Core Set Of Measures Research Articles

Telitacicept add-on therapy in refractory idiopathic inflammatory myopathy: insights from a pilot study.

This study aimed to evaluate the therapeutic efficacy of telitacicept based on the conventional treatment in adults with idiopathic inflammatory myopathy (IIM), focusing on its impact on clinical manifestations. IIM patients who had been treated with telitacicept for at least 3 months based on the conventional treatment from January 2023 to January 2024 were included in this study. The clinical response to telitacicept was determined based on the ACR/EULAR criteria for minimal, moderate, and major improvement in the total improvement score (TIS). Disease activity was monitored using Core Set Measures (CSMs), while myositis damage was assessed with established assessment tools. The Manual Muscle Test assessed the muscle performance for 8 muscle groups (MMT-8). A total of 11 patients administered with telitacicept (160 mg per week) were included in this study. Post-treatment assessments revealed improvements in all patients according to ACR/EULAR criteria. Notably, there was a significant reduction in the prednisone dosage from baseline to last visit (27.05 ± 12.47 mg to 12.05 ± 7.32 mg; p< 0.005). Enhancements were observed in MMT-8 scores improved (from 109.18 ± 14.18-137.64 ± 15.28; p< 0.005) and in the reduction of creatine kinase (CK) levels (from 2670.27 ± 2675.00 U/l to 561.09 ± 754.09; p< 0.05). Telitacicept demonstrated effectiveness in treating refractory inflammatory myopathy, contributing to a significant reduction in steroid dosage among the patients. These findings highlight the potential of telitacicept as a valuable therapeutic option in the management of IIM.

Performance and trend of core measures among oral cancer patients: A population-based cohort study

Abstract Objectives This study explores the performance and trend of core measures, which were established as evidence-based indicators to assess and improve the quality of care for oral cancer patients. Methods This retrospective cohort study uses the National Health Insurance Research Database (NHIRD), Taiwan Cancer Registry, and Cause of Death Statistics, provided by the Health and Welfare Data Science Center (HWDC), Ministry of Health and Welfare (MOHW). The study population was adult patients hospitalized for oral cancer surgery with stage I-IV between 2014 and 2021. The trend tests and the generalized linear mixed model (GLMM) were applied. Results A total of 23392 oral cancer patients were enrolled. The core measure set used in this study included five indicators (two process-related and three outcome-related indicators). Process indicators’ mean achievement rates significantly increased from 82.6% to 85.7% (p = 0.018, trend test). On the other hand, most patients demonstrated good achievement rates to the outcome indicators (98.9% to 99.3%) (p = 0.218, trend test). Overall indicators’ 100% achievement rate increased over time from 62.9% in 2014 to 66.2% in 2021 (p &amp;lt; 0.001, trend test). Subgroup analyses were performed by age, stage, and comorbidity score. The analysis of the GLMM revealed that the 100% achievement to overall indicators was positively associated with age&amp;lt;45, not-low socioeconomic status, body mass index ≥ 24, squamous cell carcinoma, recent treatment year, treated with surgery only, negative surgical margins, and receiving care in a high-volume hospital (all p &amp;lt; 0.01). Conclusions The results highlight a significant measurable improvement in the quality of oral cancer care. However, there is still room for enhancement in process indicator performance. Key messages • The results highlight a significant measurable improvement in the quality of oral cancer care. • There is still room for enhancement in process indicator performance.

Increased Cytokine Levels in Seronegative Myositis: Potential Th17 Immune Response Implications

Th17 cells are known for producing IL-17 and their role in the pathogenesis of various autoimmune diseases, including myositis. Likewise, the participation of the IL-23/IL-17 pathway in autoimmunity has been confirmed. In this study, we aimed to evaluate the behavior of cytokines in myositis, focusing on the autoantibodies profile and the myositis core set measures. Twenty-five myositis patients were enrolled in this cross-sectional study. An expert rheumatologist evaluated the myositis core set measures. Serum levels of cytokines and chemokines were quantified using the LEGENDplex Multi-Analyte Flow Assay Kit from BioLegend. The autoantibodies detection was carried out using the line-blot assay kit Euroline: Autoimmune Inflammatory Myopathies from EUROIMMUN. We found higher serum levels of IL-33, CXCL8, IL-6, IL-23, and IL-12p70 in seronegative patients. A multiple linear regression analysis revealed that MYOACT scores could be predicted by the increment of IL-23 and the decrement of CCL2, IL-10, and CXCL8 serum levels. These findings suggest that the immune response in seronegative myositis patients exhibits an IL-23-driven Th17 immune response. The relevance of this discovery lies in its potential therapeutic implications. Insights into the IL-23-driven Th17 immune response in seronegative patients highlight the potential for targeted therapies aimed at modulating Th17 activity.

High-intensity resistance training improves quality of life, muscle endurance and strength in patients with myositis: a randomised controlled trial

Myositis is associated with reduced quality of life, which is accompanied by significant impairments in muscle endurance and strength, altogether representing cardinal traits in patients with myositis. This randomised controlled trial aimed to investigate the effect of high-intensity resistance training on quality of life in patients with myositis. Thirty-two patients with established, stable myositis were randomised to 16 weeks of high-intensity resistance training (intervention group) or 16 weeks of usual care (control group). Primary outcome was quality of life assessed as the change in the physical component summary score (PCS) of the Short Form-36 health questionnaire from baseline to post-intervention. Secondary outcomes included functional capacity measures, such as functional index 3, and International Myositis Assessment and Clinical Studies Group (IMACS) disease activity and damage core set measures, including manual muscle testing 8 (MMT8). The primary outcome PCS showed an improvement in favour of high-intensity resistance training with a between-group difference of 5.33 (95% CI 0.61; 10.05) (p = 0.03). Additionally, functional index 3 showed a between-group difference indicating greater gains with high-intensity resistance training 11.49 (95% CI 3.37; 19.60) (p = 0.04), along with a between-group improvement in MMT8 1.30 (95% CI 0.09; 2.51) (p = 0.04). High-intensity resistance training for 16 weeks effectively improved quality of life in patients with myositis. Clinical measures of muscle endurance and muscle strength were also found to improve with high-intensity resistance training, while patients stayed in disease remission. Consequently, progressively adjusted high-intensity resistance training is feasible and causes no aggravation of the disease, while benefitting patients with myositis.Clinical trial registration: Clinicaltrials.gov ID: NCT04486261—https://clinicaltrials.gov/study/NCT04486261.

The impact of pain on daily activities in patients with idiopathic inflammatory myopathies: Report from the OMERACT myositis working group

BackgroundInternational focus groups with patients with idiopathic inflammatory myopathies (IIM) conducted by the OMERACT Myositis Working Group over the years demonstrated the pain as an important symptom experienced by these patients. In this study, we aimed to examine the frequency and degree of pain interference, the aspects of daily life impacted by pain, and the factors associated with pain interference in adults with IIM. MethodsThis was a prospective observational study with two visits. The patients who fulfilled the probable/definite IIM (ACR/EULAR Myositis Classification Criteria) were enrolled. Pain interference was assessed with PROMIS pain interference form (6a). Myositis core set measures and PROMIS fatigue (7a) and physical function (8b) were obtained at both visits. Logistic regression and linear mixed models were performed to assess the association between pain interference and other parameters. ResultsA total of 129 patients with IIM (60 % females) were recruited from U.S., South Korea, Netherlands, Sweden, and Australia. Approximately 71 % reported pain interference. The patients in the greater pain interference group were more likely to be female, had significantly worse patient/physician global disease activity, fatigue, and physical function than those in the lower pain interference group. The most commonly impacted life aspect was household chores. Manual muscle testing, patient/physician global disease activity, fatigue, and physical function were all significantly associated with pain interference score >60. ConclusionThe majority of the patients with IIM experience the impact of pain on their daily activities, particularly household chores. Myositis disease activity, duration, and subtype could be associated with greater pain interference.

Developing evaluation measures for health departments sharing and linking HIV and STI surveillance data

Enhancing data sharing, quality, and use across siloed HIV and STI programs is critical for national and global initiatives to reduce new HIV infections and improve the health of people with HIV. As part of the Enhancing Linkage of STI and HIV Surveillance Data in the Ryan White HIV/AIDS Program initiative, four health departments (HDs) in the U.S. received technical assistance to better share and link their HIV and STI surveillance data. The process used to develop evaluation measures assessing implementation and outcomes of linking HIV and STI data systems involved six steps: 1) measure selection and development, 2) review and refinement, 3) testing, 4) implementation and data collection, 5) data quality review and feedback, and 6) dissemination. Findings from pilot testing warranted slight adaptations, including starting with a core set of measures and progressively scaling up. Early findings showed improvements in data quality over time. Lessons learned included identifying and engaging key stakeholders early; developing resources to assist HDs; and considering measure development as iterative processes requiring periodic review and reassessment to ensure continued utility. These findings can guide programs and evaluations, especially those linking data across multiple systems, in developing measures to track implementation and outcomes over time.

P127 Comparison of the Efficacy, Safety and Immunogenicity of a Proposed Biosimilar MSB11456 with Tocilizumab Reference Product in Moderate-to-Severe Rheumatoid Arthritis: Results of a Randomized Double-Blind Study

Abstract Background/Aims Tocilizumab is an anti-interleukin-6 receptor monoclonal antibody indicated for treating rheumatoid arthritis (RA) and other inflammatory diseases. MSB11456 is a proposed biosimilar to US-licensed tocilizumab and EU-approved tocilizumab. It has already shown equivalent pharmacokinetic, pharmacodynamic safety, tolerability, and immunogenicity profiles to these products given subcutaneously (SC) as a single dose in healthy volunteers. This Phase III, multi-centre, randomised, double-blind, multiple fixed-dose, parallel group study compared efficacy, safety and immunogenicity of MSB11456 and EU-approved tocilizumab administered SC in moderate-to-severe RA patients. Methods Patients were randomised to 162mg MSB11456 or EU-approved tocilizumab for 24 weeks (W). At W24, patients receiving EU-approved tocilizumab were re-randomised to continue treatment or switch to MSB11456 for up to W52. Safety evaluations were conducted up to W63. A change from baseline in Disease Activity Score-28 Joint Count-ESR (DAS28-ESR) at W24 was analysed, as the primary efficacy endpoint, using analysis of covariance to determine the least squares mean (LSM) difference between MSB11456 and EU-approved tocilizumab; equivalence was considered if the 90% confidence interval (CI) was entirely within the FDA equivalence interval -0.6 to 0.5. Secondary endpoints were 20% improvement in ACR core set measures at W24 and DAS28-ESR at W12. Additional endpoints included ACR50/70, change in DAS28-CRP, Simplified and Clinical Disease Activity Indexes, evaluation of immunogenicity up to W55 and safety up to W63. Results Clinically relevant LSM decreases from baseline in DAS28-ESR were observed from W2 up to W24 with both treatments. The 90% CI for LSM difference in the change from baseline in DAS28-ESR between treatments was fully included within the predefined equivalence interval, which demonstrated therapeutic equivalence of MSB11456 and EU-approved tocilizumab (Table 1). Other efficacy endpoint analyses supported this conclusion. No discernible patterns in the nature or frequency of treatment-emergent adverse events (TEAEs) were identified to suggest a difference between drugs. Anti-drug antibodies incidence was similar among treatment arms. Switching from EU-approved tocilizumab to MSB11456 had no clinically relevant impact on efficacy or safety. Conclusion Equivalent efficacy, immunogenicity and safety profiles of MSB11456 and EU-approved tocilizumab were demonstrated in moderate-to-severe RA patients, confirming equivalence between MSB11456 and the EU-approved tocilizumab. Disclosure A. Zubrzycka-Sienkiewicz: None. M. Misterska-Skora: None. M. Socik-Pojawa: None. K. Klama: None. M. Ullman: Other; Employee of Fresenius Kabi SwissBioSim - Sponsor of the study. C. Petit-Frere: Other; Employee of Fresenius Kabi SwissBioSim - Sponsor of the study. A. Illes: Other; Employee of Fresenius Kabi SwissBioSim - Sponsor of the study. P. Baker: Other; Employee of Fresenius Kabi SwissBioSim - Sponsor of the study. J. Monnet: Other; Employee of Fresenius Kabi SwissBioSim - Sponsor of the study. J. Morais: Other; Employee of Fresenius Kabi SwissBioSim - Sponsor of the study. J. Brzezicki: None.

E059 Identifying the associations between anxiety/depression and disease activity in idiopathic inflammatory myopathy

Abstract Background/Aims Idiopathic inflammatory myopathy (IIM) is characterised by myositis, which can impact activities of daily living. The 2022 BSR IIM management guideline recommends assessing/managing factors associated with poor mental wellbeing and quality of life. Research into anxiety and depression associated with IIM is limited. This study aims to investigate associations between anxiety/depression and IIM disease activity. Methods The MYOPROSP study recruited UK adults with verified IIM throughout a 36 month period between 2016 and 2020. Patient questionnaires were collected at three, six, and 12 months. Participants completed the EQ-5D-5L questionnaire, which includes a question relating to anxiety and depression with five possible responses: “I am (not/slightly/moderately/severely/extremely) anxious or depressed”. The cohort was divided by response to the EQ-5D-5L anxiety/depression question at the time of recruitment. Disease activity was assessed using International Myositis Assessment &amp; Clinical Studies Group (IMACS) Disease Activity Core Set Measures (see Table 1) and summarised across each EQ-5D-5L anxiety/depression group. The EQ-5D-5L visual analogue scale (VAS) relating to “overall health” (higher values correspond to better health) this value was summarised across each EQ-5D-5L anxiety/depression group. Only participants with complete data at recruitment were included in analysis. One-way ANOVA was performed to determine statistical significance (p &amp;lt; 0.05) of each IMACS Disease Activity Core Set Measure and EQ-5D-5L VAS across anxiety/depression groups. Results Complete data on 35 participants (71% female) was collected. All participants reported to have no, slight, or moderate anxiety/depression (i.e. no participant reported severe or extreme anxiety/depression) (Table 1). The “not anxious/depressed” group demonstrated higher EQ-5D VAS values (reflecting better perceived health), shorter disease duration, and higher CK levels, compared to groups with “slight” and “moderate” anxiety/depression. All other investigated variables did not consistently vary across anxiety/depression groups. One-way ANOVA identified that only disease duration and EQ-5D VAS were significantly associated with EQ-5D-5L anxiety/depression group. Conclusion Anxiety and depression are associated with longer disease duration and poorer overall health in adults with IIM. These findings suggest that anxiety/depression in adults with IIM may be due to sustained muscle damage and resulting impacts upon activities of daily living and quality of life, rather than disease activity. Disclosure N.Z. Aziz: None. A. Oldroyd: None. F. Bozan: None. X. Lyu: None. J.A. Lamb: None. P. Gordon: None. D.A. Isenberg: None. N. McHugh: None. H. Gunawardena: None. P. Kiely: None. P.M. Machado: Consultancies; PMM has received consulting/speaker’s fees from Abbvie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB. J. Miller: None. S. Tansley: None. A. Bharadwaj: None. R. Laxminarayan: None. N. Jordan: None. C. Yee: None. D. Makkuni: None. J. Taylor: None. P.C. Lanyon: Consultancies; PCL has received consultancy fees from Pfizer. Grants/research support; PCL has received research grants, speaker fees and conference attendance support from CSL Vifor. V.H. Ong: None. A. Prabu: None. M. Akil: None. K.M. Douglas: None. E. Stathopoulou: None. M. Regan: None. H. Chinoy: None.

A patient centered assessment of the 2016 ACR-EULAR Myositis Response Criteria: evaluating the meaningfulness of response.

The ACR-EULAR Myositis Response Criteria (Total Improvement Score [TIS]) is a composite measure calculated using changes in myositis core set measures. It is unclear if achieving improvement per TIS reflects improvement in any symptoms of myositis patients. In this study, we examined the association between achieving TIS improvement and patient-centered outcome measures (PCOMs). Adults with myositis were enrolled in a prospective study with baseline and 6-month visits. Six core set measures were collected at each visit along with the following PCOMs: Fatigue (visual analogue scale [VAS] and short form 36 [SF36]), pain (VAS, SF36), health-related quality of life (SF-36), physical function (PROMIS-physical function, SF36, sit-to-stand, timed up-and-go, and six-min walk) and physical activity (actigraphy). Mann-Whitney U was used to compare PCOMs between improvement groups. Spearman correlation and regression models were used for correlation and association between TIS and PCOMs, respectively. Of 50 patients (six polymyositis, 24 dermatomyositis, 9 necrotizing myopathy, 11 anti-synthetase syndrome) enrolled (mean age: 52, 60% female), 21 patients satisfied the TIS improvement criteria at 6-months. PCOMs including fatigue, pain, quality of life, physical activity and physical function demonstrated significantly greater improvement in patients who had minimal TIS improvement compared with those with no improvement. Greater PCOM improvements were seen with moderate-major TIS improvement. TIS correlated moderately-strongly with most PCOMs. Achieving improvement criteria was accompanied by significant clinical improvements in fatigue, pain, health-related quality of life, physical function, and physical activity. These results support the use of TIS as a clinically meaningful metric of improvement.

Pain is Common in Myositis and Associated with Disease Activity.

Understanding pain in myositis remains challenging. This study aimed to assess patient-reported pain and its correlation with myositis core set measures (CSMs), patient-reported outcomes (PROs), and functional measures. Fifty subjects underwent baseline, 3-month, and 6-month assessments, evaluating myositis CSMs, functional measures, and patient-reported outcomes. Pain was measured using three methods: (1) a 10-cm Visual Analogue Scale (VAS), (2) pain score from the HAQ-DI, and (3) SF-36 (Short Form survey) pain questions. Correlations between disease activity measures and pain were examined at baseline, and changes in both were assessed at 6 months, along with longitudinal change of pain. The change in pain was also correlated with the published 2016 ACR/EULAR myositis response criteria, physician/patient's assessment of change. Nearly half of patients (45%) reported moderate to severe pain in all 3 pain scales, with higher severity of pain in PM/NM subset. At baseline, pain severity showed a strong correlation with most CSMs, PROs and functional outcomes in all the 3 pain scales and similar trends were noted for change in pain at the 6 months. On longitudinal analysis, the physical function scores and fatigue showed strong correlation with pain. Pain improved in myositis patients with improvement in disease activity over time. Pain is common in myositis and is associated with multiple measures of disease activity, PROs, and functional outcomes in myositis. Most importantly pain improves with improvement in disease activity. SF-36 pain questions have good psychometric properties.

Treatment Patterns and Effectiveness of Tofacitinib in Patients Initiating Therapy for Rheumatoid Arthritis: Results From the CorEvitas Rheumatoid Arthritis Registry.

This real-world analysis assessed baseline demographics/characteristics and treatment patterns/effectiveness in patients with rheumatoid arthritis (RA) initiating tofacitinib (TOF) in the US CorEvitas RA Registry. The primary analysis of this study included patients with RA initiating TOF with a 12-month follow-up visit from November 2012 to January 2021. Outcomes included baseline demographics/characteristics and TOF initiation/discontinuation reasons, treatment patterns, and effectiveness (disease activity and patient-reported outcomes [PROs] at 12 months); the primary effectiveness outcome was Clinical Disease Activity Index low disease activity (CDAI LDA). All data, analyzed descriptively, were stratified by TOF regimen (monotherapy vs combination therapy), line of therapy (second- to fourth-line), time of initiation (2012-2014, 2015-2017, or 2018-2020), and dose (5 mg twice daily vs 11 mg once daily). Of 2874 patients with RA who initiated TOF, 1298 had a qualifying 12-month follow-up visit; of these, 43.1% were monotherapy and 66.5% were fourth-line therapy. Overall, tumor necrosis factor inhibitors (40.8%) were the most common treatment immediately prior to TOF initiation. The most common reason for TOF initiation (among those with a reason) was lack/loss of efficacy of prior treatment (67.7%). Overall, at 12 months, 31.9% and 10.1% had achieved CDAI LDA and remission, respectively; 22.4%, 10.4%, and 5% had achieved ≥ 20%, ≥ 50%, and ≥ 70% improvement in modified American College of Rheumatology core set measures, respectively; and improvements in PROs were observed. Effectiveness was generally similar across TOF stratifications. TOF effectiveness (CDAI LDA) was observed in a US real-world setting of patients with RA regardless of TOF regimen, line of therapy, time of initiation, and dose. (ClinicalTrials.gov: NCT04721808).

Patient reported outcome for physical function in idiopathic inflammatory myopathy.

There is an unmet need to develop patient-reported outcomes (PRO) measures for Idiopathic Inflammatory Myopathies (IIM). To investigate the feasibility, compliance, and psychometric properties of NIH's Patient-Reported Outcomes Measurement Information System (PROMIS) physical function-20 (PF-20) in a large U.S. IIM population. "Myositis Patient Centered Tele-Research" (My PACER) is a multicentre prospective observational study of IIM patients, competitively recruited through traditional in-person clinic visits (Center-Based Cohort [CBC]), and remotely using smartphone and web-based technology (Tele-Research Cohort [TRC]). The CBC was further randomly divided (1:1 ratio) into a traditional local sub-cohort, and a remote sub-cohort. Data collected included PRO and other patient self-assessments monthly for 6 months. Clinician-reported outcomes were obtained at baseline and 6 months. 120 IIM patients were enrolled (82 TRC/38 CBC, mean age 55 ± 13.4, 75% females, 81% Caucasians), with similar demographics and mean PROMIS PF-20 score between cohorts. The PROMIS PF-20 score was not associated with age, sex or race. The compliance and completion rates were similar between TRC and CBC as well as sub-cohorts. PROMIS PF-20 showed strong test-retest reliability at 1 month. PROMIS PF-20 was significantly associated with all core set measures except extra-muscular global and CK, as well as with most of symptoms, function and physical activity measures. PROMIS PF-20 illustrated concordant change with myositis response criteria and patient assessment, with a large effect size. PROMIS PF-20 demonstrates favorable psychometric properties including reliability, validity and responsiveness in a large cohort of myositis patients, with similar adherence in local or remotely enrolled patients.

A Review of The Evidence for the Utility of Physical Activity Monitor Use in Patients with Idiopathic Inflammatory Myopathies.

Few proven therapies exist for patients with idiopathic inflammatory myopathies (IIM), partly due to the lack of reliable and valid outcome measures for assessing treatment responses. The current core set measures developed by the International Myositis Assessment and Clinical Studies group were developed to standardize assessments of disease activity and treatment effect. None of the current measures address functional improvement in muscle weakness. Therefore, supplemental measures for more objectively assessing physical activity levels and fatiguability in free-living settings are needed to assess disease activity more comprehensively. Validated physical activity monitors (PAMs) have the potential to serve as an objective functional outcome measure in clinical trials and observational studies. This review examines the current evidence for using body-worn PAMs in clinical settings with IIM patients. A practical overview of methods for PAM use in clinical patient populations (including measurement details and data processing) that focuses on IIM patients is also presented.

Identifying core measures to be used in mental health research with care experienced young people: A Delphi study

BackgroundCare experienced young people, including those who are neurodivergent, experience worse mental health outcomes than their non-care counterparts. Understanding the mental health of this population, including how it changes over time, is critically important to the development of more effective, supportive services. However, one of the challenges to this is the lack of consensus around a set of suitable mental health measures that can be used with care experienced young people, including those who are neurodivergent. AimThe primary aim of this study was to develop consensus around a core set of measures that can be used by researchers when investigating the mental health of care experienced young people, including with those who are neurodivergent. Additional research questions included: (1) what are the strengths and limitations of these measures?; (2) what is the value and drawbacks of attempting to develop a set of core measures?; (3) what do young people with care experience think about the measures? MethodsThis study used a mixed methods approach. The primary method was a classical Delphi design where consensus from a panel of experts (n = 18) was sought in relation to the recommendation of 7 mental health measures. These measures covered 4 domains: general mental health, quality of life/related quality of life, anxiety and depression, suicide and self-harm. Alongside the Delphi, an advisory group of care experienced young people (n = 6) was asked to examine the suitability/ appropriateness of the collection of measures. FindingsThere were a number of strengths and limitations of the measures highlighted by the panel of experts. Given these, only the SDQ and the RCADS-25 were recommended for routine use with care experienced young people. Moreover, the panel recommended the use of the SDQ for care experienced young people who are neurodivergent. In addition, the advisory group suggested that there would need to be significant changes to the wording and content of all measures to improve their suitability. Lastly, a tension exists relating to the utility of recommending a core set and the potential restrictions this may impose.

Abstract A022: Assessing, understanding, and addressing social determinants of cancer health disparities through patient navigation among rural Arkansans

Abstract The Winthrop P. Rockefeller Cancer Institute at the University of Arkansas for Medical Sciences (UAMS), Office of Community Outreach and Engagement has developed a Cancer Patient Navigation Program dedicated to improving cancer care for everyone in Arkansas. The team includes nurse navigators and community health workers that help bridge the gap between cancer patients, and financial resources in the community, and health care providers. The Cancer Patient Navigation Program emphasizes patient empowerment through prevention, screening, and treatment for rural and underserved populations across the state. The aim of the program is to help eliminate barriers to health care by providing resources for cancer treatment to rural and underserved populations across Arkansas. Navigators and community health works are located throughout every geographic region of Arkansas and are representative of the diversity in the communities they serve. Navigators and community health workers use the Protocol for Responding to and Assessing Patients’ Assets, Risks, and Experiences (PRAPARE®) to identify cancer patients’ barriers to care. PRAPARE® is a standardized patient risk assessment tool consisting of a set of national core measures as well as a process for addressing the social drivers at both the patient and population levels. Since May 2022, the Cancer Patient Navigation program has assessed and addressed the needs of 350 cancer patients. The data collected by navigators and community health workers has improved care coordination services, increased collaborations with local community partners with similar goals, and provided a unique opportunity for UAMS to better understand challenges of cancer patients and provide more appropriate services and care that is needed on a community level. The PRAPRE data has allowed the Office of Community Outreach and Engagement to understand the number of social determinants risks as well as the most common social determinant risks in our patient population. The risk tally score established a baseline to determine who might be more “at risk” by both geographic location and cancer diagnosis. To date, the data collected has been analyzed to track referrals and interventions. The data will further be used to ensure community-engagement priorities and resources are integrated into all Winthrop P. Rockefeller Cancer Institute research cores and clinical enterprises. Addressing the adverse social drivers of health will ultimately allow UAMS to improve patient well-being, facilitate access to prevention, screening, and treatment. Citation Format: Valandra L. German. Assessing, understanding, and addressing social determinants of cancer health disparities through patient navigation among rural Arkansans [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A022.

Society for Maternal-Fetal Medicine Special Statement: Clinical quality measures in obstetrics

This article provides an updated overview and critique of clinical quality measures relevant to obstetrical care. The history of the quality movement in the USA and the proliferation of quality metrics over the past quarter century are reviewed. Common uses of quality measures are summarized: payment programs, accreditation, public reporting, and quality improvement projects. We present listings of metrics that are reported by physicians or hospitals, either voluntarily or by mandate, to government agencies, payers, “watchdog” ratings organizations, and other entities. The costs and other burdens of extracting data and reporting metrics are summarized. The potential for unintended adverse consequences of the use of quality metrics is discussed along with approaches to mitigating adverse consequences. Finally, some recent attempts to develop simplified core measure sets are presented, with the promise that the complex and burdensome quality-metric enterprise may improve in the near future.

Radiological assessment of hip disease in children with cerebral palsy: development of a core measurement set.

Hip disease is common in children with cerebral palsy (CP) and can decrease quality of life and function. Surveillance programmes exist to improve outcomes by treating hip disease at an early stage using radiological surveillance. However, studies and surveillance programmes report different radiological outcomes, making it difficult to compare. We aimed to identify the most important radiological measurements and develop a core measurement set (CMS) for clinical practice, research, and surveillance programmes. A systematic review identified a list of measurements previously used in studies reporting radiological hip outcomes in children with CP. These measurements informed a two-round Delphi study, conducted among orthopaedic surgeons and specialist physiotherapists. Participants rated each measurement on a nine-point Likert scale ('not important' to 'critically important'). A consensus meeting was held to finalize the CMS. Overall, 14 distinct measurements were identified in the systematic review, with Reimer's migration percentage being the most frequently reported. These measurements were presented over the two rounds of the Delphi process, along with two additional measurements that were suggested by participants. Ultimately, two measurements, Reimer's migration percentage and femoral head-shaft angle, were included in the CMS. This use of a minimum standardized set of measurements has the potential to encourage uniformity across hip surveillance programmes, and may streamline the development of tools, such as artificial intelligence systems to automate the analysis in surveillance programmes. This core set should be the minimum requirement in clinical studies, allowing clinicians to add to this as needed, which will facilitate comparisons to be drawn between studies and future meta-analyses.

The use of high-sensitivity cardiac troponin I in assessing cardiac involvement and Disease prognosis in idiopathic inflammatory myopathy

ObjectivesCardiac involvement is one of the most serious complications of idiopathic inflammatory myopathy (IIM) that indicates poor prognosis. However, there is a lack of effective biomarkers for the identification of cardiac involvement and the prediction of prognosis in IIM. Here, we aimed to explore the value of different cardiac biomarkers in IIM patients.MethodsA total of 142 IIM patients in the Department of Rheumatology and Immunology, Ruijin Hospital from July 2019 to October 2022 were included in this study. The clinical characteristics, laboratory tests, treatments and prognosis were recorded. The disease activity was assessed according to the core set measures. The correlations of the serum cardiac biomarkers levels with disease activity were analyzed by the Spearman correlation test. Risk factors for cardiac involvement were evaluated by multivariate logistic regression analysis.ResultsHigher high-sensitivity cardiac troponin I (hs-cTnI) levels were associated with cardiac involvement (n = 41) in IIM patients [adjusted OR 7.810 (95% CI: 1.962–31.097); p = 0.004], independent of other serum cardiac biomarkers. The abnormal hs-cTnI had the highest AUC for distinguishing of cardiac involvement in IIM patients (AUC = 0.848, 95% CI: 0.772,0.924; p < 0.001). Besides, we found that high serum levels of hs-cTnI were significantly correlated with disease activity. Moreover, patients with higher serum levels of hs-cTnI tended to suffer from poor prognosis.ConclusionsSerum hs-cTnI testing may play a role in screening for cardiac involvement in IIM patients. Abnormal levels of serum hs-cTnI were associated with increased disease activity and poor prognosis.

The Patient-Centered Dental Home: A Framework for Quality Measurement, Improvement, and Integration.

This study completed the development of a standardized patient-centered dental home (PCDH) framework to align and integrate with the patient-centered medical home. This study identified measure concepts and specific measures and standards to complete the 4-level measurement framework to implement and evaluate a PCDH. This study built on prior model development, which identified the PCDH definition and characteristics and the components nested within those characteristics. An environmental scan identified existing oral health care quality measure concepts, measures, and standards for rating by the project's National Advisory Committee (NAC). A modified Delphi process, adapted from the RAND appropriateness method, was used to obtain structured feedback from the NAC. NAC members rated measure concepts on importance and, subsequently, specific measures and standards on feasibility, validity, and actionability using a 1 to 9 rating scale. Criteria for model inclusion were based on median ratings and rating dispersion. Open-ended comments were elicited to inform model inclusion as well as identify additional concepts. We identified more than 500 existing oral health care measures and standards. A structured process was used to identify a subset that best aligned with a PCDH for rating by the NAC. Four Delphi rounds were completed, with 2 rounds to rate measure concepts and 2 rounds to rate measures and standards. NAC quantitative ratings and qualitative comments resulted in a total of 61 measure concepts and 47 measures and standards retained for inclusion in the framework. The NAC ratings of measure concepts, and specific measures and standards nested within those concepts, completed the 4-level PCDH measurement framework. The resulting framework allows for the development and implementation of core measure sets to identify and evaluate a PCDH, facilitating quality improvement and dental-medical integration. Clinicians, payers, health care systems, and policy makers can use the results of this study to guide and assess implementation of the various components of a patient-centered dental home and to support dental-medical integration.

An international study to explore the feasibility of collecting standardised outcome data for Complex Regional Pain Syndrome: recommendations for an international clinical research registry.

Complex Regional Pain Syndrome (CRPS) is a persistent pain condition with low prevalence. Multi-centre collaborative research is needed to attain sufficient sample sizes for meaningful studies. This international observational study: (1) tested the feasibility and acceptability of collecting outcome data using an agreed core measurement set (2) tested and refined an electronic data management system to collect and manage the data. Adults with CRPS, meeting the Budapest diagnostic clinical criteria, were recruited to the study from 7 international research centres. After informed consent, a questionnaire comprising the core set outcome measures was completed: on paper at baseline (T1), and at 3 or 6 months (T2) using a paper or e-version. Participants and clinicians provided feedback on the data collection process. Clinicians completed the CRPS severity score at T1 and optionally, at T2. Ethical approval was obtained at each international centre. Ninety-eight adults were recruited (female n=66; mean age 46.6 years, range 19-89), of whom 32% chose to receive the T2 questionnaire in an electronic format. Fifty-five participants completed both T1 and T2. Eighteen participants and nine clinicians provided feedback on their data collection experience. This study confirmed the questionnaire core outcome data are feasible and practicable to collect in clinical practice. The electronic data management system provided a robust means of collecting and managing the data across an international population. The findings have informed the final data collection tools and processes which will comprise the first international, clinical research registry and data bank for CRPS.