Publications

BACKGROUND: Acne is a common disease of the face, chest and back, initially triggered by androgens. 3mg Drospirenone (DRSP)/0.02 mg ethinyl estradiol (EE), an oral contraceptive and antiandrogen, has been effective in treatment studies of facial acne in women, but investigations on its efficacy for truncal acne are limited.<BR>

OBJECTIVE: In this study, we sought to evaluate the safety and efficacy of 3mg DRSP/0.02 mg EE versus placebo in the treatment of truncal acne in women.<BR>

METHODS: Females, age 18-45, with 10 to 50 truncal acne lesions, were randomized in this double-blind study to 3mg DRSP/0.02 mg EE (n=15) or placebo (n=10) administered in a 24/4 regimen given for 24 weeks. Noninflammatory, inflammatory and total truncal acne lesion counts were assessed from baseline to endpoint and mean percent change compared. Investigator Global Assessment (IGA) and Subject Global Assessment (SGA) were assessed based on scoring scales, and the percentage of subjects rated as success with clear (score 0) or almost clear (score 1) were computed.<BR>

RESULTS: The 3mg DRSP/0.02 mg EE group had significant reductions in mean percent change in noninflammatory, inflammatory and total lesions by 52.1%, 53.2%, and 57.3%, respectively, compared to placebo with -9.2%, 18.2% and 17.0 %, respectively, by week 24 (p = 0.02, 0.05 and 0.02, respectively). The percentage of subjects on 3mg DRSP/ 0.02 mg EE rated as treatment success were 53.3% and 60% based on IGA and SGA respectively. The regimen was also well tolerated by patients.<BR>

CONCLUSIONS: 3mg DRSP/ 0.02 mg EE is a safe and significantly effective treatment for moderate truncal acne.

OBJECTIVE: To develop and assess content validity of the Psoriasis Symptom Inventory (PSI), a patient-reported outcome (PRO) measure of psoriasis symptoms.

METHODS: Following initial literature exploration and input from experts, concept elicitation was conducted in two rounds (focus groups and individual interviews) with 59 subjects with mild to severe psoriasis. Transcripts were coded to identify symptom concepts and develop a conceptual framework using ATLAS.ti software. Qualitative content analysis and clinical expert input supported item generation and development of a draft measure. Two rounds of face-to-face cognitive interviews with 40 subjects with moderate to severe psoriasis were conducted to test subject comprehension and content coverage.

RESULTS: Concepts of itching, scaling, flaking, tearing/cracking, burning, stinging, pain, bleeding and color of appearance were the most common symptom-related expressions. Saturation of concept was demonstrated. Severity was identified as the most meaningful attribute of psoriasis symptoms. A final 8-item measure was developed to assess patient-perceived symptom severity for itch, pain, burning, stinging, cracking, scaling, flaking and redness. Twenty-four-hour recall and 7-day recall versions were prepared for future quantitative assessment of measurement properties.

CONCLUSIONS: The PSI is a short, low burden, patient-reported measure of psoriasis symptom severity with documented evidence of content validity.

BACKGROUND: As clinician-patient face time comes under pressure, clinicians might consider substituting testing for time spent in diagnostic reasoning, history, and physical exam.

OBJECTIVES: To explore the relationship between clinician-patient time and medical resource utilization.

METHODS: In the Massachusetts General Hospital/Massachusetts General Physician Organization outpatient radio frequency identification project, clinicians and patients wore real-time location system (RTLS) tags. "Face time" was defined as the duration patients and clinicians were colocated. Radiology testing was used as a proxy for medical resource use. A radiology test was determined to be associated with a clinical encounter if it involved the same patient and clinician and occurred less than 3 months after the index encounter. Radiologic data were derived from the electronic health record and test appropriateness proxy score from the radiology order entry system. Data were synthesized and analyzed using standard structured query language and statistical analysis.

RESULTS: From July 2008 to October 2010, 2086 clinical encounter medical records and RTLSmeasured face times could be associated: 1957 for primary care (PC) and 129 for urgent care (UC). Of these, 471 met study criteria. In PC, shorter face time was associated with more testing, but shorter wait times and flow times. In UC, testing was not associated with shorter face times, but was associated with shorter wait times and longer flow times.

CONCLUSION: Our pilot suggests RTLS can capture face time and trade-offs between face time and testing. Ongoing studies will elucidate how these trade-offs affect patients, clinicians, and healthcare systems.

BACKGROUND: Ongoing evaluation of biological agents in patients with moderate-to-severe psoriasis is needed to support their long-term use.

OBJECTIVE: To evaluate long-term efficacy and safety of ustekinumab through 5 years in the PHOENIX 1 study.

METHODS: Patients were randomized to placebo or ustekinumab (45 mg or 90 mg) at Weeks 0, 4 and every-12-weeks thereafter; placebo patients crossed-over to ustekinumab at Week 12. Clinical response through Week 244 was evaluated using the Psoriasis Area and Severity Index (PASI) in the Overall Population (i.e. patients receiving ≥ 1 dose of ustekinumab), Initial Responders (i.e. PASI 75 responders [Weeks 28/40] re-randomized at Week 40 to continue every-12-week maintenance) and Partial Responders (i.e. <PASI 75 responders adjusted to every-8-week maintenance at Weeks 28 or 40). Safety endpoints were evaluated through Week 264 for the Overall Population.

RESULTS: Overall, 68.7% (517/753) of ustekinumab-treated patients completed treatment through Week 244. Initial clinical responses were generally maintained through Week 244 (PASI 75: 63.4% and 72.0%; PASI 90: 39.7% and 49.0%; PASI 100: 21.6% and 26.4%) for patients receiving 45 mg and 90 mg, respectively. Similarly, PASI 75 responses were generally maintained among Initial Responders [79.1% (45 mg) and 80.8% (90 mg)] and Partial Responders [57.6% (45 mg) and 55.1% (90 mg)]. With 3104 patient-years of follow-up, rates of overall adverse events (AEs), serious AEs, serious infections, malignancies and major adverse cardiovascular events were generally consistent over time and comparable between doses.

CONCLUSIONS: Through 5 years of continuous treatment, ustekinumab demonstrated stable clinical response and a safety profile consistent with previous reports.

PROBLEM: Accountable care organizations (ACOs) emphasize cost-effectiveness, rewarding health care systems that provide the highest-quality care delivered by the most cost-efficient providers. Transitioning to an ACO model introduces distinct challenges for specialist physicians within academic health centers. As skin diseases constitute a large number of visits to primary care providers and specialists and place a significant financial burden on the health care system, the authors sought to identify specialist-driven strategies for cost-effective, patient-centered care delivery in dermatology.

APPROACH: As part of the Massachusetts General Hospital's transition to an ACO, the Department of Dermatology in 2012 employed a team-based strategy to identify measures aimed at curbing the rate of rise in per-patient medical expense. Their approach may represent a methodological framework that translates to other specialist workforces.

OUTCOMES: The authors identified four action areas: (1) rational, cost-conscious prescribing within therapeutic classes; (2) enhanced management of urgent access and follow-up appointment scheduling; (3) procedure standardization; and (4) interpractitioner variability assessment. They describe the practices implemented in these action areas, which include a mix of changes in both clinical decision making and operational practice and are aimed at improving overall quality and value of care delivery. They also offer recommendations for other specialty departments

NEXT STEPS: Involving specialist physicians in care delivery redesign efforts provides unique insights to enhance quality, cost-effectiveness, and efficiency of care delivery. With increasing emphasis on ACO models, further specialist-driven strategies for ensuring patient-centered delivery warrant development alongside other delivery reform efforts.

BACKGROUND: Psoriasis has a profound negative effect on quality of life that is often underappreciated by health care professionals and the public.

OBJECTIVE: We sought to assess the perception of the burden of psoriasis relative to other medical conditions in first-year medical students, and to determine if wearing a temporary tattoo simulating psoriasis during a teaching exercise would change their perceptions.

METHODS: Participants completed a questionnaire assessing their perception of the impact of psoriasis and other common medical conditions (visual analog scale). Participants then wore a temporary tattoo of a psoriatic lesion for 24 hours and completed the same questionnaire after this exercise.

RESULTS: Of 91 students approached, 61 completed the study. At baseline, psoriasis (mean = 23.6) and eczema (mean = 23.3) were perceived as having the lowest physical burden of diseases queried (P < .0001), whereas the mental impact of psoriasis was scored comparably with arthritis, heart disease, and diabetes (mean = 45.1-56.7), but lower than cancer (mean = 82.2) and depression (mean = 93.8). After the exercise, the perception of the impact of eczema (physical: mean = 37.3, P < .0001; mental: mean = 66.6, P = .0005) and psoriasis (physical: mean = 37.8, P = .0014; mental: mean = 68.6, P = .0293) was significantly increased.

LIMITATIONS: The exercise did not simulate the chronic nature of psoriasis or the scaling and pruritic characteristics of psoriatic lesions. The survey instrument used to assess empathy has not been previously validated and statistical analysis was limited by small sample size and the absence of a control group.

CONCLUSIONS: Temporary tattoos are a novel and effective method of teaching medical students about the psychological burden of psoriasis.