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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., 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.

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., 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.

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OBJECTIVE: To estimate the extent of and the reasons for ineligibility in randomized controlled trials (RCTs) of systemic sclerosis (SSc) patients included in the EUSTAR database, and to determine the association between patient's features and generalizability of study results. METHODS: We searched Clinicaltrials.gov for all records on interventional SSc-RCTs registered from January 2013 to January 2018. Two reviewers selected studies, and information on the main trial features were retrieved. Data from 8046 patients having a visit in the EUSTAR database since 2013 were used to check patient's eligibility. The proportion of potentially eligible patients per trial, and the risk factors for ineligibility were analyzed. Complete-, worst- and best-case analyses were performed. RESULTS: Of the 37 RCTs included, 43% were conducted in Europe, 35% were industry-funded, and 87% investigated pharmacological treatments. Ninety-one percent of 8046 patients included could have participated in at least one RCT. In complete-case analysis, the median [range] proportion of eligible patients having the main organ complication targeted by each study was 60% [10-100] in the overall sample of trials, ranging from 50% [32-79] for trials on skin fibrosis to 90% [34-77] for those targeting Raynaud's phenomenon. Among the criteria checked, treatment- and safety-related but not demographic were the main barriers to patient's recruitment. Older age, absence of Raynaud's phenomenon, and lower mRSS were independently associated with the failure to fulfill criteria for any of the included studies. CONCLUSIONS: Patient's representativeness in SSc-RCTs is highly variable and is driven more by treatment- and safety-related rather than demographic criteria.

OBJECTIVES: RF and ACPA are used as diagnostic tools and their presence has been associated with clinical response to some biologic DMARDs (bDMARDs) in RA. This study compared the impact of seropositivity on drug discontinuation and effectiveness of bDMARDs in patients with RA, using head-to-head comparisons in a real-world setting. METHODS: We conducted a pooled analysis of 16 observational RA registries. Inclusion criteria were a diagnosis of RA, initiation of treatment with rituximab (RTX), abatacept (ABA), tocilizumab (TCZ) or TNF inhibitors (TNFis) and available information on RF and/or ACPA status. Drug discontinuation was analysed using Cox regression, including drug, seropositivity, their interaction, adjusting for concomitant and past treatments and patient and disease characteristics and accounting for country and calendar year of bDMARD initiation. Effectiveness was analysed using the Clinical Disease Activity Index evolution over time. RESULTS: Among the 27 583 eligible patients, the association of seropositivity with drug discontinuation differed across bDMARDs (P for interaction <0.001). The adjusted hazard ratios for seropositive compared with seronegative patients were 1.01 (95% CI 0.95, 1.07) for TNFis, 0.89 (0.78, 1.02)] for TCZ, 0.80 (0.72, 0.88) for ABA and 0.70 (0.59, 0.84) for RTX. Adjusted differences in remission and low disease activity rates between seropositive and seronegative patients followed the same pattern, with no difference in TNFis, a small difference in TCZ, a larger difference in ABA and the largest difference in RTX (Lundex remission difference +5.9%, low disease activity difference +11.6%). CONCLUSION: Seropositivity was associated with increased effectiveness of non-TNFi bDMARDs, especially RTX and ABA, but not TNFis.

Purpose: To provide guidance regarding the desirable size of pre-tests of psychometric questionnaires, when the purpose of the pre-test is to detect misunderstandings, ambiguities, or other difficulties participants may encounter with instrument items (called <>). Methods: We computed (a) the power to detect a problem for various levels of prevalence and various sample sizes, (b) the required sample size to detect problems for various levels of prevalence, and (c) upper confidence limits for problem prevalence in situations where no problems were detected. Results: As expected, power increased with problem prevalence and with sample size. If problem prevalence was 0.05, a sample of 10 participants had only a power of 40% to detect the problem, and a sample of 20 achieved a power of 64%. To achieve a power of 80%, 32 participants were necessary if the prevalence of the problem was 0.05, 16 participants if prevalence was 0.10, and 8 if prevalence was 0.20. If no problems were observed in a given sample, the upper limit of a two-sided 90% confidence interval reached 0.26 for a sample size of 10, 0.14 for a sample size of 20, and 0.10 for a sample of 30 participants. Conclusions: Small samples (5-15 participants) that are common in pre-tests of questionaires may fail to uncover even common problems. A default sample size of 30 participants is recommended.

Background socioeconomic circumstances (SEC) during a person's lifespan influence a wide range of health outcomes. However, solid evidence of the association of early- and adult-life SEC with health trajectories in ageing is still lacking. This study assessed whether early-life SEC are associated with muscle strength in later life—a biomarker of health—and whether this relationship is caused by adult-life SEC and health behaviours. Methods we used data from the Survey of Health Ageing and Retirement in Europe, a 12-year population-based cohort study with repeated measurement in six waves (2004-15) and retrospective collection of life-course data. Participants' grip strength was assessed by using a handheld dynamometer. Confounder-adjusted logistic mixed-effect models were used to examine the associations of early- and adult-life SEC with the risk of low muscle strength (LMS) in older age. Results a total of 24,179 participants (96,375 observations) aged 50-96 living in 14 European countries were included in the analyses. Risk of LMS was increased with disadvantaged relative to advantaged early-life SEC. The association between risk of LMS and disadvantaged early-life SEC gradually decreased when adjusting for adult-life SEC for both sexes and with unhealthy behaviours for women. After adjusting for these factors, all associations between risk of LMS and early-life SEC remained significant for women. Conclusion early-life SEC are associated with muscle strength after adjusting for adult-life SEC and behavioural lifestyle factors, especially in women, which suggests that early life may represent a sensitive period for future health.

Background: Children with biliary atresia rapidly develop liver fibrosis secondary to inflammatory destruction of the biliary tract. Noninvasive detection of liver fibrosis in neonatal/infantile cholestasis is an additional criterion for the diagnosis of biliary atresia, leading to prompt surgical exploration. Objective: To assess the value of US with acoustic radiation force impulse (ARFI) elastography to detect biliary atresia in the workup of neonatal/infantile cholestasis. Materials and methods: In this retrospective study, 20 children with cholestasis suspected of having biliary atresia were investigated by US and ARFI. We evaluated the association between US findings and the diagnosis of biliary atresia and with two scores of liver fibrosis obtained from liver biopsy. Results: In univariate analyses, gallbladder size, triangular cord sign, spleen size and ARFI values were found to be associated with biliary atresia, though only the triangular cord sign remained significant when elevated gamma glutamyltransferase (GGT) was included as a predictor. In contrast, spleen size and ARFI correlated with the degree of liver fibrosis on biopsy (r > 0.70, P < 0.001), which remained significant when gamma glutamyltransferase elevation was included as a predictor. Conclusion: The addition of ARFI to a standard abdominal US in the initial workup of the neonate with possible infantile cholestasis can provide reliable information on liver fibrosis and help in the diagnosis of biliary atresia.

OBJECTIVE To explore the effect of apps measuring patient-reported outcomes (PROs) on patient-provider interaction in the rheumatic diseases in an observational setting. METHODS Patients in the Swiss Clinical Quality Management in Rheumatic Diseases Registry were offered mobile apps (iDialog and COmPASS) to track disease status between rheumatology visits using validated PROs (Rheumatoid Arthritis Disease Activity Index-5 score, Bath Ankylosing Spondylitis Disease Activity Index score, Routine Assessment of Patient Index Data-3 score and Visual Analogue Scale score for pain, disease activity and skin symptoms). We assessed two aspects of patient-provider interaction: shared decision making (SDM) and physician awareness of disease fluctuations. We used logistic regressions to compare outcomes among patients who (1) used an app and discussed app data with their physician (app+discussion group), (2) used an app without discussing the data (app-only group) or (3) did not use any app (non-app users). RESULTS 2111 patients were analysed, including 1799 non-app users, 150 app-only users and 162 app+discussion users (43% male; with 902 patients with rheumatoid arthritis, 766 patients with axial spondyloarthritis and 443 patients with psoriatic arthritis). App users were younger than non-app users (mean age of 47 vs 51 years, p<0.001). Compared with non-app users, the app+discussion group rated their rheumatologist more highly in SDM (OR 1.7, 95% CI 1.1 to 2.4) and physician awareness of disease fluctuations (OR 2.0, 95% CI 1.3 to 3.1). This improvement was absent in the app-only group. CONCLUSION App users who discussed app data with their rheumatologist reported more favourably on patient-provider interactions than app users who did not and non-app users. Apps measuring PROs may contribute little to patient-provider interactions without integration of app data into care processes.

OBJECTIVES To analyse the predictive value of anti-carbamylated protein (anti-CarP) and anti-peptidyl-arginine deiminase type-3 (anti-PAD3) antibodies, alone or in combination with rheumatoid factors (RFs) and anti-citrullinated protein antibodies (ACPA), to identify patients at high risk of developing severe rheumatoid arthritis (RA) outcomes. METHODS Patients within the « Swiss Clinical Quality Management » registry with a biobank sample were tested for RFs, ACPA, anti-CarP, and anti-PAD3 antibodies. We examined the association of each autoantibody with DAS28, HAQ and radiographic damage (Ratingen) at baseline and longitudinally. RESULTS Analyses included 851 established RA patients and 516 disease controls [axial spondyloarthritis (axSpA = 320) and psoriatic arthritis (PsA = 196)]. Anti-CarP and anti-PAD3 antibodies were respectively present in 22.4% and 10.7% of the whole RA population, and in 13.2% and 3.8% of the RF and ACPA double seronegative patients. At baseline, RA patients with anti-PAD3 had higher DAS28 (4.2 vs 3.7; p = 0.005) and significantly more radiographic damage (14.9 vs 8.8; p = 0.02) than anti-PAD3 negative patients. In ACPA negative subgroup, baseline Ratingen scores were significantly higher in anti-PAD3 positive patients (p = 0.01). The combination of anti-PAD3, RF IgM, and ACPA was associated with significantly higher baseline radiographic scores than the double seropositive group (p = 0.04). The presence of any two of the previous autoantibodies was associated with significantly greater radiographic progression over 10 years than if all were absent (p = 0.02). There were no differences on RA outcome measures with regards to anti-CarP. CONCLUSIONS Anti-PAD3 antibodies are associated with higher disease activity and joint damage scores in RA patients.

Objectives This study aimed to examine the cumulative disadvantage of different forms of childhood misfortune and adult-life socioeconomic conditions with regard to trajectories and levels of self-rated health in old age and whether these associations differed between welfare regimes (Scandinavian, Bismarckian, Southern European, and Eastern European). Method The study included 24,004 respondents aged 50 to 96 from the longitudinal SHARE survey. Childhood misfortune included childhood socioeconomic conditions, adverse childhood experiences, and adverse childhood health experiences. Adult-life socioeconomic conditions consisted of education, main occupational position, and financial strain. We analyzed associations with poor self-rated health using confounder-adjusted mixed-effects logistic regression models for the complete sample and stratified by welfare regime. Results Disadvantaged respondents in terms of childhood misfortune and adult-life socioeconomic conditions had a higher risk of poor self-rated health at age 50. However, differences narrowed with aging between adverse-childhood-health-experiences categories (driven by Southern and Eastern European welfare regimes), categories of education (driven by Bismarckian welfare regime), and main occupational position (driven by Scandinavian welfare regime). Discussion Our research did not find evidence of cumulative disadvantage with aging in the studied life-course characteristics and age range. Instead, trajectories showed narrowing differences with differing patterns across welfare regimes.

Objectives This study aimed to examine the cumulative disadvantage of different forms of childhood misfortune and adult-life socioeconomic conditions with regard to trajectories and levels of self-rated health in old age and whether these associations differed between welfare regimes (Scandinavian, Bismarckian, Southern European, and Eastern European). Method The study included 24,004 respondents aged 50 to 96 from the longitudinal SHARE survey. Childhood misfortune included childhood socioeconomic conditions, adverse childhood experiences, and adverse childhood health experiences. Adult-life socioeconomic conditions consisted of education, main occupational position, and financial strain. We analyzed associations with poor self-rated health using confounder-adjusted mixed-effects logistic regression models for the complete sample and stratified by welfare regime. Results Disadvantaged respondents in terms of childhood misfortune and adult-life socioeconomic conditions had a higher risk of poor self-rated health at age 50. However, differences narrowed with aging between adverse-childhood-health-experiences categories (driven by Southern and Eastern European welfare regimes), categories of education (driven by Bismarckian welfare regime), and main occupational position (driven by Scandinavian welfare regime). Discussion Our research did not find evidence of cumulative disadvantage with aging in the studied life-course characteristics and age range. Instead, trajectories showed narrowing differences with differing patterns across welfare regimes.

Maha Emad Ibrahim,1,2 Kerstin Weber,3 Delphine S Courvoisier,1,4,5 Stéphane Genevay1 1Division of Rheumatology, University Hospitals of Geneva, Geneva, Switzerland; 2Department of Physical Medicine, Rheumatology and Rehabilitation, Suez Canal University, Ismailia, Egypt; 3Medical Direction, University Hospitals of Geneva, Geneva, Switzerland; 4Quality of Care Service, Geneva University Hospitals, Geneva, Switzerland; 5Department of Readaptation and Geriatrics, University of Geneva, Geneva, SwitzerlandCorrespondence: Maha Emad IbrahimDepartment of Physical Medicine, Rheumatology and Rehabilitation, Suez Canal University, Ring Road, Ismailia 41511, EgyptTel +20 1005607210Email maha.ibrahim@med.suez.edu.egPurpose: Physical dysfunction in chronic low back pain patients is influenced by psychological variables rather than by pain severity. Assessing personality traits may help clinicians address the complexity of patients’ experiences and design treatments that target these vulnerabilities. This study aimed to identify the distinguishing personality traits of a cohort of patients with disabling chronic low back pain and to determine associations between those traits and fear-avoidance beliefs, depressive, and anxious moods.Patients and Methods: This cross-sectional study included 102 chronic low back pain patients (57% male), who failed standard management and were referred to a multidisciplinary rehabilitation program. All patients completed the five domains of the NEO Personality Inventory (NEO PI)–Revised (Neuroticism, Extraversion, Openness to experience, Agreeableness and Conscientiousness), the Tampa Scale for Kinesiophobia (TSK), and the Hospital Anxiety and Depression Scale (HADS). One-sample t-test was used to compare sample personality means with average population norms. Association between the five personality domains with TSK and HADS was assessed using Pearson’s correlation, adjusted for patient demographics and pain

The self-rated health (SRH) item is frequently used in health surveys but variations of its form (wording, response options) may hinder comparisons between versions over time or across surveys. The objectives were to determine (a) whether three SRH forms are equivalent, (b) the form with the best construct validity and (c) the best coding scheme to maximize equivalence across forms.

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.

This study aimed to assess whether cumulative disadvantage in childhood misfortune and adult-life socioeconomic conditions influence the risk of frailty in old age and whether welfare regimes influence these associations.

Cognitive aging is characterized by large heterogeneity, which may be due to variations in childhood socio-economic conditions (CSC). Although there is substantial evidence for an effect of CSC on levels of cognitive functioning at older age, results on associations with cognitive decline are mixed. We examined by means of an accelerated longitudinal design the association between CSC and cognitive trajectories from 50 to 96 years. Cognition included two functions generally found to decline with aging: delayed recall and verbal fluency. Data are from six waves of the Survey of Health, Aging, and Retirement in Europe (SHARE), conducted between 2004 and 2015 (n = 24,066 at baseline; 56% female, age 50+). We found a consistent CSC pattern in levels of cognitive functioning in later life. Older people with disadvantaged CSC had lower levels of cognitive functioning than those with more advantaged CSC. We also find that decline is almost 1.6 times faster in the most advantaged group compared with the most disadvantaged group. The faster decline for people with more advantaged CSC becomes less pronounced when we additionally control for adulthood socio-economic conditions and current levels of physical activity, depressive symptoms, and partner status. Our findings are in line with the latency, pathway, and cumulative model and lend support to theories of cognitive reserve, stating that neuronal loss can no longer be repaired in people with more cognitive reserve once the underlying pathology is substantial and speed of decline is accelerated.

Objectives: This paper aimed to assess associations of childhood socioeconomic conditions (CSC) with the risk of frailty in old age and whether adulthood socioeconomic conditions (ASC) influence this association. Methods: Data from 21 185 individuals aged 50 years and older included in the longitudinal Survey of Health, Ageing, and Retirement in Europe were used. Frailty was operationalized as a sum of presenting weakness, shrinking, exhaustion, slowness, or low activity. Confounder-adjusted multilevel logistic regression models were used to analyze associations of CSC and ASC with frailty. Results: While disadvantaged CSC was associated with higher odds of (pre-)frailty in women and men (OR=1.73, 95%CI 1.34, 2.24; OR=1.84, 95%CI 1.27, 2.66, respectively), this association was mediated by ASC. Personal factors and demographics, such as birth cohort, chronic conditions and difficulties with activities of daily living, increased the odds of being (pre-)frail. Discussion: Findings suggest that CSC are associated with frailty at old age. However, when taking into account ASC, this association no longer persists. The results show the importance of improving socioeconomic conditions over the whole life course in order to reduce health inequalities in old age.

Background: Welfare regimes in Europe modify individuals' socioeconomic trajectories over their life-course, and, ultimately, the link between socioeconomic circumstances (SECs) and health. This paper aimed to assess whether the associations between life-course SECs (early-life, young adult-life, middle-age and old-age) and risk of poor self-rated health (SRH) trajectories in old age are modified by welfare regimes (Scandinavian [SC], Bismarckian [BM], Southern European [SE], Eastern European [EE]). Methods: We used data from the longitudinal SHARE survey. Early-life SECs consisted of four indicators of living conditions at age 10. Young adult-life, middle-age, and old-age SECs indicators were education, main occupation and satisfaction with household income, respectively. The association of life-course SECs with poor SRH trajectories was analysed by confounder-adjusted multilevel logistic regression models stratified by welfare regime. We included 24 011 participants (3626 in SC, 10 256 in BM, 6891 in SE, 3238 in EE) aged 50 to 96 years from 13 European countries. Results: The risk of poor SRH increased gradually with early-life SECs from most advantaged to most disadvantaged. The addition of adult-life SECs differentially attenuated the association of early-life SECs and SRH at older age across regimes: education attenuated the association only in SC and SE regimes and occupation only in SC and BM regimes; satisfaction with household income attenuated the association across regimes. Conclusions: Early-life SECs have a long-lasting effect on SRH in all welfare regimes. Adult-life SECs attenuated this influence differently across welfare regimes.

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.

Cognitive aging is characterized by large heterogeneity, which may be due to variations in childhood socio-economic conditions (CSC). Although there is substantial evidence for an effect of CSC on levels of cognitive functioning at older age, results on associations with cognitive decline are mixed. We examined by means of an accelerated longitudinal design the association between CSC and cognitive trajectories from 50 to 96 years. Cognition included two functions generally found to decline with aging: delayed recall and verbal fluency. Data are from six waves of the Survey of Health, Aging, and Retirement in Europe (SHARE), conducted between 2004 and 2015 (n = 24,066 at baseline; 56% female, age 50+). We found a consistent CSC pattern in levels of cognitive functioning in later life. Older people with disadvantaged CSC had lower levels of cognitive functioning than those with more advantaged CSC. We also find that decline is almost 1.6 times faster in the most advantaged group compared with the most disadvantaged group. The faster decline for people with more advantaged CSC becomes less pronounced when we additionally control for adulthood socio-economic conditions and current levels of physical activity, depressive symptoms, and partner status. Our findings are in line with the latency, pathway, and cumulative model and lend support to theories of cognitive reserve, stating that neuronal loss can no longer be repaired in people with more cognitive reserve once the underlying pathology is substantial and speed of decline is accelerated.

This study aimed to assess whether cumulative disadvantage in childhood misfortune and adult-life socioeconomic conditions influence the risk of frailty in old age and whether welfare regimes influence these associations.

Background: Welfare regimes in Europe modify individuals' socioeconomic trajectories over their life-course, and, ultimately, the link between socioeconomic circumstances (SECs) and health. This paper aimed to assess whether the associations between life-course SECs (early-life, young adult-life, middle-age and old-age) and risk of poor self-rated health (SRH) trajectories in old age are modified by welfare regimes (Scandinavian [SC], Bismarckian [BM], Southern European [SE], Eastern European [EE]). Methods: We used data from the longitudinal SHARE survey. Early-life SECs consisted of four indicators of living conditions at age 10. Young adult-life, middle-age, and old-age SECs indicators were education, main occupation and satisfaction with household income, respectively. The association of life-course SECs with poor SRH trajectories was analysed by confounder-adjusted multilevel logistic regression models stratified by welfare regime. We included 24 011 participants (3626 in SC, 10 256 in BM, 6891 in SE, 3238 in EE) aged 50 to 96 years from 13 European countries. Results: The risk of poor SRH increased gradually with early-life SECs from most advantaged to most disadvantaged. The addition of adult-life SECs differentially attenuated the association of early-life SECs and SRH at older age across regimes: education attenuated the association only in SC and SE regimes and occupation only in SC and BM regimes; satisfaction with household income attenuated the association across regimes. Conclusions: Early-life SECs have a long-lasting effect on SRH in all welfare regimes. Adult-life SECs attenuated this influence differently across welfare regimes.

Objectives: This paper aimed to assess associations of childhood socioeconomic conditions (CSC) with the risk of frailty in old age and whether adulthood socioeconomic conditions (ASC) influence this association. Methods: Data from 21 185 individuals aged 50 years and older included in the longitudinal Survey of Health, Ageing, and Retirement in Europe were used. Frailty was operationalized as a sum of presenting weakness, shrinking, exhaustion, slowness, or low activity. Confounder-adjusted multilevel logistic regression models were used to analyze associations of CSC and ASC with frailty. Results: While disadvantaged CSC was associated with higher odds of (pre-)frailty in women and men (OR=1.73, 95%CI 1.34, 2.24; OR=1.84, 95%CI 1.27, 2.66, respectively), this association was mediated by ASC. Personal factors and demographics, such as birth cohort, chronic conditions and difficulties with activities of daily living, increased the odds of being (pre-)frail. Discussion: Findings suggest that CSC are associated with frailty at old age. However, when taking into account ASC, this association no longer persists. The results show the importance of improving socioeconomic conditions over the whole life course in order to reduce health inequalities in old age.

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.

Purpose: Among the many questionnaires available to evaluate low back pain (LBP) patients, the Core Outcome Measures Index (COMI) has the unique advantage to investigate five dimensions using seven short questions. The aim of this study was to explore additional properties of the questionnaire in a French-speaking non-surgical population. Methods: This study was conducted on 168 patients suffering from subacute or chronic LBP and followed up for 6months in three French-speaking countries. In addition to basic psychometric properties (e.g., construct validity, floor and ceiling effect, reproducibility), internal validity was analyzed by a factor analysis using Cronbach's alpha. Responsiveness and sensitivity to change were assessed through minimal detectable change (MDC), effect size, and Minimal Clinically Important Improvement (MCII). We used an anchor-based method with receiver operating characteristic (ROC) curve analysis to assess MCII and the Patient Acceptable Symptom State. Results: Construct validity, reliability (Cronbach's alpha=0.87), reproducibility and the absence of floor and ceiling effects were confirmed. Factor analysis indicated a one-dimensional construct that validates the use of a sum score. The MDC (2.1) was inferior to the MCII (2.3). The limit below which the patient claims to be in a fair condition (Patient Acceptable Symptom State) was set at 3. Conclusions: The COMI is a self-report questionnaire with the capacity to easily and quickly explore several dimensions in patients with LBP that can be then summarized in a meaningful sum score. Additional knowledge provided by our study should encourage the widespread use of the COMI among the spine community.

Background and objective: Some subjects with untreated periodontitis exhibit elevated levels of distinct inflammatory markers in serum. The aim of the study was to assess whether nonsurgical periodontal therapy changes the levels of these markers and lowers these peaks. Methods: Forty periodontally diseased subjects received nonsurgical periodontal therapy (full-mouth scaling and root planing within 48h) with either adjunctive systemic amoxicillin and metronidazole (n = 19) or placebo (n = 21). Serum samples, obtained at baseline (BL) and 3months after treatment (M3), were evaluated for 15 cytokines and 9 acute-phase proteins using the Bio-Plex bead array multianalyte detection system. For each analyte, peak values were defined as greater than the mean + 2 standard deviations (SD) of measurements found in 40 periodontally healthy persons. Proportions were compared using Fisher's exact test. Results: At M3, a significantly better primary clinical outcome (persisting pockets of >4mm with bleeding on probing) was obtained in patients treated with scaling and root planing plus antibiotics compared to those receiving placebo (3.3 ± 5.1 vs. 6.8 ± 7.8 pockets per patient, p < 0.05). The levels of cytokines and acute-phase proteins of periodontitis patients were usually below the mean + 2 SD threshold of healthy persons. However, values above threshold were found in some individuals. Eleven patients showed a peak value of one analyte, and seven patients showed two peaks. In the remaining 12 patients, between three and ten analytes showed peak values. Therapy greatly reduced the number of subjects with four or more peaks (BL, 11 subjects; M3, 1 subject, p = 0.003). With regards to the reduction of peaks, no specific benefit of adjunctive antibiotics could be seen. Conclusion: Subjects with untreated periodontitis may show high peaks for several inflammatory markers in serum simultaneously. Nonsurgical periodontal treatment with or without antibiotics reduced most of these pe

Objectives: This study aimed to assess whether cumulative disadvantage in childhood misfortune and adult-life socioeconomic conditions influence the risk of frailty in old age and whether welfare regimes influence these associations. Method: Data from 23,358 participants aged 50 years and older included in the longitudinal SHARE survey were used. Frailty was operationalized according to Fried’s phenotype as presenting either weakness, shrinking, exhaustion, slowness, or low activity. Confounder-adjusted mixed-effects logistic regression models were used to analyze associations of childhood misfortune and life-course socioeconomic conditions with frailty. Results: Childhood misfortune and poor adult-life socioeconomic conditions increased the odds of (pre-)frailty at older age. With aging, differences narrowed between categories of adverse childhood experiences (driven by Scandinavian welfare regime) and adverse childhood health experiences (driven by Eastern European welfare regime), but increased between categories of occupational position (driven by Bismarckian welfare regime). Discussion: These findings suggest that childhood misfortune is linked to frailty in old age. Such a disadvantaged start in life does not seem to be compensated by a person’s life-course socioeconomic trajectory, though certain types of welfare regimes affected this relationship. Apart from main occupational position, our findings do not support the cumulative dis/advantage theory, but rather show narrowing differences.

Objective To compare the real-word effectiveness of subcutaneous tocilizumab (TCZ-SC) and intravenous tocilizumab (TCZ-IV) in rheumatoid arthritis (RA). Methods Patients with RA with TCZ from eight European registries were included. Drug retention was compared using unadjusted Kaplan-Meier and Cox models adjusted for baseline patient, disease and treatment characteristics, using a strata term for year of treatment initiation and country of registry. The proportions of patients achieving Clinical Disease Activity Index (CDAI) remission and low disease activity (LDA) at 1 year were compared using samples matched on the same covariates and corrected for attrition using LUNDEX. Results 3448 patients were retrieved, 2414 with TCZ-IV and 1034 with TCZ-SC. Crude median retention was 3.52 years (95% CI 3.22 to 3.85) for TCZ-IV and 2.12 years for TCZ-SC (95% CI 1.88 to 2.38). In a country-stratified and year of treatment initiation–stratified, covariate-adjusted analysis, hazards of discontinuation were similar between TCZ-SC and TCZ-IV treated patients (HR 0.93, 95% CI 0.80 to 1.09). The average adjusted CDAI change at 1 year was similar in both groups (−6.08). After matching, with 560 patients in each group, CDAI remission corrected for attrition at 1 year was also similar between TCZ-SC and TCZ-IV (10.4% in TCZ-IV vs 12.8% in TCZ-SC (difference: 2.4%, bootstrap 95% CI −2.1% to 7.6%)), but CDAI LDA was lower in TCZ-IV patients: 41.0% in TCZ-IV versus 49.1% in TCZ-SC (difference: 8.0 %; bootstrap 95% CI 2.4% to 12.4%). Conclusion With similar retention and effectiveness, TCZ-SC is an adequate alternative to TCZ-IV for RA. When possible, considering the costs of the TCZ-IV route, TCZ-SC should be the preferred mode of administration

Background: Acoustic radiation force impulse (ARFI) imaging) is correlated with histopathological findings using METAVIR and semiquantitative scoring system (SSS) criteria for liver fibrosis. Objective: To compare acoustic radiation force impulse imaging with biopsy results in the evaluation of liver fibrosis in children. Materials and methods: Children with chronic liver disease and healthy children underwent acoustic radiation force impulse imaging liver measurements. ARFI gives a shear-wave velocity corresponding to tissue elasticity. In 39 children with liver disease, the values obtained were correlated with biopsy results. Receiver-operating characteristic (ROC) curves were used to determine the reliability of ARFI in estimating liver fibrosis in children. Results: ARFI mean value was 1.12 in the healthy group and 1.99 in children with chronic liver disease. ROC curves show that an ARFI cutoff of 1.34m/s is predictive of both METAVIR and SSS scores with a sensitivity of SSS > 2:0.85; METAVIR > F0:0.82. A cutoff of 2m/s yielded a sensitivity of 100% to detect SSS > 4 or METAVIR > F2. Conclusion: Acoustic radiation force impulse imaging is a reliable, noninvasive and rapid method to estimate moderate to severe liver fibrosis in children. It might prove useful to clinicians for fibrosis monitoring in children with liver disease and postpone the time of liver biopsy

BACKGROUND: The probability of a disease following a diagnostic test depends on the sensitivity and specificity of the test, but also on the prevalence of the disease in the population of interest (or pre-test probability). How physicians use this information is not well known. OBJECTIVE: To assess whether physicians correctly estimate post-test probability according to various levels of prevalence and explore this skill across respondent groups. DESIGN: Randomized trial. PARTICIPANTS: Population-based sample of 1,361 physicians of all clinical specialties. INTERVENTION: We described a scenario of a highly accurate screening test (sensitivity 99% and specificity 99%) in which we randomly manipulated the prevalence of the disease (1%, 2%, 10%, 25%, 95%, or no information). MAIN MEASURES: We asked physicians to estimate the probability of disease following a positive test (categorized as <60%, 60-79%, 80-94%, 95-99.9%, and >99.9%). Each answer was correct for a different version of the scenario, and no answer was possible in the "no information” scenario. We estimated the proportion of physicians proficient in assessing post-test probability as the proportion of correct answers beyond the distribution of answers attributable to guessing. KEY RESULTS: Most respondents in each of the six groups (67%-82%) selected a post-test probability of 95-99.9%, regardless of the prevalence of disease and even when no information on prevalence was provided. This answer was correct only for a prevalence of 25%. We estimated that 9.1% (95% CI 6.0-14.0) of respondents knew how to assess correctly the post-test probability. This proportion did not vary with clinical experience or practice setting. CONCLUSIONS: Most physicians do not take into account the prevalence of disease when interpreting a positive test result. This may cause unnecessary testing and diagnostic errors

Background: Acoustic radiation force impulse imaging (ARFI) is a recent ultrasound technique to assess tissue stiffness. Objective: Our aim was to describe the feasibility and to define normal ARFI values in liver in children. Materials and methods: ARFI values were measured in 103 children (ages 2weeks to 17years) divided into four age groups, at a minimum depth of 3cm. In 20 children, measurements were done at 3-, 4- and 5-cm depth in the liver to assess the suitability of measurement location. The impact of age groups and of depth groups was examined using multilevel models. The precision of the measurements was determined using intraclass correlation coefficient (ICC). Results: There was no statistical difference between measurements taken at different ages, with a mean propagation velocity of 1.12m/s (range: 0.73 to 1.45m/s). There was no significant difference according to the depth of the regions of interest (up to 5cm). The ICC was 0.77 (95% CI 0.69-0.83). Conclusion: ARFI is feasible in children at any age with an acceptable reliability. The depth of measurements in the liver seems to have no influence on test results. We set the standard ARFI elastography values for healthy liver in children

Purpose: We explored health differences between population groups who describe their health as excellent, very good, good, fair, or poor. Methods: We used data from a population-based survey which included self-rated health (SRH) and three global measures of health: the SF36 general health score (computed from the 4 items other than SRH), the EQ-5D health utility, and a visual analogue health thermometer. We compared health characteristics of respondents across the five health ratings. Results: Survey respondents (N=1.844, 49.2% response) rated their health as excellent (12.2%), very good (39.1%), good (41.9%), fair (6.0%), or poor (0.9%). The means of global health assessments were not equidistant across these five groups, for example, means of the health thermometer were 95.8 (SRH excellent), 88.8 (SRH very good), 76.6 (SRH good), 49.7 (SRH fair), and 33.5 (SRH poor, p<0.001). Recoding the SRH to reflect these mean values substantially improved the variance explained by the SRH, for example, the linear r 2 increased from 0.50 to 0.56 for the health thermometer if the SRH was coded as poor=1, fair=2, good=3.7, very good=4.5, and excellent=5. Furthermore, transitions between response options were not explained by the same health-related characteristics of the respondents. Conclusions: The adjectival SRH is not an evenly spaced interval scale. However, it can be turned into an interval variable if the ratings are recoded in proportion to the underlying construct of health. Possible improvements include the addition of a rating option between good and fair or the use of a numerical scale instead of the classic adjectival scale

Previous research suggests that certain dimensions of perfectionism are associated with insomnia. However, the exact processes whereby perfectionism may influence sleep have as yet remained unexplored. The present study tested the hypothesis that perfectionistic individuals are particularly prone to engage in counterfactual thinking and to experience counterfactual emotions (regret, shame, and guilt) at bedtime, which have been shown to impair sleep. One hundred eighty university students completed questionnaires on perfectionism, counterfactual processing, and insomnia severity. Analyses revealed that three dimensions of perfectionism were significantly related to insomnia severity: Concern over mistakes and doubts about action showed positive correlations, whereas organization showed a negative correlation. Moreover, the frequency of counterfactual thoughts and emotions at bedtime largely mediated the effects of these dimensions of perfectionism on insomnia severity. These findings highlight how personality-related patterns of behavior may translate into affective arousal at bedtime, thereby increasing the risk of insomnia.

Some evidences suggest that obesity impairs the effectiveness of TNF inhibitors. We examined the impact of body mass index (BMI) on the clinical effectiveness of abatacept in rheumatoid arthritis (RA) patients. This is a pooled analysis of 10 prospective cohorts of RA patients. All patients with available BMI were included in this study. The primary endpoint was drug retention of abatacept in the different BMI categories. Multivariable Cox regression was used to estimate hazard ratios (HRs) for drug discontinuation. A secondary endpoint was EULAR/LUNDEX response rates at 6/12 months. Of the 2015 RA patients initiating therapy with IV abatacept, 380 (18.9%) were classified as obese. Obese patients had more functional disability, and were less often RF positive. The median abatacept retention time was 1.91 years for obese RA patients compared to 2.12 years for non-obese patients (p = 0.15). The risk of abatacept discontinuation was not significantly different for overweight (HR 1.03 (95% CI 0.89-1.19)), or for obese (HR 1.08 (95% CI 0.89-1.30)) compared to normal-weight patients. Rheumatoid factor positivity reduced the risk of abatacept discontinuation (HR 0.83 (95% CI 0.72-0.95)), while previous biologic therapy was positively associated with drug interruption (HRs increasing from 1.68 to 2.16 with the line of treatments). Obese and non-obese patients attained similar rates of EULAR/LUNDEX clinical response at 6/12 months. Drug retention and clinical response rates to abatacept do not seem to be decreased by obesity in RA patients.

Objective To compare users' speed, number of entry errors and satisfaction in using two current devices for electronic data collection in clinical research: handheld and laptop computers. Design The authors performed a randomized cross-over trial using 160 different paper-based questionnaires and representing altogether 45,440 variables. Four data coders were instructed to record, according to a random predefined and equally balanced sequence, the content of these questionnaires either on a laptop or on a handheld computer. Instructions on the kind of device to be used were provided to data-coders in individual sealed and opaque envelopes. Study conditions were controlled and the data entry process performed in a quiet environment. Measurements The authors compared the duration of the data recording process, the number of errors and users' satisfaction with the two devices. The authors divided errors into two separate categories, typing and missing data errors. The original paper-based questionnaire was used as a gold-standard. Results The overall duration of the recording process was significantly reduced (2.0 versus 3.3 min) when data were recorded on the laptop computer (p < 0.001). Data accuracy also improved. There were 5.8 typing errors per 1,000 entries with the laptop compared to 8.4 per 1,000 with the handheld computer (p < 0.001). The difference was even more important for missing data which decreased from 22.8 to 2.9 per 1,000 entries when a laptop was used (p < 0.001). Users found the laptop easier, faster and more satisfying to use than the handheld computer. Conclusions Despite the increasing use of handheld computers for electronic data collection in clinical research, these devices should be used with caution. They double the duration of the data entry process and significantly increase the risk of typing errors and missing data. This may become a particularly crucial issue in studies where these devices are provided to patients or healthcare

Objective Measurement of health utility is important for quality improvement, but instruments vary in their content. Multi-attribute health utility measures typically assess a small number of health problems, e.g. the EuroQoL EQ-5D questionnaire explores five dimensions of health. We aimed to examine whether a small number of dimensions explains a sufficient amount of variance in self-perceived health, and what can be gained from adding additional dimensions. Design Cross-sectional mail survey that explored health utility and self-perceived health. Setting General resident population of French-speaking Switzerland. Participants Non-institutionalized adults. Main outcome measures EQ-5D (which measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue health scale between 0 and 100 (VAS)). A subsample rated five additional health dimensions (sleep, memory/concentration, energy/fatigue, sight/hearing, contacts with others). Results In total, 349 adults returned the extended 10-item questionnaire. All added items were strongly and significantly associated with the VAS for perceived health. The proportion of variance explained (R2) in the VAS was 0.47 for the original EQ-5D items (adjusted for attenuation: 0.65), 0.47 for the new items (adjusted for attenuation: 0.65) and 0.56 for the 10 items together (adjusted for attenuation: 0.78). Forty-four percent of the respondents who had a perfect health utility on the EQ-5D reported at least one problem in the new health dimensions. Conclusion Self-perceived health among the general public is influenced by more health dimensions than are typically measured in a multi-attribute health-utility instrument

PURPOSE: The Core Outcome Measure Index (COMI) is a multidimensional questionnaire that investigates five dimensions in low back pain (LBP) patients, but does not address the psychological dimension. As the biopsychosocial perspective is recognized as important to capture the entire clinical picture of these patients, this multicenter prospective cohort study was designed to investigate the psychometric properties of a modified version of the COMI (COMIAD) which included 2 additional items, exploring anxiety and depression, respectively. METHODS: 168 subacute or chronic LBP patients recruited in spine clinics completed a set of questionnaires before and after treatment (follow-up at 6 months). Construct validity was explored by comparing each item of the COMIAD to validated full-length questionnaires. Thus two additional questionnaires were included to assess the construct validity of the anxiety and depression measures. The psychometric properties of the COMI and COMIAD were then compared. RESULTS: The two new items showed good internal consistency, high correlations with the corresponding full-length questionnaires, no floor or ceiling effect and good reproducibility (test-retest agreement kappa 0.68 for anxiety, 0.62 for depression). The addition of the 2 items did not alter internal validity (Cronbach's alpha = 0.88 and 0.87, respectively). The smallest detectable difference, the Minimal Clinically Important Improvement and the Patient Acceptable Symptom State were only minimally affected by the changes. CONCLUSION: The questions exploring anxiety and depression have good intrinsic and psychometric capacities (i.e., no floor or ceiling effects and high correlations with full-length scales) and did not significantly modify the psychometrics of the original COMI questionnaire. The COMIAD offers the possibility to include the psychological dimension in the multidimensional evaluation without significantly affecting questionnaire length.

PURPOSE: The Core Outcome Measure Index (COMI) is a multidimensional questionnaire that investigates five dimensions in low back pain (LBP) patients, but does not address the psychological dimension. As the biopsychosocial perspective is recognized as important to capture the entire clinical picture of these patients, this multicenter prospective cohort study was designed to investigate the psychometric properties of a modified version of the COMI (COMIAD) which included 2 additional items, exploring anxiety and depression, respectively. METHODS: 168 subacute or chronic LBP patients recruited in spine clinics completed a set of questionnaires before and after treatment (follow-up at 6 months). Construct validity was explored by comparing each item of the COMIAD to validated full-length questionnaires. Thus two additional questionnaires were included to assess the construct validity of the anxiety and depression measures. The psychometric properties of the COMI and COMIAD were then compared. RESULTS: The two new items showed good internal consistency, high correlations with the corresponding full-length questionnaires, no floor or ceiling effect and good reproducibility (test-retest agreement kappa 0.68 for anxiety, 0.62 for depression). The addition of the 2 items did not alter internal validity (Cronbach's alpha = 0.88 and 0.87, respectively). The smallest detectable difference, the Minimal Clinically Important Improvement and the Patient Acceptable Symptom State were only minimally affected by the changes. CONCLUSION: The questions exploring anxiety and depression have good intrinsic and psychometric capacities (i.e., no floor or ceiling effects and high correlations with full-length scales) and did not significantly modify the psychometrics of the original COMI questionnaire. The COMIAD offers the possibility to include the psychological dimension in the multidimensional evaluation without significantly affecting questionnaire length.