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Transverse myelitis (TM) is a rare spinal cord inflammatory disorder that can cause paralysis. It can affect both children and adults and can have a variety of causes. Future clinical trials are needed to improve the understanding and treatment of TM, but the outcome data needed to correctly design and power such trials are limited. A prospective study of pediatric TM outcomes at defined time points after symptom onset will provide the necessary information for future interventional trials. OBJECTIVES: The specific aims of the Collaborative Assessment of Pediatric Transverse Myelitis: Understand, Reveal, Educate (CAPTURE) study were to determine the responses to various treatments for pediatric TM. Furthermore, the study was originally designed to determine which patient-reported outcomes correlated best with clinician-acquired measures. Due to the appearance of a new clinically significant variant of TM, termed acute flaccid myelitis (AFM), post hoc analyses were implemented to understand the impact of treatment on patients diagnosed with AFM. METHODS: This was a prospective, nonrandomized, observational trial using data from 2 patient cohorts. The cohorts included 1 group of patients who completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric and/or Parent Proxy short forms at designated time points but did not have in-person evaluations at any of the recruiting centers. The second cohort completed the same patient- and/or parent-reported outcome assessments as cohort 1 but were also examined by clinicians at one of the recruiting centers at designated time points to collect predefined clinical measurements. The in-person cohort had neurologic exams and data that were entered into a Research Electronic Data Capture (REDCap) database. For patients who did not complete in-person examinations, their medical records were reviewed at the University of Texas Southwestern Medical Center and the data abstracted. Patients were followed for up to 12 months from TM onset. Clinically distinct subtypes of TM were identified, and the responses to various therapies were analyzed. RESULTS: We were unable to adequately assess the planned primary outcome of the study due to underrecruitment but were able to collect several important data sets. All 3 patients (100%) with appropriate available treatment data (ie, those who had Functional Independence Measure for Children [WeeFIM] total scores at onset and 12 months postonset, and were treated with plasma exchange [PLEX] as their first-line therapy at onset) achieved the minimum clinically significant increase in WeeFIM total score of 22 points. Of the 8 patients treated with intravenous immunoglobulin as their first-line therapy at onset, potentially followed by PLEX, 4 (50%) patients achieved the minimum clinically significant increase in WeeFIM total score of 22 points. Those patients treated with PLEX as their first-line therapy did not have an increase in the relative risk of achieving the minimum clinically significant increase in WeeFIM total score compared with those who did not receive PLEX as their first-line therapy (P = .24 by Fisher exact test; 95% CI, 0-4.16 points). Additionally, the PROMIS Parent Proxy Mobility subset and WeeFIM Motor subset were shown to be highly correlated (⍴ = −0.84; 95% CI, −0.91 to −0.74 points; P < .0001). Last, the analysis of the sample of patients with AFM yielded information necessary for the understanding of this condition. CONCLUSIONS: Despite its limitations, the CAPTURE study had several important accomplishments. First, we quantified demographics and outcomes of patients with classically described TM and the newly recognized variant, AFM. The data collected in this study justify the need for future prospective trials of therapeutic interventions and allow for the appropriate design and powering of those studies. Finally, this report outlines correlations between the patient-reported PROMIS Mobility scale and the Motor section of the clinician-derived WeeFIM scale, indicating that this patient-reported outcome can be used for observational studies and tracks well with the gold standard of clinician-derived motor function. LIMITATIONS: This study was limited by underrecruitment and missing data. Because of these limitations, it was not possible to complete the preplanned primary end point analysis.
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Transverse myelitis (TM) is a rare spinal cord inflammatory disorder that can cause paralysis. It can affect both children and adults and can have a variety of causes. Future clinical trials are needed to improve the understanding and treatment of TM, but the outcome data needed to correctly design and power such trials are limited. A prospective study of pediatric TM outcomes at defined time points after symptom onset will provide the necessary information for future interventional trials. OBJECTIVES: The specific aims of the Collaborative Assessment of Pediatric Transverse Myelitis: Understand, Reveal, Educate (CAPTURE) study were to determine the responses to various treatments for pediatric TM. Furthermore, the study was originally designed to determine which patient-reported outcomes correlated best with clinician-acquired measures. Due to the appearance of a new clinically significant variant of TM, termed acute flaccid myelitis (AFM), post hoc analyses were implemented to understand the impact of treatment on patients diagnosed with AFM. METHODS: This was a prospective, nonrandomized, observational trial using data from 2 patient cohorts. The cohorts included 1 group of patients who completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric and/or Parent Proxy short forms at designated time points but did not have in-person evaluations at any of the recruiting centers. The second cohort completed the same patient- and/or parent-reported outcome assessments as cohort 1 but were also examined by clinicians at one of the recruiting centers at designated time points to collect predefined clinical measurements. The in-person cohort had neurologic exams and data that were entered into a Research Electronic Data Capture (REDCap) database. For patients who did not complete in-person examinations, their medical records were reviewed at the University of Texas Southwestern Medical Center and the data abstracted. Patients were followed for up to 12 months from TM onset. Clinically distinct subtypes of TM were identified, and the responses to various therapies were analyzed. RESULTS: We were unable to adequately assess the planned primary outcome of the study due to underrecruitment but were able to collect several important data sets. All 3 patients (100%) with appropriate available treatment data (ie, those who had Functional Independence Measure for Children [WeeFIM] total scores at onset and 12 months postonset, and were treated with plasma exchange [PLEX] as their first-line therapy at onset) achieved the minimum clinically significant increase in WeeFIM total score of 22 points. Of the 8 patients treated with intravenous immunoglobulin as their first-line therapy at onset, potentially followed by PLEX, 4 (50%) patients achieved the minimum clinically significant increase in WeeFIM total score of 22 points. Those patients treated with PLEX as their first-line therapy did not have an increase in the relative risk of achieving the minimum clinically significant increase in WeeFIM total score compared with those who did not receive PLEX as their first-line therapy (P = .24 by Fisher exact test; 95% CI, 0-4.16 points). Additionally, the PROMIS Parent Proxy Mobility subset and WeeFIM Motor subset were shown to be highly correlated (⍴ = −0.84; 95% CI, −0.91 to −0.74 points; P < .0001). Last, the analysis of the sample of patients with AFM yielded information necessary for the understanding of this condition. CONCLUSIONS: Despite its limitations, the CAPTURE study had several important accomplishments. First, we quantified demographics and outcomes of patients with classically described TM and the newly recognized variant, AFM. The data collected in this study justify the need for future prospective trials of therapeutic interventions and allow for the appropriate design and powering of those studies. Finally, this report outlines correlations between the patient-reported PROMIS Mobility scale and the Motor section of the clinician-derived WeeFIM scale, indicating that this patient-reported outcome can be used for observational studies and tracks well with the gold standard of clinician-derived motor function. LIMITATIONS: This study was limited by underrecruitment and missing data. Because of these limitations, it was not possible to complete the preplanned primary end point analysis.
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"In healthcare today, there is an increasing focus on measuring and improving health outcomes. This short, simple and practical guide provides the steps needed for healthcare professionals to start measuring health outcomes in a way that can improve how care is delivered day-to-day"--
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Patient Outcome Assessment --- Public Health. --- Health Plan Implementation . --- United States
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In accessible, eminently practical language, this book defines MBC for professionals across the spectrum of behavioral health care and human services; delves into research methods, basic statistics, and data management; and even features a compendium of assessments for busy clinicians to reference, listed and organized by mental health concern.
Psychometrics --- Patient-Centered Care --- Mental Health Services --- Patient Outcome Assessment --- Outcome and Process Assessment, Health Care --- methods --- standards
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A patientreported outcome (PRO) draws on patients answers to a series of questions in order to quantify their views on their own health. The purpose of PROs is to get patients′ own assessment of their health and healthrelated quality of life. The aim of this new title is to provoke and encourage thinking about the wide range of ways in which PRO data, routinely collected in the context of health service delivery, can be used to inform decisions, for example; What opportunities do these data present?What are the limitations of PROs, and what are the possible pitfalls in the use and interpretation of data produced from them?What work needs to be done in order to get the most out of PRO data?What have been the experiences of the English NHS with its PROs programme and what can other health systems learn?Using Patient Reported Outcomes to Improve Health Care provides an overview and explanation of PRO instruments and how PROs data might be used by patients in choosing both where to receive treatment, and also what treatment is best for them.Throughout this book, and drawing on international examples, the Authors consider ways in which the collected data can be used to transform decisionmaking in healthcare organisations, by those who commission health care and assess value for money, and also how data can be used to benchmark and improve clinical performance. The authors also discuss how clinicians on a more day to day level might use data to guide referral practices, ensuring that the people who receive health care are those that will benefit from it the most.This new title is the only resource to exclusively introduce, explain and show how PROs can be best used to improve healthcare and patient outcomes. Includes real life examples and case studies of PROs in practiceAssesses the growing evidence base for PROs in practiceEditor team from Office of Health Economics (OHE), The King′s Fund and Kings College London with contributions from practising clinicians, GPs and other healthcare professionals
Patient Outcome Assessment --- Delivery of Health Care --- Quality Improvement --- Data Collection --- organization & administration --- Patient outcomes --- W 84.4 Quality of health care (General) --- Data Collection. --- Patient Outcome Assessment. --- Quality Improvement. --- organization & administration. --- Health Care --- Patient Care Management --- Patient Participation --- Physician-Patient Relations --- Professional-Patient Relations
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Rehabilitation centers. --- Outcome assessment (Medical care) --- Assessment of outcome (Medical care) --- Outcome evaluation (Medical care) --- Outcome measures (Medical care) --- Outcomes assessment (Medical care) --- Outcomes measurement (Medical care) --- Outcomes research (Medical care) --- Patient outcome assessment --- Medical care --- Health facilities --- Evaluation
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