Analysis of the quality of description of usual care interventions in clinical trials involving exercise for knee osteoarthritis: a systematic review protocol
DOI:
https://doi.org/10.62827/fb.v25i1.j161Keywords:
knee osteoarthritis; patient care; exercise.Abstract
Introduction: Treatment for Osteoarthritis (OA) includes exercises, educational and self-management programs, with new therapeutic interventions often compared to "Usual Care". Objectives: To investigate the quality of description of Usual Care as a comparator group in randomized clinical trials (RCTs) using exercise in the treatment of knee OA through a Systematic Review (SR). Methods: A search will be conducted in the MEDLINE, Embase, Cochrane Central, PEDro, CINAHL, and SPORTDiscus databases to identify RCTs that used Usual Care as a comparator in the treatment of knee OA with exercise. After selection, eligible studies will be assessed by a pair of trained researchers. The PEDro scale will be used to evaluate the risk of bias, with each study classified as "poor," "fair," "good," or "excellent," and intervention description will be assessed using the TIDieR checklist. The quality of the intervention descriptions in each RCT will be classified as "High" if the score is equal to or greater than 50% of the total score, or "Low" if it is lower. Unpaired t-tests and the chi-square test will be used for the evaluation of numerical and categorical variables, respectively. Expected Results: The results of this review are expected to summarize the quality of intervention description in RCTs in OA that are often inadequately described, especially concerning the control group, making replication in RCTs and comparison between tested therapies challenging. A well-constructed SR protocol is necessary to help clarify uncertainties about interventions generically referred to as Usual Care.
References
Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis and Cartilage. novembro de 2019;27(11):1578–89. doi: 10.1016/j.joca.2019.06.011.
Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, et al. OARSI recommendations for the management of hip and knee osteoarthritis. Osteoarthritis and Cartilage. 2010;18(4):476–99. doi: 10.1016/j.joca.2007.12.013.
Arienti C, Buraschi R, Pollet J, Lazzarini SG, Cordani C, Negrini S, et al. A systematic review opens the black box of “usual care” in stroke rehabilitation control groups and finds a black hole. Eur J Phys Rehabil Med [Internet]. 2022 [citado 31 de agosto de 2022];58(4). DOI: 10.23736/S1973-9087.22.07413-5
Goh SL, Persson MSM, Stocks J, Hou Y, Lin J, Hall MC, et al. Efficacy and potential determinants of exercise therapy in knee and hip osteoarthritis: A systematic review and meta-analysis. Annals of Physical and Rehabilitation Medicine. setembro de 2019;62(5):356–65. doi: 10.1016/j.rehab.2019.04.006
Abbott JH, Robertson MC, Chapple C, Pinto D, Wright AA, Leon De La Barra S, et al. Manual therapy, exercise therapy, or both, in addition to usual care, for osteoarthritis of the hip or knee: a randomized controlled trial. 1: clinical effectiveness. Osteoarthritis and Cartilage. 2013;21(4):525–34. doi: 10.1016/j.joca.2012.12.014.
Pisters MF, Veenhof C, Schellevis FG, De Bakker DH, Dekker J. Long-term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized controlled trial comparing two different physical therapy interventions. Osteoarthritis and Cartilage. 2010;18(8):1019–26. doi: 10.1002/art.23009.
Wallis JA, Webster KE, Levinger P, Singh PJ, Fong C, Taylor NF. A walking program for people with severe knee osteoarthritis did not reduce pain but may have benefits for cardiovascular health: a phase II randomised controlled trial. Osteoarthritis and Cartilage. 2017;25(12):1969– 79. doi: 10.1016/j.joca.2016.12.017
Yu AM, Balasubramanaiam B, Offringa M, Kelly LE. Reporting of interventions and “standard of care” control arms in pediatric clinical trials: a quantitative analysis. Pediatr Res. 2018;84(3):393–8. doi: 10.1038/s41390-018-0019-7
Paci M, Risaliti F, Pellicciari L. Reporting of “usual care” as the control group in randomized clinical trials of physiotherapy interventions for multiple sclerosis is poor: a systematic review. Neurol Sci [Internet]. doi.org/10.1007/s10072-022-06167-9
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. doi.org/doi:10.1136/bmj.g1687
de Morton NA. The PEDro scale is a valid measure of the methodological quality of clinical trials: a demographic study. Australian Journal of Physiotherapy. 2009;55(2):129–33. doi: 10.1016/s0004-9514(09)70043-1
Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;n71. doi: 10.1186/s13643-021-01626-4
Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. doi.org/doi:10.1136/bmj.g7647
Higgins JP, Green S. Cochrane Handbook for Systematic Reviews of Interventions : Cochrane Book Series. 2023. doi:10.1002/9780470712184
Yamato TP, Maher CG, Saragiotto BT, Catley MJ, Moseley AM. Rasch analysis suggested that items from the template for intervention description and replication (TIDieR) checklist can be summed to create a score. Journal of Clinical Epidemiology. 2018;101:28–34. doi: 10.1016/j.jclinepi.2018.05.014
Barros BS de, Imoto AM, O’Neil J, Duquette-Laplante F, Perrier MF, Dorion M, et al. The management of lower back pain using pilates method: assessment of content exercise reporting in RCTs. Disability and Rehabilitation. 2022;44(11):2428–36. https://doi.org/10.1080/09638288.2020.1836269
Shiwa SR, Costa LOP, Moser AD de L, Aguiar I de C, Oliveira LVF de. PEDro: a base de dados de evidências em fisioterapia. Fisioter mov. 2011;24(3):523–33. https://doi.org/10.1590/S0103-51502011000300017
Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. Journal of Clinical Epidemiology. agosto de 2010;63(8):e1–37. doi: 10.1016/j.ijsu.2011.10.001
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. Ann Intern Med. 2013;158(3):200. doi: 10.7326/0003-4819-158-3-201302050-00583
Published
Issue
Section
License
Copyright (c) 2024 Lucas, Paula, José Neto, Nívea, Ana Carolina, Areolino (Autor)
This work is licensed under a Creative Commons Attribution 4.0 International License.
Autores que publicam nesta revista concordam com os seguintes termos:
Autores mantém os direitos autorais e concedem à revista o direito de primeira publicação, com o trabalho simultaneamente licenciado sob a Licença Creative Commons Attribution 4.0 que permite o compartilhamento do trabalho com reconhecimento da autoria e publicação inicial nesta revista.
Autores têm autorização para distribuição não-exclusiva da versão do trabalho publicada nesta revista (ex.: publicar em repositório institucional ou como capítulo de livro), com reconhecimento de autoria e publicação inicial nesta revista.
