scholarly journals Rheumatoid arthritis patients with predominantly tender joints rarely achieve clinical remission despite being in ultrasound remission

Author(s):  
Hilde Berner Hammer ◽  
Inger Marie Jensen Hansen ◽  
Pentti Järvinen ◽  
Marjatta Leirisalo-Repo ◽  
Michael Ziegelasch ◽  
...  

Abstract Objectives Since subjective variables may reduce remission by composite disease activity scores (CDAS), the main objectives were to explore whether rheumatoid arthritis (RA) patients with mainly tender versuss mainly swollen joints had differences in patient reported outcome measures (PROMs), clinical or ultrasound assessments as well as in achieving remission defined by CDAS or ultrasound. Methods In a Nordic multicentre study, RA patients initiating tocilizumab were assessed by PROMs, clinical, laboratory and ultrasound assessments (36 joints, 4 tendons) at baseline, 4, 12 and 24 weeks. Remission was defined according to CDAI/Boolean or no Doppler activity present. Tender-Swollen joint differences (TSJD) were calculated. Statistics exploring changes over time/differences between groups included Wilcoxon, Mann–Whitney, Kruskal-Wallis and Spearman. Results 110 patients were included (mean (SD) age 55.6 (12.1) years, RA duration 8.7 (9.5) years). All PROMs, clinical, laboratory and ultrasound scores decreased during follow-up (p < 0.001). During follow-up, tender joint counts were primarily correlated with PROMs (r = 0.24–0.56 (p < 0.05–0.001)), and swollen joint counts with ultrasound synovitis scores (r = 0.33–0.72 (p < 0.05–0.001)). At 24 weeks patients with TSJD > 0 had higher PROMs and CDAI (p < 0.05–0.001) but lower ultrasound synovitis scores (p < 0.05). Remission by CDAI/Boolean was seen in 26–34% and by Doppler 53%, but only 2–3% of patients with TSJD > 0 achieved CDAI/Boolean remission. Conclusion Patients with more tender than swollen joints scored higher on subjective assessments but had less ultrasound synovitis. They seldom achieved CDAS remission despite many being in Doppler remission. If patients with predominantly tender joints do not reach CDAS remission, objective assessments of inflammation should be performed. Clinical trial identifier ClinicalTrials.gov, https://clinicaltrials.gov/, NCT02046616

Author(s):  
Hilde Berner Hammer ◽  
Brigitte Michelsen ◽  
Joe Sexton ◽  
Till Uhlig ◽  
Sella A. Provan

Abstract Objective The associations between fatigue and disease activity in patients with rheumatoid arthritis (RA) have not been defined. The present objectives were to explore in RA patients the cross-sectional and longitudinal relation of fatigue with subjective as well as objective assessments of disease activity. Methods RA patients were consecutively included when initiating biologic disease-modifying anti-rheumatic drugs (DMARDs) and assessed at baseline, 1, 2, 3, 6, and 12 months with investigation of fatigue, patient-reported outcome measures (PROMs; joint pain and patient’s global disease activity, MHAQ, pain catastrophizing, Mental Health score), clinical examinations (examiner’s global disease activity, 28 tender and swollen joint counts), and laboratory variables (ESR, CRP, calprotectin). Ultrasound examinations (semi-quantitative scoring (0–3)) with grey scale and power Doppler were performed of 36 joints and 4 tendons. Statistics included one-way analysis of variance, Pearson’s correlations, and multiple linear and logistic regression analysis. Results A total of 208 RA patients (mean (SD) age 53.2 (13.2) years, disease duration 9.8 (8.5) years) were included. Fatigue levels diminished during follow-up (mean (SD) baseline/12 months; 4.8 (2.8)/3.0 (2.5) (p < 0.001)). Substantial correlations were cross-sectionally found between fatigue and PROMs (median (IQR) r=0.61 (0.52-0.71)) but not with the objective inflammatory assessments. During follow-up, baseline fatigue was associated with PROMs (p < 0.001) but not with objective inflammatory assessments. However, change of fatigue was associated with change in all variables. Higher baseline fatigue levels were associated with lower clinical composite score remission rates. Conclusion Fatigue was cross-sectionally associated to subjective but not to objective disease assessments. However, change of fatigue during treatment was associated to all assessments of disease activity. Trial registration number Anzctr.org.au identifier ACTRN12610000284066, Norwegian Regional Committee for Medical and Health Research Ethics South East reference number 2009/1254 Key Points• In this longitudinal study of patients with established RA, fatigue was associated with patient reported outcome measures at each visit, but not with objective assessments of inflammation including calprotectin and comprehensive ultrasound examinations.• Changes in fatigue during biological treatment were associated with changes in patient reported outcome measures, clinical, laboratory and ultrasound assessments.• Baseline fatigue was associated with all patient reported outcome measures, but not objective assessments of inflammation at all the prospective visits.• Higher baseline fatigue levels were associated with lower remission rates as assessed by clinical composite scores.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1057.3-1058
Author(s):  
E. Traianos ◽  
B. Dibnah ◽  
D. Lendrem ◽  
Y. Clark ◽  
V. Macrae ◽  
...  

Background:Fatigue is reported as a common symptom among autoimmune and other chronic diseases such as fibromyalgia (FM), a long-term condition with uncertain pathophysiology. Previous studies from our group suggest that non-invasive vagus nerve stimulation (nVNS) may contribute to the improvement of patient reported outcome measures (PROMs) of fatigue in patients with primary Sjögren’s Syndrome (1).Objectives:This follow-up study uses the gammaCore device (electroCore) to assess the effect of nVNS on PROMs of fatigue and immune responses in chronic fatigue syndrome (CFS), FM and rheumatoid arthritis (RA).Methods:The study included thirteen CFS, fourteen FM and fifteen RA patients who used the gammaCore nVNS device twice daily over a 26-day period. Pre- and post- nVNS bloods were drawn at baseline and final visits. Whole blood samples were stimulated with 2 ng/mL lipopolysaccharide (LPS) and the IL-6 and TNF-α cytokine concentrations were quantified at 24 hours. In addition, the epidermal growth factor (EGF), IFN-γ, IL-6, IP-10, MIP-1α, and TNF-α levels were measured in ‘pre-nVNS’ serum and flow cytometric profiles of whole blood immune cells were analysed. The patient reported outcome measures (PROMs) recorded at each visit were the Visual Analogue Scale (VAS) (0-100 cm) of abnormal fatigue, Hospital Anxiety and Depression (HAD) Scale, Orthostatic Grading Scale, Epworth Sleepiness Scale (daytime sleepiness), and Profile of fatigue (PRO-F) for Physical and Mental fatigue. Paired t-tests were performed to assess for changes in PROMs, cytokine levels, and cell subset distribution and associations of cytokine response with PROMs were investigated by correlation analyses.Results:Eleven CFS, twelve FM and fourteen RA patients completed the study. There was a significant reduction in daytime sleepiness in CFS (p =0.0321) and FM (p =0.0294) patients between the final and baseline visits and a significant reduction in HAD depression (p =0.0413) in FM (Fig.1). Improvement in VAS for abnormal fatigue, HAD-Anxiety, HAD-Depression, PRO-F Physical and Mental fatigue was observed in all three groups over the study period with a reduction in VAS fatigue in 64% of CFS, 67% of FM and 62% of RA patients. There were no significant changes in the immune cell subsets or in cytokine response. Finally, higher baseline pre-nVNS supernatant IL-6 levels were predictive of an improvement in VAS fatigue (p =0.0006), Daytime Sleepiness (p =0.0466) and PRO-F Physical fatigue (p =0.0196) in RA, while higher baseline TNF-α levels were predictive of an improvement in VAS fatigue (p =0.0003), Daytime Sleepiness (p =0.0380), Orthostatic (p =0.0281) and PRO-F Physical fatigue (p =0.0007) in FM.Conclusion:Our findings suggest that nVNS may contribute to the improvement of PROMs of fatigue in CFS, FM and RA. NVNS led to significant reductions in daytime sleepiness in CFS and FM, and depression in FM. Further studies and a larger sample size are needed to investigate the potential effects of nVNS on diseases characterised by persistent fatigue.References:[1]Tarn J, Legg S, Mitchell S, Simon B, Ng WF. The Effects of Noninvasive Vagus Nerve Stimulation on Fatigue and Immune Responses in Patients With Primary Sjögren’s Syndrome. Neuromodulation Technol Neural Interface. 2018;22(5):580–5.Figure 1.VAS for abnormal fatigue and PROMs recorded at baseline and final visits in patients with chronic fatigue syndrome (CFS), fibromyalgia (FM) and rheumatoid arthritis (RA). Boxplots show the median, upper, and lower quartiles for PROMs at visit 1 and visit 3 in each disease group. Paired-t tests revealed a significant reduction in daytime sleepiness in CFS and FM (B), and a significant reduction in HAD depression in FM (E). Improvement trends were observed in VAS for abnormal fatigue, HAD-Anxiety, HAD-Depression, PRO-F Physical fatigue and PRO-F Mental fatigue in all three groups over the 26-day study period.Acknowledgements:This study received infrastructural support from the National Institute of Health Research (NIHR) Newcastle Biomedical Research Centre at Newcastle Hospitals Foundation Trust and Newcastle University.Disclosure of Interests:Emmanuella Traianos: None declared, Bethany Dibnah: None declared, Dennis Lendrem: None declared, Yasmin Clark: None declared, Victoria Macrae: None declared, Victoria Slater: None declared, Karl Wood: None declared, David Storey: None declared, Bruce Simon Shareholder of: Bruce Simon is an employee and shareholder of electroCore., Employee of: electroCore, Inc., Justyna Blake Shareholder of: Justyna Blake is an employee of electroCore, and receives stock ownership., Employee of: electroCore, Inc., Jessica Tarn: None declared, Wan Fai Ng: None declared


RMD Open ◽  
2020 ◽  
Vol 6 (3) ◽  
pp. e001372
Author(s):  
Sella Aarrestad Provan ◽  
Brigitte Michelsen ◽  
Joseph Sexton ◽  
Tillmann Uhlig ◽  
Hilde Berner Hammer

ObjectivesTo define fatigue trajectories in patients with rheumatoid arthritis (RA) who initiate biological DMARD (bDMARD) treatment, and explore baseline predictors for a trajectory of continued fatigue.MethodsOne-hundred and eighty-four patients with RA initiating bDMARDs were assessed at 0, 1, 2, 3, 6 and 12 months. Swollen and tender joint counts, patient reported outcomes (PROMs), blood samples and ultrasound examinations were collected at each time point. Fatigue was assessed by the fatigue Numeric Rating Scale (0–10) from the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire. Clinically significant fatigue was predefined as fatigue ≥4. Three trajectories of interest were defined according to level of RAID fatigue: no fatigue (≤3 at 5/6 visits), improved fatigue (≥4 at start, but ≤3 at follow-up) and continued fatigue (≥4 at 5/6 visits). Baseline variables were compared between groups by bivariate analyses, and logistic regression models were used to explore baseline predictors of continued vs improved fatigue.ResultsThe majority of patients starting bDMARD therapy followed one of three fatigue trajectories, (no fatigue; n=61, improved; n=33 and continued fatigue; n=53). Patients with continued fatigue were more likely to be anti–citrullinated protein antibody and/or rheumatoid factor positive and had higher baseline PROMs compared to the other groups, while there were no differences between the groups for variables of inflammation including. Patient global, tender joint count and anxiety were predictors for the continued fatigue trajectory.DiscussionA trajectory of continued fatigue was determined by PROMs and not by inflammatory RA disease activity.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Salzwedel ◽  
I Koran ◽  
E Langheim ◽  
A Schlitt ◽  
J Nothroff ◽  
...  

Abstract Introduction Comprehensive cardiac rehabilitation (CR) programs based on the bio-psycho-social approach of the international classification of functioning and disease are carried out to achieve improved prognosis, superior health-related quality of life (HRQL) and social integration. We aimed to identify predictors of returning to work (RTW) and HRQL among cardiovascular risk factors and physical performance as well as patient-reported outcome measures (PROMs) modifiable during CR. Methods We designed a prospective observational multi-center study and enrolled 1,586 patients (2017/18) in 12 German rehabilitation centers regardless of their primary allocation diagnoses (e.g. acute myocardial infarction (AMI), coronary artery bypass grafting (CABG), coronary artery disease (CAD), valvular disease). Besides general data (e.g. age, gender, diagnoses), parameters of risk factor management (e.g. smoking, lipid profile, hypertension, lifestyle change motivation), physical performance (e.g. maximum exercise capacity, endurance training load, 6-min walking distance), and PROMs (e.g. depression, heart-focused anxiety, HRQL, subjective well-being, somatic and mental health, pain, general self-efficacy, pension desire as well as self-assessment of occupational prognosis using several questionnaires) were documented at CR admission and discharge. 6 months after discharge, status of RTW and HRQL (SF-12) were captured by a follow-up (FU) survey and analyzed in multivariable regression models with multiple imputation of missing values. Results Out of the study participants, 1,262 patients (54±7 years, 77% men) responded to the follow-up survey and could be analyzed regarding the outcome parameters. Most of them were assigned to CR primarily due to AMI (40%) or CAD without myocardial infarction (18%), followed by heart valve diseases in 12% of patients and CABG (8%). 864 patients (69%) returned to work within the follow-up period. Pension desire, negative self-assessed occupational prognosis, heart-focussed anxiety, major life events, smoking and heart failure were negatively associated with RTW, while higher endurance training load, HRQL and work stress were positively associated (Figure 1). HRQL after 6 months was determined more by PROMs (e.g. pension desire, heart-focused anxiety, physical/mental HRQL in SF-12, physical/mental health in indicators of rehab-status questionnaire (IRES-24), stress, well-being in the World Health Organization well-being index and self-efficacy expectations) than by clinical parameters or physical performance. Conclusions Patient-reported outcome measures predominantly influenced RTW and HRQL in heart-disease patients, whereas patients' pension desire and heart-focussed anxiety had a dominant impact on all investigated endpoints. Therefore, the multi-component CR approach focussing on psychosocial support is crucial for subjective health prognosis and occupational resumption. Figure 1. Predictors of returning to work Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German pension insurance


2021 ◽  
pp. bmjsrh-2020-200954
Author(s):  
Chelsey Porter Erlank ◽  
Jonathan Lord ◽  
Kathryn Church

IntroductionThe English government approved both stages of early medical abortion (EMA), using mifepristone and misoprostol under 10 weeks’ gestation, for at-home use on 30 March 2020. MSI Reproductive Choices UK (MSUK), one of the largest providers of abortion services in England, launched a no-test telemedicine EMA pathway on 6 April 2020. The objectives of this study were to report key patient-reported outcome measures and to assess whether our sample was representative of the whole population receiving no-test telemedicine EMA.MethodsA sample of all MSUK’s telemedicine EMA patients between April and August 2020 were invited to opt in to a follow-up call to answer clinical and satisfaction questions. A total of 1243 (13.7% of all telemedicine EMAs) were successfully followed-up, on average within 5 days post-procedure.ResultsPatients reported high confidence in telemedicine EMA and high satisfaction with the convenience, privacy and ease of managing their abortion at home. The sample responding were broadly equivalent to the whole population receiving telemedicine. No patient reported that they were unable to consult privately. The majority (1035, 83%) of patients reported preferring the telemedicine pathway, with 824 (66%) indicating that they would choose telemedicine again if COVID-19 were no longer an issue.ConclusionsTelemedicine EMA is a valued, private, convenient and more accessible option that is highly acceptable for patients seeking an abortion, especially those for whom in-clinic visits are logistically or emotionally challenging. Evidence that this pathway would be a first choice again in future for most patients supports the case to make telemedicine EMA permanent.


2021 ◽  
Vol 9 (1) ◽  
pp. 232596712096792
Author(s):  
James L. Cook ◽  
Kylee Rucinski ◽  
Cory R. Crecelius ◽  
Richard Ma ◽  
James P. Stannard

Background: Return to sport (RTS) after osteochondral allograft (OCA) transplantation for large unipolar femoral condyle defects has been consistent, but many athletes are affected by more severe lesions. Purpose: To examine outcomes for athletes who have undergone large single-surface, multisurface, or bipolar shell OCA transplantation in the knee. Study Design: Case series; Level of evidence, 4. Methods: Data from a prospective OCA transplantation registry were assessed for athletes who underwent knee transplantation for the first time (primary transplant) between June 2015 and March 2018 for injury or overuse-related articular defects. Inclusion criteria were preinjury Tegner level ≥5 and documented type and level of sport (or elite unit active military duty); in addition, patients were required to have a minimum of 1-year follow-up outcomes, including RTS data. Patient characteristics, surgery type, Tegner level, RTS, patient-reported outcome measures (PROMs), compliance with rehabilitation, revisions, and failures were assessed and compared for statistically significant differences. Results: There were 37 included athletes (mean age, 34 years; range, 15-69 years; mean body mass index, 26.2 kg/m2; range, 18-35 kg/m2) who underwent large single-surface (n = 17), multisurface (n = 4), or bipolar (n = 16) OCA transplantation. The highest preinjury median Tegner level was 9 (mean, 7.9 ± 1.7; range, 5-10). At the final follow-up, 25 patients (68%) had returned to sport; 17 (68%) returned to the same or higher level of sport compared with the highest preinjury level. The median time to RTS was 16 months (range, 7-26 months). Elite unit military, competitive collegiate, and competitive high school athletes returned at a significantly higher proportion ( P < .046) than did recreational athletes. For all patients, the Tegner level at the final follow-up (median, 6; mean, 6.1 ± 2.7; range, 1-10) was significantly lower than that at the highest preinjury level ( P = .007). PROMs were significantly improved at the final follow-up compared with preoperative levels and reached or exceeded clinically meaningful differences. OCA revisions were performed in 2 patients (5%), and failures requiring total knee arthroplasty occurred in 2 patients (5%), all of whom were recreational athletes. Noncompliance was documented in 4 athletes (11%) and was 15.5 times more likely ( P = .049) to be associated with failure or a need for revision than for compliant patients. Conclusion: Large single-surface, multisurface, or bipolar shell OCA knee transplantations in athletes resulted in two-thirds of these patients returning to sport at 16 to 24 months after transplantation. Combined, the revision and failure rates were 10%; thus, 90% of patients were considered to have successful 2- to 4-year outcomes with significant improvements in pain and function, even when patients did not RTS.


Author(s):  
Gareth S. Turnbull ◽  
Claire Marshall ◽  
Jamie A. Nicholson ◽  
Deborah J. MacDonald ◽  
Nicholas D. Clement ◽  
...  

Abstract Introduction The Olympia femoral stem is a stainless steel, anatomically shaped, polished and three-dimensionally tapered implant designed for use in cemented total hip arthroplasty (THA). The primary aim of this study was to determine the long-term survivorship, radiographic outcome, and patient-reported outcome measures (PROMs) of the Olympia stem. Patients and methods Between May 2003 and December 2005, 239 patients (264 THAs) underwent a THA with an Olympia stem in our institution. Patient-reported outcome measures were assessed using the Oxford Hip Score (OHS), EuroQol-5 dimensions (EQ-5D) score, and patient satisfaction at mean 10 years following THA. Patient records and radiographs were then reviewed at a mean of 16.5 years (SD 0.7, 15.3–17.8) following THA to identify occurrence of complications or revision surgery for any cause following surgery. Radiographs were assessed for lucent lines and lysis according to Gruen’s zones Results Mean patient age at surgery was 68.0 years (SD 10.9, 31–93 years). There were 156 women (65%, 176 THAs). Osteoarthritis was the indication for THA in 204 patients (85%). All cause stem survivorship at 10 years was 99.2% (95% confidence interval [CI], 97.9%–100%) and at 15 years was 97.5% (94.6%–100%). The 15-year stem survival for aseptic loosening was 100%. Analysis of all-cause THA failure demonstrated a survivorship of 98.5% (96.3%–100%) at 10 years and 95.9% (92.4%–99.4%) at 15 years. There were 9 THAs with non-progressive lucent lines in a single Gruen zone and 3 had lines in two zones, and no patient demonstrated signs for lysis. At a mean of 10-year (SD 0.8, 8.7–11.3) follow-up, mean OHS was 39 (SD 10.3, range 7–48) and 94% of patients reported being very satisfied or satisfied with their THA. Conclusions The Olympia stem demonstrated excellent 10-year PROMs and very high rates of stem survivorship at final follow-up beyond 15 years.


Children ◽  
2021 ◽  
Vol 8 (7) ◽  
pp. 587
Author(s):  
Isabel I. Sreeram ◽  
Chantal A. ten Kate ◽  
Joost van Rosmalen ◽  
Johannes M. Schnater ◽  
Saskia J. Gischler ◽  
...  

Increasing numbers of children and adults with chronic disease status highlight the need for a value-based healthcare system. Patient-reported outcome measures (PROMs) are essential to value-based healthcare, yet it remains unclear how they relate to clinical outcomes such as health and daily functioning. We aimed to assess the added value of self-reported PROMs for health status (HS) and quality of life (QoL) in the long-term follow-up of children with foregut anomalies. We evaluated data of PROMs for HS and/or QoL among eight-year-olds born with congenital diaphragmatic hernia (CDH), esophageal atresia (EA), or congenital lung malformations (CLM), collected within the infrastructure of a multidisciplinary, longitudinal follow-up program. Clinical outcomes were categorized into different outcome domains, and their relationships with self-reported HS and QoL were assessed through multivariable linear regression analyses. A total of 220 children completed HS and/or QoL self-reports. In children with CDH and EA, lower cognition was significantly associated with lower self-reported HS. Due to the low number of cases, multivariable linear regression analysis was not possible in children with CLM. HS, QoL, and clinical outcomes represent different aspects of a child’s wellbeing and should be measured simultaneously to facilitate a more holistic approach to clinical decision making.


2020 ◽  
Vol 11 ◽  
pp. 215145932095006
Author(s):  
Philip B. Kaiser ◽  
Erik T. Newman ◽  
Christopher Haggerty ◽  
Paul T. Appleton ◽  
John J. Wixted ◽  
...  

Purpose: We propose that geriatric comminuted intra-articular distal humerus fractures can be effectively treated with a limited fixation approach aimed at achieving varus/valgus stability with columnar fixation, but allowing intra-articular comminution to heal by secondary congruency against an intact olecranon, thus avoiding an olecranon osteotomy. Methods: Fifty-six elderly patients with AO 13-C type fractures, who underwent surgical fixation with ≥12-months of follow-up were retrospectively reviewed. Thirty patients were treated with intra-articular open reduction internal fixation (ORIF) with an olecranon osteotomy and 26 patients were treated with our limited fixation (L-ORIF) approach. Outcomes were range of motion (ROM), complications, additional surgery, and patient-reported outcome measures (PROMIS). Results: At final follow-up, the average elbow ROM was 97° (40°-155°) in the ORIF group and 86.5° (20°-145°) in the L-ORIF group. There was a trend toward more complications and additional surgery in the ORIF group. PROMIS scores for pain were 53.1 and 52.14, and PROMIS functional scores were 41.7 and 41.4 in the ORIF and L-ORIF group respectively. No differences in outcomes were statistically significant. Conclusion: A limited fixation technique based on achieving varus/valgus stability with columnar fixation, demonstrated equivalent outcomes in elderly patients with intra-articular distal humerus fractures when compared to intra-articular ORIF with an olecranon osteotomy


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