Dataset Information

Consensus Guidelines for Improving Quality of Assessment and Training for Neuromuscular Diseases.

ABSTRACT: 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.

SUBMITTER: Duong T

PROVIDER: S-EPMC8631528 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Consensus Guidelines for Improving Quality of Assessment and Training for Neuromuscular Diseases.

Duong Tina T Krosschell Kristin J KJ James Meredith K MK Nelson Leslie L Alfano Lindsay N LN Eichinger Katy K Mazzone Elena E Rose Kristy K Lowes Linda P LP Mayhew Anna A Florence Julaine J King Wendy W Senesac Claudia R CR Eagle Michelle M

Frontiers in genetics 20211110

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 t ...[more]

PMID: 34858470

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Project description:ObjectivesTo review the content of recommendations within antenatal oral healthcare guidance documents and appraise the quality of their methodology to inform areas of development, clinical practice, and research focus.MethodA systematic search of five electronic databases, Google search engine, and databases from relevant professional and guideline development groups published in English, developed countries, and between 2010 and 2020 was undertaken to identify guidance documents related to antenatal oral healthcare. Quality of documents was appraised using the Appraisal of Guidelines Research and Evaluation II tool, and a 3-step quality cut-off value was used. Inductive thematic analysis was employed to categories discreet recommendations into themes.ResultsSix guidelines and one consensus statement were analysed. Two documents developed within Australia scored ≥60% across five of the six domains of the quality appraisal tool and were recommended for use. Four documents (developed in the United States and Canada) were recommended for use with modifications, whilst one document (developed in Europe) was not recommended. A total of 98 discreet recommendations were identified and demonstrated considerable unanimity but differed in scope and level of information. The main content and number of recommendations were inductively categorised within the following clinical practice points: risk factor assessments (n = 2), screening and assessment (n = 10), pre-pregnancy care (referral, n = 1), antenatal care (health education and advice, n = 14; management of nausea and vomiting, n = 7; referral, n = 2), postnatal care (health education and advice, n = 1; anticipatory guidance, n = 6), documentation (n = 4), coordinated care (n = 4), capacity building (n = 6), and community engagement (n = 1).ConclusionThe methodological rigour of included guidance documents revealed areas of strengths and limitations and posit areas for improvement. Further research could centre on adapting antenatal oral healthcare guidelines and consensus statements to local contexts. More high-quality studies examining interventions within antenatal oral healthcare are needed to support the development of recommendations.

Project description:BackgroundParticipation in quality controls, also called external quality assessment (EQA) schemes, is required for the ISO15189 accreditation of the Medical Centers of Human Genetics. However, directives on the minimal frequency of participation in genetic quality control schemes are lacking or too heterogeneous, with a possible impact on health care quality.ObjectiveThe aim of this project is to develop Belgian guidelines on the frequency of participation in quality controls for genetic testing in the context of rare diseases.MethodsA group of experts analyzed 90 EQA schemes offered by accredited providers and focused on analyses used for the diagnosis of rare diseases. On that basis, the experts developed practical recommendations about the minimal frequencies of participation of the Medical Centers of Human Genetics in quality controls and how to deal with poor performances and change management. These guidelines were submitted to the Belgian Accreditation Body and then reviewed and approved by the Belgian College of Human Genetics and Rare Diseases and by the National Institute for Health and Disability Insurance.ResultsThe guidelines offer a decisional algorithm for the minimal frequency of participation in human genetics EQA schemes. This algorithm has been developed taking into account the scopes of the EQA schemes, the levels of experience, and the annual volumes of the Centers of Human Genetics in the performance of the tests considered. They include three key principles: (1) the recommended annual assessment of all genetic techniques and technological platforms, if possible through EQAs covering the technique, genotyping, and clinical interpretation; (2) the triennial assessment of the genotyping and interpretation of specific germline mutations and pharmacogenomics analyses; and (3) the documentation of actions undertaken in the case of poor performances and the participation to quality control the following year. The use of a Bayesian statistical model has been proposed to help the Centers of Human Genetics to determine the theoretical number of tests that should be annually performed to achieve a certain threshold of performance (eg, a maximal error rate of 1%). Besides, the guidelines insist on the role and responsibility of the national public health authorities in the follow-up of the quality of analyses performed by the Medical Centers of Human Genetics and in demonstrating the cost-effectiveness and rationalization of participation frequency in these quality controls.ConclusionsThese guidelines have been developed based on the analysis of a large panel of EQA schemes and data collected from the Belgian Medical Centers of Human Genetics. They are applicable to other countries and will facilitate and improve the quality management and financing systems of the Medical Centers of Human Genetics.

Dataset Information

Consensus Guidelines for Improving Quality of Assessment and Training for Neuromuscular Diseases.

Publications

Consensus Guidelines for Improving Quality of Assessment and Training for Neuromuscular Diseases.

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