Publications

PURPOSE: People in socially disadvantageous positions may receive less time with their clinicians and consequently reduced access to healthcare resources, potentially magnifying health disparities. Socio-cultural characteristics of clinicians and patients may influence the time spent together. The purpose of this paper is to explore the relationship between clinician/patient time and clinician and patient characteristics using real-time location systems (RTLS).

DESIGN/METHODOLOGY/APPROACH: In the MGH/MGPO Outpatient RFID (radio-frequency identification) project clinicians and patients wore RTLS tags during the workday to measure face-time (FT), the duration patients and clinicians are co-located, wait time (WT); i.e. from registration to clinical encounter and flow time (FLT) from registration to discharge. Demographic data were derived from the health system's electronic medical record (EMR). The RTLS and EMR data were synthesized and analyzed using standard structured-query language and statistical analytic methods.

FINDINGS: From January 1, 2009 to January 1, 2011, 1,593 clinical encounters were associated with RTLS measured FTs, which differed with socioeconomic status and gender: women and lower income people received greater FT. WT was significantly longer for lower socioeconomic patients and for patients seeing trainee clinicians, women or majority ethnic group clinicians (Caucasian). FLT was shortest for men, higher socioeconomic status and for attending physician patients. Demographic concordance between patient and clinician did not significantly affect process times.

RESEARCH LIMITATIONS/IMPLICATIONS: The study demonstrates the feasibility of using RTLS to capture clinically relevant process measures and suggests that the clinical delivery system surrounding a clinical encounter may more significantly influence access to clinician time than individual patient and clinician characteristics.

ORIGINALITY/VALUE: Applying RTLS to healthcare is coming. We can now successfully install and run these systems in healthcare settings and extract useful information from them. Interactions with the clinical delivery system are at least as important as interactions with clinicians for providing access to care: measure FT, WT and FLT with RTLS; link clinical behavior, e.g. FT, with patient characteristics; explore how individual characteristics interact with system behavior.

BACKGROUND: Multiple metrics evaluate the efficacy of psoriasis treatment, but interestingly, the correlation between the mostly widely used clinical trial efficacy end point, the physician-rendered Psoriasis Area Severity Index PASI score and, the most widely used quality of life metric, the Dermatology Life Quality Index DLQI, is not always high.

OBJECTIVE: To perform a systematic review to determine PASI to DLQI correlation.

METHODS: RCTs of biological agents for the treatment of moderate-to-severe psoriasis were reviewed in accordance with PRISMA guidelines. The mean percentage PASI improvement and change in mean DLQI values were recorded and compared for treatment groups from baseline to 10-16 weeks of therapy.

RESULTS: A search of the literature yielded 155 sources, of which 13 RCTs met inclusion and exclusion criteria. Percentage of PASI improvement from baseline correlates with DLQI changes with an r(2) value of 0.80 from baseline through weeks 10-16. When grouped by mean percentage reduction in PASI, agents demonstrating >75% mean reduction in PASI demonstrated a mean DLQI improvement over agents that achieved <75%-50% mean reduction in PASI or <50% mean reduction in PASI [minimal clinically important difference (MCID) 3.2]. In addition, a reduction in mean PASI of at least 75%, predicted a mean movement from DLQI band 3 to DLQI band 1, in all nine treatment arms demonstrating such efficacy.

CONCLUSIONS: Mean PASI and DLQI correlate predictably in patients with chronic moderate-to-severe plaque psoriasis undergoing treatment with biological agents. A reduction in PASI of at least 75% can translate to significant quality-of-life improvement in patients treated with these therapies.

BACKGROUND: Rates of malignancies and hospitalized infectious events (HIEs) among psoriasis patients are higher than in the general population, but it is unclear if higher rates are associated with the underlying inflammatory state, treatments or both.

OBJECTIVES: To assess the incidence of malignancies and HIEs in a healthy US population, a psoriasis population, and four treated psoriasis populations.

METHODS: Using a US claims database, we identified a general population, a psoriasis cohort, and four treatment cohorts [non-biologic systemics, etanercept, other TNF blockers (adalimumab, infliximab) and phototherapy] to assess the incidence of lymphomas, nonmelanoma skin cancer (NMSC), all malignancies (excluding NMSC), and HIEs, standardized for age and sex.

RESULTS: Among 40 987 patients with psoriasis, 11% were prescribed non-biologics, 15% etanercept, 6% other TNF blockers and 11% phototherapy. For all cancers, the psoriasis population rate (114/10 000 person-years) was 20% greater than the rate found in the general population (95/10 000 person-years). For NMSC, the psoriasis population rate (129/10 000 person-years) was 65% greater than the general population rate (78/10 000 person-years). The incidence rate for each treatment modality was lower than the overall psoriasis cohort, except for phototherapy. There was little difference in the rates of lymphomas. NMSC rates were higher among patients treated with phototherapy. HIE rates ranged from 165/10 000 person-years for the phototherapy group to 262/10 000 person-years for the other anti-TNF group.

CONCLUSIONS: Patients with psoriasis appear to have higher rates of malignancy and HIE than the general population, with little difference in rates between the treatment methods, except for a higher rate of cancer among those receiving phototherapy.

BACKGROUND: Hidradenitis suppurativa is a chronic, debilitating disease that is difficult to treat. Once medical management fails, wide local excision offers the best chance for cure. However, the resultant wound often proves too large or contaminated for immediate closure.

METHODS: The authors performed a retrospective chart review of hidradenitis cases managed surgically between 2005 and 2010. Data collected included patient characteristics, management method, and outcomes. Approximately half of the patients received internal vacuum-assisted closure therapy using the vacuum-assisted closure system and delayed closure and half of the patients received immediate primary closure at the time of their excision. Delayed closure consisted of closing the majority of the wound in a linear fashion following internal vacuum-assisted closure while accepting healing by means of secondary intention for small wound areas.

RESULTS: Patients managed with internal vacuum-assisted closure had wounds on average four times larger in area than patients managed without internal vacuum-assisted closure. In both groups, all wounds were eventually closed primarily. Healing times averaged 2.2 months with internal vacuum-assisted closure and 2.7 months without. At an average follow-up time of 2.3 months, all patients with internal vacuum-assisted closure had no recurrence of their local disease.

CONCLUSIONS: Severe hidradenitis presents a treatment challenge, as surgical excisions are often complicated by difficult closures and unsatisfactory recurrence rates. This study demonstrates that wide local excision with reasonable outcomes can be achieved using accelerated delayed primary closure. This method uses internal vacuum-assisted closure as a bridge between excision and delayed primary closure, facilitating closure without recurrence in large, heavily contaminated wounds.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

BACKGROUND: Psoriasis symptoms have a significant negative impact on health-related quality of life, impairing physical functioning and well-being.

OBJECTIVE: To evaluate the impact of brodalumab, a human anti-interleukin-17R monoclonal antibody, on psoriasis symptom severity as measured by a novel patient-reported outcome measure, the Psoriasis Symptom Inventory, and dermatology-specific health-related quality of life as measured by the Dermatology Life Quality Index (DLQI).

METHODS: This was a secondary analysis of a phase II, randomized, double-blind, placebo-controlled clinical study of patients with moderate-to-severe psoriasis (n = 198) treated with brodalumab or placebo. This analysis assessed Psoriasis Symptom Inventory scores and DLQI scores over time. Analyses were conducted on all patients who were randomized and received one or more injections of the study drug according to intention to treat using last observation carried forward to impute missing data.

RESULTS: At week 12, subjects in the brodalumab groups had significant improvements in mean Psoriasis Symptom Inventory total scores [8.5 (70 mg), 15.8 (140 mg), 16.2 (210 mg) and 12.7 (280 mg)] compared with placebo (4.8). Mean improvements in DLQI were clinically meaningful (≥ 5.7) in the brodalumab groups (6.2, 9.1, 9.6 and 7.1, respectively) and significantly greater than placebo (3.1). Improvements in Psoriasis Symptom Inventory were observed as early as week 2 and in DLQI by week 4. All eight Psoriasis Symptom Inventory item scores improved significantly among the brodalumab groups by week 12.

CONCLUSIONS: Results were from a single randomized clinical trial and may not generalize to broader patient populations. However, treatment with brodalumab provided significant improvement in psoriasis symptoms in patients with moderate-to-severe psoriasis.

BACKGROUND: The Ferriman-Gallwey hirsutism score is the currently accepted standard for assessing excess hair growth that may indicate hyperandrogenicity. The score was originally based on 60 Caucasian women, and recent studies suggest that it may need modification to be used in other populations.

OBJECTIVES: To investigate ethnic, racial, and pigmentary variations in hair growth of the upper lip in diverse multinational populations.

RESULTS: Variations in hair growth of the upper lip were significantly related to self-reported ethnicity and race. In a logistic regression with racial groups and skin lightness, all racial groupings (African American, Hispanic, Asian Indian, and East Asian) were predictive of hair growth (all p<0.0001), but skin lightness was not (all p>0.05).

CONCLUSION: The observed differences in constitutive hair growth illustrate the need to develop an ethnically stratified visual scoring method to more accurately characterize the severity of excess hair growth.

OBJECTIVE: To determine if algorithmically generated double-booking recommendations could increase patient volume per clinical session without increasing the burden on physicians.

STUDY DESIGN: A randomized controlled trial was conducted with 519 clinical sessions for 13 dermatologists from December 1, 2011, through March 31, 2012.

METHODS: Sessions were randomly assigned to "Smart-Booking," an algorithm that generates double-booking recommendations using a missed appointment (no-shows + same-day cancella- tions) predictive model (c-statistic 0.71), or to a control arm where usual booking rules were applied. The primary outcomes were the average number and variance of arrived patients per session, after controlling by physician. In addition, physicians received a survey after each session to quantify how busy they felt during that session.

RESULTS: 257 sessions were randomized to Smart-Booking and 262 sessions were randomized to control booking. Using a generalized multivariate linear model, the average number of arrived patients per session was higher in the Smart-Booking intervention arm than the control (15.7 vs 15.2, difference between groups 4.2; 95% CI, 0.08-0.75; P = .014).The variance was also higher in the intervention than control (3.72 vs 3.33, P = .38).The survey response rate was 92% and the physicians reported being similarly busy in each study arm.

CONCLUSIONS: Algorithmically generated double-booking recommendations of dermatology clinical sessions using individual physician assumptions and predictive modeling can increase the number of arrived patients without overburdening physicians, and is likely scalable to other settings.

OBJECTIVE: Although not well-understood, dermatologic diseases studied in clinical trials often demonstrate substantial response to placebo. The study objective is to determine if optimism, public self-consciousness and other personality traits predict response to placebo or active treatment in a dermatology clinical trial.

METHODS: A questionnaire was mailed to subjects previously enrolled in a two-center rosacea study who had been randomized to either a treatment or placebo gel. The questionnaire included the Revised Life Orientation Test (LOT-R), the Public Self-Consciousness Scale, and questions to assess personality traits.

RESULTS: Forty-seven subjects out of 83 (57%) returned the questionnaire. There was no statistically significant difference in the LOT-R score in those who responded to placebo versus those who did not (18.08 vs 17.92, P =0.92) nor in those who responded to active treatment versus those who did not (16.27 vs 15.86, P =0.79). There was no statistically sigificant difference in public-self consciousness among placebo or active treatment responders versus non-responders (11.75 vs 10.67, P =0.66; 13.55 vs 14.45, P =0.68). The placebo responders were more likely to report that they were not unusually sensitive to most drugs/medications (X2= 8.33, P =0.004).

CONCLUSION: Although this pilot study is small, there was no meaningful difference in levels of optimism or public self-consciousness among those who responded to placebo. Placebo responders were more likely to report that they were not sensitive to most drugs/medications, raising the possibility that they are actually less likely to detect when they are on medications.

BACKGROUND: Psoriasis is associated with several comorbidities and behavioural risk factors.

OBJECTIVES: To evaluate demographic and disease characteristics in patients enrolled in the Psoriasis Longitudinal Assessment and Registry (PSOLAR).

METHODS: PSOLAR is a global, prospective, longitudinal, disease-based registry that includes a postmarketing commitment to evaluate safety in patients with psoriasis. Enrolled patients had to be receiving, or be eligible to receive, conventional systemic or biological agents. Demographic/disease characteristics, medical histories, lifestyle risk factors and previous treatments are collected at enrolment. Efficacy and safety data are collected every 6 months for 8 years, and data are extracted annually. Selected parameters are evaluated by age quartile using post hoc analyses.

RESULTS: As of 23 August 2012, 11 900 patients were enrolled at 301 sites in North America, Europe and Latin America. Over half of the PSOLAR population (54·7%) is male, with a mean age of 48·6 years and mean body mass index of 30·9 kg m(-2) at enrolment. Mean duration of disease at enrolment was 17·5 years, and mean Physician's Global Assessment score was 2·0. Psoriatic arthritis (35·5%) and cardiovascular diseases (38·2%) were highly prevalent. Diabetes mellitus type II was reported in 11·4% of patients. Depression and anxiety were noted in 14·7% and 11·1% of patients, respectively; 79·0% reported any alcohol use and 56·7% reported smoking or a history of smoking. The occurrence of most comorbidities, including cardiovascular disease and risk factors, increased with age.

CONCLUSIONS: In the PSOLAR population, multiple and age-appropriate comorbidities are associated with psoriasis and may affect the selection of psoriasis treatments.