Time trends and modifiable factors of COVID-19 contact tracing coverage, Geneva, Switzerland, June 2020 to February 2022.

BackgroundContact tracing was one of the central non-pharmaceutical interventions implemented worldwide to control the spread of SARS-CoV-2, but its effectiveness depends on its ability to detect contacts.AimEvaluate the proportion of secondary infections captured by the contact tracing system in Geneva.MethodsWe analysed 166,892 concomitant infections occurring at the same given address from June 2020 until February 2022 using an extensive operational database of SARS-CoV-2 tests in Geneva. We used permutation to compare the total number of secondary infections occurring at the same address with that reported through manual contact tracing.ResultsContact tracing captured on average 41% of secondary infections, varying from 23% during epidemic peaks to 60% during low epidemic activity. People living in wealthy neighbourhoods were less likely to report contacts (odds ratio (OR): 1.6). People living in apartment buildings were also less likely to report contacts than those living in a house (OR: 1.1-3.1) depending on the SARS-CoV-2 variant, the building size and the presence of shops. This under-reporting of contacts in apartment buildings decreased during periods of mandatory wearing of face masks and restrictions on private gatherings.ConclusionContact tracing alone did not detect sufficient secondary infections to reduce the spread of SARS-CoV-2. Campaigns targeting specific populations, such as those in wealthy areas or apartment buildings, could enhance coverage. Additionally, measures like wearing face masks, improving ventilation and implementing restrictions on gatherings should also be considered to reduce infections resulting from interactions that may not be perceived as high risk.

Evaluation of discontinuation for adverse events of JAK inhibitors and bDMARDs in an international collaboration of rheumatoid arthritis registers (the 'JAK-pot' study).

BACKGROUND: In a clinical trial setting, patients with rheumatoid arthritis (RA) taking the Janus kinase inhibitor (JAKi) tofacitinib demonstrated higher adverse events rates compared with those taking the tumour necrosis factor inhibitors (TNFi) adalimumab or etanercept. OBJECTIVE: Compare treatment discontinuations for adverse events (AEs) among second-line therapies in an international real-world RA population. METHODS: Patients initiating JAKi, TNFi or a biological with another mode of action (OMA) from 17 registers participating in the 'JAK-pot' collaboration were included. The primary outcome was the rate of treatment discontinuation due to AEs. We used unadjusted and adjusted cause-specific Cox proportional hazard models to compare treatment discontinuations for AEs among treatment groups by class, but also evaluating separately the specific type of JAKi. RESULTS: Of the 46 913 treatment courses included, 12 523 were JAKi (43% baricitinib, 40% tofacitinib, 15% upadacitinib, 2% filgotinib), 23 391 TNFi and 10 999 OMA. The adjusted cause-specific hazard rate of treatment discontinuation for AEs was similar for TNFi versus JAKi (1.00, 95% CI 0.92 to 1.10) and higher for OMA versus JAKi (1.11, 95% CI 1.01 to 1.23), lower with TNFi compared with tofacitinib (0.81, 95% CI 0.71 to 0.90), but higher for TNFi versus baricitinib (1.15, 95% CI 1.01 to 1.30) and lower for TNFi versus JAKi in patients 65 or older with at least one cardiovascular risk factor (0.79, 95% CI 0.65 to 0.97). CONCLUSION: While JAKi overall were not associated with more treatment discontinuations for AEs, subgroup analyses suggest varying patterns with specific JAKi, such as tofacitinib, compared with TNFi. However, these observations should be interpreted cautiously, given the observational study design.

2022 EULAR recommendations for screening and prophylaxis of chronic and opportunistic infections in adults with autoimmune inflammatory rheumatic diseases

To develop EULAR recommendations for screening and prophylaxis of chronic and opportunistic infections in patients with autoimmune inflammatory rheumatic diseases (AIIRD). An international Task Force (TF) (22 members/15 countries) formulated recommendations, supported by systematic literature review findings. Level of evidence and grade of recommendation were assigned for each recommendation. Level of agreement was provided anonymously by each TF member. Four overarching principles (OAP) and eight recommendations were developed. The OAPs highlight the need for infections to be discussed with patients and with other medical specialties, in accordance with national regulations. In addition to biologic/ targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for which screening for latent tuberculosis (TB) should be performed, screening could be considered also before conventional synthetic DMARDs, glucocorticoids and immunosuppressants. Interferon gamma release assay should be preferred over tuberculin skin test, where available. Hepatitis B (HBV) antiviral treatment should be guided by HBV status defined prior to starting antirheumatic drugs. All patients positive for hepatitis-C-RNA should be referred for antiviral treatment. Also, patients who are non-immune to varicella zoster virus should be informed about the availability of postexposure prophylaxis should they have contact with this pathogen. Prophylaxis against Pneumocystis jirovecii seems to be beneficial in patients treated with daily doses >15­30mg of prednisolone or equivalent for >2­4 weeks. These recommendations provide guidance on the screening and prevention of chronic and opportunistic infections. Their adoption in clinical practice is recommended to standardise and optimise care to reduce the burden of opportunistic infections in people living with AIIRD.

Effect of SARS-CoV-2 prior infection and mRNA vaccination on contagiousness and susceptibility to infection.

The immunity conferred by SARS-CoV-2 vaccines and infections reduces the transmission of the virus. To answer how the effect of immunity is shared between a reduction of infectiousness and an increased protection against infection, we examined >50,000 positive cases and >110,000 contacts from Geneva, Switzerland (June 2020 to March 2022). We assessed the association between secondary attack rate (i.e. proportion of new cases among contacts) and immunity from natural infection and/or vaccination, stratifying per four SARS-CoV-2 variants and adjusting for index cases and contacts' socio-demographic characteristics and the propensity of the contacts to be tested. Here we show that immunity protected contacts from infection, rather than reducing infectiousness of index cases. Natural infection conferred the strongest immunity. Hybrid immunity did not surpass recent infection. Although of smaller amplitude, the reduction in infectiousness due to vaccination was less affected by time and by the emergence of new SARS-CoV-2 variants than the susceptibility to infection. These findings support the role of vaccine in reducing infectiousness and underscore the complementary role of interventions reducing SARS-CoV-2 propagation, such as mask use or indoor ventilation.

Validation of the regret coping scale for healthcare professionals (RCS-HCP) in portuguese for Brazil

Introduction: assessing the ability to cope with regret can contribute to support strategies for health professionals. However, in Brazil only few instruments evaluate this ability in general. Objective: this study aimed was to adapt and validate the Regret Coping Scale for Healthcare Professionals (RCS-HCP) to Brazilian Portuguese . Methods: the instruments were translated, and the psychometric properties evaluated for validity and reliability. Three hundred and forty-one professionals participated, with an average age of 38.6 ± 9.2, and 87 participated in a retest survey 30 days later. Results: exploratory factor analysis showed adequacy of the structure (KMO = 0.786) composed of three factors. In the confirmation, the performance was close to acceptable. Reliability was good for the maladaptive strategies (α = 0.834) and adequate for the problem-focused initiatives (α = 0.717), but slightly too low for adaptive strategies (α = 0.595). Test- retest showed lower than expected values, with a Spearman- Brown coefficient of 0.703. Conclusion: the RCS-HCP scale showed satisfactory performance in relation to the properties evaluated.

Introdução: a avaliação da capacidade de lidar com o arrependimento pode contribuir para estratégias de apoio aos profissionais de saúde. No entanto, no Brasil existem poucos instrumentos que avaliam essa habilidade no contexto geral. Objetivo: o objetivo do estudo foi adaptar e validar a Regret Coping Scale for Healthcare Professionals (RCS-HCP) para profissionais de saúde brasileiros. Método: na validação, os instrumentos foram traduzidos e as propriedades psicométricas avaliadas quanto à validade e confiabilidade. Participaram 341 profissionais, com média de idade de 38,6 ± 9,2, e 87 participaram de uma pesquisa de reteste 30 dias depois. Resultados: a análise fatorial exploratória mostrou adequação da estrutura (KMO = 0,786) composta por três fatores. Na confirmação, o desempenho ficou próximo do aceitável. A confiabilidade foi boa para as estratégias mal adaptativas (α = 0,834) e adequada para as estratégias focadas no problema (α = 0,717), mas um pouco baixa demais para as estratégias adaptativas (α = 0,595). Teste-reteste apresentou valores abaixo do esperado, com coeficiente de Spearman-Brown de 0,703. Conclusão: a escala RCS-HCP apresentou desempenho satisfatório em relação às propriedades avaliadas.

Management of giant-cell arteritis in Switzerland: an online national survey.

AIMS OF THE STUDY: To assess current practices in diagnosing, treating, and following-up giant-cell arteritis by specialists in Switzerland and to identify the main barriers to using diagnostic tools. METHODS: We performed a national survey of specialists potentially caring for patients with giant-cell arteritis. The survey was sent by email to all members of the Swiss Societies of Rheumatology and for Allergy and Immunology. A reminder was sent to nonresponders after 4 and 12 weeks. Its questions covered the following dimensions: respondents' main characteristics, diagnosis, treatment, and imaging's role during follow-up. The main study results were summarized using descriptive statistics. RESULTS: Ninety-one specialists, primarily aged 46-65 years (n = 53/89; 59%), working in academic or nonacademic hospitals or private practice, and treating a median of 7.5 (interquartile range [IQR]: 3-12) patients with giant-cell arteritis per year participated in this survey. Ultrasound of temporal arteries/large vessels (n = 75/90; 83%) and positron-emission-tomography-computed tomography (n = 52/91; 57%) or magnetic resonance imaging (n = 46/90; 51%) of the aorta/extracranial arteries were the most common techniques used to diagnose giant-cell arteritis with cranial or large vessel involvement, respectively. Most participants reported a short time to obtain imaging tests or arterial biopsy. The glucocorticoid tapering scheme, glucocorticoid-sparing agent, and glucocorticoid-sparing treatment duration varied among the participants. Most physicians did not follow a predefined repeat imaging scheme for follow-up and mainly relied on structural changes (vascular thickening, stenosis, or dilatation) to drive treatment choice. CONCLUSIONS: This survey indicates that imaging and temporal biopsy are rapidly accessible for diagnosing giant-cell arteritis in Switzerland but highlights heterogeneous practice in many disease management areas.

Heart rate recovery to assess fitness: comparison of different calculation methods in a large cross-sectional study.

We propose a cross-sectional study based on 980 maximal effort tests to quantify the effect of the calculation method of heart rate recovery (HRR) on its association with cardiorespiratory fitness (CRF). For five different time t0 after exercise cessation, HRR has been calculated as: the difference and the ratio between maximal measured heart rate and heart rate (HR) at t0HR at t0the decay time of an exponential decay encompassing the first t0 minutes of the HR recovery.The associations between HRR indices and CRF were estimated from generalized estimating equations stratified by gender and adjusted for age and body mass index. For HRR indices based on exponential regression, no significant association with CRF was found, whereas the other HRR indices are associated with CRF when t0 is at least 1 minute and is maximum for t0 = 2 minutes for females and t0 = 3 minutes for males.

Glucocorticoids prescribing practices in systemic sclerosis: an analysis of the EUSTAR database.

OBJECTIVES: To estimate the prevalence of long-term exposure to glucocorticoids (GCs) and to identify factors associated with, and variations in prescribing practices over time and across recruiting countries. METHODS: We included patients with SSc having a visit recorded in the EUSTAR database from January 2013 onward. We analysed the prevalence and the main features of GCs users, their exposure to GCs over time, and their GCs dosages. Multivariable linear regression was used to analyse the factors identified as associated with GCs intake duration. Time trends, and variations in GCs utilization across recruiting countries were explored. Missing data were imputed using multiple imputation with chained equations. RESULTS: The 9819 patients included were mostly females (85%), the majority had lcSSc (73%), and the median age was 58 years. At baseline, 34% of patients (n = 2769/8109) (48% dcSSc vs 29% lcSSc) were on GCs, and the median dose was 7.5 mg/day. GCs users were more frequently males and anti-Scl70 positive, and more commonly had dcSSc and more severe disease. On average, GCs users spent 25% of their follow-up time (median 33.2 months) on GCs, with no significant between-subsets difference. Notably, 33% (n = 971/2959) and 22% (n = 647/2959) of patients followed up for >1 year had received GCs for >6 and >12 months, respectively. Multivariable analysis showed that patient and disease characteristics poorly explained the variability in GCs exposure (adjusted-R2 = 0.06, P < 0.001). GCs utilization varied within and across countries, and gradually decreased over time (36% in 2013 vs 23% in 2018). CONCLUSIONS: GCs are widely and long-term prescribed in SSc, with significant between-countries and within-country differences. A gradual decrease in their utilization has been observed.

After JAK inhibitor failure: to cycle or to switch, that is the question - data from the JAK-pot collaboration of registries.

OBJECTIVES: The expanded therapeutic arsenal in rheumatoid arthritis (RA) raises new clinical questions. The objective of this study is to compare the effectiveness of cycling Janus kinase inhibitors (JAKi) with switching to biologic disease-modifying antirheumatic drug (bDMARD) in patients with RA after failure to the first JAKi. METHODS: This is a nested cohort study within data pooled from an international collaboration of 17 national registries (JAK-pot collaboration). Data from patients with RA with JAKi treatment failure and who were subsequently treated with either a second JAKi or with a bDMARD were prospectively collected. Differences in drug retention rates after second treatment initiation were assessed by log-rank test and Cox regression analysis adjusting for potential confounders. Change in Clinical Disease Activity Index (CDAI) over time was estimated using a linear regression model, adjusting for confounders. RESULTS: 365 cycling and 1635 switching patients were studied. Cyclers were older and received a higher number of previous bDMARDs. Both strategies showed similar observed retention rates after 2 years of follow-up. However, adjusted analysis revealed that cycling was associated with higher retention (p=0.04). Among cyclers, when the first JAKi was discontinued due to an adverse event (AE), it was more likely that the second JAKi would also be stopped due to an AE. Improvement in CDAI over time was similar in both strategies. CONCLUSIONS: After failing the first JAKi, cycling JAKi and switching to a bDMARD appear to have similar effectiveness. Caution is advised if an AE was the reason to stop the first JAKi.

2022 EULAR recommendations for screening and prophylaxis of chronic and opportunistic infections in adults with autoimmune inflammatory rheumatic diseases.

OBJECTIVES: To develop EULAR recommendations for screening and prophylaxis of chronic and opportunistic infections in patients with autoimmune inflammatory rheumatic diseases (AIIRD). METHODS: An international Task Force (TF) (22 members/15 countries) formulated recommendations, supported by systematic literature review findings. Level of evidence and grade of recommendation were assigned for each recommendation. Level of agreement was provided anonymously by each TF member. RESULTS: Four overarching principles (OAP) and eight recommendations were developed. The OAPs highlight the need for infections to be discussed with patients and with other medical specialties, in accordance with national regulations. In addition to biologic/targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for which screening for latent tuberculosis (TB) should be performed, screening could be considered also before conventional synthetic DMARDs, glucocorticoids and immunosuppressants. Interferon gamma release assay should be preferred over tuberculin skin test, where available. Hepatitis B (HBV) antiviral treatment should be guided by HBV status defined prior to starting antirheumatic drugs. All patients positive for hepatitis-C-RNA should be referred for antiviral treatment. Also, patients who are non-immune to varicella zoster virus should be informed about the availability of postexposure prophylaxis should they have contact with this pathogen. Prophylaxis against Pneumocystis jirovecii seems to be beneficial in patients treated with daily doses >15-30 mg of prednisolone or equivalent for >2-4 weeks. CONCLUSIONS: These recommendations provide guidance on the screening and prevention of chronic and opportunistic infections. Their adoption in clinical practice is recommended to standardise and optimise care to reduce the burden of opportunistic infections in people living with AIIRD.

Decrease of heart rate variability during exercise: An index of cardiorespiratory fitness.

The present study proposes to measure and quantify the heart rate variability (HRV) changes during effort as a function of the heart rate and to test the capacity of the produced indices to predict cardiorespiratory fitness measures. Therefore, the beat-to-beat cardiac time interval series of 18 adolescent athletes (15.2 ± 2.0 years) measured during maximal graded effort test were detrended using a dynamical first-order differential equation model. HRV was then calculated as the standard deviation of the detrended RR intervals (SDRR) within successive windows of one minute. The variation of this measure of HRV during exercise is properly fitted by an exponential decrease of the heart rate: the SDRR is divided by 2 every increase of heart rate of 20 beats/min. The HR increase necessary to divide by 2 the HRV is linearly inversely correlated with the maximum oxygen consumption (r = -0.60, p = 0.006), the maximal aerobic power (r = -0.62, p = 0.006), and, to a lesser extent, to the power at the ventilatory thresholds (r = -0.53, p = 0.02 and r = -0.47, p = 0.05 for the first and second threshold). It indicates that the decrease of the HRV when the heart rate increases is faster among athletes with better fitness. This analysis, based only on cardiac measurements, provides a promising tool for the study of cardiac measurements generated by portable devices.

Effectiveness of TNF-inhibitors, abatacept, IL6-inhibitors and JAK-inhibitors in 31 846 patients with rheumatoid arthritis in 19 registers from the 'JAK-pot' collaboration.

BACKGROUND: JAK-inhibitors (JAKi), recently approved in rheumatoid arthritis (RA), have changed the landscape of treatment choices. We aimed to compare the effectiveness of four current second-line therapies of RA with different modes of action, since JAKi approval, in an international collaboration of 19 registers. METHODS: In this observational cohort study, patients initiating tumour necrosis factor inhibitors (TNFi), interleukin-6 inhibitors (IL-6i), abatacept (ABA) or JAKi were included. We compared the effectiveness of these treatments in terms of drug discontinuation and Clinical Disease Activity Index (CDAI) response rates at 1 year. Analyses were adjusted for patient, disease and treatment characteristics, including lines of therapy and accounted for competing risk. RESULTS: We included 31 846 treatment courses: 17 522 TNFi, 2775 ABA, 3863 IL-6i and 7686 JAKi. Adjusted analyses of overall discontinuation were similar across all treatments. The main single reason of stopping treatment was ineffectiveness. Compared with TNFi, JAKi were less often discontinued for ineffectiveness (adjusted HR (aHR) 0.75, 95% CI 0.67 to 0.83), as was IL-6i (aHR 0.76, 95% CI 0.67 to 0.85) and more often for adverse events (aHR 1.16, 95% CI 1.03 to 1.33). Adjusted CDAI response rates at 1 year were similar between TNFi, JAKi and IL-6i and slightly lower for ABA. CONCLUSION: The adjusted overall drug discontinuation and 1 year response rates of JAKi and IL-6i were similar to those observed with TNFi. Compared with TNFi, JAKi were more often discontinued for adverse events and less for ineffectiveness, as were IL-6i.

Accounting for missing data caused by drug cessation in observational comparative effectiveness research: a simulation study.

OBJECTIVES: To assess the performance of statistical methods used to compare the effectiveness between drugs in an observational setting in the presence of attrition. METHODS: In this simulation study, we compared the estimations of low disease activity (LDA) at 1 year produced by complete case analysis (CC), last observation carried forward (LOCF), LUNDEX, non-responder imputation (NRI), inverse probability weighting (IPW) and multiple imputations of the outcome. All methods were adjusted for confounders. The reasons to stop the treatments were included in the multiple imputation method (confounder-adjusted response rate with attrition correction, CARRAC) and were either included (IPW2) or not (IPW1) in the IPW method. A realistic simulation data set was generated from a real-world data collection. The amount of missing data caused by attrition and its dependence on the 'true' value of the data missing were varied to assess the robustness of each method to these changes. RESULTS: LUNDEX and NRI strongly underestimated the absolute LDA difference between two treatments, and their estimates were highly sensitive to the amount of attrition. IPW1 and CC overestimated the absolute LDA difference between the two treatments and the overestimation increased with increasing attrition or when missingness depended on disease activity at 1 year. IPW2 and CARRAC produced unbiased estimations, but IPW2 had a greater sensitivity to the missing pattern of data and the amount of attrition than CARRAC. CONCLUSIONS: Only multiple imputation and IPW2, which considered both confounding and treatment cessation reasons, produced accurate comparative effectiveness estimates.

EULAR points to consider when analysing and reporting comparative effectiveness research using observational data in rheumatology.

BACKGROUND: Comparing treatment effectiveness over time in observational settings is hampered by several major threats, among them confounding and attrition bias. OBJECTIVES: To develop European Alliance of Associations for Rheumatology (EULAR) points to consider (PtC) when analysing and reporting comparative effectiveness research using observational data in rheumatology. METHODS: The PtC were developed using a three-step process according to the EULAR Standard Operating Procedures. Based on a systematic review of methods currently used in comparative effectiveness studies, the PtC were formulated through two in-person meetings of a multidisciplinary task force and a two-round online Delphi, using expert opinion and a simulation study. Finally, feedback from a larger audience was used to refine the PtC. Mean levels of agreement among the task force were calculated. RESULTS: Three overarching principles and 10 PtC were formulated, addressing, in particular, potential biases relating to attrition or confounding by indication. Building on Strengthening the Reporting of Observational Studies in Epidemiology guidelines, these PtC insist on the definition of the baseline for analysis and treatment effectiveness. They also focus on the reasons for stopping treatment as an important consideration when assessing effectiveness. Finally, the PtC recommend providing key information on missingness patterns. CONCLUSION: To improve the reliability of an increasing number of real-world comparative effectiveness studies in rheumatology, special attention is required to reduce potential biases. Adherence to clear recommendations for the analysis and reporting of observational comparative effectiveness studies will improve the trustworthiness of their results.

Occupational risk of SARS-CoV-2 infection and reinfection during the second pandemic surge: a cohort study.

OBJECTIVES: This cohort study including essential workers, assessed the risk and incidence of SARS-CoV-2 infection during the second surge of COVID-19 according to baseline serostatus and occupational sector. METHODS: Essential workers were selected from a seroprevalence survey cohort in Geneva, Switzerland and were linked to a state centralised registry compiling SARS-CoV-2 infections. Primary outcome was the incidence of virologically confirmed infections from serological assessment (between May and September 2020) to 25 January 2021, according to baseline antibody status and stratified by three predefined occupational groups (occupations requiring sustained physical proximity, involving brief regular contact or others). RESULTS: 10 457 essential workers were included (occupations requiring sustained physical proximity accounted for 3057 individuals, those involving regular brief contact, 3645 and 3755 workers were classified under 'Other essential occupations'). After a follow-up period of over 27 weeks, 5 (0.6%) seropositive and 830 (8.5%) seronegative individuals had a positive SARS-CoV-2 test, with an incidence rate of 0.2 (95% CI 0.1 to 0.6) and 3.2 (95% CI 2.9 to 3.4) cases per person-week, respectively. Incidences were similar across occupational groups. Seropositive essential workers had a 93% reduction in the hazard (HR of 0.07, 95% CI 0.03 to 0.17) of having a positive test during the follow-up with no significant between-occupational group difference. CONCLUSIONS: A 10-fold reduction in the hazard of being virologically tested positive was observed among anti-SARS-CoV-2 seropositive essential workers regardless of their sector of occupation, confirming the seroprotective effect of a previous SARS-CoV2 exposure at least 6 months after infection.

Portuguese validation of the Regret Intensity Scale (RIS-10) for measuring the intensity of regret associated with the provision of attention in health.

OBJECTIVES: The aim of the study was to adapt and validate the Regret Intensity Scale-10 (RIS-10) for Brazilian health professionals. METHODS: The validation study took place in two phases, in which the first was the translation of the instruments and the second, the field validation using psychometric properties validity and reliability of the scale with 341 professionals (doctors, nurses and physiotherapists) linked to hospitals. Validity was assessed using content validities (six judges evaluation), criteria (correlation with the Life Satisfaction Scale - SWLS and Self-Reporting Questionnaire 20 -SRQ-20) and construct (exploratory analysis using the rotation method Promax, based on the slope graph and the Kaiser criterion and confirmatory using the structural equation model) after applying the questionnaire to professionals.Reliability was measured by Cronbach's α coefficient and retest test over a maximum period of 30 days. Reproducibility was calculated by intraclass correlation. RESULTS: A total of 341 professionals participated, with an average age of 38.6 ± 9.2 years. The content validity index (CVI) was 1.00, for all items of the scale in the proportion of agreement of the judges. Exploratory factor analysis showed a satisfactory correlation (Kaiser-Meyer-Olkin = 0.88), suggesting a two-factor model, which comprises the main components of the emotion of regret (Factor I - emoticons, Factor II - feelings), accounting for 64% of the total variation of the first factor. In the confirmation, the index standardized root mean squared residual = 0.063 was close to the acceptable and other values were below. The scale correlated positively with SRQ-20 (p < 0.001) and negatively with SLWS (p = 0.003). Reliability showed (Cronbach's α = 0.863) and test-retest reliability showed lower values than expected. The Bland-Altman graph showed a mean bias of -1.5 with lower and upper limits of 15.8 to 12.8 respectively. CONCLUSIONS: The RIS-10 adapted for the population performed adequately in the psychometric properties evaluated for the assessment of the intensity of regret related to the provision of health care.

Portuguese validation of the Regret Intensity Scale (RIS-10) for measuring the intensity of regret associated with the provision of attention in health / Validación al portugués de la Escala de Intensidad de Arrepentimiento (RIS-10) para medir la intensidad del arrepentimiento asociado a la prestación de atención en salud / Validação da versão em português da escala Regret Intensity Scale (RIS-10) para medir a intensidade do arrependimento associada à prestação de atenção em saúde

Objective. The aim of the study was to adapt and validate the Regret Intensity Scale-10 (RIS-10) for Brazilian health professionals. Methods. The validation study took place in two phases, in which the first was the translation of the instruments and the second, the field validation using psychometric properties validity and reliability of the scale with 341 professionals (doctors, nurses and physiotherapists) linked to hospitals. Validity was assessed using content validities (six judges evaluation), criteria (correlation with the Life Satisfaction Scale - SWLS and Self-Reporting Questionnaire 20 -SRQ-20) and construct (exploratory analysis using the rotation method Promax, based on the slope graph and the Kaiser criterion and confirmatory using the structural equation model) after applying the questionnaire to professionals.Reliability was measured by Cronbach's α coefficient and retest test over a maximum period of 30 days. Reproducibility was calculated by intraclass correlation. Results. A total of 341 professionals participated, with an average age of 38.6 ± 9.2 years. The content validity index (CVI) was 1.00, for all items of the scale in the proportion of agreement of the judges. Exploratory factor analysis showed a satisfactory correlation (Kaiser-Meyer-Olkin = 0.88), suggesting a two-factor model, which comprises the main components of the emotion of regret (Factor I ­ emoticons, Factor II - feelings), accounting for 64% of the total variation of the first factor. In the confirmation, the index standardized root mean squared residual = 0.063 was close to the acceptable and other values were below. The scale correlated positively with SRQ-20 (p < 0.001) and negatively with SLWS (p = 0.003). Reliability showed (Cronbach's α = 0.863) and test­retest reliability showed lower values than expected. The Bland-Altman graph showed a mean bias of -1.5 with lower and upper limits of 15.8 to 12.8 respectively. Conclusion. The RIS-10 adapted for the population performed adequately in the psychometric properties evaluated for the assessment of the intensity of regret related to the provision of health care.

Objetivo. Adaptar y validar la Escala de Intensidad de Arrepentimiento-10 (RIS-10) para profesionales de la salud brasileños. Métodos. Este estudio de validación se realizó en dos fases: la primera fue la traducción de los instrumentos y la segunda, la validación de campo evaluando las propiedades psicométricas de validez y confiabilidad de la escala con 341 profesionales (médicos, enfermeras y fisioterapeutas) vinculados a hospitales. La validez se evaluó mediante la validez de contenido (evaluación de seis jueces), criterios (correlación con la Escala de Satisfacción de Vida - SWLS y Self-Reporting Questionnaire 20 -SRQ-20) y constructo (análisis exploratorio mediante el método de rotación Promax, basado en el gráfico de pendiente (Criterio de Kaiser y confirmatorio por el modelo de ecuación estructural) luego de aplicar el cuestionario a los profesionales. La confiabilidad se midió mediante el coeficiente α de Cronbach y la prueba de reprueba en un período máximo de 30 días. La reproducibilidad se calculó por correlación intraclase. Resultados. Participaron 341 profesionales, con una edad media de 38.6 ± 9.2 años. El índice de validez de contenido (IVC) fue de 1.00 para todos los ítems de la escala en proporción de acuerdo con los jueces. El análisis factorial exploratorio mostró una correlación satisfactoria (Kaiser-Meyer-Olkin = 0.88), sugiriendo un modelo de dos factores, que comprende los componentes principales de la emoción de arrepentimiento (Factor I - emociones, Factor II - sentimientos), correspondiente al 64% de la variación total del primer factor. Tras la confirmación, el índice cuadrático medio residual estandarizado = 0.063 estuvo cerca de ser aceptable y los otros valores estaban por debajo. La escala se correlacionó positivamente con SRQ-20 (p<0.001) y negativamente con SLWS (p = 0.003). La confiabilidad mostró un α de Cronbach = 0.863 y la confiabilidad test-retest mostró valores más bajos de lo esperado. El gráfico de Bland-Altman mostró un sesgo medio de -1.5 con límites inferior y superior de 15.8 a 12.8, respectivamente. Conclusión. El RIS-10 adaptado a la población mostró un desempeño adecuado en las propiedades psicométricas utilizadas para evaluar la intensidad del arrepentimiento relacionado con la prestación de atención a la salud.

Objetivo. O objetivo do estudo foi adaptar e validar a Regret Intensity Scale-10 (RIS-10) para profissionais de saúde brasileiros. Métodos. O estudo de validação ocorreu em duas fases, sendo a primeira a tradução dos instrumentos e a segunda, a validação de campo utilizando as propriedades psicométricas validade e confiabilidade da escala com 341 profissionais (médicos, enfermeiros e fisioterapeutas) vinculados a hospitais. A validade foi avaliada por meio de validades de conteúdo (avaliação de seis juízes), critérios (correlação com a Escala de Satisfação de Vida - SWLS e Self-Reporting Questionnaire 20 -SRQ-20) e construto (análise exploratória usando o método de rotação Promax, com base no gráfico de inclinação e critério de Kaiser e confirmatório pelo modelo de equações estruturais) após aplicação do questionário aos profissionais. A confiabilidade foi medida pelo coeficiente α de Cronbach e teste de reteste em um período máximo de 30 dias. A reprodutibilidade foi calculada por correlação intraclasse. Resultados. Participaram 341 profissionais, com média de idade de 38.6 ± 9.2 anos. O índice de validade de conteúdo (IVC) foi de 1,00, para todos os itens da escala na proporção de concordância dos juízes. A análise fatorial exploratória mostrou correlação satisfatória (Kaiser-Meyer-Olkin = 0.88), sugerindo um modelo de dois fatores, que compreende os principais componentes da emoção de arrependimento (Fator I - emoções, Fator II - sentimentos), correspondendo a 64% da variação total do primeiro fator. Na confirmação, o índice raiz quadrada média residual padronizada = 0.063 ficou próximo do aceitável e os demais valores ficaram abaixo. A escala correlacionou-se positivamente com SRQ-20 (p <0.001) e negativamente com SLWS (p = 0.003). A confiabilidade apresentou (α de Cronbach = 0.863) e a confiabilidade teste-reteste apresentou valores menores do que o esperado. O gráfico de Bland-Altman mostrou um viés médio de -1.5 com limites inferior e superior de 15.8 a 12.8, respectivamente. Conclusão. O RIS-10 adaptado para a população apresentou desempenho adequado nas propriedades psicométricas avaliadas para avaliação da intensidade do arrependimento relacionado à prestação de cuidados de saúde

Imputing missing data of function and disease activity in rheumatoid arthritis registers: what is the best technique?

Objective: To compare several methods of missing data imputation for function (Health Assessment Questionnaire) and for disease activity (Disease Activity Score-28 and Clinical Disease Activity Index) in rheumatoid arthritis (RA) patients. Methods: One thousand RA patients from observational cohort studies with complete data for function and disease activity at baseline, 6, 12 and 24 months were selected to conduct a simulation study. Values were deleted at random or following a predicted attrition bias. Three types of imputation were performed: (1) methods imputing forward in time (last observation carried forward; linear forward extrapolation); (2) methods considering data both forward and backward in time (nearest available observation-NAO; linear extrapolation; polynomial extrapolation); and (3) methods using multi-individual models (linear mixed effects cubic regression-LME3; multiple imputation by chained equation-MICE). The performance of each estimation method was assessed using the difference between the mean outcome value, the remission and low disease activity rates after imputation of the missing values and the true value. Results: When imputing missing baseline values, all methods underestimated equally the true value, but LME3 and MICE correctly estimated remission and low disease activity rates. When imputing missing follow-up values at 6, 12, or 24 months, NAO provided the least biassed estimate of the mean disease activity and corresponding remission rate. These results were not affected by the presence of attrition bias. Conclusion: When imputing function and disease activity in large registers of active RA patients, researchers can consider the use of a simple method such as NAO for missing follow-up data, and the use of mixed-effects regression or multiple imputation for baseline data.