Understanding potential participation barriers to improve trial design and outcomes: clinical trial simulation in palmoplantar pustulosis as a case study.

OBJECTIVES: Evaluate the experiences and perceptions of patients participating in a simulated clinical trial and identify ways to enhance future patient-centric trial designs. DESIGN: International, multicentre, non-interventional, virtual clinical trial visits with patient debriefs and advisory boards. SETTING: Virtual clinic visits and accompanying advisory boards. PARTICIPANTS: Nine patients with palmoplantar pustulosis for simulated trial visits; 14 patients and patient representatives for advisory boards. MAIN OUTCOME MEASURES: Qualitative responses to trial documentation, visit schedule and logistics, and trial design were collected during patient debriefs. Results were discussed at two virtual advisory board meetings. RESULTS: Patients identified key barriers to participation and potential difficulties encountered when attending trial visits and completing assessments. They also proposed recommendations to overcome these challenges. Patients recognised the need for comprehensive informed consent forms, but recommended use of non-technical language, brevity and additional support to aid understanding. Other trial documentations should be relevant to the disease and include known efficacy and safety of the study drug. Patients were concerned about receiving placebo, stopping existing medications and being unable to receive the study drug after trial completion; therefore, patients and physicians recommended an open-label extension following trial completion. Trial visits were too numerous (n=20) and too long (3-4 hours each); patients recommended improvements to the design to make best use of their time and reduce unnecessary waiting. They also requested financial and logistical support. Patients expressed a desire for study outcomes that matter to them, related to their ability to undertake normal daily activities and not be a burden to others. CONCLUSIONS: Simulated trials are an innovative method for assessing trial design and acceptance from a patient-centric perspective, enabling specific improvements to be made prior to trial initiation. Incorporation of recommendations from simulated trials could enhance trial recruitment and retention, and optimise trial outcomes and data quality.

Likelihood of COVID-19 Vaccination Among Individuals Living With Psoriatic Disease: Results From a Large Real-World Survey

Introduction: Development and dissemination of novel COVID-19 vaccines represent an opportunity to end the COVID-19 pandemic by vaccinating an estimated 80% of the population. Objectives: This study examines perceptions, and demographic and clinical factors influencing the likelihood of adults with psoriasis receiving a novel COVID-19 vaccine. Methods: A cross sectional study conducted from October?November 2020 of 1405 adults with psoriatic disease with prior contact to a patient advocacy organization. The main outcome of interest was the likelihood of receiving a COVID-19 vaccine. Chi-square tests and logistic regression examined the relationship between individual characteristics and likelihood of receiving a COVID-19 vaccine. Results: Most participants (65%) received a flu vaccination in the last 12 months and were (64.2%) likely to receive a COVID-19 vaccine, while 35.9% reported being unlikely receive a vaccine. Likelihood of COVID-19 vaccination was associated with receiving the flu vaccine, race, ethnicity, sex, BMI, age, income, severity of PsO and PsA. When controlling for ethnicity, race, male sex, overweight/obese status, age, biologic use, disease type, comorbidities linked with worse COVID-19 outcomes, PsA symptoms, and skin disease severity, individuals who received the flu vaccine and those with annual household income over $75,000 were most likely to receive a COVID-19 vaccine. Conclusions: Vaccine hesitancy among individuals with psoriatic disease is considerable. Dermatologists and rheumatologists can increase COVID-19 vaccine uptake by actively engaging their patients on this topic using guidance published by the National Psoriasis Foundation on the management of psoriatic disease during the COVID-19 pandemic.

National Psoriasis Foundation COVID-19 Task Force guidance for management of psoriatic disease during the pandemic: Version 2-Advances in psoriatic disease management, COVID-19 vaccines, and COVID-19 treatments.

OBJECTIVE: To update guidance regarding the management of psoriatic disease during the COVID-19 pandemic. STUDY DESIGN: The task force (TF) includes 18 physician voting members with expertise in dermatology, rheumatology, epidemiology, infectious diseases, and critical care. The TF was supplemented by nonvoting members, which included fellows and National Psoriasis Foundation staff. Clinical questions relevant to the psoriatic disease community were informed by inquiries received by the National Psoriasis Foundation. A Delphi process was conducted. RESULTS: The TF updated evidence for the original 22 statements and added 5 new recommendations. The average of the votes was within the category of agreement for all statements, 13 with high consensus and 14 with moderate consensus. LIMITATIONS: The evidence behind many guidance statements is variable in quality and/or quantity. CONCLUSIONS: These statements provide guidance for the treatment of patients with psoriatic disease on topics including how the disease and its treatments affect COVID-19 risk, how medical care can be optimized during the pandemic, what patients should do to lower their risk of getting infected with severe acute respiratory syndrome coronavirus 2 (including novel vaccination), and what they should do if they develop COVID-19. The guidance is a living document that is continuously updated by the TF as data emerge.

National Psoriasis Foundation COVID-19 Task Force Guidance for Management of Psoriatic Disease During the Pandemic: Version 1.

OBJECTIVE: To provide guidance about management of psoriatic disease during the coronavirus disease 2019 (COVID-19) pandemic. STUDY DESIGN: A task force (TF) of 18 physician voting members with expertise in dermatology, rheumatology, epidemiology, infectious diseases, and critical care was convened. The TF was supplemented by nonvoting members, which included fellows and National Psoriasis Foundation (NPF) staff. Clinical questions relevant to the psoriatic disease community were informed by questions received by the NPF. A Delphi process was conducted. RESULTS: The TF approved 22 guidance statements. The average of the votes was within the category of agreement for all statements. All guidance statements proposed were recommended, 9 with high consensus and 13 with moderate consensus. LIMITATIONS: The evidence behind many guidance statements is limited in quality. CONCLUSION: These statements provide guidance for the management of patients with psoriatic disease on topics ranging from how the disease and its treatments impact COVID-19 risk and outcome, how medical care can be optimized during the pandemic, what patients should do to lower their risk of getting infected with severe acute respiratory syndrome coronavirus 2 and what they should do if they develop COVID-19. The guidance is intended to be a living document that will be updated by the TF as data emerge.