Are large clinical trials in orthopaedic trauma justified?
| Autor: | Sprague, S, Tornetta, P, Slobogean, GP, O'Hara, NN, McKay, P, Petrisor, B, Jeray, KJ, Schemitsch, EH, Sanders, D, Bhandari, M, Guyatt, GH, Walter, S, Anglen, J, Bosse, M, Liew, S, Sancheti, P, Tai, K, Heels-Ansdell, D, Buckingham, L, Duraikannan, A, Tanner, SL, Snider, RG, Altman, D, Gandhi, R, Bischoff, M, Della Rocca, GJ, Ristevski, B, Rajaratnam, K, Williams, D, Denkers, M, Bednar, D, Sadler, J, Kwok, D, Drew, B, Wong, I, Madden, K, Hall, JA, McKee, MD, Ahn, H, Whelan, D, Waddell, J, Daniels, T, Bogoch, E, Nauth, A, Vicente, MR, Hidy, JT, Lawendy, AR, Gurr, K, Carey, T, Bailey, C, MacLeod, M, Bartley, D, Tieszer, C, Coles, C, Leighton, R, Richardson, CG, Biddulph, M, Gross, M, Dunbar, M, Amirault, JD, Alexander, D, Coady, C, Glazebrook, M, Johnston, D, Oxner, W, Trenholm, JA, Reardon, G, Trask, K, MacDonald, S, Papp, S, Gofton, W, Liew, A, Kingwell, S, O'Neill, J, Johnson, G, Wai, E, Foxall, J, Broekhuyse, HM, O'Brien, PJ, Blachut, PA, Lefaivre, KA, Johal, R, Leduc, S, Laflamme, GY, Beaumont, P, Malo, M, Benoit, B, Rouleau, D, Ranger, P, Fournier, J, Tardif, K, Reindl, R |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Reoperation
medicine.medical_specialty lcsh:Diseases of the musculoskeletal system Sports medicine medicine.medical_treatment Pilot Projects 03 medical and health sciences 0302 clinical medicine Rheumatology Internal medicine Epidemiology Medicine and Health Sciences Medicine Humans Multicenter Studies as Topic Orthopedics and Sports Medicine Orthopedic Procedures 030212 general & internal medicine Therapeutic Irrigation Saline Orthopaedic trial Randomized Controlled Trials as Topic FLOW trial business.industry Sample size Confidence interval 3. Good health Clinical trial Sample size determination Relative risk Orthopedic surgery Large trials lcsh:RC925-935 business 030217 neurology & neurosurgery Research Article |
| Zdroj: | BMC Musculoskeletal Disorders BMC Musculoskeletal Disorders, Vol 19, Iss 1, Pp 1-7 (2018) Bone and Joint Institute |
| ISSN: | 1471-2474 |
| Popis: | The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study. The pilot study analysis of 89 patients and initial incremental enrolments in the FLOW definitive trial favored low pressure compared to high pressure (RR: 1.50, 95% CI: 0.75–3.04; RR: 1.39, 95% CI: 0.60–3.23, respectively), which is in contradiction to the final enrolment, which found no difference between high and low pressure (RR: 1.04, 95% CI: 0.81–1.33). In the soap versus saline comparison, the FLOW pilot study suggested that re-operation rate was similar in both the soap and saline groups (RR: 0.98, 95% CI: 0.50–1.92), whereas the FLOW definitive trial found that the re-operation rate was higher in the soap treatment arm (RR: 1.28, 95% CI: 1.04–1.57). Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008. |
| Databáze: | OpenAIRE |
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