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Claire Bombardier,
Glen S Hazlewood,
Pooneh Akhavan, Orit Schieir,
Anne Dooley,
Boulos Haraoui,
Majed Khraishi,
Sharon A Leclercq,
Jean Légaré,
Dianne P Mosher,
James Pencharz,
Janet E Pope,
John Thomson,
Carter Thorne,
Michel Zummer,
Michael A Gardam,
Johan Askling,
Vivian Bykerk
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ABSTRACT: The Canadian Rheumatology Association (CRA) has developed recommendations for the pharmacological management of rheumatoid arthritis (RA) with traditional and biologic disease-modifying antirheumatic drugs (DMARD) in 2 parts. Part II, focusing on specific safety aspects of treatment with traditional and biologic DMARD in patients with RA, is reported here.
Key questions were identified a priori based on results of a national needs-assessment survey. A systematic review of all clinical practice guidelines and consensus statements regarding treatment with traditional and biologic DMARD in patients with RA published between January 2000 and June 2010 was performed in Medline, Embase, and CINAHL databases, and was supplemented with a "grey literature" search including relevant public health guidelines. Systematic reviews of postmarketing surveillance and RA registry studies were performed to update included guideline literature reviews as appropriate. Guideline quality was independently assessed by 2 reviewers. Guideline characteristics, recommendations, and supporting evidence from observational studies and randomized trials were synthesized into evidence tables. The working group voted on recommendations using a modified Delphi technique.
Thirteen recommendations addressing perioperative care, screening for latent tuberculosis infection prior to the initiation of biologic DMARD, optimal vaccination practices, and treatment of RA patients with active or a history of malignancy were developed for rheumatologists, other primary prescribers of RA drug therapies, and RA patients.
These recommendations were developed based on a synthesis of international RA and public health guidelines, supporting evidence, and expert consensus in the context of the Canadian health system. They are intended to help promote best practices and improve healthcare delivery for persons with RA.
The Journal of Rheumatology 06/2012; 39(8):1583-602. · 3.69 Impact Factor
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Vivian P Bykerk,
Pooneh Akhavan,
Glen S Hazlewood, Orit Schieir,
Anne Dooley,
Boulos Haraoui,
Majed Khraishi,
Sharon A Leclercq,
Jean Légaré,
Diane P Mosher,
James Pencharz,
Janet E Pope,
John Thomson,
Carter Thorne,
Michel Zummer,
Claire Bombardier
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ABSTRACT: The Canadian Rheumatology Association (CRA) has developed recommendations for the pharmacological management of rheumatoid arthritis (RA) with traditional and biologic disease-modifying antirheumatic drugs (DMARD) in 2 parts. Part 1 is reported here.
The CRA Therapeutics Committee assembled a national working group of RA clinical experts, researchers, patient consumers, and a general practitioner. Treatment questions were developed a priori based on results of a national needs assessment survey. A systematic review of all clinical practice guidelines and consensus statements regarding treatment with traditional and biologic DMARD in patients with RA published between January 2000 and June 2010 was performed in Medline, Embase, and CINAHL databases, and the grey literature. Guideline quality was assessed by 2 independent reviewers, and guideline characteristics, recommendations, and supporting evidence from observational studies and randomized controlled trials were synthesized into evidence tables. The full working group reviewed the evidence tables and developed recommendations using a modified Delphi technique.
Five overarching principles and 26 recommendations addressing general RA management strategies and treatment with glucocorticoids and traditional and biologic DMARD were developed for rheumatologists, other primary prescribers of RA drug therapies, and patients with RA.
These recommendations were developed based on a synthesis of international guidelines, supporting evidence, and expert consensus considering the Canadian healthcare context with the intention of promoting best practices and improving healthcare delivery for persons with RA.
The Journal of Rheumatology 09/2011; 39(8):1559-82. · 3.69 Impact Factor
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ABSTRACT: To describe Canadian clinical practice patterns in the pharmacological management of rheumatoid arthritis (RA) and identify practice variations.
A 44-item pre-guideline needs assessment survey was sent to all members of the Canadian Rheumatology Association (CRA). Descriptive statistics were used to summarize respondent characteristics and practice patterns.
Survey respondents (n = 164) reported variations in practice regarding assessment strategies, treatment with disease-modifying antirheumatic drug monotherapy versus combination therapy, methotrexate dosing and escalation, corticosteroid strategies, and optimal use of biologics.
Practice variations identified in this pre-guideline needs assessment survey were used to formulate key treatment questions for the development of CRA recommendations.
The Journal of Rheumatology 09/2011; 39(8):1555-8. · 3.69 Impact Factor
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ABSTRACT: Knowledge about the range of symptoms experienced by patients with SSc, and their impact on daily functioning is limited. The objective of the present study was to identify symptoms of SSc that patients rated as frequent and that highly impacted their ability to carry out daily activities.
A total of 464 persons with SSc responded to the Canadian Scleroderma Patient Survey of Health Concerns and Research Priorities, including questions regarding the frequency and impact of 69 SSc symptoms. Descriptive analyses were performed dichotomizing symptom frequencies as never or rarely vs sometimes, most of the time or always and symptom impact on daily activities as no or minimal impact vs moderate to severe impact.
The five highest rated symptoms in terms of frequency and moderate to severe impact on daily activities, respectively, were: fatigue (89 and 72%), RP (86 and 67%), hand stiffness (81 and 59%), joint pain (81 and 64%) and difficulty sleeping (76 and 59%). In addition to these symptoms, items related to decreased hand function (difficulty making a fist and difficulty holding objects) and pain (muscle pain and joint tenderness) were frequently endorsed and commonly associated with moderate to severe impact on daily activities.
This study confirmed the importance for quality of life of core symptoms of SSc, such as pain, fatigue and limitations in hand function. It also identified areas with very little research, such as sleep problems, that appear to play important roles in daily functioning, and that merit more focused study.
Rheumatology (Oxford, England) 12/2010; 50(4):762-7. · 4.24 Impact Factor
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Brett D Thombs,
Wim van Lankveld,
Marielle Bassel,
Murray Baron,
Robert Buzza,
Shirley Haslam,
Jennifer A Haythornthwaite,
Marie Hudson,
Lisa R Jewett,
Ruby Knafo, [......],
Vanessa L Malcarne,
Katherine Milette,
Sarosh J Motivala,
Evan G Newton,
Warren R Nielson,
Marion Pacy,
Ilya Razykov, Orit Schieir,
Suzanne Taillefer,
Maureen Worron-Sauve
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ABSTRACT: OBJECTIVE:: There is relatively little research on important patient-reported outcomes that affect quality of life in systemic sclerosis (SSc) and even less research on psychological, behavioral, and educational intervention strategies. The objective was to review existing evidence and to develop a consensus research agenda for behavioral health and psychological research in SSc. METHODS:: An international panel of recognized experts in behavioral and psychological health in SSc, rheumatologists, patients, and patient advocates was convened to identify areas of concern for patients with SSc and to develop a research agenda. As part of this process, the PubMed and PsychInfo databases were searched from inception for the keywords "scleroderma" in conjunction with keywords related to each identified topic area. All relevant original and review articles were examined. RESULTS:: Key areas where behavioral health and psychological approaches may be useful to assess and improve quality of life in SSc include depression, fatigue, pain, pruritus, body image distress, and sexual function. Less researched areas that warrant attention include sleep, fear of disease progression and dependency, family and couples relationships, and healthcare factors. CONCLUSION:: Qualitative and quantitative studies are needed to (1) develop and evaluate assessment tools for SSc patient-reported outcomes; (2) assess potential causal and maintaining factors, as well as trajectories, of important problems faced by patients; and (3) develop and test psychological, behavioral, and educational interventions to reduce distress and increase overall well-being. Collaborative approaches that include multiple centers and that actively involve patients and patient advocates in the research process are needed.
Arthritis care & research. 03/2010; 62(8):1181-9.
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ABSTRACT: Large descriptive studies of pain in systemic sclerosis (SSc) are lacking. The present study estimated prevalence, severity, and associations between SSc clinical variables and pain in all patients with SSc and in limited cutaneous (lcSSc) and diffuse cutaneous (dcSSc) subsets.
Patients enrolled in a multicenter SSc registry (n = 585) completed a standardized clinical assessment and questionnaires about their physical and psychosocial health, including a pain severity numerical rating scale (NRS; range 0-10). Pain prevalence and severity were estimated with descriptive statistics. Crude and adjusted associations between specific SSc clinical variables and pain were estimated with linear regression for the entire group and by SSc subtype.
Of the patients, 484 (83%) reported pain (268 [46%] mild pain [NRS 1-4], 155 [27%] moderate pain [NRS 5-7], and 61 [10%] severe pain [NRS 8-10]). More frequent episodes of Raynaud's phenomenon, active ulcers, worse synovitis, and gastrointestinal (GI) symptoms were associated with pain in multivariate analysis adjusting for demographic variables, depressive symptoms, and comorbid conditions. Patients with dcSSc reported only slightly higher mean +/- SD pain than those with lcSSc (dcSSc 3.9 +/- 2.8 versus lcSSc 3.4 +/- 2.7; Hedges's g = 0.18, P = 0.05). Regression estimates did not differ significantly between SSc subsets.
Pain symptoms were common in the present study of patients with SSc and were independently associated with more frequent episodes of Raynaud's phenomenon, active ulcers, worse synovitis, and GI symptoms. Subsetting by extent of skin involvement was only minimally related to pain severity and did not affect associations with clinical variables. More attention to pain and how to best manage it is needed in SSc.
Arthritis care & research. 03/2010; 62(3):409-17.
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Arthritis care & research. 01/2010; 62(1):139-40; author reply 140.
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Biological psychiatry 04/2009; 66(3):e1-2; author reply e3. · 8.93 Impact Factor
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Murray Baron, Orit Schieir,
Marie Hudson,
Russell Steele,
Audrée Janelle-Montcalm,
Jessica Bernstein,
Michael Starr,
Michel Gagné,
Michael Stein,
Harb Kang, [......],
Christian Pineau,
Andrzej Gutkowski,
Michel Zummer,
Jean-Pierre Mathieu,
Suzanne Mercille,
Sophie Ligier,
Jiri Krasny,
Carole Bertrand,
Sai Yan Yuen,
Jan Schulz
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ABSTRACT: To adapt the self-administered comorbidity questionnaire (SCQ) into the Early Inflammatory Arthritis-SCQ (EIA-SCQ) and assess its clinimetric properties in EIA.
The EIA-SCQ and indices of disease activity, function, pain, health-related quality of life (HRQoL) and health resource utilization were administered to 320 patients with EIA. Twenty patients completed the EIA-SCQ a second time 1 week later. Construct validity was evaluated by testing the hypotheses that a valid comorbidity index would correlate well with age, weakly with HRQoL and recent resource utilization and poorly with indices of disease activity, function and pain.
The intra-class correlation coefficient between repeat scores was 0.93 (95% CI 0.83-0.97). Kappa values for individual items ranged from 0.64 to 1.0. EIA-SCQ scores correlated moderately with age (Tau B = 0.29, P < 0.001) and weakly with function (HAQ-DI Tau B = 0.09, P = 0.03), pain (McGill Pain Questionnaire Tau B = 0.09, P = 0.05), some measures of HRQoL [the SF-36 mental component score (MCS) Tau B = - 0.08, P < 0.05; World Health Organization Disease Assessment Schedule II score Tau B = 0.09, P = 0.03] and a measure of resource utilization (number of tests in the last 4 months Tau B = 0.10, P = 0.04). The EIA-SCQ did not correlate with other measures of disease activity, another HRQoL measure [SF-36 physical component score (PCS)] or other measures of resource utilization.
The EIA-SCQ is reliable and valid for use in EIA. It has the potential to become a useful measure of comorbidity in outcome studies of EIA when the resources for a full medical chart review are unavailable.
Rheumatology (Oxford, England) 02/2009; 48(4):390-4. · 4.24 Impact Factor
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Orit Schieir,
Brett D Thombs,
Marie Hudson,
Suzanne Taillefer,
Russell Steele,
Laeora Berkson,
Carole Bertrand,
Francois Couture,
Mary-Ann Fitzcharles,
Michel Gagné, [......],
Harb Kang,
Morton Kapusta,
Sophie Ligier,
Jean-Pierre Mathieu,
Henri Ménard,
Suzanne Mercille,
Michael Starr,
Michael Stein,
Michel Zummer,
Murray Baron
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ABSTRACT: To assess the longitudinal relationships, including directionality, among chronic pain, symptoms of depression, and disease activity in patients with early inflammatory arthritis (EIA).
One hundred eighty patients with EIA completed an examination, including swollen joint count, and were administered the Center for Epidemiological Studies Depression Scale (CES-D) and the McGill Pain Questionnaire (MPQ) at 2 timepoints 6 months apart. Cross-lagged panel path analysis was used to simultaneously assess concurrent and longitudinal relationships among pain, symptoms of depression, and number of swollen joints.
Pain, symptoms of depression, and number of swollen joints decreased over time (p < 0.001) and were prospectively linked to pain, symptoms of depression, and number of swollen joints, respectively, at 6 months. Symptoms of depression and pain were correlated with each other at baseline (0.47) and at 6-month followup assessments (0.28). Baseline symptoms of depression significantly predicted pain symptoms at 6 months (standardized regression coefficient = 0.28, p = 0.001), whereas pain and disease activity did not predict the course of any other variable after controlling for baseline values.
Symptoms of depression predicted the trajectory of pain from baseline to 6 months. In addition, there were reciprocal/bidirectional associations between pain and symptoms of depression over time. More research is needed to better understand the relationship between pain and depressive symptoms and how to best manage patients with EIA who have high levels of both.
The Journal of Rheumatology 01/2009; 36(2):231-9. · 3.69 Impact Factor
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ABSTRACT: The goal of this study was to identify target areas for psychosocial intervention for depressed patients with early inflammatory arthritis.
One hundred and sixty-five patients with early inflammatory arthritis (> or =1 joint with synovitis for > or =6 weeks and <1 year with a diagnosis of either rheumatoid or undifferentiated inflammatory arthritis) were referred to the McGill Early Arthritis Registry (McEAR) by their rheumatologist. McEAR patients agree to periodic physical exams and to completing questionnaires. Demographic, disease and psychosocial factors were compared between patients screening positive and negative for depression using independent samples t tests and Pearson's chi(2) test and then were entered into a logistic regression model examining the likelihood of screening positive for depression.
Thirty-eight (23%) patients screened positive for depressive symptoms. Patients with symptoms of depression had significantly worse disease severity, disability, and pain, engaged in more emotional preoccupation coping, had less self-efficacy for pain and other arthritis-related symptoms, smaller social networks and were less satisfied with social support than the nondepressed group. In logistic regression analyses, pain and emotional preoccupation coping were positively related to the likelihood of screening positive for depression, while satisfaction with social support was negatively related to the likelihood of screening positive for depression
Higher pain levels, emotional preoccupation coping and dissatisfaction with social support were related to depressive symptoms in this study. This suggests that the optimal care of depressed patients with inflammatory arthritis would include a psychosocial approach that addresses these specific target areas.
Psychotherapy and Psychosomatics 07/2008; 77(5):298-305. · 6.28 Impact Factor
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ABSTRACT: Reported rates of depressive symptoms in patients with systemic sclerosis (SSc) are high. No depression assessment tools, however, have been validated for patients with SSc. Our objective was to assess the internal consistency reliability, convergent validity, and structural/construct validity of the Center for Epidemiologic Studies Depression Scale (CES-D) in patients with SSc.
We conducted a cross-sectional, multicenter study of 470 SSc patients. Internal consistency reliability was assessed with Cronbach's alpha and structural/construct validity with confirmatory factor analysis.
Internal consistency reliability was good for the overall CES-D scale (alpha = 0.88) and for its 4 factors (alpha = 0.67-0.88). Correlations of the CES-D total score were -0.73 with mental health, -0.36 with physical health, 0.41 with disability, and 0.44 with pain. The 4-factor model originally found in the general population and validated for patients with rheumatoid arthritis (depressed affect, somatic/vegetative, [lack of] positive affect, and interpersonal factors) fit the data well, as did a second-order version of the same model with an overarching depression factor that loaded onto each of the 4 first-order factors. The 4-factor model fit the SSc data better than alternative models.
Internal consistency reliability and convergent validity were good, the 4-factor structure reported in the general population was replicated, and a second-order model with an overarching depression factor fit well. These findings indicate that the CES-D is a valid and reliable measure of depressive symptoms for patients with SSc.
Arthritis & Rheumatism 04/2008; 59(3):438-43. · 7.87 Impact Factor
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ABSTRACT: Objective
Reported rates of depressive symptoms in patients with systemic sclerosis (SSc) are high. No depression assessment tools, however, have been validated for patients with SSc. Our objective was to assess the internal consistency reliability, convergent validity, and structural/construct validity of the Center for Epidemiologic Studies Depression Scale (CES-D) in patients with SSc.Methods
We conducted a cross-sectional, multicenter study of 470 SSc patients. Internal consistency reliability was assessed with Cronbach's alpha and structural/construct validity with confirmatory factor analysis.ResultsInternal consistency reliability was good for the overall CES-D scale (α = 0.88) and for its 4 factors (α = 0.67–0.88). Correlations of the CES-D total score were −0.73 with mental health, −0.36 with physical health, 0.41 with disability, and 0.44 with pain. The 4-factor model originally found in the general population and validated for patients with rheumatoid arthritis (depressed affect, somatic/vegetative, [lack of] positive affect, and interpersonal factors) fit the data well, as did a second-order version of the same model with an overarching depression factor that loaded onto each of the 4 first-order factors. The 4-factor model fit the SSc data better than alternative models.Conclusion
Internal consistency reliability and convergent validity were good, the 4-factor structure reported in the general population was replicated, and a second-order model with an overarching depression factor fit well. These findings indicate that the CES-D is a valid and reliable measure of depressive symptoms for patients with SSc.
Arthritis & Rheumatism 03/2008; 59(3):438 - 443. · 7.87 Impact Factor
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Murray Baron, Orit Schieir,
Marie Hudson,
Russell Steele,
Sousan Kolahi,
Laeora Berkson,
Francois Couture,
M A Fitzcharles,
Michel Gagné,
Bruce Garfield,
Andrzej Gutkowski,
Harb Kang,
Morton Kapusta,
Sophie Ligier,
Jean-Pierre Mathieu,
Henri Ménard,
Michael Starr,
Michael Stein,
Michel Zummer
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ABSTRACT: To assess the clinimetric properties of a new health-related quality of life (HRQOL) instrument, the World Health Organization Disability Assessment Schedule II (WHODAS II), in patients with early inflammatory arthritis.
Internal consistency as well as criterion, construct, and discriminative validity of the WHODAS II were assessed in 172 patients with early inflammatory arthritis who completed the WHODAS II, the Medical Outcomes Study Short Form 36 (SF-36), and other measures of disease severity, functioning, pain, depression, and resource use. Test-retest reliability of the WHODAS II was assessed by having a subset of 20 patients complete the WHODAS II a second time, 1 week after the first assessment.
The WHODAS II had high internal consistency (Cronbach's alpha = 0.96 for patients working or in school and 0.93 for patients not working or in school). Test-retest intraclass correlation coefficients of the WHODAS II total score and subscales ranged from 0.82-0.96. The WHODAS II total score was strongly correlated with the SF-36 physical component score (Kendall's tau-b 0.51, P < 0.001) and moderately correlated with the SF-36 mental component score (tau-b 0.43, P < 0.001). WHODAS II correlations with disease outcomes ranged from Kendall's tau-b 0.15-0.55. The WHODAS II significantly differentiated between every aspect of disease severity assessed with the exception of measures of health resource use.
The WHODAS II is a valid and reliable measure of HRQOL in cross-sectional studies of patients with early inflammatory arthritis. Research is still required to investigate potential item redundancy and determine its usefulness in longitudinal studies.
Arthritis & Rheumatism 03/2008; 59(3):382-90. · 7.87 Impact Factor
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ABSTRACT: Between 36% and 65% of patients with systemic sclerosis (SSc) report symptoms of depression above cutoff thresholds on self-report questionnaires. The objective of this study was to assess whether these high rates result from differential reporting of somatic symptoms related to the high physical burden of SSc.
Symptom profiles reported on the Center for Epidemiologic Studies Depression Scale (CES-D) were compared between a multicenter sample of 403 patients with SSc and a sample of respondents to an Internet depression survey, matched on total CES-D score, age, race/ethnicity, and sex. An exact nonparametric generalized Mantel-Haenszel procedure was used to identify differential item functioning between groups.
Patients with SSc reported significantly higher frequencies (moderate to large effect size; P < 0.01) on 4 CES-D somatic symptom items: bothered, appetite, effort, and sleep. Internet respondents had higher item scores on 2 items that assessed interpersonal difficulties (unfriendly, large effect size; P < 0.01; disliked, large effect size; P < 0.01) and on 2 items that assessed lack of positive effect (happy, moderate effect size; P = 0.01; enjoy, large effect size; P < 0.01). Adjustment of standard CES-D cutoff criteria for potential bias due to somatic symptom reporting resulted in a reduction of only 3.6% in the number of SSc patients with significant symptoms of depression.
High rates of depressive symptoms in SSc are not due to bias related to the report of somatic symptoms. The pattern of differential item functioning between the SSc and Internet groups, however, suggests some qualitative differences in depressive symptom presentation.
Arthritis & Rheumatism 03/2008; 59(3):431-7. · 7.87 Impact Factor
