scholarly journals Advancing the Development of Patient-reported Outcomes for Adult Myositis at OMERACT 2016: An International Delphi Study

2017 ◽  
Vol 44 (11) ◽  
pp. 1683-1687 ◽  
Author(s):  
Jin Kyun Park ◽  
Christopher A. Mecoli ◽  
Helene Alexanderson ◽  
Malin Regardt ◽  
Lisa Christopher-Stine ◽  
...  
Keyword(s):  
Focus Groups ◽  
Delphi Study ◽  
Patient Reported Outcomes ◽  
Qualitative Content Analysis ◽  
Healthcare Providers ◽  
The United States ◽  
Delphi Survey ◽  
Modified Delphi ◽  
Patient Reported ◽  
Pharmaceutical Industries

Objective.To define a set of core patient-reported domains and respective instruments for use in idiopathic inflammatory myopathies (IIM). Previously, we reported a systematic literature review on patient-reported outcomes (PRO) in IIM followed by conducting international focus groups to elicit patient perspectives of myositis symptoms and effects.Methods.Based on qualitative content analysis of focus groups, an initial list of 26 candidate domains was constructed. We subsequently conducted an international modified Delphi survey to identify the importance of each of the 26 domains. Participants were asked to rate each domain on a scale of 0–10 (0 = not important, 10 = very important).Results.In this first round of the Delphi survey, 643 patients participated from the United States (n = 543), Sweden (n = 49), and South Korea (n = 51). Of the 26 domains, 19 (73%) were rated of high importance (≥ 7/10). The top 5 domains were muscle symptoms, fatigue, interactions with healthcare, medication side effects, and pain. During Outcome Measures in Rheumatology (OMERACT) 2016, we discussed the goal for ultimate reduction in the number of domains and the importance of considering representation of healthcare providers from other specialties, caregivers, representatives of pharmaceutical industries, and regulatory authorities in the next rounds of Delphi to represent broader perspectives on IIM.Conclusion.Further prioritization and a reduction in the number of domains will be needed for the next Delphi. At the next biennial OMERACT meeting, we aim to present and seek voting on a Myositis Preliminary PRO Core Set to enable ultimate measure selection and development.

scholarly journals Perceptions of Patients, Caregivers, and Healthcare Providers of Idiopathic Inflammatory Myopathies: An International OMERACT Study

2018 ◽  
Vol 46 (1) ◽  
pp. 106-111 ◽  
Author(s):  
Christopher A. Mecoli ◽  
Jin Kyun Park ◽  
Helene Alexanderson ◽  
Malin Regardt ◽  
Merrilee Needham ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Qualitative Content Analysis ◽  
Healthcare Providers ◽  
The United States ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Idiopathic Inflammatory Myopathies ◽  
Inflammatory Myopathies ◽  
Patient Reported ◽  
Initial List

Objective.Patient-reported outcome measures (PROM) that incorporate the patient perspective have not been well established in idiopathic inflammatory myopathies (IIM). As part of our goal to develop IIM-specific PROM, the Outcome Measures in Rheumatology (OMERACT) Myositis special interest group sought to determine which aspects of disease and its effects are important to patients and healthcare providers (HCP).Methods.Based on a prior qualitative content analysis of focus groups, an initial list of 24 candidate domains was constructed. We subsequently conducted an international survey to identify the importance of each of the 24 domains to be assessed in clinical research. Patients with IIM, their caregivers, and HCP treating IIM completed the survey.Results.In this survey, a total of 638 respondents completed the survey, consisting of 510 patients, 101 HCP, and 27 caregivers from 48 countries. Overall, patients were more likely to rank “fatigue,” “cognitive impact,” and “difficulty sleeping” higher compared with HCP, who ranked “joint symptoms,” “lung symptoms,” and “dysphagia” higher. Both patients and providers rated muscle symptoms as their top domain. In general, patients from different countries were in agreement on which domains were most important. One notable exception was that patients from Sweden and the Netherlands ranked lung symptoms significantly higher compared to other countries including the United States and Australia (mean weighted rankings of 2.86 and 2.04 vs 0.76 and 0.80, respectively; p < 0.0001).Conclusion.Substantial differences exist in how IIM is perceived by patients compared to HCP, with different domains prioritized. In contrast, patients’ ratings across the world were largely similar.

scholarly journals Identifying Foot and Ankle Patients at Risk to Fall Based on Patient Reported Outcomes Assessments

2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0002
Author(s):  
Judith Baumhauer ◽  
Jack Teitel ◽  
Allison McIntyre ◽  
David Mitten ◽  
Jeff Houck
Keyword(s):  
At Risk ◽  
Effect Size ◽  
Fall Risk ◽  
Patient Reported Outcomes ◽  
The United States ◽  
Foot And Ankle ◽  
Falls Risk ◽  
Orthopaedic Patients ◽  
Patient Reported ◽  
Patients At Risk

Category: Other Introduction/Purpose: Each year approximately 30-40% of people over the age of 65 fall. Approximately one half of these falls result in an injury with the estimated annual direct medical costs of $30 billion. Pain, mobility issues, neuropathy and post-operative weight bearing limitations make foot and ankle patients particularly vulnerable to falls. Current approaches to determine at risk patients are cumbersome and time consuming requiring performance testing and “hands on” clinical assessment. The efficiency of obtaining PRO, such as PROMIS, in the clinical arena has been well documented. The purpose of this study is determine if patient reported outcomes (PROMIS) can identify orthopaedic and specifically foot and ankle patients at risk to fall. Methods: Prospective patient reported outcomes (PROMIS CAT physical function, pain interference and depression and CMS fall risk assessment questions) and patient demographics were collected for all patients at each clinic visit from an academic orthopaedic multi-specialty practice between January 2015 and November 2017. Standardized yes/no validated self-reported fall risk questions include: “Have you fallen in the last year?” and “Do you feel you are at risk of falling?” Histograms, t-tests, confidence intervals and effect size were used to determine the fall risk “YES” patients were different than the “NO” for ALL orthopaedic patients and specifically foot and ankle patients. Logistic Regression was used to determine if age, gender, height, weight, and PROMIS scales predicted self-reported falls risk. Results: 94,761 orthopaedic patients comprising 315,273 visits (44% male, mean age 53.7+/-17 years) and 13,720 foot/ankle patients comprising 33,480 visits (37% male, mean age 52.7+/-16.1 years) had complete data for analysis. Table 1 provides the means/SD/p-values/effect sizes for patient self-identifying at risk to fall stratified by PROMIS PF/ PI/Dep t-scores. Although all PROMIS scores demonstrated significant impairment between patients at risk designation (yes/no), PROMIS PF had the largest effect size for ALL Ortho and FOOT AND ANKLE patients (0.8 and 0.7 respectively). Patients who are at risk to fall have PROMIS PF t-scores >1.5 lower than the United States normative population while the patients not at risk are less <1 SD. In the adjusted regression models gender and PROMIS PF had the largest coefficients. Conclusion: Falls are a major threat to quality of life and independence yet prevention/treatment strategies are difficult to implement across a health system. There is also a tremendous societal cost with orthopaedic surgeons often the recipient of these debilitated patients. PROMIS assessments are part of the AOFAS OFAR initiative to track patient recovery with treatment and can additional be used to fulfill a quality indicator requirement by CMS. This study demonstrates these assessments (PROMIS threshold values) can also be linked to self-report falls risk (yes/no) and may identify patients at risk with no face to face time required from the provider.

A patient reported outcomes of treatments for desmoid tumors: An international natural history study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11560-11560
Author(s):  
Danielle Braggio ◽  
Amanda Lucas ◽  
Lynne Hernandez ◽  
Kelly Mercier
Keyword(s):  
Natural History ◽  
Active Surveillance ◽  
Desmoid Tumor ◽  
Patient Reported Outcomes ◽  
The United States ◽  
Desmoid Tumors ◽  
Targeted Agents ◽  
Natural History Study ◽  
Systemic Treatments ◽  
Patient Reported

11560 Background: The Desmoid Tumor Research Foundation (DTRF) launched the natural history study (NHS) in 2017. At this time, there are no standard-of-care options for this rare sarcoma. The treatments, clinical descriptors, and the patient reported outcomes to pharmacologic agents are described here within. Methods: The web-based natural history study launched September 2017 in collaboration with the National Organization of Rare Disorders. It contains 15 surveys covering diagnostics, disease, treatment, care management, and quality of life. Treatment types included in the DTRF NHS were pharmacology, surgery, radiation, high-intensity focused ultrasound (HiFU), and active surveillance (watch and wait). Results: While surgery was once the primary intervention for desmoid tumor patients, the NHS participants reported that 47.6% had received active surveillance or no systemic treatment at diagnosis. This is most common for desmoid tumors located in abdominal wall (54/103; 52.4%). There were 87 reported cases of complete surgical resection, 38 incomplete resections, and 23 bowel resections. 9 amputations were reported; 8 participants reported recurrent disease following the removal of the limb. The non-surgical interventions, such as radiation and HiFU, were mostly described for participants with chest wall tumors (15 pts) and joints/extremities (10 pts). Many options for systemic therapies were described including sorafenib (44/284; 15.5%), sulindac (36/284; 12.7%), and anti-hormonal agents tamoxifen and toremifene (34/285; 10.9%) were described. Targeted agents, such as gamma secretase inhibitor, pazopanib, and sorafenib, were greater in the United States than the non-US country participants (21% vs 9%). Multiple lines of treatments were reported by 81 participants, surgery is greatest as the first intervention for all tumor locations (49/81, 60%), with the exception of those with head/neck tumors who received chemotherapy (6/11, 55%). Analysis has started to evaluate the efficacy of systemic treatments from these NHS data. The table describes the participant reported outcomes of anti-hormonal agents, chemotherapeutics, non-steroidal anti-inflammatories, and targeted agents. Both chemotherapies and targeted agents were reported to have 38.1% response rates from the participants with 34.3% and 23.8% of participants reported progressive disease on therapy, respectively. Conclusions: Desmoid tumor NHS study participants reported the use of many treatment modalities demonstrating a range of frequency of use by tumor location and efficacy. Data collection through the DTRF NHS is ongoing.[Table: see text]

The Development and Initial Findings of A Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease (SPARC IBD)

2021 ◽  
Author(s):  
Laura E Raffals ◽  
Sumona Saha ◽  
Meenakshi Bewtra ◽  
Cecile Norris ◽  
Angela Dobes ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Data ◽  
Bowel Disease ◽  
Patient Reported Outcomes ◽  
Data Entry ◽  
The United States ◽  
Predictors Of Response ◽  
Patient Reported ◽  
Inflammatory Bowel ◽  
Reported Data

Abstract Background Clinical and molecular subcategories of inflammatory bowel disease (IBD) are needed to discover mechanisms of disease and predictors of response and disease relapse. We aimed to develop a study of a prospective adult research cohort with IBD (SPARC IBD) including longitudinal clinical and patient-reported data and biosamples. Methods We established a cohort of adults with IBD from a geographically diverse sample of patients across the United States with standardized data and biosample collection methods and sample processing techniques. At enrollment and at time of lower endoscopy, patient-reported outcomes (PRO), clinical data, and endoscopy scoring indices are captured. Patient-reported outcomes are collected quarterly. The quality of clinical data entry after the first year of the study was assessed. Results Through January 2020, 3029 patients were enrolled in SPARC, of whom 66.1% have Crohn’s disease (CD), 32.2% have ulcerative colitis (UC), and 1.7% have IBD-unclassified. Among patients enrolled, 990 underwent colonoscopy. Remission rates were 63.9% in the CD group and 80.6% in the UC group. In the quality study of the cohort, there was 96% agreement on year of diagnosis and 97% agreement on IBD subtype. There was 91% overall agreement describing UC extent as left-sided vs extensive or pancolitis. The overall agreement for CD behavior was 83%. Conclusion The SPARC IBD is an ongoing large prospective cohort with longitudinal standardized collection of clinical data, biosamples, and PROs representing a unique resource aimed to drive discovery of clinical and molecular markers that will meet the needs of precision medicine in IBD.

scholarly journals Patient-reported outcomes and psycho-oncological screening in hematology: a practical example of routine electronic monitoring

2020 ◽  
Vol 13 (3) ◽  
pp. 285-293
Author(s):  
Jens Lehmann ◽  
Lisa M. Wintner ◽  
Monika Sztankay ◽  
Wolfgang Willenbacher ◽  
Roman Weger ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Electronic Monitoring ◽  
Healthcare Providers ◽  
Point Of View ◽  
Functional Impairments ◽  
Oncological Treatment ◽  
Outpatient Unit ◽  
Physician Contact ◽  
Patient Reported ◽  
Oncological Screening

Summary Patient-reported outcomes (PROs) have gained increasing importance in oncology. PROs can supplement medical treatment with important information about the patient’s quality of life (QoL), which is typically assessed using standardized questionnaires. PROs capture the symptomatology and functional impairments as perceived by the patient without further interpretation by another party. In this article, we describe how routinely assessed electronic PROs (ePROs) at the outpatient unit of the Department of Hematology Innsbruck complement the Austrian Myeloma Registry (AMR) and clinical routine. There is a broad body of literature showing that ePRO assessments can supplement patient–physician contact and help focus communication on clinically relevant issues that matter for the patient. Based on ePRO results, physicians can initiate clinical action such as referring patients to psycho-oncological treatment. Electronic PRO assessments might facilitate communication between healthcare providers among themselves but also between healthcare providers and patients, and make it possible to incorporate the patients’ point of view into treatment in a standardized way. The example depicted herein demonstrates how ePRO assessments can be integrated and used in routine monitoring and for psycho-oncological screening.

Preparing School and District Leaders for Success in Developing and Facilitating Integrative STEM in Higher Education

2020 ◽  
pp. 194277512096214
Author(s):  
Rachel Louise Geesa ◽  
Krista M. Stith ◽  
Mary A. Rose
Keyword(s):  
Higher Education ◽  
Stem Education ◽  
Professional Learning ◽  
Delphi Study ◽  
Educational Leaders ◽  
The United States ◽  
District Leaders ◽  
Educational Leadership Programs ◽  
Modified Delphi ◽  
Development Objectives

Higher education institutions in the United States with graduate-level educational leadership programs traditionally do not offer professional learning opportunities in integrative STEM education. The objective of this paper is to share our journey to prepare and implement a course designed for P-12 educational leaders to build knowledge and skills to lead impactful integrative STEM programming. Results of the demand survey indicated a high amount of interest in an integrative STEM education course. Findings from interviews and the modified Delphi study informed our decisions for the development, objectives, assessments, and outcomes of the course to enhance integrative STEM culture in educational settings.

scholarly journals Clinical indicators to identify neuropathic pain in low back-related leg pain: protocol for a modified Delphi study

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033547 ◽  
Author(s):  
Jai Mistry ◽  
Deborah Falla ◽  
Tim Noblet ◽  
Nicola R Heneghan ◽  
Alison B Rushton
Keyword(s):  
Neuropathic Pain ◽  
Delphi Study ◽  
A Priori ◽  
Healthcare Providers ◽  
Leg Pain ◽  
Eligibility Criterion ◽  
Low Back ◽  
Clinical Indicators ◽  
Modified Delphi ◽  
Ethical Approval

IntroductionNeuropathic low back-related leg pain (LBLP) can be a challenge to healthcare providers to diagnose and treat. Accurate diagnosis of neuropathic pain is fundamental to ensure appropriate intervention is given. However, to date there is no gold standard to diagnose neuropathic LBLP. A Delphi study will therefore be conducted to obtain an expert-derived consensus list of clinical indicators to identify a neuropathic component to LBLP.Methods/analysisIncluded participants will be considered experts within the field as measured against a predefined eligibility criterion. Through an iterative multistage process, participants will rate their agreement with a list of clinical indicators and suggest any missing clinical indicators during each round. Agreement will be measured using a 5-point Likert scale. Descriptive statistics will be used to measure agreement; median, IQR and percentage of agreement. A priori consensus criteria will be defined for each round. Data analysis at the end of round three will enable a list of clinical indicators to be derived.Ethics and disseminationEthical approval was gained from the University of Birmingham (ERN_19-1142). On completion of the study, findings will be disseminated in a peer-reviewed journal and presented at relevant conferences.

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