Reporting of patient-reported outcomes in recent trials in rheumatoid arthritis: a systematic literature review

Kalyoncu, Umut; Dougados, Maxime; Jp, Daurès; Gossec, Laure

doi:10.1136/ard.2007.084848

Cited by 153 publications

(124 citation statements)

References 47 publications

(37 reference statements)

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“…Instruments for measuring PROs are easy to administer and some, like the Health Assessment Questionnaire (HAQ), have been proven to be reliable, valid, and sensitive to change (11). There are several ways to explore PROs: some are qualitative (12), whereas others are quantitative such as by assessing the frequency of different outcome measures (4,5).…”

Section: Introductionmentioning

confidence: 99%

Clinical outcomes in psoriatic arthritis: A systematic literature review

Palominos¹,

Gaujoux-Viala²,

Fautrel³

et al. 2012

Arthritis Care & Research

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Objective. Many outcomes have been proposed in the assessment of psoriatic arthritis (PsA). The Outcome Measures in Rheumatology (OMERACT) core set for PsA evaluation comprises 6 domains: joints, skin, function, pain, patient's global assessment, and quality of life. The objective of this work was to assess reporting of outcomes in PsA, including patient-reported outcomes (PROs) in recent publications. Methods. A systematic literature search of clinical trials related to PsA and reporting at least 1 clinical outcome between 2006 and 2010 was performed in PubMed, i.e., just before to just after publication of the OMERACT core set. All clinical outcomes were noted and subdivided into domains of health. Data analysis was descriptive. Results. Fifty-eight articles (12,405 patients) were included in the analysis: 17 (29%) were randomized clinical trials; the patients' mean ؎ SD age was 48.2 ؎ 5.4 years and the mean ؎ SD disease duration was 9.0 ؎ 3.1 years. Eighty-four different outcomes were reported, with a mean ؎ SD of 6.9 ؎ 4.3 per study. Patients were mainly assessed using the 6 core set domains, reported in 37.9% (quality of life) to 55.2% (skin) of articles; however, the core set was rarely completely reported since only 10.3% of the studies reported all 6 core domains. PROs were heterogeneous and in particular there was no consensus regarding the number of joints to assess and instruments for dactylitis and enthesitis. PROs were assessed in more than 75% of publications using 28 different instruments. Conclusion. There is great heterogeneity in PsA assessment, even since publication of the OMERACT core set. Better consensus on instruments to assess each domain of health and better insight into which outcomes are important for patients is needed.

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Section: Introductionmentioning

confidence: 99%

Clinical outcomes in psoriatic arthritis: A systematic literature review

Palominos¹,

Gaujoux-Viala²,

Fautrel³

et al. 2012

Arthritis Care & Research

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“…The Stanford Health Assessment Questionnaire-Disability Index (HAQ) is a commonly used instrument to assess functional ability in Rheumatoid Arthritis (RA). It has been extensively validated [2], recommended by the American College of Rheumatology [3] and measured in the majority of studies of RA treatments [4]. Patients' perceptions of other instruments used in rheumatology have been qualitatively evaluated in depth [5,6], but perceptions of the HAQ need further investigation.…”

Section: Introductionmentioning

confidence: 99%

Persons with Rheumatoid Arthritis Challenge the Relevance of the Health Assessment Questionnaire: A Qualitative Study of Patient Perception

Ebbevi

Essén

Forsberg

2017

Preprint

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Background. The Stanford Health Assessment Questionnaire-Disability Index (HAQ) is widely used to measure functional ability in persons with Rheumatoid Arthritis (RA). The instrument was developed with limited involvement from persons with RA, and their perception of the instrument has not been studied in depth. The aim of this study was to explore how persons with RA experience the use of the HAQ in care.Methods. Forty persons with RA were purposefully recruited to participate in semi-structured interviews. The interviews were then analyzed qualitatively using thematic analysis.Results. The participants questioned the relevance of the HAQ but nevertheless experienced that the instrument had a profound effect on their understanding of health and how care is delivered. The analysis resulted in three themes: Problems with individual items, meaning of the summative score, and effects on care and health perceptions. Conclusions.To make the HAQ relevant to persons with RA, it needs to be revised or to include an option to select items most meaningful to the respondent. To ensure relevance, the HAQ update should preferably be cocreated by researchers, clinicians and persons with RA.

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“…The HAQ questionnaire is widely used in clinical practice for the study rheumatic diseases in adults, particularly in rheumatoid arthritis [11]. This questionnaire is a useful tool for evaluation of functional status, its change during treatment.…”

Section: Introductionmentioning

confidence: 99%

“…This questionnaire is a useful tool for evaluation of functional status, its change during treatment. HAQ score is also associated with disease activity, mortality, and need in joint replacement [11], [12]. Most often, for the quality of life (QoL) assessment in adult patients, the SF-36 questionnaire is used [12].…”

Section: Introductionmentioning

confidence: 99%

Influence of juvenile idiopathic arthritis on the quality of life of young adults in the transition period to adult rheumatologic care

Dzhus

2017

PMGP

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Background. Young adults with juvenile idiopathic arthritis (JIA) often have an active disease with signi icant functional impairment in adulthood that can affect their physical and mental functions. Aim.To determine the impact of JIA on quality of life (QoL) in young adults with JIA during the transition healthcare. Materials and methods.The cross-sectional study of 89 young adults aged 16 to 22 years with a history of JIA regardless of the presence or absence of active in lammation at the time of the survey was performed in the Oleksandrivsky Central Clinical Hospital in Kyiv, Ukraine in the period between April 2015 and February 2017. 25 age-and sex-matched controls (without rheumatic disease) were included. There was performed an evaluation of the age at disease onset, duration, JIA activity, received therapy and quality of life.Results. Out of 89, 37 (41,6%) patients were considered to be in remission. Juvenile idiopathic arthritis had a large impact on the physical scales of quality of life. Patients with JIA had worse (p <0.001) physical health in comparison with the control group. The pain was the most important factor affecting the quality of life in cases of juvenile idiopathic arthritis. The indices responsible for the physical (p<0.001), role (borderline signi icance, p=0.04) functioning, and intensity of pain (p<0.001) were decreased, compared with the control group. However, the indicators responsible for psychological function in patients with JIA did not differ from the control group. The correlation analysis revealed signi icant negative association between disability severity (HAQ) and physical function (r=-0,56, p<0.001), role function (r=-0,33, p<0.001), pain intensity (r=-0,60, p<0.001), general health (r=-0,40, p=0.01), vital activity (r=-0,46, p<0.001), social function (r=-0,48, p<0.001), mental health (r=-0,42, p<0.001).Conclusion. In our transitional cohort of patients at the era of biological therapies, juvenile idiopathic arthritis had a larger effect on the physical than mental SF-36 subscale. The pain was the main factor in luencing the quality of life.

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Reporting of patient-reported outcomes in recent trials in rheumatoid arthritis: a systematic literature review

Abstract: PROs are reported with great heterogeneity in recently published trials in RA. Some domains that appear important from the patient's perspective are infrequently reported. Further work is needed in this field.

Cited by 153 publications

References 47 publications

Clinical outcomes in psoriatic arthritis: A systematic literature review

Clinical outcomes in psoriatic arthritis: A systematic literature review

Persons with Rheumatoid Arthritis Challenge the Relevance of the Health Assessment Questionnaire: A Qualitative Study of Patient Perception

Influence of juvenile idiopathic arthritis on the quality of life of young adults in the transition period to adult rheumatologic care

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