The use of routinely collected patient-reported outcome measures in rheumatoid arthritis
Introduction
Rheumatoid arthritis (RA) is the most frequent type of inflammatory arthritis, affecting 1–2% of the world population [1]. It is characterized by progressive joint damage, comorbidities, diminished health-related quality of life (HRQoL) and premature mortality [2], [3]. The resulting physical disability over a long period of time exposes people to significant financial burden including direct medical costs, e.g., due to expensive drugs and joint replacement surgery, and indirect costs due to sick leave [4]. Severity of disease and resulting disability are evaluated by using a combination of assessments, including pathophysiological manifestations, such as laboratory or imaging, clinician-reported outcome measures, and patient-reported outcome measures (PROMs). PROMs are questionnaires that patients complete to provide information about their health status or aspects of HRQoL. PROMs are now considered part of the core set of measures that are recommended in order to determine activity of the disease and response to treatment [5]. The latter is particularly relevant as PROMs provide information that may not be considered especially important by physicians, e.g., sleeping difficulties and fatigue [6], [7]. Their use reflects a desire for assessment of the effectiveness, monitoring and accountability of health care provision, and reflects the need to place patients’ perspectives at the center of health care delivery.
Prior systematic reviews have focused on the type of PROMs reported in randomized controlled trials (RCTs) [8], [9]. These reviews describe that, although the types of PROMs collected have been consistent with recent RA core set recommendations, some health domains that are important to patients such as psychological status and coping, are rarely collected. Increasingly, PROMs are also being collected in RA registries and RA cohorts, which constitute excellent sources of information for clinical rheumatology [10]. RA registries and cohorts generally involve thousands of unselected patients, and are therefore considered to be more representative of real-world patient populations than clinical trials [11]. Furthermore, data from registries and cohorts provide valuable information on real-world treatment choices and outcomes, that reflect the patients’ perspective [10]. This makes large scale collection of PROMs an ideal data source for answering clinical research questions, but also policy-oriented research, including economic evaluation and quality of clinical care provided at different levels of the health care system [12]. Specifically, PROMs data may be used to support improved decision making and waste reduction throughout the care pathway, from initiation of therapy or choice of treatment (e.g., PROMs to support shared decision making) and ongoing clinical management (e.g., PROMs to guide changes in treatment), to reviewing clinical practice in the search for improved care delivery (e.g., PROMs as part of ongoing quality review and improvement). It is unclear whether all these areas are being addressed by the registries currently collecting these measures.
To our knowledge, no review has given an overview of the type of PROMs routinely collected in clinical practice of RA, or how these have been used. Therefore, this review aimed to identify commonly used PROMs for RA in adults routinely collected in clinical practice, and to evaluate the objectives of collecting these measures to understand the practical barriers of use of PROMs.
Section snippets
Methods
A systematic literature review was conducted to identify current registries, databases and cohorts (hereafter referred to collectively as registries) of RA patients. Investigators involved with these registries were invited to participate in a follow-up survey to: (1) investigate if PROMs were collected that were not published and (2) collect information on perceived barriers to the routine collection of PROMs.
Search results
3665 publications were identified from Medline Ovid and Embase, of which 118 (3%) were identified as duplicates (Fig. 1). A total of 3547 articles were screened by title and abstract, of which 475 (13%) were retained. Another 212 articles were excluded at the full-text screening stage due to not including PROMs (n = 91), using study designs other than observational, longitudinal or cross-sectional (n = 78), not using registry data (n = 43). 98 articles (3% of those identified) therefore met
Discussion
This systematic review provides an overview of the routine collection of PROMs in RA during the 5 years reviewed, using data from articles reporting results from observational registries. We supplemented this information with a survey of investigators of these registries. Our results show the routine collection of PROMs for RA patients is widespread, with a total of 98 studies published between 2011 and 2016, using data from 37 registries spread across 15 different countries.
We found
Conclusion
PROMs are being collected widely in rheumatology registries, however, there seems to be a discrepancy between the extent of collected PROMs and evaluated and presented PROMs in published research. PROMs data, interpreted and used appropriately, can bring improvement by addressing several aspects of waste in the current system. Rethinking the role of PROMs in rheumatology research is required and further work involving a greater variety of PROMs is needed to use this information as broadly as
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2019, Pharmacological ResearchCitation Excerpt :Although rheumatoid arthritis (RA) is a chronic, inflammatory, autoimmune disease that mainly affects the joints, [1] it may also have extra-articular consequences involving the pulmonary, nervous and cardiovascular systems [2]. Its systemic manifestations include pain, fatigue and inflammation that affect both physical and mental health, and its constitutional symptoms recorded trough patient-reported outcomes (PROs) can be used to assess the patients’ treatment responses and quality of life [3]. The pathogenesis of RA is still unclear, but it is known that it involves pro-inflammatory cytokines, particularly interleukin 6 (IL-6), [3] a pleiotropic cytokine that plays a role in the neuroendocrine system, insulin resistance, lipid metabolism, vascular disease, mitochondrial activities, and neuropsychological behaviour, and also mediates communications between the immune and central nervous system (CNS) [4].
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