Sarah Mackie | University of Leeds (original) (raw)

Papers by Sarah Mackie

Research paper thumbnail of Patient Reported Outcomes in Large Vessel Vasculitides

Current Rheumatology Reports, 2021

Purpose of Review The goal of this paper is to review current and future uses of patient-reported... more Purpose of Review The goal of this paper is to review current and future uses of patient-reported outcomes in large vessel vasculitis. The large vessel vasculitides comprise Giant Cell Arteritis and Takayasu arteritis; both are types of systemic vasculitis which affect the larger blood vessels. Patient-reported outcomes (PROs) capture the impact of these diseases on health-related quality of life. Recent Findings Generic PROs such as the SF-36 are currently used to compare HRQOL of people with GCA and TAK within clinical trials and observational studies and to make comparisons with the general population and HRQoL in other diseases. The development of a disease-specific PRO for GCA is currently underway. Beyond clinical trials, there is much interest in the use of PROs within routine clinical care, particularly E-PROs for remote use. Summary Further work will be needed to complete the development of disease-specific PROs for people with large vessel vasculitis and to establish feasi...

Research paper thumbnail of The evolution of instrument selection for inclusion in core outcome sets at OMERACT: Filter 2.2

Seminars in Arthritis and Rheumatism, 2021

INTRODUCTION OMERACT uses an evidence-based framework known as the 'OMERACT Filter Instrument... more INTRODUCTION OMERACT uses an evidence-based framework known as the 'OMERACT Filter Instrument Selection Algorithm' (OFISA) to guide decisions in the assessment of outcome measurement instruments for inclusion in a core outcome set for interventional and observational clinical trials. METHODS A group of OMERACT imaging and patient-centered outcome methodologists worked with imaging outcome groups to facilitate the selection of imaging outcome measurement instruments using the OFISA approach. The lessons learned from this work influenced the evolution to Filter 2.2 and necessitated changes to OMERACT's documentation and processes. RESULTS OMERACT has revised documentation and processes to incorporate the evolution of instrument selection to Filter 2.2. These revisions include creation of a template for detailed definitions of the target domain which is a necessary first step for instrument selection, modifications to the Summary of Measurement Properties (SOMP) table to account for sources of variability, and development of standardized reporting tables for each measurement property. CONCLUSIONS OMERACT Filter 2.2 represents additional modifications of the OMERACT guide for working groups in their rigorous assessment of measurement properties of instruments of various types, including imaging outcome measurement instruments. Enhanced reporting aims to increase the transparency of the evidence base leading to judgements for the endorsement of instruments in core outcome sets.

Research paper thumbnail of P185 Patient perceptions of physical activity following a diagnosis of giant cell arteritis: a multinational qualitative study

Rheumatology, 2020

Background Giant cell arteritis (GCA) is the most common vasculitis in the UK, with an incidence ... more Background Giant cell arteritis (GCA) is the most common vasculitis in the UK, with an incidence of 220 cases per million in adults over 50 years of age. The physical symptoms as well as the side effects of glucocorticoids may impact patients’ ability to exercise. Maintaining physical activity (PA) has been shown to be beneficial to disease activity in other inflammatory conditions and is also a specific priority for GCA patients. The aim of this project was to explore patient perceptions of physical activity in GCA. Methods Multinational qualitative study, using interviews with 36 patients from the UK (25) and Australia (11), all of whom had a definitive diagnosis from imaging or biopsy. Interviews were recorded, transcribed, and analysed using inductive thematic analysis. This is secondary analysis of data collected to explore health-related quality of life in people with GCA. Results 107 individual themes were reported by patients, which divided broadly into two overarching theme...

Research paper thumbnail of 342. Is Plasma Viscosity an Acceptable Substitute for Erythrocyte Sedimentation Rate for the Diagnosis of Giant Cell Arteritis?

Rheumatology, 2014

to the ACR 1990 criteria or the CHCC diagnostic criteria in the three rheumatology departments of... more to the ACR 1990 criteria or the CHCC diagnostic criteria in the three rheumatology departments of the two city hospitals in Kyiv between 1972 and 2010. Survival was calculated using the Kaplan-Meier method. Demographics (age at diagnosis, sex), clinical and laboratory parameters (including ESR, the presence of hepatitis B virus (HBV) and creatinine level), were tested as potential prognostic factors in multivariate Cox models. Clinical activities of patients were calculated according to the Birmingham Vasculitis Activity Score (BVAS). Results: The median duration of follow-ups was 92 months and 15 (28.3%) deaths were recorded. According to the analysis 25% of patients with PAN die within the first 7 years, and 50% don't live more than 17 years. Cumulative survival rates at 1, 3, 5 and 10 years was 88.6; 84.2; 81.8 and 68.2%, respectively. Comparison survival of patients with PAN according to age and sex revealed that gender cumulative survival function didn't differ significantly (P ¼ 0.58), but age at onset of the disease of more than 60 years significantly reduces the survival of patients with PAN. Survival curves of groups of patients with different disease activity determined by BVAS were not significantly different (P ¼ 0.59). HBV infection in patients with PAN and ESR level at the onset of the disease didn't affect the survival of patients. Multivariate analysis showed that presence of increased creatinine levels more than 140 mg/ dl, cardiac involvement and patient age over 60 years were significant negative prognostic factors for patient survival. Other factors (including weight loss, gastrointestinal and CNS involvement, diastolic hypertension, etc.) didn't have influence on the survival curves. Comparison groups of patients with PAN distributed by the 5-factor score revealed the presence of two or more adverse prognostic factors significantly reduce survival (p < 0.05), and the presence of only one factor has no effect on mortality. Conclusion: Despite current treatment the prognosis of patients with PAN remains unfavourable. Cumulative survival of patients with PAN at 1, 3, 5 and 10 years of observation is 89, 84, 82 and 68%, respectively. Vasculitis activity detected by BVAS and the level of ESR no effect on mortality. The increased creatinine levels more than 140 mg/dl, presence of cardiac involvement and patient age over 60 years are predictors of poor survival of patients with PAN.

Research paper thumbnail of Assessment of the face validity, feasibility and utility of a patient-completed questionnaire for polymyalgia rheumatica: a postal survey using the QQ-10 questionnaire

Pilot and feasibility studies, 2018

The development of a patient-reported outcome measure (PROM) for polymyalgia rheumatica (PMR), a ... more The development of a patient-reported outcome measure (PROM) for polymyalgia rheumatica (PMR), a condition that causes pain, stiffness and disability, is necessary as there is no current validated disease-specific measure. Initial literature synthesis and qualitative research established a conceptual framework for the condition along with a list of symptoms and effects of PMR that patients felt were important to them. These findings were used to derive the candidate items for a patient-completed questionnaire. We aim to establish the face validity of this initial "long form" of a PROM. People with a current or previous diagnosis of PMR were recruited both from the community and from rheumatology clinics. They were asked to complete the PMR questionnaire along with the QQ-10 questionnaire, which is a measure used to assess the face validity, feasibility and utility of patient healthcare questionnaires. A total of 28 participants with an age range of 59-85 years and a length...

Research paper thumbnail of The OMERACT Core Domain Set for Outcome Measures for Clinical Trials in Polymyalgia Rheumatica

The Journal of rheumatology, 2017

To inform development of a core domain set for outcome measures for clinical trials in polymyalgi... more To inform development of a core domain set for outcome measures for clinical trials in polymyalgia rheumatica (PMR), we conducted patient consultations, a systematic review, a Delphi study, and 2 qualitative studies. Domains identified by 70% or more of physicians and/or patients in the Delphi study were selected. The conceptual framework derived from the 2 qualitative research studies helped inform the meaning of each domain and its relationship to the others. The draft core domain set was refined by further discussion with patients and physicians who had participated in the Delphi study. At the Outcome Measures in Rheumatology (OMERACT) 2016, the domains were discussed and prioritized by 8 breakout groups. Formal voting took place at the end of the workshop and in the final plenary. Ninety-three percent of voters in the final plenary agreed that the inner core of domains considered mandatory for clinical trials of PMR should consist the following: laboratory markers of systemic in...

Research paper thumbnail of Rheumatoid Arthritis

The Autoimmune Diseases, 2006

Publisher Summary Rheumatoid arthritis (RA) is a systemic inflammatory disorder characterized by ... more Publisher Summary Rheumatoid arthritis (RA) is a systemic inflammatory disorder characterized by symmetrical synovitis of peripheral joints and tendon sheaths. In the absence of treatment, there is progressive damage to soft tissue, cartilage, and bone, resulting in deformity and disability. Subcutaneous nodules and involvement of other organs may also occur. Rheumatoid factor, an autoantibody that binds to the constant region (Fc) of immunoglobulin, is usually present. Serial radiographs are often used to monitor progression of RA, but ultrasound and magnetic resonance imaging are more sensitive in the detection of subclinical synovitis and early erosions. Such studies suggest that bone damage occurs in proportion to the level of synovitis but not in its absence. Moreover, new animal models and developments in high-throughput techniques of genomics and proteomics promise new insight in the pathogenesis of RA. Further advances in the understanding of tolerance and immunoregulation can shed light on the key events leading to autoimmunity in RA. The advent of anti-TNF therapy has revolutionized the field and encouraged the development of further novel therapies.

Research paper thumbnail of A spectrum of susceptibility to rheumatoid arthritis within HLA-DRB1: stratification by autoantibody status in a large UK population

Research paper thumbnail of An unusual complication of appendicitis

Annals of the Rheumatic Diseases, 2004

Research paper thumbnail of Stiffness Is the Cardinal Symptom of Inflammatory Musculoskeletal Diseases, Yet Still Variably Measured: Report from the OMERACT 2016 Stiffness Special Interest Group

The Journal of rheumatology, Jan 15, 2016

The objectives of the Outcome Measures in Rheumatology (OMERACT) Stiffness special interest group... more The objectives of the Outcome Measures in Rheumatology (OMERACT) Stiffness special interest group (SIG) are to characterize stiffness as an outcome in rheumatic disease and to identify and validate a stiffness patient-reported outcome (PRO) in rheumatology. At OMERACT 2016, international groups presented and discussed results of several concurrent research projects on stiffness: a literature review of rheumatoid arthritis (RA) stiffness PRO measures, a qualitative investigation into the RA and polymyalgia rheumatica patient perspective of stiffness, data-driven stiffness conceptual model development, development and testing of an RA stiffness PRO measure, and a quantitative work testing stiffness items in patients with RA and psoriatic arthritis. The literature review identified 52 individual stiffness PRO measures assessing morning or early morning stiffness severity/intensity or duration. Items were heterogeneous, had little or inconsistent psychometric property evidence, and did ...

Research paper thumbnail of A Patient-reported Outcome Measure for Effect of Glucocorticoid Therapy in Adults with Inflammatory Diseases Is Needed: Report from the OMERACT 2016 Special Interest Group

The Journal of rheumatology, 2017

The need for a standardized instrument to measure the effect of glucocorticoid (GC) therapy has b... more The need for a standardized instrument to measure the effect of glucocorticoid (GC) therapy has been well documented in the literature. The aim of the first GC Special Interest Group was to define a research agenda around the development of a patient-reported outcome measure (PROM) in this area. The results of a background literature search and the preliminary results of a pilot survey and 2 qualitative studies were presented to facilitate the development of a research agenda. It was agreed that there was a need for a data-driven PROM that identified both positive and negative effects of GC therapy to be used across all inflammatory indications for systemic GC use in adults. A research agenda was developed, consisting of further qualitative work to assess the effect of GC across different groups including various indications for GC use, different age groups, different dosages, and duration of treatment. There was agreement on the need for a PROM in this area and a research agenda wa...

Research paper thumbnail of Outcome Measures in Polymyalgia Rheumatica. A Systematic Review

The Journal of rheumatology, Jan 15, 2015

To identify the instruments used to assess polymyalgia rheumatica (PMR) in published studies. A s... more To identify the instruments used to assess polymyalgia rheumatica (PMR) in published studies. A systematic literature review of clinical trials and longitudinal observational studies related to PMR, published from 1970 to 2014, was carried out. All outcome and assessment instruments were extracted and categorized according to core areas and domains, as defined by the OMERACT (Outcome Measures in Rheumatology) Filter 2.0. Thirty-five articles (3221 patients) were included: 12 randomized controlled trials (RCT); 3 nonrandomized trials; and 20 observational studies. More than 20 domains were identified, measured by 29 different instruments. The most frequently used measures were pain, morning stiffness, patient global assessment and physician global assessment, erythrocyte sedimentation rate, and C-reactive protein. The definition of outcomes varied considerably between studies. The outcome measures and instruments used in PMR are numerous and diversely defined. The establishment of a ...

Research paper thumbnail of Development of a Provisional Core Domain Set for Polymyalgia Rheumatica: Report from the OMERACT 12 Polymyalgia Rheumatica Working Group

The Journal of rheumatology, Jan 15, 2015

The Outcome Measures in Rheumatology (OMERACT) polymyalgia rheumatica (PMR) working group aims to... more The Outcome Measures in Rheumatology (OMERACT) polymyalgia rheumatica (PMR) working group aims to develop a core set of outcome measures to be used in clinical trials for PMR. Previous reports from OMERACT 11 included a qualitative study of the patient experience and a preliminary literature review. A 3-round Delphi survey of clinicians and patients with PMR was undertaken to identify a candidate core domain set for PMR research. Additionally, a literature review of outcome measures and their respective measurement instruments was undertaken. Meetings of patient research partners and clinicians were convened to review face validity of the provisional core domain set, which was subsequently presented and discussed at the OMERACT 12 congress. Of the 60 clinicians taking part in round 1, 55 took part in round 2 and 51 in round 3. Of the 55 patients who took part in round 1, 46 and 35 took part in subsequent rounds. In total, 91% of participants in round 3 deemed the resulting draft cor...

Research paper thumbnail of AB0905 Late-onset spondyloarthropathy mimicking polymalgia rheumatica: Evidence from MRI

Annals of the Rheumatic Diseases, 2012

ABSTRACT

Research paper thumbnail of Accuracy of musculoskeletal imaging for the diagnosis of polymyalgia rheumatica: systematic review

RMD open, 2015

To review the evidence for accuracy of imaging for diagnosis of polymyalgia rheumatica (PMR). Sea... more To review the evidence for accuracy of imaging for diagnosis of polymyalgia rheumatica (PMR). Searches included MEDLINE, EMBASE and PubMed. Evaluations of diagnostic accuracy of imaging tests for PMR were eligible, excluding reports with <10 PMR cases. Two authors independently extracted study data and three authors assessed methodological quality using modified QUADAS-2 criteria. 26 studies of 2370 patients were evaluated: 10 ultrasound scanning studies; 6 MRI studies; 1 USS and MRI study; 7 18-fluorodeoxyglucose-positron emission tomography (PET) studies; 1 plain radiography and 1 technetium scintigraphy study. In four ultrasound studies, subacromial-subdeltoid bursitis had sensitivity 80% (95% CI 55% to 93%) and specificity 68% (95% CI 60% to 75%), whereas bilateral subacromial-subdeltoid bursitis had sensitivity 66% (95% CI 43% to 87%) and specificity 89% (95% CI 66% to 97%). Sensitivity for ultrasound detection of trochanteric bursitis ranged from 21% to 100%. In four ultras...

Research paper thumbnail of Current evidence for therapeutic interventions and prognostic factors in polymyalgia rheumatica: a systematic literature review informing the 2015 European League Against Rheumatism/American College of Rheumatology recommendations for the management of polymyalgia rheumatica

Annals of the Rheumatic Diseases, 2015

To summarise evidence on therapeutic interventions and prognostic factors in polymyalgia rheumati... more To summarise evidence on therapeutic interventions and prognostic factors in polymyalgia rheumatica (PMR). A systematic literature review was conducted using Ovid Medline, Embase, PubMed, CINAHL, Web of Science and the Cochrane Library (1970 through April 2014). Quality of evidence (QoE) of identified studies was appraised by Grading of Recommendations Assessment, Development and Evaluation (GRADE) (interventions) and the Quality In Prognosis Studies (QUIPS) methodologies (prognostic factors). Out of 10 931 titles identified, 52 articles were finally selected. A single study indicated that an initial prednisone dose of 20 mg/day is associated with a lower short-term relapse rate than 10 mg/day but at the cost of a higher rate of adverse events. Another study suggested a comparable efficacy of intramuscular methylprednisolone and oral glucocorticoids (GCs) with lower cumulative GC doses and less weight gain in the former group. Moderate to high QoE (1-2 studies) indicated a benefit of methotrexate in remission rates and cumulative GC doses in early PMR. Anti-tumour necrosis factor α agents are ineffective for PMR treatment. Among prognostic factors, female sex, high erythrocyte sedimentation rate (ESR) and peripheral arthritis were associated in some studies with a higher relapse risk. Women and patients with high ESR also appeared to have a longer duration of treatment. Several studies of varying quality, however, failed to prove these associations. In PMR, evidence for initial GC doses and subsequent tapering regimens is limited. Intramuscular methylprednisolone and methotrexate may be effective GC sparing agents. Female sex, high ESR and peripheral arthritis at disease outset are potential risk factors for a worse prognosis.

Research paper thumbnail of Whole-body MRI of patients with polymyalgia rheumatica identifies a distinct subset with complete patient-reported response to glucocorticoids

Annals of the Rheumatic Diseases, 2015

To determine whether whole-body MRI defines clinically relevant subgroups within polymyalgia rheu... more To determine whether whole-body MRI defines clinically relevant subgroups within polymyalgia rheumatica (PMR) including glucocorticoid responsiveness. 22 patients with PMR and 16 with rheumatoid arthritis (RA), untreated and diagnosed by consultant rheumatologists, underwent whole-body, multiple-joint MRI, scored by two experts. Patients with PMR reported whether they felt &amp;amp;amp;amp;amp;amp;#39;back to normal&amp;amp;amp;amp;amp;amp;#39; on glucocorticoid therapy and were followed for a median of 2 years. All patients with PMR were deemed to respond to glucocorticoids clinically. A characteristic pattern of symmetrical, extracapsular inflammation, adjacent to greater trochanter, acetabulum, ischial tuberosity and/or symphysis pubis, was observed in 14/22 of the PMR cases. In PMR, this pattern was associated with complete glucocorticoid response (p=0.01), higher pretreatment C-reactive protein (CRP) and serum interleukin-6 (IL-6), and better post-treatment fatigue and function. Only 1/14 in the extracapsular group could stop glucocorticoids within 1 year, compared with 4/7 of the others. A score derived from the five sites discriminating best between PMR and RA correlated with IL-6 (p&amp;amp;amp;amp;amp;amp;lt;0.002). IL-6 levels ≥16.8 pg/mL had 86% sensitivity and 86% specificity for the extracapsular MRI pattern. A subset of patients with rheumatologist-diagnosed PMR had a characteristic, extracapsular pattern of MRI inflammation, associated with elevated IL-6/CRP and with complete patient-reported glucocorticoid responsiveness.

Research paper thumbnail of 2015 Recommendations for the management of polymyalgia rheumatica: a European League Against Rheumatism/American College of Rheumatology collaborative initiative: Figure 1

Annals of the Rheumatic Diseases, 2015

Therapy for polymyalgia rheumatica (PMR) varies widely in clinical practice as international reco... more Therapy for polymyalgia rheumatica (PMR) varies widely in clinical practice as international recommendations for PMR treatment are not currently available. In this paper, we report the 2015 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) recommendations for the management of PMR. We used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology as a framework for the project. Accordingly, the direction and strength of the recommendations are based on the quality of evidence, the balance between desirable and undesirable effects, patients&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; and clinicians&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; values and preferences, and resource use. Eight overarching principles and nine specific recommendations were developed covering several aspects of PMR, including basic and follow-up investigations of patients under treatment, risk factor assessment, medical access for patients and specialist referral, treatment strategies such as initial glucocorticoid (GC) doses and subsequent tapering regimens, use of intramuscular GCs and disease modifying anti-rheumatic drugs (DMARDs), as well as the roles of non-steroidal anti-rheumatic drugs and non-pharmacological interventions. These recommendations will inform primary, secondary and tertiary care physicians about an international consensus on the management of PMR. These recommendations should serve to inform clinicians about best practices in the care of patients with PMR.

Research paper thumbnail of Accuracy of musculoskeletal imaging for the diagnosis of polymyalgia rheumatica: systematic review

RMD Open, 2015

To review the evidence for accuracy of imaging for diagnosis of polymyalgia rheumatica (PMR). Sea... more To review the evidence for accuracy of imaging for diagnosis of polymyalgia rheumatica (PMR). Searches included MEDLINE, EMBASE and PubMed. Evaluations of diagnostic accuracy of imaging tests for PMR were eligible, excluding reports with &amp;amp;amp;amp;amp;amp;amp;amp;lt;10 PMR cases. Two authors independently extracted study data and three authors assessed methodological quality using modified QUADAS-2 criteria. 26 studies of 2370 patients were evaluated: 10 ultrasound scanning studies; 6 MRI studies; 1 USS and MRI study; 7 18-fluorodeoxyglucose-positron emission tomography (PET) studies; 1 plain radiography and 1 technetium scintigraphy study. In four ultrasound studies, subacromial-subdeltoid bursitis had sensitivity 80% (95% CI 55% to 93%) and specificity 68% (95% CI 60% to 75%), whereas bilateral subacromial-subdeltoid bursitis had sensitivity 66% (95% CI 43% to 87%) and specificity 89% (95% CI 66% to 97%). Sensitivity for ultrasound detection of trochanteric bursitis ranged from 21% to 100%. In four ultrasound studies reporting both subacromial-subdeltoid bursitis and glenohumeral synovitis, detection of subacromial-subdeltoid bursitis was more accurate than that of glenohumeral synovitis (p=0.004). MRI and PET/CT revealed additional areas of inflammation in the spine and pelvis, including focal areas between the vertebrae and anterior to the hip joint, but the number of controls with inflammatory disease was inadequate for precise specificity estimates. Subacromial-subdeltoid bursitis appears to be the most helpful ultrasound feature for PMR diagnosis, but interpretation is limited by study heterogeneity and methodological issues, including variability in blinding and potential bias due to case-control study designs. Recent MRI and PET/CT case-control studies, with blinded readers, yielded promising data requiring validation within a diagnostic cohort study.

Research paper thumbnail of P14. Investigations prior to temporal artery biopsy: a retrospective audit of compliance with the British Society for Rheumatology Guidelines for giant cell arteritis

Rheumatology

patients were admitted to the study and followed prospectively for at least 12 months during the ... more patients were admitted to the study and followed prospectively for at least 12 months during the past 12 years. PMR diagnosis had to be confirmed at 6-month follow-up by an expert rheumatologist. Sensitivity of the new ACR/EULAR classification criteria was analysed and compared with the previous Healey's criteria. Results: 108 patients entered the study (mean age 68.2 AE 16.8 years, female 76.2%, mean disease duration 11.02 AE 4.9 weeks, mean ESR 74.2 AE 25.8 mm/1 h, mean CRP 59.1 AE 41.9 mg/l, mean Leeb's index of disease activity 40.4 AE 15.1. 103 (96%) pts had bilateral shoulder complaints, 94% had morning stiffness of >45 min duration, 95/ 102 (88/94%) had elevated ESR/CRP, 58% had hip pain, 98% had normal RF/aCCP, 46% did not have peripheral joint involvement. 82% had US signs of bilateral shoulder involvement. 94,4% satisfied the ACR/EULAR classification criteria for PMR, whereas 88% those of the Healey's criteria. Conclusion: In our series of new onset PMR pts sensitivity of the new ACR/EULAR classification criteria seems to be higher when compared with the previous Healey's criteria. US examination does not seem to increase the sensitivity of the clinical criteria.

Research paper thumbnail of Patient Reported Outcomes in Large Vessel Vasculitides

Current Rheumatology Reports, 2021

Purpose of Review The goal of this paper is to review current and future uses of patient-reported... more Purpose of Review The goal of this paper is to review current and future uses of patient-reported outcomes in large vessel vasculitis. The large vessel vasculitides comprise Giant Cell Arteritis and Takayasu arteritis; both are types of systemic vasculitis which affect the larger blood vessels. Patient-reported outcomes (PROs) capture the impact of these diseases on health-related quality of life. Recent Findings Generic PROs such as the SF-36 are currently used to compare HRQOL of people with GCA and TAK within clinical trials and observational studies and to make comparisons with the general population and HRQoL in other diseases. The development of a disease-specific PRO for GCA is currently underway. Beyond clinical trials, there is much interest in the use of PROs within routine clinical care, particularly E-PROs for remote use. Summary Further work will be needed to complete the development of disease-specific PROs for people with large vessel vasculitis and to establish feasi...

Research paper thumbnail of The evolution of instrument selection for inclusion in core outcome sets at OMERACT: Filter 2.2

Seminars in Arthritis and Rheumatism, 2021

INTRODUCTION OMERACT uses an evidence-based framework known as the 'OMERACT Filter Instrument... more INTRODUCTION OMERACT uses an evidence-based framework known as the 'OMERACT Filter Instrument Selection Algorithm' (OFISA) to guide decisions in the assessment of outcome measurement instruments for inclusion in a core outcome set for interventional and observational clinical trials. METHODS A group of OMERACT imaging and patient-centered outcome methodologists worked with imaging outcome groups to facilitate the selection of imaging outcome measurement instruments using the OFISA approach. The lessons learned from this work influenced the evolution to Filter 2.2 and necessitated changes to OMERACT's documentation and processes. RESULTS OMERACT has revised documentation and processes to incorporate the evolution of instrument selection to Filter 2.2. These revisions include creation of a template for detailed definitions of the target domain which is a necessary first step for instrument selection, modifications to the Summary of Measurement Properties (SOMP) table to account for sources of variability, and development of standardized reporting tables for each measurement property. CONCLUSIONS OMERACT Filter 2.2 represents additional modifications of the OMERACT guide for working groups in their rigorous assessment of measurement properties of instruments of various types, including imaging outcome measurement instruments. Enhanced reporting aims to increase the transparency of the evidence base leading to judgements for the endorsement of instruments in core outcome sets.

Research paper thumbnail of P185 Patient perceptions of physical activity following a diagnosis of giant cell arteritis: a multinational qualitative study

Rheumatology, 2020

Background Giant cell arteritis (GCA) is the most common vasculitis in the UK, with an incidence ... more Background Giant cell arteritis (GCA) is the most common vasculitis in the UK, with an incidence of 220 cases per million in adults over 50 years of age. The physical symptoms as well as the side effects of glucocorticoids may impact patients’ ability to exercise. Maintaining physical activity (PA) has been shown to be beneficial to disease activity in other inflammatory conditions and is also a specific priority for GCA patients. The aim of this project was to explore patient perceptions of physical activity in GCA. Methods Multinational qualitative study, using interviews with 36 patients from the UK (25) and Australia (11), all of whom had a definitive diagnosis from imaging or biopsy. Interviews were recorded, transcribed, and analysed using inductive thematic analysis. This is secondary analysis of data collected to explore health-related quality of life in people with GCA. Results 107 individual themes were reported by patients, which divided broadly into two overarching theme...

Research paper thumbnail of 342. Is Plasma Viscosity an Acceptable Substitute for Erythrocyte Sedimentation Rate for the Diagnosis of Giant Cell Arteritis?

Rheumatology, 2014

to the ACR 1990 criteria or the CHCC diagnostic criteria in the three rheumatology departments of... more to the ACR 1990 criteria or the CHCC diagnostic criteria in the three rheumatology departments of the two city hospitals in Kyiv between 1972 and 2010. Survival was calculated using the Kaplan-Meier method. Demographics (age at diagnosis, sex), clinical and laboratory parameters (including ESR, the presence of hepatitis B virus (HBV) and creatinine level), were tested as potential prognostic factors in multivariate Cox models. Clinical activities of patients were calculated according to the Birmingham Vasculitis Activity Score (BVAS). Results: The median duration of follow-ups was 92 months and 15 (28.3%) deaths were recorded. According to the analysis 25% of patients with PAN die within the first 7 years, and 50% don't live more than 17 years. Cumulative survival rates at 1, 3, 5 and 10 years was 88.6; 84.2; 81.8 and 68.2%, respectively. Comparison survival of patients with PAN according to age and sex revealed that gender cumulative survival function didn't differ significantly (P ¼ 0.58), but age at onset of the disease of more than 60 years significantly reduces the survival of patients with PAN. Survival curves of groups of patients with different disease activity determined by BVAS were not significantly different (P ¼ 0.59). HBV infection in patients with PAN and ESR level at the onset of the disease didn't affect the survival of patients. Multivariate analysis showed that presence of increased creatinine levels more than 140 mg/ dl, cardiac involvement and patient age over 60 years were significant negative prognostic factors for patient survival. Other factors (including weight loss, gastrointestinal and CNS involvement, diastolic hypertension, etc.) didn't have influence on the survival curves. Comparison groups of patients with PAN distributed by the 5-factor score revealed the presence of two or more adverse prognostic factors significantly reduce survival (p < 0.05), and the presence of only one factor has no effect on mortality. Conclusion: Despite current treatment the prognosis of patients with PAN remains unfavourable. Cumulative survival of patients with PAN at 1, 3, 5 and 10 years of observation is 89, 84, 82 and 68%, respectively. Vasculitis activity detected by BVAS and the level of ESR no effect on mortality. The increased creatinine levels more than 140 mg/dl, presence of cardiac involvement and patient age over 60 years are predictors of poor survival of patients with PAN.

Research paper thumbnail of Assessment of the face validity, feasibility and utility of a patient-completed questionnaire for polymyalgia rheumatica: a postal survey using the QQ-10 questionnaire

Pilot and feasibility studies, 2018

The development of a patient-reported outcome measure (PROM) for polymyalgia rheumatica (PMR), a ... more The development of a patient-reported outcome measure (PROM) for polymyalgia rheumatica (PMR), a condition that causes pain, stiffness and disability, is necessary as there is no current validated disease-specific measure. Initial literature synthesis and qualitative research established a conceptual framework for the condition along with a list of symptoms and effects of PMR that patients felt were important to them. These findings were used to derive the candidate items for a patient-completed questionnaire. We aim to establish the face validity of this initial "long form" of a PROM. People with a current or previous diagnosis of PMR were recruited both from the community and from rheumatology clinics. They were asked to complete the PMR questionnaire along with the QQ-10 questionnaire, which is a measure used to assess the face validity, feasibility and utility of patient healthcare questionnaires. A total of 28 participants with an age range of 59-85 years and a length...

Research paper thumbnail of The OMERACT Core Domain Set for Outcome Measures for Clinical Trials in Polymyalgia Rheumatica

The Journal of rheumatology, 2017

To inform development of a core domain set for outcome measures for clinical trials in polymyalgi... more To inform development of a core domain set for outcome measures for clinical trials in polymyalgia rheumatica (PMR), we conducted patient consultations, a systematic review, a Delphi study, and 2 qualitative studies. Domains identified by 70% or more of physicians and/or patients in the Delphi study were selected. The conceptual framework derived from the 2 qualitative research studies helped inform the meaning of each domain and its relationship to the others. The draft core domain set was refined by further discussion with patients and physicians who had participated in the Delphi study. At the Outcome Measures in Rheumatology (OMERACT) 2016, the domains were discussed and prioritized by 8 breakout groups. Formal voting took place at the end of the workshop and in the final plenary. Ninety-three percent of voters in the final plenary agreed that the inner core of domains considered mandatory for clinical trials of PMR should consist the following: laboratory markers of systemic in...

Research paper thumbnail of Rheumatoid Arthritis

The Autoimmune Diseases, 2006

Publisher Summary Rheumatoid arthritis (RA) is a systemic inflammatory disorder characterized by ... more Publisher Summary Rheumatoid arthritis (RA) is a systemic inflammatory disorder characterized by symmetrical synovitis of peripheral joints and tendon sheaths. In the absence of treatment, there is progressive damage to soft tissue, cartilage, and bone, resulting in deformity and disability. Subcutaneous nodules and involvement of other organs may also occur. Rheumatoid factor, an autoantibody that binds to the constant region (Fc) of immunoglobulin, is usually present. Serial radiographs are often used to monitor progression of RA, but ultrasound and magnetic resonance imaging are more sensitive in the detection of subclinical synovitis and early erosions. Such studies suggest that bone damage occurs in proportion to the level of synovitis but not in its absence. Moreover, new animal models and developments in high-throughput techniques of genomics and proteomics promise new insight in the pathogenesis of RA. Further advances in the understanding of tolerance and immunoregulation can shed light on the key events leading to autoimmunity in RA. The advent of anti-TNF therapy has revolutionized the field and encouraged the development of further novel therapies.

Research paper thumbnail of A spectrum of susceptibility to rheumatoid arthritis within HLA-DRB1: stratification by autoantibody status in a large UK population

Research paper thumbnail of An unusual complication of appendicitis

Annals of the Rheumatic Diseases, 2004

Research paper thumbnail of Stiffness Is the Cardinal Symptom of Inflammatory Musculoskeletal Diseases, Yet Still Variably Measured: Report from the OMERACT 2016 Stiffness Special Interest Group

The Journal of rheumatology, Jan 15, 2016

The objectives of the Outcome Measures in Rheumatology (OMERACT) Stiffness special interest group... more The objectives of the Outcome Measures in Rheumatology (OMERACT) Stiffness special interest group (SIG) are to characterize stiffness as an outcome in rheumatic disease and to identify and validate a stiffness patient-reported outcome (PRO) in rheumatology. At OMERACT 2016, international groups presented and discussed results of several concurrent research projects on stiffness: a literature review of rheumatoid arthritis (RA) stiffness PRO measures, a qualitative investigation into the RA and polymyalgia rheumatica patient perspective of stiffness, data-driven stiffness conceptual model development, development and testing of an RA stiffness PRO measure, and a quantitative work testing stiffness items in patients with RA and psoriatic arthritis. The literature review identified 52 individual stiffness PRO measures assessing morning or early morning stiffness severity/intensity or duration. Items were heterogeneous, had little or inconsistent psychometric property evidence, and did ...

Research paper thumbnail of A Patient-reported Outcome Measure for Effect of Glucocorticoid Therapy in Adults with Inflammatory Diseases Is Needed: Report from the OMERACT 2016 Special Interest Group

The Journal of rheumatology, 2017

The need for a standardized instrument to measure the effect of glucocorticoid (GC) therapy has b... more The need for a standardized instrument to measure the effect of glucocorticoid (GC) therapy has been well documented in the literature. The aim of the first GC Special Interest Group was to define a research agenda around the development of a patient-reported outcome measure (PROM) in this area. The results of a background literature search and the preliminary results of a pilot survey and 2 qualitative studies were presented to facilitate the development of a research agenda. It was agreed that there was a need for a data-driven PROM that identified both positive and negative effects of GC therapy to be used across all inflammatory indications for systemic GC use in adults. A research agenda was developed, consisting of further qualitative work to assess the effect of GC across different groups including various indications for GC use, different age groups, different dosages, and duration of treatment. There was agreement on the need for a PROM in this area and a research agenda wa...

Research paper thumbnail of Outcome Measures in Polymyalgia Rheumatica. A Systematic Review

The Journal of rheumatology, Jan 15, 2015

To identify the instruments used to assess polymyalgia rheumatica (PMR) in published studies. A s... more To identify the instruments used to assess polymyalgia rheumatica (PMR) in published studies. A systematic literature review of clinical trials and longitudinal observational studies related to PMR, published from 1970 to 2014, was carried out. All outcome and assessment instruments were extracted and categorized according to core areas and domains, as defined by the OMERACT (Outcome Measures in Rheumatology) Filter 2.0. Thirty-five articles (3221 patients) were included: 12 randomized controlled trials (RCT); 3 nonrandomized trials; and 20 observational studies. More than 20 domains were identified, measured by 29 different instruments. The most frequently used measures were pain, morning stiffness, patient global assessment and physician global assessment, erythrocyte sedimentation rate, and C-reactive protein. The definition of outcomes varied considerably between studies. The outcome measures and instruments used in PMR are numerous and diversely defined. The establishment of a ...

Research paper thumbnail of Development of a Provisional Core Domain Set for Polymyalgia Rheumatica: Report from the OMERACT 12 Polymyalgia Rheumatica Working Group

The Journal of rheumatology, Jan 15, 2015

The Outcome Measures in Rheumatology (OMERACT) polymyalgia rheumatica (PMR) working group aims to... more The Outcome Measures in Rheumatology (OMERACT) polymyalgia rheumatica (PMR) working group aims to develop a core set of outcome measures to be used in clinical trials for PMR. Previous reports from OMERACT 11 included a qualitative study of the patient experience and a preliminary literature review. A 3-round Delphi survey of clinicians and patients with PMR was undertaken to identify a candidate core domain set for PMR research. Additionally, a literature review of outcome measures and their respective measurement instruments was undertaken. Meetings of patient research partners and clinicians were convened to review face validity of the provisional core domain set, which was subsequently presented and discussed at the OMERACT 12 congress. Of the 60 clinicians taking part in round 1, 55 took part in round 2 and 51 in round 3. Of the 55 patients who took part in round 1, 46 and 35 took part in subsequent rounds. In total, 91% of participants in round 3 deemed the resulting draft cor...

Research paper thumbnail of AB0905 Late-onset spondyloarthropathy mimicking polymalgia rheumatica: Evidence from MRI

Annals of the Rheumatic Diseases, 2012

ABSTRACT

Research paper thumbnail of Accuracy of musculoskeletal imaging for the diagnosis of polymyalgia rheumatica: systematic review

RMD open, 2015

To review the evidence for accuracy of imaging for diagnosis of polymyalgia rheumatica (PMR). Sea... more To review the evidence for accuracy of imaging for diagnosis of polymyalgia rheumatica (PMR). Searches included MEDLINE, EMBASE and PubMed. Evaluations of diagnostic accuracy of imaging tests for PMR were eligible, excluding reports with <10 PMR cases. Two authors independently extracted study data and three authors assessed methodological quality using modified QUADAS-2 criteria. 26 studies of 2370 patients were evaluated: 10 ultrasound scanning studies; 6 MRI studies; 1 USS and MRI study; 7 18-fluorodeoxyglucose-positron emission tomography (PET) studies; 1 plain radiography and 1 technetium scintigraphy study. In four ultrasound studies, subacromial-subdeltoid bursitis had sensitivity 80% (95% CI 55% to 93%) and specificity 68% (95% CI 60% to 75%), whereas bilateral subacromial-subdeltoid bursitis had sensitivity 66% (95% CI 43% to 87%) and specificity 89% (95% CI 66% to 97%). Sensitivity for ultrasound detection of trochanteric bursitis ranged from 21% to 100%. In four ultras...

Research paper thumbnail of Current evidence for therapeutic interventions and prognostic factors in polymyalgia rheumatica: a systematic literature review informing the 2015 European League Against Rheumatism/American College of Rheumatology recommendations for the management of polymyalgia rheumatica

Annals of the Rheumatic Diseases, 2015

To summarise evidence on therapeutic interventions and prognostic factors in polymyalgia rheumati... more To summarise evidence on therapeutic interventions and prognostic factors in polymyalgia rheumatica (PMR). A systematic literature review was conducted using Ovid Medline, Embase, PubMed, CINAHL, Web of Science and the Cochrane Library (1970 through April 2014). Quality of evidence (QoE) of identified studies was appraised by Grading of Recommendations Assessment, Development and Evaluation (GRADE) (interventions) and the Quality In Prognosis Studies (QUIPS) methodologies (prognostic factors). Out of 10 931 titles identified, 52 articles were finally selected. A single study indicated that an initial prednisone dose of 20 mg/day is associated with a lower short-term relapse rate than 10 mg/day but at the cost of a higher rate of adverse events. Another study suggested a comparable efficacy of intramuscular methylprednisolone and oral glucocorticoids (GCs) with lower cumulative GC doses and less weight gain in the former group. Moderate to high QoE (1-2 studies) indicated a benefit of methotrexate in remission rates and cumulative GC doses in early PMR. Anti-tumour necrosis factor α agents are ineffective for PMR treatment. Among prognostic factors, female sex, high erythrocyte sedimentation rate (ESR) and peripheral arthritis were associated in some studies with a higher relapse risk. Women and patients with high ESR also appeared to have a longer duration of treatment. Several studies of varying quality, however, failed to prove these associations. In PMR, evidence for initial GC doses and subsequent tapering regimens is limited. Intramuscular methylprednisolone and methotrexate may be effective GC sparing agents. Female sex, high ESR and peripheral arthritis at disease outset are potential risk factors for a worse prognosis.

Research paper thumbnail of Whole-body MRI of patients with polymyalgia rheumatica identifies a distinct subset with complete patient-reported response to glucocorticoids

Annals of the Rheumatic Diseases, 2015

To determine whether whole-body MRI defines clinically relevant subgroups within polymyalgia rheu... more To determine whether whole-body MRI defines clinically relevant subgroups within polymyalgia rheumatica (PMR) including glucocorticoid responsiveness. 22 patients with PMR and 16 with rheumatoid arthritis (RA), untreated and diagnosed by consultant rheumatologists, underwent whole-body, multiple-joint MRI, scored by two experts. Patients with PMR reported whether they felt &amp;amp;amp;amp;amp;amp;#39;back to normal&amp;amp;amp;amp;amp;amp;#39; on glucocorticoid therapy and were followed for a median of 2 years. All patients with PMR were deemed to respond to glucocorticoids clinically. A characteristic pattern of symmetrical, extracapsular inflammation, adjacent to greater trochanter, acetabulum, ischial tuberosity and/or symphysis pubis, was observed in 14/22 of the PMR cases. In PMR, this pattern was associated with complete glucocorticoid response (p=0.01), higher pretreatment C-reactive protein (CRP) and serum interleukin-6 (IL-6), and better post-treatment fatigue and function. Only 1/14 in the extracapsular group could stop glucocorticoids within 1 year, compared with 4/7 of the others. A score derived from the five sites discriminating best between PMR and RA correlated with IL-6 (p&amp;amp;amp;amp;amp;amp;lt;0.002). IL-6 levels ≥16.8 pg/mL had 86% sensitivity and 86% specificity for the extracapsular MRI pattern. A subset of patients with rheumatologist-diagnosed PMR had a characteristic, extracapsular pattern of MRI inflammation, associated with elevated IL-6/CRP and with complete patient-reported glucocorticoid responsiveness.

Research paper thumbnail of 2015 Recommendations for the management of polymyalgia rheumatica: a European League Against Rheumatism/American College of Rheumatology collaborative initiative: Figure 1

Annals of the Rheumatic Diseases, 2015

Therapy for polymyalgia rheumatica (PMR) varies widely in clinical practice as international reco... more Therapy for polymyalgia rheumatica (PMR) varies widely in clinical practice as international recommendations for PMR treatment are not currently available. In this paper, we report the 2015 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) recommendations for the management of PMR. We used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology as a framework for the project. Accordingly, the direction and strength of the recommendations are based on the quality of evidence, the balance between desirable and undesirable effects, patients&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; and clinicians&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; values and preferences, and resource use. Eight overarching principles and nine specific recommendations were developed covering several aspects of PMR, including basic and follow-up investigations of patients under treatment, risk factor assessment, medical access for patients and specialist referral, treatment strategies such as initial glucocorticoid (GC) doses and subsequent tapering regimens, use of intramuscular GCs and disease modifying anti-rheumatic drugs (DMARDs), as well as the roles of non-steroidal anti-rheumatic drugs and non-pharmacological interventions. These recommendations will inform primary, secondary and tertiary care physicians about an international consensus on the management of PMR. These recommendations should serve to inform clinicians about best practices in the care of patients with PMR.

Research paper thumbnail of Accuracy of musculoskeletal imaging for the diagnosis of polymyalgia rheumatica: systematic review

RMD Open, 2015

To review the evidence for accuracy of imaging for diagnosis of polymyalgia rheumatica (PMR). Sea... more To review the evidence for accuracy of imaging for diagnosis of polymyalgia rheumatica (PMR). Searches included MEDLINE, EMBASE and PubMed. Evaluations of diagnostic accuracy of imaging tests for PMR were eligible, excluding reports with &amp;amp;amp;amp;amp;amp;amp;amp;lt;10 PMR cases. Two authors independently extracted study data and three authors assessed methodological quality using modified QUADAS-2 criteria. 26 studies of 2370 patients were evaluated: 10 ultrasound scanning studies; 6 MRI studies; 1 USS and MRI study; 7 18-fluorodeoxyglucose-positron emission tomography (PET) studies; 1 plain radiography and 1 technetium scintigraphy study. In four ultrasound studies, subacromial-subdeltoid bursitis had sensitivity 80% (95% CI 55% to 93%) and specificity 68% (95% CI 60% to 75%), whereas bilateral subacromial-subdeltoid bursitis had sensitivity 66% (95% CI 43% to 87%) and specificity 89% (95% CI 66% to 97%). Sensitivity for ultrasound detection of trochanteric bursitis ranged from 21% to 100%. In four ultrasound studies reporting both subacromial-subdeltoid bursitis and glenohumeral synovitis, detection of subacromial-subdeltoid bursitis was more accurate than that of glenohumeral synovitis (p=0.004). MRI and PET/CT revealed additional areas of inflammation in the spine and pelvis, including focal areas between the vertebrae and anterior to the hip joint, but the number of controls with inflammatory disease was inadequate for precise specificity estimates. Subacromial-subdeltoid bursitis appears to be the most helpful ultrasound feature for PMR diagnosis, but interpretation is limited by study heterogeneity and methodological issues, including variability in blinding and potential bias due to case-control study designs. Recent MRI and PET/CT case-control studies, with blinded readers, yielded promising data requiring validation within a diagnostic cohort study.

Research paper thumbnail of P14. Investigations prior to temporal artery biopsy: a retrospective audit of compliance with the British Society for Rheumatology Guidelines for giant cell arteritis

Rheumatology

patients were admitted to the study and followed prospectively for at least 12 months during the ... more patients were admitted to the study and followed prospectively for at least 12 months during the past 12 years. PMR diagnosis had to be confirmed at 6-month follow-up by an expert rheumatologist. Sensitivity of the new ACR/EULAR classification criteria was analysed and compared with the previous Healey's criteria. Results: 108 patients entered the study (mean age 68.2 AE 16.8 years, female 76.2%, mean disease duration 11.02 AE 4.9 weeks, mean ESR 74.2 AE 25.8 mm/1 h, mean CRP 59.1 AE 41.9 mg/l, mean Leeb's index of disease activity 40.4 AE 15.1. 103 (96%) pts had bilateral shoulder complaints, 94% had morning stiffness of >45 min duration, 95/ 102 (88/94%) had elevated ESR/CRP, 58% had hip pain, 98% had normal RF/aCCP, 46% did not have peripheral joint involvement. 82% had US signs of bilateral shoulder involvement. 94,4% satisfied the ACR/EULAR classification criteria for PMR, whereas 88% those of the Healey's criteria. Conclusion: In our series of new onset PMR pts sensitivity of the new ACR/EULAR classification criteria seems to be higher when compared with the previous Healey's criteria. US examination does not seem to increase the sensitivity of the clinical criteria.