Effectiveness of a positive psychology and mindfulness-based app on mental health for parents of children with a neurodevelopmental disorder: study protocol of a pragmatic international randomized controlled trial.

INTRODUCTION: Parents of children with a neurodevelopmental disorder (NDD) experience more stress than parents of typically developing children. In a cocreation process with experts and parents, a low-threshold application that uses exercises based on the principles of positive psychology and mindfulness was developed. This application, called "Adappt," aims at enhancing the ability to adapt of the parents and caregivers of children with NDDs and at supporting their mental health. This protocol describes the evaluation study of the effectiveness of Adappt, its core working mechanisms and user experiences. METHOD: A pragmatic international multicenter randomized controlled trial will compare the effectiveness of Adappt with a (delayed) waitlist control condition. At least 212 parents or primary caregivers of children younger than 18 years diagnosed with or suspected of a NDD will be randomly assigned to the intervention or waitlist control condition. Participants are excluded if they have severe anxiety or depression levels or are in treatment for mental health issues. Measures will be collected online at baseline, post-intervention (1 month after baseline), and 4 and 7 months after baseline. The primary outcome is the improvement in generic sense of ability to adapt as measured with the Generic Sense of Ability to Adapt Scale (GSAAS; (Front Psychol 14:985408, 2023)) at 4-month follow-up. Secondary outcomes are mental well-being, (parental) distress, and client satisfaction with "Adappt." DISCUSSION: Results of this study will contribute to knowledge on the effectiveness of a low-threshold application for parents of children with a NDD in multiple countries. If the application is found to be effective in improving mental health, recommendations will be made for implementation in health care. TRIAL REGISTRATION: This study is registered on clinicaltrials.gov (NCT06248762) on February 8, 2024, and the Open Science Framework ( https://osf.io/5znqv ).

Predicting which intervention works better for whom: Moderators of treatment effect of Mindfulness-Based Cognitive Therapy and Positive Psychology Intervention in patients with bipolar disorder.

BACKGROUND: This study aimed to identify moderators of treatment effect (i.e. depressive symptoms and well-being) of Mindfulness-Based Cognitive Therapy (MBCT) and Positive Psychology Intervention (PPI) in patients with bipolar disorder. METHODS: Data were drawn from two multicenter randomized controlled trials investigating effectiveness of MBCT vs treatment as usual (TAU; n = 144) and PPI vs TAU (n = 97) in bipolar disorder. Outcomes were assessed at baseline, posttreatment, and 12 months after baseline. Data were analyzed using separate linear regression models, comparing the pooled MBCT or PPI outcomes to TAU, and comparing MBCT to PPI. RESULTS: The exploratory analyses not corrected for multiple comparisons showed a number of variables that were associated with stronger response to the interventions, including higher baseline anxiety, lower well-being, and lower levels of self-focused positive rumination, well-being, and self-compassion, and variables associated with a stronger response to either MBCT (higher levels of depression and anxiety and being married) or PPI (being male). After correcting for multiple testing, depressive symptoms appeared to be the most robust variable associated with better response to MBCT than PPI. LIMITATIONS: The RCTs handled slightly different enrollment criteria and outcome measures. CONCLUSIONS: The most robust finding is that patients with more severe symptomatology seem to benefit more from MBCT than PPI. CLINICAL IMPLICATIONS: This is a first step to improve personalized assignment of third-wave CBT interventions for patients with bipolar disorder. However, before definite treatment assignment criteria can be formulated and implemented in clinical practice, these findings should be replicated.

PERFECTRA: a pragmatic, multicentre, real-life study comparing treat-to-target strategies with baricitinib versus TNF inhibitors in patients with active rheumatoid arthritis after failure on csDMARDs.

OBJECTIVE: To compare the effectiveness of a strategy administering baricitinib versus one using TNF-inhibitors (TNFi) in patients with rheumatoid arthritis (RA) after conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) failure in a real-life treat-to-target (T2T) setting. METHODS: Patients with biological and targeted synthetic DMARD (b/tsDMARD) naïve RA with disease duration ≤5 years without contraindications to b/tsDMARD were randomised to either TNFi or baricitinib when csDMARD failed to achieve disease control in a T2T setting. Changes in clinical and patient-reported outcome measures (PROMs) were assessed at 12-week intervals for 48 weeks. The primary endpoint was non-inferiority, with testing for superiority if non-inferiority is demonstrated, of baricitinib strategy in the number of patients achieving American College of Rheumatology 50 (ACR50) response at 12 weeks. Secondary endpoints included 28-joint count Disease Activity Score with C reactive protein (DAS28-CRP) <2.6, changes in PROMs and radiographic progression. RESULTS: A total of 199 patients (TNFi, n=102; baricitinib, n=97) were studied. Both study groups were similar. Baricitinib was both non-inferior and superior in achieving ACR50 response at week 12 (42% vs 20%). Moreover, 75% of baricitinib patients achieved DAS28-CRP <2.6 at week 12 compared with 46% of TNFi patients. On secondary outcomes throughout the duration of the study, the baricitinib strategy demonstrated comparable or better outcomes than TNFi strategy. Although not powered for safety, no unexpected safety signals were seen in this relatively small group of patients. CONCLUSION: Up to present, in a T2T setting, patients with RA failing csDMARDs have two main strategies to consider, Janus Kinases inhibitor versus bDMARDs (in clinical practice, predominantly TNFi). The PERFECTRA study suggested that starting with baricitinib was superior over TNFi in achieving response at 12 weeks and resulted in improved outcomes across all studied clinical measures and PROMs throughout the study duration in these patients.

Test-Retest Reliability of the Generalized Pain Questionnaire in Patients with Rheumatoid Arthritis and Preliminary Reference Values for Non-Clinical and Several Clinical Samples.

Introduction: Generalized pain hypersensitivity is a characteristic feature in many different types of chronic pain. Recently, a 7-item self-reported Generalized Pain Questionnaire (GPQ) was developed to evaluate the presence and severity of generalized pain hypersensitivity in chronic pain patients. Here, we evaluate the test-retest reliability of the GPQ and report on preliminary reference values for various patient groups and healthy subjects. Methods: Eighty-five patients diagnosed with Rheumatoid Arthritis (RA) completed the GPQ twice over a 2-week interval. Relative and absolute indicators of reliability were determined using data of 69 patients (81.2% retest response rate). Using readily available datasets, preliminary reference data were established in two nonclinical populations (NCP1; N = 30 and NCP2; N = 111), and for patients diagnosed with RA (N = 114), gout (N = 97), fibromyalgia (N=98), or neuropathy (N = 25), or participants in a pain rehabilitation program (N = 33). Results: Total GPQ scores had an ICC of 0.78 (95% CI: 0.67 to 0.86). While no systematic or proportional differences were found for the GPQ total score; two (near-)significant systematic differences were observed for the individual questions. The standard error of measurement and minimal detectable change were 2.22 and 6.2, respectively. Mean ± SD scores were found to be 0.8 ± 1.2 (NCP1), 4.0 ± 4.6 (NCP2), 6.4 ± 5.5 (Gout), 6.5 ± 5.1 (RA), 8.1 ± 4.5 (Neuropathy), 13.6 ± 4.0 (Rehabilitation) and 16.0 ± 5.0 (Fibromyalgia). Discussion: This study shows that the GPQ has acceptable reliability to be used as a tool to evaluate the presence and intensity of generalized pain hypersensitivity. The absolute measures of reliability and the preliminary reference values reported here aid in the interpretation of future studies with the GPQ.

Predicting non-improvement of symptoms in daily mental healthcare practice using routinely collected patient-level data: a machine learning approach.

Objectives: Anxiety and mood disorders greatly affect the quality of life for individuals worldwide. A substantial proportion of patients do not sufficiently improve during evidence-based treatments in mental healthcare. It remains challenging to predict which patients will or will not benefit. Moreover, the limited research available on predictors of treatment outcomes comes from efficacy RCTs with strict selection criteria which may limit generalizability to a real-world context. The current study evaluates the performance of different machine learning (ML) models in predicting non-improvement in an observational sample of patients treated in routine specialized mental healthcare. Methods: In the current longitudinal exploratory prediction study diagnosis-related, sociodemographic, clinical and routinely collected patient-reported quantitative outcome measures were acquired during treatment as usual of 755 patients with a primary anxiety, depressive, obsessive compulsive or trauma-related disorder in a specialized outpatient mental healthcare center. ML algorithms were trained to predict non-response (< 0.5 standard deviation improvement) in symptomatic distress 6 months after baseline. Different models were trained, including models with and without early change scores in psychopathology and well-being and models with a trimmed set of predictor variables. Performance of trained models was evaluated in a hold-out sample (30%) as a proxy for unseen data. Results: ML models without early change scores performed poorly in predicting six-month non-response in the hold-out sample with Area Under the Curves (AUCs) < 0.63. Including early change scores slightly improved the models' performance (AUC range: 0.68-0.73). Computationally-intensive ML models did not significantly outperform logistic regression (AUC: 0.69). Reduced prediction models performed similar to the full prediction models in both the models without (AUC: 0.58-0.62 vs. 0.58-0.63) and models with early change scores (AUC: 0.69-0.73 vs. 0.68-0.71). Across different ML algorithms, early change scores in psychopathology and well-being consistently emerged as important predictors for non-improvement. Conclusion: Accurately predicting treatment outcomes in a mental healthcare context remains challenging. While advanced ML algorithms offer flexibility, they showed limited additional value compared to traditional logistic regression in this study. The current study confirmed the importance of taking early change scores in both psychopathology and well-being into account for predicting longer-term outcomes in symptomatic distress.

Further evaluation of inflammatory and non-inflammatory aspects of pain in rheumatoid arthritis patients.

Objective: A high discrepancy between the number of tender and swollen joints (e.g. ΔTSJ ≥ 7) has previously been used as an indication for the presence of changes in central mechanisms in patients with moderate-to-high disease activity. In this study, we explored whether the ΔTSJ can also be used to obtain insights into the underlying pain mechanisms in patients with on average well-controlled disease activity. Methods: A 2 year retrospective analysis of routinely obtained 28-joint DAS (DAS28) components was performed on 45 patients with low inflammatory activity at the group level. All patients underwent pressure pain threshold (PPT) and electrical pain threshold (EPT) measurements and completed four self-report questionnaires [short-form 36 (SF-36v2); central sensitization inventory (CSI); generalized pain questionnaire (GPQ); and the pain catastrophizing scale (PCS)]. Results: Patients with a ΔTSJ ≥ 3 at least once in the past 2 years showed significantly lower EPT and PPT values and higher levels of pain and disability on the SF-36v2 compared with the ΔTSJ < 3 group. Furthermore, GPQ scores were significantly higher in those with ΔTSJ ≥ 3, while CSI and PCS scores were similar. Conclusion: These findings suggest that in patients in the ΔTSJ ≥ 3 group, mechanisms other than inflammation (only) underlie the pain. Moreover, our findings suggest that among the multiple potential underlying psychological mechanisms, pain catastrophizing (as measured by the PCS) and psychological hypervigilance (as measured by the CSI) do not play an important role. These findings could be useful in the clinical management of the patient. Depending on the dominant mechanism underlying the (persistent) pain, patients might respond differently to treatment.

Objectively assessed long-term wearing patterns and predictors of wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of foot ulceration: a 12 months observational study.

BACKGROUND: Orthopaedic footwear can only be effective in preventing diabetic foot ulcers if worn by the patient. Robust data on long-term wearing time of orthopaedic footwear are not available, and needed to gain more insights into wearing patterns and associated factors (i.e. participants' demographic, disease-related characteristics, and footwear usability). We aimed to objectively assess long-term wearing patterns and identify factors associated with wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of ulceration. METHODS: People diagnosed with diabetes mellitus type 1 and 2 with loss of protective sensation and/or peripheral artery disease and prescribed with orthopaedic footwear were included and followed for 12 months. The primary outcome was mean daily wearing time, continuously measured using a temperature sensor inside the footwear (Orthotimer®). Adherence to wearing orthopaedic footwear was calculated as percentage of wearing time of a total assumed 16 h out-of-bed daytime, where adherence < 60% was a pre-determined non-adherent threshold. Wearing time patterns were assessed by calculating participants' wearing (in)consistency. One-way analyses of variance tested for wearing time differences between subgroups, weekdays, and weekend days. Factors potentially associated with wearing time were collected by questionnaires and medical files. Univariately associated factors were included in multivariate linear regression analysis. RESULTS: Sixty one participants were included (mean (SD) age: 68.0 (7.4) years; females: n = 17; type 2 diabetes mellitus: n = 54). Mean (SD) overall daily wearing time was 8.3 (6.1) hours/day. A total of 40 (66%) participants were non-adherent. Participants with a consistent wearing pattern showed higher daily wearing times than participants with an inconsistent pattern. Mean (SD) wearing times were 12.7 (4.3) vs 3.6 (4.8) hours/day, respectively (P < 0.001). Mean (SD) wearing time was significantly higher (P < 0.010) during weekdays (8.7 (6.0) hours/day) compared to Saturday (8.0 (6.1) hours/day) and Sunday (6.9 (6.2) hours/day). In the multivariate model (R2 = 0.28), "satisfaction with my wear of orthopaedic footwear" was positively associated (P < 0.001) with wearing time. The other seven multivariate model factors (four demographic variables and three footwear usability variables) were not associated with wearing time. CONCLUSIONS: Only one out of three people at moderate to high risk of foot ulceration were sufficiently adherent to wearing their orthopaedic footwear. Changing people's wearing behaviour to a more stable pattern seems a potential avenue to improve long-term adherence to wearing orthopaedic footwear. Investigated factors are not associated with daily wearing time. Based on these factors the daily wearing time cannot be estimated in daily practice. TRIAL REGISTRATION: Netherlands Trial Register NL7710. Registered: 6 May 2019.

Exploring mental health dynamics during eating disorder treatment: A psychometric network study with panel data.

To explore mental health associations during eating disorder (ED) treatment. Based on the dual-continua model of mental health, general and ED-specific psychopathology, as well as emotional, psychological, and social well-being were considered as mental health domains.Network analyses with panel data were applied to explore within- (temporal and contemporaneous networks) and between-person effects in a sample of 1250 female ED patients during 12 months of outpatient treatment. The associations between the domains and their centrality were examined. Autoregressive and cross-lagged effects were also estimated.ED psychopathology was the most central domain in the temporal network. ED psychopathology changes predicted further ED psychopathology changes and small changes in the other domains. Weak bi-directional associations were found between changes in the well-being domains and general psychopathology. In contrast to the temporal network, ED psychopathology was the least central and psychological well-being the most central domain in the contemporaneous and between-subjects networks. This suggests a central role of psychological well-being for experiencing mental health within time points.ED psychopathology may change relatively independent from other mental health domains. Well-being domains may be considered as more stable aspects of mental health.

First validation of the model of sustainable mental health: Structural model validity and the indirect role of adaptation.

OBJECTIVES: There is a growing interest in mental well-being as a vital outcome in clinical practice in addition to mental illness. The model of sustainable mental health (SMH) was recently introduced to delineate how interventions can improve mental health by targeting barriers and resources of adaptation to life stressors, improving the ability to adapt and thereby reducing mental illness and improving mental well-being. The aim of the current study is to empirically validate the conceptual model of SMH as well as the assumed indirect role of ability to adapt. METHODS: This study used an existing dataset of the general population with self-reported reduced well-being due to the corona crisis (n = 849, mean age 53 years, SD = 15). Measurements of mental illness (depression and anxiety), mental well-being, ability to adapt, a specific barrier for adaptation (i.e., repetitive negative thinking), and a specific resource for adaptation (i.e., positive reframing) were included. Structural equation modeling was used to assess both the structural validity of the model and the indirect effect of ability to adapt. RESULTS: An acceptable to good fit was found for the model of SMH and all paths between the proposed elements of the model were significant and in the hypothesized direction. Ability to adapt served as an indirect pathway trough which repetitive negative thinking (B = 0.149, 95% confidence interval [CI] = 0.016-0.028) and positive reframing (B = 0.163, 95% CI = 0.065-0.123) were linked with mental illness and mental well-being. CONCLUSION: The current study provides the first empirical support of the internal validity of the model of SMH in a sample of the general population with reduced well-being, suggesting that barriers and resources to adaptation have an effect on mental illness and mental well-being through the ability to adapt. The model of SMH may therefore be a good model to use in research and clinical practice for developing, implementing, and evaluating a balanced treatment approach targeting both barriers and resources for adaptation.

Introduction of the generic sense of ability to adapt scale and validation in a sample of outpatient adults with mental health problems.

Introduction: The ability to adapt is a core aspect of daily human life. Recent models and theories emphasize its essential role for health and well-being. It concerns the perceived ability to readjust and actively deal with the psychosocial consequences of challenging events. While many questionnaires measure competences related to adaptability to specific conditions, a scale that measures a generic sense of the ability to adapt is lacking. The aim of the present study is to introduce the Generic Sense of Ability to Adapt Scale (GSAAS) and to examine its psychometric properties. Methods: The article describes two sub-studies. In the first study the items of the GSAAS were generated and field-tested in a cross-sectional non-clinical sample using item analysis, exploratory factor analysis and Rasch analysis. Results: This resulted in a 10-item questionnaire measuring a single dimension with good reliability (Cronbach's α = 0.87). In the second study the 10-item scale was validated using a cross-sectional sample of 496 outpatient adults with mental health problems. Confirmatory factor analysis confirmed the unidimensional structure of the GSAAS and the absence of measurement variance across gender, age and education. Reliability was high (α = 0.89) and moderate to strong correlations between the GSAAS and concurrent validation measures confirmed its convergent validity. Regarding incremental validity, the GSAAS accounted for 7.4% additional explained variance in symptomatic distress above and beyond sense of coherence. Discussion: In conclusion, the GSAAS appears to be a reliable and valid instrument to assess people's generic sense of the ability to adapt. It is a practical and quick tool that can be used to measure a vital aspect of health in research and clinical treatment settings.

A multicomponent positive psychology intervention for euthymic patients with bipolar disorder to improve mental well-being and personal recovery: A pragmatic randomized controlled trial.

OBJECTIVE: Mental well-being and personal recovery are important treatment targets for patients with bipolar disorder (BD). The goal of this study was to evaluate the effectiveness of an 8-week group multicomponent positive psychology intervention (PPI) for euthymic patients with BD as an adjunct to treatment as usual (TAU) compared to TAU alone. METHODS: Patients with BD were randomized to receive TAU (n = 43) or the PPI in addition to TAU (n = 54). The primary outcome was well being measured with the Mental Health Continuum-Short Form. Personal recovery was measured with the Questionnaire about the Process of Recovery. Data were collected at baseline, mid-treatment, post-treatment and 6- and 12-month follow-up. Life chart interviews were conducted at 12 months to retrospectively assess recurrence of depression and mania. RESULTS: Significant group-by-time interaction effects for well-being and personal recovery were found favouring the PPI. At post-treatment, between-group differences were significant for well-being (d = 0.77) and personal recovery (d = 0.76). Between-group effects for well-being were still significant at 6-month follow-up (d = 0.72). Effects on well-being and personal recovery within the intervention group were sustained until 12-month follow-up. Survival analyses showed no significant differences in time to recurrence. CONCLUSIONS: The multicomponent PPI evaluated in this study is effective in improving mental well-being and personal recovery in euthymic patients with BD and would therefore be a valuable addition to the current treatment of euthymic BD patients. The fact that the study was carried out in a pragmatic RCT demonstrates that this intervention can be applied in a real-world clinical setting.

Impact of adverse drug reactions on the treatment pathways of early rheumatoid arthritis patients: a prospective observational cohort study.

BACKGROUND: Several patient characteristics may be of influence on treatment pathways of rheumatoid arthritis (RA) patients in clinical practice. The aim of this study is to analyze treatment pathways of early RA patients stratified for gender and adverse drug reaction (ADR) occurrence. RESEARCH DESIGN AND METHODS: Treatment pathways of patients included in the DREAM-RA treat-to-target cohort I between 16th of July 2006-30th of April 2020 were assessed. Treatment pathways were visualized in Sankey diagrams. Follow-up time, duration per treatment and the number of treatments received were stratified for gender and ADR occurrence and analyzed. Independent t-tests and chi-square tests were performed where applicable. RESULTS: Treatment pathways of 372 patients (follow-up: 2488.4 years, mean 6.7 ± 3.7 years) were analyzed. The Sankey diagrams visualize that treatment pathways became increasingly varied and complex over time. No significant differences were found when comparing female patients and male patients. However, the average treatment duration was shorter in patients with ADRs (1.8 vs. 2.7 years, p < 0.05), and the number of treatments higher (3.5 vs. 2.5, p < 0.05). CONCLUSIONS: Treatment pathways increase in complexity over time. Differences were found between patients with and without ADRs, with patients that experience ADRs receiving more and shorter treatments.

The Traumatic Grief Inventory-Clinician Administered: A psychometric evaluation of a new interview for ICD-11 and DSM-5-TR prolonged grief disorder severity and probable caseness.

BACKGROUND: There is a need for an interview-based measure to assess Prolonged Grief Disorder (PGD) included in the text revision of the fifth Diagnostic and Statistical Manual for Mental Disorder (DSM-5-TR) and 11th edition of the International Classification of Disease (ICD-11). We evaluated the psychometric properties of the Traumatic Grief Inventory-Clinician Administered (TGI-CA); a new interview measuring DSM-5-TR and ICD-11 PGD severity and probable caseness. METHODS: In 211 Dutch and 222 German bereaved adults, the: (i) factor structure, (ii) internal consistency, (iii) test-retest reliability, (iv) measurement invariance across subgroups (e.g., differing in language), (v) prevalence of probable caseness, (vi) convergent validity, and (vii) known-groups validity were examined. RESULTS: Confirmatory factor analyses (CFAs) showed acceptable fit for the unidimensional model for DSM-5-TR and ICD-11 PGD. Omega values indicated good internal consistency. Test-retest reliability was high. Multi-group CFAs demonstrated configural and metric invariance for DSM-5-TR and ICD-11 PGD criteria for all group-comparisons; for some we found support for scalar invariance. Rates of probable caseness for DSM-5-TR PGD were lower than ICD-11 PGD. Optimal agreement in probable caseness was reached when increasing the number of accessory symptoms for ICD-11 PGD from 1+ to 3+. Convergent and known-groups validity was demonstrated for both criteria-sets. LIMITATIONS: The TGI-CA was developed to assess PGD severity and probable caseness. Clinical diagnostic interviews for PGD are needed. CONCLUSIONS: The TGI-CA seems a reliable and valid interview for DSM-5-TR and ICD-11 PGD symptomatology. More research in larger and more diverse samples is needed to further test its psychometric properties.

Development and validation of a Manic Thought Inventory.

OBJECTIVE: This article describes the development and psychometric evaluation of the Manic Thought Inventory (MTI), a patient-driven self-report inventory to assess the presence of typical (hypo)manic cognitions. METHODS: The initial item pool was generated by patients with bipolar disorder (BD) type I and assessed for suitability by five psychiatrists specialized in treating BD. Study 1 describes the item analysis and exploratory factor structure of the MTI in a sample of 251 patients with BD type I. In study 2, the factor structure was validated with confirmatory factor analysis, and convergent and divergent validity were assessed in an independent sample of 201 patients with BD type I. RESULTS: Study 1 resulted in a 50-item version of the MTI measuring one underlying factor. Study 2 confirmed the essentially unidimensional underlying construct in a 47-item version of the MTI. Internal consistency of the 47-item version of the MTI was excellent (α = 0.97). The MTI showed moderate to large positive correlations with other measures related to mania. It was not correlated with measures of depression. CONCLUSION: The MTI showed good psychometric properties and can be useful in research and clinical practice. Patients could use the MTI to select items that they recognize as being characteristic of their (hypo)manic episodes. By monitoring and challenging these items, the MTI could augment current psychological interventions for BD.

The impact of health literacy: associations with disease activity and medication prescription in patients with rheumatoid arthritis.

OBJECTIVE: The aim of this study was to explore the longitudinal associations between health literacy profiles and disease activity and medication prescription in patients with RA. METHODS: Patients with RA who previously completed the Health Literacy Questionnaire (HLQ) and were assigned 1 of 10 distinct health literacy profiles based on cluster analysis were further aggregated into three groups: 'several health literacy limitations', 'some health literacy limitations' and 'good health literacy'. Linear mixed modelling (LMM) was used to analyse the association between health literacy groups and disease activity over the course of 1 year. Chi-squared tests and logistic regression analyses were used to compare medication prescriptions between the groups. RESULTS: A total of 108 patients with RA were included. LMM showed a significant effect of health literacy group on disease activity over time (P = 0.010). Patients with 'good health literacy' had significantly lower disease activity over time [28-joint DAS with ESR (DAS28-ESR) = 2.4] than patients with 'several health literacy limitations' (DAS28-ESR = 3.1), independent of age, gender and education level. Patients with 'good health literacy' were most often prescribed a biologic DMARD (50%), whereas patients with 'some health literacy limitations' more commonly received a conventional synthetic DMARD only [72.7%; odds ratio (OR) 4.24], and patients with 'several health literacy limitations' were more often prescribed prednisolone (52.4%; OR 3.56). CONCLUSION: Significant differences in longitudinal disease activity and medication prescription were observed between groups with different health literacy levels. These results stress the importance of insights into the role of health literacy in treatment and outcomes in patients with RA.

First-time adverse drug reactions, survival analysis, and the share of adverse drug reactions in treatment discontinuation in real-world rheumatoid arthritis patients: a comparison of first-time treatment with adalimumab and etanercept.

BACKGROUND: This study aims to compare nature and frequency of adverse drug reactions (ADRs), time to first ADR, drug survival, and the share of ADRs in treatment discontinuation of first-time treatment with adalimumab (ADA) and etanercept (ETN) in real-world RA patients. RESEARCH DESIGN AND METHODS: Retrospective, single-center cohort study including naïve patients treated between January 2003-April 2020. Time to first ADR and drug survival of first-time treatment were studied using Kaplan-Meier and Cox-regression models up to 10 years, with 2- and 5-year post-hoc sensitivity analysis. Nature and frequencies of first-time ADRs and causes of treatment discontinuation were assessed. RESULTS: In total, 416 patients (ADA: 255, ETN: 161, 4865 patient years) were included, of which 92 (22.1%) experienced ADR(s) (ADA: 59, 23.1%; ETN: 33, 20.4%). Adjusted for age, gender and concomitant conventional DMARD use, ADA was more likely to be discontinued than ETN up to 2-, 5- and 10-year follow-up (adjusted HRs 1.63; 1.62; 1.59 (all p<0.001)). ADRs were the second reason of treatment discontinuation (ADA 20.7%, ETN 21.4%). CONCLUSIONS: Despite seemingly different nature and frequencies, ADRs are the second reason of treatment discontinuation for both bDMARDs. Furthermore, 2-, 5-, and 10-year drug survival is longer for ETN compared to ADA.

Physical and mental fatigue in post-COVID syndrome and their associations over time: A small-sample ESM-study to explore fatigue, quality of sleep and behaviours.

OBJECTIVE: Post-COVID syndrome leaves millions of people with severe fatigue, yet little is known about its nature in daily life. In this exploratory study, momentary associations between physical and mental fatigue, quality of sleep and behaviours over two weeks in patients with post-COVID syndrome were assessed. METHOD: Data on fatigue levels, quality of sleep and behaviours was collected for 14 consecutive days using the experience sampling method in ten ex-hospitalised patients with post-COVID syndrome. RESULTS: Multilevel linear regression modelling showed strong associations between physical and mental fatigue (ß = 0.61, p ≤0.001), significant both between and within individuals. Sleeping more hours at night was associated with less physical and mental fatigue the following day (ß = -0.35, p = .001; ß = -0.27, p = .008). Strenuous relaxation (B = 0.45, p ≤0.001; B = 0.28, p = .004) and social contacts (B = -0.33, p = .003; B = -0.22, p = .02) were associated with physical and mental fatigue at the same measurement point. Performing household chores decreased physical and mental fatigue (B = -0.29, p = .02; B = -0.30, p = .006) two hours later on the same day, whereas eating and drinking increased physical fatigue (B = 0.20, p = .05) two hours later on the same day. CONCLUSION: Physical fatigue and mental fatigue were strongly associated and revealed fluctuations in fatigue levels between individuals, which might suggest potentially different post-COVID subgroups. Indications for potential risk and beneficial behaviours for fatigue were found.

Continuous effectiveness and safety after a hospital-wide switch to adalimumab biosimilar: An observational study in rheumatoid arthritis patients.

The objective of this study was to examine the maintenance of effect and safety after a hospital-wide switch for economic reasons from adalimumab originator Humira® to biosimilar Amgevita® in real-world rheumatoid arthritis (RA) patients and patient satisfaction with the switch. We conducted a single-center retrospective observational study of RA patients on the course of their disease activity (DAS28, ESR, and CRP), health-related quality of life (SF-36), and functional disability (HAQ-DI) before and up to 1 year after the switch, supplemented with a cross-sectional survey on satisfaction and experienced side effects approximately 18 months after the switch. Treatment outcomes were analyzed with linear mixed modeling and generalized estimating equations. Of 52 RA patients sufficient data were available. Disease activity levels, the proportion of patients in remission, and SF-36 and HAQ-DI scores did not significantly change from before the switch. Overall, patients were satisfied with the switch. Three patients (7.9%) stopped the biosimilar due to side effects. In conclusion, switching to the adalimumab biosimilar did not result in increased disease activity or worse patient-reported outcomes. Also, there was no apparent evidence of increased side effects. Patients themselves were mostly satisfied with the switching experience.

The effectiveness of a web-based Dutch parenting program to prevent overweight in children 9-13 years of age: Results of a two-armed cluster randomized controlled trial.

INTRODUCTION: Although parental support is an important component in programs designed to prevent overweight in children, current programs pay remarkably little attention to the role of parenting. We therefore developed a web-based parenting program entitled "Making a healthy deal with your child". This e-learning program can be incorporated into existing overweight prevention programs. The aim of this study was to determine the effectiveness of this e-learning program. MATERIALS AND METHODS: The effectiveness was examined in a two-armed cluster randomized controlled trial. The participants were 475 parent-child dyads of children 9-13 years of age in the Netherlands who participated in an existing schoolclass-based overweight prevention program. At the school grade level, parents were randomly assigned to either the intervention or the control condition. Measurements were taken from both parents and children at baseline, and 5 and 12 months after baseline. Primary outcomes included the child's dietary and sedentary behavior, and level of physical activity. Secondary outcomes included general parenting style, specific parenting practices, and parental self-efficacy. Linear mixed effects models and generalized linear mixed effects models were conducted in R. RESULTS: Intention-to-treat analyses and completers only revealed no significant effects between the intervention and control condition on energy balance-related behaviors of the child and parenting skills after correction for multiple testing. The parents' mean satisfaction with the e-learning program (on a 10-point scale) was 7.0±1.1. CONCLUSIONS: Although parents were generally satisfied with the parenting program, following this program had no significant beneficial effects regarding the children's energy balance-related behaviors or the parenting skills compared to the control condition. This program may be more beneficial if used by high-risk groups (e.g. parents of children with unhealthy energy balance-related behaviors and/or with overweight) compared to the general population, warranting further study.

Further Validation of a Dutch Translation of the Sussex Oxford Compassion for the Self Scale in Samples of Crisis Line Volunteers, Military Personnel and Nursing Students.

Self-compassion is considered an important, transdiagnostic factor for mental health. The Sussex Oxford Compassion for the Self Scale (SOCS-S) is a recently developed comprehensive measure of self-compassion, that was found to have promising psychometric properties among health care staff and university students in the initial validation study. The aim of this study is the further psychometric evaluation of a Dutch translation of the SOCS-S in different populations and settings. The SOCS-S was administered in three different Dutch samples [crisis line volunteers (n = 560), military personnel (n = 244) and nursing students (n = 255)]. The results confirm the five-factor structure of the SOCS-S and its reliability and criterion and convergent validity across the samples. Measurement invariance was demonstrated for gender in two samples and for age in all three samples, but not across professions. Finally, the SOCS-S was found to explain additional variance in mental health in comparison to a widely used self-compassion measure (SCS-SF).