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...

Descripción completa

Guardado en:
Detalles Bibliográficos
Autores principales: Tina Duong, Kristin J. Krosschell, Meredith K. James, Leslie Nelson, Lindsay N. Alfano, Katy Eichinger, Elena Mazzone, Kristy Rose, Linda P. Lowes, Anna Mayhew, Julaine Florence, Wendy King, Claudia R. Senesac, Michelle Eagle
Formato: article
Lenguaje:EN
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://doaj.org/article/981e516b28d04a8384a87ee77f7b25aa
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
id oai:doaj.org-article:981e516b28d04a8384a87ee77f7b25aa
record_format dspace
spelling 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)
institution DOAJ
collection DOAJ
language EN
topic clinical outcomes assessment
clinical evaluation education
neuromuscular disease (NMD)
evaluator training
clinical trial readiness
Genetics
QH426-470
spellingShingle 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 AT tinaduong consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT tinaduong consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT kristinjkrosschell consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT meredithkjames consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT leslienelson consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT lindsaynalfano consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT lindsaynalfano consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT katyeichinger consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT elenamazzone consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT kristyrose consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT lindaplowes consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT lindaplowes consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT annamayhew consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT julaineflorence consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT wendyking consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT claudiarsenesac consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT michelleeagle consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
AT michelleeagle consensusguidelinesforimprovingqualityofassessmentandtrainingforneuromusculardiseases
_version_ 1718440400150069248