Treatment of Hidradenitis Suppurativa Evaluation Study (THESEUS): protocol for a prospective cohort study.

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic, painful, inflammatory skin disease with estimates of prevalence in the European population of 1%-2%. Despite being a relatively common condition, the evidence base for management of HS is limited. European and North American management guidelines rely on consensus for many aspects of treatment and within the UK variations in management of HS have been identified. The HS James Lind Alliance Priority Setting Partnership (PSP) published a top 10 list of future HS research priorities including both medical and surgical interventions. The aims of the THESEUS study are to inform the design of future HS randomised controlled trials (RCTs) and to understand how HS treatments are currently used. THESEUS incorporates several HS PSP research priorities, including investigation of oral and surgical treatments. Core outcome domains have been established by the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC) and THESEUS is designed to validate instruments to measure the domains. METHODS AND ANALYSIS: The THESEUS study is a prospective observational cohort study. Participants, adults with active HS of any severity, will be asked to select one of five HS treatment options that is appropriate for their HS care. Participants will be allocated to their chosen treatment intervention and followed for a period of up to 12 months. Outcomes will be assessed at 3-monthly intervals using HISTORIC core outcome instruments. Video recordings of the surgical and laser operations will provide informational and training videos for future trials. Nested mixed-methods studies will characterise the interventions in clinical practice, understand facilitators and barriers to recruitment into future HS RCTs and examine patients' and clinicians' perspectives on HS treatment choices. TRIAL REGISTRATION NUMBER: ISRCTN69985145.

Learning from disease registries during a pandemic: Moving toward an international federation of patient registries.

High-quality dermatology patient registries often require considerable time to develop and produce meaningful data. Development time is influenced by registry complexity and regulatory hurdles that vary significantly nationally and institutionally. The rapid emergence of the coronavirus disease 2019 (COVID-19) global pandemic has challenged health services in an unprecedented manner. Mobilization of the dermatology community in response has included rapid development and deployment of multiple, partially harmonized, international patient registries, reinventing established patient registry timelines. Partnership with patient organizations has demonstrated the critical nature of inclusive patient involvement. This global effort has demonstrated the value, capacity, and necessity for the dermatology community to adopt a more cohesive approach to patient registry development and data sharing that can lead to myriad benefits. These include improved utilization of limited resources, increased data interoperability, improved ability to rapidly collect meaningful data, and shortened response times to generate real-world evidence. We call on the global dermatology community to support the development of an international federation of patient registries to consolidate and operationalize the lessons learned during this pandemic. This will provide an enduring means of applying this knowledge to the maintenance and development of sustainable, coherent, and impactful patient registries of benefit now and in the future.

Measuring the impact of COVID-19 on the quality of life of the survivors, partners and family members: a cross-sectional international online survey.

OBJECTIVE: This study aimed to measure the impact of COVID-19 on the quality of life (QoL) of survivors and their partners and family members. DESIGN AND SETTING: A prospective cross-sectional global online survey using social media. PARTICIPANTS: Patients with COVID-19 and partners or family members (age ≥18 years). INTERVENTION: Online survey from June to August 2020. MAIN OUTCOME MEASURE: The EuroQol group five dimensions three level (EQ-5D-3L) to measure the QoL of survivors of COVID-19, and the Family Reported Outcome Measure (FROM-16) to assess the impact on their partner/family member's QoL. RESULTS: The survey was completed by 735 COVID-19 survivors (mean age=48 years; females=563) at a mean of 12.8 weeks after diagnosis and by 571 partners and 164 family members (n=735; mean age=47 years; females=246) from Europe (50.6%), North America (38.5%) and rest of the world (10.9%). The EQ-5D mean score for COVID-19 survivors was 8.65 (SD=1.9, median=9; range=6-14). 81.1% (596/735) reported pain and discomfort, 79.5% (584/735) problems with usual activities, 68.7% (505/735) anxiety and depression and 56.2% (413/735) problems with mobility. Hospitalised survivors (20.1%, n=148) and survivors with existing health conditions (30.9%, n=227) reported significantly more problems with mobility and usual activities (p<0.05), with hospitalised also experiencing more impact on self-care (p≤0.001). Among 735 partners and family members, the mean FROM-16 score (maximum score=highest impact =32) was 15 (median=15, range=0-32). 93.6% (688/735) reported being worried, 81.7% (601/735) frustrated, 78.4% (676/735) sad, 83.3% (612/735) reported impact on their family activities, 68.9% (507/735) on sleep and 68.1% (500/735) on their sex life. CONCLUSION: COVID-19 survivors reported a major persisting impact on their physical and psychosocial health. The lives of their partners and other family members were also severely affected. There is a need for a holistic support system sensitive to the needs of COVID-19 survivors and their family members who experience a major 'secondary burden'.