Consensus Guidelines for Improving Quality of Assessment and Training for Neuromuscular Diseases
Critical components of successful evaluation of clinical outcome assessments (COAs) in multisite clinical trials and clinical practice are standardized training, administration, and documented reliability of scoring. Experiences of evaluators, alongside patient differences from regional standards of...
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Frontiers Media S.A.
2021
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oai:doaj.org-article:981e516b28d04a8384a87ee77f7b25aa2021-11-10T08:26:58ZConsensus Guidelines for Improving Quality of Assessment and Training for Neuromuscular Diseases1664-802110.3389/fgene.2021.735936https://doaj.org/article/981e516b28d04a8384a87ee77f7b25aa2021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fgene.2021.735936/fullhttps://doaj.org/toc/1664-8021Critical components of successful evaluation of clinical outcome assessments (COAs) in multisite clinical trials and clinical practice are standardized training, administration, and documented reliability of scoring. Experiences of evaluators, alongside patient differences from regional standards of care, may contribute to heterogeneity in clinical center’s expertise. Achieving low variability and high reliability of COA is fundamental to clinical research and to give confidence in our ability to draw rational, interpretable conclusions from the data collected. The objective of this manuscript is to provide a framework to guide the learning process for COAs for use in clinics and clinical trials to maximize reliability and validity of COAs in neuromuscular disease (NMD). This is a consensus-based guideline with contributions from fourteen leading experts in clinical outcomes and the field of clinical outcome training in NMD. This framework should guide reliable and valid assessments in NMD specialty clinics and clinical trials. This consensus aims to expedite study start up with a progressive training pathway ranging from research naïve to highly experienced clinical evaluators. This document includes recommendations for education guidelines and roles and responsibilities of key stakeholders in COA assessment and implementation to ensure quality and consistency of outcome administration across different settings.Tina DuongTina DuongKristin J. KrosschellMeredith K. JamesLeslie NelsonLindsay N. AlfanoLindsay N. AlfanoKaty EichingerElena MazzoneKristy RoseLinda P. LowesLinda P. LowesAnna MayhewJulaine FlorenceWendy KingClaudia R. SenesacMichelle EagleMichelle EagleFrontiers Media S.A.articleclinical outcomes assessmentclinical evaluation educationneuromuscular disease (NMD)evaluator trainingclinical trial readinessGeneticsQH426-470ENFrontiers in Genetics, Vol 12 (2021) |
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clinical outcomes assessment clinical evaluation education neuromuscular disease (NMD) evaluator training clinical trial readiness Genetics QH426-470 |
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clinical outcomes assessment clinical evaluation education neuromuscular disease (NMD) evaluator training clinical trial readiness Genetics QH426-470 Tina Duong Tina Duong Kristin J. Krosschell Meredith K. James Leslie Nelson Lindsay N. Alfano Lindsay N. Alfano Katy Eichinger Elena Mazzone Kristy Rose Linda P. Lowes Linda P. Lowes Anna Mayhew Julaine Florence Wendy King Claudia R. Senesac Michelle Eagle Michelle Eagle Consensus Guidelines for Improving Quality of Assessment and Training for Neuromuscular Diseases |
description |
Critical components of successful evaluation of clinical outcome assessments (COAs) in multisite clinical trials and clinical practice are standardized training, administration, and documented reliability of scoring. Experiences of evaluators, alongside patient differences from regional standards of care, may contribute to heterogeneity in clinical center’s expertise. Achieving low variability and high reliability of COA is fundamental to clinical research and to give confidence in our ability to draw rational, interpretable conclusions from the data collected. The objective of this manuscript is to provide a framework to guide the learning process for COAs for use in clinics and clinical trials to maximize reliability and validity of COAs in neuromuscular disease (NMD). This is a consensus-based guideline with contributions from fourteen leading experts in clinical outcomes and the field of clinical outcome training in NMD. This framework should guide reliable and valid assessments in NMD specialty clinics and clinical trials. This consensus aims to expedite study start up with a progressive training pathway ranging from research naïve to highly experienced clinical evaluators. This document includes recommendations for education guidelines and roles and responsibilities of key stakeholders in COA assessment and implementation to ensure quality and consistency of outcome administration across different settings. |
format |
article |
author |
Tina Duong Tina Duong Kristin J. Krosschell Meredith K. James Leslie Nelson Lindsay N. Alfano Lindsay N. Alfano Katy Eichinger Elena Mazzone Kristy Rose Linda P. Lowes Linda P. Lowes Anna Mayhew Julaine Florence Wendy King Claudia R. Senesac Michelle Eagle Michelle Eagle |
author_facet |
Tina Duong Tina Duong Kristin J. Krosschell Meredith K. James Leslie Nelson Lindsay N. Alfano Lindsay N. Alfano Katy Eichinger Elena Mazzone Kristy Rose Linda P. Lowes Linda P. Lowes Anna Mayhew Julaine Florence Wendy King Claudia R. Senesac Michelle Eagle Michelle Eagle |
author_sort |
Tina Duong |
title |
Consensus Guidelines for Improving Quality of Assessment and Training for Neuromuscular Diseases |
title_short |
Consensus Guidelines for Improving Quality of Assessment and Training for Neuromuscular Diseases |
title_full |
Consensus Guidelines for Improving Quality of Assessment and Training for Neuromuscular Diseases |
title_fullStr |
Consensus Guidelines for Improving Quality of Assessment and Training for Neuromuscular Diseases |
title_full_unstemmed |
Consensus Guidelines for Improving Quality of Assessment and Training for Neuromuscular Diseases |
title_sort |
consensus guidelines for improving quality of assessment and training for neuromuscular diseases |
publisher |
Frontiers Media S.A. |
publishDate |
2021 |
url |
https://doaj.org/article/981e516b28d04a8384a87ee77f7b25aa |
work_keys_str_mv |
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