Category Archives: Publication Writing

INNOVATIONS IN PEER-REVIEW

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Peer Review is the process of evaluation of manuscripts submitted for scientific publication in journals/books, pre-clinical or clinical study reports, research progress reports etc., by experts or peers with similar competence as manuscript authors. It plays a pivotal role in scholarly publications with objective to ascertain quality, reliability and credibility of the work reported in the manuscripts and reports through qualitative scrutiny. This contributes to the acceptability of scientific work as authentic, rigorous and coherent for the intended purpose. Also, it widens networking opportunities within the scientific fraternity.

Types of Peer Review

  • Single blind review: This is the traditional and most common type of review in which the reviewer’s name is hidden from the author.
  • Double-blind review: In this kind of review, there is anonymity of both the author and the reviewer to each other.
  • Open review: The identity of the author and the reviewer are known to each other and there is more transparent communication during the review process.

Peer-review is a golden practice to improve the quality of publications but comes with its own set of disadvantages and shortcomings. Table 1 details the various featural pros and cons of different types of peer-review.

Table 1 Advantages and Disadvantages of Peer-Reviewing [1]

Ethics of Peer Review

As the reviewing experts are essentially from the same area or field of the study as of the authors of documents under review, some conflict of interests or differences in viewpoints may introduce bias that might come in the way of a fair peer review. For instance, a reviewer may not accept the manuscript/report under review if the author’s hypothesis is different from that of the reviewer. Indeed, many journals take this possibility into account and allow the authors submitting manuscripts to give the name(s) of reviewers to whom the manuscript should not be sent for review in addition to names of reviewers the authors would like to recommend. But then, peer review by reviewers recommended by the authors may also occasionally lead to undeservingly favored evaluation.

To avoid undesirable contentions, it is a prerogative for a peer-reviewer to adhere to ethical guidelines outlined by the Committee of Publication Ethics (COPE), which categorises the ethical responsibility of a peer-review into confidentiality of the data reviewed, objectivity of the review process and diligence towards their competency, following processes, policies and conduct [6].

A few ethical practices that should be incorporated in peer-reviewing are as follows:

  • Maintaining objectivity and diligence in assessing a document
  • Avoiding any favoritism or likewise, negative bias
  • Respecting confidentiality of the manuscript
  • Avoiding giving any personal or derogatory remarks
  • Refraining from disrespectful tone of criticism
  • Maintaining timeliness
  • Adhering to the rationales, norms, policies and specific scope of the journal
  • Promptly reporting any unethical duplication or data fabrication/design
  • Staying discrete from the author during the review process to avoid any unwanted confrontation

Essential Components of Peer-Reviewing

Studies conducted by scientists/experts/professional are rendered into a detailed article or manuscript, a draft of which is then sent to the journal editor. The article is sent by the journal editor to peer reviewers before publication. The reviewers then assess the manuscript and extend their comments focusing on the following aspects:

  • Adequacy of the background information (literature survey) justifying the necessity and purpose of the study reported
  • Appropriateness and adequacy of the materials and methods employed to generate the data
  • Compliance to national and international regulatory requirements [e.g. Good Laboratory/Manufacturing/Clinical Practices (GLP/GMP/GCP), Animal ethics, OECD/ICH/USFDA guidelines etc.]
  • Analysis of data using appropriate (statistical) methods
  • Proper interpretation and discussion of the data/results and the conclusions drawn.
  • Originality of the study
  • Presentation of the manuscript relying on legible and comprehendible language that is grammatically, technically and scientifically correct

Innovations in Peer Review

Any advancement or innovation in a process primarily requires recognition of the prevalent roadblocks. “Necessity is the mother of invention”, Plato’s misattributed proverb reflects the rationale of some compelling advancements that peer-reviewing attributes to the share of challenges it had faced.” Addressing some fundamental conundrums, there are many driven groups across the scientific fraternity who have offer valuable innovative answers.

  • Raising the satisfaction quotient of the author-reviewer-editor trilogy by ‘Volunpeers’

Lack of familiarity with the subject matter causes many reviewers to decline from reviewing. To overcome this challenge, the journal of Molecular biology enabled a Reviewer Recognition Platform, that facilitates reviewers, christened as ‘Volunpeers’ (to represent the rationale of this platform), to register for their area of expertise and receive manuscripts for reviewing according to their preference. The outcome of this platform was impressive! It proudly flaunted a high rate of involvement and satisfaction from both the reviewer and the editor and establishes a faith that peer reviewing indeed has not reached an intimidating stagnancy. Figure 1 indicates the promisingly positive impacts of Volunpeer-ing on various critical aspects [2].

Figure 1: Impact of Peer-Reviewing through the Reviewer Recognition Platform ‘Volunpeer’
  • Expediting the process of review and making it less cumbersome and time‑consuming

The dichotomy of time versus quality lead many to attempt to address long and tiresome process of reviewing. Recently, The Journal of Bone & Joint Surgery (JBJS) has initiated below mentioned tiny steps to upgrade their overall peer-review process [3].

  • Automated and weekly reminder emails to editors
  • Weekly reminder emails for editor queue statistics
  • Monthly emails delineating acceptance rates and transfer rates by editor
  • Shortened deadlines for peer-reviewing
  • Addition of manuscript Xtract in Editorial Manager that reduces manual entry for basic data like manuscript title, author-names, abstract and affiliations
  • Refining the review process by spotting errors and maintaining quality standards of review

The quality of any manuscript proportions directly to the errors established during review and editing process. A keen study conducted on ‘Improving the peer-review process and editorial quality by studying key errors escaping the review and editorial process in top scientific journals [4]. Figure 1 shows the common trend of errors encountered during review.

Figure 1: Proportion and types of errors during review/editing process [4]

The recognition of these error-patterns led to the application of a novel mistake index, independent of the journal’s impact factor. Mistake Index Total (MIT) represented the fraction of corrections published by total number of items published in a year and Mistake Index Paper (MIP) represented the fraction of corrections published by the total number of papers (categorised by articles) published in a year. These were then statistically analysed and applied on scientific journals of diverse disciplines to determine the type, rate of occurrence and severity of errors encountered. It is hence recommended that a detailed guideline based upon MIT and MIP be provided to reviewers, authors and editors, which can help them minimise error redundancy, reduce time-to-correction and reinforce quality of published manuscripts [4].

  • Ensuring recruitment of competent reviewers and providing visibility, value and appreciation for their efforts by R-index

On a more humane level, getting good reviewers and providing visibility, value and appreciation for their efforts stays a huge contributing factor to optimising the quality and efficiency of peer-review. Lack of recognition of time and valuable expertise of the reviewer often is a big dampener for review quality. A simple yet cutting-edge R-index (Reviewer index), has emerged as an essential metric to quantify and credit a scientist’s contribution as a reviewer, regardless of his/her stage of career. Based on the list of reviewers for any particular journal, number of papers reviewed, total number of words against the journal’s impact factor, and eventually fostered by the editor’s feedback on individual review, a score ranging from 0 to 1 is credited to the reviewers. Widely being accepted and implemented, this index is open doors to a wider academic productivity and increased transparency within the scientific community and works reciprocally towards maintaining and enhancing the quality of reviewing [5].

Conclusion

With a fair share of recognition as well as criticism that it comes with, peer-review is undoubtedly an essential component of the publication world. Although an overall positive impact and effectiveness of peer review mechanism to improve upon quality in biomedical journals has been observed in clinical trial and other comparative study publications, it is still difficult to ascertain its tangible impact, considering the aforesaid challenges [7]. Nevertheless, the brighter side shows that the existing peer-review paradigm is inevitably treading towards innovations; profoundly embedded into the process of scientific progress, its indispensable purpose gives reasons enough to boost its operations and we hope to witness more streamlining, transparency, efficiency, robustness and inventive tableaus in its modus operandi.

Turacoz Healthcare Solutions aims to provide information on the latest trends, updates and advances to help researchers stay abreast of important innovations in peer-review in the field of scientific publications. Turacoz Healthcare provides an end-to-end support for scientific communications, clinical trial documents and disclosures, regulatory documents writing and submissions, and medico-marketing writing along with e-modules & e-books on healthcare and research.

Reference

  1. https://www.elsevier.com/en-in/reviewers/what-is-peer-review
  2. https://www.elsevier.com/connect/reviewers-update/innovation-in-peer-review-introducing-volunpeers
  3. https://www.csescienceeditor.org/article/new-innovations-in-peer-review/
  4. https://peerj.com/articles/1670/
  5. https://royalsocietypublishing.org/doi/full/10.1098/rsos.140540
  6. https://www.aje.com/arc/ethics-peer-review/
  7. https://www.bmj.com/content/349/bmj.g4145

Significance of Publication Planning

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Publication planning is that part of the pharmaceutical landscape that ensures that data from pharma companies (clinical trials, commentaries on drug/device class, and other publications supporting the efficacy of drug/device) is disseminated through medical journal articles–an important aspect of pharma companies’ overall marketing strategy. To publish a mix of editorials, primary and secondary publication, and review papers is the goal of efficient publication planning. Strategic publication planning can maximize product visibility throughout its life cycle. The launch of new drug/device in the market can be successful if the key clinical messages reach the target audience at the right time, for which publication planning is essential. The most successful drugs launched in the last 10-15 years have ridden on the back of a very well-implemented publication strategies. Overall, publication planning aids in the accurate reporting of scientific research, thereby promoting ethical transparency at every stage of medical research through the involvement of investigators, journal editors, and publication professionals.

An effective publication planning team is the key to an efficient publication plan. It is the publication planning team that creates a proactive plan to deliver client‑focused solutions and enable strategic planning and timely implementation of the publication plan. The first step in a publication plan is a “GAP analysis”, which can identify gaps in the literature. Thereafter, the team does an analysis of strengths, weaknesses, opportunities, and threats (SWOT) comprising product strengths, weaknesses, market opportunities, and market threats to understand which areas need maximum focus during implementation of the publication plan. For example, if the product in question has more safety issues compared to its competitors, then the publications would mostly be aimed to showcase that the safety concerns are unfounded. The publication planning team also analyzes the Health Economics and Outcomes Research (HEOR) related to the product and various competitors available in the market. In addition, it is the responsibility of the publication planning team to discuss issues related to authorship and data interpretation, and to ensure all the professionals involved in the publication process meet scientific and ethical standards. A good publication planner gets the best key opinion leaders (KOLs), study investigators, and a publication agency (if needed) to write the papers. This allows authors to concentrate only on scientific discussion, and not on logistical issues. Moreover, it encourages transparent communication between researchers and contributors.

There are also a few ethical issues that the publication planning team needs to deal with. These are shown in Figure 1.

Figure 1: Ethical issues relating to publication planning

Apart from ethical considerations the publication strategy team should know the audience; whether they intend to reach out to primary-care physicians, specialists, allied health specialists, managed care specialists, hospital pharmacists, retail pharmacists, formulary managers, and calibrate their publication plan accordingly. Based on this, they should select the journals for publication. Although publishing in a top-tier journals is prestigious, and adds substantially to a product’s first impression, it should be balanced against the length of time to publication. Prestige cannot make up for a publication that arrives too late. Early publication planning helps to ensure both goals are achieved. Finally, ensuring that a publication coincides with important meetings is an important part of efficient publication planning. This can ensure that the medical representatives at these scientific meetings have evidence to back their claims regarding the drugs/devices they are promoting.

With new guidelines such as GPP3 in place, there is an increased scrutiny on publication planning. Therefore, understanding good publication practices for providing structure and ethical implementation of the publication plan are important.

Turacoz Healthcare Solutions (THS), a medical communication company, offers services to healthcare professionals in clinical research, regulatory writing, medico marketing writing, publication writing and support for conducting medical advisory board meetings. Turacoz understands the importance of a good publication which is in line with the new GPP3 guidelines. We follow the same updated guidelines for all our publications and comply with all legal, ethical and regulatory requirements. To know more about our specialization, please do visit our services section.

Health Economics and Outcome Research

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Health economics and outcomes research (HEOR) activities comprise of Pharmacoeconomics (PE) research and health technology assessment (HTA) activities. Health economics (HE) is applied to analyze the economic aspects of health and healthcare, with focus on the costs and consequences of healthcare interventions.

PE, a sub-discipline of HE, provides a comparative value assessment between two pharmaceutical products or treatment mix. Outcome research (OR) helps in evaluating the effect of healthcare interventions on patient-related clinical, humanistic, and economic outcomes.

Thus, HEOR is a discipline that helps the stakeholders to fully understand the product value and its potential in real-world clinical practice. In healthcare industry, the stakeholders and payer rely on HEOR to gain market access and remain competitive. For this, pharmaceutical and medical technology manufactures provide clinical development information (i.e. efficacy, safety and quality) and economic evidences to guide decision makers regarding patient access to specific drugs and services. These evidences help in determining whether the treatment is effective in the populations they serve.

Sources of HEOR Evidence

To generate outcomes to monitor and evaluate healthcare services, we need to collect evidences from different sources which can be further used for decision-making processes. These evidences can be collected from different sources as shown in Figure 1:

Health Economics and Outcome Research 2

Figure 1: Sources of health economics and outcome research (HEOR) evidence

Need of HEOR Evidences

The HEOR evidences are helpful in identifying unmet needs and addressing evidence gaps. The real-world data can be used to determine primary randomized control trial (RCT) endpoints (e.g. laboratory test results) which is considered as the most relevant clinical outcomes for physicians and healthcare decision makers. These evidences also help in promoting the patient-centered research and helps in developing and evaluating the cost containment strategies.

Tools for HEOR

There are several approaches which can be applied to the collected evidences through which a meaningful outcome can be achieved. Below are some tools which are used to analyze data.

  • Exploratory Data Assessment
  • Epidemiology study
  • Cost-benefit Analysis (CBA)
  • Cost of Illness Analysis
  • Budget Impact Model (BIM)
  • Cost-effectiveness Analysis (CEA)
  • Satisfaction Assessment
  • HRQL Analysis
  • Assessment of Analysis Compliance and Persistence
  • Market Assessment
  • Pricing Strategy

Types of Outcomes

Generally, the outcomes are of three types namely, clinical outcomes, economic outcomes and humanistic outcomes.

Health Economics and Outcome Research-2Today there is increased emphasis on HEOR activities due to the growing power of payers in the healthcare decision-making. This has led to HEOR professionals covering all aspects of drug development to ensure they have the right data and analysis. This growing importance of HEOR is reflected in the phenomenal increase in the field-based HEOR professionals employed by the pharma companies.

Turacoz Healthcare Solution (THS) aim to deliver the best quality and guideline compliant documents to the pharma and different sectors of healthcare industry. We are dedicated in providing scientific/medical writing support to the industry and academia. With expertise in several clinical trial related documents like Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs) Prescribing Information (PI), and Common Technical Documents (CTDs). We also provide services for health economics and outcome research.

Transparency in Scholarly Publishing

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A research publication is considered as the highest-level medium of dissemination of research findings. Scholarly publications play an important role in disseminating findings, thoughts, and analysis to the scientific, academic, and lay communities. Transparency is an ethic that strengthens the credibility and integrity of research work as well as bonding among the scholarly communities. Due to frequent questioning on research credibility, pressure for open access by governments, and high incidences of research frauds, it has become important to form and follow the principles of transparency.

Principles of Transparency

The Committee on Publication Ethics (COPE), the Directory of Open Access Journals (DOAJ), the Open Access Scholarly Publishers Association (OASPA), and the World Association of Medical Editors (WAME) together have structured the principles of transparency, discuss all aspects of publication ethics and formulate the best practices to overcome any issue in this regard. The various principles of transparency and best practice in scholarly publishing are described as under:

These principle also help in differentiating the legitimate journals and publishers from the non-legitimate ones.

As per transparency, the scholars should give an access to the research data and methods employed for deriving the conclusion. The data production methods should be shared in a much wider platform. If scholar’s research is based on another researcher’s data, he or she should always cite their data clearly. The rules of data confidentiality, wherever applicable should be followed ethically.

Both the perspectives of transparency, viz. transparency in policy context and transparency in research process should be followed to make the scholarly publishing stronger and more reliable.

Publication plan carrying complete information about all types of publications or articles to be formed from the research or clinical studies also contributes towards ethical practice. A proper and firm publication planning can help researchers follow appropriate publishing practices, in time publication of research and hence, increased transparency.

Turacoz Healthcare Solutions (THS) provides end-to-end medical publication writing support including scholarly or academic publication, research publication, manuscripts, slide deck as well as regulatory writing support for clinical trials which includes Prescribing Information (PI), Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Clinical Evaluation Reposts (CERs) and Common Technical Documents (CTDs). Our documents are guideline compliant and are as per the current pharma and the healthcare standards. We aim to extend our services to different domains of the industry around the globe.

Graphical Abstract

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What is graphical abstract?

Graphical abstract is a concise and visual/pictorial summary of the main findings of any publication manuscript. It helps readers to understand the findings of a manuscript in a better way and in a simplified manner. They are not replacements of traditional textual abstracts instead are an addition to them.

Why Graphical Abstract?

Graphical abstract should not be considered as a burden or waste of time by the authors. Therefore, it is necessary for them to understand the rationale behind the use of graphical abstract. Graphical abstract is a well-suited platform to share or disseminate the research via social media in today’s time and help attract the readers to encourage them to further read the article. Graphical abstract can help reader to quickly get the take-home message.

Hullan et al. analyzed 54 graphical abstracts and outlined the common patterns of graphical abstract designs observed in published literature. They include:

  1. Process illustrations: The most common layout presenting the processes “using (hand‑crafted) illustrations on a linear or forking layout”.
  2. Result representation: Data visualizations in the form of line charts to depict research results was used by numerous graphical abstracts.
  3. Parallel layouts: These graphical abstracts include “parallel pictures laid out horizontally on the graphical abstract plane”.

Recently, the use of graphical abstract is gaining momentum. A recent study by Pferschy‑Wenzig et al. compared the visibility of manuscripts published with graphical abstracts with that of publications without the one in the journal ‘Molecules’. The study found that the manuscripts published without graphical abstract had significantly higher abstract views, PDF downloads, and total citations. However, this study included the comparison of research from a limited timeframe and also focused on one journal. Future research on other journals comparing research from longer time periods is warranted.

Some tips for designing a graphical abstract

  1. Always refer to the journals guidelines to check specifications for graphical abstracts. For example; Elsevier has the specifications on image size, font, file type
  2. Refer to the examples of graphical abstract from the publisher and see the one to which the new study matches and design it accordingly. Elsevier has enlisted 16 good examples of graphical abstracts for articles published in their journals
  3. Keep it simple and to one image only
  4. Focus on the design and composition
  5. Stay away from using saturated distracting colors for the abstract
  6. Graphical abstract should present the results of the study rather than the method used to obtain the results or the referenced literature, unless necessary
  7. Must be self-explanatory
  8. Must include keywords in the image
  9. Microsoft paint, Microsoft PowerPoint, adobe illustrator, ChenDraw, Coreldraw can be used to design graphical abstract. Several software available online can also be used, such as Mind the Graph, Inkscape etc.
  10. You can also refer to agencies offering services for graphical abstract designing

Turacoz Healthcare Solutions (THS) is a medical writing agency with specialized medical writing and editing services of Publication writing, Regulatory writing, and Medico-marketing document for the pharma industry. This blog aims to spread awareness about the increasing use of graphical abstracts in publications and its role in disseminating the published research information to a wide audience via online media.