft-versus-host disease, to illustrate personalized, data-driven dermatology.

Incorporating Patient-Reported Outcomes as a Vital Sign for Dermatologic Clinical Care and Clinical Investigations.

Patient-reported outcomes (PROs) provide quantitative assessments of patients' experiences with their skin diseases. PROs are usually much more comprehensive than what can be gleaned from a brief clinical history and more informative than what dermatologists can gather on clinical examination. Correlations between PROs and clinician assessments (e.g., investigator global assessment, PASI) are poor to moderate at best, and therefore data from each source are not redundant and can complement one another. PROs should serve as skin vital signs in dermatology. PROs can offer snapshots of the intensity of a symptom as well as the effects of symptoms, emotions, and functioning on a patient's skin-related QOL. Just as clinicians obtain a baseline blood pressure before starting antihypertensives, dermatology-specific PROs serve as a baseline from which clinicians can monitor (even remotely) for improvement or side effects with treatment and for flares. Both PROs and conventional vital signs are usually normal. It is when they are abnormal or different than expected that they become informative. We conclude by offering a roadmap for investigators to conduct the next steps in PRO research necessary to establish guidelines for transitioning PROs from clinical research and trials to routine clinical use.

Validity of Using Billing Codes From Electronic Health Records to Estimate Skin Cancer Counts.

IMPORTANCE: Patients can develop multiple skin cancers, and their medical data can be spread over multiple health care systems. This fragmented care, combined with the lack of skin cancer registries, has limited our ability both to provide accurate estimates of incidence and to study the pathogenesis of multiple skin cancers. OBJECTIVE: To assess whether standard diagnostic and procedural codes present in the electronic health records at a single health care system are a valid proxy for estimating the number of overall skin cancers. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of patients seen at a single-center tertiary care hospital (ie, Vanderbilt University Medical Center) between July 1, 2008, and June 30, 2018. All patients with at least 1 electronic health record-based diagnostic or procedural code for any skin cancer and at least 1 pathology report of a skin cancer. EXPOSURE: The number of International Classification of Disease (ICD) or Current Procedural Terminology (CPT) codes relating to skin cancer. MAIN OUTCOMES AND MEASURES: Pearson correlation coefficient and R2 were calculated for the total number of ICD or CPT codes for skin cancer and histologically verified skin cancers. RESULTS: In this cohort study of 35 901 patients, the mean (SD) age was 70.4 (14.4) years, 20 404 (56.8%) were men, and 31 623 (88.1%) were White individuals. Of these patients, 6307 had at least 1 ICD or CPT code or pathology report for a skin cancer, of whom 5688 patients had both a CPT code related to skin malignancy and a histologically verified skin cancer. There was a strong linear correlation between the number of CPT codes and pathology records (r = 0.87). There was a poor correlation between the number of ICD codes and pathology records (r = 0.22). CONCLUSIONS AND RELEVANCE: This cohort study found that the use of ICD codes was a poor proxy measure for the number of skin cancers per patient. In contrast, CPT codes accounted for more than 75% of the variability in the number of skin cancers (R2 = 0.76) and were a better proxy measure for the total number of skin cancers per patient.

Differences in quality of life in patients with cutaneous lupus erythematosus with varying income levels.

BACKGROUND: Cutaneous lupus erythematosus (CLE) is an autoimmune photosensitive skin condition. The impact of income on quality of life has been incompletely characterized in CLE. OBJECTIVES: We aimed to assess how annual income affects quality of life among CLE patients. METHODS: In this cross-sectional study of 238 patients with CLE, relationships between predictor variables including annual income and each SKINDEX-29 + 3 subdomain were identified using univariate and multivariable analyses. In addition, answers to individual SKINDEX-29 + 3 questions were compared across income groups. Clinical factors in patients making less than <10,000 USD (N = 85) with worse SKINDEX-29 + 3 scores were also identified by univariate and multivariable analyses. RESULTS: Patients making <10,000 USD annually experienced worse quality of life across multiple SKINDEX-29 + 3 subdomains (p < 0.05). These patients specifically experienced poorer quality of life relating to social isolation and self-consciousness. (p < 0.001). Among those making <10,000 USD, predictors for worse quality of life included females, smokers, and those with higher skin disease activity were identified (p < 0.05).Limitations: This is a single center study. Income was also self-reported and could not be verified. CONCLUSIONS: Lower income is related to poorer quality of life in patients with CLE. Specifically, patients experience limitations regarding social isolation and self-consciousness.

Development of Phenotyping Algorithms for the Identification of Organ Transplant Recipients: Cohort Study.

BACKGROUND: Studies involving organ transplant recipients (OTRs) are often limited to the variables collected in the national Scientific Registry of Transplant Recipients database. Electronic health records contain additional variables that can augment this data source if OTRs can be identified accurately. OBJECTIVE: The aim of this study was to develop phenotyping algorithms to identify OTRs from electronic health records. METHODS: We used Vanderbilt's deidentified version of its electronic health record database, which contains nearly 3 million subjects, to develop algorithms to identify OTRs. We identified all 19,817 individuals with at least one International Classification of Diseases (ICD) or Current Procedural Terminology (CPT) code for organ transplantation. We performed a chart review on 1350 randomly selected individuals to determine the transplant status. We constructed machine learning models to calculate positive predictive values and sensitivity for combinations of codes by using classification and regression trees, random forest, and extreme gradient boosting algorithms. RESULTS: Of the 1350 reviewed patient charts, 827 were organ transplant recipients while 511 had no record of a transplant, and 12 were equivocal. Most patients with only 1 or 2 transplant codes did not have a transplant. The most common reasons for being labeled a nontransplant patient were the lack of data (229/511, 44.8%) or the patient being evaluated for an organ transplant (174/511, 34.1%). All 3 machine learning algorithms identified OTRs with overall >90% positive predictive value and >88% sensitivity. CONCLUSIONS: Electronic health records linked to biobanks are increasingly used to conduct large-scale studies but have not been well-utilized in organ transplantation research. We present rigorously evaluated methods for phenotyping OTRs from electronic health records that will enable the use of the full spectrum of clinical data in transplant research. Using several different machine learning algorithms, we were able to identify transplant cases with high accuracy by using only ICD and CPT codes.

Quality of Life Assessed Using Skindex-16 Scores Among Patients With Acne Receiving Isotretinoin Treatment.

Importance: Acne is a common dermatologic condition and significantly affects psychosocial health and quality of life. An international task force recommended routine use of quality-of-life measures for clinic visits associated with acne management, but this has yet to translate into clinical practice. Objective: To assess mean Skindex-16 scores over time among patients with moderate to severe acne receiving isotretinoin treatment. Design, Setting, and Participants: A longitudinal, retrospective case series study of Skindex-16 data collected at monthly visits from 57 consecutive patients with acne receiving isotretinoin; data were collected and evaluated between November 23, 2016, and January 22, 2019. Continuous variables were compared using quantile regression. Multivariable linear mixed models evaluated mean (95% CI) score trajectory over time. Main Outcomes and Measure: Skindex-16 scores, including normalized scores for the emotional, symptomatic, and functional aspects of having skin disease as well as an overall score. Results: Fifty-seven patients (31 [54.4 %] males, with median [interquartile range] age of 17.2 [15.9-18.1] years) in this case series study completed the Skindex-16 at baseline and at least once during follow-up. Baseline Skindex-16 scores were similar by sex but worse with increasing age. Emotional impact was more bothersome to patients with acne requiring isotretinoin treatment than either symptoms or functioning. Improvements of greater than 50% in overall and Emotional domain scores were seen by month 2 of receiving isotretinoin treatment (eg, overall scores decreased from 39.4 to 17.5 by month 2; a decrease of 22.0; P < .001). Qualitatively, Skindex-16 scores reached their nadir between months 3 and 5; at month 4, overall Skindex-16 scores showed a 4.4-fold improvement (from 39.4 at baseline to 8.9; P < .001) and Emotional domain scores showed a 4.8-fold improvement (from 57.7 at baseline to 11.9; P < .001). Conclusions and Relevance: The findings of this case series suggest that patients receiving isotretinoin treatment achieve greater than a 50% improvement in quality of life by month 2 and can expect approximately 4-fold to 5-fold improvements from baseline with a full course of isotretinoin. This study shows the potential of routine administration of quality of life measures to assess patient care in dermatology.

Development of a patient decision aid for the management of superficial basal cell carcinoma (BCC) in adults with a limited life expectancy.

BACKGROUND: Basal cell carcinoma (BCC) is a slow-growing, rarely lethal skin cancer that affects people 65 years or older. A range of treatment options exist for BCC, but there is little evidence available to guide patients and providers in selecting the best treatment options. OBJECTIVES: This study outlines the development of a patient decision aid (PDA) for low-risk BCC that can be used by patients and providers to assist in shared decision-making. METHODS: In accordance with the International Patient Decision Aids Standards (IPDAS) Collaboration framework, feedback from focus groups and semi-structured interviews with patients and providers, an initial prototype of the PDA was developed. This was tested using cognitive interviews and iteratively updated. RESULTS: We created eighteen different iterations using feedback from 24 patients and 34 providers. The key issues identified included: 1) Addressing fear of cancer; 2) Communicating risk and uncertainty; 3) Values clarification; and 4) Time lag to benefit. LIMITATIONS: The PDA does not include all possible treatment options and is currently paper based. CONCLUSIONS: Our PDA has been specifically adapted and designed to support patients with a limited life expectancy in making decisions about their low risk BCC together with their doctors.

Association between financial links to indoor tanning industry and conclusions of published studies on indoor tanning: systematic review.

OBJECTIVE: To assess whether an association exists between financial links to the indoor tanning industry and conclusions of indoor tanning literature. DESIGN: Systematic review. DATA SOURCES: PubMed, Embase, and Web of Science, up to 15 February 2019. STUDY SELECTION CRITERIA: Articles discussing indoor tanning and health were eligible for inclusion, with no article type restrictions (original research, systematic reviews, review articles, case reports, editorials, commentaries, and letters were all eligible). Basic science studies, articles describing only indoor tanning prevalence, non-English articles, and articles without full text available were excluded. RESULTS: 691 articles were included in analysis, including empiric articles (eg, original articles or systematic reviews) (357/691; 51.7%) and non-empiric articles letters (eg, commentaries, letters, or editorials) (334/691; 48.3%). Overall, 7.2% (50/691) of articles had financial links to the indoor tanning industry; 10.7% (74/691) articles favored indoor tanning, 3.9% (27/691) were neutral, and 85.4% (590/691) were critical of indoor tanning. Among the articles without industry funding, 4.4% (27/620) favored indoor tanning, 3.5% (22/620) were neutral, and 92.1% (571/620) were critical of indoor tanning. Among the articles with financial links to the indoor tanning industry, 78% (39/50) favored indoor tanning, 10% (5/50) were neutral, and 12% (6/50) were critical of indoor tanning. Support from the indoor tanning industry was significantly associated with favoring indoor tanning (risk ratio 14.3, 95% confidence interval 10.0 to 20.4). CONCLUSIONS: Although most articles in the indoor tanning literature are independent of industry funding, articles with financial links to the indoor tanning industry are more likely to favor indoor tanning. Public health practitioners and researchers need to be aware of and account for industry funding when interpreting the evidence related to indoor tanning. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019123617.

Effects of increased actinic keratosis count on skin-related quality of life: results from the Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial.

BACKGROUND: Actinic keratoses (AKs) are very common and it is therefore important to consider how morbidity of this disease impacts quality of life (QoL). Previous longitudinal studies of skin-related QoL in a high-risk population found no effect of increased AK counts on subsequent skin-related QoL, even though higher AK counts were associated with worse skin-related QoL cross-sectionally. OBJECTIVES: To determine if development of new actinic keratoses (AKs) are associated with worse skin-related QoL in those at high risk of keratinocyte carcinoma (KC). MATERIALS AND METHODS: A prospective analysis was performed using data from the Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial, a randomized, double-blinded, placebo-controlled trial of topical 5-fluorouracil for chemoprevention of KC. We report correlates of skin-related quality of life, a secondary outcome of the trial. Demographic and health-related information were self-reported and AK multiplicity on the face/ears were noted on semi-annual skin exams. Skindex-29 and Skin Cancer Index instruments were used to assess skin-related QoL yearly. RESULTS: Participants with increased AK counts had worse skin-related QoL compared to those with unchanged or decreased counts, particularly in Year 1. CONCLUSION: Our findings of impaired skin-related QoL associated with AKs underscore the importance of appropriate management to reduce the burden of disease.

Validating a Quality-of-Life Instrument for Allergic Contact Dermatitis.

BACKGROUND: Contact dermatitis is a prevalent condition that has a significant impact on quality of life (QoL). Although many generic dermatological QoL instruments exist, none were developed by and for patients with allergic contact dermatitis (ACD). OBJECTIVE: The aim of the study was to create and validate a reliable QoL instrument specific for the ACD population. METHODS: We identified QoL items specific to ACD through a series of qualitative interviews with ACD patients and experts. We created a 17-question survey that queries the patient across the following 3 major domains: symptoms, functioning, and emotions. We used statistical methods to evaluate the reliability and validity of this tool. RESULTS: Ninety patients with relevant positive results on patch testing completed the novel ACD instrument and the Skindex-29. This instrument exhibited reliability and validity in individuals with ACD and was more sensitive than the generic tool Skindex-29. CONCLUSIONS: This novel instrument is the first tool developed specifically to assess the unique impacts of ACD on QoL. Providers can reliably use this index to assess the specific aspects of the disease most problematic for the ACD patient and use this information to more properly inform counseling and management.

Assessment of Sleep Disturbances and Exhaustion in Mothers of Children With Atopic Dermatitis.

Importance: The well-being and development of children is strongly influenced by parents' physical and psychosocial health. Data from small, clinic-based studies suggest that sleep loss may be common in parents of children with atopic dermatitis (AD), but longitudinal population-based studies are lacking. Objectives: To compare sleep disturbances over time between mothers of children with and without AD and to determine whether these disturbances are associated with the child's disease severity and the child's sleep disturbances. Design, Setting, and Participants: In the ongoing Avon Longitudinal Study of Parents and Children, all pregnant women residing in Avon, United Kingdom, with an expected delivery date between April 1, 1991, and December 31, 1992, were recruited. Analyses for this study, a secondary analysis of this cohort, were performed from September 2017 to September 2018. Mother-child pairs were followed up with a time-varying measure of child AD activity and severity and self-reported maternal sleep measures repeated at multiple time points between child ages 6 months and 11 years. Main Outcomes and Measures: Time-varying binary measures of maternal sleep duration (<6 vs ≥6 hours per night), difficulty falling asleep, early morning awakening, subjectively insufficient sleep, and daytime exhaustion. Results: The study followed up 13 988 mother-child pairs from birth for a median duration of 11 (interquartile range, 7-11) years. Among the cohort, 11 585 of 13 972 mothers (82.9%) were aged 21 to 34 years and 12 001 of 12 324 (97.4%) were of white race/ethnicity; 7220 of 13 978 children (51.7%) were male. Sleep duration (adjusted odds ratio [AOR], 1.09; 95% CI, 0.90-1.32) and early morning awakenings (AOR, 1.16; 95% CI, 0.93-1.46) were similar between mothers of children with and without AD. In contrast, mothers of children with AD were more likely to report difficulty falling asleep (AOR, 1.36; 95% CI, 1.01-1.83), subjectively insufficient sleep (AOR, 1.43; 95% CI, 1.24-1.66), and daytime exhaustion (AOR, 1.41; 95% CI, 1.12-1.78) independent of the child's comorbid asthma and/or allergic rhinitis. For all measures, worse child AD severity was associated with worse maternal sleep outcomes. The magnitude and significance of the associations were largely unchanged after adjustment for child sleep disturbances. Conclusions and Relevance: Mothers of children with AD reported difficulty falling asleep, subjectively insufficient sleep, and daytime exhaustion throughout the first 11 years of childhood. However, child sleep disturbances did not fully explain maternal sleep disturbances, and future research should investigate other mechanisms. In caring for children with AD, clinicians should consider maternal sleep disturbances and caregiver fatigue.