Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial.

BACKGROUND: Axial spondyloarthritis (AxSpA) is a chronic disease which results in fatigue, pain, and reduced quality of life (QoL). Traditional Chinese medicine (TCM), especially acupuncture, has shown promise in managing pain. Although a TCM collaborative model of care (TCMCMC) has been studied in cancer, there are no randomized controlled trials investigating TCM in AxSpA. Therefore, we will conduct a pragmatic trial to determine the clinical effectiveness, safety, and cost-effectiveness of TCMCMC for patients with AxSpA. We define TCMCMC as standard TCM history taking and physical examination, acupuncture, and TCM non-pharmacological advice and communications with rheumatologists in addition to usual rheumatologic care. The purpose of this paper is to describe the rationale for and methodology of this trial. METHODS/DESIGN: This pragmatic randomized controlled trial will recruit 160 patients who are diagnosed with AxSpA and have inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs). Simple randomization to usual rheumatologic care or the intervention (TCMCMC) with a 1:1 allocation ratio will be used. Ten 30-min acupuncture sessions will be provided to patients assigned to the TCMCMC arm. All participants will continue to receive usual rheumatologic care. The primary endpoint - spinal pain - will be evaluated at week 6. Secondary endpoints include clinical, quality of life, and economic outcome measures. Patients will be followed up for up to 52 weeks, and adverse events will be documented. DISCUSSION: This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of a TCMCMC for patients with AxSpA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03420404 . Registered on 14 February 2018.

Prognostic factors for mortality due to pneumonia among adults from different age groups in Singapore and mortality predictions based on PSI and CURB-65.

INTRODUCTION: Pneumonia is associated with considerable mortality. However, there is limited information on age-specific prognostic factors for death from pneumonia. METHODS: Patients hospitalised with a diagnosis of pneumonia through the emergency department were stratified into three age groups: 18-64 years, 65-84 years and ≥ 85 years. Multivariate logistic regression and receiver operating characteristic curve analyses were conducted to evaluate prognostic factors for mortality and the performance of pneumonia severity scoring tools for mortality prediction. RESULTS: A total of 1,902 patients were enrolled (18-64 years: 614 [32.3%]; 65-84 years: 944 [49.6%]; ≥ 85 years: 344 [18.1%]). Mortality rates increased with age (18-64 years: 7.3%; 65-84 years: 16.1%; ≥ 85 years: 29.7%; p < 0.001). Malignancy and tachycardia were prognostic of mortality among patients aged 18-64 years. Male gender, malignancy, congestive heart failure and eight other parameters reflecting acute disease severity were associated with mortality among patients aged 65-84 years. For patients aged ≥ 85 years, altered mental status, tachycardia, blood urea nitrogen, hypoxaemia, arterial pH and pleural effusion were significantly predictive of mortality. The Pneumonia Severity Index (PSI) was more sensitive than CURB-65 (confusion, uraemia, respiratory rate ≥ 30 per minute, low blood pressure, age ≥ 65 years) for mortality prediction across all age groups. CONCLUSION: The predictive effect of prognostic factors for mortality varied among patients with pneumonia from the different age groups. PSI performed significantly better than CURB-65 for mortality prediction, but its discriminative power decreased with advancing age.

Use of magnetic resonance imaging in detecting subclinical synovitis in rheumatoid arthritis and correlation of imaging findings with interleukin-18 levels.

AIM: We studied the usefulness of magnetic resonance imaging (MRI) in detecting subclinical inflammation in patients with asymptomatic RA and tested the hypothesis of interleukin (IL)-18 as a marker of disease activity. METHODS: Thirteen RA patients with Disease Activity Score of 28 joints (DAS28) < 2.6 were evaluated. The patients underwent clinical evaluation, laboratory tests and MRI assessment. Imaging of bilateral hands and wrists was performed using validated acquisition and scoring techniques. Serum IL-18 levels were concurrently measured. RESULTS: MRI assessments showed that 92.3% and 76.9% of patients had synovitis and bone marrow edema, respectively, despite being in clinical remission. Eight out of 12 patients (66.7%) had erosions on MRI which were not visualised on plain radiographs. Of all the 182 joints studied for synovitis on MRI, only one had clinical evidence of joint swelling. Comparison of the total sum scores of synovitis between the right and left hand and wrist joints of individual patients showed a significant difference between the two sides. Measurements of IL-18 indicated that a large proportion (54%) of the patients had undetectable or very low levels of the cytokine. CONCLUSION: MRI is more sensitive in detecting erosions compared with X-rays, and is superior in its ability to detect subclinical inflammation in RA patients. Despite being in clinical remission, a large majority of patients had imaging-detected synovitis and bone marrow edema. Our study highlights the usefulness of MRI for the accurate evaluation of disease activity. In the utility of MRI, it may be important to assess bilateral hands and wrists, instead of limiting to the dominant side.

An exploratory study of response shift in health-related quality of life and utility assessment among patients with osteoarthritis undergoing total knee replacement surgery in a tertiary hospital in Singapore.

OBJECTIVE: To investigate the influence of response shift (RS) on health-related quality of life (HRQOL) and utility assessment among patients undergoing total knee replacement. METHODS: Consenting patients undergoing total knee replacement were interviewed to determine their HRQOL by using the six-dimensional health state short form, derived from SF-36, and the EuroQol five-dimensional questionnaire at baseline (pretest 1) and the six-dimensional health state short form, derived from SF-36, at 6 (pretest 2) and 18 months after surgery (post-test). RS was studied by using a "then-test" approach by contacting participants 18 months after surgery and asking them to evaluate their HRQOL at baseline (then-test 1) and at 6 (then-test 2) and 18 months after surgery. RS was calculated as the score difference between pretest and then-test scores for a given time point. Relationships between RS and external variables were explored by using univariate and multiple liner regression analyses. RESULTS: In 74 subjects (63% response rate, median age 68 years), median (interquantile range) six-dimensional health state short form, derived from SF-36, scores for then-tests at baseline (0.48 [0.42-0.49]) and at 6 months (0.72 [0.66-0.79]) after surgery were significantly different from respective pretest scores (0.61 [0.58-0.68] at baseline, P = 0.000; 0.69 [0.63-0.72] at 6 months, P = 0.000), showing RS at both time points. RS at baseline (0.14 [0.08-0.20]) was significantly larger than that at 6 months (-0.05 [0.14 to 0.00], P = 0.000). EuroQol five-dimensional questionnaire pretest and then-test scores at baseline also differed significantly (0.69 [0.17-0.73] vs. -0.18 [-0.23 to 0.00], P = 0.000). RS at baseline was not affected by assessed demographic or medical variables. RS at 6 months was greater in subjects with more years of education (16% of variance in multiple liner regression, P < 0.01). CONCLUSION: RS was present and impacted HRQOL and utility assessment among patients undergoing total knee replacement before and 6 months after surgery.

In vivo pro- and anti-inflammatory cytokines in normal and patients with rheumatoid arthritis.

INTRODUCTION: Rheumatoid arthritis (RA) is a chronic, deforming arthritis that can lead to disabilities and poor quality of life. Cytokines are protein mediators of inflammation and are produced as a result of the activation of various cellular reactions. They are the final mediators and/or regulators of the inflammatory process. MATERIALS AND METHODS: The sera from 64 RA patients were assayed for both Th-1 and Th-2 related cytokines and soluble TNF-alpha receptors (IFN-gamma, TGF-beta, TNF-alpha, IL-1beta, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IL-18, sTNF-R1 and sTNFR2) using ELISA. RESULTS: The pro-inflammatory cytokines (IL-1, IL-6, IL-8, IL-18 and TNF- alpha) were significantly elevated in RA patients, while TGF-beta, an immunomodulatory cytokine, was elevated in control individuals. When the RA patients were categorised as active or inactive based on DAS scores, similar cytokines profiles were observed in both RA sub-groups. However, assays of sTNF-R1 and sTNFR-2 were noted to be significantly elevated in inactive RA patients when compared to active patients. CONCLUSION: Our findings indicate that local production of cytokine inhibitors is capable of diminishing disease activity and cytokine activity.

Direct and indirect costs of osteoarthritis in Singapore: a comparative study among multiethnic Asian patients with osteoarthritis.

OBJECTIVE: To estimate and compare the direct and indirect costs of osteoarthritis (OA) in multiethnic Asian patients with OA in Singapore. METHODS: The study was a retrospective and cross-sectional design. Patients were stratified according to ethnicity and presence or absence of joint surgery. Direct costs were estimated from both a societal and a patient perspective using the Singapore General Hospital database; indirect costs were estimated using the human capital approach. All costs were expressed as mean costs per patient per annum in 2003 Singapore dollars. RESULTS: A total of 1179 patients (83.6% Chinese, 7.2% Malay, 3.5% Indian, 5.7% others) were included in estimating direct costs, of which 513 (43.5%) had total knee replacement (TKR) and 92 (7.8%) total hip replacement (THR), while 105 patients (71.4% Chinese, 14.3% Malay, 14.3% Indian) were included in estimating indirect costs. Direct costs to patients ranged from 1460 dollars to 7477 dollars for Chinese, 1362 dollars-7211 dollars for Malays, 1688 dollars-6226 dollars for Indians, and 1437 dollars-12,140 dollars for other ethnic patients; direct costs to society ranged from 3351 dollars to 15,799 dollars for Chinese, 2939 dollars-15,436 dollars for Malays, 3150 dollars-10,990 dollars for Indians, and 2597 dollars-17,879 dollars for other ethnic patients. In contrast, the indirect costs ranged from 1215 dollars to 3834 dollars for Chinese, 1138 dollars-6116 dollars for Malays, and 1371 dollars-5292 dollars for Indians. However, most ethnic variations were not statistically significant. CONCLUSION: The economic burden of OA to society and patients increased by 3-fold or more in the patients with TKR/THR compared to those without. The ethnic differences in health resources consumed were more apparent when the disease progressed.