Showing papers by "Steven N. Goodman published in 2015"

Meta-research: Evaluation and Improvement of Research Methods and Practices.

Abstract: As the scientific enterprise has grown in size and diversity, we need empirical evidence on the research process to test and apply interventions that make it more efficient and its results more reliable. Meta-research is an evolving scientific discipline that aims to evaluate and improve research practices. It includes thematic areas of methods, reporting, reproducibility, evaluation, and incentives (how to do, report, verify, correct, and reward science). Much work is already done in this growing field, but efforts to-date are fragmented. We provide a map of ongoing efforts and discuss plans for connecting the multiple meta-research efforts across science worldwide.

CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomized trials

Abstract: R controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions. However, randomized trials can yield biased results if they lack methodological rigour.1 To assess a trial accurately, readers of a published report need complete, clear, and transparent information on its methodology and findings. Unfortunately, attempted assessments frequently fail because authors of many trial reports neglect to provide lucid and complete descriptions of that critical information.2–4 That lack of adequate reporting fuelled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 19965 and its revision five years later.6–8 While those statements See related editorial on page 892.

Data monitoring committees for pragmatic clinical trials.

Abstract: In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an independent data monitoring committee due to their potential impact on clinical practice. However, the very features that make a trial "pragmatic" may pose challenges in terms of which aspects of a trial to monitor and when it is appropriate for a data monitoring committee to intervene. Using the Pragmatic-Explanatory Continuum Indicator Summary tool that draws distinctions between pragmatic and explanatory clinical trials, we review characteristics of pragmatic clinical trials that may have implications for data monitoring committees and interim monitoring plans. These include broad eligibility criteria, a focus on subjective patient-centered outcomes, and in some cases a lack of standardized follow-up procedures across study sites. Additionally, protocol adherence is often purposefully not addressed in pragmatic trials in order to accurately represent the clinical practice setting and maintain practicability of implementation; there are differing viewpoints as to whether adherence should be assessed and acted upon by data monitoring committees in these trials. Some other issues not specifically related to the Pragmatic-Explanatory Continuum Indicator Summary criteria may also merit special consideration in pragmatic trials. Thresholds for early termination of a pragmatic clinical trial might be controversial. The distinguishing features of pragmatic clinical trials require careful consideration when developing interim data monitoring plans, and trial sponsors, investigators, and data monitoring committees should agree on a plan before trial inception. Finally, special expertise, such as an informatics, may be helpful on data monitoring committees for some pragmatic clinical trials. Patient representatives may provide particularly valuable insights in the monitoring process.

Informatics: Make sense of health data.

Abstract: Develop the science of data synthesis to join up the myriad varieties of health information, insist Julian H. Elliott, Jeremy Grimshaw and colleagues.

Clinical trial data sharing: what do we do now?

Abstract: This commentary discusses the Institute of Medicine report on sharing clinical trial data and envisions a world with realigned incentives so that the maximum benefits can be derived from making mor...

An interview with David Sackett, 2014-2015

Abstract: As part of its interest in publishing profiles of prominent clinical trialists, Clinical Trials asked David Sackett in 2013 if he would agree to be interviewed for the journal. Not surprisingly, we were not the only ones calling, and in 2014, David agreed to sit down with his selected autobiographical interviewer, former mentee Brian Haynes, for a profile that could be available to all those interested. Over the course of several months, until shortly before his death on 13 May 2015 from cholangiocarcinoma, David recounted in extraordinary detail the trajectory of his personal and professional journey. The level of texture and detail therein was itself testimony to his incredible and lively intellect. For Clinical Trials, we have chosen to publish just those segments most relevant to his career in clinical trials, comprising only about 10% of the full profile, which can be found at http://fhs.mcmaster.ca/ceb/ docs/David_L_Sackett_Interview_in_2014_2015.pdf. As noted in the editorial found in this issue, David was an ardent advocate for using clinical trials as a guide for clinical decision making, and since 1999, he was a very active member of the Society for Clinical Trials (SCT) and regular columnist in this journal. We are tremendously grateful not just for his career and professional contributions but also for his extraordinary generosity in taking the time to share his life story with us and the world during his final months.