Kế hoạch phân tích thống kê cho một thử nghiệm lâm sàng ngẫu nhiên pha III thực tiễn kiểm tra can thiệp vật lý trị liệu thay đổi hành vi để tăng cường hoạt động thể chất sau khi phẫu thuật thay khớp hông và khớp gối: thử nghiệm PEP-TALK

Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Dore C, et al. Guidelines for the content of statistical analysis plans in clinical trials. JAMA. 2017;318(23):2337–43. https://doi.org/10.1001/jama.2017.18556. National Joint Registry. 17th Annual Report. https://reports.njrcentre.org.uk/Portals/0/PDFdownloads/NJR%2017th%20Annual%20Report%202020.pdf. Accessed 28 Jan 2021. Dailiana ZH, Papakostidou I, Varitimidis S, Liaropoulos L, Zintzaras E, Karachalios T, et al. Patient-reported quality of life after primary major joint arthroplasty: a prospective comparison of hip and knee arthroplasty. BMC Musculoskelet Disord. 2015;16(1):366. https://doi.org/10.1186/s12891-015-0814-9. Papakostidou I, Dailiana ZH, Papapolychroniou T, Liaropoulos L, Zintzaras E, Karachalios TS, et al. Factors affecting the quality of life after total knee arthroplasties: a prospective study. BMC Musculoskelet Disord. 2012;13(1):116. https://doi.org/10.1186/1471-2474-13-116. Inacio MC, Pratt NL, Roughead EE, Graves SE. Comparing co-morbidities in total joint arthroplasty patients using the RxRisk-V, Elixhauser, and Charlson Measures: a cross-sectional evaluation. BMC Musculoskelet Disord. 2015;16(1):385. https://doi.org/10.1186/s12891-015-0835-4. Peter WF, Dekker J, Tilbury C, Tordoir RL, Verdegaal SH, Onstenk R, et al. The association between comorbidities and pain, physical function and quality of life following hip and knee arthroplasty. Rheumatol Int. 2015;35(7):1233–41. https://doi.org/10.1007/s00296-015-3211-7. Smith E, Hoy DG, Cross M, Vos T, Naghavi M, Buchbinder R, et al. PICO. The global burden of other musculoskeletal disorders: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014;73(8):1462–9. https://doi.org/10.1136/annrheumdis-2013-204680. Sampson UK, Fowkes FG, MM MD, Criqui MH, Aboyans V, Norman PE, et al. Global and regional burden of death and disability from peripheral artery disease: 21 world regions, 1990 to 2010. Glob Heart. 2014;9(1):145–158.e21. Withers TM, Lister S, Sackley C, Clark A, Smith TO. Is there a difference in physical activity levels in patients before and up to one year after unilateral total hip replacement? A systematic review and meta-analysis. Clin Rehabil. 2017;31(5):639–50. https://doi.org/10.1177/0269215516673884. Smith TO, Hilton G, Mansfield M, Mann CJV, Sackley CM. Does physical activity change following hip and knee arthroplasty? An analysis of data from the Osteoarthritis Initiative. Physiotherapy. 2018;104(1):80–90. https://doi.org/10.1016/j.physio.2017.02.001. Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386(9995):743–800. Lee CD, Folsom AR, Blair SN. Physical activity and stroke risk: a meta-analysis. Stroke. 2003;34(10):2475–81. https://doi.org/10.1161/01.STR.0000091843.02517.9D. Laaksonen DE, Lindström J, Lakka TA, Eriksson JG, Niskanen L, Wikström K, et al. Physical activity in the prevention of type 2 diabetes: the Finnish diabetes prevention study. Diabetes. 2005;54(1):158–65. https://doi.org/10.2337/diabetes.54.1.158. Lee IM. Physical activity and cancer prevention--data from epidemiologic studies. Med Sci Sports Exerc. 2003;35(11):1823–7. https://doi.org/10.1249/01.MSS.0000093620.27893.23. Nocon M, Hiemann T, Müller-Riemenschneider F, Thalau F, Roll S, Willich SN. Association of physical activity with all-cause and cardiovascular mortality: a systematic review and meta-analysis. Eur J Cardiovasc Prev Rehabil. 2008;15(3):239–46. https://doi.org/10.1097/HJR.0b013e3282f55e09. Smith TO, Parsons S, Fordham B, on behalf of the PEP-TALK Trial Collaborators, et al. Behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement (PEP-TALK): study protocol for a pragmatic randomised controlled trial. BMJ Open. 2020;10(7):e035014. https://doi.org/10.1136/bmjopen-2019-035014. SooHoo NF, Li Z, Chenok KE, Bozic KJ. Responsiveness of patient reported outcome measures in total joint arthroplasty patients. J Arthroplast. 2015;30(2):176–91. https://doi.org/10.1016/j.arth.2014.09.026. Naal FD, Impellizzeri FM, Leunig M. Which is the best activity rating scale for patients undergoing total joint arthroplasty? Clin Orthop Relat Res. 2009;467(4):958–65. https://doi.org/10.1007/s11999-008-0358-5. Binkley JM, Stratford OW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): Scale development, measurement properties, and clinical application. Phys Ther. 1999;79(4):371–83. Dawson J, Fitzpatrick R, Carr A, Murray D. Questionnaire on the perceptions of patients about total hip replacement. J Bone Joint Surg (Br). 1996;78(2):185–90. Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg (Br). 1998;80(1):63–9. https://doi.org/10.1302/0301-620X.80B1.0800063. Murray DW, Fitzpatrick R, Rogers K, Pandit H, Beard DJ, Carr AJ, et al. The use of the Oxford hip and knee scores. J Bone Joint Surg (Br). 2007;89(8):1010–4. https://doi.org/10.1302/0301-620X.89B8.19424 PMID: 17785736. Bonsaksen T, Kottorp A, Gay C, Fagermoen MS, Lerdal A. Rasch analysis of the General Self-Efficacy Scale in a sample of persons with morbid obesity. Health Qual Life Outcomes. 2013;11(1):202. https://doi.org/10.1186/1477-7525-11-202. Miller RP, Kori S, Todd D. The Tampa Scale: a measure of kinesiophobia. Clin J Pain. 1991;7(1):51–2. https://doi.org/10.1097/00002508-199103000-00053. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70. https://doi.org/10.1111/j.1600-0447.1983.tb09716.x. Herdman M, Gudex C, Lloyd A, Janssen MF, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36. https://doi.org/10.1007/s11136-011-9903-x. van Hout B, Janssen MF, Feng YS, Kohlmann T, Busschbach J, Golicki D, et al. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5 L to EQ-5D-3L value sets. Value Health. 2012;15(5):708–15. https://doi.org/10.1016/j.jval.2012.02.008. Brooks R. EuroQol: the current state of play. Health Policy. 1996;37(1):53–72. https://doi.org/10.1016/0168-8510(96)00822-6. Bell M, King M, Fairclough D. Bias in area under the curve for longitudinal clinical trials with missing patient reported outcome data: summary measures versus summary statistics. SAGE Open. 2014. https://doi.org/10.1177/2158244014534858. Sullivan TR, White IR, Salter AB, Ryan P, Lee KJ. Should multiple imputation be the method of choice for handling missing data in randomized trials? Stat Methods Med Res. 2018;27(9):2610–26. https://doi.org/10.1177/0962280216683570. White IR, Royston P, Wood AM. Multiple imputation using chained equations: Issues and guidance for practice. Stat Med. 2011;30(4):377–99. https://doi.org/10.1002/sim.4067 Epub 2010 Nov 30. PMID: 21225900. Brookes ST, Whitley E, Peters TJ, Mulheran PA, Egger M, Davey Smith G. Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives. Health Technol Assess. 2001;5(33):1–56. https://doi.org/10.3310/hta5330. Lamb SE, Lall R, Hansen Z, Castelnuovo E, Withers EJ, Nichols V, et al. Underwood M; BeST trial group. A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The Back Skills Training (BeST) trial. Health Technol Assess. 2010;14(41):1–253, iii-iv. StataCorp. Stata statistical software: release 15. College Station: StatCorp LLC; 2017. R Core Team. R: a language and environment for statistical computing. Vienna: R Foundation for Statistical Computing; 2019. Finfer S, Bellomo R. Why publish statistical analysis plans? Crit Care Resusc. 2009;11(1):5–6.