OBJECTIVES: Risky alcohol use before surgery is associated with an increased risk of postoperative complications and longer hospital stays. Preoperative alcohol interventions can improve surgical outcomes but are not commonly integrated into routine care. This study sought to better understand patient's and provider's perceptions of alcohol-related surgical health and healthcare practices and illuminate gaps in care and how they could be improved. METHODS: This study used a descriptive qualitative research design. Data were collected between July 2017 and March 2018. One-on-one interviews assessed domains related to knowledge, gaps in alcohol-related screening and intervention, and interest in enhancing alcohol-related care. Key themes emerged from a process of iterative coding and thematic analysis. RESULTS: Participants included elective surgical patients who met alcohol screening criteria (n = 20) and surgical healthcare providers (n = 9). Participants had modest or low awareness of alcohol-related surgical health risks. Basic alcohol screening was a routine part of care, but results were often discounted or overlooked. Providers did not routinely initiate preoperative alcohol education or intervention. Providers viewed improving alcohol-related clinical practices as a low priority. Patients were interested in receiving alcohol interventions before surgery if they were delivered in a nonjudgement style and focused on surgical health optimization. CONCLUSIONS: This study highlights potential gaps in alcohol-related knowledge and care, and found providers place a low priority on alcohol interventions in the perioperative context. Given the high complication rate associated with preoperative alcohol use, these topics are worthy of future research. To be successful strategies to overcome specific barriers to alcohol screening and intervention must address the needs of patients and providers.

BACKGROUND: Underreporting of harms in randomized controlled trials (RCTs) may lead to incomplete or erroneous assessments of the perceived benefit-to-harm profile of an intervention. To compare benefit with harm in clinical practice and future clinical studies, adverse event (AE) profiles including severity need to be understood. Even though patients report harm symptoms earlier and more frequently than clinicians, rheumatology RCTs currently do not provide a reporting framework from the patient's perspective regarding harms. Our objective for this meta-research project was to identify AEs in order to determine harm clusters and whether these could be self-reported by patients. Our other objective was to examine reported severity grading of the reported harms.

METHODS: We considered primary publications of RCTs eligible if they were published between 2008 and 2018 evaluating pharmacological interventions in patients with a rheumatic or musculoskeletal condition and if they were included in Cochrane reviews. We extracted data on harms such as reported AE terms together with severity (if described), and categorized AE- and severity-terms into overall groups. We deemed all AEs with felt components appropriate for patient self-reporting.

RESULTS: The literature search identified 187 possible Cochrane reviews, of which 94 were eligible for evaluation, comprising 1,297 articles on individual RCTs. Of these RCTs, 93 pharmacological trials met our inclusion criteria (including 31,023 patients; representing 20,844 accumulated patient years), which reported a total of 21,498 AEs, corresponding to 693 unique reported terms for AEs. We further sub-categorized these terms into 280 harm clusters (i.e., themes). AEs appropriate for patient self-reporting accounted for 58% of the AEs reported. Among the reported AEs, we identified medical terms for all of the 117 harm clusters appropriate for patient reporting and lay language terms for 86%. We intended to include severity grades of the reported AEs, but there was no evidence for systematic reporting of clinician- or patient-reported severity in the primary articles of the 93 trials. However, we identified 33 terms suggesting severity, but severity grading was discernible in only 9%, precluding a breakdown by severity in this systematic review.

CONCLUSIONS: Our results support the need for a standardized framework for patients' reporting of harms in rheumatology trials. Reporting of AEs with severity should be included in future reporting of harms, both from the patients' and investigators' perspectives.

REGISTRATION: PROSPERO: CRD42018108393.

BACKGROUND: Recovery of consciousness is the most important survival factor in patients with acute brain injury and disorders of consciousness (DoC). Since most deaths in the intensive care unit (ICU) occur after withdrawal of life-support, medical decision-making is crucial for acute DoC patients. Neuroimaging informs decision-making, yet the precise effects of MRI on decision-making in the ICU are poorly understood. We investigated the impact of brain MRI on prognostication, therapeutic decisions and physician confidence in ICU patients with DoC.

METHODS: In this simulated decision-making study utilizing a prospective ICU cohort, a panel of neurocritical experts first reviewed clinical information (without MRI) from 75 acute DoC patients and made decisions about diagnosis, prognosis and treatment. Following review of the MRI, the panel then decided if the initial decisions needed revision. In parallel, a blinded neuroradiologist reassessed all neuroimaging.

RESULTS: MRI led to changes in clinical management of 57 (76%) of patients (Number-Needed-to-Test for any change: 1.32), including revised diagnoses (20%), levels of care (21%), diagnostic confidence (43%) and prognostications (33%). Decisions were revised more often with stroke than with other brain injuries (p = 0.02). However, although MRI revealed additional pathology in 81%, this did not predict revised clinical decision-making (p-values ≥0.08).

CONCLUSION: MRI results changed decision-making in 3 of 4 ICU patients, but radiological findings were not predictive of clinical decision-making. This highlights the need to better understand the effects of neuroimaging on management decisions. How MRI influences decision-making in the ICU is an important avenue for research to improve acute DoC management.

OBJECTIVE: Our primary objective was to develop an Outcome Measures in Rheumatology (OMERACT) core domain set to capture the impact of glucocorticoids (GC), both positive and negative, on patients with Rheumatic conditions.

METHODS: The OMERACT Filter 2.1 was used to guide core domain selection. Systematic literature reviews, qualitative studies and quantitative surveys were conducted by the OMERACT GC Impact working group to identify candidate domains for a core domain set. A summary of prior work and Delphi exercise were presented at the OMERACT 2020 virtual GC workshop. A proposed GC Impact core domain set derived from this work was presented for discussion in facilitated breakout groups. Participants voted on the proposed GC Impact core domain set.

RESULTS: 113 people, including 23 patient research partners, participated in two virtual workshops conducted at different times on the same day. The proposed mandatory domains to be evaluated in clinical trials involving GCs were: infection, bone fragility, hypertension, diabetes, weight, fatigue, mood disturbance and death. In addition, collection of disease specific outcomes was included in the core domain set as "mandatory in specific circumstances". The proposed core domain set was endorsed by 100% (23/23) of the patient research partners and 92% (83/90) of the remaining participants, including clinicians, researchers and industry stakeholders.

CONCLUSION: A GC Impact core domain set was endorsed at the OMERACT 2020 virtual workshop. The OMERACT GC Impact working group will now progress to identify, develop and validate measurement tools to best address these domains in clinical trials.

OBJECTIVES: To investigate if patients with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) have an increased risk of cancer compared with the general population, and furthermore to identify specific cancer types associated with increased risk.

METHODS: This is an observational cohort study of 5310 patients with CLE or SLE identified in the Danish National Patient Register from 1 January 1995 to 31 December 2014. The cohort was followed up for cancer by linkage to the Danish Cancer Registry. Based on the age, sex, and calendar specific cancer rates of the general population of Denmark, standardised incidence ratios (SIRs) were calculated.

RESULTS: The patients with CLE or SLE were followed for 40.724 person-years, each group's average duration of follow-up being 6.9 and 8.1 years. The SIR for overall cancer (except non-melanoma skin cancer (NMSC)) was increased in patients with CLE 1.35 (95%CI 1.15 to 1.58) and patients with SLE 1.45 (95%CI 1.30 to 1.62). Both groups had high risks of hematological - including a 3-4-fold increased risk of non-Hodgkin lymphoma -, pancreatic, and lung cancers. Several cancers associated with oncogenic viruses as liver and tongue/mouth/pharynx were increased in the SLE group, while the risk of ovarian cancer was increased 2-4-fold only in the CLE group.

CONCLUSION: The overall risk of cancer was significantly increased in both patients with CLE and SLE. SIRs for hematological, pancreatic and lung cancers were elevated in both groups. Extra awareness of cancer in patients with SLE and patients with CLE should be considered.

OBJECTIVES: To assess secular trends in baseline characteristics of PsA patients initiating their first or subsequent biologic DMARD (bDMARD) therapy and to explore prescription patterns and treatment rates of bDMARDs from 2006 to 2017 in the Nordic countries.

METHODS: PsA patients registered in the Nordic rheumatology registries initiating any treatment with bDMARDs were identified. The bDMARDs were grouped as original TNF inhibitor [TNFi; adalimumab (ADA), etanercept (ETN) and infliximab (IFX)]; certolizumab pegol (CZP) and golimumab (GOL); biosimilars and ustekinumab, based on the date of release. Baseline characteristics were compared for the five countries, supplemented by secular trends with R2 calculations and point prevalence of bDMARD treatment.

RESULTS: A total of 18 089 patients were identified (Denmark, 4361; Iceland, 449; Norway, 1948; Finland, 1069; Sweden, 10 262). A total of 54% of the patients were female, 34.3% of patients initiated an original TNFi, 8% CZP and GOL, 7.5% biosimilars and 0.3% ustekinumab as a first-line bDMARD. Subsequent bDMARDs were 25.2% original TNFi, 9% CZP and GOL, 12% biosimilars and 2.1% ustekinumab. From 2015 through 2017 there was a rapid uptake of biosimilars. The total of first-line bDMARD initiators with lower disease activity increased from 2006 to 2017, where an R2 close to 1 showed a strong association.

CONCLUSION: Across the Nordic countries, the number of prescribed bDMARDs increased from 2006 to 2017, indicating a previously unmet need for bDMARDs in the PsA population. In recent years, PsA patients have initiated bDMARDs with lower disease activity compared with previous years, suggesting that bDMARDs are initiated in patients with a less active inflammatory phenotype.