Toward Electronic Health Recording: Evaluation of Electronic Patient-reported Outcome Measures System for Remote Monitoring of Early Rheumatoid Arthritis

2016 ◽  
Vol 43 (12) ◽  
pp. 2106-2112 ◽  
Author(s):  
Yasser El Miedany ◽  
Maha El Gaafary ◽  
Sally Youssef ◽  
Sami Bahlas ◽  
Samah Almedany ◽  
...  

Objective.To assess the use of electronic patient-reported outcome measures (ePROM) in standard clinical practice for early rheumatoid arthritis (RA) management, the ePROM ability to enhance clinical care, and how computing technology can improve the patients’ adherence to therapy.Methods.In a double-blinded randomized-controlled study, 211 patients with early RA diagnosed according to American College of Rheumatology/European League Against Rheumatism criteria completed a PROM in paper format at their first clinic visit. Patients were then randomized to Group 1, which completed an ePROM questionnaire monthly, or Group 2, which continued the standard paper PROM format. Over a 12-month period, Group 1 patients were assessed every 3 months in the clinic, whereas Group 2 patients were assessed in the clinic initially monthly for 6 months, then every 3 months. The primary endpoint was the equivalence of outcomes [Routine Assessment of Patient Index Data 3 (RAPID-3) and 28-joint Disease Activity Score (DAS28)] in both groups. The secondary endpoint was the patients’ adherence to their medications.Results.There was no significant difference between disease activity measures as well as DAS28 and RAPID-3 scores at 3, 6, and 12 months of management, although there was a trend toward lower patient-reported tender joint count and functional disability score in the active group versus the control group. The patients’ adherence to antirheumatic therapy was significantly higher (p < 0.01) in the ePROM group, whereas stopping disease-modifying antirheumatic drugs for intolerability was significantly higher (p < 0.01) in the control group at 12 months of treatment.Conclusion.We found ePROM equivalent to standard paper PROM format. Further, it enabled the patients to personally monitor how they are doing regarding their disease activity and helped to optimize their adherence to their treatment.

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.


RMD Open ◽  
2016 ◽  
Vol 2 (2) ◽  
pp. e000202 ◽  
Author(s):  
Jos Hendrikx ◽  
Marieke J de Jonge ◽  
Jaap Fransen ◽  
Wietske Kievit ◽  
Piet LCM van Riel

2014 ◽  
Vol 96 (5) ◽  
pp. 348-351 ◽  
Author(s):  
N Roberts ◽  
B Bradley ◽  
D Williams

Introduction Electronic patient reported outcome measures (PROMs) enable real time reporting back to the patient and medical team, comparison between similar patient cohorts and long-term cost effective outcome measurement. The primary objective of this three-phase pilot study was to measure uptake using a web-based PROM system following the introduction of two separate process improvements. Methods Eighty consecutive new elective orthopaedic patients in a single surgeon’s practice were recruited for the study. Patients in Group 1 (n=26) received only a letter reminding them to complete a symptom score. Those in Group 2 (n=31) also received a reminder SMS (short message service) message via their mobile or home telephone and those in Group 3 (n=23) also had access to a tablet computer in clinic. Results The mean patient age in Group 1 was 55 years (range: 24–80 years), in Group 2 it was 60 years (range: 23–85 years) and in Group 3 it was 58 years (range: 37–78 years) (p>0.05). Overall, 79% of patients had internet access, and 35% of Group 1, 55% of Group 2 and 74% of Group 3 recorded an electronic PROM score (p=0.02). In Group 3, 94% of patients listed for an operation completed an electronic PROM score (p=0.006). Conclusions Collecting PROM data effectively in everyday clinical practice is challenging. Electronic collection should meet that challenge and improve healthcare delivery but it is in its infancy. This pilot study shows that the combination of an SMS reminder and access to a Wi-Fi enabled tablet computer in the clinic setting enabled 94% of patients listed for an operation to complete a score on a web-based clinical outcomes system. Additional staff training and telephone call reminders may further improve uptake.


Rheumatology ◽  
2019 ◽  
Vol 59 (8) ◽  
pp. 1853-1861 ◽  
Author(s):  
James M Gwinnutt ◽  
Kimme L Hyrich ◽  
Mark Lunt ◽  
Anne Barton ◽  
Suzanne M M Verstappen ◽  
...  

Abstract Objectives To describe outcomes of patients with early RA in a patient acceptable symptom state (PASS) at treatment initiation and to identify clusters of symptoms associated with poor outcomes. Methods Data came from the Rheumatoid Arthritis Medication Study, a UK multicentre cohort study of RA patients starting MTX. The HAQ, DAS28 and other patient-reported outcome measures (PROMs) were collected at baseline, and at 6 and 12 months. Patients answering yes to the question ‘Is your current condition satisfactory, when you take your general functioning and your current pain into consideration?’ were defined as PASS; patients answering no were defined as N-PASS. Symptom clusters in the baseline PASS group were identified using K-medians cluster analysis. Outcomes of baseline PASS vs N-PASS patients and each cluster are compared using random effects models. Results Of 1127 patients, 572 (50.8%) reported being in PASS at baseline. Over one year, baseline PASS patients had lower DAS28 (mean difference = −0.71, 95% CI −0.83, −0.59) and HAQ scores (mean difference = −0.48, 95% CI −0.56, −0.41) compared with N-PASS patients. Within the baseline PASS group, we identified six symptom clusters. Clusters characterized by high disease activity and high PROMs, or moderate disease activity and high PROMs, had the worst outcomes compared with the other clusters. Conclusion Despite reporting their condition as ‘satisfactory’, early RA patients with high PROM scores are less likely to respond to therapy. This group may require increased vigilance to optimize outcomes.


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


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 582.1-582
Author(s):  
S. Pazmino ◽  
A. Lovik ◽  
A. Boonen ◽  
D. De Cock ◽  
V. Stouten ◽  
...  

Background:Commonly used disease activity scores in rheumatoid arthritis (RA) include one patient reported outcome (PRO) -the patient’s global health assessment (PGA). Exploratory factor analysis (EFA) was performed on data from the 2 year Care in early Rheumatoid Arthritis (CareRA) trial to explain the evolution of disease burden extracting 3 factors.1Objectives:To assess the evolution and relative responsiveness over time of clinical, laboratory and patient assessments included in composite scores, together with other PROs like pain, fatigue and functionality in patients with early RA (≤1 year) treated to target (T2T) within the CareRA trial.Methods:DMARD naïve patients with early RA (n=379) were included, randomized to remission induction with COBRA-like treatment schemes (n=332) or MTX monotherapy (n=47) and T2T.Components of disease activity scores (swollen/tender joint count (S/TJC), C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), and physician (PhGH) or patient (PGA) global health assessment), pain and fatigue (both on 0-100 scale) and HAQ were recorded at every visit.Missing data was handled with multiple imputation (n=15). Clustering was removed with multiple outputation (n=1000), then each of the 15 000 datasets was analyzed by EFA with principal component extraction and oblimin rotation. The analyses were combined after re-ordering the factors by maximizing factor congruence. The 3 extracted factors and their individual components (with their loadings) were: 1. Patient containing PGA (0.87), pain (0.86), fatigue (0.90) and HAQ (0.5) 2.Clinical with SJC (0.92), TJC (0.89) and PhGH (0.76) and 3.Laboratory with CRP(0.87) and ESR (0.78).1(Pazmino, ACR 2019 abstract, Table 3)Afterwards, variables were first normalized to a 0-1 scale, then multiplied -weighted- by the factor loadings previously obtained.1For each Patient, Clinical and Laboratory severity score, the weighted variables belonging to each score were summed together and then re-scaled to 0-1 (higher values suggest more burden).The percentage (%) improvement from baseline to week 104 and the area under the curve (AUC) across time points were calculated per factor.Differences in % improvement and AUC were compared between patients not achieving and achieving early and sustained (week 16 to 104) disease activity score remission (DAS28CRP <2.6) with ANOVA. Bonferroni correction was used for multiple testing.Results:Severity scores of Patient, Clinical and Laboratory factors improved rapidly over time (Figure 1). In patients achieving sustained remission (n=122), Patient, Clinical and Laboratory scores improved 56%, 90% and 27% respectively. In patients not achieving sustained remission (n=257) the improvement was 32%, 78% and 9% respectively (p<0.001 only for clinical improvement).Patients in CareRA who achieved sustained remission had an AUC of 15.1, 3.4 and 4.7 in Patient, Clinical and Laboratory scores respectively, compared to 32.3, 10.0, and 7.2 in participants not achieving sustained remission (p<0.001 for all comparisons).Conclusion:Patient, Clinical and Laboratory severity scores improved rapidly over time in patients achieving rapid and sustained disease control. However, overall, Patient burden seemed not to improve to the same extent as Clinical burden. Patient’s unmet needs in terms of pain, fatigue, functionality and overall well-being should thus be given more attention, even in patients in sustained remission.References:[1]Pazmino S,et al.Including Pain, Fatigue and Functionality Regularly in the Assessment of Patients with Early Rheumatoid Arthritis Separately Adds to the Evaluation of Disease Status [abstract]. ACR. 2019.Disclosure of Interests:Sofia Pazmino: None declared, Anikó Lovik: None declared, Annelies Boonen Grant/research support from: AbbVie, Consultant of: Galapagos, Lilly (all paid to the department), Diederik De Cock: None declared, Veerle Stouten: None declared, Johan Joly: None declared, Delphine Bertrand: None declared, Rene Westhovens Grant/research support from: Celltrion Inc, Galapagos, Gilead, Consultant of: Celltrion Inc, Galapagos, Gilead, Speakers bureau: Celltrion Inc, Galapagos, Gilead, Patrick Verschueren Grant/research support from: Pfizer unrestricted chair of early RA research, Speakers bureau: various companies


2020 ◽  
Vol 102-B (6_Supple_A) ◽  
pp. 24-30
Author(s):  
Andrew T. Livermore ◽  
Jill A. Erickson ◽  
Brenna Blackburn ◽  
Christopher L. Peters

Aims A significant percentage of patients remain dissatisfied after total knee arthroplasty (TKA). The aim of this study was to determine whether the sequential addition of accelerometer-based navigation for femoral component preparation and sensor-guided ligament balancing improved complication rates, radiological alignment, or patient-reported outcomes (PROMs) compared with a historical control group using conventional instrumentation. Methods This retrospective cohort study included 371 TKAs performed by a single surgeon sequentially. A historical control group, with the use of intramedullary guides for distal femoral resection and surgeon-guided ligament balancing, was compared with a group using accelerometer-based navigation for distal femoral resection and surgeon-guided balancing (group 1), and one using navigated femoral resection and sensor-guided balancing (group 2). Primary outcome measures were Patient-Reported Outcomes Measurement Information System (PROMIS) and Knee injury and Osteoarthritis Outcome (KOOS) scores measured preoperatively and at six weeks and 12 months postoperatively. The position of the components and the mechanical axis of the limb were measured postoperatively. The postoperative range of motion (ROM), haematocrit change, and complications were also recorded. Results There were 194 patients in the control group, 103 in group 1, and 74 in group 2. There were no significant differences in baseline demographics between the groups. Patients in group 2 had significantly higher baseline mental health subscores than control and group 1 patients (53.2 vs 50.2 vs 50.2, p = 0.041). There were no significant differences in any PROMs at six weeks or 12 months postoperatively (p > 0.05). There was no difference in the rate of manipulation under anaesthesia (MUA), complication rates, postoperative ROM, or blood loss. There were fewer mechanical axis outliers in groups 1 and 2 (25.2%, 14.9% respectively) versus control (28.4%), but this was not statistically significant (p = 0.10). Conclusion The sequential addition of navigation of the distal femoral cut and sensor-guided ligament balancing did not improve short-term PROMs, radiological outcomes, or complication rates compared with conventional techniques. The costs of these added technologies may not be justified. Cite this article: Bone Joint J 2020;102-B(6 Supple A):24–30.


2019 ◽  
Vol 1 (8) ◽  
pp. 507-515
Author(s):  
Maria Rydholm ◽  
Ingegerd Wikström ◽  
Sofia Hagel ◽  
Lennart T. H. Jacobsson ◽  
Carl Turesson

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