Abstract：
UNASSIGNED: The lack of standardized disability progression evaluation in multiple sclerosis (MS) hinders reproducibility of clinical study results, due to heterogeneous and poorly reported criteria.
UNASSIGNED: To demonstrate the impact of using different parameters when evaluating MS progression, and to introduce an automated tool for reproducible outcome computation.
UNASSIGNED: Re-analyzing BRAVO clinical trial data (NCT00605215), we examined the fluctuations in computed treatment effect on confirmed disability progression (CDP) and progression independent of relapse activity (PIRA) when varying different parameters. These analyses were conducted using the msprog package for R, which we developed as a tool for CDP assessment from longitudinal data, given a set of criteria that can be specified by the user.
UNASSIGNED: The BRAVO study reported a hazard ratio (HR) of 0.69 (95% confidence interval (CI): 0.46-1.02) for CDP. Using the different parameter configurations, the resulting treatment effect on CDP varied considerably, with HRs ranging from 0.59 (95% CI: 0.41-0.86) to 0.72 (95% CI: 0.48-1.07). The treatment effect on PIRA varied from an HR = 0.62 (95% CI: 0.41-0.93) to an HR = 0.65 (95% CI: 0.40-1.04).
UNASSIGNED: The adoption of an open-access tool validated by the research community, with clear parameter specification and standardized output, could greatly reduce heterogeneity in CDP estimation and promote repeatability of study results.
UNASSIGNED: To demonstrate the impact of using different parameters when evaluating MS progression, and to introduce an automated tool for reproducible outcome computation.
UNASSIGNED: Re-analyzing BRAVO clinical trial data (NCT00605215), we examined the fluctuations in computed treatment effect on confirmed disability progression (CDP) and progression independent of relapse activity (PIRA) when varying different parameters. These analyses were conducted using the msprog package for R, which we developed as a tool for CDP assessment from longitudinal data, given a set of criteria that can be specified by the user.
UNASSIGNED: The BRAVO study reported a hazard ratio (HR) of 0.69 (95% confidence interval (CI): 0.46-1.02) for CDP. Using the different parameter configurations, the resulting treatment effect on CDP varied considerably, with HRs ranging from 0.59 (95% CI: 0.41-0.86) to 0.72 (95% CI: 0.48-1.07). The treatment effect on PIRA varied from an HR = 0.62 (95% CI: 0.41-0.93) to an HR = 0.65 (95% CI: 0.40-1.04).
UNASSIGNED: The adoption of an open-access tool validated by the research community, with clear parameter specification and standardized output, could greatly reduce heterogeneity in CDP estimation and promote repeatability of study results.
摘要：
■多发性硬化症（MS）缺乏标准化的残疾进展评估，阻碍了临床研究结果的可重复性，由于标准不同且报告不充分。
■为了证明在评估MS进展时使用不同参数的影响，并引入用于可重复结果计算的自动化工具。
■重新分析BRAVO临床试验数据（NCT00605215），我们检查了在改变不同参数时,对确认的残疾进展(CDP)和独立于复发活动度的进展(PIRA)的计算治疗效果的波动.这些分析是使用用于R的msprog软件包进行的，我们从纵向数据中开发了CDP评估工具，给定一组可以由用户指定的标准。
■BRAVO研究报告CDP的风险比（HR）为0.69（95％置信区间（CI）：0.46-1.02）。使用不同的参数配置，对CDP的治疗效果差异很大，HR范围为0.59（95%CI：0.41-0.86）至0.72（95%CI：0.48-1.07）。对PIRA的治疗效果从HR=0.62（95％CI：0.41-0.93）到HR=0.65（95％CI：0.40-1.04）不等。
■采用由研究界验证的开放获取工具，具有明确的参数规格和标准化的输出，可以大大降低CDP估计的异质性，提高研究结果的可重复性。
■为了证明在评估MS进展时使用不同参数的影响，并引入用于可重复结果计算的自动化工具。
■重新分析BRAVO临床试验数据（NCT00605215），我们检查了在改变不同参数时,对确认的残疾进展(CDP)和独立于复发活动度的进展(PIRA)的计算治疗效果的波动.这些分析是使用用于R的msprog软件包进行的，我们从纵向数据中开发了CDP评估工具，给定一组可以由用户指定的标准。
■BRAVO研究报告CDP的风险比（HR）为0.69（95％置信区间（CI）：0.46-1.02）。使用不同的参数配置，对CDP的治疗效果差异很大，HR范围为0.59（95%CI：0.41-0.86）至0.72（95%CI：0.48-1.07）。对PIRA的治疗效果从HR=0.62（95％CI：0.41-0.93）到HR=0.65（95％CI：0.40-1.04）不等。
■采用由研究界验证的开放获取工具，具有明确的参数规格和标准化的输出，可以大大降低CDP估计的异质性，提高研究结果的可重复性。
