Demographic gaps and requirements for participation: A systematic review of clinical trial designs in Hidradenitis Suppurativa

Background: Hidradenitis suppurativa (HS) is a chronic inflammatory disease that disproportionally affects women, as well as Black and biracial individuals. While adalimumab remains the only therapy approved by the Food and Drug Administration for HS, many HS clinical trials for novel and re-tasked therapies are ongoing or upcoming. To optimize treatment equity, reflect the patient population, and facilitate trial participation, it is important to elucidate aspects of clinical trial protocols that may systematically exclude specific patient groups or impose hardships. Objective: The study aimed to systematically review inclusion and exclusion criteria as well as participant demographics in HS clinical trials. Methods: A literature search of PubMed, Embase, Cochrane Central, and Web of Science databases was conducted. Peer-reviewed publications of randomized controlled trials that were written in English and had at least 10 participants were included. Title and abstract screening and data extraction were completed by two independent reviewers, with disagreements resolved by a third. Results: Twenty-three studies totaling 1,496 adult participants met the inclusion criteria. Race and ethnicity were not reported in 473/1,496 (31.6%) and 1,420/1,496 (94.9%) trial participants, respectively. Trial participants were predominantly white (811/1,023, 79.3%) and female (1,057/1,457, 72.5%). The median of each study’s average age was 35.7 years (IQR 33.5–38.0), and 17/23 (73.9%) trials excluded pediatric patients. Nearly all participants had Hurley Stage II (499/958, 52.0%) or Hurley Stage III (385/958, 40.2%) disease. Many trials excluded patients who were pregnant (19/23, 82.6%) and breastfeeding (13/23, 56.5%), or who had HS that was “too severe” (8/23, 34.8%) or “too mild” (16/23, 70.0%). Frequently, trial protocols required prolonged washout periods from HS therapies, relatively long duration in the study’s placebo arm, and prohibited concurrent analgesic use. Conclusions: This systematic review of 23 HS clinical trials totaling 1,496 participants identified substantial hardships imposed by trial participation, high rates of missing race and ethnicity data, and low representation of key patient groups, including those who identify as Black. Future trials with pragmatic study designs, broader inclusion criteria, and study sites in diverse communities may alleviate burdens of trial participation and improve enrollment of diverse patient groups

Examining Some of Students’ Challenges and Use of Algorithmic ProblemSolving Approaches in Electrochemical Titrations

Redox titration problems are considered difficult for students to learn due to their abstract nature, the myriad amount of representations, and the mathematical competency required to learn and solve. The goal of this research project is to examine challenges students face in learning about redox titration-related problems, approaches they use in learning about electrochemical titration problems, and reliance on algorithmic problem-solving instead of conceptual understanding in solving these problems. The research project took place at the City College of New York, which is an urban, minority serving, and public institution. The research instrument used in this research investigation is a survey comprised of Likert-type and open-ended questions. The number of research participants is n = 184. The data was collected and analyzed and histograms and figures were made based on the data analysis. A single factor ANOVA method was performed on the Likert-type questions which showed evidence against the null hypothesis and that shows a strong relationship between variables. The data indicate that the principal barrier to learning about redox titration related problems is that students’ reliance on algorithmic problems solving, rote learning, and mathematical approaches. Students’ dependence on rote learning and memorization in problem solving could be attributed to the lack of well-developed understanding of the concepts. The investigation shows that students focus on surface features in learning and this translates to hindrance of knowledge transfer

Comparison of mental health outcomes among adults with psoriasis on biologic versus oral therapies: a population-based study

<p><b>Purpose:</b> We sought to compare the impact of biologic versus oral therapies on mental health outcomes among adult U.S. residents with moderate-to-severe psoriasis.</p> <p><b>Methods:</b> We performed a nationwide, cross-sectional study comparing 2,303,534 (weighted) adults with moderate-to-severe psoriasis on biologic versus oral therapies and their associated mental health outcomes using the 2003–2015 Medical Expenditure Panel Survey (MEPS). Mental health outcomes were measured with the Kessler 6 (K6), a validated measure of psychological distress, and Patient Health Questionnaire 2 (PHQ2), a screening tool for depression.</p> <p><b>Results:</b> The mean K6 score for residents on biologic therapies was significantly lower than that of residents on oral therapies (2.72 [95% CI: 2.27–3.17] versus 3.70 [95% CI: 3.27–4.12]; <i>p</i> < .001). The mean PHQ2 score for residents on biologic therapies was also significantly lower than that of residents on oral therapies (0.540 [95% CI: 0.390–0.690] versus 0.890 [95% CI: 0.749–1.031]; <i>p</i> < .001). Based on adjusted multivariable linear regression models, biologic therapy was associated with significant reductions in K6 (<i>p</i> < .001) and PHQ2 (<i>p</i> = .016) scores compared to oral therapy.</p> <p><b>Conclusions:</b> Therapeutic choices for psoriasis impact mental health outcomes. Biologic therapy is associated with reductions in psychological distress and depression as compared to oral therapy in the U.S. adult moderate-to-severe psoriasis population.</p

Are Your Patients Satisfied? A Systematic Review of Treatment Satisfaction Measures in Psoriasis

Treatment satisfaction is paramount to the field of dermatology. Treatment dissatisfaction directly impacts patient outcomes and health care delivery. A critical need exists for standardized, validated treatment satisfaction measures in dermatology. Comprehensive evaluation of the performance of treatment satisfaction instruments used in psoriasis is lacking. We sought to critically appraise the literature on measurement properties of treatment satisfaction instruments used in psoriasis. We performed a systematic review to identify treatment satisfaction instruments used in psoriasis and corresponding studies on their measurement properties. We followed the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology to inform a best evidence synthesis. Eleven instruments were identified. Six achieved positive content validity ratings, 2 achieved positive reliability and structural validity ratings, and 1 achieved a positive internal consistency rating. The REFlective evaLuation of psoriasis Efficacy of Treatment and Severity (REFLETS) and the Spanish Satisfaction With Treatment of Psoriasis Questionnaire (SSWTPQ) had the highest overall performance. Measurement property data for treatment satisfaction instruments were found to be insufficient in identifying a single best treatment satisfaction instrument for psoriasis. Additional studies are required to better characterize the measurement properties of treatment satisfaction measures and allow for standardized assessments across psoriasis clinical trials and clinical practice

Examination of Treatment Satisfaction Instruments in Psoriasis: 2017 Results from the Psoriasis Working Group of the International Dermatology Outcome Measures (IDEOM)

BACKGROUND/AIMS: In dermatology clinical trials, assessment of patients\u27 treatment satisfaction is crucial but often lacking. To address this need, IDEOM\u27s Psoriasis Working Group seeks to evaluate, develop, and validate treatment satisfaction instruments for the psoriasis population. The Psoriasis Working Group aimed to determine (1) factors affecting psoriasis patients\u27 satisfaction with their therapies, (2) adequacy of two commonly used generic treatment satisfaction instruments in reflecting the psoriasis patients\u27 perspective, and (3) whether a need exists to develop a new treatment satisfaction instrument. METHODS: Patient perspectives on satisfaction with treatment efficacy, safety, convenience, and overall satisfaction were elicited.Stakeholders were presented with information regarding the feasibility and content validity of two generic treatment instruments, the Treatment Satisfaction Questionnaire for Medication (TSQM) and the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q). We conducted a nominal group discussion and survey to determine whether stakeholders considered these instruments feasible and adequate to address treatment satisfaction for psoriasis therapies. RESULTS: Forty-five stakeholders participated in the nominal group discussion and survey. 53% of participants voted that the TSQM and SATMED-Q are not adequate and that we should create a new dermatology-specific treatment satisfaction instrument. Patients and other stakeholders also provided feedback on aspects of treatment satisfaction important to them. These include speed of onset and durability of therapeutic effect of a medication, permanence of side effects, and convenience of administering the medication. CONCLUSION: Stakeholders, including patients and providers, determined that generic treatment satisfaction questionnaires are not adequate to evaluate treatment satisfaction in psoriasis patients

A Provider Global Assessment Quality Measure for Clinical Practice for Inflammatory Skin Disorders

In our evolving health care system, dermatologists are increasingly being asked to prove the value of care they provide to patients with severe skin diseases. Current quality measures for inflammatory dermatoses have limited validity and feasibility. Through collaboration and a modified Delphi process, International Dermatology Outcome Measures and the American Academy of Dermatology sought to reach consensus on a valid and feasible provider-assessed global disease severity metric to be incorporated into a quality measure for inflammatory dermatoses. To inform the modified Delphi process, a review of the literature was performed, and data were collected on current provider-assessed global disease severity metrics. After literature review, 36 members of International Dermatology Outcome Measures and the American Academy of Dermatology participated in the modified Delphi process to reach consensus on features of the metric. Psoriasis, atopic dermatitis, and acne achieved overwhelming consensus for inflammatory dermatoses that could be measured in a global disease severity metric. Consensus was also reached on the use of a 5-point ordinal scale with descriptors provided through referenced electronic platforms. Expert development of quality measures incorporating this metric and its inclusion in data collection platforms are critical to enabling dermatologists to prove the value of care provided to patients with severe inflammatory dermatoses