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What evidence is used to underpin the design of strength-based exercise interventions evaluated in randomised controlled trials for rheumatoid arthritis? A systematic review protocol

INTRODUCTION: Healthcare researchers designing strength-based exercise interventions must choose an appropriate dose to test before evaluating its effect using a definitive/phase-III randomised controlled trial (RCT). Compared with early phase testing employed by pharmaceutical trials, it is questio...

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Autores principales: Boniface, Graham, Norris, Meriel, Williamson, Esther, Gandhi, Varsha, Kirtley, Shona, O’Connell, Neil
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6144333/
https://www.ncbi.nlm.nih.gov/pubmed/30206094
http://dx.doi.org/10.1136/bmjopen-2018-024127
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author Boniface, Graham
Norris, Meriel
Williamson, Esther
Gandhi, Varsha
Kirtley, Shona
O’Connell, Neil
author_facet Boniface, Graham
Norris, Meriel
Williamson, Esther
Gandhi, Varsha
Kirtley, Shona
O’Connell, Neil
author_sort Boniface, Graham
collection PubMed
description INTRODUCTION: Healthcare researchers designing strength-based exercise interventions must choose an appropriate dose to test before evaluating its effect using a definitive/phase-III randomised controlled trial (RCT). Compared with early phase testing employed by pharmaceutical trials, it is questionable whether exercise-based trials employ the same rigour for establishing tolerated dosage. Consequently, it is unclear if participants are initially prescribed optimal doses of exercise, which may potentially impact on study outcomes. Using trials of strength-based exercise interventions in adults with rheumatoid arthritis (RA) as an exemplar, the aims of this review are to (1) identify the proportion of RCTs that use phase I/II trials with dose escalation methodology for setting prescription parameters, (2) determine type and level of evidence used to justify prescription parameters of strength-based exercise interventions evaluated by RCTs, (3) explore consistency and applicability of the evidence underpinning prescription parameters in RCTs and (4) explore if a relationship exists between risk of bias for RCTs evaluating strength-based interventions and the level of evidence used to underpin prescription parameters. METHODS AND ANALYSIS: Focusing on RCT’s evaluating strength-based exercise interventions in adults with RA published after 2000, the following databases will be searched: Allied and Complementary Medicine Database, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Excerpta Medica Database, Medline and Physiotherapy Evidence Database. For each RCT, we will identify the evidence used to underpin prescription parameters. Both trial and underpinning evidence will have key information about the intervention extracted using the template for intervention description and replication checklist. Risk of bias will be assessed according to Cochrane. Levels of evidence will be assessed against the Oxford Centre for Evidence-Based Medicine and relationships between RCT and underpinning evidence explored and described narratively. Two independent assessors will be involved throughout data selection and extraction with recourse to a third reviewer should agreement not be reached. ETHICS AND DISSEMINATION: No ethical issues are identified. Dissemination will be via publication. PROSPERO REGISTRATION NUMBER: CRD42018090963.
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spelling pubmed-61443332018-09-21 What evidence is used to underpin the design of strength-based exercise interventions evaluated in randomised controlled trials for rheumatoid arthritis? A systematic review protocol Boniface, Graham Norris, Meriel Williamson, Esther Gandhi, Varsha Kirtley, Shona O’Connell, Neil BMJ Open Rehabilitation Medicine INTRODUCTION: Healthcare researchers designing strength-based exercise interventions must choose an appropriate dose to test before evaluating its effect using a definitive/phase-III randomised controlled trial (RCT). Compared with early phase testing employed by pharmaceutical trials, it is questionable whether exercise-based trials employ the same rigour for establishing tolerated dosage. Consequently, it is unclear if participants are initially prescribed optimal doses of exercise, which may potentially impact on study outcomes. Using trials of strength-based exercise interventions in adults with rheumatoid arthritis (RA) as an exemplar, the aims of this review are to (1) identify the proportion of RCTs that use phase I/II trials with dose escalation methodology for setting prescription parameters, (2) determine type and level of evidence used to justify prescription parameters of strength-based exercise interventions evaluated by RCTs, (3) explore consistency and applicability of the evidence underpinning prescription parameters in RCTs and (4) explore if a relationship exists between risk of bias for RCTs evaluating strength-based interventions and the level of evidence used to underpin prescription parameters. METHODS AND ANALYSIS: Focusing on RCT’s evaluating strength-based exercise interventions in adults with RA published after 2000, the following databases will be searched: Allied and Complementary Medicine Database, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Excerpta Medica Database, Medline and Physiotherapy Evidence Database. For each RCT, we will identify the evidence used to underpin prescription parameters. Both trial and underpinning evidence will have key information about the intervention extracted using the template for intervention description and replication checklist. Risk of bias will be assessed according to Cochrane. Levels of evidence will be assessed against the Oxford Centre for Evidence-Based Medicine and relationships between RCT and underpinning evidence explored and described narratively. Two independent assessors will be involved throughout data selection and extraction with recourse to a third reviewer should agreement not be reached. ETHICS AND DISSEMINATION: No ethical issues are identified. Dissemination will be via publication. PROSPERO REGISTRATION NUMBER: CRD42018090963. BMJ Publishing Group 2018-09-10 /pmc/articles/PMC6144333/ /pubmed/30206094 http://dx.doi.org/10.1136/bmjopen-2018-024127 Text en © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Rehabilitation Medicine
Boniface, Graham
Norris, Meriel
Williamson, Esther
Gandhi, Varsha
Kirtley, Shona
O’Connell, Neil
What evidence is used to underpin the design of strength-based exercise interventions evaluated in randomised controlled trials for rheumatoid arthritis? A systematic review protocol
title What evidence is used to underpin the design of strength-based exercise interventions evaluated in randomised controlled trials for rheumatoid arthritis? A systematic review protocol
title_full What evidence is used to underpin the design of strength-based exercise interventions evaluated in randomised controlled trials for rheumatoid arthritis? A systematic review protocol
title_fullStr What evidence is used to underpin the design of strength-based exercise interventions evaluated in randomised controlled trials for rheumatoid arthritis? A systematic review protocol
title_full_unstemmed What evidence is used to underpin the design of strength-based exercise interventions evaluated in randomised controlled trials for rheumatoid arthritis? A systematic review protocol
title_short What evidence is used to underpin the design of strength-based exercise interventions evaluated in randomised controlled trials for rheumatoid arthritis? A systematic review protocol
title_sort what evidence is used to underpin the design of strength-based exercise interventions evaluated in randomised controlled trials for rheumatoid arthritis? a systematic review protocol
topic Rehabilitation Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6144333/
https://www.ncbi.nlm.nih.gov/pubmed/30206094
http://dx.doi.org/10.1136/bmjopen-2018-024127
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