First-line options for systemic juvenile idiopathic arthritis treatment: an observational study of Childhood Arthritis and Rheumatology Research Alliance Consensus Treatment Plans.

BACKGROUND: The Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed consensus treatment plans (CTPs) to compare treatment initiation strategies for systemic juvenile idiopathic arthritis (sJIA). First-line options for sJIA treatment (FROST) was a prospective observational study to assess CTP outcomes using the CARRA Registry. METHODS: Patients with new-onset sJIA were enrolled if they received initial treatment according to the biologic CTPs (IL-1 or IL-6 inhibitor) or non-biologic CTPs (glucocorticoid (GC) monotherapy or methotrexate). CTPs could be used with or without systemic GC. Primary outcome was achievement of clinical inactive disease (CID) at 9 months without current use of GC. Due to the small numbers of patients in the non-biologic CTPs, no statistical comparisons were made between the CTPs. RESULTS: Seventy-three patients were enrolled: 63 (86%) in the biologic CTPs and 10 (14%) in the non-biologic CTPs. CTP choice appeared to be strongly influenced by physician preference. During the first month of follow-up, oral GC use was observed in 54% of biologic CTP patients and 90% of non-biologic CTPs patients. Five (50%) non-biologic CTP patients subsequently received biologics within 4 months of follow-up. Overall, 30/53 (57%) of patients achieved CID at 9 months without current GC use. CONCLUSION: Nearly all patients received treatment with biologics during the study period, and 46% of biologic CTP patients did not receive oral GC within the first month of treatment. The majority of patients had favorable short-term clinical outcomes. Increased use of biologics and decreased use of GC may lead to improved outcomes in sJIA.

Optimizing the Start Time of Biologics in Polyarticular Juvenile Idiopathic Arthritis: A Comparative Effectiveness Study of Childhood Arthritis and Rheumatology Research Alliance Consensus Treatment Plans.

OBJECTIVE: The optimal time to start biologics in polyarticular juvenile idiopathic arthritis (JIA) remains uncertain. The Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed 3 consensus treatment plans (CTPs) for untreated polyarticular JIA to compare strategies for starting biologics. METHODS: Start Time Optimization of Biologics in Polyarticular JIA (STOP-JIA) was a prospective, observational, CARRA Registry study comparing the effectiveness of 3 CTPs: 1) the step-up plan (initial nonbiologic disease-modifying antirheumatic drug [DMARD] monotherapy, adding a biologic if needed, 2) the early combination plan (DMARD and biologic started together), and 3) the biologic first plan (biologic monotherapy). The primary outcome measure was clinically inactive disease according to the provisional American College of Rheumatology (ACR) criteria, without glucocorticoids, at 12 months. Secondary outcome measures included Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference and mobility scores, inactive disease as defined by the clinical Juvenile Arthritis Disease Activity Score in 10 joints (JADAS-10), and the ACR Pediatric 70 criteria (Pedi 70). RESULTS: Of 400 patients enrolled, 257 (64%) began the step-up plan, 100 (25%) the early combination plan, and 43 (11%) the biologic first plan. After propensity score weighting and multiple imputation, clinically inactive disease according to the ACR criteria was achieved in 37% of those on the early combination plan, 32% on the step-up plan, and 24% on the biologic first plan (P = 0.17). Inactive disease according to the clinical JADAS-10 (score ≤2.5) was also achieved in more patients on the early combination plan than the step-up plan (59% versus 43%; P = 0.03), as was ACR Pedi 70 (81% versus 62%; P = 0.008), but generalizability was limited by missing data. PROMIS measures improved in all groups, but without significant differences. Twenty serious adverse events were reported (mostly infections). CONCLUSION: Achievement of clinically inactive disease without glucocorticoids did not significantly differ between groups at 12 months. While there was a significantly higher likelihood of early combination therapy achieving inactive disease according to the clinical JADAS-10 and ACR Pedi 70, these results require further exploration.

Evaluation of a combined blood glucose monitoring and gaming system (Didget®) for motivation in children, adolescents, and young adults with type 1 diabetes.

The purpose of this study was to assess the performance and acceptability of a blood glucose meter coupled with a gaming system for children, adolescents, and young adults with type 1 diabetes. During an in-clinic visit, duplicate blood samples were tested by subjects (N = 147; aged 5-24 yr) and health care providers (HCPs) to evaluate the accuracy and precision of the Didget® system. Subjects' meter results were compared against Yellow Springs Instruments (YSI) reference results and HCP results using least squares regression and error grid analyses. Precision was measured by average within-subject and within-HCP coefficient of variation (CV). During the home-use component of this study, subjects (n = 58) tested their blood glucose at least two to three times daily for 3-5 d to evaluate routine use of the system. Subjects' meter results showed significant correlations with both YSI (r(2) = 0.94; p < 0.001 for regression slope) and HCP results (r(2) = 0.96; p < 0.001). Average within-subject and within-HCP CVs were 5.9 and 7.2%, respectively. Overall satisfaction was assessed by subjects, their parents or guardians, and HCP surveys. Subject satisfaction with the Didget® system was good to excellent; most subjects found the system easy to use, motivating, and helpful for building good blood glucose monitoring habits. Most HCPs agreed that the system fulfilled a need in diabetes management. In conclusion, the Didget® system was precise and clinically accurate in the hands of children, adolescents, and young adults with type 1 diabetes.

Development of a scale to measure quality of visits with relatives with dementia.

OBJECTIVES: The purpose of this study was to develop a Family Visit Scale for Dementia (FAVS-D) measuring the quality of visits between nursing home residents with dementia and their family members. DESIGN: Scale development using a two step process based on survey data. SETTING: One Veterans Administration and eleven community nursing homes. PARTICIPANTS: One hundred and fifteen family members visiting residents with dementia. MEASUREMENTS: Responses to a preliminary scale of 41 items, developed from a qualitative study, and responses to a 15 item scale, generated from the preliminary scale by eliminating items that were answered "does not apply" by a significant number of family members and by sequential iterations that removed items with low or high item total correlations or with high item-item correlations. Questionnaires were anonymously completed by family members after visit with a relative with dementia. RESULTS: Final FAVS-D has 14 item after eliminating 1 question that family members considered confusing. The mean score of FAVS-D was 18.7 + 6.6 (mean + SD) with a range of -10 to 28. After leaving out one outlier value, the distribution of FAVS-D score was not different from normal distribution. Reliability coefficient alpha for FAVS-D was 0.77. The factor analysis produced 4 factors: factor 1 (7 items, ? = .82) related to nursing staff interaction with residents and visitors, factor 2 (4 items, ? = .73) related to meaningfulness of the visit, factor 3 (2 items, ? = .85) related to cleanliness and factor 4 (1 item) related to the connection established between the visitor and the resident. There was a significant difference between total FAVS-D scores of two facilities that provided most of the questionnaires. Subscores for nursing staff and meaningfulness factors in these two facilities were also significantly different, while subscores for cleanliness and connection were similar. CONCLUSIONS: This study indicates that it is possible to measure family visit satisfaction. The most important factors of FAVS-D, are factor 1 related to nursing staff activity and explaining 25% of variance, and factor 2 related to meaningfulness of the visit and explaining 16% of variance. When the facility staff becomes more involved with families of their residents and helps them make visit more meaningful, the families feel more satisfied with the visits.

Family member perception of quality of their visits with relatives with dementia: a pilot study.

OBJECTIVE: The purpose of the investigation was to identify factors influencing quality of visits with institutionalized patients suffering from dementia. STUDY DESIGN: Two focus groups of family members of patients residing on a Dementia Special Care Unit. SETTING: Dementia Special Care Unit in a Veterans Administration Hospital. PARTICIPANTS: Spouses and adult children of institutionalized patients with dementia. INTERVENTION: During the focus group the family members were asked to identify factors that contribute to the quality of their visits with loved ones suffering from dementia. The group sessions were recorded and transcribed verbatim. Data obtained during the sessions were analyzed and specific factors affecting the visiting experience were identified. RESULTS: Numerous factors affecting the visiting experience were identified and were grouped into personal, interpersonal, and environmental domains. CONCLUSIONS: The presence of visitors in the long-term care setting is very important. Visiting provides a link with the families and communities, and promotes the quality of life for patients with dementia. Satisfying experience during the visits helps the families to enjoy the interaction and promotes their involvement with their institutionalized relatives. Health care providers should make efforts to improve the quality of visits.

Effects of continuous activity programming on behavioral symptoms of dementia.

OBJECTIVES: To describe the effect of continuous activity programming on behavioral symptoms of dementia. DESIGN: Observational study based on quality improvement data. SETTING: Two Dementia Special Care Units in different locations. PARTICIPANTS: Ninety veterans with dementia provided with long-tem care. INTERVENTION: Continuous activity programming. MEASUREMENTS: Data were extracted from the MDS files and obtained by questionnaires filled out by staff members not involved in activity programming. RESULTS: Two settings of continuous activity programming, requiring no additional staffing, resulted in increased number of hours residents were involved in activities, decreased use of psychotropic medications, improved nutrition, and increased family satisfaction without additional staff. When additional staff was available, more intensive continuous activity programming further decreased agitation and improved sleep. CONCLUSION: Continuous activity programming may be instituted without staffing change but the benefit is increased if additional staffing is available.