Randomized trials have demonstrated the efficacy of patient decision aids to facilitate shared decision making in clinical situations with multiple medically reasonable options for treatment. ...However, little is known about how best to implement these tools into routine clinical practice. In addition, reliable implementation of decision aids has been elusive and spread within pediatrics has been slow. We sought to develop and reliably implement a decision aid for treatment of children with juvenile idiopathic arthritis.
To design our decision aid, we partnered with patient, parent, and clinician stakeholders from the Pediatric Rheumatology Care and Outcomes Improvement Network. Six sites volunteered to use quality improvement methods to implement the decision aid. Four of these sites collected parent surveys following visits to assess outcomes. Parents reported on clinician use of the decision aid and the amount of shared decision making and uncertainty they experienced. We used chi-square tests to compare eligible visits with and without use of the decision aid on the experience of shared decision making and uncertainty.
After 18 rounds of testing and revision, stakeholders approved the decision aid design for regular use. Qualitative feedback from end-users was positive. During the implementation project, the decision aid was used in 35% of visits where starting or switching medication was discussed. Clinicians used the decision aid as intended in 68% of these visits. The vast majority of parents reported high levels of shared decision making following visits with (64/76 = 84%) and without (80/95 = 84%) use of the decision aid (p = 1). Similarly, the vast majority of parents reported no uncertainty following visits with (74/76 = 97%) and without (91/95 = 96%) use of the decision aid (p = 0.58).
Although user acceptability of the decision aid was high, reliable implementation in routine clinical care proved challenging. Our parsimonious approach to outcome assessment failed to detect a difference between visits with and without use of our aid. Innovative approaches are needed to facilitate use of decision aids and the assessment of outcomes.
Healthcare providers were rapidly forced to modify the way they practiced medicine during the coronavirus disease 2019 (COVID-19) pandemic. Many providers transitioned from seeing their patients in ...person to virtually using telemedicine platforms with limited training and experience using this medium. In pediatric rheumatology, this was further complicated as musculoskeletal exams typically require hands-on assessment of patients. The objective of this study was to examine the adoption of telemedicine into pediatric rheumatology practices, to assess its benefits and challenges, and to gather opinions on its continued use. A survey was sent to the lead representatives of each Pediatric Rheumatology Care and Outcomes Improvement Network (PR-COIN) site to collect data about their center's experience with telemedicine during the COVID-19 pandemic. Quantitative data were analyzed using descriptive statistics, and qualitative data were thematically analyzed. Responses were received from the majority 19/21 (90%) of PR-COIN sites. All respondents reported transitioning from in-person to primarily virtual patient visits during the COVID-19 pandemic. All centers reported seeing both new consultations and follow-up patients over telemedicine. Most centers reported using both audio and video conferencing systems to conduct their telemedicine visits. The majority of respondents 13/19 (68%) indicated that at least 50% of their site's providers consistently used pediatric Gait Arms Legs and Spine (pGALS) to perform active joint count assessments over telemedicine. Over half of the centers 11/19 (58%) reported collecting patient-reported outcomes (PROs), but the rate of reliably documenting clinical components varied. A few sites 7/19 (37%) reported performing research-related activity during telemedicine visits. All centers thought that telemedicine visits were able to meet providers' needs and support their continued use when the pandemic ends. Benefits reported with telemedicine visits included convenience and continuity of care for families. Conversely, challenges included limited ability to perform physical exams and varying access to technology. Pediatric rheumatology providers were able to transition to conducting virtual visits during the COVID-19 pandemic. Healthcare providers recognize how telemedicine can enhance their practice, but challenges need to be overcome in order to ensure equitable, sustainable delivery of quality and patient-centered care.
The translation of research findings into clinical practice is challenging, especially fields like in pediatric rheumatology, where the evidence base is limited, there are few clinical trials, and ...the conditions are rare and heterogeneous. Implementation science methodologies have been shown to reduce the research- to- practice gap in other clinical settings may have similar utility in pediatric rheumatology. This paper describes the key discussion points from the inaugural Childhood Arthritis and Rheumatology Research Alliance Implementation Science retreat held in February 2020. The aim of this report is to synthesize those findings into an Implementation Science Roadmap for pediatric rheumatology research. This roadmap is based on three foundational principles: fostering curiosity and ensuring discovery, integration of research and quality improvement, and patient-centeredness. We include six key steps anchored in the principles of implementation science. Applying this roadmap will enable researchers to evaluate the full range of research activities, from the initial clinical design and evidence acquisition to the application of those findings in pediatric rheumatology clinics and direct patient care.
To describe protocol adaptations to the Fibromyalgia Integrative Training for Teens (FIT Teens) randomized controlled trial in response to the COVID-19 pandemic. The overarching aims of the FIT Teens ...multi-site 3-arm comparative effectiveness trial are to assess whether a specialized neuromuscular exercise training intervention combined with cognitive-behavioral therapy (CBT) is superior to CBT alone or graded aerobic exercise alone.
The trial was originally designed as an in-person, group-based treatment with assessments at baseline, mid- and post-treatment, and four follow-up time points. The original study design and methodology was maintained with specific modifications to screening, consenting, assessments, and group-based treatments to be delivered in remote (telehealth) format in response to COVID-19 restrictions.
Study enrollment was paused in March 2020 for five months to revise operations manuals, pilot remote treatment sessions for accuracy and fidelity, complete programming of REDCap assent/consent and assessment materials, train study staff for new procedures and obtain regulatory approvals. The trial was relaunched and has been successfully implemented in remote format since July 2020. Trial metrics thus far demonstrate a consistent rate of enrollment, strong attendance at remote treatment sessions, high retention rates and high treatment fidelity after protocol adaptations were implemented.
Preliminary findings indicate that FIT Teens protocol adaptations from in-person to remote are feasible and allowed for sustained enrollment, retention, and treatment fidelity comparable to the in-person format. Methodologic and statistical considerations resulting from the adaptations are discussed as well as implications for interpretation of results upon completion of the trial.
NCT 03268421.
To determine the frequency of laboratory abnormalities with methotrexate (MTX) use in patients with juvenile idiopathic arthritis (JIA); to identify potential risk factors for MTX toxicity requiring ...medical interventions; and to compare the frequency of liver function abnormalities in patients treated with MTX to those not treated with MTX.
Results of MTX surveillance laboratory testing (SLT) available in clinical databases were reviewed for 588 children with JIA. Information on demographics, JIA features, and factors previously associated with increased frequency of SLT abnormalities was obtained.
Results of SLT performed in at least 4-month intervals were available for 138 JIA patients whose JIA was not treated with MTX, and for 198 JIA patients treated with MTX plus folic acid. On SLT of the MTX-treated patients, there were 44 of 2650 (1.7%) AST tests and 90 of 2647 (3.4%) ALT tests that exceeded 2 times the upper limit of normal (> 2 ULN) in 30 children (15%). AST or ALT tests at > 2 ULN occurred more often with systemic JIA (p = 0.04), macrophage activation syndrome, during infections, in systemic antibiotic use, and after intensifying JIA drug regimens. AST or ALT results at > 2 ULN were as frequent among MTX-treated children as those not treated with MTX. Renal and hematological abnormalities with MTX were uncommon.
Liver enzyme abnormalities > 2 ULN are rare in JIA, irrespective of MTX exposure. These data suggest that the adult standard of SLT every 4-8 weeks may not be necessary in children treated with MTX, especially if certain risk factors are absent.
Initial benchmarking of childhood-onset systemic lupus erythematosus (cSLE) quality indicators revealed suboptimal performance across multiple centers. Our aim was to improve cardiovascular and bone ...health screenings at a tertiary treatment center for cSLE. This included annual measurements of vitamin D, lipid profiles, and bone mineral density through dual-energy x-ray absorptiometry (DXA).
Quality improvement methodology was applied to design and implement a standardized previsit planning process to electronically entered and saved orders for needed screenings prior to a scheduled clinic visit. Process outcomes were measured using statistical process control charts. Univariate analyses were completed to assess patient-level factors.
During the study, 123 patients with cSLE participated across 619 clinic visits. The percentage of patients with completed screenings improved from 54% to 92% for annual vitamin D, 55% to 84% for annual lipid profiles, and 57% to 78% for DXA, which was sustained for more than 1 year. Providers responded to a majority of abnormal results, and improvement in the average vitamin D level was observed over time. Higher levels of disease activity, damage, number of clinic visits, and screenings completed at baseline were observed in patients with all screenings completed at the end of the intervention.
Implementation of elements of the chronic illness care model for cSLE management improved performance of cardiovascular and bone health screenings, a step toward preventing longterm morbidity in cSLE. Our study also suggests that more patient interaction with the healthcare system may promote successful completion of health maintenance screenings.
In a cohort of 70 patients with childhood-onset systemic lupus erythematosus (cSLE): to determine the baseline adherence to medications and visits; to investigate the effects of cellular text ...messaging reminders (CTMR) on adherence to clinic visits; and to study the influence of CTMR on adherence to use of hydroxychloroquine (HCQ).
CTMR were sent to 70 patients prior to clinic visits for 14 months. A subgroup of patients were evaluated for medication adherence to HCQ: 19 patients receiving CTMR prior to each scheduled HCQ dose were compared to 22 patients randomized to standard of care education about HCQ. Visit adherence was measured using administrative databases. Pharmacy refill information, self-report of adherence, and HCQ blood levels were utilized to monitor medication adherence to HCQ. Sufficient adherence to visits or HCQ was defined as estimates > 80%. Disease activity was primarily monitored with the Systemic Lupus Erythematosus Disease Activity Index.
At baseline, 32% of patients were sufficiently adherent to HCQ, and 81% to clinic visits. Visit adherence improved significantly by > 80% among those who were nonadherent to clinic visits at the baseline CTMR (p = 0.01). CTMR did not influence adherence to HCQ over time.
Patients with cSLE were only modestly adherent to HCQ and clinic visits. CTMR may be effective for improving visit adherence among adolescents and young adults with cSLE, but it does not improve adherence to HCQ.
Objective
To measure agreement among raters when scoring the physician/provider global assessment (PGA) of disease activity in patients with juvenile idiopathic arthritis (JIA) with no apparent ...disease activity, and to identify clinical and laboratory parameters that most strongly influence provider scoring of the PGA.
Methods
Profiles of clinical and laboratory findings from 20 patients with JIA with no apparent disease activity were given to 51 providers, who were asked to score the PGA using a 21‐circle visual analog scale (range 0–10). Following initial scoring, providers discussed each profile and reasons for assigning the score given, and then were asked to rescore each profile. Providers were asked to list variables that influenced their scoring most strongly. Using a mixed‐model approach, the intraclass correlation coefficient (ICC) of the final scores served as the measure of concordance.
Results
A total of 504 PGA scores were obtained. The overall ICC of the initial scores was 0.18. Thus, 18% of nonconcordance of the scores was attributable to patient differences, while 82% was due to provider variation. Variables that influenced scoring most strongly were (in order of frequency) presence of pain, questionable temporomandibular joint involvement, loss of joint motion, presence of any morning stiffness, psoriasis, and past history of uveitis.
Conclusion
The low ICC suggests poor agreement among providers scoring the PGA in JIA patients with low or no disease activity. Given the ubiquitous use of the PGA in classification and response criteria for JIA and other pediatric rheumatic diseases, substantive efforts are needed to bring about greater uniformity in scoring of global disease activity by providers.
Treat to target (T2T) is a strategy of adjusting treatment until a target is reached. An international task force recommended T2T for juvenile idiopathic arthritis (JIA) treatment. Implementing T2T ...in a standard and reliable way in clinical practice requires agreement on critical elements of (1) target setting, (2) T2T strategy, (3) identifying barriers to implementation, and (4) patient eligibility. A consensus conference was held among Pediatric Rheumatology Care and Outcomes Improvement Network (PR-COIN) stakeholders to inform a statement of understanding regarding the PR-COIN approach to T2T.
PR-COIN stakeholders including 16 healthcare providers and 4 parents were invited to form a voting panel. Using the nominal group technique, 2 rounds of voting were held to address the above 4 areas to select the top 10 responses by rank order.
Incorporation of patient goals ranked most important when setting a treatment target. Shared decision making (SDM), tracking measurable outcomes, and adjusting treatment to achieve goals were voted as the top elements of a T2T strategy. Workflow considerations, and provider buy-in were identified as key barriers to T2T implementation. Patients with JIA who had poor prognostic factors and were at risk for high disease burden were leading candidates for a T2T approach.
This consensus conference identified the importance of incorporating patient goals as part of target setting and of the influence of patient stakeholder involvement in drafting treatment recommendations. The network approach to T2T will be modified to address the above findings, including solicitation of patient goals, optimizing SDM, and better workflow integration.
Objective
To describe the selection, development, and implementation of quality measures (QMs) for juvenile idiopathic arthritis (JIA) by the Pediatric Rheumatology Care and Outcomes Improvement ...Network (PR‐COIN), a multihospital learning health network using quality improvement methods and leveraging QMs to drive improved outcomes across a JIA population since 2011.
Methods
An American College of Rheumatology–endorsed multistakeholder process previously selected initial process QMs. Clinicians in PR‐COIN and parents of children with JIA collaboratively selected outcome QMs. A committee of rheumatologists and data analysts developed operational definitions. QMs were programmed and validated using patient data. Measures are populated by registry data, and performance is displayed on automated statistical process control charts. PR‐COIN centers use rapid‐cycle quality improvement approaches to improve performance metrics. The QMs are revised for usefulness, to reflect best practices, and to support network initiatives.
Results
The initial QM set included 13 process measures concerning standardized measurement of disease activity, collection of patient‐reported outcome assessments, and clinical performance measures. Initial outcome measures were clinical inactive disease, low pain score, and optimal physical functioning. The revised QM set has 20 measures and includes additional measures of disease activity, data quality, and a balancing measure.
Conclusion
PR‐COIN has developed and tested JIA QMs to assess clinical performance and patient outcomes. The implementation of robust QMs is important to improve quality of care. PR‐COIN's set of JIA QMs is the first comprehensive set of QMs used at the point‐of‐care for a large cohort of JIA patients in a variety of pediatric rheumatology practice settings.
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