EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis: 2023 update.

INTRODUCTION: Hip and knee osteoarthritis (OA) are increasingly common with a significant impact on individuals and society. Non-pharmacological treatments are considered essential to reduce pain and improve function and quality of life. EULAR recommendations for the non-pharmacological core management of hip and knee OA were published in 2013. Given the large number of subsequent studies, an update is needed. METHODS: The Standardised Operating Procedures for EULAR recommendations were followed. A multidisciplinary Task Force with 25 members representing 14 European countries was established. The Task Force agreed on an updated search strategy of 11 research questions. The systematic literature review encompassed dates from 1 January 2012 to 27 May 2022. Retrieved evidence was discussed, updated recommendations were formulated, and research and educational agendas were developed. RESULTS: The revised recommendations include two overarching principles and eight evidence-based recommendations including (1) an individualised, multicomponent management plan; (2) information, education and self-management; (3) exercise with adequate tailoring of dosage and progression; (4) mode of exercise delivery; (5) maintenance of healthy weight and weight loss; (6) footwear, walking aids and assistive devices; (7) work-related advice and (8) behaviour change techniques to improve lifestyle. The mean level of agreement on the recommendations ranged between 9.2 and 9.8 (0-10 scale, 10=total agreement). The research agenda highlighted areas related to these interventions including adherence, uptake and impact on work. CONCLUSIONS: The 2023 updated recommendations were formulated based on research evidence and expert opinion to guide the optimal management of hip and knee OA.

EULAR recommendations for the non-pharmacological management of systemic lupus erythematosus and systemic sclerosis.

OBJECTIVE: To develop evidence-based recommendations for the non-pharmacological management of systemic lupus erythematosus (SLE) and systemic sclerosis (SSc). METHODS: A task force comprising 7 rheumatologists, 15 other healthcare professionals and 3 patients was established. Following a systematic literature review performed to inform the recommendations, statements were formulated, discussed during online meetings and graded based on risk of bias assessment, level of evidence (LoE) and strength of recommendation (SoR; scale A-D, A comprising consistent LoE 1 studies, D comprising LoE 4 or inconsistent studies), following the European Alliance of Associations for Rheumatology standard operating procedure. Level of agreement (LoA; scale 0-10, 0 denoting complete disagreement, 10 denoting complete agreement) was determined for each statement through online voting. RESULTS: Four overarching principles and 12 recommendations were developed. These concerned common and disease-specific aspects of non-pharmacological management. SoR ranged from A to D. The mean LoA with the overarching principles and recommendations ranged from 8.4 to 9.7. Briefly, non-pharmacological management of SLE and SSc should be tailored, person-centred and participatory. It is not intended to preclude but rather complement pharmacotherapy. Patients should be offered education and support for physical exercise, smoking cessation and avoidance of cold exposure. Photoprotection and psychosocial interventions are important for SLE patients, while mouth and hand exercises are important in SSc. CONCLUSIONS: The recommendations will guide healthcare professionals and patients towards a holistic and personalised management of SLE and SSc. Research and educational agendas were developed to address needs towards a higher evidence level, enhancement of clinician-patient communication and improved outcomes.

Defining the minimal important change (MIC) and meaningful change value (MCV) for the Psoriatic Arthritis Disease Activity Score (PASDAS) in a routine practice cohort of patients with psoriatic arthritis.

OBJECTIVE: The aim of the study was to determine the Minimal Important Change (MIC) values and Meaningful Change (MCV) values for the Psoriatic Arthritis Disease Activity Score (PASDAS) and the Standard Error of Measurement (s.e.m.) of the PASDAS. METHODS: The routine practice data for 544 patients with PsA was available for analysis. An anchor-based method using linear regression analyses was used to determine the MICs and MCVs for the PASDAS. With this anchor-based method, we compared changes in the PASDAS score with an external reference (anchor). The anchor question inquired whether the patient's well-being had changed since their previous visit. It consisted of a 7-point Likert scale (range: very much improved to very much deteriorated). Interperiod correlation matrix analysis was performed to determine the s.e.m. RESULTS: The overall MIC and MCV for the PASDAS were 0.67 (95% CI: 0.55, 0.79) and 1.34 (95% CI: 1.21, 1.46), respectively. Results for improvement and deterioration were 0.65 (95% CI: 0.46, 0.83) and 0.71 (95% CI: 0.49, 0.93) for the MIC, respectively, and 1.29 (95% CI: 1.11, 1.48) and 1.42 (95% CI: 1.19, 1.64) for the MCV, respectively. The s.e.m. was determined at 0.81. CONCLUSION: The MIC for the PASDAS is a tool for physicians treating patients with PsA enabling them to give context to the patient's perspective of disease activity, while the MCV might aid the use of the PASDAS in PsA clinical trials.

Being overweight is associated with not reaching low disease activity in women but not men with psoriatic arthritis.

OBJECTIVE: To assess sex differences in disease activity parameters and health-related quality of life in PsA, and to assess whether determinants associated with not reaching treatment target differed between men and women. METHODS: Routine practice data of 855 PsA patients, who were all tightly monitored and treated, was used. Sex differences including, but not limited to, PsA Disease Activity Score (PASDAS), skin/nail disease, SF-12 PCS/MCS, and inflammatory back pain (IBP) were assessed. Multivariate analyses were used to examine determinants associated with not reaching treatment target (PASDAS ≤ 3.2) in men and women. RESULTS: Women had worse scores for-among others-swollen and tender joints, CRP, enthesitis and function (all P < 0.001). Higher PASDAS scores were found for women [3.5 (1.5)] than men [2.7 (1.5), P < 0.001]. Likewise, women were more often not at PASDAS treatment target (OR = 2.03, P < 0.001). No difference in current medication use was found. Nail disease, IBP, number of DMARDs used (past and current), and BMI were associated with not reaching treatment target in the overall sample. For women, but not men, BMI was associated with not reaching PASDAS low disease activity (LDA) (OR between 2.41 and 3.43, P < 0.001). CONCLUSIONS: Women with PsA in a tightly monitored and treated setting have more severe disease than men. This is demonstrated by worse scores for women in both subjective and objective disease activity measures, in addition to women less often reaching the treatment target. Notably, being overweight is associated with higher disease activity in women, but not men.

Parents' experiences with a home-based upper limb training program using a video coaching approach for infants and toddlers with unilateral cerebral palsy: a qualitative interview study.

BACKGROUND: Although early home-based upper limb training programs are promising, in-depth understanding of parents' experiences with these programs is still limited. We developed an early home-based upper limb training program for infants and toddlers (8-36 months) with or at risk of unilateral cerebral palsy using video coaching for parents. The aim of this qualitative study was to evaluate parents' experiences with the home-based training program using a video coaching approach in order to optimize implementation strategies. METHODS: We held semi-structured interviews with parents of 13 children with unilateral cerebral palsy, who participated in our program in the period from 2014 - 2017. On average, parents had delivered two training periods of the program at the time of the interviews. Interviews were analyzed using inductive thematic content analysis. RESULTS: We identified three overarching interacting themes that shaped the experiences of parents with the program: 1) Parental learning comprising the subthemes parents' training competencies and the facilitative and reinforcing role of video coaching, 2) Parental load comprising the subthemes flexibility of the program, supportive network, competing demands, and child's mood and functional capacities, and 3) Parental perseverance comprising the subthemes beliefs and expectancies and seeing child's functional improvements. CONCLUSIONS: For successful implementation of an early home-based upper limb training program using video coaching, support in delivering home-training from a therapist or from others within parents' social network, is needed to relieve parental load. Seeing functional improvements of their child on the videos increased parents' motivation to continue with the training. Positively phrased feedback from an occupational therapist stimulated parents' perseverance and training competency.

Measuring disease activity in psoriatic arthritis: PASDAS implementation in a tightly monitored cohort reveals residual disease burden.

OBJECTIVES: We aimed to investigate the disease activity and overall disease burden of (subgroups of) patients with PsA using the Psoriatic Arthritis Disease Activity Score (PASDAS) in an already tightly monitored cohort. METHODS: This is a cross-sectional study evaluating data from the first visit of 855 PsA patients after implementation of the PASDAS in our tightly monitored cohort [e.g. DAS 28 (DAS28) was provided as an anchor]. Differences in clinical outcomes between subgroups of patients using established cut-offs for disease activity status [i.e. very low (VLDA), low (LDA), moderate (MDA), and high disease activity (HDA)] were examined. RESULTS: Based on the PASDAS, 53.1% of patients were in VLDA/LDA. 29.5% of patients had ≥1 swollen joint, 20.6% had ≥1 enthesitis index point and 3.0% had active dactylitis. Based on DAS28, 77.5% of the patients were in VLDA/LDA. Patients reaching both DAS28 VLDA/LDA status and PASDAS VLDA/LDA status [N = 445 (52.0%)] were compared with patients reaching only DAS28 VLDA/LDA status [N = 218 (25.5%)]. For these latter patients, significantly worse scores on separate parameters were found in measures used for PASDAS/DAS28 calculation (e.g. swollen and tender joint count and patient's visual analogue scale global disease activity) as well as other disease measures (e.g. function and inflammatory back pain). This result remained, even when the stricter VLDA cut-off was used for the DAS28. CONCLUSION: PASDAS implementation uncovered relevant residual disease activity in a quarter of patients previously assessed as being in DAS28 VLDA/LDA, underscoring the potential value of PASDAS measurements in PsA clinical care.

Translation, cross-cultural adaptation, reliability and construct validity of the Dutch Oxford Knee Score - Activity and Participation Questionnaire.

BACKGROUND: Patients undergoing total knee arthroplasty (TKA) tend to be younger and tend to receive TKA at an earlier stage compared to 20 years ago. The Oxford Knee Score - Activity and Participation (OKS-APQ) questionnaire evaluates higher levels of activity and participation, reflecting activity patterns of younger or more active people. The purpose of this study was to translate the OKS-APQ questionnaire into Dutch, and to evaluate its measurement properties in pre- and postoperative TKA patients. METHODS: The OKS-APQ was translated and adapted according to the forward-backward translation multi step approach and tested for clinimetric quality. Floor and ceiling effects, structural validity, construct validity, internal consistency and test-retest reliability were evaluated using COSMIN quality criteria. The OKS-APQ, the Oxford Knee Score (OKS), the Short Form-36 (SF-36), a Visual Analogue Scale (VAS) for pain and the Forgotten Joint Score (FJS) were assessed in 131 patients (72 preoperative and 59 postoperative TKA patients), and the OKS-APQ was administered twice in 50 patients (12 preoperative and 38 postoperative TKA patients), after an interval of minimal 2 weeks. RESULTS: Floor effects were observed in preoperative patients. Confirmatory factor analyses (CFA) indicated a good fit of a 1-factor model by the following indices: (Comparative Fit Index (CFI): 0.97, Tucker-Lewis Index (TLI): 0.96 and Standardized Root Mean Square Residual (SRMR): 0.03). Construct validity was supported as > 75% of the hypotheses were confirmed. Internal consistency (Cronbach α's from 0.81 to 0.95) was good in the pooled and separate pre- and postoperative samples and test-retest reliability (Intraclass Correlation Coefficients (ICCs) from 0.63 - 0.85) were good in postoperative patients and moderate in preoperative patients. The standard Error of Measurements (SEMs) ranged from 8.5 - 12.2 and the Smallest Detectable Changes in individuals (SDCind) ranged from 23.5 - 34.0 (on a scale from 0 to 100). CONCLUSIONS: Preliminary findings suggest that the Dutch version of the OKS-APQ is reliable and valid for a Dutch postoperative TKA patient sample. However, in a preoperative TKA sample, the OKS-APQ seems less suitable, because of floor effects and lower test-retest reliability. The Dutch version of the OKS-APQ can be used alongside the OKS to discriminate among levels of activity and participation in postoperative patients.

Targeting self-efficacy more important than dysfunctional behavioral cognitions in patients with longstanding chronic low back pain; a longitudinal study.

BACKGROUND: Multidisciplinary pain management programs based on cognitive behavioral training (CBT) principles have been shown moderately effective in improving daily functioning in patients with chronic low back pain (CLBP). To optimize health-related outcomes as daily functioning, a clear understanding of the working mechanisms of these programs is warranted. Being confident to achieve a desired outcome, i.e. self-efficacy, is suggested to be a more potent determinant for beneficial treatment outcomes than restructuring the patient's dysfunctional behavioral cognitions (pain catastrophizing and fear of movement [FoM]), but the evidence is scarce. The objective of this study was twofold: 1) to determine whether a two-week pain management program resulted in post-treatment improvements in self-efficacy and decreased dysfunctional behavioral cognitions in patients with CLBP, and 2) to examine the unique contribution of self-efficacy to improvement in post-treatment disability. METHODS: A secondary analysis of an historical cohort study was performed, including 524 patients (59% females). PRIMARY OUTCOME: functional status (Oswestry Disability Index v2.1a). SECONDARY OUTCOMES: catastrophizing (Pain Catastrophizing Scale), FoM (Tampa Scale for Kinesiophobia), and self-efficacy (Pain Self-Efficacy Questionnaire). ASSESSMENTS: pre-, post-treatment, 1, and 12-months follow-up. Paired Student's t-tests were applied and clinical relevancy of improvements was described using minimal clinical important changes. Adjusted multivariate linear regression analyses were performed to explore the unique contribution of self-efficacy. RESULTS: The mean age of patients was 46 (SD = 9.5) years and they had longstanding CLBP (mean 12.5 [SD = 10.8] years). Mean functional status, self-efficacy, and dysfunctional behavioral cognitions improved significantly at post-treatment, with improvements maintained at 12 months follow-up. Post-treatment relevant improvements in self-efficacy and dysfunctional behavioral cognitions ranged from 62.4% (FoM) to 68.7% (self-efficacy). Post-treatment self-efficacy improved the model explaining post-treatment functional disability (basic model R2 = 0.49, F(6,517) = 83.67, p < 0.001; final model R2 = 0.57, F(8,515) = 85.20, p < 0.001). This was further substantiated by the relative contribution (standardized betas) of self-efficacy: 5.67 times more than catastrophizing and 9.75 times more than FoM. CONCLUSIONS: Targeting self-efficacy contributes to fast improvement in functional status for selected and motivated patients with persistent CLBP. In pain management programs and (online) self-management programs for CLBP, targeting patients' self-efficacy should have a prominent place.

Effect of Interactive eHealth Interventions on Improving Medication Adherence in Adults With Long-Term Medication: Systematic Review.

BACKGROUND: Medication nonadherence leads to suboptimal treatment outcomes, making it a major priority in health care. eHealth provides an opportunity to offer medication adherence interventions with minimal effort from health care providers whose time and resources are limited. OBJECTIVE: The aim of this systematic review is twofold: (1) to evaluate effectiveness of recently developed and tested interactive eHealth (including mHealth) interventions on medication adherence in adult patients using long-term medication and (2) to describe strategies among effective interventions. METHODS: MEDLINE, EMBASE, Cochrane Library, PsycINFO, and Web of Science were systematically searched from January 2014 to July 2019 as well as reference lists and citations of included articles. Eligible studies fulfilled the following inclusion criteria: (1) randomized controlled trial with a usual care control group; (2) a total sample size of at least 50 adult patients using long-term medication; (3) applying an interactive eHealth intervention aimed at the patient or patient's caregiver; and (4) medication adherence as primary outcome. Methodologic quality was assessed using the Cochrane risk of bias tool. Selection and quality assessment of studies were performed by 2 researchers (BP and BvdB or JV) independently. A best evidence synthesis was performed according to the Cochrane Back Review Group. RESULTS: Of the 9047 records screened, 22 randomized clinical trials were included reporting on 29 interventions. Most (21/29, 72%) interventions specified using a (mobile) phone for calling, SMS text messaging, or mobile apps. A majority of all interactive interventions (17/29) had a statistically significant effect on medication adherence (P<.05). Of these interventions, 9 had at least a small effect size (Cohen d ≥ 0.2) and 3 showed strong odds for becoming adherent in the intervention group (odds ratio > 2.0). Our best evidence synthesis provided strong evidence for a positive effect of interventions using SMS text messages or interactive voice response, mobile app, and calls as mode of providing adherence tele-feedback. Intervention strategies "to teach medication management skills," "to improve health care quality by coordinating medication adherence care between professionals," and "to facilitate communication or decision making between patients and health care providers" also showed strong evidence for a positive effect. CONCLUSIONS: Overall, this review supports the hypothesis that interactive eHealth interventions can be effective in improving medication adherence. Intervention strategies that improve patients' treatment involvement and their medication management skills are most promising and should be considered for implementation in practice.

Shared decision making in routine clinical care of patients with rheumatoid arthritis: an assessment of audio-recorded consultations.

OBJECTIVES: Although shared decision making (SDM) is advocated in rheumatoid arthritis (RA) treatment, it is largely unclear when, how and to what extent SDM is applied in routine clinical care of patients with RA. This study aimed to investigate the level of SDM in RA treatment from an observer perspective and to assess associations between the level of SDM and characteristics of the clinician, patient and consultation. METHODS: The level of SDM was investigated by scoring audio-recordings of 168 routine consultations with unique patients with the observer patient involvement (OPTION) scale (scale 0-100, higher OPTION scores indicating higher levels of SDM). Associations between the level of SDM and characteristics of the clinician, patient and consultation were assessed using multilevel modelling. Statistical significance was set at p<0.05. RESULTS: The mean OPTION score was 28.3 (SD=15.1). The multilevel model included four characteristics: clinician age, patient age, consultation duration and type of treatment decision. There were significant, positive associations between the level of SDM and the consultation duration (b=0.63, 95% CI 0.16 to 1.11), decision for stopping and/or starting medication (b=14.30, 95% CI 5.62 to 22.98), decision for adjusting medication doses (b=8.36, 95% CI 3.92 to 12.81) and decision for administering single dose glucocorticoids (b=15.03, 95% CI 9.12 to 20.93). Thus, a higher level of SDM was significantly associated with a longer consultation duration and the type of treatment decision. No other significant associations were found. CONCLUSIONS: Overall, the level of SDM in RA treatment leaves room for improvement. To foster SDM in routine clinical care, training programmes on patient-centred communication skills may be helpful.

Cognitive-behavioural and social factors do not predict recurrent secondary healthcare use in patients with fibromyalgia: a longitudinal study.

OBJECTIVES: Healthcare use in fibromyalgia (FM) is relatively high. Besides disease-related variables, cognitive-behavioural factors have been concurrently associated with healthcare use. It is unknown whether cognitive-behavioural and social factors also predict future healthcare use. The aim of this study was to identify cognitive-behavioural and social factors predicting recurrent secondary healthcare use in FM. METHODS: Using self-reported questionnaires, healthcare use, cognitive-behavioural, social, sociodemographic and disease-related variables including comorbidities were collected in 199 patients with FM, in a prospective longitudinal cohort spanning 18 months. Patients were recruited after receiving their diagnosis and protocolled treatment advice by a rheumatologist. Univariate and multivariate logistic regression models examined whether and which variables were predictors for recurrent secondary healthcare use. Internal validation was performed to correct for over-fit of the final multivariate model. RESULTS: Recurrent secondary healthcare use was lower than initial secondary healthcare use. Univariate analysis showed that having at least one comorbidity, depressive feelings, severe consequences of FM, low personal control and a high severity of fibromyalgia predicted recurrent secondary healthcare use. In the multivariate model, having at least one comorbidity was the only remaining predictor for recurrent secondary healthcare use. CONCLUSIONS: Our results suggest that the existence of comorbidities as communicated by the patient is the strongest warning signal for recurrent secondary healthcare use in FM. There seems no value in using cognitive-behavioural and social factors for early identification of patients with FM at risk for recurrent secondary healthcare use.

Interventions to improve upper limb function for children with bilateral cerebral palsy: a systematic review.

AIM: To systematically review the efficacy of interventions on upper limb function in children 0 to 19 years of age with bilateral cerebral palsy on the basis of outcome measures of upper limb function and measures of activities and/or participation according to the International Classification of Functioning, Disability and Health. METHOD: Cochrane, PubMed, Embase, CINAHL, and Web of Science were searched from inception to September 2017. Methodological quality and strength of evidence were analysed by two independent raters using Sackett's level of evidence and the American Academy for Cerebral Palsy and Developmental Medicine (AACPDM) guidelines. RESULTS: Fifteen studies with a large variety of interventions and heterogeneity in outcome measures met the inclusion criteria. Twelve studies provided level IV evidence according to AACPDM guidelines. For three small randomized controlled trials the level of evidence was II. Only one of these trials showed strong methodological quality: a study on hand-arm bimanual intensive therapy including lower extremities. INTERPRETATION: We identified a large variety of interventions, heterogeneity in outcome measures, and generally weak to moderate methodological quality for most studies. We recommend further research specifically aimed at bimanual-intensive, goal-directed, and task-specific training programmes for the upper limb in children with bilateral cerebral palsy, using either high-quality (multicentre) trials or well-designed single-case trials. WHAT THIS PAPER ADDS: There is a large variety of interventions on upper limb function in children with bilateral cerebral palsy. Heterogeneity of outcome measures and interventions impeded firm conclusions about intervention efficacy. Most studies had low-level evidence and weak to moderate methodological quality. The strongest evidence from a small randomized controlled trial was for hand-arm bimanual intensive therapy including lower extremities.

Intervenciones para mejorar la función de las extremidades superiores en niños con parálisis cerebral bilateral: una revisión sistemática OBJETIVO: Revisar sistemáticamente la eficacia de la función de la extremidad superior con las intervenciones realizadas en niños de 0 a 19 años de edad con parálisis cerebral bilateral basada en medidas de la función de la extremidad superior, de actividades y / o participación, según la Clasificación Internacional del Funcionamiento, de la Discapacidad y de la Salud. MÉTODO: Se investigaron desde su inicio hasta septiembre del 2017 las siguientes bases de datos: Cochrane, PubMed, Embase, CINAHL y Web of Science. Tres evaluadores independientes analizaron la calidad metodológica y la calidad de la evidencia utilizando el nivel de evidencia de Sackett y las guias de la Academia Americana para la Parálisis Cerebral y Medicina del Desarrollo (AACPDM). RESULTADOS: Quince estudios con una gran variedad de intervenciones y heterogeneidad en las escalas de resultado cumplieron con los criterios de inclusión. Doce estudios proporcionaron evidencia nivel IV de acuerdo con las guías de la AACPDM. Otros tres ensayos pequeños controlados y aleatorios se clasificaron como nivel II de evidencia. Solo uno de estos ensayos mostró una calidad metodológica sólida que consista en un estudio sobre terapia bimanual intensiva mano-brazo que incluía extremidades inferiores. INTERPRETACIÓN: Se identificaron una gran variedad de intervenciones, heterogeneidad en las escalas de medición de los resultados, y en general una calidad metodológica de débil a moderada para la mayoría de los estudios. Recomendamos investigaciones adicionales dirigidas específicamente a programas de entrenamiento bimanual, orientado a objetivos específicos para la tarea del miembro superior en niños con parálisis cerebral bilateral, utilizando ensayos de alta calidad (multicéntricos) o ensayos dirigidos a estudiar solo un concepto bien diseñados.

Intervenções para melhorar a função do membro superior em crianças com paralisia cerebral bilateral: uma revisão sistemática OBJETIVO: Revisar sistematicamente a eficácia de intervenções para a função do membro superior em crianças de 0 a 19 anos de idade com paralisia cerebral bilateral com base em medidas de resultado da função do membro superior e medidas de atividades e/ou participação de acordo com a Classificação Internacional de Funcionalidade, Incapacidade e Saúde. MÉTODO: Cochrane, PubMed, Embase, CINAHL, e Web of Science foram pesquisadas do início até setembro de 2017. A qualidade metodológica e força da evidência foram analisados por três avaliadores independentes usando o nível Sackett's e evidência e as diretrizes da Academia Americana de Paralisia Cerebral e Medicina do Desenvolviemnto (AACPDM). RESULTADOS: Quinze estudos com uma grande variedade de intervenções e heterogeneidade de medidas de resultado atenderam aos critérios de inclusão. Doze estudos forneceram evidência nível IV de acordo com as diretrizes da AACPDM. Para três pequenos estudos randomizados controlados o nível de evidência foi II. Apenas um destes estudos mostrou forte qualidade metodológica: um estudo sobre terapia intensive bimanual mão-braço incluindo as extremidades inferiores. INTERPRETAÇÃO: Identificamos uma grande variedade de intervenções, heterogeneidade em medidas de resultado, e em geral qualidade metodológica de fraca a moderada para a maioria dos estudos. Recomendamos mais pesquisas especificamente voltadas para programas de treinamento intensivos bimanuais, direcionados a objetivos e específicos para tarefas para o membro superior de crianças com paralisia cerebral usando ou estudos de alta qualidade (multicêntricos) ou estudos de sujeito único bem desenhados.

Down-titration and discontinuation strategies of tumour necrosis factor-blocking agents for rheumatoid arthritis in patients with low disease activity.

BACKGROUND: Anti-tumour necrosis factor (TNF) agents are effective in treating people with rheumatoid arthritis (RA), but are associated with (dose-dependent) adverse effects and high costs. To prevent overtreatment, several trials have assessed the effectiveness of down-titration compared with continuation of the standard dose. This is an update of a Cochrane Review published in 2014. OBJECTIVES: To evaluate the benefits and harms of down-titration (dose reduction, discontinuation, or disease activity-guided dose tapering) of anti-TNF agents on disease activity, functioning, costs, safety, and radiographic damage compared with usual care in people with RA and low disease activity. SEARCH METHODS: We searched MEDLINE, Embase, Web of Science and CENTRAL (29 March 2018) and four trial registries (11 April 2018) together with reference checking, citation searching, and contact with study authors to identify additional studies. We screened conference proceedings (American College of Rheumatology and European League Against Rheumatism 2005-2017). SELECTION CRITERIA: Randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing down-titration (dose reduction, discontinuation, disease activity-guided dose tapering) of anti-TNF agents (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab) to usual care/no down-titration in people with RA and low disease activity. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodology. MAIN RESULTS: One previously included trial was excluded retrospectively in this update because it was not an RCT/CCT. We included eight additional trials, for a total of 14 studies (13 RCTs and one CCT, 3315 participants in total) reporting anti-TNF down-titration. Six studies (1148 participants) reported anti-TNF dose reduction compared with anti-TNF continuation. Eight studies (2111 participants) reported anti-TNF discontinuation compared with anti-TNF continuation (three studies assessed both anti-TNF discontinuation and dose reduction), and three studies assessed disease activity-guided anti-TNF dose tapering (365 participants). These studies included data on all anti-TNF agents, but primarily adalimumab and etanercept. Thirteen studies were available in full text, one was available as abstract. We assessed the included studies generally at low to moderate risk of bias; our main concerns were bias due to open-label treatment and unblinded outcome assessment. Clinical heterogeneity between the trials was high. The included studies were performed at clinical centres around the world and included people with early as well as established RA, the majority of whom were female with mean ages between 47 and 60. Study durations ranged from 6 months to 3.5 years.We found that anti-TNF dose reduction leads to little or no difference in mean disease activity score (DAS28) after 26 to 52 weeks (high-certainty evidence, mean difference (MD) 0.06, 95% confidence interval (CI) -0.11 to 0.24, absolute risk difference (ARD) 1%) compared with continuation. Also, anti-TNF dose reduction does not result in an important deterioration in function after 26 to 52 weeks (Health Assessment Questionnaire Disability Index (HAQ-DI)) (high-certainty evidence, MD 0.09, 95% CI 0.00 to 0.19, ARD 3%). Next to this, anti-TNF dose reduction may slightly reduce the proportion of participants switched to another biologic (low-certainty evidence), but probably slightly increases the proportion of participants with minimal radiographic progression after 52 weeks (moderate-certainty evidence, risk ratio (RR) 1.22, 95% CI 0.76 to 1.95, ARD 2% higher). Anti-TNF dose reduction may cause little or no difference in serious adverse events, withdrawals due to adverse events and proportion of participants with persistent remission (low-certainty evidence).Results show that anti-TNF discontinuation probably slightly increases the mean disease activity score (DAS28) after 28 to 52 weeks (moderate-certainty evidence, MD 0.96, 95% CI 0.67 to 1.25, ARD 14%), and that the RR of persistent remission lies between 0.16 and 0.77 (low-certainty evidence). Anti-TNF discontinuation increases the proportion participants with minimal radiographic progression after 52 weeks (high-certainty evidence, RR 1.69, 95% CI 1.10 to 2.59, ARD 7%) and may lead to a slight deterioration in function (HAQ-DI) (low-certainty evidence). It is uncertain whether anti-TNF discontinuation influences the number of serious adverse events (due to very low-certainty evidence) and the number of withdrawals due to adverse events after 28 to 52 weeks probably increases slightly (moderate-certainty evidence, RR 1.46, 95% CI 0.75 to 2.84, ARD 1% higher).Anti-TNF disease activity-guided dose tapering may result in little or no difference in mean disease activity score (DAS28) after 72 to 78 weeks (low-certainty evidence). Furthermore, anti-TNF disease activity-guided dose tapering results in little or no difference in the proportion of participants with persistent remission after 18 months (high-certainty evidence, RR 0.89, 95% CI 0.75 to 1.06, ARD -9%) and may result in little or no difference in switching to another biologic (low-certainty evidence). Anti-TNF disease activity-guided dose tapering may slightly increase proportion of participants with minimal radiographic progression (low-certainty evidence) and probably leads to a slight deterioration of function after 18 months (moderate-certainty evidence, MD 0.2 higher, 0.02 lower to 0.42 higher, ARD 7% higher), It is uncertain whether anti-TNF disease activity-guided dose tapering influences the number of serious adverse events due to very low-certainty evidence. AUTHORS' CONCLUSIONS: We found that fixed-dose reduction of anti-TNF, after at least three to 12 months of low disease activity, is comparable to continuation of the standard dose regarding disease activity and function, and may be comparable with regards to the proportion of participants with persistent remission. Discontinuation (also without disease activity-guided adaptation) of anti-TNF is probably inferior to continuation of treatment with respect to disease activity, the proportion of participants with persistent remission, function, and minimal radiographic damage. Disease activity-guided dose tapering of anti-TNF is comparable to continuation of treatment with respect to the proportion of participants with persistent remission and may be comparable regarding disease activity.Caveats of this review are that available data are mainly limited to etanercept and adalimumab, the heterogeneity between studies, and the use of superiority instead of non-inferiority designs.Future research should focus on the anti-TNF agents infliximab and golimumab; assessment of disease activity, function, and radiographic outcomes after longer follow-up; and assessment of long-term safety, cost-effectiveness, and predictors for successful down-titration. Also, use of a validated flare criterion, non-inferiority designs, and disease activity-guided tapering instead of fixed-dose reduction or discontinuation would allow researchers to better interpret study findings and generalise to clinical practice.

The patient perspective on biologic DMARD dose reduction in rheumatoid arthritis: a mixed methods study.

Objectives: The aim of this study was to identify the factors that play a role for patients with RA when considering dose reduction (i.e. gradual tapering until discontinuation) of biological DMARDs (bDMARDs), and to determine their relative importance. Methods: A mixed methods design was used in which we identified influencing factors by performing semi-structured interviews and ranked these factors using a Maximum Difference Scaling questionnaire. Also, we looked at the influence of several patient characteristics on this ranking. Results: For sub study 1 and 2, 22 and 192 patients with RA were included, respectively, in the analyses. Thirty factors were identified from the interviews-characterized into nine themes-and appraised in the questionnaire. Most respondents had a positive attitude towards bDMARD dose reduction. The study showed that patients are concerned that dose reduction will lead to a disease flare that affects their daily life (pain, function). It is important for them to know that it is possible to increase the dose if (further) reduction fails and that the bDMARD will be effective again. Patients value the opinion of their rheumatologist, and being involved in the decision to start tapering is highly ranked as well. The most important factors were consistent between different groups of patients. Conclusion: The results from this study facilitate implementation of bDMARD dose reduction; they inform care providers on what is important for patients and provide a basis for shared decision making.

Preoperative psychosocial factors predicting patient's functional recovery after total knee or total hip arthroplasty: a systematic review.

OBJECTIVE: To evaluate the predictive value of preoperative psychosocial factors on the perceived and observed postoperative patient's functional recovery during the post-hospital phase and up to 12 months after hospital discharge of patients who underwent total knee or total hip arthroplasty. METHODS: A systematic review was performed. MEDLINE, CINAHL, EMBASE and PsychINFO were systematically screened in order to find prospective longitudinal studies. Risk of bias was assessed using a modified version of a 27-item checklist for prognostic studies, as previously used by Veerbeek. A qualitative analysis was performed using the method of Zwikker. RESULTS: A total of 26 studies, with a total of 11,020 patients, were included. In total, 22 studies were judged as having a high risk of bias. Overall, no longitudinal association with perceived or observed functional recovery was found in all of the seven preoperative psychosocial categories: A: mental well-being, B: cognitions, C: beliefs, D: expectations, E: coping, F: social support or G: personality traits in total joint arthroplasty. Mental well-being seems to be the exception in one time period (>6 weeks through ≤3 months) and change score in observed functional recovery, but only in patients awaiting total knee arthroplasty (100% and 75% of the variables were significantly and consistently associated, respectively). CONCLUSION: Overall, the results of this systematic review suggest that there is no longitudinal association between preoperative psychosocial factors and perceived or observed patient's postoperative functional recovery after total joint arthroplasty. The psychological category mental well-being is related to observed postoperative recovery >6 weeks through ≤3 months and to change score after total knee arthroplasty.

Treatment Beliefs Underlying Intended Treatment Choices in Knee and Hip Osteoarthritis.

PURPOSE: Patients' beliefs about treatment modalities for knee and hip osteoarthritis (OA) will underlie their treatment choices. Based on the Theory of Planned Behavior, it is hypothesized that patients' beliefs, subjective norm, and perceived behavioral control guide their treatment choices. Also, symptom severity and one's inherent tendency to approach or avoid situations are assumed to play a role. The objective of this study was to test whether these variables were associated with intended treatment choices in knee and hip OA. METHODS: Patients with knee and hip OA were randomly selected from hospital patient records. They completed the Treatment beliefs in OsteoArthritis questionnaire to assess positive and negative treatment beliefs regarding five treatment modalities: physical activities, pain medication, physiotherapy, injections, and arthroplasty. Other measures were intention, subjective norm, perceived behavioral control (ASES), symptom severity (WOMAC), and the person's general tendency to approach or avoid situations (RR/BIS scales). Three models were tested using path analyses to examine the hypothesized associations. RESULTS: Participants were 289 patients. Positive treatment beliefs and subjective norm were consistently associated with intended treatment choice across all treatment modalities. Negative treatment beliefs were associated with intended treatment choices for pain medication and arthroplasty. Other associations were not significant. CONCLUSIONS: This is the first study testing the Theory of Planned Behavior in the context of treatment choices in OA. Findings suggest that foremost positive beliefs about treatment modalities and the norms of one's social environment guide a specific treatment choice. Unexpectedly, symptom severity was not related to intended treatment choices.

Hierarchical structure and importance of patients' reasons for treatment choices in knee and hip osteoarthritis: a concept mapping study.

OBJECTIVES: To improve patients' use of conservative treatment options of hip and knee OA, in-depth understanding of reasons underlying patients' treatment choices is required. The current study adopted a concept mapping method to thematically structure and prioritize reasons for treatment choice in knee and hip OA from a patients' perspective. METHODS: Multiple reasons for treatment choices were previously identified using in-depth interviews. In consensus meetings, experts derived 51 representative reasons from the interviews. Thirty-six patients individually sorted the 51 reasons in two card-sorting tasks: one based on content similarity, and one based on importance of reasons. The individual sortings of the first card-sorting task provided input for a hierarchical cluster analysis (squared Euclidian distances, Ward's method). The importance of the reasons and clusters were examined using descriptive statistics. RESULTS: The hierarchical structure of reasons for treatment choices showed a core distinction between two categories of clusters: barriers [subdivided into context (e.g. the healthcare system) and disadvantages] and outcome (subdivided into treatment and personal life). At the lowest level, 15 clusters were identified of which the clusters Physical functioning, Risks and Prosthesis were considered most important when making a treatment decision for hip or knee OA. CONCLUSION: Patients' treatment choices in knee and hip OA are guided by contextual barriers, disadvantages of the treatment, outcomes of the treatment and consequences for personal life. The structured overview of reasons can be used to support shared decision-making.

Development of responder criteria for multicomponent non-pharmacological treatment in fibromyalgia.

OBJECTIVES: There is a need to identify individual treatment success in patients with fibromyalgia (FM) who received non-pharmacological treatment. The present study described responder criteria for multicomponent non-pharmacological treatment in FM, and estimated and compared their sensitivity and specificity. METHODS: Candidate responder sets were 1) identified in literature; and 2) formulated by expert group consensus. All candidate responder sets were tested in a cohort of 129 patients with FM receiving multicomponent non-pharmacological treatment. We used two gold standards (both therapist's and patient's perspective), assessed at six months after the start of treatment. RESULTS: Seven responder sets were defined (three identified in literature and four formulated by expert group consensus), and comprised combinations of domains of 1) pain; 2) fatigue; 3) patient global assessment (PGA); 4) illness perceptions; 5) limitations in activities of daily living (ADL); and 6) sleep. The sensitivity and specificity of literature-based responder sets (n=3) ranged between 17%-99% and 15%-95% respectively, whereas the expert-based responder sets (n=4) performed slightly better with regard to sensitivity (range 41%-81%) and specificity (range 50%-96%). Of the literature-based responder sets the OMERACT-OARSI responder set with patient's gold standard performed best (sensitivity 63%, specificity 75% and ROC area = 0.69). Overall, the expert-based responder set comprising the domains illness perceptions and limitations in ADL with patient's gold standard performed best (sensitivity 47%, specificity 96% and ROC area = 0.71). CONCLUSIONS: We defined sets of responder criteria for multicomponent non-pharmacological treatment in fibromyalgia. Further research should focus on the validation of those sets with acceptable performance.

Development of the "Treatment beliefs in knee and hip OsteoArthritis (TOA)" questionnaire.

BACKGROUND: Use of conservative treatment modalities in osteoarthritis (OA) is suboptimal, which appears to be partly due to patients' beliefs about treatments. The aim of this study was to develop a research instrument assessing patients' beliefs about various treatment modalities of hip and knee OA: the 'Treatment beliefs in OA (TOA) questionnaire'. METHODS: The item pool that was retrieved from interviews with patients and healthcare providers comprised beliefs regarding five treatment modalities: physical activity, pain medication, physiotherapy, injections and arthroplasty. After an extensive selection procedure, a draft questionnaire with 200 items was constructed. Descriptive analyses and exploratory factor analyses with oblique rotation were conducted for each treatment modality separately to decide upon the final questionnaire. Internal consistency and test-retest reliability were determined. RESULTS: The final questionnaire comprised 60 items. It was completed by 351 patients with knee or hip OA. Each of the five treatment modalities yielded a two factor solution with 37% to 51% explained variance and high face validity. Factor I included 'positive treatment beliefs' and factor II 'negative treatment beliefs'. Internal consistency (Cronbach α's from 0.72 to 0.87) and test-retest reliability (i.e. intraclass correlation coefficient from 0.66-0.88; standard error of measurement from 0.06-0.11) were satisfactory to good. CONCLUSIONS: The TOA questionnaire is the first questionnaire assessing positive and negative treatment beliefs regarding five treatment modalities for knee and hip OA. The instrument will help to understand whether and to what extent treatment beliefs influence treatment choices.

Barriers Impeding the Use of Non-pharmacological, Non-surgical Care in Hip and Knee Osteoarthritis: The Views of General Practitioners, Physical Therapists, and Medical Specialists.

BACKGROUND: Non-pharmacological, non-surgical treatment modalities are underused in the management of knee and hip osteoarthritis (OA). One possible explanation for this could be healthcare providers' opinions about these treatment modalities. The objective of this qualitative study was to identify healthcare providers' views on non-pharmacological, non-surgical care for OA. METHODS: Semi-structured in-depth interviews with 24 healthcare providers (rheumatologists, orthopedic surgeons, physical therapists and general practitioners) were held. Interviews were transcribed verbatim and analyzed using a three-step thematic approach. Two independent researchers continuously reflected upon, compared, discussed, and adjusted the codings. RESULTS: Eight themes were identified reflecting three main barriers to the provision of non-pharmacological, non-surgical care: perceived lack of expertise of the healthcare provider (including a lack of knowledge and skills that are required to support patients), perceived lack of evidence-based treatment (regarding weight management, and the intensity and dosage of physical exercise), and suboptimal organization of care (including hampered dialogue between disciplines and lack of clarity about the roles and responsibilities of disciplines). CONCLUSIONS: Healthcare providers report multiple barriers impeding non-pharmacological, non-surgical care for patients with knee and hip OA. To overcome these barriers, education focused on initiating and supporting lifestyle changes, promotion of interventions according to evidence-based recommendations, and improved organization of care are proposed.