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1.  Outcome measures in acute gout: a systematic literature review 
The Journal of rheumatology  2013;41(3):558-568.
Objective
Five core domains have been endorsed by Outcomes Measures in Rheumatology (OMERACT) for acute gout: pain, joint swelling, joint tenderness, patient global assessment, and activity limitation. The aim of this work was to evaluate instruments for these domains according to the OMERACT filter: truth, feasibility, and discrimination.
Methods
A systematic search strategy for instruments used to measure the acute gout core domains was formulated. For each method, articles were assessed by two reviewers to summarise information according to the specific components of the OMERACT filter.
Results
Seventy-seven articles and abstracts met the inclusion criteria. Pain was most frequently reported (76 studies, 20 instruments). The pain instruments used most often were 100mm visual analog scale (VAS) and 5-point Likert scale. Both methods have high feasibility, face and content validity, within- and between-group discrimination. Four-point Likert scales assessing index joint swelling and tenderness have been used in numerous acute gout studies; these instruments are feasible, with high face and content validity, and show within- and between-group discrimination. Five-point patient global assessment of response to treatment (PGART) scales are feasible and valid, and show within- and between-group discrimination. Measures of activity limitations were infrequently reported, and insufficient data were available to make definite assessments of the instruments for this domain.
Conclusion
Many different instruments have been used to assess the acute gout core domains. Pain VAS and 5-point Likert scales, 4-point Likert scales of index joint swelling and tenderness and 5-point PGART instruments meet the criteria for the OMERACT filter.
doi:10.3899/jrheum.131244
PMCID: PMC4217650  PMID: 24334652
gout; pain; measurement; outcome
2.  Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout 
The Journal of rheumatology  2014;41(3):574-580.
Objective
To determine the extent to which instruments that measure core outcome domains in acute gout fulfil the OMERACT filter requirements of truth, discrimination and feasibility.
Methods
Patient-level data from four randomised controlled trials of agents designed to treat acute gout and one observational study of acute gout were analysed. For each available measure construct validity, test-retest reliability, within-group change using effect size, between-group change using the Kruskall-Wallis statistic and repeated measures generalised estimating equations were assessed. Floor and ceiling effects were also assessed and MCID was estimated. These analyses were presented to participants at OMERACT 11 to help inform voting for possible endorsement.
Results
There was evidence for construct validity and discriminative ability for 3 measures of pain (0 to 4 Likert, 0 to 10 numeric rating scale, 0 to 100 mm visual analogue scale). Likewise, there appears to be sufficient evidence for a 4-point Likert scale to possess construct validity and discriminative ability for physician assessment of joint swelling and joint tenderness. There was some evidence for construct validity and within-group discriminative ability for the Health Assessment Questionnaire as a measure of activity limitations, but not for discrimination between groups allocated to different treatment.
Conclusions
There is sufficient evidence to support measures of pain (using Likert, numeric rating scale or visual analogue scales), joint tenderness and swelling (using Likert scale) as fulfilling the requirements of the OMERACT filter. Further research on a measure of activity limitations in acute gout clinical trials is required.
doi:10.3899/jrheum.131245
PMCID: PMC4212978  PMID: 24429178
gout; outcome measures; psychometrics
3.  New classification criteria for gout: a framework for progress 
Rheumatology (Oxford, England)  2013;52(10):1748-1753.
The definitive classification or diagnosis of gout normally relies upon the identification of MSU crystals in SF or from tophi. Where microscopic examination of SF is not available or is impractical, the best approach may differ depending upon the context. For many types of research, clinical classification criteria are necessary. The increasing prevalence of gout, advances in therapeutics and the development of international research collaborations to understand the impact, mechanisms and optimal treatment of this condition emphasize the need for accurate and uniform classification criteria for gout. Five clinical classification criteria for gout currently exist. However, none of the currently available criteria has been adequately validated. An international project is currently under way to develop new validated gout classification criteria. These criteria will be an essential step forward to advance the research agenda in the modern era of gout management.
doi:10.1093/rheumatology/ket154
PMCID: PMC4047282  PMID: 23611919
gout; classification; urate; research
4.  OMERACT endorsement of measures of outcome for studies of acute gout 
The Journal of rheumatology  2013;41(3):569-573.
Objective
To determine the extent to which OMERACT participants agree that instruments that have been used in clinical trials and measure OMERACT core outcome domains in acute gout fulfil the filter requirements of truth, discrimination and feasibility and to determine where future research efforts need to be directed.
Methods
The results of a systematic literature review and analysis of individual-level data from recent clinical studies of acute gout were presented to OMERACT participants. The information was discussed in breakout groups and opinion was defined by subsequent voting in a plenary session. Endorsement was defined as at least 70% of participants voting in agreement with the proposition (where the denominator excluded those participants who did not vote or who voted ‘don’t know’).
Results
The following measures were endorsed for use in clinical trials of acute gout: (1) 5-point Likert scale and/or VAS (0 to 100mm) to measure pain; (2) 4-point Likert scale for joint swelling; (3) 4-point Likert scale for joint tenderness; and (4) 5-point Likert scale for patient global assessment of response to treatment. Measures for the activity limitations domain were not endorsed.
Conclusions
Measures of pain, joint swelling, joint tenderness and patient global assessment in acute gout were endorsed at OMERACT-11. These measures should now be used in clinical trials of acute gout.
doi:10.3899/jrheum.131246
PMCID: PMC4162875  PMID: 24334651
gout; outcome measures; psychometrics
5.  Establishing a person-centred framework of self-identity after traumatic brain injury: a grounded theory study to inform measure development 
BMJ Open  2014;4(5):e004630.
Objective
To develop a theoretically sound, client-derived framework to underpin development of a measure reflecting the impact of traumatic brain injury (TBI) on a person's self-identity.
Design
Grounded theory, based on transcription of audio recordings from focus group meetings with people who have experienced TBI, analysed with constant comparative methods.
Setting
8 different urban and rural communities in New Zealand.
Participants
49 people (34 men, 15 women), 6 months to 36 years after mild-to-severe TBI.
Results
The central concept emerging from the data was that of desiring to be or having lost a sense of being an integrated and valued person. The three main subthemes were: (1) having a coherent, satisfying and complete sense of oneself, (2) respect, validation and acceptance by others and (3) having a valued place in the world.
Conclusions
This study reinforces the notion that change in self-identity is an important aspect of life after TBI, and provides information on what this concept means to people with TBI. In order to scientifically evaluate relationships between self-identity and other aspects of health (eg, depression, quality of life), and to test the effect of interventions to address problems with self-identity after TBI, a quantitative tool for evaluation of this construct is required. Themes from this research provide a foundation for the development of a measure of self-identity grounded in the language and experience of people with TBI.
doi:10.1136/bmjopen-2013-004630
PMCID: PMC4024597  PMID: 24833684
Traumatic Brain Injury; Self-Identity; Qualitative Research; Outcome; Self-Concept; Lived Experience
6.  Tophus measurement as an outcome measure for clinical trials of chronic gout: progress and research priorities 
The Journal of rheumatology  2011;38(7):10.3899/jrheum.110272.
Despite the recognition that tophus regression is an important outcome measure in clinical trials of chronic gout, there is no agreed method of tophus measurement. A number of methods have been used in clinical trials of chronic gout, from simple physical measurement techniques to complex advanced imaging methods. This paper summarises the methods of tophus measurement that have been used and discusses the properties of these methods. Physical measurement using Vernier calipers fulfils most aspects of the Outcomes Measures in Rheumatology (OMERACT) filter. Rigorous testing of the complex methods, particularly with respect to reliability and sensitivity to change is needed, to determine the appropriate use of these methods. Further information is also required regarding which method of physical measurement is best for use in future clinical trials. The need to develop and test a patient reported measure of tophus burden is also highlighted.
doi:10.3899/jrheum.110272
PMCID: PMC3882031  PMID: 21724716
7.  Reduced creatinine clearance is associated with early development of subcutaneous tophi in people with gout 
Background
Although typically a late feature of gout, tophi may present early in the course of disease. The aim of this study was to identify factors associated with the presence of early tophaceous disease.
Methods
People with gout for <10 years were prospectively recruited, and had a comprehensive clinical assessment including examination for subcutaneous tophi. The clinical factors independently associated with the presence and number of tophi were analyzed using regression models.
Results
Of the 290 participants, there were 47 (16.2%) with clinically apparent tophi. In univariate analysis, those with tophi were older, were more frequently taking diuretics and colchicine prophylaxis, and had lower creatinine clearance. The association between the presence of tophi and creatinine clearance was strongest in those with creatinine clearance ≤30 ml/min. In logistic regression analysis, creatinine clearance ≤30 ml/min was associated with the presence of tophi, even after adjusting for ethnicity, corticosteroid use, colchicine use and diuretic use (multivariate adjusted odds ratio 7.0, p = 0.005). Participants with tophi reported higher frequency of gout flares, pain scores, patient global assessment scores, and HAQ scores.
Conclusions
The presence of tophi is associated with more symptomatic disease in people with gout for <10 years. Creatinine clearance is independently associated with early presentation of subcutaneous tophi.
doi:10.1186/1471-2474-14-363
PMCID: PMC3878111  PMID: 24359261
Gout; Tophus; Kidney; Creatinine
8.  Prescription and dosing of urate-lowering therapy, rather than patient behaviours, are the key modifiable factors associated with targeting serum urate in gout 
Background
Long term serum urate (SU) lowering to a target of <0.36 mmol/l (6 mg/dl) is recommended for effective gout management. However, many studies have reported low achievement of SU targets. The aim of this cross-sectional study was to examine the clinical and psychological factors associated with SU targets in patients with gout.
Methods
Patients with gout for <10 years were recruited from primary and secondary care settings. SU target was defined as SU concentration <0.36 mmol/L at the time of the study visit. Both clinical and psychological factors associated with SU target were analysed. The relationship between SU target and measures of gout activity such as flare frequency, tophi, work absences, and Health Assessment Questionnaire-II was also analysed.
Results
Of the 273 patients enrolled into the study, 89 (32.6%) had SU concentration <0.36 mmol/L. Urate-lowering therapy (ULT) use was strongly associated with SU target (p < 0.001). In those patients prescribed ULT (n = 181), allopurinol dose, patient confidence to keep SU under control, female sex, and ethnicity were independently associated with SU target. Other patient psychological measures and health-related behaviours, including adherence scores, were not independently associated with SU target in those taking ULT. Creatinine clearance, diuretic use, age, and body mass index were not associated with SU target. Patients at SU target reported lower gout flare frequency, compared with those not at target (p = 0.03).
Conclusions
ULT prescription and dosing are key modifiable factors associated with achieving SU target. These data support interventions focusing on improved use of ULT to optimise outcomes in patients with gout.
doi:10.1186/1471-2474-13-174
PMCID: PMC3493372  PMID: 22978848
Gout; Urate; Target; Allopurinol
9.  The Essential Research Curriculum for Doctor of Pharmacy Degree Programs 
Pharmacotherapy  2010;30(9):966.
doi:10.1592/phco.30.9.966
PMCID: PMC3061314  PMID: 20795851
curriculum; research; doctor of pharmacy degree
10.  Circulating mediators of bone remodeling in psoriatic arthritis: implications for disordered osteoclastogenesis and bone erosion 
Arthritis Research & Therapy  2010;12(4):R164.
Introduction
Diverse bone pathologies are observed in patients with psoriatic arthritis (PsA). Uncoupling of bone remodeling with disordered osteoclastogenesis has been implicated in the pathogenesis of PsA. The aim of this study was to examine the role of soluble mediators of bone remodeling within the circulation of patients with PsA.
Methods
Patients with PsA (n = 38), with psoriasis (n = 10), and healthy controls (n = 12) were studied. Serum was obtained for testing of Dikkopf-1 (Dkk-1), macrophage-colony stimulating factor (M-CSF), osteoprotegerin (OPG), and receptor activator of nuclear factor-κB ligand (RANKL) with ELISA. Patients with PsA also had bone densitometry, plain radiographs of the hands and feet, and assessment of peripheral blood osteoclast precursors. Radiographs were scored for erosion, joint-space narrowing, osteolysis, and new bone formation.
Results
Compared with those with psoriasis and healthy controls, patients with PsA had higher circulating concentrations of Dkk-1 and M-CSF. In patients with PsA, M-CSF and RANKL, but not Dkk-1, concentrations positively correlated with radiographic erosion, joint-space narrowing, and osteolysis scores. Mediators of bone remodeling did not correlate with the number of joints with new bone formation or with total hip-bone mineral density. Peripheral blood CD14+/CD11b+ cells, and the number of osteoclast-like cells and resorptive pits after culture with RANKL and M-CSF also correlated with radiographic damage scores. Circulating M-CSF concentrations correlated with the percentage of peripheral blood CD14+/CD11b+ cells.
Conclusions
Systemic expression of soluble factors that promote osteoclastogenesis is disordered in patients with PsA and may contribute to periarticular bone loss in this disease.
doi:10.1186/ar3123
PMCID: PMC2945067  PMID: 20796300
11.  MRI bone oedema scores are higher in the arthritis mutilans form of psoriatic arthritis and correlate with high radiographic scores for joint damage 
Introduction
The aim of this study was to investigate the magnetic resonance imaging (MRI) features of bone disease in the arthritis mutilans (AM) form of psoriatic arthritis (PsA).
Methods
Twenty-eight patients with erosive PsA were enrolled (median disease duration of 14 years). Using x-rays of both hands and feet, 11 patients were classified as AM and 17 as non-AM (erosive psoriatic arthritis without bone lysis)by two observers. MRI scans (1.5T) of the dominant hand (wrist and fingers scanned separately) were obtained using standard contrast-enhanced T1-weighted and fat-saturated T2-weighted sequences. Scans were scored separately by two readers for bone erosion, oedema and proliferation using a PsA MRI scoring system. X-rays were scored for erosions and joint space narrowing.
Results
On MRI, 1013 bones were scored by both readers. Reliability for scoring erosions and bone oedema was high (intraclass correlation coefficients = 0.80 and 0.77 respectively) but only fair for bone proliferation (intraclass correlation coefficient = 0.42). MRI erosion scores were higher in AM patients (53.0 versus 15.0, p = 0.004) as were bone oedema and proliferation scores (14.7 versus 10.0, p = 0.056 and 3.6 versus 0.7, p = 0.003 respectively). MRI bone oedema scores correlated with MRI erosion scores and X-ray erosion and joint space narrowing scores (r = 0.65, p = 0.0002 for all) but not the disease activity score 28-C reactive protein (DAS28CRP) or pain scores.
Conclusions
In this patient group with PsA, MRI bone oedema, erosion and proliferation were all more severe in the AM-form. Bone oedema scores did not correlate with disease activity measures but were closely associated with X-ray joint damage scores. These results suggest that MRI bone oedema may be a pre-erosive feature and that bone damage may not be coupled with joint inflammation in PsA.
doi:10.1186/ar2586
PMCID: PMC2688232  PMID: 19126234
14.  Effectiveness of a clinical pathway for acute stroke care in a district general hospital: an audit 
Background
Organised stroke care saves lives and reduces disability. A clinical pathway might be a form of organised stroke care, but the evidence for the effectiveness of this model of care is limited.
Methods
This study was a retrospective audit study of consecutive stroke admissions in the setting of an acute general medical unit in a district general hospital. The case-notes of patients admitted with stroke for a 6-month period before and after introduction of the pathway, were reviewed to determine data on length of stay, outcome, functional status, (Barthel Index, BI and Modified Rankin Scale, MRS), Oxfordshire Community Stroke Project (OCSP) sub-type, use of investigations, specific management issues and secondary prevention strategies. Logistic regression was used to adjust for differences in case-mix.
Results
N = 77 (prior to the pathway) and 76 (following the pathway). The median (interquartile range, IQR) age was 78 years (67.75–84.25), 88% were European NZ and 37% were male. The median (IQR) BI at admission for the pre-pathway group was less than the post-pathway group: 6 (0–13.5) vs. 10 (4–15.5), p = 0.018 but other baseline variables were statistically similar. There were no significant differences between any of the outcome or process of care variables, except that echocardiograms were done less frequently after the pathway was introduced. A good outcome (MRS<4) was obtained in 66.2% prior to the pathway and 67.1% after the pathway. In-hospital mortality was 20.8% and 23.1%. However, using logistic regression to adjust for the differences in admission BI, it appeared that admission after the pathway was introduced had a significant negative effect on the probability of good outcome (OR 0.29, 95%CI 0.09-0.99).
Conclusion
A clinical pathway for acute stroke management appeared to have no benefit for the outcome or processes of care and may even have been associated with worse outcomes. These data support the conclusions of a recent Cochrane review.
doi:10.1186/1472-6963-6-16
PMCID: PMC1403773  PMID: 16504101

Results 1-15 (15)