Dataset Information

Which patient reported outcome domains are important to the rheumatologists while assessing patients with rheumatoid arthritis?

ABSTRACT:

Background

Patient-reported outcomes (PROs) aid in rheumatoid arthritis (RA) management, but it is not well understood which measures would be most relevant to the rheumatologists for making treatment decisions.

Methods

We recruited rheumatologists nationally to participate in moderated structured group teleconference discussions using the nominal group technique. Participants in each group generated lists of the elements from patient's history and signs that they use to make treatment recommendations for RA. Each participant then selected the three most important elements from the generated list. The results of each group were then combined and summarized.

Results

Twenty-five rheumatologists participated in 4 groups (group size ranged from 4 to 8) and 150 available ranking votes across all groups. The statements generated across the 4 groups were categorized into 13 topics (including symptoms, physical function, comorbidities, social aspects, physical findings, response to treatment, treatment adherence, pain management, side effects, tests, access to care, contraception, and organ involvement), 10 of which received ranking votes. Symptoms received the highest ranking (46% of votes), followed by physical function (16%), and physical findings (13%). Among the unranked topics, social aspects had the highest number of statements (8 statements).

Conclusion

Rheumatologists highly valued patient-reported RA symptoms and physical function to inform their treatment decisions, even above objective data such as physical findings and test results. These results can guide the selection of validated PRO measures to assess these domains to inform the clinical care of patients with rheumatoid arthritis.

SUBMITTER: Jagpal A

PROVIDER: S-EPMC6727422 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Which patient reported outcome domains are important to the rheumatologists while assessing patients with rheumatoid arthritis?

Jagpal Aprajita A O'Beirne Ronan R Morris Melanie S MS Johnson Bernadette B Willig James J Yun Huifeng H Cherrington Andrea L AL Fraenkel Liana L Curtis Jeffrey R JR Safford Monika M MM Navarro-Millán Iris I

BMC rheumatology 20190905

<h4>Background</h4>Patient-reported outcomes (PROs) aid in rheumatoid arthritis (RA) management, but it is not well understood which measures would be most relevant to the rheumatologists for making treatment decisions.<h4>Methods</h4>We recruited rheumatologists nationally to participate in moderated structured group teleconference discussions using the nominal group technique. Participants in each group generated lists of the elements from patient's history and signs that they use to make trea ...[more]

PMID: 31517249

Similar Datasets

Project description:IntroductionAs the therapeutic landscape for rheumatoid arthritis (RA) continues to change, it is relevant to examine current treatment patterns among rheumatologists. The purpose of this study was to identify attitudes and practices of US rheumatologists with respect to RA.MethodsNine-hundred and one US-practicing rheumatologists were sent electronic invites (via email or fax) to participate in a case-vignette survey in April 2013. All respondents were currently practicing rheumatology and seeing at least one RA patient per week. The survey examined current attitudes, existing knowledge, management choices and perceived barriers in the management of RA. Data collection stopped once 125 responses were received.ResultsApproximately half of the 125 respondents were very familiar with current clinical practice guidelines for RA diagnosis and management. There was no consensus on which validated tools to use when assessing RA severity, with 54% using Physician Global Assessment and 34% using Disease Activity Score 28 at initial assessment. Most respondents (74%) used methotrexate (MTX) as initial therapy for a newly diagnosed RA patient. Eighty-six percent of respondents would add a tumor necrosis factor inhibitor (TNFi) when MTX alone could not control RA. There was no consensus on which treatment should be used when a TNFi is ineffective. The majority of respondents (66% of respondents) would prescribe TNFis indefinitely in patients with continued response. If a patient was in stable remission on MTX and a TNFi, respondents were most likely to maintain this regimen (53% of respondents); a notable minority (43%) would lower the MTX dose. When prescribing biologics, respondents were most concerned with infection; infection was considered a very significant barrier to biologic use. Although 98% of respondents indicated that they personally educate patients about RA, only 42% provide written material.ConclusionsThe lack of consistency in responses suggests that rheumatologists may benefit from continuing medical education on; clinical practice guidelines; the most recent evidence for management of patients in remission; the use of biologic agents after infection; and management of patients with RA and comorbidities.

Project description:OBJECTIVE:This article reviews and compares four commonly used approaches to assess patient responsiveness with a treatment or therapy (return to normal (RTN), minimal important difference (MID), minimal clinically important improvement (MCII), OMERACT-OARSI [Outcome Measures in Rheumatology-Osteoarthris Reseach Society International] (OO)) and demonstrates how each of the methods can be formulated in a multilevel modelling (MLM) framework. DESIGN:Cohort study. SETTING:A cohort of patients undergoing total hip and knee replacement were recruited from a single UK National Health Service hospital. POPULATION:400 patients from the Arthroplasty Pain Experience cohort study undergoing total hip (n=210) and knee (n=190) replacement who completed the Intermittent and Constant Osteoarthritis Pain questionnaire prior to surgery and then at 3, 6 and 12 months after surgery. PRIMARY OUTCOMES:The primary outcome was defined as a response to treatment following total hip or knee replacement. We compared baseline scores, change scores and proportion of individuals defined as 'responders' using traditional and MLM approaches with patient responsiveness. RESULTS:Using existing approaches, baseline and change scores are underestimated, and the variance of baseline and change scores overestimated in comparison with MLM approaches. MLM increases the proportion of individuals defined as responding in RTN, MID and OO criteria compared with existing approaches. Using MLM with the MCII criteria reduces the number of individuals identified as responders. CONCLUSION:MLM improves the estimation of the SD of baseline and change scores by explicitly incorporating measurement error into the model and avoiding regression to the mean when making individual predictions. Using refined definitions of responsiveness may lead to a reduction in misclassification when attempting to predict who does and does not respond to an intervention and clarifies the similarities between existing methods.

Project description:BACKGROUND:Rheumatoid arthritis (RA) is associated with significantly diminished health-related quality of life. Patient-reported outcomes (PROs) are considered important in RA; however, some symptoms such as morning joint stiffness (MJS) and fatigue that are considered important by patients are not captured by the American College of Rheumatology "core set" measures for RA trials. The US Food and Drug Administration has endorsed electronic capture of clinical trial data including PROs, and electronic PRO (ePRO) systems may lead to more accurate and complete data capture, improved compliance, and patient acceptance compared with paper-based methods. Our objective was to assess the implementation of ePRO measures of Duration and Severity of MJS, Severity of Worst Tiredness, and Severity of Worst Joint Pain in baricitinib RA-BEAM and RA-BUILD phase 3 randomized clinical trials (RCTs). METHODS:A daily electronic diary (handheld device; Invivodata®, Inc.) was utilized to capture PRO data in the RCTs. Three "reporting window" options were incorporated to accommodate differences in patients' routine daily schedules, and alarms were programmed for each reporting window. Duration of MJS was recorded in "hours and minutes," and Severity of MJS, Worst Tiredness, and Worst Joint Pain were captured on a 0 to 10 rating scale, with a higher score indicating more severe symptoms. The patients and site staff were trained to use the daily electronic diary. RESULTS:Patients with moderately to severely active RA used the daily electronic diary in the RA-BEAM study (N?=?1305) and RA-BUILD study (N?=?684). The average compliance, calculated as total days completed by patients compared with total days expected to complete the diary, through Week 12 was high (RA-BEAM 94% patients; RA-BUILD 93% patients), potentially attributable to appropriate training, clarity of instructions, simple user interface, and electronic device design. Identified process challenges included non-timely issuance of the device, low battery, inadequate training of patients before data collection, inappropriate diary set-up, and first response entry 1?day after the baseline visit. CONCLUSIONS:High compliance rates support the use of the daily electronic PRO diary in large RCTs. Despite the anticipated issues, the daily electronic diary is expected to reduce recall bias and improve the quality of PRO data collection. TRIAL REGISTRATION:RA-BEAM ( NCT01710358 ) and RA-BUILD ( NCT01721057 ).

Dataset Information

Which patient reported outcome domains are important to the rheumatologists while assessing patients with rheumatoid arthritis?

Background

Methods

Results

Conclusion

Publications

Which patient reported outcome domains are important to the rheumatologists while assessing patients with rheumatoid arthritis?

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure