Development and validation of a self-updating gout register from electronic health records data.

OBJECTIVE: To develop an automatic gout register from electronic health records (EHRs) data. METHODS: We analysed the EHR of all patients >18 years old from a tertiary academic hospital (2013-2022) based on six criteria: International Classification of Diseases 10 gout diagnosis, urate-lowering therapy prescription, monosodium urate crystals in joint aspiration and gout-related terms in problem lists, clinical or imaging reports. We assessed the positive and negative predictive value (PPV and NPV) of the query by chart reviews. RESULTS: Of 2 110 902 outpatients and inpatients, 10 289 had at least one criterion for gout. The combination of joint aspiration OR diagnostic in the problem list OR≥2 other criteria created a register of 5138 patients, with a PPV of 92.4% (95% CI 88.5% to 95.0%) and an NPV of 94.3% (95% CI 91.9% to 96.0%). PPV and NPV were similar among outpatients and inpatients. Incidence was 2.9 per 1000 person-year and dropped by 30% from the COVID-19 pandemic onward. Patients with gout were on average 71.2 years old (SD 14.9), mainly male (76.5%), overweight (69.5%) and polymorbid (mean number of comorbidities of 3, IQR 1-5). More than half (57.4%) had received a urate-lowering treatment, 6.7% had a gout that led to a hospitalisation or ≥2 flares within a year and 32.9% received a rheumatology consultation. CONCLUSION: An automatic EHR-based gout register is feasible, valid and could be used to evaluate and improve gout management. Interestingly, the register uncovered a marked underdiagnosis or under-reporting of gout since the COVID-19 pandemic.

Comparative effectiveness of baricitinib and alternative biological DMARDs in a Swiss cohort study of patients with RA.

OBJECTIVES: This observational study compares the effectiveness of baricitinib (BARI), a targeted synthetic disease-modifying antirheumatic drug (tsDMARD), with alternative biological DMARDs (bDMARDs) in patients with rheumatoid arthritis (RA), from a prospective, longitudinal cohort. METHODS: We compared patients initiating a treatment course (TC) of BARI, tumour necrosis factor inhibitors (TNFi) or bDMARDs with other modes of action (OMA), during a period when all these DMARDs were available in Switzerland. The primary outcome was drug maintenance; secondary outcomes included discontinuation rates related specifically to ineffectiveness and adverse events. We further analysed rates of low disease activity (LDA) and remission (REM) at 12 months and drug maintenance in bDMARD-naïve and tsDMARD-naïve population. RESULTS: A total of 1053 TCs were included: 273 on BARI, 473 on TNFi and 307 on OMA. BARI was prescribed to older patients with longer disease duration and more previous treatment failures than TNFi. Compared with BARI, the adjusted drug maintenance was significantly shorter for TNFi (HR for discontinuation: 1.76; 95% CI, 1.32 to 2.35) but not compared with OMA (HR 1.27; 95% CI, 0.93 to 1.72). These results were similar in the b/tsDMARD-naïve population. The higher discontinuation of TNFi was mostly due to increased discontinuation for ineffectiveness (HR 1.49; 95% CI, 1.03 to 2.15), with no significant differences in drug discontinuation for adverse events (HR 1.46; 95% CI, 0.83 to 2.57). The LDA and REM rates at 12 months did not differ significantly between the three groups. CONCLUSIONS: BARI demonstrated a significantly higher drug maintenance compared with TNFi, mainly due to lower drug discontinuations for ineffectiveness. We found no difference in drug maintenance between BARI and OMA. Clinical outcomes did not differ between the three groups. Our results suggest that BARI is an appropriate therapeutic alternative to bDMARDs in the management of RA.

Validation of French versions of the 15-item picker patient experience questionnaire for adults, teenagers, and children inpatients.

Objectives: No French validated concise scales are available for measuring the experience of inpatients in pediatrics. This study aims to adapt the adult PPE-15 to a pediatric population, and translating it in French, as well as to establish reference values for adults, teenagers, and parents of young children. Methods: Cultural adaptation involved forward and backward translations, along with pretests in all three populations. Dimensional structure and internal consistency were assessed using principal component analysis, exploratory factor analysis, and Cronbach's alpha. Construct validity was assessed by examining established associations between patient satisfaction and inpatient variables, including length of stay, and preventable readmission. Results: A total of 25,626 adults, 293 teenagers and 1,640 parents of young children completed the French questionnaires. Factor analysis supported a single dimension (Cronbach's alpha: adults: 0.85, teenagers: 0.82, parents: 0.80). Construct validity showed the expected pattern of association, with dissatisfaction correlating with patient- and stay-related factors, notably length of stay, and readmission. Conclusion: The French versions of the PPE-15 for adults, teenagers and parents of pediatric patients stand as valid and reliable instruments for gauging patient satisfaction regarding their hospital stay after discharge.

Comparison of patients with isolated cutaneous lupus erythematosus versus systemic lupus erythematosus with cutaneous lupus erythematosus as the sole clinical feature: A monocentric study of 149 patients.

BACKGROUND: Cutaneous lupus erythematosus (CLE) may present as an isolated entity or be classified as Systemic lupus erythematosus (SLE) by the presence of laboratory abnormalities, including cytopenia, low complement levels, and/or autoantibodies (CLE with laboratory SLE). OBJECTIVE: To compare isolated CLE and CLE with laboratory SLE and to validate an existing 3-item score with age < 25 years (1 point), phototypes V to VI (1 point), antinuclear antibodies ≥ 1:320 (5 points) to predict the risk of progression from CLE to severe SLE (sSLE). METHODS: Monocentric cohort study including consecutive patients with CLE. CLE with laboratory SLE was defined by 2019 American College of Rheumatology/European League Against Rheumatism classification criteria for SLE score of ≥10 points at baseline with CLE as the sole clinical feature. RESULTS: Of the 149 patients with CLE, 20 had CLE with laboratory SLE. The median follow-up duration was 11.3 years (IQR: 5.1-20.5). Ten patients (7%) had sSLE developed. In survival analysis, the risk of progression to sSLE was higher among CLE with laboratory SLE (hazard ratio = 6.69; 95% CI: 1.93-23.14, P < .001) compared to isolated CLE. In both groups, none of the patients with a risk score ≤ 2 had sSLE developed. LIMITATIONS: Monocentric study with a limited number of patients. CONCLUSIONS: CLE with laboratory patients with SLE have a higher risk of progression to sSLE than isolated CLE.

Development and validation of the physical effort scale (PES).

OBJECTIVES: Previous literature has primarily viewed physical effort as an aversive experience. However, recent research suggests that effort can also be valued positively. These differences in approach and avoidance tendencies toward physical effort may play a key role in the self-regulation of physical activity behaviors. The aim of this study was to develop a scale that measures these tendencies and contributes to a better understanding of physical effort and how it affects behavior. METHODS: The Physical Effort Scale (PES) was developed in Study 1 based on expert evaluations (n = 9) and cognitive interviews (n = 10). In Study 2 (n = 680, 69% female), content validity and dimensional structure were examined using principal component analysis and confirmatory factor analysis. Item reduction was conducted using item response theory. Preliminary construct validity was explored using regression. Study 3 (n = 297, 71% female) was used to validate dimensional structure, internal consistency, and construct validity, and to assess test-retest reliability. RESULTS: In Study 1, 44 items were rated for content validity, of which 18 were selected and refined based on cognitive interviews. Analyses from Study 2 allowed reducing the scale to 8 items with a two-dimension structure: tendency to approach (n = 4) and to avoid physical effort (n = 4). The two subscales showed high internal consistency (α = 0.897 for the approach dimension and 0.913 for the avoidance dimension) and explained usual levels of physical activity, providing preliminary evidence of construct validity. Study 3 confirmed the two-dimension structure with high internal consistency (α = 0.907 and 0.916 for the approach and avoidance dimension, respectively) and revealed acceptable test-retest reliability (intraclass correlation >0.66). Patterns of associations with other constructs showed expected relationships, confirming the concurrent, convergent, and discriminant validity of the scale. CONCLUSIONS: The PES is a valid and reliable measure of individual differences in the valuation of physical effort. This scale can assess the propensity to engage in physically demanding tasks in non-clinical populations. The PES and its manual are available in the Supplementary Material.

Oral glucocorticoid use in patients with rheumatoid arthritis initiating TNF-inhibitors, tocilizumab or abatacept: Results from the international TOCERRA and PANABA observational collaborative studies.

OBJECTIVE: To evaluate and compare the use of oral glucocorticoids with three classes of bDMARDs in patients with rheumatoid arthritis (RA). METHODS: We included patients from 13 observational registries treated with a TNF-inhibitor, abatacept or tocilizumab and with available information on the use of oral glucocorticoids. The main outcome was oral glucocorticoid withdrawal. A McNemar test was used to analyse the change in the use of glucocorticoids after 1 year. Kaplan-Meier estimates and Cox regressions, adjusted for patient, treatment, and disease characteristics, were used to evaluate glucocorticoid discontinuation in patients with glucocorticoids at baseline. Because of heterogeneity, analyses were done by registers and pooled using random-effects meta-analysis. RESULTS: A total of 12,334 participants treated with TNF-inhibitors, 2100 with tocilizumab and 3229 with abatacept were included. At one-year, oral glucocorticoid use decreased in all treatment groups (odds ratio for stopping vs. starting of 2.19 [95% CI 1.58; 3.04] for TNF-inhibitors, 2.46 [1.39; 4.35] for tocilizumab; 1.73 [1.25; 2.21] for abatacept). Median time to glucocorticoid withdrawal was ≈2 years or more in most countries, with a gradual decrease over time. Compared to TNF-inhibitors, crude hazard ratios of glucocorticoid discontinuation were 0.65[0.48-0.87] for abatacept, and 1.04 [0.76-1.43] for tocilizumab, and adjusted hazard ratios were 1.1 [0.83-1.47] for abatacept, and 1.30 [0.96-1.78] for tocilizumab. CONCLUSION: After initiation of a bDMARD, glucocorticoid use decreased similarly in all treatment groups. However, glucocorticoid withdrawal was much slower than advocated by current international guidelines. More effort should be devoted to glucocorticoid tapering when low disease activity is achieved.

A potential role for chlamydial infection in rheumatoid arthritis development.

OBJECTIVES: To assess the relationship between self-reported and serologic evidence of prior chlamydial infection, rheumatoid arthritis (RA)-related autoantibodies and risk of RA-development. METHODS: This is a nested study within a prospective Swiss-based cohort including all first-degree relatives of RA patients (RA-FDR) who answered a question on past chlamydial infections. Primary outcome was systemic autoimmunity associated with RA (RA-autoimmunity) defined as positivity for anti-citrullinated peptide antibodies (ACPA) and/or rheumatoid factor (RF). Secondary outcomes were high levels of RA-autoimmunity, RA-associated symptoms and RA-autoimmunity, and subsequent seropositive RA diagnosis. We conducted a nested case-control analysis by measuring the serological status against Chlamydia trachomatis' major outer membrane protein. We replicated our analysis in an independent United States-based RA-FDR cohort. RESULTS: Among 1231 RA-FDRs, 168 (13.6%) developed RA-autoimmunity. Prevalence of self-reported chlamydial infection was significantly higher in individuals with RA-autoimmunity compared with controls (17.9% vs 9.8%, OR = 2.00, 95%CI: 1.27-3.09, p < 0.01). This association remained significant after adjustments (OR = 1.91, 95%CI: 1.20-2.95). Stronger effect sizes were observed in later stages of RA development. There was a similar trend between a positive C. trachomatis serology and high levels of RA-autoimmunity (OR = 3.05, 95% CI: 1.10-8.46, p= 0.032). In the replication cohort, there were significant associations between chlamydial infection and RF positivity and incident RA, but not anti-CCP positivity. CONCLUSIONS: Self-reported chlamydial infections are associated with elevated RA-autoimmunity in at risk individuals. The differing association of chlamydial infections and ACPA/RF between cohorts will need to be explored in future studies but is consistent with a role of mucosal origin of RA-related autoimmunity.

When Illegitimate Tasks Threaten Patient Safety Culture: A Cross-Sectional Survey in a Tertiary Hospital.

Objectives: The current study investigates the prevalence of illegitimate tasks in a hospital setting and their association with patient safety culture outcomes, which has not been previously investigated. Methods: We conducted a cross-sectional survey in a tertiary referral hospital. Patient safety culture outcomes were measured using the Hospital Survey on Patient Safety Culture questionnaire; the primary outcome measures were a low safety rating for the respondent's unit and whether the respondent had completed one or more safety event reports in the last 12 months. Analyses were adjusted for hospital department and staff member characteristics relating to work and health. Results: A total of 2,276 respondents answered the survey (participation rate: 35.0%). Overall, 26.2% of respondents perceived illegitimate tasks to occur frequently, 8.1% reported a low level of safety in their unit, and 60.3% reported having completed one or more safety event reports. In multivariable analyses, perception of a higher frequency of illegitimate tasks was associated with a higher risk of reporting a low safety rating and with a higher chance of having completed event reports. Conclusion: The prevalence of perceived illegitimate tasks was rather high. A programme aiming to reduce illegitimate tasks could provide support for a causal effect of these tasks on safety culture outcomes.

COVID-19 Vaccination Rate under Different Political Incentive: A Counterfactual Trend Approach Using Nationwide Data.

(1) Background: France implemented a COVID-19 certificate in July 2021 to incentivize the population to uptake COVID-19 vaccines. However, little is known about the variation in its impact across age groups and its dependence on socio-demographic, economic, logistic, or political factors. (2) Methods: Using France's weekly first dose vaccination rate, a counterfactual trend approach allowed for the estimation of the vaccination rate across age groups at a small geographical level before and after the implementation of the health pass. The effect of the health pass was operationalized as the vaccination rate among those who would not be vaccinated without it. (3) Results: Vaccination before the health pass varied greatly among age groups and was mainly influenced by territory (lower in rural and overseas territories when compared to urban and metropolitan ones), political beliefs, and socio-economic disparities. Vaccine logistics played a minor but significant role, while the impact of COVID-19 did not affect the vaccination rate. The health pass increased the vaccination overall but with varying efficiency across groups. It convinced mainly young people politically close to the governmental vaccination strategy and living in urban metropolitan areas with low socio-economical discrepancies. The selected variables explained most of the variability of the vaccination rate before the health pass; they explained, at most, a third of the variation in the health pass effect on vaccination. (4) Conclusions: From a public health perspective, the French health pass increased the overall vaccination, but failed to promote preventive behaviours in all segments of society, particularly in vulnerable communities.

Time to Publication and Time-Lag Publication Bias for Randomized Trials on Connective Tissue Diseases.

OBJECTIVE: To assess the time from completion to publication of randomized controlled trials (RCTs) on connective tissue diseases (CTDs), investigate the factors associated with, and explore the influence of significance of study results on time to publication (time-lag publication bias). METHODS: We included interventional, phase 2/3, 3, or 4 RCTs on CTDs registered in Clinicaltrials.gov from 2000 to 2016, whose results had been published in a peer-review journal less than 5 years after their completion. Main trial features, including the significance of primary outcome results, were collected. Time to publication was the time from study completion to the earliest publication date. Multivariable linear regression was used to identify factors associated with time to publication. RESULTS: We included 62 studies, mostly phase 3 (61%) trials on pharmacologic treatments (94%); we recruited patients with systemic lupus (55%) or systemic sclerosis (23%) and planned to enroll a median of 131 (IQR [interquartile range]: 61-288) patients. Twenty-two (35%) reported at least a statistically significant primary outcome. Median time to publication was 28 months (IQR: 17-36). In a multivariable analysis, time to publication progressively improved over time (faster publication in recent years, with the average time to publication decreasing by 1.3 [95% CI: 0.3-2.3] months per year) and was not influenced by the significance of primary outcome results, funder, impact factor of the journal, number of recruiting countries, and comparator. CONCLUSION: A high proportion of CTDs-RCTs is published beyond 2 years from completion. We did not find evidence of time-lag publication bias, and time to publication improved over time.

Deep learning diagnostic and severity-stratification for interstitial lung diseases and chronic obstructive pulmonary disease in digital lung auscultations and ultrasonography: clinical protocol for an observational case-control study.

BACKGROUND: Interstitial lung diseases (ILD), such as idiopathic pulmonary fibrosis (IPF) and non-specific interstitial pneumonia (NSIP), and chronic obstructive pulmonary disease (COPD) are severe, progressive pulmonary disorders with a poor prognosis. Prompt and accurate diagnosis is important to enable patients to receive appropriate care at the earliest possible stage to delay disease progression and prolong survival. Artificial intelligence-assisted lung auscultation and ultrasound (LUS) could constitute an alternative to conventional, subjective, operator-related methods for the accurate and earlier diagnosis of these diseases. This protocol describes the standardised collection of digitally-acquired lung sounds and LUS images of adult outpatients with IPF, NSIP or COPD and a deep learning diagnostic and severity-stratification approach. METHODS: A total of 120 consecutive patients (≥ 18 years) meeting international criteria for IPF, NSIP or COPD and 40 age-matched controls will be recruited in a Swiss pulmonology outpatient clinic, starting from August 2022. At inclusion, demographic and clinical data will be collected. Lung auscultation will be recorded with a digital stethoscope at 10 thoracic sites in each patient and LUS images using a standard point-of-care device will be acquired at the same sites. A deep learning algorithm (DeepBreath) using convolutional neural networks, long short-term memory models, and transformer architectures will be trained on these audio recordings and LUS images to derive an automated diagnostic tool. The primary outcome is the diagnosis of ILD versus control subjects or COPD. Secondary outcomes are the clinical, functional and radiological characteristics of IPF, NSIP and COPD diagnosis. Quality of life will be measured with dedicated questionnaires. Based on previous work to distinguish normal and pathological lung sounds, we estimate to achieve convergence with an area under the receiver operating characteristic curve of > 80% using 40 patients in each category, yielding a sample size calculation of 80 ILD (40 IPF, 40 NSIP), 40 COPD, and 40 controls. DISCUSSION: This approach has a broad potential to better guide care management by exploring the synergistic value of several point-of-care-tests for the automated detection and differential diagnosis of ILD and COPD and to estimate severity. Trial registration Registration: August 8, 2022. CLINICALTRIALS: gov Identifier: NCT05318599.

Long term anti-SARS-CoV-2 antibody kinetics and correlate of protection against Omicron BA.1/BA.2 infection.

Binding antibody levels against SARS-CoV-2 have shown to be correlates of protection against infection with pre-Omicron lineages. This has been challenged by the emergence of immune-evasive variants, notably the Omicron sublineages, in an evolving immune landscape with high levels of cumulative incidence and vaccination coverage. This in turn limits the use of widely available commercial high-throughput methods to quantify binding antibodies as a tool to monitor protection at the population-level. Here we show that anti-Spike RBD antibody levels, as quantified by the immunoassay used in this study, are an indirect correlate of protection against Omicron BA.1/BA.2 for individuals previously infected by SARS-CoV-2. Leveraging repeated serological measurements between April 2020 and December 2021 on 1083 participants of a population-based cohort in Geneva, Switzerland, and using antibody kinetic modeling, we found up to a three-fold reduction in the hazard of having a documented positive SARS-CoV-2 infection during the Omicron BA.1/BA.2 wave for anti-S antibody levels above 800 IU/mL (HR 0.30, 95% CI 0.22-0.41). However, we did not detect a reduction in hazard among uninfected participants. These results provide reassuring insights into the continued interpretation of SARS-CoV-2 binding antibody measurements as an independent marker of protection at both the individual and population levels.

Effectiveness of a Mobile App (PIMPmyHospital) in Reducing Therapeutic Turnaround Times in an Emergency Department: Protocol for a Pre- and Posttest Study.

BACKGROUND: Delays in reviewing issued laboratory results in emergency departments (EDs) can adversely affect efficiency and quality of care. One opportunity to improve therapeutic turnaround time could be to provide real-time access to laboratory results on mobile devices available to every caregiver. We developed a mobile app named "Patients In My Pocket in my Hospital" (PIMPmyHospital) to help ED caregivers automatically obtain and share relevant information about the patients they care for including laboratory results. OBJECTIVE: This pre- and posttest study aims to explore whether the implementation of the PIMPmyHospital app impacts the timeliness with which ED physicians and nurses remotely access laboratory results while actively working in their real-world environment, including ED length of stay, technology acceptance and usability among users, and how specific in-app alerts impact on its effectiveness. METHODS: This single-center study of nonequivalent pre- and posttest comparison group design will be conducted before and after the implementation of the app in a tertiary pediatric ED in Switzerland. The retrospective period will cover the previous 12 months, and the prospective period will cover the following 6 months. Participants will be postgraduate residents pursuing a ≤6-year residency in pediatrics, pediatric emergency medicine fellows, and registered nurses from the pediatric ED. The primary outcome will be the mean elapsed time in minutes from delivery of laboratory results to caregivers' consideration by accessing them either through the hospital's electronic medical records or through the app before and after the implementation of the app, respectively. As secondary outcomes, participants will be queried about the acceptance and usability of the app using the Unified Theory of Acceptance and Use of Technology model and the System Usability Scale. ED length of stay will be compared before and after the implementation of the app for patients with laboratory results. The impact of specific alerts on the app, such as a flashing icon or sound for reported pathological values, will be reported. RESULTS: Retrospective data collection gathered from the institutional data set will span a 12-month period from October 2021 to October 2022, while the 6-month prospective collection will begin with the implementation of the app in November 2022 and is expected to cease at the end of April 2023. We expect the results of the study to be published in a peer-reviewed journal in late 2023. CONCLUSIONS: This study will show the potential reach, effectiveness, acceptance, and use of the PIMPmyHospital app among ED caregivers. The findings of this study will serve as the basis for future research on the app and any further development to improve its effectiveness. Trial Registration: ClinicalTrials.gov NCT05557331; https://clinicaltrials.gov/ct2/show/NCT05557331. TRIAL REGISTRATION: ClinicalTrials.gov NCT05557331; https://clinicaltrials.gov/ct2/show/NCT05557331. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/43695.

Changes of health-related quality of life 6 months after high-risk oncological upper gastrointestinal and hepatobiliary surgery: a single-centre prospective observational study (ChangeQol Study).

INTRODUCTION: Postoperative health-related quality of life (HRQoL) is an essential outcome in oncological surgery, particularly for elderly patients undergoing high-risk surgery. Previous studies have suggested that, on average, HRQoL returns to premorbid normal levels in the months following major surgery. However, the averaging of effect over a studied cohort may hide the variation of individual HRQoL changes. The proportions of patients who have a varied HRQoL response (stable, improvement, or a deterioration) after major oncological surgery is poorly understood. The study aims to describe the patterns of these HRQoL changes at 6 months after surgery, and to assess the patients and next-of-kin regret regarding the decision to undergo surgery. METHODS AND ANALYSIS: This prospective observational cohort study is carried out at the University Hospitals of Geneva, Switzerland. We include patients over 18 years old undergoing gastrectomy, esophagectomy, pancreas resection or hepatectomy. The primary outcome is the proportion of patients in each group with changes in HRQoL (improvement, stability or deterioration) 6 months after surgery, using a validated minimal clinically important difference of 10 points in HRQoL. The secondary outcome is to assess whether patients and their next-of-kin may regret their decision to undergo surgery at 6 months. We measure the HRQoL using the EORTC QLQ-C30 questionnaire before and 6 months after surgery. We assess regret with the Decision Regret Scale (DRS) at 6 months after surgery. Key other perioperative data include preoperative and postoperative place of residence, preoperative anxiety and depression (HADS scale), preoperative disability (WHODAS V.2.0), preoperative frailty (Clinical Frailty Scale), preoperative cognitive function (Mini-Mental State Examination) and preoperative comorbidities. A follow-up at 12 months is planned. ETHICS AND DISSEMINATION: The study was first approved by the Geneva Ethical Committee for Research (ID 2020-00536) on 28 April 2020. The results of this study will be presented at national and international scientific meetings, and publications will be submitted to an open-access peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04444544.

Incidence of healthcare-associated coronavirus disease 2019 (COVID-19) in the state of Geneva.

An examination of all coronavirus disease 2019 (COVID-19) cases and patient movements in Geneva indicated important disease activity within the healthcare system since the beginning of the pandemic. We estimate that 4.3% of all COVID-19 cases were likely acquired within the healthcare system, contributing to 62% of the COVID-19-related deaths.

Extent of and Reasons for Discontinuation and Nonpublication of Interventional Trials on Connective Tissue Diseases: An Observational Study.

OBJECTIVE: To assess the proportion, the reasons, and the factors associated with the discontinuation or nonpublication of randomized controlled trials (RCTs) on connective tissue diseases (CTDs). METHODS: We searched all interventional RCTs on CTDs registered in ClinicalTrials.gov since 2000. Two reviewers selected studies according to prespecified eligibility criteria. Completion status, publication status, and reported reasons for discontinuation or nonpublication were retrieved on ClinicalTrials.gov, through literature search, and by contacting investigators. Multivariable logistic regression was used to identify factors associated with study noncompletion and nonpublication. RESULTS: We included 175 studies, mostly phase III, placebo-controlled trials on pharmacologic treatments recruiting patients with systemic lupus erythematosus (51%), systemic sclerosis (20%), Sjögren's syndrome (12%), or other CTDs. Fifty-eight (33%) had been discontinued, mainly for insufficient patient accrual, with no differences in discontinuation rates across the CTDs (P > 0.5). Forty-six (35%) of 130 studies having included at least 1 patient were unpublished, and 86 (65%) were published in a peer-reviewed journal after a median of 24 months (interquartile range 15-41) from completion, with a significantly higher publication rate in completed versus discontinued studies (81% versus 22%; P < 0.001). We were able to obtain reasons for nonpublication in one-third of cases. Small sample size (<100 participants) was the only factor associated with study noncompletion and nonpublication. CONCLUSION: One of 3 registered RCTs on CTDs fails to be completed or published. This represents a waste of resources and raises ethical concerns regarding hidden clinical data and unfruitful participation by patients.

Risk factors of progression from discoid lupus to severe systemic lupus erythematosus: a registry-based cohort study of 164 patients.

BACKGROUND: No study has assessed the risk factors of progression from discoid lupus erythematosus (DLE) to severe systemic lupus erythematosus (sSLE) (defined as requiring hospitalization and specific treatment). OBJECTIVE: To identify the risks factors of and generate a predicting score for progression to sSLE among patients with isolated DLE or associated with systemic lupus erythematosus with mild biological abnormalities. METHODS: In this registry-based cohort study, multivariable analysis was performed using risk factors identified from literature and pruned by backward selection to identify relevant variables. The number of points was weighted proportionally to the odds ratio (OR). RESULTS: We included 30 patients with DLE who developed sSLE and 134 patients who did not. In multivariable analysis, among 12 selected variables, an age of <25 years at the time of DLE diagnosis (OR, 2.8; 95% CI, 1.1-7.0; 1 point), phototype V to VI (OR, 2.7; 95% CI, 1.1-7.0; 1 point), and antinuclear antibody titers of ≥1:320 (OR, 15; 95% CI, 3.3-67.3; 5 points) were selected to generate the score. Among the 54 patients with a score of 0 at baseline, none progressed to sSLE, whereas a score of ≥6 was associated with a risk of approximately 40%. LIMITATIONS: Retrospective design. CONCLUSION: In our cohort, an age of <25 years at the time of DLE diagnosis, phototype V to VI, and antinuclear antibody titers of ≥1:320 were risk factors for developing sSLE.

Implementation of recommendations in rheumatic and musculoskeletal diseases: considerations for development and uptake.

A clinical guideline is a document with the aim of guiding decisions based on evidence regarding diagnosis, management and treatment in specific areas of healthcare. Specific to rheumatic and musculoskeletal diseases (RMDs), adherence to clinical guidelines recommendations impacts the outcomes of people with these diseases. However, currently, the implementation of recommendations is less than optimal in rheumatology.The WHO has described the implementation of evidence-based recommendations as one of the greatest challenges facing the global health community and has identified the importance of scaling up these recommendations. But closing the evidence-to-practice gap is often complex, time-consuming and difficult. In this context, the implementation science offers a framework to overcome this scenario.This article describes the principles of implementation science to facilitate and optimise the implementation of clinical recommendations in RMDs. Embedding implementation science methods and techniques into recommendation development and daily practice can help maximise the likelihood that implementation is successful in improving the quality of healthcare and healthcare services.

A tutorial on ordinary differential equations in behavioral science: What does physics teach us?

The present tutorial proposes to use concepts of physics and mathematics to help behavioral scientists to use differential equations in their studies. It focuses on the first-order and the second-order (damped oscillator) differential equation. Simple examples allow to detail the meaning of the coefficients, the conditions of applicability of these differential equations, the underlying hypothesis, and their consequences for the researcher willing to use them. More complex psychological examples demonstrate the importance of parameters' interpretation. Particular attention is paid to how potential external perturbations should be considered. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

The lockdown effect: The impact of the COVID-19-related confinement on the nature of dental emergencies and the number of patients seen at the Geneva university hospital's dental clinic.

PURPOSE: The aim of this retrospective case study was to evaluate the impact of the COVID-19 confinement on consultation number and nature of dental emergencies. MATERIALS AND METHODS: The investigators implemented a retrospective case-control study and enrolled a sample of patients who presented to the University Hospital of Geneva for dental emergencies during the COVID-19 confinement from March 16 to April 26, 2020. They were compared to a matched case-control group treated in 2018 and 2019. The predictor variable was the COVID-19 confinement. The outcome variables were consultation number and nature of dental emergencies. Other study variables included age, gender, socio-economic status, delay from symptoms to consultation and type of treatment. Descriptive and bivariate statistics were computed and significance level was set at ≤ 0.05. RESULTS: The study sample was composed of 1104 patients, with 386 in the case-study and 718 in the control group. No significant change in patient numbers was observed. In the case-study group patients were significantly younger (P= 0.004), had a significantly higher proportion of acute toothache and dental infections (P= 0.01), the main reason for consultation was pain or swelling (P= 0.01) and the delay from first symptoms to consultation was shorter compared to the controls (P=0.008). CONCLUSION: The COVID-19 confinement had no impact on the consultation number of dental emergencies. However, changes in emergency type were noted, with an increase in acute toothaches and infections and patients waited less time between the onset of symptoms to consultation.