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Are large clinical trials in orthopaedic trauma justified?

ABSTRACT: BACKGROUND:The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. METHODS: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. RESULTS: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). CONCLUSIONS:Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. TRIAL REGISTRATION:NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008.

SUBMITTER: Sprague S

PROVIDER: S-EPMC5909275 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Are large clinical trials in orthopaedic trauma justified?

Sprague Sheila S Tornetta Paul P Slobogean Gerard P GP O'Hara Nathan N NN McKay Paula P Petrisor Brad B Jeray Kyle J KJ Schemitsch Emil H EH Sanders David D Bhandari Mohit M

BMC musculoskeletal disorders 20180420 1

<h4>Background</h4>The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data.<h4>Methods</h4>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 calcu ...[more]

PMID: 29678204

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Project description:Opioids are vital to pain management and sedation after trauma-related hospitalization. However, there are many confounding clinical, social, and environmental factors that exacerbate pain, post-injury care needs, and receipt of opioid prescriptions following orthopaedic trauma. This retrospective study sought to characterize differences in opioid prescribing and dosing in a national Medicaid eligible sample from 2010-2018. The study population included adults, discharged after orthopaedic trauma hospitalization, and receiving an opioid prescription within 30 days of discharge. Patients were identified using the International Classification of Diseases (ICD-9; ICD-10) codes for inpatient diagnosis and procedure. Filled opioid prescriptions were identified from National Drug Codes and converted to morphine milligram equivalents (MME). Opioid receipt and dosage (e.g., morphine milligram equivalents [MME]) were examined as the main outcomes using regressions and analyzed by year, sex, race/ethnicity, residence rurality-urbanicity, and geographic region. The study population consisted of 86,091 injured Medicaid-enrolled adults; 35.3% received an opioid prescription within 30 days of discharge. Male patients (OR = 1.12, 95% CI: 1.07-1.18) and those between 31-50 years of age (OR = 1.15, 95% CI: 1.08-1.22) were found to have increased odds ratio of receiving an opioid within 30 days of discharge, compared to female and younger patients, respectively. Patients with disabilities (OR = 0.75, 95% CI: 0.71-0.80), prolonged hospitalizations, and both Black (OR = 0.87, 95% CI: 0.83-0.92) and Hispanic patients (OR = 0.72, 95% CI: 0.66-0.77), relative to white patients, had lower odds ratio of receiving an opioid prescription following trauma. Additionally, Black and Hispanic patients received lower prescription doses compared to white patients. Individuals hospitalized in the Southeastern United States and those between the ages of 51-65 age group were found to be prescribed lower average daily MME. There were significant variations in opioid prescribing practices by race, sex, and region. National guidelines for use of opioids and other pain management interventions in adults after trauma hospitalization may help limit practice variation and reduce implicit bias and potential harms in outpatient opioid usage.

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Are large clinical trials in orthopaedic trauma justified?

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Are large clinical trials in orthopaedic trauma justified?

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