Assessment of medical professionalism using the Professionalism Mini Evaluation Exercise (P-MEX) in a multi-ethnic society: a Delphi study.

BACKGROUND: The importance of medical professionalism and its assessment has been well documented in the literature. However, there is currently no culturally-adapted tool to assess medical professionalism in Singapore. This study sets out to find consensus on relevance of the items from the Professionalism Mini Evaluation Exercise (P-MEX) for assessing medical professionalism in Singapore. METHODS: A two-round Delphi survey was completed by an expert panel consisting of program directors, associate designated institutional officials, and designated institutional official (n = 15) from residency programs in Singapore. Round 1 comprised of 23 items from the P-MEX rated on a 5-point scale (1 = Definitely include, 2 = Possibly include, 3 = Neutral, 4 = Possibly exclude, 5 = Definitely exclude). In round 2, the experts received feedback from the previous round, and were asked to re-rate the items which did not achieve consensus in the previous round. The threshold for consensus in the study was defined as 70% or greater agreement among experts. RESULTS: Completed questionnaires for both rounds were received from all 15 experts. In round 1, 18 items (78%) achieved consensus to be included. In round 2, 1 (4%) item achieved consensus to be included. However, none of the remaining items achieved consensus to be removed, and they exhibited stability in responses. A list of 19 items covering four domains of medical professionalism (Doctor-patient relationship skills, Reflective skills, Time management and Inter-professional relationship skills) was obtained during the two-rounds of Delphi survey. CONCLUSIONS: Nineteen items in the P-MEX had garnered consensus and is suitable for assessing medical professionalism in Singapore. The findings of this study can provide guidance for faculty and institutions who want to assess medical professionalism of their medical trainees.

Assessment of medical professionalism: preliminary results of a qualitative study.

BACKGROUND: The importance of medical professionalism has been well documented in the literature. Cultural background affects the constituents of professionalism. However, few studies have explored the domains of medical professionalism in an Asian context. We aim to describe the views and experiences of both patients and faculty on medical professionalism in an urban Asian city state. METHODS: Data for this qualitative study were collected through focus group discussions (FGDs) with patients and in-depth interviews (IDIs) with faculty members. The IDIs and FGDs were audio-recorded and transcribed verbatim. Thematic analysis was conducted by two independent coders using a priori framework derived from Professionalism Mini Evaluation Exercise (P-MEX). Sociodemographic data of faculty members and patients were obtained through brief questionnaires. RESULTS: A total of 31 patients (58.1% male, all had visited healthcare facilities within the past year) and 26 faculty members (42.3% male, 38.5% from medical disciplines, median years as faculty is 11) participated in this study. The results supported the four domains of medical professionalism - Doctor-patient relationship skills, Reflective skills, Time management and Inter-professional relationship skills. Two new sub-domains which emerged from data were (1) communicated effectively with patient and (2) demonstrated collegiality. CONCLUSIONS: The domains of professionalism in Singapore were similar to previous studies. This study allows a better understanding of medical professionalism to enhance the assessment and ultimately, the teaching of medical professionalism in an urban multi-ethnic Asian city.

Evaluation of a new multi-parallel line immunoassay for systemic sclerosis-associated antibodies in an Asian population.

OBJECTIVES: To compare the SSc-line immunoassay (LIA) with conventional techniques of antibody detection, to evaluate its diagnostic utility and to describe clinical associations of antibodies in Asian SSc patients. METHODS: Stored sera from patients with SSc (n = 68), SLE (n = 49), OA (n = 41) and normal controls (NCs, n = 32) were evaluated. Cohen's κ and Bland-Altman plots were used to evaluate agreement. RESULTS: There was good agreement between LIA and ELISA for anti-Scl-70 (κ = 0.97), anti-CENPA (κ = 0.83), anti-CENPB (κ = 0.96) and anti-PmScl100 (κ = 1.00) (5.48-8.22% of values outside the 95% limits of agreement using Bland-Altman plots), and between LIA and IIF for anti-CENPA (κ = 0.81) and anti-CENPB (κ = 0.77) (P < 0.001). Using LIA, of 32 (32/68, 47%) SSc patients negative for anti-Scl-70 and anti-CENPA/B, 5 (5/32, 15%) were positive for anti-Ku, -Nor90, -fibrillarin and -RP155. Specificity of each antibody for SSc was at least 97% (vs OA/NC) and 94% (vs SLE), except for anti-Ro52 (63%). Anti-CENPB was associated with joint pain [odds ratio (OR) 0.17], interstitial lung disease (OR 0.24) and telangiectasia (OR 4.00) (P < 0.05). Anti-Ro60 was associated with pulmonary arterial hypertension (OR 3.89, P = 0.041). CONCLUSION: The SSc-LIA has good agreement with conventional techniques for selected antibodies and has good diagnostic utility.

Facilitators of and barriers to implementing a traditional Chinese medicine collaborative model of care for axial spondyloarthritis: a qualitative study.

BACKGROUND: Conventional therapy may be inadequate for many patients with axial spondyloarthritis (axSpA). Traditional Chinese medicine (TCM) may be a viable alternative, but its effectiveness for axSpA is unknown. We are currently conducting a pragmatic randomised controlled trial (RCT) to investigate the effectiveness of a TCM collaborative model of care (TCMCMC), which combines usual rheumatologic care with acupuncture for patients with axSpA. This nested qualitative sub-study aims to identify facilitators of and barriers to the implementation of the TCMCMC. METHODS: We conducted individual in-depth interviews with participants who had completed the acupuncture regimen to elicit opinions on the facilitators of and barriers to the implementation of the TCMCMC. The interviews were transcribed and analysed using thematic analysis. RESULTS: Twelve participants were included, with data saturation occurring after 10 interviews. The analysis revealed both a number of important 'facilitators' and 'barriers'. Facilitators to the implementation of the TCMCMC included effectiveness of TCM to relieve symptoms, inadequacy of conventional treatment and positive social perceptions of TCM. Barriers included scepticism towards TCM, inability of TCM to provide instant relief, needle-related discomfort, variable effectiveness of TCM influenced by physicians' skills and experience and the high cost of TCM. Recommendations to overcome barriers included further patient education about TCM. CONCLUSION: Policymakers should take into account the various feasibility factors identified in this study when developing and implementing a TCMCMC. TRIAL REGISTRATION NUMBER: NCT03420404 (ClinicalTrials.gov).

Professionalism in traditional Chinese medicine (TCM) practitioners: a qualitative study.

BACKGROUND: Medical professionalism is important for establishing public trust in doctors. Its definition is culture-sensitive. However, no research has explored medical professionalism in Traditional Chinese Medicine (TCM) practitioners. This study aims to (a) establish the domains of professionalism in TCM practitioners in Singapore, and to (b) compare the domains of professionalism of practitioners trained in TCM and practitioners trained in conventional medicine. METHODS: Data for this qualitative study was collected through in-depth interviews (IDIs) with TCM practitioners. IDIs were audio-recorded and transcribed verbatim. Thematic analysis was conducted by two independent coders using the Professionalism Mini-Evaluation Exercise (P-MEX) as a framework. The domains of professionalism in TCM and conventional medicine were then compared, using data from a similar study on professionalism in practitioners trained in conventional medicine. RESULTS: A total of 27 TCM practitioners (40.7% male) participated in this study. The four domains of professionalism in the P-MEX, namely doctor-patient relationship skills, reflective skills, time management and inter-professional relationship skills, and two new sub-domains, "communicated effectively with patient" and "demonstrated understanding and integrated with conventional medicine", were relevant to TCM practitioners. This is largely similar to that of practitioners trained in conventional medicine, with a few differences, including "ensured continuity of care" and "used health resources appropriately". CONCLUSION: The domains of professionalism in TCM practitioners were established and they are similar to that of practitioners trained in conventional medicine. This study is the first to define medical professionalism in TCM practitioners. Findings will provide guidance on the education of professionalism in TCM practitioners.

Evaluation of Scleroderma Clinical Trials Consortium training recommendations on modified Rodnan skin score assessment in scleroderma.

AIM: The modified Rodnan skin score (mRSS) is a validated outcome measure for skin thickness in systemic sclerosis (SSc). Training has been shown to reduce variability in the measurement of mRSS. Our objective was to assess the inter- and intra-observer variability of mRSS scoring using the proposed recommendations for training by the Scleroderma Clinical Trials Consortium (SCTC) and World Scleroderma Foundation (WSF). METHOD: Fifty-two trainees and eight adult SSc patients participated in the SSc skin scoring workshop that was conducted in two sessions by four teachers. Each session, attended by 26 trainees, had a teaching and evaluation phase. The teaching phase comprised of: (a) lecture on mRSS scoring; (b) video demonstration of mRSS scoring; and (c) live demonstration of mRSS on one SSc patient. In the evaluation phase, each trainee independently assessed the mRSS in four SSc patients. For intra-observer reliability, 14 trainees re-assessed the mRSS of two SSc patients whom they had previously examined. We computed the inter- and intra-observer variability using a linear mixed model. RESULTS: For the evaluation phase, 34 (65.4%) trainees were within five units of the established teachers' score in 3 out of 4 patients. Overall, the whole group had acceptable inter-observer variability (intra-class correlation coefficient [ICC] = 0.71, mean = 8.64 and within-patient standard deviation [SD] = 4.25). The intra-observer ICC was 0.85 and within-patient SD was 2.73. CONCLUSION: There was good inter-observer and excellent intra-observer reliability. This is the first study examining the training of assessors using the SCTC/WSF recommendations and our results support the importance of standardized training for skin scoring.

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.

Epidemiology of spondyloarthritis in the People's Republic of China: review of the literature and commentary.

OBJECTIVES: The prevalence of spondyloarthritis (SpA) and its prototype ankylosing spondylitis (AS) varies considerably in different parts of the world. With 20% of the world's population in China, there is potential for a significant disease burden. Eight of the 10 articles providing primary data on the prevalence of SpA in China are in the Chinese language; our objective is to review all 10 articles for English readers. METHODS: Articles were retrieved by search engines in both the English language (www.pubmed.gov) and Chinese language web sites (www.cnki.net). We limited our search to publications of the period 1994 to 2006, and the key words used were (entered as Chinese characters) "prevalence AND spondyloarthropathy," "prevalence AND ankylosing spondylitis," "epidemiology AND spondyloarthropathy," and "epidemiology AND ankylosing spondylitis." For each survey, we examined the number of subjects surveyed, the survey instrument, the criteria used for classifying patients as SpA or AS, and other methodological quality issues. RESULTS: There were 2 AS surveys in the military and 8 surveys in the civilian communities. Overall, the pooled prevalence of AS for the military and civilian communities is 0.24%, 95% confidence interval (CI: 0.17 to 0.32) and 0.23%, 95% CI (0.19 to 0.28), respectively. There is 1 SpA survey in the military and 4 surveys in the civilian communities. The prevalence of SpA in the military survey is 0.45%. The pooled prevalence of SpA from the civilian surveys is 0.93%, 95%CI (0.53 to 1.65). We found that the survey methodology is generally not well reported, giving rise to concerns about the methodological quality and hence validity of the results. CONCLUSION: The prevalence of AS and SpA in China are similar to Caucasians in the U.S. or Europe.

Validation of the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument 2.0 in English- and Chinese-speaking patients in a multi-ethnic Singapore systemic sclerosis cohort.

The aim of this study was to (1) translate the Gastrointestinal Tract Instrument (GIT) 2.0 from English to Chinese and (2) validate both versions in a multi-ethnic systemic sclerosis cohort in Singapore (SCORE). The English GIT2.0 was translated to Chinese using a standard forward-backward translation approach. Psychometric evaluation of the GIT2.0 included internal consistency reliability (using Cronbach's alpha), test-retest reliability (using intra-class correlation coefficient (ICC)), scale level factor analysis, and construct validity (using Spearman correlation) against the modified Scleroderma Health Assessment Questionnaire (S-HAQ) and the SF-36 v2. Most of the patients were females (88.6%) and Chinese (78.2%), with mean (SD) age of 51.0 (13.0) years and median disease duration of 4.5 years. We administered English (n = 146) and Chinese (n = 74) GIT2.0. The mean (SD) total GIT score was 0.29 (0.37). There was good internal consistency (Cronbach's alpha >0.70 for all subscales) and good test-retest reliability for the scale and all subscales (ICC 0.71-0.92) except for "diarrhoea" (ICC = 0.54). Our hypothesised a priori construct validity was supported by moderate correlations between the total GIT score and S-HAQ GI subscale (r = 0.446), and the social functioning subscale and SF36v2 role-social domain (r = 0.337), and weak-to-moderate correlation between the emotional subscale and SF-36v2 role-emotional (r = 0.295) and mental health (r = 0.298) domains and mental component summary (r = 0.356). Exploratory factor analysis of the seven subscales yielded a two-factor solution explaining 69.63% of the total variance. This study provides evidence for the reliability and validity of the English and Chinese GIT2.0 to be used in Singapore for research and routine practice.

Singapore Chapter of Rheumatologists consensus statement on the eligibility for government subsidy of biologic disease modifying anti-rheumatic agents for the treatment of psoriatic arthritis.

AIM: In Singapore, patients with psoriatic arthritis (PsA) constitute a significant disease burden. There is good evidence for the efficacy of anti-tumor necrosis factor (anti-TNF) in PsA; however cost remains a limiting factor. Non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) hence remain the first-line treatment option in PsA in spite of limited evidence. The Singapore Chapter of Rheumatologists aims to develop national guidelines for clinical eligibility for government-assisted funding of biologic disease modifying anti- rheumatic drugs (bDMARDs) for PsA patients in Singapore. METHODS: Evidence synthesis was performed by reviewing seven published guidelines on use of biologics for PsA. Using the modified Research and Development/University of California at Los Angeles Appropriateness Method (RAM), rheumatologists rated indications for therapies for different clinical scenarios. Points reflecting the output from the formal group consensus were used to formulate the practice recommendations. RESULTS: Ten recommendations were formulated relating to initiation, continuation and options of bDMARD therapy. The panellists agreed that a bDMARD is indicated if a patient has active PsA with at least five swollen and tender joints, digits or entheses and has failed two nbDMARD strategies at optimal doses for at least 3 months each. Any anti-TNF may be used and therapy may be continued if an adequate PsARC response is achieved by 3 months after commencement. CONCLUSION: The recommendations developed by a formal group consensus method may be useful for clinical practice and guiding funding decisions by relevant authorities in making bDMARD usage accessible and equitable to eligible patients in Singapore.

Consensus development on eligibility of government subsidisation of biologic disease modifying anti-rheumatic agents for treatment of ankylosing spondylitis: The Singapore experience.

INTRODUCTION: The beneficial effects of biologic disease-modifying anti-rheumatic drugs (bDMARDs), such as tumour necrosis factor inhibitors (anti-TNF) in active ankylosing spondylitis (AS) are well established. The significant costs on patients in the absence of financial subsidization can limit their use. The objective was to describe a consensus development process on recommendations for government-assisted funding of biologic therapy for AS patients in Singapore. METHODS: Evidence synthesis followed by a modified RAND/UCLA Appropriateness Method (RAM) was used. Eleven rheumatologists rated indications for therapies for different proposed clinical scenarios. Points reflecting the output from the formal group consensus were used to formulate 10 practice recommendations. RESULTS: It was agreed that a bDMARD (anti-TNF) is indicated if a patient has active AS with a Bath Ankylosing Spondylitis Activity Index (BASDAI) ≥ 4 and spinal pain of ≥ 4 cm on visual analogue scale (VAS) on two occasions at least 12 weeks apart, despite being on a minimum of two sequential non-steroidal anti-inflammatory drugs at maximal tolerated dose for at least 4 weeks, in addition to adherence to an appropriate physiotherapy program for at least 3 months. To qualify for continued biologic therapy, a patient must have documentation of response every 3 months and at least 50% improvement in BASDAI and reduction of spinal pain VAS ≥ 2 cm. CONCLUSION: A validated and feasible consensus process can enable pragmatic standardized recommendations to be developed for bDMARD subsidization for AS patients in a local Asian context.

Do English and Chinese EQ-5D versions demonstrate measurement equivalence? An exploratory study.

BACKGROUND: Although multiple language versions of health-related quality of life instruments are often used interchangeably in clinical research, the measurement equivalence of these versions (especially using alphabet vs pictogram-based languages) has rarely been assessed. We therefore investigated the measurement equivalence of English and Chinese versions of the EQ-5D, a widely used utility-based outcome instrument. METHODS: In a cross-sectional study, either EQ-5D version was administered to consecutive outpatients with rheumatic diseases. Measurement equivalence of EQ-5D item responses and utility and visual analog scale (EQ-VAS) scores between these versions was assessed using multiple regression models (with and without adjusting for potential confounding variables), by comparing the 95% confidence interval (95%CI) of score differences between these versions with pre-defined equivalence margins. An equivalence margin defined a magnitude of score differences (10% and 5% of entire score ranges for item responses and utility/EQ-VAS scores, respectively) which was felt to be clinically unimportant. RESULTS: Sixty-six subjects completed the English and 48 subjects the Chinese EQ-5D. The 95%CI of the score differences between these versions overlapped with but did not fall completely within pre-defined equivalence margins for 4 EQ-5D items, utility and EQ-VAS scores. For example, the 95%CI of the adjusted score difference between these EQ-5D versions was -0.14 to +0.03 points for utility scores and -11.6 to +3.3 points for EQ-VAS scores (equivalence margins of -0.05 to +0.05 and -5.0 to +5.0 respectively). CONCLUSION: These data provide promising evidence for the measurement equivalence of English and Chinese EQ-5D versions.

Singapore Chapter of Rheumatologists Consensus Statement on the Eligibility for Government Subsidy of Biologic Disease Modifying Antirheumatic Agents for Treatment of Rheumatoid Arthritis (RA).

INTRODUCTION: Up to 30% of patients with rheumatoid arthritis (RA) respond inadequately to conventional non-biologic disease modifying antirheumatic drugs (nbDMARDs), and may benefit from therapy with biologic DMARDs (bDMARDs). However, the high cost of bDMARDs limits their widespread use. The Chapter of Rheumatologists, College of Physicians, Academy of Medicine, Singapore aims to define clinical eligibility for government-assisted funding of bDMARDs for local RA patients. MATERIALS AND METHODS: Evidence synthesis was performed by reviewing 7 published guidelines on use of biologics for RA. Using the modified RAND/UCLA Appropriateness Method (RAM), rheumatologists rated indications for therapies for different clinical scenarios. Points reflecting the output from the formal group consensus were used to formulate the practice recommendations. RESULTS: Ten recommendations including diagnosis of RA, choice of disease activity measure, initiation and continuation of bDMARD and option of first and second-line therapies were formulated. The panellists agreed that a bDMARD is indicated if a patient has (1) active RA with a Disease Activity Score in 28 joints (DAS28) score of ≥3.2, (2) a minimum of 6 swollen and tender joints, and (3) has failed a minimum of 2 nbDMARD combinations of adequate dose regimen for at least 3 months each. To qualify for continued biologic therapy, a patient must have (1) documentation of DAS28 every 3 months and (2) at least a European League Against Rheumatism (EULAR) moderate response by 6 months after commencement of therapy. CONCLUSION: The recommendations developed by a formal group consensus method may be useful for clinical practice and guiding funding decisions by relevant authorities in making bDMARDs usage accessible and equitable to eligible patients in Singapore.

A comparison of the EuroQol-5D and the Health Utilities Index mark 3 in patients with rheumatic disease.

OBJECTIVE: To compare the performance of 2 commonly used utility-based health-related quality of life (HRQoL) instruments [the EuroQol-5D (EQ-5D) and Health Utilities Index mark 3 (HUI3)] in patients with rheumatic disease. METHODS: Consecutive outpatients with rheumatic diseases were interviewed twice within 2 weeks using a standard questionnaire containing the EQ-5D, HUI3, and the Medical Outcome Study Short-Form 36 Health Survey (SF-36, used to categorize health status) and assessing clinical and demographic characteristics. EQ-5D and HUI3 utility scores were compared and their construct validity and test-retest reliability were examined by comparing these scores in groups differing in health status and using intraclass correlation coefficients (ICC), respectively. RESULTS: EQ-5D and HUI3 utility scores in 114 patients differentiated well between varying health states; e.g., patients with higher SF-36 vitality scores had better EQ-5D and HUI3 utility scores (mean: 0.79 for both instruments) than patients with lower vitality scores (mean: 0.68 and 0.69, respectively) (p < 0.01 for both comparisons). ICC values for the EQ-5D and HUI3 were 0.64 and 0.75, respectively (n = 90, median interval: 7 days). EQ-5D and HUI3 utility scores were similar (mean +/- SD: 0.75 +/- 0.21 vs 0.76 +/- 0.17, p = 0.647, paired t test) and showed moderate correlation (Spearman's r: 0.45, p < 0.001). Differences were present in patients' responses to these 2 instruments: e.g., 12 patients reporting no problems with mobility (EQ-5D item) reported different levels of disability with ambulation (HUI3 item). CONCLUSIONS: The EQ-5D and HUI3 performed equally well in measuring utility-based HRQoL in patients with rheumatic disease, although they measured slightly different, though related, dimensions of health.