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Medical and scientific writing: Time to go lean and mean.

ABSTRACT: The Lean Six Sigma methodology for process improvements and driving efficiency is old, but lean writing was adopted late by the pharmaceutical world in terms of size of the documents. The documents were lean earlier, and then became voluminous, and now we are about to complete a full circle in this regard, i.e., coming back to the lean documents again using e-formats and hyperlinking. Furthermore, writing has become more and more precise over time. The need for this lean and mean medical and scientific writing arose from voluminous research globally, both industry and academia which are abuzz with skyrocketing regulatory and scientific submission volumes. The quantum of literature is so much that reviewers or information seekers firmly believe that going through even selected and relevant literature has become highly challenging. Considering this, there has been much insistence on downsizing the medical writing documents, which could be tempting enough to be leveraged for scientific publications as well. Here, we present the need for lean and mean medical writing, discuss this concept in relation to the pharmaceutical industry, and how to apply this to key documents. Furthermore, presented is the proposed algorithm for lean and mean clinical study reports and manuscripts. These thoughts are aligned to the recently established concept of data transparency, and can be easily achieved by web links between the protocols and clinical trial results disclosed publicly, and the corresponding manuscripts.

SUBMITTER: Bhardwaj P

PROVIDER: S-EPMC5543761 | biostudies-other | 2017 Jul-Sep

REPOSITORIES: biostudies-other

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Project description:BackgroundWriting plays a central role in the communication of scientific ideas and is therefore a key aspect in researcher education, ultimately determining the success and long-term sustainability of their careers. Despite the growing popularity of e-learning, we are not aware of any existing study comparing on-line vs. traditional classroom-based methods for teaching scientific writing.MethodsForty eight participants from a medical, nursing and physiotherapy background from US and Brazil were randomly assigned to two groups (n = 24 per group): An on-line writing workshop group (on-line group), in which participants used virtual communication, google docs and standard writing templates, and a standard writing guidance training (standard group) where participants received standard instruction without the aid of virtual communication and writing templates. Two outcomes, manuscript quality was assessed using the scores obtained in Six subgroup analysis scale as the primary outcome measure, and satisfaction scores with Likert scale were evaluated. To control for observer variability, inter-observer reliability was assessed using Fleiss's kappa. A post-hoc analysis comparing rates of communication between mentors and participants was performed. Nonparametric tests were used to assess intervention efficacy.ResultsExcellent inter-observer reliability among three reviewers was found, with an Intraclass Correlation Coefficient (ICC) agreement = 0.931882 and ICC consistency = 0.932485. On-line group had better overall manuscript quality (p = 0.0017, SSQSavg score 75.3 +/- 14.21, ranging from 37 to 94) compared to the standard group (47.27 +/- 14.64, ranging from 20 to 72). Participant satisfaction was higher in the on-line group (4.3 +/- 0.73) compared to the standard group (3.09 +/- 1.11) (p = 0.001). The standard group also had fewer communication events compared to the on-line group (0.91 +/- 0.81 vs. 2.05 +/- 1.23; p = 0.0219).ConclusionOur protocol for on-line scientific writing instruction is better than standard face-to-face instruction in terms of writing quality and student satisfaction. Future studies should evaluate the protocol efficacy in larger longitudinal cohorts involving participants from different languages.

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Medical and scientific writing: Time to go lean and mean.

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