Piloto de ensaios clínicos randômicos: o que precisamos saber?

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https://doi.org/10.17267/2317-3378rec.2024.e5654

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Referências

(1) Kandi V, Vadakedath S. Clinical Trials and Clinical Research: A Comprehensive Review. Cureus. 2023;15(2):e35077. https://doi.org/10.7759/cureus.35077 DOI: https://doi.org/10.7759/cureus.35077

(2) Pronk AJM, Roelofs A, Flum DR, Bonjer HJ, Hilal MA, Dijkgraaf MGW, et al. Two decades of surgical randomized controlled trials: worldwide trends in volume and methodological quality. Br J Surg. 2023;110(10):1300-8. https://doi.org/10.1093/bjs/znad160 DOI: https://doi.org/10.1093/bjs/znad160

(3) Singh AP, Vadakedath S, Kandi V. Clinical Research: A Review of Study Designs, Hypotheses, Errors, Sampling Types, Ethics, and Informed Consent. Cureus. 2023;15(1):e33374. https://doi.org/10.7759/cureus.33374 DOI: https://doi.org/10.7759/cureus.33374

(4) Fletcher RH, Fletcher SW, Fletcher GS. Epidemiologia clínica: elementos essenciais. Tradução de Martins RM. 5 ed. Porto alegre: Artmed; 2014.

(5) Zabor EC, Kaizer AM, Hobbs BP. Randomized Controlled Trials. Chest. 2020;158(1S):S79-S87. https://doi.org/10.1016/j.chest.2020.03.013 DOI: https://doi.org/10.1016/j.chest.2020.03.013

(6) Khan MIU, Mbuagbaw L, Holek M, Bdair F, Durrani ZH, Mellor K, et al. Transparency of informed consent in pilot and feasibility studies is inadequate: a single-center quality assurance study. Pilot Feasibility Stud. 2021;7(96):1-10. https://doi.org/10.1186/s40814-021-00828-w DOI: https://doi.org/10.1186/s40814-021-00828-w

(7) Lawson DO, Mellor K, Saskia E, Lee C, Kim KH, Kim K, et al. Pilot and Feasibility Studies in Rehabilitation Research: A Review and Educational Primer for the Physiatrist Researcher. Am J Phys Med Rehabil. 2022;101(4):372-83. https://doi.org/10.1097/PHM.0000000000001797 DOI: https://doi.org/10.1097/PHM.0000000000001797

(8) Kaur N, Figueiredo S, Bouchard V, Moriello C, Mayo N. Where have all the pilot studies gone? A follow-up on 30 years of pilot studies in Clinical Rehabilitation. Clin Rehabil. 2017;31(9):1238-48. https://doi.org/10.1177/0269215517692129 DOI: https://doi.org/10.1177/0269215517692129

(9) Charlesworth M, Klein AA, White SM. A bibliometric analysis of the conversion and reporting of pilot studies published in six anaesthesia journals. Anaesthesia. 2020;75(2):247-53. https://doi.org/10.1111/anae.14817 DOI: https://doi.org/10.1111/anae.14817

(10) Morgan B, Hejdenberg J, Kuleszewicz K, Armstrong D, Ziebland S. Are some feasibility studies more feasible than others? A review of the outcomes of feasibility studies on the ISRCTN registry. Pilot Feasibility Stud. 2021;7(195):1-8. https://doi.org/10.1186/s40814-021-00931-y DOI: https://doi.org/10.1186/s40814-021-00931-y

(11) Khan MIU, Brar HK, Sun CY, He R, El-Khechen HA, Mellor K, et al. The reporting of pilot and feasibility studies in the top dental specialty journals is suboptimal. Pilot Feasibility Stud. 2022;8(224):1-8. https://doi.org/10.1186/s40814-022-01182-1 DOI: https://doi.org/10.1186/s40814-022-01182-1

(12) Mellor K, Albury C, Dutton SJ, Eldridge S, Hopewell S. Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting. Pilot Feasibility Stud. 2023;9(59):1-10. https://doi.org/10.1186/s40814-023-01291-5 DOI: https://doi.org/10.1186/s40814-023-01291-5

(13) Mbuagbaw L, Chen LH, Aluko E, Stevens-Uninsky M, Eze-Onuorah ACJ, Garcia MC, et al. Empirical progression criteria thresholds for feasibility outcomes in HIV clinical trials: a methodological study. Pilot Feasibility Stud. 2023;9(96):1-9. https://doi.org/10.1186/s40814-023-01342-x DOI: https://doi.org/10.1186/s40814-023-01342-x

(14) Aschbrenner KA, Kruse G, Gallo JJ, Clark VLP. Applying mixed methods to pilot feasibility studies to inform intervention trials. Pilot Feasibility Stud. 2022;8(217):1-13. https://doi.org/10.1186/s40814-022-01178-x DOI: https://doi.org/10.1186/s40814-022-01178-x

(15) Shah A, Gustafson O, Vollam S. Pilot and feasibility studies - more than just measuring metrics. Anaesthesia. 2020;75(5):693. https://doi.org/10.1111/anae.15019 DOI: https://doi.org/10.1111/anae.15019

(16) Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012;65(3):301-8. https://doi.org/10.1016/j.jclinepi.2011.07.011 DOI: https://doi.org/10.1016/j.jclinepi.2011.07.011

(17) Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014;15(264):1-13. https://doi.org/10.1186/1745-6215-15-264 DOI: https://doi.org/10.1186/1745-6215-15-264

(18) Kleidon TM, Schults JA, Wainwright C, Mihala G, Gibson V, Saiyed M, et al. Comparison of midline catheters and peripherally inserted central catheters to reduce the need for general anesthesia in children with respiratory disease: A feasibility randomized controlled trial. Paediatr Anaesth. 2021;31(9):985-995. https://doi.org/10.1111/pan.14229 DOI: https://doi.org/10.1111/pan.14229

(19) Pearse I, Marsh N, Rickard CM, Ullman AJ, Larsen E, Pelecanos A, et al. Polyhexamethylene biguanide discs versus unmedicated dressings for prevention of central venous catheter-associated infection in the intensive care unit: A pilot randomised controlled trial to assess protocol safety and feasibility. Aust Crit Care. 2022;35(5):512-9. https://doi.org/10.1016/j.aucc.2021.05.015 DOI: https://doi.org/10.1016/j.aucc.2021.05.015

(20) Horne E, Lancaster GA, Matson R, Cooper A, Ness A, Leary S. Pilot trials in physical activity journals: a review of reporting and editorial policy. Pilot Feasibility Stud. 2018;4(125):1-13. https://doi.org/10.1186/s40814-018-0317-1 DOI: https://doi.org/10.1186/s40814-018-0317-1

(21) Shanthanna H, Kaushal A, Mbuagbaw L, Couban R, Busse J, Thabane L. A cross-sectional study of the reporting quality of pilot or feasibility trials in high-impact anesthesia journals. Can J Anaesth. 2018;65(11):1180-95. https://doi.org/10.1007/s12630-018-1194-z DOI: https://doi.org/10.1007/s12630-018-1194-z

(22) McGrath M, Chen C, Braga LH, Farrokhyar F. Quality of reporting for pilot randomized controlled trials in the pediatric urology literature-A systematic review. J Pediatr Urol. 2021;17(6):846-54. https://doi.org/10.1016/j.jpurol.2021.09.012 DOI: https://doi.org/10.1016/j.jpurol.2021.09.012

(23) Pearson N, Naylor PJ, Ashe MC, Fernandez M, Yoong SL, Wolfenden L. Guidance for conducting feasibility and pilot studies for implementation trials. Pilot Feasibility Stud. 2020;6(167):1-12. https://doi.org/10.1186/s40814-020-00634-w DOI: https://doi.org/10.1186/s40814-020-00634-w

Publicado

27.09.2024

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1.
dos Santos LM, Silva BSM, de Souza ER, Bittencourt IS, Rocha PK, Kusahara DM. Piloto de ensaios clínicos randômicos: o que precisamos saber?. Rev Enf Contemp [Internet]. 27º de setembro de 2024 [citado 30º de outubro de 2024];13:e5654. Disponível em: https://journals.bahiana.edu.br/index.php/enfermagem/article/view/5654

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